Allergy Remedy Tablets - Loratadine 10mg

02243880

3 years from date of manufacture

Loratadine 10mg

Colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate and microcrystalline cellulose.

White, oval, biconvex tablet, scored and engraved "LO" over "10" on one side and "APO" on the other.

Diameter: 0.2000 x 0.3000 shallow oval
Thickness: 0.106" - 0.116"

Store at room temperature (15 to 30°C). Protect from exposure to excessive moisture.

Provides relief from hayfever and helps stop sneezing, runny nose and watery eyes without causing drowsiness.

Adults and children 12 years of age and over: 10 mg (1 tablet), once daily.

If you are pregnant, nursing a baby, or have liver disease, seek the advice of a physician before using this product. Do not exceed the recommended dosage. Prolonged usage should only be on the advice of a physician.

Increases in plasma concentrations of Loratadine have been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other drugs known to inhibit hepatic metabolism should be coadministered with caution until definitive interaction studies can be completed.

Contraindicated in patients who have shown hypersensitivity or idiosyncrasy to the drug or its components.

When administered concomitantly with alcohol, Loratadine has no potentiating effects as measured by psychomotor performance studies.

Adverse experiences reported with Loratadine in adults during the clinical trials were mild and consisted of fatigue, headache, dry mouth and sedation. In addition, the following were reported less frequently (less than 1%): appetite increased, coughing, dizziness, nausea and palpitations.

Adverse experiences reported in pediatric patients are nervousness and hyperkinesias. Gastrointestinal adverse reactions reported during pediatric trials may have been slightly more frequent in the younger patients (less than or equal to 30 kg), but in older children (greater than 30 kg) is similar to placebo.

During the marketing of Loratadine, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.

Somnolence, tachycardia and headache have been reported with overdoses of the conventional Loratadine formulation. A single acute ingestion of 160 mg produced no adverse effects.

In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive. Discontinuation of use, gastric lavage or induction of emesis (except in patients with impaired consciousness) and support of vital functions are advised.