Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Lennon
AP LORATADINE 10 mg TABLETS D862 SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): AP LORATADINE 10 mg TABLETS COMPOSITION: Each tablet contains 10 mg loratadine . PHARMACOLOGICAL CLASSIFICATION: A 5.7.1 Antihistaminics PHARMACOLOGICAL ACTION: Loratadine is a tricyclic antihistamine with long-acting selective peripheral H 1 receptor antagonist activity. It does not readily cross the blood brain barrier. Following administration, maximal serum levels are reached within 1,5 hours and clinical effect is achieved within 2 hours. Most of a dose is excreted equally in the urine and faeces. INDICATIONS: AP LORATADINE tablets are used for the symptomatic relief of chronic urticaria and allergic rhinitis. CONTRA-INDICATIONS: AP LORATADINE tablets are contra-indicated in patients who have shown hypersensitivity to any of its ingredients. The safety of loratadine during pregnancy or lactation has not been established. The safety of loratadine in the elderly has not been established. DOSAGE AND DIRECTIONS FOR USE: One AP LORATADINE tablet (10 mg) taken once daily. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: SIDE-EFFECTS: The most commonly reported side-effects are fatigue, dry mouth, allergic symptoms like rash, headache, gastro-intestinal disturbances (eg. gastric upsets/nausea) and somnolence. The more uncommon side-effects include alopecia, anaphylaxis and an abnormal hepatic functioning. SPECIAL PRECAUTIONS: AP LORATADINE lacks significant sedative effects. Patients should however be warned that a small number of individuals may experience sedation. Patients experiencing sedation or impaired concentration should be advised not to drive or perform complicated tasks. Sedation may be enhanced by the simultaneous intake of alcohol or other central nervous depressants. Less frequent incidences of abnormal he Прочитать полный документ