FEMIN

What it is

FEMIN capsules contain the active ingredient mefenamic acid 250 mg per capsule. FEMIN is a hard capsule formulation. Mefenamic acid is one of the fenamate series of non-steroidal anti-inflammatory agents.

Approved indications

— Treatment of primary dysmenorrhoea — Treatment of primary menorrhagia — Short-term relief of mild to moderate pain such as dental pain and soft tissue pain

Dosing overview

For dysmenorrhoea: 2 capsules (500 mg) three times daily with meals from the onset of pain and continued for the usual duration of pain. For menorrhagia: 2 capsules (500 mg) three times daily with meals and from the onset of menses and continued according to the judgement of the physician. Therapy should not be continued for more than 7 days except on the advice of a physician. For other indications: 2 capsules (500 mg) three times daily, with meals.

Key safety warnings

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with dose or duration of use. To minimise the potential risk for an adverse cardiovascular event in patients treated with mefenamic acid, especially in patients with cardiovascular risk factors, the lowest effective dose should be used for the shortest duration possible. NSAIDs, including mefenamic acid, can cause serious, potentially fatal gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine. The frequency of such events may increase with dose or duration of use, but can occur at any time without warning. NSAIDs may very rarely cause serious cutaneous adverse events such as drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and generalised bullous fixed drug eruption which can be fatal and occur without warning. FEMIN should be used with caution in known asthmatics.

Contraindications

FEMIN is contraindicated in patients showing evidence of chronic inflammation and/or active ulceration of either the upper or lower gastrointestinal tract and patients with pre-existing renal disease. FEMIN is contraindicated in patients in whom aspirin and/or other non-steroidal anti-inflammatory drugs have induced symptoms of bronchospasm, allergic rhinitis or urticaria, because the potential exists for cross-sensitivity. FEMIN is contraindicated in patients with impaired renal function and patients with severe hepatic impairment. FEMIN is contraindicated in patients previously experiencing diarrhoea on taking this drug. FEMIN is contraindicated in patients with severe heart failure. FEMIN is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. FEMIN is contraindicated in children under 14 years of age. FEMIN is contraindicated in patients in the third trimester of pregnancy or who are breastfeeding.

PBS listing

FEMIN 250 mg capsule is listed on the PBS as a restricted item with an ex-manufacturer price of A$4.56.

Regulatory history

FEMIN mefenamic acid 250 mg capsule was first registered on the Australian Register of Therapeutic Goods on 7 July 2017 (ARTG 275277). A second ARTG entry (ARTG 301375) was registered on 28 March 2018.