- NAME OF THE MEDICINAL PRODUCT
Loratadine Tablets 10mg Taj Pharma
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains:
Loratadine USP???????????????????????????????????? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?????????? q.s
- PHARMACEUTICAL FORM
White to off-white, oval tablet
- CLINICAL PARTICULARS
4.1 Therapeutic indications
Loratadine?? Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
4.2 Posology and method of administration
Posology
Adults:
One tablet once daily.
Paediatric population
Children 6 years of age and older with a body weight greater than 30 kg:
One tablet once daily
For appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, there are other formulations more suitable.
Children under 2 years of age:
Safety and efficacy of Loratadine?? Tablets have not been established. No data are available.
Patients with hepatic impairment
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of Loratadine?? . An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg.
Patients with renal impairment
No dosage adjustments are required in patients with renal insufficiency.
Elderly
No dosage adjustments are required in the elderly.
Method of administration
Oral use. The tablet may be taken without regard to mealtime.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Loratadine?? Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).
This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The administration of Loratadine?? Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
4.5 Interaction with other medicinal products and other forms of interaction
When administered concomitantly with alcohol, Loratadine?? Tablets have no potentiating effects as measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of Loratadine?? ?(see Section 5.2), which may cause an increase in adverse events.
Increase in plasma concentrations of Loratadine?? ?has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).
Paediatric population
Interaction studies have only been performed in adults.
4.6 Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity of Loratadine?? . Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Loratadine?? Tablets during pregnancy.
Breast-feeding
Loratadine?? ?is excreted in breast milk. Therefore, the use of Loratadine?? Tablets is not recommended in breast-feeding women.
Fertility
There are no data available on male and female fertility.
4.7 Effects on ability to drive and use machines
In clinical studies that assessed driving ability, no impairment was observed in patients receiving Loratadine?? . Loratadine?? Tablets has no or negligible influence on the ability to drive and use machines. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
4.8 Undesirable effects
Summary of the safety profile
In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticarial (CIU), at the recommended dose of 10mg daily, adverse reactions with Loratadine?? ?were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).
Tabulated list of adverse reactions
The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. Frequencies are defined as 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) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Experience Term |
| Immune system disorders | Very rare | Hypersensitivity reactions (including angioedema and anaphylaxis) |
| Nervous system disorders | Very rare | Dizziness, convulsion |
| Cardiac disorders | Very rare | Tachycardia, palpitation |
| Gastrointestinal disorders | Very rare | Nausea, dry mouth, gastritis |
| Hepatobiliary disorders | Very rare | Abnormal hepatic function |
| Skin and subcutaneous tissue disorders | Very rare | Rash, alopecia |
| General disorders and administration site conditions | Very rare | Fatigue |
| Investigations | Not known | Weight increase |
?
Paediatric population
In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
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
Overdosage with Loratadine?? ?increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.
In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine?? ?is not removed by haemodialysis and it is not known if Loratadine?? ?is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.
- PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group : antihistamines ? H1?antagonist,
Mechanism of action
Loratadine?? , the active ingredient in Loratadine?? Tablets, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.
Pharmacodynamic effects
Loratadine?? ?has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.
During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.
Loratadine?? ?has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.
Human histamine skin wheal studies following a single 10 mg dose has shown that the antihistamine effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with Loratadine?? .
Clinical efficacy and safety
Over 10,000 subjects (12 years and older) have been treated with Loratadine?? ?10 mg tablets in controlled clinical trials. Loratadine?? ?10 mg tablets once daily was superior to placebo and similar to clemastine in improving the effects on nasal and non-nasal symptoms of AR. In these studies somnolence occurred less frequently with Loratadine?? ?than with clemastine and about the same frequency as terfenadine and placebo.
Among these subjects (12 years and older), 1000 subjects with CIU were enrolled in placebo controlled studies. A once daily 10 mg dose of Loratadine?? ?was superior to placebo in the management of CIU as demonstrated by the reduction of associated itching, erythema and hives. In these studies the incidence of somnolence with Loratadine was similar to placebo.
Paediatric population
Approximately 200 paediatric subjects (6 to 12 years of age) with seasonal allergic rhinitis received doses of Loratadine?? ?syrup up to 10 mg once daily in controlled clinical trials. In another study, 60 paediatric subjects (2 to 5 years of age) received 5 mg of Loratadine syrup once daily. No unexpected adverse events were observed.
The paediatric efficacy was similar to the efficacy observed in adults.
5.2 Pharmacokinetic properties
Absorption
Loratadine?? ?is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the absorption of Loratadine?? ?but without influencing the clinical effect. The bioavailability parameters of Loratadine and of the active metabolite are dose proportional.
Distribution
Loratadine?? ?is highly bound (97% to 99%) and its active major metabolite desLoratadine? ?(DL) moderately bound (73% to 76%) to plasma proteins.
In healthy subjects, plasma distribution half-lives of Loratadine?? ?and its active metabolite are approximately 1 and 2 hours, respectively.
Biotransformation
After oral administration, Loratadine?? ?is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desLoratadine?? ?(DL)- is pharmacologically active and responsible for a large part of the clinical effect. Loratadine?? ?and DL achieve maximum plasma concentrations (Tmax) between 1?1.5 hours and 1.5?3.7 hours after administration, respectively.
Elimination
Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as Loratadine?? ?or DL.
The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for Loratadine?? ?and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.
Renal impairment
In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for Loratadine?? ?and its metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of Loratadine?? ?and its active metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of Loratadine?? ?or its active metabolite in subjects with chronic renal impairment.
Hepatic impairment
In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of Loratadine?? ?were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for Loratadine?? ?and its active metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
Elderly
The pharmacokinetic profile of Loratadine?? ?and its active metabolite is comparable in healthy volunteers and in healthy geriatric volunteers.
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 and carcinogenic potential.
In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.
- PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Monohydrate
Maize Starch
Magnesium Stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
PVC/PVDC/Al blisters.
Pack sizes:
Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local 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
LORATADINE TABLETS 10MG TAJ PHARMA
(Loratadine)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 10 days.
WHAT IS IN THIS LEAFLET:
- What Loratadine 10 mg Tablets ?(Loratadine ) is and what it is used for
- What you need to know before you take Loratadine
- How to take Loratadine
- Possible side effects
- How to store Loratadine
- Contents of the pack and other information
- WHAT LORATADINE IS AND WHAT IT IS USED FOR
Loratadine belong to a class of medicines known as antihistamines.
Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body.
The tablet relieves symptoms associated with allergic rhinitis (for example, hayfever) such as sneezing, runny or itchy nose and burning or itchy eyes.
The tablet may also be used to help relieve symptoms of urticaria (itching and redness), which is often known as hives or nettle rash.
- WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE
Do not take Loratadine:
- if you are allergic to loratadine, or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or breastfeeding
- if you have phenylketonuria (a metabolism disorder)
Warnings and precautions:
Talk to your doctor or pharmacist before taking Loratadine:
- if you have severe liver disease
- if you have to undergo any skin tests, it may be necessary to stop taking this medicine at least 2 days before the test to make sure the result of the test is correct.
Children
Loratadine is not recommended for children younger than 2 years old as efficacy and safety have not been established. Do not give Loratadine to children between 2 and 12 years old who weigh less than 30 kg. There are other more suitable formulations.
Other medicines and Loratadine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Potential interaction may occur with medicines that make some liver enzymes less active resulting in elevated levels of loratadine. This may cause an increase in adverse events.
Loratadine with food, drink and alcohol
The tablets can be taken with or without a meal.
The tablets will normally disintegrate in the mouth in contact with saliva, therefore water or other liquids are not normally needed.
Loratadine has not been shown to add to the effects of an alcoholic drink.
Pregnancy, breast-feeding and fertility
The use of Loratadine during pregnancy and breast-feeding is?not recommended. 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.
If you are nursing a baby, taking Loratadine is not recommended, because loratadine is excreted in breast milk.
Driving and using machines
In clinical studies that assessed driving ability, no impairment was observed in patients receiving loratadine.
At the recommended dose, Loratadine are not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Loratadine contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicine.
Loratadine contains less than 7 mg?sorbitol?in each orodispersible tablet.
Loratadine contains less than 1 mmol sodium (23 mg) per orodispersible tablet, that is to say essentially ?sodium-free?.
Loratadine contain 0.5 mg aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
- HOW TO TAKE LORATADINE
Always take Loratadine exactly as described in this leaflet or your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Loratadine is intended to be put on the tongue (see below) and for oral use.
Loratadine break easily, so you should handle the tablets carefully and with dry hands only.
Method of use
- Tear one blister unit along the perforations.
2. Peel open the backing in direction of the arrow and take the tablet out carefully. The tablet should not be pushed through the backing.
3. Put the tablet on your tongue as soon as it is removed from the packaging. It will melt in your mouth directly. Water is not required to swallow the tablet.
Loratadine are dispersed in your mouth in contact with saliva and can be therefore taken without water. They have a sweet orange taste.
Giving this medicine to children
It is important to know how much your child weighs to make sure that you give the correct amount of medicine. For example, a 9 year old child weighs about 30kg (four and half stone).
If in doubt weigh your child and then follow the instructions in the table.
Do not give to children under 2 years or who weigh less than 30kg (four and half stone).
The recommended dose is:
Adults and children over 12 years:?take one tablet once a day.
Children of 2 to 12 years who weigh more than 30 kg (four and half stone):
Take one tablet once a day.
Children of 2 to 12 years who weigh less than 30 kg (four and half stone): Do not give?this medicine.
If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions
Duration of treatment:
You must contact a doctor if your symptoms do not improve or even get worse after 10 days.
If you take more tablets than you should:
If you take more Loratadine than recommended, contact your doctor or pharmacist. Taking more tablets than recommended may cause drowsiness, rapid heartbeat and headache.
If you forget to take Loratadine:
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
?
- POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are:
- drowsiness
- headache
- increased appetite
- difficulty sleeping
The most commonly reported side effects in children aged 2 to 12 years are:
- headache
- nervousness
- tiredness
Very rare side effects (may affect up to to 1 in 10,000 people) have also been observed during the marketing of loratadine:
- severe allergic reactions (including swelling)
- dizziness
- convulsion
- fast or irregular heartbeat
- nausea (feeling sick)
- dry mouth
- upset stomach
- liver problems
- hair loss
- rash
- tiredness
Not known,?frequency cannot be estimated from the available data:
- weight increased
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.
- HOW TO STORE LORATADINE
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 and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not throw away 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.
- CONTENTS OF THE PACK AND OTHER INFORMATION
What Loratadine contains
Each uncoated tablet contains:
Loratadine USP???????????????????????????????????? 10mg
Excipients? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?????????? q.s
The other ingredients are sweet orange flavour, aspartame, citric acid anhydrous, silica colloidal anhydrous, maize starch dried, lactose anhydrous, magnesium stearate, croscarmellose sodium, mannitol, sorbitol, crospovidone, silica colloidal hydrated, polysorbate 80, povidone, microcrystalline cellulose.
What Loratadine looks like and contents of the pack
Loratadine tablets are white, round and flat.
PVC/PVDC/Al blisters.
Pack sizes:Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release 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
