Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Almus Pharmaceuticals Ltd
N02BA01
Aspirin
300mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
DISPERSIBLE ASPIRIN 300MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. INDEX 1 1. WHAT DISPERSIBLE ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE 3. HOW TO TAKE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE 6. FURTHER INFORMATION 1 1. WHAT DISPERSIBLE ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR Dispersible Aspirin tablets belong to a group of medicines which have analgesic (pain relieving), anti-inflammatory (inflammation reducing) and anti-pyretic (temperature reducing) properties. These tablets may be used for the relief of: • headache, toothache, migraine, neuralgia (nerve pain), sore throat or period pains. • symptoms of influenza, feverishness, rheumatic pains, sciatica (nerve pain of the leg/back), lumbago (lower back pain), fibrositis (muscular rheumatism), muscular aches and pains. 2. BEFORE YOU TAKE DO NOT TAKE Dispersible Aspirin tablets and TELL your doctor if you have: • an ALLERGY (hypersensitivity) to aspirin, salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) or other ingredients in the product. You may have developed difficulty breathing, a runny nose, itchy skin or swelling after taking aspirin or a NSAID previously (see section 6) • a STOMACH ULCER or a history of ulcers or INDIGESTION • BLEEDING in the STOMACH and/or INTESTINES , or other kinds of bleeding such as BLEEDING from the BLOOD VESSELS OF THE BRAIN • NASAL POLYPS associated with ASTHMA • HAEMOPHILIA or other BLOOD CLOTTING disorder or are taking medicines to thin the blood. • SEVERE liver, kidney or heart failure • are in the THIRD trimester of pregnancy • taking METHOTREXATE (more than 15mg a week) • a child UNDER 16 years old. IMPORTANT WARNING: There is a possible association between asp Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dispersible Aspirin Tablets 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg Aspirin 3 PHARMACEUTICAL FORM White uncoated tablets 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be dispersed in water before administration. ADULTS INCLUDING ELDERLY: _ _1-2 tablets at intervals of not less than 4 hours, to a maximum of four doses in 24 hours. CHILDREN: Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). To be dispersed in water for oral use. 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 induced by aspirin or other NSAIDs). • Nasal polyps associated with asthma (high risk of severe sensitivity reactions). • Active, or history of recurrent peptic ulcer, dyspepsia and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages. • Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia. • Concurrent anticoagulant therapy should be avoided. • Severe hepatic impairment • Severe renal impairment • Severe cardiac failure • Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); • Methotrexate used at doses >15mg/week (see section 4.5). • children under 16 years old, unless specifically indicated (e.g. Kawasaki’s disease). 4.4 SPECIAL WARNINGS AND Read the complete document