post-title portfolio-title Paroxetine Hydrochloride Tablets USP 30mg Taj Pharma 2020-01-20 10:50:18 no no

Paroxetine Hydrochloride Tablets USP 30mg Taj Pharma

  1. Name of the medicinal product

Paroxetine Hydrochloride Tablets USP 10mg Taj Pharma
Paroxetine Hydrochloride Tablets USP 20mg Taj Pharma
Paroxetine Hydrochloride Tablets USP 30mg Taj Pharma
Paroxetine Hydrochloride Tablets USP 40mg Taj Pharma

  1. Qualitative and quantitative composition

a) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ? ? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

b) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ? 20mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

c) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ? ?30mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

d) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ?40mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ?q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Film coated tablet.

  1. Clinical particulars

4.1 Therapeutic indications

Treatment of:

  • Major Depressive Episode
  • Obsessive Compulsive Disorder
  • Panic Disorder with and without agoraphobia
  • Social Anxiety Disorders / Social phobia
  • Generalised Anxiety Disorder
  • Post ? traumatic Stress Disorder

4.2 Posology and method of administration

Posology

MAJOR DEPRESSIVE EPISODE

The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy.

As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response.

Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.

OBSESSIVE COMPULSIVE DISORDER

The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg / day.

Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see section 5.1 Pharmacodynamic properties).

PANIC DISORDER

The recommended dose is 40 mg daily. Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient’s response up to the recommended dose. A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology, which is generally recognised to occur early in the treatment of this disorder. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day.

Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see section 5.1 Pharmacodynamic properties).

SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA

The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties).

GENERALISED ANXIETY DISORDER

The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties).

POST-TRAUMATIC STRESS DISORDER

The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg / day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties).

GENERAL INFORMATION

WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE:

Abrupt discontinuation should be avoided (see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects). The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Special Populations:

  • Older people

Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects. Dosing should commence at the adult starting dose. Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily.

  • Children and adolescents (7?17 years)

Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility. In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects).

  • Children aged below 7 years

The use of paroxetine has not been studied in children less than 7 years. Paroxetine should not be used, as long as safety and efficacy in this age group have not been established.

  • Renal/Hepatic Impairment

Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 ml/minute) or in those with hepatic impairment. Therefore, dosage should be restricted to the lower end of the dosage range.

Method of administration

It is recommended that paroxetine is administered once daily in the morning with food.

The tablet should be swallowed rather than chewed. Shake bottle before use.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). In exceptional circumstances, linezolid (an antibiotic which is a reversible non-selective MAOI) can be given in combination with paroxetine provided that there are facilities for close observation of symptoms of serotonin syndrome and monitoring of blood pressure (see section 4.5).

Treatment with paroxetine can be initiated:

  • two weeks after discontinuation of an irreversible MAOI, or
  • at least 24 hours after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid, methylthioninium chloride (methylene blue; a preoperative visualising agent which is a reversible non-selective MAOI)).

At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI.

Paroxetine should not be used in combination with thioridazine, because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see section 4.5 Interactions with other medicinal products and other forms of interaction). Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.

Paroxetine should not be used in combination with pimozide (see section 4.5 Interactions with other medicinal products and other forms of interaction).

4.4 Special warnings and precautions for use

Treatment with paroxetine should be initiated cautiously two weeks after terminating treatment with an irreversible MAOI or 24 hours after terminating treatment with a reversible MAO inhibitor. Dosage of paroxetine should be increased gradually until an optimal response is reached (see section 4.3 Contraindications and section 4.5 Interactions with other medicinal products and other forms of interaction).

Paediatric population

Use in Children and Adolescents under 18 years of age

Paroxetine should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which paroxetine is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old (see also section 5.1).

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Akathisia/psychomotor restlessness

The use of paroxetine has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.

Serotonin Syndrome/Neuroleptic Malignant Syndrome

On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome?like events may occur in association with treatment of paroxetine, particularly when given in combination with other serotonergic and/or neuroleptic drugs. As these syndromes may result in potentially life-threatening conditions, treatment with paroxetine should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated. Paroxetine should not be used in combination with serotonin?precursors (such as L?tryptophan, oxitriptan) due to the risk of serotonergic syndrome.

(See Sections 4.3 Contraindications and 4.5 Interactions with other medicinal products and other forms of interaction).

Mania

As with all antidepressants, paroxetine should be used with caution in patients with a history of mania. Paroxetine should be discontinued in any patient entering a manic phase.

Renal/hepatic Impairment

Caution is recommended in patients with severe renal impairment or in those with hepatic impairment. (See section 4.2 Posology and Method of Administration).

Diabetes

In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. Additionally, there have been studies suggesting that an increase in blood glucose levels may occur when paroxetine and pravastatin are co-administered (see section 4.5).

Epilepsy

As with other antidepressants, paroxetine should be used with caution in patients with epilepsy.

Seizures

Overall the incidence of seizures is less than 0.1% in patients treated with paroxetine. The drug should be discontinued in any patient who develops seizures.

Electroconvulsive therapy (ECT)

There is little clinical experience of the concurrent administration of paroxetine with ECT.

Glaucoma

As with other SSRIs, paroxetine can cause mydriasis and should be used with caution in patients with narrow angle glaucoma or history of glaucoma.

Cardiac Conditions

The usual precautions should be observed in patients with cardiac conditions.

Hyponatraemia

Hyponatraemia has been reported rarely, predominantly in the elderly. Caution should also be exercised in those patients at risk of hyponatraemia e.g. from concomitant medications and cirrhosis. The hyponatraemia generally reverses on discontinuation of paroxetine.

Haemorrhage

There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs. Other haemorrhagic manifestations e.g. gastrointestinal and gynaecologicalhaemorrhage have been reported. Elderly patients may be at an increased risk for non-menses related events of bleeding.

Caution is advised in patients taking SSRIs concomitantly with oral anticoagulants, drugs known to affect platelet function or other drugs that may increase risk of bleeding (e.g. atypical antipsychotics such as clozapine, phenothiazines, most TCAs, acetylsalicylic acid, NSAIDs, COX?2 inhibitors) as well as in patients with a history of bleeding disorders or conditions which may predispose to bleeding (see section 4.8).

Interaction with tamoxifen

Paroxetine, a potent inhibitor of CYP2D6, may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, paroxetine should whenever possible be avoided during tamoxifen treatment (see section 4.5).

Drugs affecting gastric pH

In patients receiving oral suspension, the paroxetine plasma concentration may be influenced by gastric pH. In vitro data have shown that an acidic environment is required for release of the active drug from the suspension, hence absorption may be reduced in patients with a high gastric pH or achlorhydria, such as after the use of certain drugs (antacid drugs, histamine H2-receptor antagonists, proton pump inhibitors), in certain disease states (e.g. atrophic gastritis, pernicious anemia, chronic Helicobacter pylori infection), and after surgery (vagotomy, gastrectomy). The pH dependency should be taken into account when changing paroxetine formulation (e.g. the plasma paroxetine concentration may decrease after changing from tablet to oral suspension in patients with a high gastric pH). Caution is therefore recommended in patients when initiating or ending treatment with drugs increasing gastric pH. Dose adjustments may be necessary in such situations.

Withdrawal symptoms seen on discontinuation of paroxetine treatment

Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects). In clinical trials adverse events seen on treatment discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo. The occurrence of withdrawal symptoms is not the same as the drug being addictive or dependence producing.

The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.

Dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances have been reported. Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally these symptoms are self?limiting and usually resolve within two weeks, though in some individuals they may be prolonged (two-three months or more). It is therefore advised that paroxetine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient’s needs (see ?Withdrawal Symptoms Seen on Discontinuation of Paroxetine?, Section 4.2 Posology and method of administration).

4.5 Interaction with other medicinal products and other forms of interaction

Serotonergic drugs

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome: see Section 4.4 Special warnings and precautions for use). Caution should be advised and a closer clinical monitoring is required when serotonergic drugs (such as L-tryptophan, triptans, tramadol, linezolid, methylthioninium chloride (methylene blue)), SSRIs, lithium, pethidine and St. John’s Wort ??Hypericumperforatum?? preparations) are combined with paroxetine. Caution is also advised with fentanyl used in general anaesthesia or in the treatment of chronic pain. Concomitant use of paroxetine and MAOIs is contraindicated because of the risk of serotonin syndrome (see Section 4.3 Contraindications).

Pimozide

Increased pimozide levels of on average 2.5 times have been demonstrated in a study of a single low dose pimozide (2 mg) when co-administered with 60 mg paroxetine. This may be explained by the known CYP2D6 inhibitory properties of paroxetine. Due to the narrow therapeutic index of pimozide and its known ability to prolong QT interval, concomitant use of pimozide and paroxetine is contraindicated (see Section 4.3 Contraindications).

Drug metabolising enzymes

The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug metabolising enzymes.

When paroxetine is to be co?administered with a known drug metabolising enzyme inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.

No initial dosage adjustment is considered necessary when the drug is to be co?administered with known drug metabolising enzyme inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin) or with fosamprenavir/ritonavir. Any paroxetine dosage adjustment (either after initiation or following discontinuation of an enzyme inducer) should be guided by clinical effect (tolerability and efficacy).

Neuromuscular Blockers

SSRIs may reduce plasma cholinesterase activity resulting in a prolongation of the neuromuscular blocking action of mivacurium and suxamethonium

Fosamprenavir/ritonavir:?Co-administration of fosamprenavir/ritonavir 700/100 mg twice daily with paroxetine 20 mg daily in healthy volunteers for 10 days significantly decreased plasma levels of paroxetine by approximately 55%. The plasma levels of fosamprenavir/ritonavir during co-administration of paroxetine were similar to reference values of other studies, indicating that paroxetine had no significant effect on metabolism of fosamprenavir/ritonavir. There are no data available about the effects of long-term co-administration of paroxetine and fosamprenavir/ritonavir exceeding 10 days.

Procyclidine:?Daily administration of paroxetine increases significantly the plasma levels of procyclidine. If anti?cholinergic effects are seen, the dose of procyclidine should be reduced.

Anticonvulsants:?carbamazepine, phenytoin, sodium valproate: Concomitant administration does not seem to show any effect on pharmacokinetic/dynamic profile in epileptic patients.

CYP2D6 inhibitory potency of paroxetine:

As with other antidepressants, including other SSRIs, paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme. These include certain tricyclic antidepressants (e.g. clomipramine, nortriptyline, and desipramine), phenothiazine neuroleptics (e.g. perphenazine and thioridazine, see section 4.3 Contraindications), risperidone, atomoxetine, certain Type 1c antiarrhythmics (e.g. propafenone and flecainide) and metoprolol. It is not recommended to use paroxetine in combination with metoprolol when given in cardiac insufficiency, because of the narrow therapeutic index of metoprolol in this indication.

Pharmacokinetic interaction between CYP2D6 inhibitors and tamoxifen, showing a 65-75% reduction in plasma levels of one of the more active forms of tamoxifen, i.e.endoxifen, has been reported in the literature. Reduced efficacy of tamoxifen has been reported with concomitant usage of some SSRI antidepressants in some studies. As a reduced effect of tamoxifen cannot be excluded, co-administration with potent CYP2D6 inhibitors (including paroxetine) should whenever possible be avoided (see section 4.4).

Alcohol

As with other psychotropic drugs patients should be advised to avoid alcohol use while taking paroxetine.

Oral anticoagulants

A pharmacodynamic interaction between paroxetine and oral anticoagulants may occur. Concomitant use of paroxetine and oral anticoagulants can lead to an increased anticoagulant activity and haemorrhagicrisk. Therefore, paroxetine should be used with caution in patients who are treated with oral anticoagulants (see section 4.4 Special warnings and precautions for use).

NSAIDs and acetylsalicylic acid, and other antiplatelet agents

A pharmacodynamic interaction between paroxetine and NSAIDs/acetylsalicylic acid may occur. Concomitant use of paroxetine and NSAIDs/acetylsalicylic acid can lead to an increased haemorrhagic risk (see section 4.4 Special warnings and precautions for use).

Caution is advised in patients taking SSRIs concomitantly with oral anticoagulants, drugs known to affect platelet function or increase risk of bleeding (e.g. atypical antipsychotics such as clozapine, phenothiazines, most TCAs, acetylsalicylic acid, NSAIDs, COX?2 inhibitors) as well as in patients with a history of bleeding disorders or conditions that may predispose to bleeding.

Pravastatin

An interaction between paroxetine and pravastatin has been observed in studies suggesting that co-administration of paroxetine and pravastatin may lead to an increase in blood glucose levels. Patients with diabetes mellitus receiving both paroxetine and pravastatin may require dosage adjustment of oral hypoglycaemic agents and/or insulin (see section 4.4).

Drugs affecting gastric pH

In vitro data have shown that dissociation of paroxetine from the oral suspension is pH-dependant. Therefore, drugs that alter gastric pH (such as antacid drugs, proton pump inhibitors or histamine H2-receptor antagonists) may affect plasma paroxetine concentrations in patients taking the oral suspension (see section 4.4).

4.6 Fertility, pregnancy and lactation

Pregnancy

Some epidemiological studies suggest an increased risk of congenital malformations, particularly cardiovascular (e.g. ventricular and atrial septum defects), associated with the use of paroxetine during the first trimester. The mechanism is unknown. The data suggest that the risk of having an infant with a cardiovascular defect following maternal paroxetine exposure is less than 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population.

Paroxetine should only be used during pregnancy when strictly indicated. The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant. Abrupt discontinuation should be avoided during pregnancy (see ?Withdrawal Symptoms Seen on Discontinuation of Paroxetine?, section 4.2 Posology and method of administration).

Neonates should be observed if maternal use of paroxetine continues into the later stages of pregnancy, particularly the third trimester.

The following symptoms may occur in the neonate after maternal paroxetine use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping. These symptoms could be due to either serotonergic effects or withdrawal symptoms. In a majority of instances the complications begin immediately or soon (< 24 hours) after delivery.

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may have an increased risk of persistent pulmonary hypertension of the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population one to two cases of PPHN per 1000 pregnancies occur.

Animal studies showed reproductive toxicity, but did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Section 5.3 Preclinical Safety Data).

Breast-feeding

Small amounts of paroxetine are excreted into breast milk. In published studies, serum concentrations in breast?fed infants were undetectable (< 2 nanogram/ml) or very low (< 4 nanogram/ml) and no signs of drug effects were observed in these infants. Since no effects are anticipated, breast-feeding can be considered.

Fertility

Animal data have shown that paroxetine may affect sperm quality (see section 5.3).?In vitro?data with human material may suggest some effect on sperm quality; however, human case reports with some SSRIs (including paroxetine) have shown that an effect on sperm quality appears to be reversible.

Impact on human fertility has not been observed so far.

4.7 Effects on ability to drive and use machines

Clinical experience has shown that therapy with paroxetine is not associated with impairment of cognitive or psychomotor function. However, as with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.

Although paroxetine does not increase the mental and motor skill impairments caused by alcohol, the concomitant use of paroxetine and alcohol is not advised.

4.8 Undesirable effects

Some of the adverse drug reactions listed below may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy. Adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as:

very common (? 1/10), common (? 1/100, <1/10), uncommon (? 1/1,000, <1/100), rare (? 1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.

Blood and lymphatic system disorders

Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (including ecchymosis and gynaecological bleeding).

Very rare: thrombocytopenia.

Immune system disorders

Very rare: allergic reactions (including anaphylactoid reactions and angioedema).

Endocrine disorders

Very rare: syndrome of inappropriate anti?diuretic hormone secretion (SIADH).

Metabolism and nutrition disorders

Common: increases in cholesterol levels, decreased appetite.

Uncommon: altered glycaemic control has been reported in diabetic patients (see section 4.4).]

Rare: hyponatraemia.

Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti?diuretic hormone secretion (SIADH).

Psychiatric disorders

Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares).

Uncommon: confusion, hallucinations.

Rare: manic reactions, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4).

Frequency not known: suicidal ideation, suicidal behavior and aggression..

Cases of suicidal ideation and suicidal behaviour have been reported during paroxetine therapy or early after treatment discontinuation (see section 4.4).

Cases of aggression were observed in post marketing experience.

These symptoms may also be due to the underlying disease.

Nervous system disorders

Common: dizziness, tremor, headache, concentration impaired.

Uncommon: extrapyramidal disorders.

Rare: convulsions, restless legs syndrome (RLS).

Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).

Reports of extrapyramidal disorder including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication.

Eye disorders

Common: blurred vision.

Uncommon: mydriasis (see section 4.4 Special warnings and precautions for use).

Very rare: acute glaucoma.

Ear and labyrinth disorders

Frequency not known: tinnitus.

Cardiac disorders

Uncommon: sinus tachycardia.

Rare: bradycardia.

Vascular disorders

Uncommon: transient increases or decreases of blood pressure, postural hypotension.

Transient increases or decreases in blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.

Respiratory, thoracic and mediastinal disorders

Common: yawning.

Gastrointestinal disorders

Very common: nausea.

Common: constipation, diarrhoea, vomiting, dry mouth.

Very rare: gastrointestinal bleeding.

Hepato?biliary disorders

Rare: elevation of hepatic enzymes.

Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure).

Elevation of hepatic enzymes have been reported. Post-marketing reports of hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure) have also been received very rarely. Discontinuation of paroxetine should be considered if there is prolonged elevation of liver function test results.

Skin and subcutaneous tissue disorders

Common: sweating.

Uncommon: skin rashes, pruritus.

Very rare: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity reactions.

Renal and urinary disorders

Uncommon: urinary retention, urinary incontinence.

Reproductive system and breast disorders

Very common: sexual dysfunction.

Rare:hyperprolactinaemia/galactorrhoea, menstrual disorders (including menorrhagia, metrorrhagia, amenorrhoea, menstruation delayed and menstruation irregular).

Very rare: priapism.

Musculoskeletal?and connective tissue?disorders

Rare: arthralgia, myalgia.

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown

General disorder and administration site conditions

Common: asthenia, body weight gain.

Very rare: peripheral oedema.

WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE TREATMENT

Common: dizziness, sensory disturbances, sleep disturbances, anxiety, headache.

Uncommon: agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhoea, irritability.

Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances have been reported.

Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and method of administration and section 4.4 Special warnings and precautions for use).

ADVERSE EVENTS FROM PAEDIATRIC CLINICAL TRIALS

The following adverse events were observed:

Increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.

Additional events that were seen are: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations), bleeding related adverse events, predominantly of the skin and mucous membranes.

Events seen after discontinuation/tapering of paroxetine are: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special warnings and precautions for use).

See section 5.1 for more information on paediatric clinical trials.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms and Signs

A wide margin of safety is evident from available overdose information on paroxetine.

Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8 “Undesirable effects”, fever and involuntary muscle contractions have been reported. Patients have generally recovered without serious sequelae even when doses of up to 2000 mg have been taken alone. Events such as coma or ECG changes have occasionally been reported and, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic drugs, with or without alcohol.

Treatment

No specific antidote is known.

The treatment should consist of those general measures employed in the management of overdose with any antidepressant.

Administration of 20-30 g activated charcoal may be considered if possible within a few hours after overdose intake to decrease absorption of paroxetine. Supportive care with frequent monitoring of vital signs and careful observation is indicated. Patient management should be as clinically indicated.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antidepressants ? selective serotonin reuptake inhibitors.

Mechanism of Action

Paroxetine is a potent and selective inhibitor of 5?hydroxytryptamine (5?HT, serotonin) uptake and its antidepressant action and effectiveness in the treatment of OCD, Social Anxiety disorder / Social Phobia, General Anxiety Disorder, Post?Traumatic Stress Disorder and Panic Disorder is thought to be related to its specific inhibition of 5?HT uptake in brain neurones.

Paroxetine is chemically unrelated to the tricyclic, tetracyclic and other available antidepressants.

Paroxetine has low affinity for muscarinic cholinergic receptors and animal studies have indicated only weak anticholinergic properties.

In accordance with this selective action,?in vitro?studies have indicated that, in contrast to tricyclic antidepressants, paroxetine has little affinity for alpha1, alpha2 and beta?adrenoceptors, dopamine (D2), 5?HT1 like, 5?HT2 and histamine (H1) receptors. This lack of interaction with post?synaptic receptors?in vitro?is substantiated by?in vivo?studies which demonstrate lack of CNS depressant and hypotensive properties.

Pharmacodynamic Effects

Paroxetine does not impair psychomotor function and does not potentiate the depressant effects of ethanol.

As with other selective 5?HT uptake inhibitors, paroxetine causes symptoms of excessive 5?HT receptor stimulation when administered to animals previously given monoamine oxidase (MAO) inhibitors or tryptophan.

Behavioural and EEG studies indicate that paroxetine is weakly activating at doses generally above those required to inhibit 5?HT uptake. The activating properties are not ?amphetamine?like? in nature.

Animal studies indicate that paroxetine is well tolerated by the cardiovascular system. Paroxetine produces no clinically significant changes in blood pressure, heart rate and ECG after administration to healthy subjects.

Studies indicate that, in contrast to antidepressants which inhibit the uptake of noradrenaline, paroxetine has a much reduced propensity to inhibit the antihypertensive effects of guanethidine.

In the treatment of depressive disorders, paroxetine exhibits comparable efficacy to standard antidepressants.

There is also some evidence that paroxetine may be of therapeutic value in patients who have failed to respond to standard therapy.

Morning dosing with paroxetine does not have any detrimental effect on either the quality or duration of sleep. Moreover, patients are likely to experience improved sleep as they respond to paroxetine therapy.

Adult suicidality analysis

A paroxetine-specific analysis of placebo controlled trials of adults with psychiatric disorders showed a higher frequency of suicidal behaviour in young adults (aged 18-24 years) treated with paroxetine compared with placebo (2.19% vs 0.92%). In the older age groups, no such increase was observed. In adults with major depressive disorder (all ages), there was an increase in the frequency of suicidal behaviour in patients treated with paroxetine compared with placebo (0.32% vs 0.05%); all of the events were suicide attempts. However, the majority of these attempts for paroxetine (8 of 11) were in younger adults (see also section 4.4).

Dose response

In the fixed dose studies there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses. However, there are some clinical data suggesting that up-titrating the dose might be beneficial for some patients.

Long-term efficacy

The long-term efficacy of paroxetine in depression has been demonstrated in a 52 week maintenance study with relapse prevention design: 12% of patients receiving paroxetine (20 ?40 mg daily) relapsed, versus 28% of patients on placebo.

The long-term efficacy of paroxetine in treating obsessive compulsive disorder has been examined in three 24 week maintenance studies with relapse prevention design. One of the three studies achieved a significant difference in the proportion of relapsers between paroxetine (38%) compared to placebo (59%).

The long-term efficacy of paroxetine in treating panic disorder has been demonstrated in a 24 week maintenance study with relapse prevention design: 5% of patients receiving paroxetine (10-40 mg daily) relapsed, versus 30% of patients on placebo. This was supported by a 36 week maintenance study.

The long-term efficacy of paroxetine in treating social anxiety disorder and generalised anxiety disorder and Post-Traumatic Stress Disorderhas not been sufficiently demonstrated.

Adverse Events from Paediatric Clinical Trials

In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age. Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations).

In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special warnings and precautions for use).

In five parallel group studies with a duration of eight weeks up to eight months of treatment, bleeding related adverse events, predominantly of the skin and mucous membranes, were observed in paroxetine treated patients at a frequency of 1.74% compared to 0.74% observed in placebo treated patients.

5.2 Pharmacokinetic properties

Absorption

Paroxetine is well absorbed after oral dosing and undergoes first-pass metabolism. Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that absorbed from the gastrointestinal tract. Partial saturation of the first-pass effect and reduced plasma clearance occur as the body burden increases with higher single doses or on multiple dosing. This results in disproportionate increases in plasma concentrations of paroxetine and hence pharmacokinetic parameters are not constant, resulting in non?linear kinetics. However, the non-linearity is generally small and is confined to those subjects who achieve low plasma levels at low doses.

Steady state systemic levels are attained by 7 to 14 days after starting treatment with immediate or controlled release formulations and pharmacokinetics do not appear to change during long term therapy.

Distribution

Paroxetine is extensively distributed into tissues and pharmacokinetic calculations indicate that only 1% of the paroxetine in the body resides in the plasma.

Approximately 95% of the paroxetine present is protein bound at therapeutic concentrations.

No correlation has been found between paroxetine plasma concentrations and clinical effect (adverse experiences and efficacy).

Biotransformation

The principal metabolites of paroxetine are polar and conjugated products of oxidation and methylation which are readily cleared. In view of their relative lack of pharmacological activity, it is most unlikely that they contribute to paroxetine’s therapeutic effects.

Metabolism does not compromise paroxetine’s selective action on neuronal 5?HT uptake.

Elimination

Urinary excretion of unchanged paroxetine is generally less than 2% of dose whilst that of metabolites is about 64% of dose. About 36% of the dose is excreted in faeces, probably via the bile, of which unchanged paroxetine represents less than 1% of the dose. Thus paroxetine is eliminated almost entirely by metabolism.

Metabolite excretion is biphasic, being initially a result of first?pass metabolism and subsequently controlled by systemic elimination of paroxetine.

The elimination half-life is variable but is generally about one day.

Special Patient Populations

Older people

Renal/Hepatic Impairment

Increased plasma concentrations of paroxetine occur in elderly subjects and in those subjects with severe renal impairment or in those with hepatic impairment, but the range of plasma concentrations overlaps that of healthy adult subjects.

5.3 Preclinical safety data

Toxicology studies have been conducted in rhesus monkeys and albino rats; in both, the metabolic pathway is similar to that described for humans. As expected with lipophilic amines, including tricyclic antidepressants, phospholipidosis was detected in rats. Phospholipidosis was not observed in primate studies of up to one-year duration at doses that were six times higher than the recommended range of clinical doses.

Carcinogenesis: In two-year studies conducted in mice and rats, paroxetine had no tumorigenic effect.

Genotoxicity: Genotoxicity was not observed in a battery of?in vitro?and?in vivo?tests.

Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility by reducing fertility index and pregnancy rate. In rats, increased pup mortality and delayed ossification were observed. The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate.

  1. Pharmaceutical particulars

6.1 List of excipients

Cellulose microcrystalline, Calcium hydrogen phosphate dehydrate, Croscarmellose sodium, Silica colloidal anhydrous, Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blisters packs containing 7, 14, 28, 30, 50, 100 and 500 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of ?Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail:?tajgroup@tajpharma.com

Paroxetine Hydrochloride Tablets USP 10mg, 20mg, 30mg, 40mg Taj Pharma
(Paroxetine)

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Paroxetine is and what it is used for
  2. What you need to know before you take Paroxetine
  3. How to take Paroxetine
  4. Possible side effects
  5. How to store Paroxetine
  6. Contents of the pack and other information

 

  1. What Paroxetine is and what it is used for

?

Paroxetine is a treatment for adults with depression (major depressive episode) and/or anxiety disorders. The anxiety disorders that paroxetine is used to treat are: obsessive compulsive disorder(repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or

avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event) and generalised anxiety disorder (generally feeling very anxious or nervous).

Paroxetine belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how paroxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you get better.

  1. What you need to know before you take Paroxetine

Do not take Paroxetine:

  • If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
  • If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide, linezolid and methylthioninium chloride (methylene blue)), or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking paroxetine once you have stopped taking the MAOI.
  • If you are taking anti-psychotic medicines called thioridazine or pimozide.

If any of these apply to you, tell your doctor and do not take Paroxetine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking paroxetine

  • if you have problems with your kidneys or liver or if you have heart trouble
  • if you have epilepsy or have a history of fits or seizures
  • if you have ever had episodes of mania (overactive behaviour or thoughts)
  • if you are having a treatment for severe depression called electro convulsive therapy (ECT)
  • if you are diabetic
  • if you have low levels of sodium in your blood
  • if you have glaucoma (high pressure in the eye)
  • if you are taking tamoxifen to treat breast cancer or fertility problems. Paroxetine may make tamoxifen less effective, so your doctor may recommend you take another antidepressant
  • if you have a history of bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, such as clomipramine, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
  • if you under 18 years old (see ?Children and adolescents under 18?).

Please check with your doctor if any of the above apply to you or you are not sure.

Children and adolescents under 18

Paroxetine film-coated tablets should not be used for children and adolescents under 18 years.Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe paroxetine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed paroxetine for you (or your child) and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the conditions listed above develop or worsen when you (or your child) are taking paroxetine. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of this age group have not yet been demonstrated.

In studies in children under 18 years old some patients had withdrawal effects when they stopped taking paroxetine. These effects were mostly similar to those seen in adults after stopping paroxetine (see section 3, ?How to take Paroxetine?).

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

  • If you have previously had thoughts about killing or harming yourself.
  • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to ahospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxietydisorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Please discuss these things with your doctor if you have any concerns.

Important side effects seen with Paroxetine film-coated tablets

Some patients who take paroxetine develop akathisia, where they feel restless and feel like they can?tsit or stand still. Other patients develop serotonin syndrome, where they have some or all of thefollowing symptoms: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of paroxetine, see section 4, ?Possible Side Effects?.

Other medicines and Paroxetine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can affect the way paroxetine works, or make it more likely that you?ll have side effects. Paroxetine can also affect the way some other medicines work.

These include:

  • Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide to treat depression and methylthioninium chloride (methylene blue)) see ?Do not take paroxetine?, in this section
  • Thioridazine or pimozide (which are anti-psychotics, used to treat psychiatric conditions) see ?Do not take Paroxetine?, in this section
  • Aspirin (acetylsalicylic acid), ibuprofen or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) like celecoxib or rofecoxib, etodolac, diclofenac and meloxicam (used to treat pain and inflammation)
  • Medicines used to reduce the risk of blood clots forming (antiplatelets) such as clopidogrel
  • Pain killers e.g. tramadol, pethidine
  • Medicines called triptans e.g. sumatriptan (used to treat migraine)
  • Other medicines to treat depression including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline and desipramine
  • A dietary supplement called tryptophan
  • Medicines such as lithium, risperidone, perphenazine, clozapine (called anti-psychotics)
  • Fentanyl, which is used in general anaesthesia or to treat chronic pain
  • A combination of fosamprenavir and ritonavir (used to treat Human Immunodeficiency Virus(HIV) infection)
  • St John?s Wort (a herbal remedy for depression)
  • Phenobarbital, phenytoin or carbamazepine (used to treat fits or epilepsy)
  • Atomoxetine (to treat attention deficit hyperactivity disorder (ADHD))
  • Procyclidine (to relieve tremor, especially in Parkinson?s Disease)
  • Warfarin or other medicines (called anticoagulants) used to thin the blood
  • Medicines used to treat an irregular heartbeat such as propafenone and flecainide
  • Metoprolol, a beta-blocker (to treat high blood pressure and heart problems)
  • Pravastatin, used to treat high cholesterol
  • Rifampicin (to treat tuberculosis (TB) and leprosy)
  • Linezolid (an antibiotic used to treat infection)
  • Tamoxifen, which is used to treat breast cancer or fertility problems
  • Mivacurium or suxamethonium (medicines used to relax muscles)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Paroxetine with food and alcohol

Do not drink alcohol while you are taking paroxetine. Alcohol may make your symptoms or side effects worse. Taking paroxetine in the morning with food will reduce the likelihood of you feeling sick (nausea).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast -feeding, think you might be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine. Paroxetine is not recommendedduring pregnancy as it may cause harm to the baby. Your doctor may decide that it is better for you to change to another treatment or to gradually stop taking paroxetine while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking paroxetine.

Make sure your midwife and/or doctor know you are taking paroxetine. When taken duringpregnancy, particularly in the last 3 months of pregnancy, medicines like paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

Symptoms include:

  • trouble with breathing
  • a blue-ish skin or being too hot or cold
  • blue lips
  • vomiting or not feeding properly
  • being very tired, not able to sleep or crying a lot
  • stiff or floppy muscles
  • tremors, jitters or fits
  • exaggerated reflexes

If your baby has any of these symptoms when it is born, or you are concerned about your baby?s health, contact your doctor or midwife who will be able to advise you.

Paroxetine may pass into breast milk in very small amounts. If you are taking paroxetine, talk toyour doctor before you start breast-feeding.

Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

Possible side effects of paroxetine include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not drive or use machinery.

  1. How to take Paroxetine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

 

The recommended doses for different conditions are set out in the table below.

 

Starting dose Recommended daily Maximum daily
dose dose
Depression 20 mg 20 mg 50 mg
Obsessive Compulsive Disorder 20 mg 40 mg 60 mg
Panic Disorder 10 mg 40 mg 60 mg
Social Anxiety Disorder 20 mg 20 mg 50 mg
Post-Traumatic Stress Disorder 20 mg 20 mg 50 mg
Generalised Anxiety Disorder 20 mg 20 mg 50 mg

 

Your doctor will advise you what dose to take when you first start taking Paroxetine film -coated tablets. Most people start to feel better after a couple of weeks. If you don?t start to feel better afterthis time, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually, 10 mg at a time, up to a maximum daily dose.

Take your tablets in the morning with food. Do not chew the tablets but swallow them whole with a drink of water.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Your doctor will talk to you about how long you will need to keep taking your tablets. This may be for many months or even longer.

Use in older people

If you are elderly (over 65) the maximum dose you should take is 40 mg per day.

Use in children and adolescents

Children and adolescents under 18 years old should not usually take paroxetine, unless your doctorhas decided that taking this medicine is in their best interest.

Patients with liver or kidney disease

If you have trouble with your liver or severe kidney disease, your doctor may decide that you should have a lower dose of paroxetine than usual.

If you take more Paroxetine than you should

Never take more tablets than your doctor recommends. If you take too many tablets (or someone else does), tell your doctor or go to a hospital straight away. Show them the pack of tablets.

Someone who has taken an overdose of paroxetine may have any one of the symptoms listed in section 4, ?Possible side effects?, or the following symptoms: being sick, widening of the pupils, fever, headache, uncontrollable tightening of the muscles and increase in heart rate.

If you forget to take Paroxetine

Take your medicine at the same time every day.

If you do forget a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose. You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

What to do if you?re feeling no better

Paroxetine will not relieve your symptoms straight away ? all antidepressants take time to work. Some people will start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven?t started to feel better.

If you stop taking Paroxetine

Do not stop taking paroxetine until your doctor tells you to.

When stopping paroxetine, your doctor will help you to reduce your dose slowly over a number of weeks or months ? this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of paroxetine you take by 10 mg a week. Most people find that any symptoms on stopping paroxetine are mild and go away on their own within two weeks. For some people, these symptoms may be more severe, or go on for longer.

If you get withdrawal effects when you are coming off your tablets your doctor may decide that youshould come off them more slowly. If you get severe withdrawal effects when you stop taking paroxetine, please see your doctor. He or she may ask you to start taking your tablets again and then come off them more slowly.

If you do get withdrawal effects, you will still be able to stop paroxetine.

Possible withdrawal effects when stopping treatment

Studies show that 3 in 10 patients notice one or more symptoms on stopping paroxetine. Some withdrawal effects on stopping occur more frequently than others.

Common (may affect up to 1 in 10 people)

  • Feeling dizzy, unsteady or off-balance
  • Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, and buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus)
  • Sleep disturbances (vivid dreams, nightmares, inability to sleep)
  • Feeling anxious

Uncommon (may affect up to 1 in 100 people)

  • Feeling sick (nausea)
  • Sweating (including night sweats)
  • Feeling restless or agitated
  • Tremor (shakiness)
  • Feeling confused or disorientated
  • Diarrhoea (loose stools)
  • Feeling emotional or irritable
  • Visual disturbances
  • Fluttering or pounding heartbeat (palpitations).

Please see your doctor if you are worried about withdrawal effects when stopping paroxetine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are more likely to happen in the first few weeks of taking paroxetine.

If any of the following happen tell your doctor immediately or go to your nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

  • Unusual bruising or bleeding, including vomiting blood or passing blood in your stools
  • Being unable to pass water.

Rare (may affect up to 1 in 1,000 people)

  • Seizures (fits)
  • Restlessness and you feel like you can?t sit or stand still, you may have a serious condition called akathisia. Increasing your dose of paroxetine may make these feelings worse.

Tiredness, feeling weak or confused and have achy, stiff or uncoordinated muscles this may bebecause your blood is low in sodium.

Very rare (may affect up to 1 in 10,000 people)

  • Allergic reactions, which may be severe

If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing (shortness of breath) or swallowing and feel weak or lightheaded resulting in collapse or loss of consciousness

  • Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called erythema multiforme
  • A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
  • A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
  • Syndrome of inappropriate antidiuretic hormone production (SIADH) which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration, as a result of improper chemical signals. Patients with SIADH may become severely ill or may have no symptoms at all
  • If you have some or all of the following symptoms you may have a serious condition called serotonin syndrome: feel confused, restless, and suffer from sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat
  • Your eyes become painful and you develop blurred vision. This may be a sign of glaucoma
  • Your skin or whites of your eyes go yellow, which may be a sign of liver problems.

Not known (frequency cannot be estimated from the available data)

  • Have thoughts of harming or killing yourself. Suicidal behaviour has been reported during paroxetine therapy or early after treatment discontinuation.

Other possible side effects during treatment

Very common (may affect more than 1 in 10 people)

  • Feeling sick (nausea). Taking your medicine in the morning with food will reduce the chance of this happening
  • Change in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common (may affect up to 1 in 10 people)

  • Decreased appetite
  • Not sleeping well (insomnia) or feeling sleepy
  • Abnormal dreams (including nightmares)
  • Feeling dizzy or shaky (tremors)
  • Headache
  • Feeling agitated
  • Feeling unusually weak
  • Yawning, dry mouth
  • Diarrhoea or constipation
  • Weight gain
  • Sweating
  • Increases in cholesterol levels
  • Being sick (vomiting)
  • Unable to concentrate properly.

Uncommon (may affect up to 1 in 100 people)

  • A faster than normal heartbeat
  • A brief increase in blood pressure, or a brief decrease in blood pressure that may make you feel dizzy or faint when you stand up suddenly
  • Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
  • Dilated pupils
  • Uncontrollable, involuntary passing of urine (urinary incontinence)
  • If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking paroxetine. Please speak to your doctor about adjusting the dosage of your insulin or diabetes medications.

Rare (may affect up to 1 in 1,000 people)

  • Abnormal production of breast milk in men and women
  • A slow heartbeat
  • An increase of liver enzymes which can be seen in a blood test
  • Panic attacks
  • Overactive behaviour or thoughts (mania)
  • Feeling detached from yourself (depersonalisation)
  • Feeling anxious
  • Pain in the joints or muscles
  • Irresistible urge to move the legs (Restless legs syndrome)
  • Increase in a hormone called prolactin in the blood
  • Menstrual period disorders (including heavy or irregular periods, bleeding between periods and absence or delay of periods).

Very rare (may affect up to 1 in 10,000 people)

  • Fluid or water retention which may cause swelling of the arms or legs

Sensitivity to sunlight

  • Painful erection of the penis that won?t go away
  • Unexplained or unusual bleeding or bruising. These may be signs of having a low blood platelet count.

Not known (frequency cannot be estimated from the available data)

  • Aggression
  • Buzzing, hissing, whistling, ringing or persistent noise in the ears (Tinnitus).

An increased risk of bone fractures has been observed in patients taking this type of medicines.

In studies of paroxetine in under 18s, common side effects that affected less than 1 in 10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in mood). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of paroxetine, although these were seen less often.

In addition, patients under 18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. How to store Paroxetine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) which is stated on the bottle, blister or carton.

The expiry date refers to the last day of that month.

Do not store above 25?C.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Paroxetine film-coated tablets contain

a) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ? ? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

b) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ? 20mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

c) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ? ?30mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

d) Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine? ? ?40mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ?q.s
Colours: Indigo Carmine Lake & Titanium Dioxide BP

The other ingredients are:

Tablet core: Calcium hydrogen phosphate, colloidal anhydrous silica, sodium starch glycolate and magnesium stearate.

Tablet coat: Talc, titanium dioxide, and basic butylated methacrylate copolymer.

Contents of the pack

Blisters packs containing 7, 14, 28, 30, 50, 100 and 500 tablets.

Not all pack sizes may be marketed.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of ?Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail:?tajgroup@tajpharma.com

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