CLARITYN 7CPR 10MG

CLARITYN 10 MG COMPRESENT

active ingredients

Each tablet contains 10 mg of loratadine. Excipients with known effects: the amount of lactose monohydrate in the composition of 10 mg loratadine tablet is 71.3 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Lactose monohydrate Corn starch Magnesium stearate

Therapeutic indications

Clarityn tablets is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population Adults One tablet once a day. Pediatric population Children from 6 years up with weight above 30 kg: one tablet once a day. For an appropriate dosage for children under 6 years of age or with a weight equal to or less than 30 kg there are other formulations more indicated. Children under 2 years old The safety and effectiveness of Clarityn have not been established. There are no available data. Patients with liver impairment Patients with severe liver impairment are given a lower initial dose since they may have a reduced clearance of loratadine. It is recommended an initial dose of 10 mg per alternate days in adults and children weighing more than 30 kg. Patients with kidney damage Dosing adjustments are not required in patients with kidney failure. Seniors Dosing adjustments are not required in the elderly. Method of administration Oral use. The tablet can be taken regardless of the time of meals.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Clarityn should be given with caution in patients with severe liver impairment (see paragraph 4.2). This medicine contains lactose; therefore patients with rare hereditary problems of galactose intolerance, lactase deficiency lapp syndrome or glucose-galactose mal absorption should not take this medicine. Clarityn administration must be interrupted at least 48 hours before skin testing since antihistamines can prevent or reduce positive reactions to skin reactivity indices.

Interactions

Clarityn’s concurrent intake with alcohol does not enhance its effects, as assessed by psychophysical performance studies. Potential interactions with all known inhibitors of the CYP3A4 and CYP2D6 can occur by determining high levels of loratadine (see paragraph 5.2), which can cause an increase in adverse events. An increase in plasma concentrations of loratadine after concurrent use with ketoconazole, erythromycin and cimetidine in controlled clinical studies, but without clinically significant variations (including electrocardiographic ones). Pediatric population Interaction studies were carried out only in adults.

Effects

Summary of security profile In clinical studies conducted in adults and adolescents in a number of indications, including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg per day, adverse reactions with loratadine were reported in a 2% higher percentage than that of patients treated with placebo. The most common adverse reactions reported with a higher frequency than placebo were drowsiness (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Table of adverse reactions The following adverse reactions reported during the period following marketing are listed in the following table, according to the classification for systems and organs. The frequencies are defined as very common (≥1/10), common (≥1/100, Classification for systems and organs Frequency Denomination of adverse event Immune system disorders Very rare Hypersensitivity reactions (including angioedema and anaphylaxis) Diseases of the nervous system Very rare Capogiro, seizures Heart disease Very rare Tachycardia, palpitations Gastrointestinal diseases Very rare Nausea, dry mouth, gastritis Hepatobiliary diseases Very rare Abnormal liver function Pathologies of skin and subcutaneous tissue Very rare Skin rash, alopecia Systemic pathologies and conditions for administration Very rare Tired Diagnostic examinations Notable Weight gain Pediatric population In clinical studies conducted in a children's population of 2 to 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%) and fatigue (1%). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Overdose of loratadine increased the frequency of anticholinergic symptoms. As a result of overdose, drowsiness, tachycardia and headaches were reported. In case of overdose, general symptomatic and support measures must be implemented and maintained for the time necessary. You can try the administration of activated carbon suspended in water. You can consider the gastric lavender. The loratadine is not eliminated with hemodialysis and is not known if it is eliminated with peritoneal dialysis. You must continue the patient's medical monitoring even after the emergency treatment.

Pregnancy

Data on a large number of pregnant women exposed to the drug (over 1000 pregnancy outcomes) showed no malformation or fetal/neonatal toxicity effects by loratadine. Animal studies show no direct or indirect harmful effects of reproductive toxicity (see paragraph 5.3). For precautionary purposes, it is preferable to avoid the use of Clarityn during pregnancy.

Food

The loratadine is excreted in breast milk. Therefore the use of Clarityn is not recommended in nursing women.

Fertility

Data on fertility in man and woman are not available.

Source: Farmadati