TICEVIS Tablet Ref.[28258] Active ingredients: Loratadine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Loratadine is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years with a body weight more than 30 kg.

4.2. Posology and method of administration

Posology

Adults and children over 12 years of age

10mg once daily (one tablet once daily).

Paediatric population

Children 2 to 12 years of age are dosed by weight

  • Bodyweight more than 30 kg: 10mg once daily (one tablet once daily).
  • Bodyweight 30 kg or less: The 10mg strength tablet is not appropriate in children with a body weight less than 30kg.

The safety and efficacy of loratadine in children under 2 years of age has 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

Symptoms

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

Management

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

60 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Tablets are packed into PVC-Al blisters in a carton box with a patient information leaflet.

Boxes of 10, 20 and 30 are available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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