Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Accord-UK Ltd
N02BA01
Aspirin
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5012617007773 5012617001955
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Aspirin Tablets 300mg x 28 (UK) 148x210 (Reel Fed) 50987587 Leaflet for Blisters 2897 T. Hull 04/02/20 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. GTIN 13 (Belgium & Slovenia): EU-Artwork-Support@accord-healthcare.com ACETYLSALICYLIC ACID 300 MG TABLETS PIL - UK Black Profile BBBA7547 C.Grant 11/02/20 21/05/20 C.Grant 148x210 7 pt Accord Barnstaple n/a 04 Version 6 12.12.2019 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Aspirin 300mg tablets but within this leaflet it will be referred to as Aspirin tablets. WHAT IS IN THIS LEAFLET 1 WHAT ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN TABLETS 3 HOW TO TAKE ASPIRIN TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ASPIRIN TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR Aspirin tablets belong to a group of medicines whic Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin 300mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg acetylsalicylic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, circular, biconvex uncoated tablets impressed "ASPIRIN 300mg" around the circumference on one face, and the identifying letters "C" and "AO" on either side of a central division line on the reverse; or, as an alternative, tablets impressed "ASPIRIN 300mg" around the circumference on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aspirin has analgesic, antipyretic and anti-inflammatory actions. It is indicated for: 1) The relief of headache, toothache, migraine, neuralgia, sore throat, dysmenorrhoea. 2) The symptomatic relief of influenza, feverishness, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pains. 3) It also has an antithrombotic action, mediated through inhibition of platelet activation, which has been shown to be useful in secondary prophylaxis following myocardial infarction, and in patients with unstable angina and cerebral transient ischaemic attacks. 4.2 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, unless specifically indicated (e.g. for Kawasaki’s disease). _Antithrombotic action:_ For its antithrombotic effect following myocardial infarction, transient ischaemic attack, or in patients with unstable angina, the recommended dose is 300mg daily. _Method of Administration _ For oral administration. 4.3 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 patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria ind Read the complete document