ASPIRIN Tablets BP 300mg (2013)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Actavis UK Limited |
|---|---|
| Διεύθυνση | Whiddon Valley, Barnstaple, N. Devon, EX32 8NS, UK |
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Name of the medicinal product
ASPIRIN TABLETS BP 300mg.
Qualitative and quantitative composition
Each tablet contains 300mg Aspirin PhEur.
Pharmaceutical form
White uncoated tablets.
Therapeutic indications
Aspirin has analgesic, antipyretic and anti-inflammatory actions. It is indicated for: The relief of headache, toothache, migraine, neuralgia, sore throat, dysmenorrhoea. The symptomatic relief of influenza, ...
Posology and method of administration
Posology Adults including elderly: 1-2 tablets (300-600mg) every 3-4 hours as required, to a maximum of 12 tablets (3.6g) daily in divided doses. Children: Do not give to children aged under 16 years, ...
Contraindications
Aspirin should not be taken by patients with the following conditions: Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs (a ...
Special warnings and precautions for use
There is a possible association between aspirin and Reyes Syndrome when given to children. Reyes syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason aspirin ...
Interaction with other medicinal products and other forms of interaction
The following drug interactions should be considered when prescribing aspirin: Analgesics avoid concomitant administration of other salicylates or other NSAIDs (including topical formulations) as increased ...
Pregnancy and lactation
Pregnancy Low doses (up to 100 mg/day) Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe. Doses of 100- 500 mg/day: ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed with Acetylsalicylic acid. Based on the pharmacodynamic properties and the side effects of acetylsalicylic acid, no ...
Undesirable effects
Side effects are grouped on the basis of System Organ Class. Within each system organ class the frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), ...
Overdose
Although considerable inter-individual variations are involved, it can be considered that the toxic dose is about 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid ...
Pharmacodynamic properties
ATC code: N02BA01 Aspirin is an anti-inflammatory analgesic and antipyretic. Aspirin is analgesic, anti-inflammatory, antipyretic and an inhibitor of platelet aggregation. It prolongs the bleeding time. ...
Pharmacokinetic properties
Following oral administration, absorption of non-ionised aspirin occurs in the stomach and intestine. Some aspirin is hydrolysed salicylate in the gut wall. After absorption aspirin is rapidly converted ...
Preclinical safety data
Not applicable.
List of excipients
Also contains maize starch, E553.
Incompatibilities
Iron salts, alkalis and carbonates.
Shelf life
Shelf life: Three years from the date of manufacture. Shelf-life after dilution/reconstitution: Not applicable. Shelf-life after first opening: Not applicable.
Special precautions for storage
Store below 25°C in a dry place.
Nature and contents of container
OTC Packs: The product containers are polyethylene snap-safe vials (CRC) or, as an alternative, amber glass bottles with clic-loc caps both with integral seal, cotton wool or polyfoam wad headspace filler. ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation: Actavis UK Limited (Trading style: Actavis) Whiddon Valley BARNSTAPLE N Devon EX32 8NS ...
Marketing authorization number(s)
PL 0142/5083 R
Date of first authorization / renewal of the authorization
7.7.80
Date of revision of the text
15/06/2013