Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tolfenamic acid
Galen Ltd
M01AG02
Tolfenamic acid
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 07613421000011
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
OBJECT 1 Tolfenamic Acid 200mg Tablets Summary of Product Characteristics Updated 22-Apr-2021 | Galen Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 lowe Read the complete document