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Tolfenamic acid tablets


Tablets containing tolfenamic acid.

Drugs List

  • tolfenamic acid 200mg tablets
  • Therapeutic Indications


    Acute migraine



    200 mg when the first symptoms of migraine appear. Treatment may be repeated once after 1 to 2 hours if a satisfactory response was not obtained initially.


    200 mg when the first symptoms of migraine appear. Treatment may be repeated once after 1 to 2 hours if a satisfactory response was not obtained initially.

    These patients are at increased risk of the serious consequences of adverse reactions.


    Children under 18 years
    Gastrointestinal haemorrhage
    History of gastrointestinal haemorrhage
    History of gastrointestinal haemorrhage secondary to NSAID
    History of gastrointestinal perforation
    History of peptic ulcer
    Peptic ulcer
    Renal impairment - glomerular filtration rate below 10ml/minute
    Severe cardiac failure
    Severe hepatic impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Females attempting to conceive
    Risk factors for cardiovascular disorder
    Cardiac impairment
    Cerebrovascular disorder
    Congestive cardiac failure
    Connective tissue disorder
    Crohn's disease
    First trimester of pregnancy
    Hepatic impairment
    History of asthma
    History of cardiac failure
    History of gastrointestinal disorder
    History of gastrointestinal ulceration
    Ischaemic heart disease
    Occlusive peripheral arterial disease
    Renal impairment - glomerular filtration rate 10-20ml/minute
    Second trimester of pregnancy
    Systemic lupus erythematosus
    Ulcerative colitis
    Uncontrolled hypertension

    May precipitate bronchospasm in patients with asthma or allergy
    NSAIDs may provoke or exacerbate asthma
    Advise ability to drive/operate machinery may be affected by side effects
    Consider the need for combination therapy with gastroprotective agents
    Discontinue if signs of gastro-intestinal bleeding occur
    Monitor renal function in patients with cardiac impairment
    Monitor renal function in patients with hepatic impairment
    Discontinue if signs of gastro-intestinal ulceration occur
    Risk of gastro-intestinal bleeding increased in the elderly
    Severe gastro-intestinal side effects may occur without warning
    Discontinue if rash with systemic, allergic or mucosal symptoms occurs
    Discontinue treatment if rash occurs
    Maintain treatment at the lowest effective dose
    Female: Reduced fertility (reversible) possible with long term use
    Advise patients to report skin rash

    NSAIDs may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Caution should be taken and renal function should be monitored in patients with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.

    Pregnancy and Lactation


    Tolfenamic acid is contraindicated in the third trimester of pregnancy due to the risk of closure of the ductus arteriosus.

    The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. Risk of possible persistent pulmonary hypertension in the newborn.

    Tolfenamic acid should not be used during the first and second trimesters unless the potential benefit to the patient outweighs the potential risk to the foetus. If short term use of an NSAID is required then ibuprofen at the recommended therapeutic doses would be the preferred choice.

    Schaefer (2007) recommends the use of more established NSAIDs, such as ibuprofen and diclofenac, during the first two trimesters. If NSAID therapy is absolutely necessary during the third trimester, foetal circulation should be monitored regularly (once or twice a week) with Doppler sonography, and medication should be stopped as soon as the first signs of ductal constriction appear. Oligohydramnios should be ruled out. If a drug, other than the more established drugs named above, of this group has been used in early pregnancy, there is no need for a termination of pregnancy or additional invasive diagnostic procedures.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use tolfenamic acid with caution in breastfeeding.

    The amount of tolfenamic acid present in breast milk is considered too small to be harmful, the use of tolfenamic acid should be avoided where possible in breast-feeding patients.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Abnormal kidney function
    Aggravation of existing asthma
    Aplastic anaemia
    Arterial thrombosis
    Aseptic meningitis
    Bullous dermatoses
    Cardiac failure
    Discolouration of urine
    Electrolyte disturbances
    Epidermal necrolysis
    Erythema multiforme
    Exacerbation of colitis or Crohn's proctocolitis
    Exfoliative dermatitis
    Eye changes
    Fluid retention
    Gastro-intestinal discomfort
    Gastro-intestinal perforation
    Gastro-intestinal ulceration
    Gastrointestinal bleeding
    Haemolytic anaemia
    Hepatic damage
    Hypersensitivity reactions
    Inhibition of platelet aggregation
    Interstitial fibrosis
    Interstitial nephritis
    Myocardial infarction
    Neck stiffness
    Nephrotic syndrome
    Non-specific allergic reactions
    Optic neuritis
    Papillary necrosis
    Peptic ulceration with perforation and haemorrhage
    Pulmonary eosinophilia
    Pulmonary infiltration
    Renal failure
    Stevens-Johnson syndrome
    Ulcerative stomatitis
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2014

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on July 18, 2014.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on July 18, 2014.

    Summary of Product Characteristics: Clotam Rapid. Galen Ltd. Revised October 2011.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    The Norwegian Porphyria Centre (NAPOS).
    Available at:
    Last revised: October 1, 2004
    Last accessed: July 18, 2014

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