MEFLAM 250, OPUSTAN 250, CONTRAFLAM, MEFENAMIC ACID 250 MG CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - MEFLAM 250, OPUSTAN 250, CONTRAFLAM, MEFENAMIC ACID 250 MG CAPSULES

Package leaflet: Information for the user

MEFLAM 250mg Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What MEFLAM 250mg Capsules are and what they are used for
2. What you need to know before you take MEFLAM 250mg Capsules

3. How to take

4. Possible side effects

5. How to store

6. Contents of the pack and other information

1. What MEFLAM 250mg Capsules are and what they used for

MEFLAM 250mg Capsules belongs to a group of medicines called non-steroid antiinflammatory drugs (NSAIDs). These medicines reduce pain and inflammation, and bring down a high temperature. MEFLAM 250mg Capsules 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. what you need to know before you take meflam 250mg capsules if you are allergic to mefenamic acid or any of the other ingredients of this medicine (listed in section 6)

if you currently have a stomach ulcer or bleeding
if you have suffered from stomach ulcers or bleeding two or more times in the past
if you suffer from inflammatory bowel disease
if 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
if you have severe problems with your kidneys or liver
if you suffer from severe heart failure
if you had a major heart surgery
if you are in the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking MEFLAM 250mg Capsules

if you have had an ulcer or some other problem affecting your stomach, or intestines
if you have asthma or wheezing attacks (or if you have had asthma in the past)
if you have any heart, liver or kidney problems
if you are elderly
if you suffer from epilepsy (fits)
if you suffer from any abnormality of the blood
if you are dehydrated (for example you have been losing fluid through vomiting, diarrhoea or passing too much or too little, urine (fluids)
if you have frequent headaches

if you drink alcohol

if you have a connective tissue disorder e.g. Systemic Lupus Erythematosus (SLE) resulting in joint pain, skin change and disorders of other organs
if you have a problem with the metabolism of sugar in your body
if 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 250mg Capsules as they reduce the signs of fever and inflammation which would otherwise be noticed.

Medicines such as MEFLAM 250mg Capsules 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.

Other medicines and MEFLAM 250mg Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

MEFLAM 250mg Capsules 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 sertaline (for depression).

Pregnancy, breast feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine. MEFLAM 250mg Capsules 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. MEFLAM 250mg Capsules should, if possible not be taken during pregnancy.

You should not take MEFLAM 250mg Capsules 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 capsules. 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 MEFLAM 250mg Capsules

MEFLAM 250mg Capsules contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. how to take meflam 250mg capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. MEFLAM 250mg Capsules should be taken with or after food. The capsules should be swallowed whole with water. Do not chew them or break them.

Adults: The recommended dose is two Capsules 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.

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

Use in Children: MEFLAM 250mg Capsules 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 250mg Capsules than you should

If you (or someone else) take too many of these capsules, 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 Capsules with you.

If you forget to take MEFLAM 250mg Capsules:

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 a double dose to make up for a forgotten capsule. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 MEFLAM 250mg Capsules 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:

The following side effects have been reported since the marketing of Meflam but the frequency for them to occur is not known (frequency cannot be estimated from the available data):

Effects on blood:

– Abnormalities in blood affecting cells in the blood and decrease of haemoglobin in blood

(anaemia) causing pallor and tiredness. These effects may result in unusual bruising or bleeding or increased risk of infection

Effects on your nervous system:

– Dizziness
– Vertigo (a spinning sensation)
– Headache
– Changes in sleep patterns
– Depression
– Hallucinations
– Nervousness

Effects on your eyes and ears:

– Hearing impairment, ringing in ears, pain in ears
– Swollen eyes, blurred vision, eye irritation and loss of colour vision

Effects on heart, chest and circulation:

– Fast or pounding heartbeat, breathlessness, high blood pressure, swollen ankles and/or

feet (oedema)

Medicines such as Ponalgic may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Effects on the stomach and digestive system:

– Constipation,
– Inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or

lips, taste changes,

– Lower gut disorders (including inflammation of the colon, or worsening of ulcerative

colitis or Crohn’s disease).

Elderly patients are more susceptible to stomach or intestinal bleeding which could be more serious as compared to those occurring in younger patients. Stop taking this medicine and see your doctor immediately if you experience any symptoms of stomach or intestinal bleeding; passing black or bloodstained stools or vomiting blood.

Effects on the liver:

– Severe liver disorders including liver failure

Effects on kidneys:

– Kidney inflammation,
– Kidney failure or kidney damage.

If you notice any change in your urine output or appearance, possibly accompanied by kidney pain, or pain in your abdomen or back contact your doctor

Effects on skin:

– Rashes, itching, redness, tenderness, thickening or scaling of skin,
– Loosening or splitting of fingernails
– Hair loss
– Increased sensitivity of the skin to sunlight

Other side effects that have been reported include:

- Inflammation of the pancreas (which may lead to severe pain in the upper abdomen or

back)

- Facial swelling
- inflammation of the lining of the brain (meningitis)
- Stroke
- Throat disorders
- Confusion
- Malaise (general feeling of discomfort)
- Inflammation of the nerves in the eye
- Allergic reaction which appears as red, round or oval patches, sometimes with blisters,

that recurs in the same place each time the drug is taken ( Fixed drug eruption).

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 MEFLAM 250mg Capsules for the shortest amount of time necessary to control your symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via 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 meflam 250mg capsules

Keep this medicine out of the sight and reach of children

Do not use MEFLAM 250mg Capsules 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is mefenamic acid. each capsule contains 250mg of mefenamic acid.

– The other ingredients are maize starch, lactose, purified water, magnesium stearate, sodium starch glycollate, sodium lauryl sulphate.

What MEFLAM 250mg Capsules look like and contents of the pack:

MEFLAM 250mg Capsules are hard gelatin capsules with a blue cap and yellow body. They are packed in polypropylene securitainers with child proof lids (50, 84, 100, 168 and 500 capsules). Not all pack sizes may be marketed.

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 February 2022.