Patient leaflet - Mefenamic Acid 250 mg capsules

1. What Mefenamic acid capsules is and what it is used for

Mefenamic acid capsules contain mefenamic acid which is a non-steroidal 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
fever in children
painful or heavy periods.

2. What you need to know before you take Mefenamic acid capsules

Do not take Mefenamic acid capsules

if you are allergic to mefenamic acid, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or any of the other ingredients of this medicine (listed in section 6)
if you have, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach or severe gastritis • if you have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) • if you have severe heart, liver or kidney problems
if you have just had heart bypass surgery • if you are more than 6 months pregnant. If any of the above apply to you, speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking mefenamic acid capsules:

if you are taking any other NSAIDs (e.g. ibuprofen, diclofenac)
if you are taking any other anti-inflammatory medicines including steroids (e.g. prednisolone)
if you are taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel) • if you are taking antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine)
if you have kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment
if you are elderly (see section 3)
if you are trying to become pregnant (see section on Fertility)
if you 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 acid capsules • if you have a bleeding disorder or if you are going to have a major operation. Mefenamic acid capsules can affect the clotting of your blood. It can make you bleed more and for longer than usual
if you have asthma, or a history of asthma, as this medicine may cause breathing difficulties • if you have a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE) • if you have epilepsy
if you are dehydrated (thirsty with dry skin, dark urine, dry mouth, headache)
if you 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 acid capsules 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.

Blood tests

Your doctor may test your blood during treatment.

Other medicines and mefenamic acid capsules

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

Some medicines may be affected by mefenamic acid or they may affect how well mefenamic acid capsules 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:
corticosteroids used to treat arthritis and inflammation
medicines such as anti-platelet agents, used to thin the blood (e.g. warfarin, aspirin, clopidogrel)
antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine) - 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).

Mefenamic acid with alcohol

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Mefenamic acid will be passed to your unborn baby. You should not take mefenamic acid capsules during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, mefenamic acid capsules can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring. DO NOT take the capsules in the last 3 months of pregnancy as they may harm your unborn child and cause problems at delivery. They can cause kidney and heart problems in your unborn baby. They may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected.

Breast-feeding

Mefenamic acid passes into breast milk and can affect the baby. You should not take the capsules while breast-feeding unless advised by your doctor.

Fertility

DO NOT take the capsules 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.

Driving and using machines

Mefenamic acid capsules 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.

Mefenamic acid capsules contain lactose

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

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

Package leaflet: Information for the user Mefenamic acid 250 mg capsules

Mefenamic acid

140 mm

35 mm

FRONT SIDE L-140 x H - 430 mm

I◄ ►I

I -

3. How to take Mefenamic acid capsules

Always take this medicine exactly as your doctor has told you. Your doctor will decide on the appropriate dose to suit your condition. Check with your doctor or pharmacist if you are not sure. - Take the capsules with or immediately after a meal.

Do NOT drink alcohol while taking mefenamic acid. Alcohol and smoking can irritate the stomach and make some of the side effects worse.

Dosage

Adults

The recommended dose is 2 capsules three times a day.

Elderly patients (over 65 years)

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.

Use in children

It is recommended that children under 12 years of age should be given Mefenamic Acid Suspension (50mg /5ml).

If you take more mefenamic acid than you should

If you take more capsules than you should you may harm your stomach, kidneys and you may get seizures (fits). Symptoms of overdose may also include headache, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting, rarely diarrhoea, disorientation, excitation, coma (loss of consciousness for a period of time), tiredness, ringing in the ears and fainting.

1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the container and any remaining capsules with you so that people can see what you have taken.
3. Do this even if you feel well.

If you forget to take mefenamic acid

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 take a double dose to make up for a forgotten dose.

If you have any further questions on 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. Do not be alarmed by this list of possible side effects. You may not experience any of them. STOP taking the capsules 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
worsening of colitis and Crohn’s disease - elevation of one or more liver function tests - failure of various organs at the same time (multi-organ failure)
heart failure.
The side effects listed below have been reported: Not known:
frequency cannot be estimated from the available data
- head-spins (vertigo)
- fatty stools
- sweating
- rapid heartbeat
  (palpitations)
- mental confusion
- loss of appetite
- constipation or bloating
- blurred vision, eye irritation
- feeling ill (malaise)
- ringing or buzzing in the ears (tinnitus) - numbness or tingling in hands or feet - sudden poor blood sugar control if you have diabetes. Your doctor or pharmacist can measure your sugar levels
- 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
- depression
- inability to sleep
- hallucinations
- nervousness
- ear pain.

Medicines such as mefenamic acid may be associated with a small increased risk of heart attack or stroke. (See section 2 - end of ‘Warnings and precautions’).

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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 Mefenamic acid capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, carton/bottle/container after EXP.

The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

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

What Mefenamic acid capsules contains

The active substance is Mefenamic acid. Each capsule contains 250 mg of Mefenamic acid. The other ingredients are Lactose monohydrate, Sodium lauryl sulfate, purified water. The capsule shells contain gelatin, titanium dioxide (E171), Patent blue V (E131), quinoline yellow (E104).

Printing ink contains shellac (E904), Dehydrated Alcohol (E1510), Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol (E1520), Strong Ammonia Solution (E527), Black Iron oxide (E172), Potassium hydroxide (E525), Purified Water.

What mefenamic acid capsules looks like and contents of the pack

Mefenamic acid capsules are hard gelatin capsules with opaque blue cap/opaque yellow body "M250" printed on capsule body; containing off-white granular powder.

Mefenamic acid 250 mg capsules are supplied in Clear PVC/Aluminium blister packs of 10, 12, 20, 30, 50, 84, 100 and 168 capsules.

Not all pack sizes may be marketed.

POM

Marketing Authorisation Holder:

Lyrus Life Sciences Limited,

C/O Thakur-Chabert 7a Vine Street

Uxbridge

United Kingdom

UB8 1QE

Manufacturer:

COPEA PHARMA LIMITED

25 Compass West,

Spindus road,

Liverpool,

L24 1YA,

United Kingdom.

The leaflet was last revised in October 2025.