Opustan 500
PATIENT INFORMATION LEAFLET
MEFLAM 500
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.
In this leaflet:
1. What are Meflam 500 and what they are used for
2. Before you take Meflam 500
3. How to take Meflam 500
4. Possible side effects
5. How to store Meflam 500
6. Further information
1. WHAT ARE MEFLAM 500 AND WHAT ARE THEY USED FOR
Meflam 500 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.
Meflam 500 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.
2. BEFORE YOU TAKE MEFLAM 500 DO NOT take Meflam 500 if:
• You know that you are allergic to Meflam 500 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 kidney or liver
You suffer from severe heart failure
• You had a major heart surgery
• You are in the last three months of pregnancy
Take special care with Meflam 500 and check with your doctor or pharmacist before taking your medicine if:
• You have asthma or wheezing attacks (or if you have had asthma in the past)
• You have had an ulcer or some other problem affecting your stomach or intestines
• You have any heart, liver or kidney problems
• You are elderly
• You suffer from epilepsy (fits)
• 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 on pregnancy).
If you are having a medical examination, tell the doctor that you are taking Meflam 500 as they reduce the signs of fever and inflammation which would otherwise be noticed.
Medicines such as Meflam 500 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 having recently taken any other medicines, including medicines obtained without a prescription.
Meflam 500 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. clopidogel)
• Antihypertensives (for the treatment of high blood pressure)
• Diuretics (to make you pass more water)
• Lithium (for depression)
• Medicines for the treatment of heart failure (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 sertaline (for depression).
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine. Contraflam 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. Contraflam should, if possible not be taken during pregnancy.
It is possible that you may be able to take Mefenamic acid tablets whilst you are breast feeding but you should speak to your doctor or pharmacist before taking these tablets.
Driving and using machines
NSAIDs may sometimes cause symptoms such as dizziness, drowsiness, weakness and visual disturbances. If you notice any such symptoms, do not drive or operate machinery and ask your doctor or pharmacist for advice.
3. HOW TO TAKE MEFLAM 500
Make sure you take your tablets exactly as directed by your doctor.
The instructions will be written on the label. You should check with your doctor or pharmacist if you are not sure.
Meflam 500 should be taken with or after food.
The Tablets should be swallowed whole with water.
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: Meflam 500 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 Meflam 500 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 container with any remaining tablets with you.
If you forget to take your Meflam 500:
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Meflam 500 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/motions
• 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 ocassionally 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, reduced salt level in the body.
• Symptoms such as sleep disturbance, depression, confusion, nervousness, hallucinations (imagining sensations), 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 auto immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease).
• Medicines such as Meflam 500 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 minimize any undesirable effect by giving you the lowest effective dose of Mefenamic acid tablets 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.
Do not use Meflam 500 after the expiry date which is stated on the label. They should be stored in a cool, dry place, below 25°C. Keep in original container to protect from light.
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.
Remember:
This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.
6. FURTHER INFORMATION
What Meflam 500 contain
Each Meflam 500 tablet contains 500mg of the active substance, mefenamic acid.
The other ingredients are microcrystalline cellulose, sodium starch glycollate, gelatin, purified water, magnesium stearate, croscarmellose sodium, colloidal silicon dioxide, methanol, methylene chloride, ethylcellulose, diethyl phthalate, methylcellulose, methocel, opaspray yellow K-I-6455.
What Meflam 500 look like and contents of the pack
Meflam 500 are caplet shaped, yellow, film-coated tablets, embossed with ‘a’ and ‘MA500’ on one side. They are packed in polypropylene securitainers with child proof lids (50, 84, 100 and 168).
Marketing Authorisation Holder and Manufacturer:
Mercury Pharmaceuticals Ltd
No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK.
This leaflet was last revised in September 2012.