CLARITYN ALLERGY Tablet Ref.[49992] Active ingredients: Loratadine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

4.1. Therapeutic indications

Clarityn Allergy 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 Clarityn Allergy 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.

4.9. 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.

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

Blister comprising 20μm aluminium foil with vinyl heat coating and a 250 μm clear, transparent polyvinylchloride (PVC) film or a 250μm clear, transparent polyvinyl chloride (PVC) film with polyvinylidene chloride (PVdC) coating.

Pack sizes of 7, 10, 14, 20 and 30 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.

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