国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Almus Pharmaceuticals Ltd
N02BA01
Aspirin
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
ASPIRIN 300MG TABLETS PATIENT INFORMATION LEAFLET READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor or pharmacist if your symptoms worsen or do not improve. _ _ IN THIS LEAFLET: 1. WHAT THIS MEDICINE IS FOR 2. BEFORE YOU TAKE THE MEDICINE 3. HOW TO TAKE THE MEDICINE 4. POSSIBLE SIDE EFFECTS 5. STORING THE MEDICINE 6. FURTHER INFORMATION 1. WHAT THIS MEDICINE IS FOR Aspirin 300mg Tablets contain aspirin, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature. This medicine is used to relieve: • sprains, strains, rheumatic pain, muscular aches and pains, sciatica (pain in the back of the thigh) and lumbago (lower back pain) • fibrositis (joint pain), joint swelling and stiffness • neuralgia (nerve pain) • headache and migraine • dental pain, period pain • sore throat and fever (high temperature) • the symptoms of colds and flu. 2. BEFORE YOU TAKE THE MEDICINE DO NOT TAKE ASPIRIN 300MG TABLETS IF YOU: • are under 16 years old, unless your doctor tells you to • have or have ever had a stomach ulcer, perforation or bleeding • are allergic to aspirin, to any of the ingredients (listed in section 6), or to ibuprofen or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching) • have severe kidney or liver disease • suffer from a bleeding disorder (e.g. haemophilia), or are taking medicines to thin your blood, asthma or gout • are taking other NSAID painkillers (e.g. ibuprofen, naproxen) • are taking medicines for thinning the blood (anticoagulants) • are in the last 3 months of pregnancy or are breastfeeding TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING ASPIRIN 300MG TABLETS IF YOU: • have asthma or have suffered from asthma 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin 300mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet containsAspirin 300mg. For excipients see Section 6.1 3 PHARMACEUTICAL FORM Tablet White circular with break line on one face 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Anti-inflammatory indications: Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, muscular aches, fibrositis, joint swelling and stiffness. Analgesic and antipyretic indications: Mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of influenza and feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Adults & children over 16 years: 1 - 3 tablets every four hours, or as directed by a doctor. Not more than 4 doses in 24 hours. Do not give to children aged under 16 years, unless Aspirin has been specifically prescribed for that child (e.g. for Kawasaki’s disease). Elderly: A lower dose is recommended. The tablets to be taken orally with water. 4.3 CONTRAINDICATIONS Aspirin is contraindicated in patients with; • active peptic ulceration or a history of peptic ulceration. • Haemophilia, haemorrhagic disease or a history of bleeding disorders. • Gout or a history of gout. • Hypersensitivity to aspirin (e.g. asthma, rhinitis, angioedema or urticaria), other NSAIDs or other tablet excipients • During the third trimester of pregnancy 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children under 16 years unless specifically indicated (e.g. for Kawasaki’s disease). Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose- galactose malabsorption should not take aspirin. Patients should be warned: • 完全なドキュメントを読む