Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pinewood Laboratories Limited trading as Pinewood Healthcare, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
This medicine is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticarial in adults and children over the age of 2 years.
10ml (10mg) of the oral solution once daily.
Children 2 to 12 years of age are dosed by weight:
Body weight more than 30kg: 10ml (10mg) of the oral solution once daily;
Body weight 30kg or less: 5ml (5mg) of the oral solution once daily.
Efficacy and safety of this medicine in children under 2 years of age has not been established.
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, and for children weighing 30kg or less, 5ml (5mg) every other day is recommended.
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
No dosage adjustments are required in the elderly.
Oral use. The oral solution may be taken without regard to meal time.
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.
Shelf life before opening – 2 years.
Shelf life after opening – 6 months.
This medicinal product does not require any special storage conditions.
Bottle made from Type III Amber Glass with a tamper evident child resistant closure having a polypropylene outer layer and a polyethylene inner layer. This product is provided with a measuring device.
Pack Sizes: 60 ml & 70ml.
No special requirements.
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