LORATADINE ZYDUS 10 mg Cpr Plq/15

Loratadine.......................................................................................................................................................10 mg

For one tablet.

Excipient with known effect: the amount of lactose monohydrate contained in one tablet of 10 mg loratadine is 78,5 mg.

LORATADINE ZYDUS 10 mg, tablet is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Dosage

Adults:10 mg once a day, i.e. one tablet once a day.

Paediatric population

Children aged 6 years and older: body weight of more than 30 kg: 10 mg once a day.

Children under 6 years of age or weighing 30 kg or less: other, more suitable pharmaceutical forms exist.

Children under 2 years: The efficacy and safety of LORATADINE ZYDUS have not been established.

Patients with hepatic impairment

In patients with severe hepatic impairment, the initial dose should be reduced due to a risk of reduced clearance of loratadine. An initial dose of 10 mg every two days is recommended for adults and children weighing more than 30 kg.

Elderly patients or patients with renal impairment

No dose adjustment is necessary in elderly patients or patients with renal impairment.

Method of administration

The tablet may be taken regardless of meals.

LORATADINE ZYDUS is contraindicated in cases of hypersensitivity to loratadine or to any of the excipients of the medicinal product.

LORATADINE ZYDUS should be used with caution in patients with severe hepatic impairment (see section. 4.2).

This medicine contains lactose. Its use is not recommended in patients with

galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).

Administration of LORATADINE ZYDUS should be discontinued at least 48 hours before performing skin tests for allergy diagnosis, as antihistamines may inhibit or reduce the skin response.

Psychomotor performance studies have not shown potentiation of the effects of LORATADINE ZYDUS when administered concomitantly with alcohol.

The risk of interactions with inhibitors of the cytochromes CYP3A4 or CYP2D6 resulting in increased plasma concentrations of loratadine may increase the risk of occurrence of adverse effects (see section Pharmacokinetics).

Pregnancy

Animal studies have not revealed a teratogenic effect of loratadine. The safety of loratadine during pregnancy has not been established. Consequently, the use of LORATADINE ZYDUS during pregnancy is not recommended.

Breast-feeding

Loratadine is excreted in breast milk. Consequently, administration of loratadine during breastfeeding is not recommended.

In clinical studies evaluating the ability to drive vehicles, no deleterious effect was observed in patients receiving loratadine. However, patients must be informed that very rarely in certain people somnolence has been described which could affect their ability to drive vehicles or use machines.

In clinical studies conducted in the paediatric population, in children aged 2 to 12 years, the frequent adverse reactions reported with a higher frequency than under placebo were: headache (2,7 %), nervousness (2,3 %) and fatigue (1 %).

In clinical studies conducted in adults and adolescents in the indications allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 10 mg, adverse reactions with loratadine were reported in 2 % more patients than those treated with placebo. The adverse reactions most frequently reported with a higher frequency than under placebo were: somnolence (1,2 %), headache (0,6 %), increased appetite (0,5 %) and insomnia (0,1 %).

Other adverse effects very rarely reported since marketing are listed in the following table:

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.ansm.sante.fr.

Overdose of loratadine increases the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported in cases of overdose.

In case of overdose, symptomatic treatment and maintenance of vital functions are recommended. Activated charcoal suspended in water may be administered. Gastric lavage may be considered. Loratadine is not eliminated by haemodialysis, and it is not known whether peritoneal dialysis can eliminate it. The patient must remain under medical supervision after emergency treatment.

Pharmacotherapeutic class:ANTIHISTAMINES FOR SYSTEMIC USE, ATC code: R06AX13.

Loratadine, the active ingredient of LORATADINE ZYDUS, is a tricyclic antihistamine acting selectively on peripheral H1 receptors.

Loratadine does not exert a significant sedative or anticholinergic effect in the majority of the population when used at the recommended dose.

During long-term treatment, no clinically significant changes were observed in vital functions, biological parameters, clinical examination, or electrocardiographic recordings.

Loratadine has no significant action at H2 receptors. It does not inhibit noradrenaline reuptake and has practically no influence on cardiovascular functions or on intrinsic pacemaker activity.

After oral administration, loratadine is rapidly and well absorbed and undergoes an important first-pass hepatic effect, being essentially metabolized by CYP3A4 and CYP2D6. The main metabolite - desloratadine - is pharmacologically active and largely responsible for the clinical effect. The maximum plasma concentrations of loratadine and desloratadine are reached (Tmax) between 1-1,5 hours and 1,5-3,7 hours after administration, respectively.

In controlled clinical studies, an increase in plasma concentrations of loratadine has been reported when administered concomitantly with ketoconazole, erythromycin or cimetidine, but without significant clinical consequence (no change in ECG tracings).

The binding of loratadine to circulating proteins is high (97% to 99%), whereas that of the metabolite is more moderate (73% to 76%).

In healthy volunteers, the distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours respectively. The main elimination half-life in healthy volunteers was 8,4 hours (range 3 to 20 hours) for loratadine and 28 hours (range 8,8 to 92 hours) for the main active metabolite.

Approximately 40% of the dose is excreted in the urine and 42% in the feces over a period of 10 days, mainly as 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 in the unchanged active form, loratadine or desloratadine.

The bioavailability of loratadine and its active metabolite is dose-dependent.

The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy adult and elderly volunteers.

Concomitant food intake may cause a slight delay in the absorption of loratadine, without consequence for the clinical effect.

In patients with chronic renal failure, the AUC and peak plasma concentrations (Cmax) of loratadine and its metabolite were higher than the AUC and plasma peaks (Cmax) observed in patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from those observed in normal subjects. Haemodialysis has no effect on the pharmacokinetics of loratadine and its active metabolite in patients with chronic renal failure.

In patients with chronic hepatic impairment of alcoholic origin, the AUC and peak plasma concentrations (Cmax) of loratadine observed were doubled, whereas the pharmacokinetic profile of the active metabolite was not significantly altered compared with that of patients with normal hepatic function. The elimination half-lives of loratadine and its metabolite were 24 hours and 37 hours respectively, and they increased in parallel with the severity of the hepatic impairment.

Loratadine and its active metabolite are excreted in breast milk in breastfeeding women.

Preclinical data reveal no specific risk for humans in the light of conventional safety, pharmacology, repeated-dose toxicity, genotoxicity or carcinogenicity studies.

Studies of reproductive function revealed no teratogenic effect in animals. However, prolonged parturition and reduced viability of the offspring were observed in rats exposed to plasma levels (AUC) 10 times higher than those reached with the doses used clinically.

3 years

No special precautions for storage.

No special requirements.