Mafepain belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs). These medicines reduce pain and inflammation, and bring down a high temperature.

Mafepain are most commonly used for relief of mild to moderate pain including muscle pains and pain after injury, headaches and toothaches, period pains and pain following an operation or after childbirth, pain due to rheumatoid arthritis and osteoarthrosis. It is also used to treat excessively heavy periods caused by abnormal function and presence of a contraceptive coil, where the disease in the pelvis has been ruled out.

DO NOT take Mafepain if:

• You are allergic to Mefenamic Acid or any of the other ingredients in these tablets (listed at the end of this leaflet)

• You currently have a stomach ulcer or bleeding

• You have suffered from stomach ulcers or bleeding two or more times in the past

• You suffer from inflammatory bowel disease

• You show any signs of allergy (such as asthma, hay fever or skin rash) to aspirin, ibuprofen or other NSAIDs. An allergic reaction may include swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.

• You have severe problems with your kidneys or liver

• You suffer from severe heart failure

• You had a major heart surgery

• You are in the last three months of pregnancy

• You are breast feeding.

Take special care with Mafepain and check with your doctor or pharmacist before taking your medicine if:

• You have had an ulcer or some other problem affecting your stomach, or intestines

• You have asthma or wheezing attacks (or if you have had asthma in the past)

• You have any heart, liver or kidney problems

• You are elderly

• You suffer from epilepsy

• You suffer from any abnormality of the blood

• You are dehydrated (for example you have been losing fluid through vomiting, diarrhoea or passing too much or too little, urine (fluids)

• You have frequent headaches

• You drink alcohol

• You have a connective tissue disorder e.g. Systemic Lupus Erythematosus (SLE) resulting in joint pain, skin change and disorders of other organs

• You have a problem with the metabolism of sugar in your body

• You are trying to get pregnant (see section pregnancy).

If you are having a medical examination, tell the doctor that you are taking Mafepain tablets as they reduce the signs of fever and inflammation which would otherwise be noticed.

Medicines such as Mafepain may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems or suffered from a previous stroke or think that you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or recently have taken any other medicines, including medicines obtained without a prescription.

Mafepain may affect or be affected by the following medicines

• Anticoagulants (drugs used to thin the blood to prevent blood clots, e.g. warfarin, heparin)

• Antiplatelet tablets (to prevent blood clots, e.g. clopidogrel)

• Antihypertensives (for the treatment of high blood pressure)

• Diuretics (to make you pass more water)

• Lithium (for depression)

• Medicines for the treatment of heart conditions (e.g. digoxin)

• Quinolone antibiotics (for an infection e.g. ciprofloxacin, norfloxacin and nalidixic acid)

• Any other NSAID (for painful or inflammatory conditions e.g. aspirin,

COX-2 selective inhibitors like (valdecoxib, paracoxib and refocoxib), ibuprofen)

• Mifepristone (used to terminate pregnancies)

• Methotrexate (which can be used to treat certain tumours and other diseases including psoriasis and rheumatoid arthritis)

• Ciclosporin or tacrolimus (used to suppress the body’s immune system, e.g. following transplants or in diseases such as psoriasis and rheumatoid arthritis)

• Corticosteroids (used for the treatment of asthma and various inflammatory conditions e.g. beclomethasone)

• Probenecid used in treatment of swollen joints

• Drugs used in diabetes (e.g. glibenclamide)

• Drug used as antibiotics (e.g. Gentamycin, Neomycin, Kanamycin)

• Zidovudine (an anti-viral drug)

• SSRIs such as fluoxetine or sertraline (for depression).

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Mafepain may make it difficult to become pregnant.

You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Mafepain should, if possible not be taken during pregnancy.

You should not take Mafepain if you are in the last three months of pregnancy or if you are breast feeding, speak to your doctor or pharmacist before taking these tablets. Mefenamic acid should not be given to the mother and the neonate, at the end of pregnancy, as there is a possibility of possible prolongation of bleeding time. During delivery, it may inhibit contractions of uterus resulting in delayed or prolonged delivery.

Driving and using machines

NSAIDs may sometimes cause symptoms such as drowsiness, dizziness, weakness and visual disturbances. If you notice any such symptoms, do not drive or operate machinery and ask your doctor or pharmacist for advice.

Important information about some of the ingredients of Mafepain tablets

This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Make sure you take your tablets exactly as directed by your doctor. You should check with your doctor or pharmacist if you are not sure.

Mafepain should be taken with or after food.

The tablets should be swallowed whole with water. Do not chew them.

Adults: The usual dose is one tablet three times each day.

For excessively heavy periods, start taking your medicine on the first day of excessive bleeding and continue as directed by your doctor.

For period pains, start taking your medicine when you first notice the pain and continue as directed by your doctor.

As a general principle, the smallest effective dose should be used.

Elderly: The adult dose can be used, although these tablets should be used with caution in patients suffering from dehydration or kidney failure.

Children: Mafepain are not recommended for use in children.

If you have a history of ulcers or some other problem affecting your stomach or intestines, you should inform your doctor or pharmacist if you notice any unusual symptoms affecting your abdomen(stomach) especially blood in your stomach, urine or stool, particularly if these symptoms occur during the initial phase of your treatment.

If you take more Mafepain than you should:

If you (or someone else) take too many of these tablets, you may experience headache, nausea, vomiting, pain in abdomen, blood in stool or vomiting, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ringing in ear, fainting, occasionally convulsions. In cases of significant poisoning acute kidney failure and liver damage are possible. Contact your doctor, or hospital immediately for advice. Bring the pack with any remaining tablets with you.

If you forget to take your Mafepain:

If you miss a dose, leave it out and take the next dose whenever it is due. After that, just carry on as before. Do not take double the dose.

If you have any further questions about these tablets, ask your doctor or pharmacist.

Like all medicines Mefenamic Acid can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Do not take if you have a peptic ulcer (ulcer in your stomach, or intestines) or bleeding in your stomach, or have had two or more episodes of peptic ulcer, stomach bleeding or perforation.

STOP TAKING the medicine and tell your doctor if you experience:

• Indigestion or heart burn

• Abdominal Pain (pains in your stomach) or other abdominal (stomach) symptoms.

If you suffer from any of the following at anytime during your treatment STOP TAKING the medicine and see a doctor immediately.

• Pass blood in your stools

• Pass loose stool (Diarrhoea)

• Pass black tarry stools

• Vomit any blood or dark particles that look like coffee grounds.

Other Side Effects:

• Mouth ulcers, malaise, fatigue, unexplained bruising, fever or sore throat may occasionally occur, if you notice any of these symptoms speak to your doctor as they may be signs of a blood disorder

• If a skin rash or jaundice (yellowing of the skin or whites of eyes) occur, tell your doctor

• Nausea (feeling sick), vomiting (being sick), loss of appetite

• Fits

• Rapid heart beats

• Reactions to the sun

• You may notice urinary symptoms such as blood in the urine or an increase or decrease in the amount of urine, ankle swelling and reduced salt levels in the body

• Symptoms such as sleep disturbance, depression, confusion, nervousness, hallucinations, noise in the ears or impaired hearing, vertigo, dizziness, tingling or other odd sensations, problems with your eyesight or drowsiness have occasionally been reported

• Symptoms of aseptic meningitis such as, over-reaction of the skin to sunlight, persistent headache, a stiff neck, fever, drowsiness or muscle pain may occur in some patients (especially in patients with existing autoimmune disorders, such as systemic lupus

erythematosus, mixed connective tissue disease)

• Medicines such as mefenamic acid may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Your doctor may try to minimise any undesirable effect by giving you the lowest effective dose of Mafepain for the shortest amount of time necessary to control your symptoms.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Store below 30°C

Do not use Mafepain after the expiry date which is stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.