Clarityn Loratadine 10mg Schering-plough 7 Tablets

NAME
CLARITYN 10 MG TABLETS

PHARMACOTHERAPEUTIC CATEGORY
antihistamine - H 1 antagonist.

ACTIVE PRINCIPLES
Loratadine.

EXCIPIENTS
Lactose monohydrate, corn starch, magnesium stearate.

INDICATIONS
Medicinal product indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients.

DOSAGE
Adults: one tablet once a day. Children aged 6 and over weighing more than 30 kg: one tablet once a day. For an appropriate dosage for children aged less than 6 years or with a weight equal to or less than 30 kg there are other more suitable formulations. Children aged less than 2 years: safety and efficacy have not been established, no data are available. Patients with severe hepatic impairment should be given a lower starting dose as they may have reduced clearance of loratadine. A starting dose of 10 mg every other day is recommended in adults and children weighing more than 30 kg. No dosage adjustments are required in patients with renal insufficiency. No dosage adjustments are required in the elderly. Method of administration: oral use. The tablet can be taken regardless of mealtimes.

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
The medicinal product should be administered with caution to patients with severe hepatic impairment. This medicine contains lactose; therefore patients with rare hereditary problems of galactose intolerance, the Lapp syndrome due to lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Administration must be interrupted at least 48 hours before skin tests as antihistamines can prevent or reduce positive reactions to skin reactivity indices.

INTERACTIONS
Concomitant intake with alcohol does not potentiate its effects, as assessed by studies on psychophysical performance. Potential interactions with all known inhibitors of CYP3A4 and CYP2D6 can occur resulting in elevated loratadine levels, which can lead to increased adverse events. Increased plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled clinical trials, but with no clinically significant changes (including electrocardiographic changes). Interaction studies have only been performed in adults.

SIDE EFFECTS
The following adverse reactions reported during the post-marketing period are listed below by system organ class. 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) and not known. Within each frequency category, adverse reactions are presented in decreasing order of severity. Disorders of the immune system. Very rare: hypersensitivity reactions' (including angioedema and anaphylaxis). Nervous system disorders. Very rare: dizziness, convulsions. Cardiac pathologies. Very rare: tachycardia, palpitations. Gastrointestinal disorders. Very rare: nausea, dry mouth, gastritis. Hepatobiliary disorders. Very rare: abnormal liver function. Skin and subcutaneous tissue disorders. Very rare: rash, alopecia. General disorders and administration site conditions. Very rare: tiredness. In clinical trials conducted in a pediatric population of children aged 2 to 12 years, the common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%) and fatigue (1%). The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Data on a large number of pregnant women exposed to the drug (over 1000 pregnancy outcomes) did not show malformative effects of fetal / neonatal toxicity by loratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid use during pregnancy. Loratadine is excreted in breast milk. Therefore, its use is not recommended in breastfeeding women. There are no data on fertility in men and women.