ASPIRIN MIGRAINE 500 Milligram Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

ACETYLSALICYLIC ACID

Commercializzato da:

Bayer PLC

INN (Nome Internazionale):

ACETYLSALICYLIC ACID

Dosaggio:

500 Milligram

Forma farmaceutica:

Tablets

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2007-07-16

Scheda tecnica

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
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_Date Printed 24/10/2006_
_CRN 2029162_
_page number: 1_
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Severe uncontrolled cardiac failure;