Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tolfenamic acid
A A H Pharmaceuticals Ltd
M01AG02
Tolfenamic acid
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401
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. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Tolfenamic Acid 200mg Tablets are and what they are used for 2. Before you take Tolfenamic Acid 200mg Tablets 3. How to take Tolfenamic Acid 200mg Tablets 4. Possible side effects 5. How to store Tolfenamic Acid 200mg Tablets 6. Further information 1. WHAT TOLFENAMIC ACID 200MG TABLETS ARE AND WHAT THEY ARE USED FOR Tolfenamic acid is one of a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain. Tolfenamic Acid 200mg Tablets are effective in treating the pain associated with an acute attack of migraine in adults. 2. BEFORE YOU TAKE TOLFENAMIC ACID 200MG TABLETS DO NOT TAKE TOLFENAMIC ACID 200MG TABLETS IF YOU • are allergic (hypersensitive) to tolfenamic acid or any of the other ingredients of Tolfenamic Acid 200mg Tablets (See section 6 for a full listing) • have previously experienced allergic reactions (e.g. asthma, nasal discharge, nettle rash or swelling of the face, lips, tongue or throat) when taking ibuprofen, aspirin or other NSAIDs • have severe liver, kidney or heart failure • are in your last three months of pregnancy • have or have ever had a peptic ulcer or peptic bleeding (ulcer or bleeding in your stomach or duodenum) • have ever had bleeding in your digestive tract due to NSAID treatment The use of this medicine in children is not recommended. TAKE SPECIAL CARE WITH TOLFENAMIC ACID 200MG TABLETS IF YOU • are taking other NSAIDs including NSAIDs known as COX-2 inhibitors • are elderly • have or have had asthma • have decrease Read the complete document
1. NAME OF THE MEDICINAL PRODUCT Clotam ® Rapid Tolfenamic Acid 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tolfenamic acid 200 mg. 3 PHARMACEUTICAL FORM Tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute migraine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see 4.4 Special warnings and precautions for use). ADULTS Migraine - acute attacks: 200mg when the first symptoms of migraine appear. The treatment can be repeated once after 1-2 hours if a satisfactory response is not obtained. CHILDREN A paediatric dosage regimen has not yet been established. ELDERLY The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. Method of administration For oral administration. To be taken preferably with or after food. 4.3 CONTRAINDICATIONS Hypersensitivity to tolfenamic acid or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. Severe heart failure, hepatic failure and renal failure (see 4.4 Special warnings and precautions for use). During the last trimester of pregnancy (see 4.6 Pregnancy and lactation). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE _In all patients_: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see 4.2 Posology and administration, an Read the complete document