Patient leaflet - MEFENAMIC ACID 500 MG FILM-COATED TABLETS
In this leaflet:
1. What this medicine is and what it is used for
Mefenamic Tablets contain mefenamic acid which is a nonsteroidal anti-inflammatory drug (NSAID).
They can help to relieve:
- symptoms of inflammation, such as redness and swelling
- pain and discomfort caused by arthritis, muscular or rheumatic disorders
- headache, muscle ache or toothache
- pain after operations, trauma
- childbirth pain
- painful or heavy periods.
2. Before you take
Do NOT take Mefenamic Tablets if you:
- are allergic to mefenamic acid, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or to any of the other ingredients (see Section 6)
- have, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach or severe gastritis
- have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)
- have severe heart, liver or kidney problems
- have just had heart bypass surgery
- are more than 6 months pregnant.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Mefenamic Tablets
Before taking the tablets, tell your doctor if you:
- are taking any other NSAIDs (e.g. ibuprofen, diclofenac)
- are taking any other anti-inflammatory medicines including steroids (e.g. prednisolone)
- are taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel)
- are taking antidepressants called selective serotonin re- uptake inhibitors (SSRIs) (e.g. paroxetine)
- have kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment
- are elderly (see Section 3)
- are trying to become pregnant (see Section on Fertility)
- have stomach or digestive tract problems or if you ever had an upset stomach after taking pain killers such as aspirin. Bleeding in the stomach or gut can occur in patients taking Mefenamic Tablets
- have a bleeding disorder or if you are going to have a major operation. Mefenamic Tablets can affect the clotting of your blood. It can make you bleed more and for longer than usual
- have asthma, or a history of asthma, as this medicine may cause breathing difficulties
- have a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE)
- have epilepsy
- are dehydrated (thirsty with dry skin, dark urine, dry mouth, headache)
- have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker). Additional monitoring may be carried out by your doctor.
Medicines such as Mefenamic Tablets may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Mefenamic Tablets or they may affect how well Mefenamic Tablets will work. Tell your doctor or pharmacist if you are taking:
- medicines that can increase the chance of getting ulcers or a bleed in the stomach or gut, such as:
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– corticosteroids used to treat arthritis and inflammation
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– medicines such as anti-platelet agents, used to thin the blood (e.g. warfarin, aspirin, clopidogrel)
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– antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g.paroxetine)
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– any other anti-inflammatory medicines (e.g. diclofenac, celecoxib)
- aspirin including low doses of aspirin used to prevent your blood from clotting in certain heart conditions.
- medicines used for high blood pressure (e.g. atenolol, ramipril, valsartan)
- diuretics (water tablets) or heart medicines (e.g. digoxin, sotalol, diltiazem)
- some diabetic medicines (e.g. glipizide, glibenclamide)
- medicines which suppress the immune system (e.g. ciclosporin, tacrolimus, methotrexate)
- lithium, a medicine used to treat mood swings and some types of depression
- a medicine usually prescribed through hospitals, called mifepristone (taken within the last 12 days)
- quinolone antibiotics (antibiotics used to treat infections)
- aminoglycoside antibiotics, used under medical supervision in hospitals
- zidovudine, a medicine used for HIV
- probenecid, a medicine used in special cases, to protect the kidneys
- medicines which bind to protein in the blood – (check with your pharmacist).
Blood tests
Your doctor may test your blood during treatment.
Pregnancy and breast feeding
Pregnancy
Mefenamic acid will be passed to your unborn baby. It is not known how much it will affect your unborn baby in the first 6 months of pregnancy.
DO NOT take the tablets in the last 3 months of pregnancy as they may delay the onset of labour and prolong its duration. They may also increase the likelihood of bleeding in the mother and in the baby.
If you need to take these tablets, your doctor can help you decide whether or not to take them during the first 6 months of pregnancy.
Breast-feeding
Mefenamic acid passes into breast milk and can affect the baby.
You should not take the tablets while breast-feeding unless advised by your doctor.
Fertility
DO NOT take the tablets if you are trying to become pregnant, as they may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Mefenamic Tablets may cause drowsiness, dizziness, fatigue or affect your vision. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert.
Important information about some of the ingredients of Mefenamic Tablets
lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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sunset yellow
This may cause allergic reactions.
3. How to take
Always take Ponstan Forte tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
- Take the tablets with or immediately after a meal.
- Do NOT drink alcohol while taking Mefenamic Tablets. Alcohol and smoking can irritate the stomach and make some of the side effects worse.
Doses
Adults and the elderly: the usual dose is 1 tablet three times a day.
Elderly patients are at a higher risk of side effects and should take the lowest effective dose for the shortest possible time, with additional monitoring carried out by their doctor.
Children: this medicine is NOT suitable for children under 12 years.
If you take more than you should
If you take more tablets than you should you may harm your stomach, kidneys and you may get seizures (fits).
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1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
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2. Take the container and any remaining tablets with you so that people can see what you have taken.
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3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Mefenamic Tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:
- difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised lumps
- blistering of the mouth, eyes, and genital region, and patchy areas of rash, peeling skin
or any of the following reactions
- diarrhoea
- passing blood in your stools (faeces/motions)
- passing black tarry stools
- vomiting any blood or dark particles that look like coffee grounds.
Seek immediate medical attention if you have any of the following symptoms:
- indigestion or heartburn, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting
- any unusual bruising or bleeding, for example nose-bleeds, pinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth
- signs of anaemia such as feeling tired, breathless, and looking pale
- fever, sore throat, mouth ulcers, repeated infections or infections that will not go away. This may be due to a low level of white blood cells
- seizures (fits)
- signs of low sodium levels such as headache, nausea, vomiting, tiredness, muscle cramps
- sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash
- fever, rash, nausea, aches and pains, passing more or less urine than usual, passing red urine or passing urine at night. This may be due to changes in your kidneys
- sudden loss or blurring of vision, loss of colour vision, eye pain which worsens with eye movement
- headache, in particular on waking in the morning. This may be due to high blood pressure
- pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas
- yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to changes in your liver.
Tell your doctor if you get any of the following side effects:
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Your doctor or pharmacist can measure your sugarlevels
- asthma or asthma that is worse than usual
- swelling of your hands and feet (around the ankles)
- sore mouth (pain or ulcers on the tongue, cheeks, lips, throat or gums)
- dizziness, drowsiness, feeling lethargic and tired
- signs of low blood pressure such as light-headedness
- reactions to the sun. Your skin may become red, painful and swollen – do not sunbathe, use a sun bed, or expose your skin to artificial UV light.
Medicines such as Mefenamic Tablets may be associated with a small increased risk of heart attack or stroke. (See Section 2 – end of ‘Take special care’).
Urine tests: Tell the doctor if you are having urine tests, as your medicine may affect the results.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store
- Keep out of the sight and reach of children.
- Do not store above 30°C. Store in the original package.
- Do not use your tablets after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month.
- If your tablets become discoloured or show signs of deterioration seek the advice of your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
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6. Further information
- Each tablet contains the active ingredient mefenamic acid 500 mg.
- Also includes lactose monohydrate, pregelatinised maize starch, maize starch, povidone, silicon dioxide, talc, magnesium stearate, croscarmellose sodium type A, sodium laurilsulfate.
What Mefenamic Tablets look like and contents of the pack
Yellow, film-coated tablets marked ‘PONSTAN FORTE’ on one side and plain on the reverse.
Supplied as 30 tablet pack size.
Manufactured by : Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton, BD23 2RW, UK.
Procured from within the EU and Repackaged by PL holder:
PilsCo Ltd, 10–16 Colvilles Place, East Kilbride, G75 0SN.
PL 39467/0335 Mefenamic acid 500 mg Film-coated Tablets
Leaflet date: 01/02/2018 -------
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