post-title portfolio-title Levocetirizine Dihydrochloride 10mg tablets Taj Pharma 2020-01-03 06:58:00 no no

Levocetirizine Dihydrochloride 10mg tablets Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Levocetirizine Dihydrochloride 10mg film-coated tablets

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:
Levocetirizine Dihydrochloride ???????????10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? q.s

  1. PHARMACEUTICAL FORM

Film-coated tablet.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Levocetirizine 10mg film-coated tablets are indicated in the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above.

4.2 Posology and method of administration

Posology

Adults and adolescents 12 years and above

The daily recommended dose is 10mg (one film-coated tablet).

Elderly:

Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below).

Renal impairment:The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

Dosing adjustments for patients with impaired renal function:

Group Creatinine clearance (ml/min) Dosage and frequency
Normal ? 80 1 tablet once daily
Mild 50 ? 79 1 tablet once daily
Moderate 30 ? 49 1 tablet once every 2 days
Severe < 30 1 tablet once every 3 days
End-stage renal disease ? Patients undergoing dialysis < 10 Contra-indicated

In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment.

Hepatic impairment

No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment adjustment of the dose is recommended (see Renal impairment above).

Paediatric population

Children aged 6 to 12 years:

The daily recommended dose is 10mg (one film-coated tablet).

For children aged 2 to 6 years no adjusted dosage is possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocetirizine.

Method of administration

The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake.

Duration of use

Intermittent allergic rhinitis (symptoms experienced for less than four days a week or for less than four weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms experienced for more than four days a week or for more than four weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens.

There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. In chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year.

4.3 Contraindications

Hypersensitivity to the active substance, to cetirizine, to hydroxyzine to any other piperazine or to any of the other excipients listed in section 6.1.

Severe renal impairment at less than 10 ml/min creatinine clearance.

4.4 Special warnings and precautions for use

Precaution is recommended with concurrent intake of alcohol (see section 4.5).

Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.

Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.

Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

Paediatric population

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric formulation of levocetirizine.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with antipyrine, pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.

In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40% while the disposition of ritonavir was slightly altered (-11%) further to concomitant cetirizine administration.

The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased.

In sensitive patients, the concurrent administration of cetirizine or levocetirizine and alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of levocetirizine in pregnant women. However, for cetirizine, the racemate of levocetirizine, a large amount of data (more than 1000 pregnancy outcomes) on pregnant women indicate no malformative or feto/ neonatal toxicity. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see section 5.3). The use of levocetirizine may be considered during pregnancy, if necessary.

Breast-feeding

Cetirizine, the racemate of levocetirizine, has been shown to be excreted in human. Therefore, the excretion of levocetirizine in human milk is likely. Adverse reactions associated with levocetirizine may be observed in breastfed infants. Therefore, caution should be exercised when prescribing levocetirizine to lactating women.

Fertility

For levocetirizine no clinical data are available.

4.7 Effects on ability to drive and use machines

Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive.

Nevertheless, some patients could experience somnolence, fatigue and asthenia under therapy with Levocetirizine. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to the medicinal product into account.

4.8 Undesirable effects

Clinical studies

Adults and adolescents above 12 years of age

In therapeutic studies in women and men aged 12 to 71 years, 15.1% of the patients in the levocetirizine 10mg group had at least one adverse drug reaction compared to 11.3% in the placebo group. 91.6 % of these adverse drug reactions were mild to moderate.

In therapeutic trials, the drop out rate due to adverse events was 1.0% (9/935) with levocetirizine 10mg and 1.8% (14/771) with placebo.

Clinical therapeutic trials with levocetirizine included 935 subjects exposed to the medicinal product at the recommended dose of 10mg daily. From this pooling, following incidence of adverse drug reactions were reported at rates of 1 % or greater (common: ?1/100 to <1/10) under levocetirizine 10mg or placebo:

Preferred Term

(WHOART)

Placebo

(n = 771)

Levocetirizine 5mg

(n = 935)

Headache 25 (3.2 %) 24 (2.6 %)
Somnolence 11 (1.4 %) 49 (5.2 %)
Mouth dry 12 (1.6 %) 24 (2.6 %)
Fatigue 9 (1.2 %) 23 (2.5 %)

Further uncommon incidences of adverse reactions (uncommon>1/1000 to<1/100) like asthenia or abdominal pain were observed.

The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1 %) under levocetirizine 10mg than under placebo (3.1%).

Paediatric population

In two placebo-controlled studies in paediatric patients aged 6-11 months and aged 1 year to less than 6 years, 159 subjects were exposed to levocetirizine at the dose of 1.210mg daily for 2 weeks and 1.210mg twice daily respectively. The following incidence of adverse drug reactions was reported at rates of 1% or greater under levocetirizine or placebo.

System Organ Class and Preferred Term Placebo (n = 83) Levocetirizine (n = 159)
Gastrointestinal Disorders
Diarrhoea 0 3 (1.9 %)
Vomiting 1 (1.2 %) 1 (0.6 %)
Constipation 0 2 (1.3 %)
Nervous System Disorder
Somnolence 2 (2.4 %) 3 (1.9 %)
Psychiatric Disorders
Sleep disorder 0 2 (1.3 %)

In children aged 6-12 years double blind placebo controlled studies were performed where 243 children were exposed to 10mg levoceirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported at rates of 1 % or greater under levocetirizine or placebo.

Preferred Term Placebo (n = 240) Levocetirizine (n = 243)
Headache 5 (2.1 %) 2 (0.8 %)
Somnolence 1 (0.4 %) 7 (2. 9 %)

Post-marketing experience

Adverse reactions from post-marketing experience are per System Organ Class and per frequency. The frequency is defined as follows: very common (?1/10); common (?1/100 to <1/10); uncommon (?1/1,000 to <1/100); rare (?1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

  • Immune system disorders:

Not known: hypersensitivity including anaphylaxis

  • Metabolism and nutrition disorders:

Not known: increased appetite

  • Psychiatric disorders:

Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare

  • Nervous system disorders:

Not known: convulsion, paraesthesia, dizziness, syncope, tremor, dysgueusia

  • Ear and labyrinth disorders:

Not known: Vertigo

  • Eyes disorders:

Not known: visual disturbances, blurred vision, oculogyration

  • Cardiac disorders:

Not known: palpitations, tachycardia

  • Respiratory, thoracic, and mediastinal disorders:

Not known: dyspnoea

  • Gastrointestinal disorders:

Not known: nausea, vomiting, diarrhoea

  • Hepatobiliary disorders:

Not known: hepatitis

  • Renal and urinary disorders:

Not known: dysuria, urinary retention

  • Skin and subcutaneous tissue disorders:

Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria

  • Musculoskeletal, connective tissues, and bone disorders:

Not known: myalgia, arthralgia

  • General disorders and administration site conditions:

Not known: oedema

  • Investigations:

Not known: weight increased, abnormal liver function tests

Description of selected adverse reactions

After levocetirizine discontinuation, pruritus has been reported.

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

Symptoms of overdose may include drowsiness in adults. In children, agitation and restlessness may initially occur, followed by drowsiness.

Management of overdoses

There is no known specific antidote to levocetirizine.

Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage may be considered shortly after ingestion of the drug.

Levocetirizine is not effectively removed by haemodialysis.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamine for systemic use, piperazine derivatives,

Mechanism of action

Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors.

Binding studies revealed that levocetirizine has high affinity for human H1-receptors (Ki = 3.2 nmol/l). Levocetirizine has an affinity 2-fold higher than that of cetirizine (Ki = 6.3 nmol/l). Levocetirizine dissociates from H1-receptors with a half-life of 115 ? 38 min.

After single administration, levocetirizine shows a receptor occupancy of 90% at 4 hours and 57% at 24 hours.

Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.

Pharmacodynamic effects

The pharmacodynamic activity of levocetirizine has been studied in randomised, controlled trials:

In a study comparing the effects of levocetirizine 5mg, desloratadine 5mg, and placebo on histamine-induced wheal and flare, levocetirizine treatment resulted in significantly decreased wheal and flare formation which was highest in the first 12 hours and lasted for 24 hours, (p<0.001) compared with placebo and desloratadine.

The onset of action of levocetirizine 10mg in controlling pollen-induced symptoms has been observed at 1 hour post drug intake in placebo controlled trials in the model of the allergen challenge chamber.

In vitro studies (Boyden chambers and cell layers techniques) show that levocetirizine inhibits eotaxin-induced eosinophil transendothelial migration through both dermal and lung cells. A pharmacodynamic experimental study?in vivo?(skin chamber technique) showed three main inhibitory effects of levocetirizine 10mg in the first 6 hours of pollen-induced reaction, compared with placebo in 14 adult patients: inhibition of VCAM-1 release, modulation of vascular permeability and a decrease in eosinophil recruitment.

Clinical efficiency and safety

The efficacy and safety of levocetirizine has been demonstrated in several double-blind, placebo controlled, clinical trials performed in adult patients suffering from seasonal allergic rhinitis or perennial allergic rhinitis, or persistent allergic rhinitis. Levocetirizine has been shown to significantly improve symptoms of allergic rhinitis, including nasal obstruction in some studies.

A 6-month clinical study in 551 adult patients (including 276 levocetirizine-treated patients) suffering from persistent allergic rhinitis (symptoms present 4 days a week for at least 4 consecutive weeks) and sensitized to house dust mites and grass pollen demonstrated that levocetirizine 10mg was clinically and statistically significantly more potent than placebo on the relief from the total symptom score of allergic rhinitis throughout the whole duration of the study, without any tachyphylaxis. During the whole duration of the study, levocetirizine significantly improved the quality of life of the patients.

In a placebo-controlled clinical trial including 166 patients suffering from chronic idiopathic urticaria, 85 patients were treated with placebo and 81 patients with levocetirizine 5mg once daily over six weeks. Treatment with levocetirizine resulted in significant decrease in pruritus severity over the first week and over the total treatment period as compared to placebo. Levocetirizine also resulted in a larger improvement of health-related quality of life as assessed by the Dermatology Life Quality Index as compared to placebo.

Chronic idiopathic urticaria was studied as a model for urticarial conditions. Since histamine release is a causal factor in urticarial diseases, levocetirizine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria.

ECGs did not show relevant effects of levocetirizine on QT interval.

Paediatric population

The paediatric safety and efficacy of levocetirizine tablets has been studied in two placebo controlled clinical trials including patients aged 6 to 12 years and suffering from seasonal and perennial allergic rhinitis, respectively. In both trials, levocetirizine significantly improved symptoms and increased health-related quality of life.

In children below the age of 6 years, clinical safety has been established from several short- or long -term therapeutic studies:

– one clinical trial in which 29 children 2 to 6 years of age with allergic rhinitis were treated with levocetirizine 1.210mg twice daily for 4 weeks

– one clinical trial in which 114 children 1 to 5 years of age with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.210mg twice daily for 2 weeks

– one clinical trial in which 45 children 6 to 11 months of age with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.210mg once daily for 2 weeks

– one long-term (18 months) clinical trial in 255 levocetirizine – treated atopic subjects aged 12 to 24 months at inclusion

The safety profile was similar to that seen in the short-term studies conducted in children 1 to 5 years of age.

5.2 Pharmacokinetic properties

The pharmacokinetics of levocetirizine are linear with dose- and time-independent with low inter-subject variability. The pharmacokinetic profile is the same when given as the single enantiomer or when given as cetirizine. No chiral inversion occurs during the process of absorption and elimination.

Absorption:

Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, Peak plasma concentrations are achieved 0.9 h after dosing. Steady state is achieved after two days. Peak concentrations are typically 270ng/ml and 308 ng/ml following a single and a repeated 10mg o.d. dose, respectively. The extent of absorption is dose-independent and is not altered by food, but the peak concentration is reduced and delayed.

Distribution:

No tissue distribution data are available in humans, neither concerning the passage of levocetirizine through the blood-brain-barrier. In rats and dogs, the highest tissue levels are found in liver and kidneys, the lowest in the CNS compartment.

In humans, levocetirizine is 90% bound to plasma proteins. The distribution of levocetirizine is restrictive, as the volume of distribution is 0.4 l/kg.

Biotransformation

The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O- dealkylation and taurine conjugation. Dealkylation pathways are primarily mediated by CYP 3A4 while aromatic oxidation involved multiple and/or unidentified CYP isoforms. Levocetirizine had no effect on the activities of CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 at concentrations well above peak concentrations achieved following a 10mg oral dose.

Due to its low metabolism and absence of metabolic inhibition potential, the interaction of levocetirizine with other substances, or vice-versa, is unlikely.

Elimination

The plasma half-life in adults is 7.9 ? 1.9 hours. The half-life is shorter in small children.

The mean apparent total body clearance is 0.63 ml/min/kg. The major route of excretion of levocetirizine and metabolites is via urine, accounting for a mean of 85.4% of the dose. Excretion via feces accounts for only 12.9% of the dose. Levocetirizine is excreted both by glomerular filtration and active tubular secretion.

Special population

Renal impairment

The apparent body clearance of levocetirizine is correlated to the creatinine clearance. It is therefore recommended to adjust the dosing intervals of levocetirizine, based on creatinine clearance in patients with moderate and severe renal impairment. In anuric end stage renal disease subjects, the total body clearance is decreased by approximately 80% when compared to normal subjects. The amount of levocetirizine removed during a standard 4-hour hemodialysis procedure was < 10%.

Paediatric population:

Data from a paediatric pharmacokinetic study with oral administration of a single dose of 10mg levocetirizine in 14 children age 6 to 11 years with body weight ranging between 20 and 40 kg show that Cmax and AUC values are about 2-fold greater than that reported in healthy adult subjects in a cross-study comparison. The mean Cmax was 450 ng/ml, occurring at a mean time of 1.2 hours, weight-normalized, total body clearance was 30% greater, and the elimination half-life 24% shorter in this paediatric population than in adults. Dedicated pharmacokinetic studies have not been conducted in paediatric patients younger than 6 years of age. A retrospective population pharmacokinetic analysis was conducted in 323 subjects (181 children 1 to 5 years of age, 18 children 6 to 11 years of age, and 124 adults 18 to 55 years of age) who received single or multiple doses of levocetirizine ranging from 1.210mg to 30 mg. Data generated from this analysis indicated that administration of 1.210mg once daily to children 6 months to 5 years of age is expected to result in plasma concentrations similar to those of adults receiving 10mg once daily.

Elderly

Limited pharmacokinetic data are available in elderly subjects. Following once daily repeat oral administration of 30 mg levocetirizine for 6 days in 9 elderly subjects (65?74 years of age), the total body clearance was approximately 33% lower compared to that in younger adults. The disposition of racemic cetirizine has been shown to be dependent on renal function rather than on age. This finding would also be applicable for levocetirizine, as levocetirizine and cetirizine are both predominantly excreted in urine. Therefore, the levocetirizine dose should be adjusted in accordance with renal function in elderly patients.

Gender:

Pharmacokinetic results for 77 patients (40 men, 37 women) were evaluated for potential effect of gender. The half-life was slightly shorter in women (7.08 ? 1.72 hr) than in men (8.62 ? 1.84 hr); however, the body weight-adjusted oral clearance in women (0.67 ? 0.16 ml/min/kg) appears to be comparable to that in men (0.59 ? 0.12 ml/min/kg). The same daily doses and dosing intervals are applicable for men and women with normal renal function.

Race:

The effect of race on levocetirizine has not been studied. As levocetirizine is primarily renally excreted, and there are no important racial differences in creatinine clearance, pharmacokinetic characteristics of levocetirizine are not expected to be different across races. No race-related differences in the kinetics of racemic cetirizine have been observed.

Hepatic impairment:

The pharmacokinetics of levocetirizine in hepatically impaired subjects have not been tested. Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg of the racemic compound cetirizine as a single dose had a 50% increase in half life along with a 40% decrease in clearance compared to healthy subjects.

Pharmacokinetic / pharmacodynamic relationship

The action on histamine-induced skin reactions is out of phase with the plasma concentrations.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential or toxicity to reproduction.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Lactose monohydrate,, Cellulose microcrystalline, Colloidal anhydrous silica,, Magnesium stearate,

Film-coating

Opadry white consisting of, Hypromellose, Titanium dioxide , Macrogol 400

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

No special requirements

6.5 Nature and contents of container

Aluminium ? Aluminium blister pack.

Pack size of 1, 2, 4, 5, 7, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 70, 90, 100, 120’s per pack.

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

LEVOCETIRIZINE DIHYDROCHLORIDE FILM-COATED TABLETS 10MG TAJ PHARMA

LEVOCETIRIZINE DIHYDROCHLORIDE

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

WHAT IS IN THIS LEAFLET:

  1. What Levocetirizine Dihydrochloride 10mg film-coated tablets is and what it is used for
  2. What you need to know before you take Levocetirizine Dihydrochloride 10mg film-coated tablets
  3. How to take Levocetirizine Dihydrochloride 10mg film-coated tablets
  4. Possible side effects
  5. How to store Levocetirizine Dihydrochloride 10mg film-coated tablets
  6. Contents of the pack and other information

 

1. WHAT LEVOCETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS IS AND WHAT IT IS USED ?FOR
Levocetirizine Dihydrochloride is the active ingredient of Levocetirizine Dihydrochloride 10mg film- coated tablets.

Levocetirizine Dihydrochloride 10mg film-coated tablets is an antiallergic medication.

For treatment of signs of illness (symptoms) associated with:

  • allergic rhinitis (including persistent allergic rhinitis);
  • nettle rash (urticaria).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOCETIRIZINE DIHYDROCHLORIDE 10MG FILM COATED TABLETS
Do not take Levocetirizine Dihydrochloride 10mg film-coated tablets :
if you are allergic to Levocetirizine Dihydrochloride to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6).
if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levocetirizine Dihydrochloride 10mg film-coated tablets.
If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice.

If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Levocetirizine Dihydrochloride 10mg film-coated tablets may cause seizure aggravation.

If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine Dihydrochloride 10mg film-coated tablets for several days before testing. This medicine may affect your allergy test results.

Children

The use of Levocetirizine Dihydrochloride 10mg film-coated tablets is not recommended in children less than 6 years since the film-coated tablets do not allow for dose adaptation.

Other medicines and Levocetirizine Dihydrochloride 10mg film-coated tablets

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

Levocetirizine Dihydrochloride 10mg film-coated tablets with food, drink and alcohol

Caution is advised if Levocetirizine Dihydrochloride is taken at the same time as alcohol or other agents acting on the brain. In sensitive patients, the concurrent administration of Levocetirizine

Dihydrochloride 10mg film-coated tablets and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.

Levocetirizine Dihydrochloride can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some patients being treated with Levocetirizine Dihydrochloride may experience somnolence / drowsiness, tiredness and exhaustion. Use caution when driving or operating machinary untill you know how this medicine affects you. However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking Levocetirizine Dihydrochloride in the recommended dosage.

Levocetirizine Dihydrochloride 10mg film-coated tablets contains lactose

These tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars you should contact your doctor before taking them.

3. HOW TO TAKE LEVOCETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS

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 dose for adults and children aged 6 years and over is one tablet daily.

Special dosage instructions for specific populations

Renal and hepatic impairment

Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.

Patients who have severe impairment of kidney function must not take Levocetirizine Dihydrochloride 10mg film-coated tablets.

Patients who only have impaired liver function should take the usual prescribed dose.

Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen on the basis of body weight; the dose will be determined by your doctor.

Elderly patients aged 65 years and above

No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.

Use in children

Levocetirizine Dihydrochloride is not recommended for children under 6 years of age.

How and when should you take Levocetirizine Dihydrochloride 10mg film-coated tablets?

For oral use only.

The Levocetirizine Dihydrochloride 10mg film-coated tablets should be swallowed whole with water and may be taken with or without food.

How long should you take Levocetirizine Dihydrochloride 10mg film-coated tablets?

The duration of use depends on the type, duration and course of your complaints and is determined by your physician.

If you take more Levocetirizine Dihydrochloride 10mg film-coated tablets than you should

If you take more Levocetirizine Dihydrochloride 10mg film-coated tablets than you should, somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.

If you think you have taken an overdose of Levocetirizine Dihydrochloride 10mg film-coated tablets, please tell your doctor who will then decide what action should be taken.

If you forget to take Levocetirizine Dihydrochloride 10mg film-coated tablets

If you forget to take Levocetirizine Dihydrochloride, or if you take a dose lower than that prescribed by your doctor, do not take a double dose to make up for a forgotten dose. Take your next dose at your normal time.

If you stop taking Levocetirizine Dihydrochloride 10mg film-coated tablets

Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking Levocetirizine Dihydrochloride, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

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

4. POSSIBLE SIDE EFFECTS

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

At the first signs of an allergic reaction, stop taking Levocetirizine Dihydrochloride 10mg film-coated

tablets and tell your doctor. Allergic reaction symptoms may include: swelling of the mouth, tongue, face and/or throat, breathing or swallowing difficulties (chest tightness or wheezing) hives, sudden fall in blood pressure leading to collapse or shock, which may be fatal.

Not known: frequency cannot be estimated from the available data

recurring thoughts of or preoccupation with suicide and hepatitis (symptoms can include yellow skin or eyes (jaundice), nausea, abdominal pain and tiredness).

Other side effects

Common: may affect up??? to in 10? people

Dry mouth, headache, tiredness and somnolence/drowsiness.

Uncommon: may affect up to 1 in 100 people, Exhaustion and abdominal pain.

Not known: frequency cannot be estimated from the available data

Other side effects such as palpitations, increased heart rate, fits, pins and needles, dizziness, fainting/loss of consciousness, tremor, dysgeusia (distortion of the sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, painful or difficult urination, inability to completely empty the bladder, swelling in the body, pruritus (itchiness), rash, urticaria (swelling, redness and itchiness of the skin), skin eruption, shortness of breath, weight increase, muscular pain, joint pain, aggressive or agitated behaviour, hallucination, depression, insomnia, abnormal liver function, increased appetite, nausea, vomiting and diarrhoea have also been reported.

Pruritus (intense itching) upon discontinuation.

Oculogyration (eyes having uncontrolled circular movements), nightmare

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet.

  1. HOW TO STORE LEVOCETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS

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

Do not use this medicine after the expiry date which is stated on the carton after ?EXP?. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Levocetirizine Dihydrochloride 10mg film-coated tablets contains

Each film-coated Tablet contains:
Levocetirizine Dihydrochloride??????????? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?????????? ?q.s

The other ingredients are Lactose monohydrate, Cellulose microcrystalline, Colloidal anhydrous silica, Magnesium stearate? and Opadry white ?consisting of Hypromellose, Titanium dioxide and Macrogol 400.

What Levocetirizine Dihydrochloride 10mg film-coated tablets looks like and contents of the pack

Film-coated tablets

They are supplied in Aluminium ? Aluminium blister pack with pack size of 1, 2, 4, 5, 7, 10, 14, 15,

20, 21, 28, 30, 40, 50, 60, 70, 90, 100, 120?s per pack

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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