LORATADINE Tablet Ref.[7506] Active ingredients: Loratadine

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 loratadine 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 10mg every other day is recommended for adults and children weighing more than 30kg.

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.

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.

In the event of overdosage, 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.

3 years.

Store in the original package.

Blister strip comprising of clear transparent PVC film (coated uniformly with PVdC on the inner side) with a backing of aluminium foil (coated with heat seal lacquer).

7, 10, 14, 20, 21, 30, and 100 tablets per pack.

Not all pack sizes are marketed.

No special requirements.