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Analgesics & Antipyretics

Mefenamic acid STADA® 500 mg


Pack size:

Box of 1 bottle x 100 film-coated tablets.

 

Composition:

Each film-coated tablet contains mefenamic acid 500 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Mild to moderate pain including headache, dental pain, postoperative and postpartum pain, and dysmenorrhoea.
  • Musculoskeletal and joint disorders such as osteoarthritis and rheumatoid arthritis.
  • Menorrhagia.

    Mefenamic acid STADA® 500 mg is administered orally. It is taken preferably with or after food.
     
  • Adults: The usual dosage is 500 mg three times daily.
  • Children 12-18 years, acute pain including dysmenorrhoea, menorrhagia: 500 mg three times daily.
  • Children under 12 years: Not recommended for children under 12 years.
  • In the treatment of mild to moderate pain, mefenamic acid should not be given for longer than 7 days at a time.

Or as advised by physicians.

 

  • Hypersensitivity to mefenamic acid or to any ingredient of the drug.
  • Inflammatory bowel disease.
  • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
  • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
  • Severe heart failure, hepatic failure and renal failure.
  • Because the potential exists for cross-sensitivity to aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs, mefenamic acid must not be given to patients who have previously shown hypersensitivity reaction (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) to these medicines.
  • During the last trimester of pregnancy.
  • Treatment of pain after coronary artery bypass graft surgery.

     

The most frequently reported side effects associated with mefenamic acid involve the gastrointestinal tract. Diarrhoea occasionally occurs following the use of mefenamic acid and may also occur after several months of continuous use. Reversible steatorrhoea has occurred with mefenamic acid; it may also provoke colitis in patients without a history of this condition.

Frequencies are not known for the following adverse reactions:

  • Haemolytic anaemia (reversible when mefenamic acid is stopped), anaemia, hypoplasia bone marrow, hematocrit decreased, thrombocytopenic purpura, temporary lowering of the white blood cell count (leukopenia)  with a risk of infection, sepsis, and disseminated intravascular coagulation. Agranulocytosis, aplastic anaemia, eosinophilia, neutropenia, pancytopenia, thrombocytopenia.
  • Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of non-specific allergic reactions and anaphylaxis respiratory tract reactivity comprising asthma, bronchospasm, or dyspnoea or assorted skin disorder including rashes of various types, pruritus, urticaria, purpura, angioedema, and more rarely exfoliative or bullous dermatoses (including epidermal necrolysis and erythema multiform).
  • Glucose intolerance in diabetic patients, hyponatraemia.
  • Confusion, depression, hallucinations, nervousness.
  • Optic neuritis, headaches, paraesthesia, dizziness, drowsiness, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, blurred vision, convulsions, insomnia.
  • Eye irritation, reversible loss of color vision, visual disturbances.
  • Ear pain, tinnitus, vertigo.
  • Oedema, hypertension and cardiac failure have been reported in association with NSAIDs treatment.
  • There has been a subsequent report of non-oliguric renal failure in elderly patients given mefenamic acid for musculoskeletal pain.
  • A report of pancreatitis associated with mefenamic acid.
  • Mefenamic acid is considered to be unsafe in patients with porphyria although there is conflicting experimental evidence of porphyrinogenicity.
  • Mefenamic acid may give a false positive in some tests for the presence of bile in the urine.
  • Risk of cardiovascular thrombotic events (see section Precautions).

     

  • Patients suffering from dehydration and renal disease, particularly the elderly.
  • Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
  • Respiratory disorders: Patients suffering from, or with a previous of bronchial asthma.
  • Cardiovascular, renal and hepatic impairment: The administration of an NSAIDs may cause a dose dependant reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
  • Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention, oedema have been reported in association with NSAIDs therapy.
  • Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Smoking and alcohol use are added risk factors.
  • SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
  • Skin reactions: Serious skin reactions, some of them fatal, including exfoliate dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrobiosis, have been reported in association with use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Mefenamic acid should be stopped at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
  • Female fertility: The use of mefenamic acid may impair female fertility.
  • Epilepsy: Caution should be exercised when treating patients suffering from epilepsy.
  • Blood counts and liver and renal function should be monitored during long-term therapy.
  • Risk of cardiovascular thrombotic events: Systemic non-aspirin nonsteroidal anti-inflammatory  drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including  myocardial infarction and stroke, either of which can be fatal. This risk may occur as early as the  first weeks of treatment and may increase with duration of use. The cardiovascular thrombotic risk has been observed most consistently at higher doses.
    Physicians should assess periodically appearance of cardiovascular adverse events, even in the  absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of  serious cardiovascular events and seek physicians immediately if these symptoms occur.
  • To minimize the risk for an adverse cardiovascular event in patients treated with Mefenamic acid  STADA® 500 mg, prescribe the lowest effective daily dose for the shortest duration possible.
  • Pregnancy: Congenital abnormalities have been reported in association with NSAIDs administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy in contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
  • Lactation: Mefenamic acid is distributed into milk. Because of the potential for adverse effects from mefenamic acid on the cardiovascular system in infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
  • Effects on ability to drive and use machines: Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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