Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID
Bayer PLC
ACETYLSALICYLIC ACID
500 Milligram
Tablets
Withdrawn
2007-07-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin Migraine Effervescent Tablets 500 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains acetylsalicylic acid 500 mg. For excipients see 6.1. 3 PHARMACEUTICAL FORM Effervescent tablets White, round, flat effervescent tablets with Bayer cross embossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of headache associated with migraine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: 1,000 mg as single dose (corresponding to two effervescent tablets). If the attack persists the dose may be repeated at intervals of 4 - 8 hours. A maximum daily dose of 3 g (six tablets) must not be exceeded. Aspirin Migraine tablets must not be taken for more than 3 days without consulting a physician. If migraine attacks occur frequently, if frequency of attacks increase or if symptoms persist, a physician should be consulted and an alternative treatment should be considered. CHILDREN: The use of Aspirin Migraine tablets is not recommended in children as no studies have included this population. Aspirin Migraine tablets must be dissolved in a glass of water before taking. 4.3 CONTRAINDICATIONS - Active peptic ulcers; - Haemorrhagic diathesis; - Hypersensitivity to acetylsalicylic acid, to other salicylates, or to any other components of the product; - A history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory drugs; - Severe hepatic failure; - Severe renal failure; IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/10/2006_ _CRN 2029162_ _page number: 1_ - Severe uncontrolled cardiac failure; Izlasiet visu dokumentu