Mefenamic acid .................................. 500 mg
Excipients q.s...................................... 1 tablet
Film coated tablet.
Box of 3 blisters x 10 tablets.
The drug has no effects on ability to drive and operate machinery.
Mefenamic acid should be used with caution in pregnant women and nursing mothers.
It is considered not to take the drug in combination with oral anticoagulant drugs, heparin by injection, other NSAIDs, high-dose salicylate, lithium, dose of methotrexate more than 15 mg/week, ticlopidine.
Association requiring precautions: diuretics, dose of methotrexate less than 15 mg/week, pentoxifylline, zidovudine.
Association, which must be taken into consideration: antihypertensive drugs (e.g. beta-blockers, angiotensin converting enzyme inhibitors, diuretics), thrombolytic agents.
Gastrointestinal disturbances: diarrhoea, nausea, vomiting, flatulence, constipation, skin rash, pruritus. Bronchial asthma may occur in patients who are allergic to aspirin and other NSAIDs. Renal failure, hepatic failure, temporary lowering of the white blood cell count, thrombocytopenia, dizziness, vertigo.
Cardiovascular thrombotic events (see Warnings and precautions).
Inform a physician about any adverse effects occur during the treatment.
Symptoms following overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care.
There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Patients should be managed by symptomatic treatment.
Store in dry places, not exceeding 30oC, protect from light.
PONCIFDHG contains the main active ingredient Mefenamic acid which exhibits analgesic, anti-inflammatory and antipyretic activities. It works by blocking the action of cyclooxygenase (COX), an enzyme involved in the synthesis of prostaglandin which plays a major role in disease-producing mechanism of inflammation, pain, and fever processes.
The drug should be withdrawn if rash, gastrointestinal hemorrhage or diarrhea occur.
Cardiovascular thrombotic events: Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.
Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.
To minimize the potential risk for an adverse cardiovascular event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
For relief of pains, including myalgia, traumatic injuries, toothache, headache, postoperative pains, postnatal pains, and dysmenorrhea.
As an anti-inflammatory for rheumatoid arthritis, osteoarthritis.
Menorrhagia accompanied by spasms and hypogastric pain. Relief of symptoms associated with pre-menopausal phase.
Hypersensitivity to mefenamic acid and other NSAIDs, aspirin. Progressive gastro-duodenal ulcer. Severe hepatic failure, severe renal failure.
Children less than 14 years of age.
The drug should be taken preferably with food. Each treatment course does not allow exceeding 7 days.
Adults and children aged more than 14 years: oral dose of 1 tablet x 3 times daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
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