Mefenamic acid STELLA 500 mg

OTC

Indications:

• 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.

Dosage:

• Adults: The usual dosage is 500 mg three times daily.
• Children 12-18 years, acute pain including dysmenorrhagia, 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.

Usage:

Mefenamic acid STELLA 500 mg is orally administered, preferably with or after food.

• Hypersensitivity to mefenamic acid or any of the other ingredients.
• 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 antiinflammatory 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 by pass graft surgery.

• Common: Diarrhoea; reversible steatorrhoea, colitis.
• Others: Blood and the lymphatic system disorders, immune system disorders, metabolism and nutritional disorders, psychiatric disorders, nervous system disorders, eye disorders, ear and labyrinth disorders, cardiac/ vascular disorders, effects on the kidneys, pancreatitis, porphyria.

Caution should be exercised when use Mefenamic acid STELLA 500 mg for:

• Patients suffering from dehydration and renal disease, particularly the elderly. Patients suffering from, or with a previous of bronchial asthma.
• Patients with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
• Patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema.
• Patients suffering from epilepsy.

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.

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis.

Mefenamic acid should be stopped at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

The use of mefenamic acid may impair female fertility.

Blood counts and liver and renal function should be monitored during long-term therapy.

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.

Treatment with Mefenamic acid STELLA 500 mg should be the lowest effective daily dose for the shortest duration possible.

Mefenamic acid STELLA 500 mg contains the azo colouring agents e.g., sunset yellow dye and tartrazine dye which may cause allergic reactions.

Mefenamic acid STELLA 500 mg 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. A decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking Mefenamic acid STELLA 500 mg. If affected, patients should not drive or operate machinery.