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Patient Information Leaflet

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 or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Mefenamic Acid is and what it is used for
2. What you need to know before you take Mefenamic Acid
3. How to take Mefenamic Acid
4. Possible side effects
5. How to store Mefenamic Acid
6. Contents of the pack and other information

Mefenamic acid is one of a group of medicines called non-steroidal anti-inflammatory drug. It causes
a reduction in the levels of prostaglandins, substances believed to be responsible for causing pain and
inflammation, and bring down a high temperature.
Mefenamic acid is used for the relief of pain and discomfort caused by arthritis, muscular pain,
headache, periods, toothache, and fever in children. It may also be used to relieve pain after operations
or 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 Mefenamic Acid Capsules if you:

are allergic to Mefenamic acid or any other ingredients of this capsule (listed in section 6)
had an allergic reaction after taking Mefenamic acid, aspirin or any other medicine used to treat
painful conditions. An allergic reaction may include skin rash, asthma, itchy or runny nose,
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or
have or have ever had peptic ulceration (ulcer in your stomach or duodenum) or bleeding in
your digestive tract
are in the last three months of pregnancy
have severe problems with your liver, kidney or heart
had a major heart surgery
suffer from inflammatory bowel disease
have ever had stomach pains, felt like being sick or had heartburn after taking aspirin or any
other medicine used to treat painful conditions

Warnings and precautions
Talk to your doctor or pharmacist before taking these Capsules if you:

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

have high blood pressure

have any other heart, liver or kidney problems
are elderly
suffer from epilepsy (fits)
suffer from any abnormality of the blood
are dehydrated ( for example you have been losing fluid through vomiting, diarrhoea or passing
too much or too little, urine (fluids)
have frequent headaches
drink alcohol
have a connective tissue disorder e.g. Systemic Lupus Erythematosus (SLE) resulting in joint
pain, skin change and disorders of other organs
have a problem with the metabolism of sugar in your body
are trying to get pregnant (see section on pregnancy)

If you are having a medical examination, tell the doctor that you are taking Mefenamic Acid Capsules
as they reduce the signs of fever and inflammation which would otherwise be noticed.
Medicines such as Mefenamic Acid 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Mefenamic Acid can affect the way some other medicines work, also some
other medicines may change the way Mefenamic Acid works.
In particular, tell your doctor if you are taking:

other non-steroidal anti-inflammatory drugs (e.g. ibuprofen)

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

medicines used to thin the blood (anticoagulants, e.g. warfarin)

diuretics (water tablets) and other drugs used to treat high blood pressure (e.g. furosemide and

medicines used for heart trouble (e.g. digoxin).

lithium, a treatment for depression

methotrexate, a drug used in cancer therapy

ciclosporin, a drug used following organ transplants

quinoline antibiotics, which are used to treat bacterial infections (e.g. ciprofloxacin)

mifepristone, a drug used for terminating pregnancy

corticosteroids, which are used to treat allergic and inflammatory diseases and immune
reactions (e.g. prednisolone)

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 fluxetine or sertaline ( for depression).
If you are not sure, talk to your doctor or pharmacist before taking Mefenamic Acid.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Mefenamic Acid Capsules may make it more difficult to become pregnant. You should inform your
doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Mefenamic Acid Capsules should, if possible not be taken during pregnancy.
It is possible that you may be able to take Mefenamic Acid Capsules whilst you are breast feeding but
you should speak to your doctor or pharmacist before taking these capsules.
Driving and using machines
NSAIDs may sometimes cause symptoms such as you feel dizzy or drowsy, weakness and visual
disturbances. If you notice any such symptoms, you should not drive or operate machinery until you
know how the drug affects you, and ask your doctor or pharmacist for advice.
Mefenamic Acid Capsule contains lactose
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.
Mefenamic acid can reduce the number of certain types of blood cells, and therefore your doctor may
wish to perform regular blood tests while you are taking this medicine.
If you have a blood test for any other reason, remember to tell the doctor that you are taking
Mefenamic acid.
If you have a urine test, tell the doctor that you are taking Mefenamic acid because the medicine may
affect the result.

Always take Mefenamic Acid exactly as your doctor has told you. The pharmacist’s label should tell
you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.
The capsules should be swallowed with a drink of water. To be taken preferably with or after food. Do
not chew them or break them.

The usual dose is 2 capsules taken three times daily.
Dysmenorrhoea (painful periods): Begin taking this medicine at the onset of period pain. Your doctor
will advise you how long you should take this medicine for.
Menorrhagia (heavy or prolonged periods): Begin taking this medicine on the first day of excessive
bleeding. Your doctor will advise you how long you should take this medicine for.

Your doctor will put you on the lowest effective dose, to minimise side effects. The adult dose can be
used; although these capsules should be used with caution in patients suffering from dehydration or
kidney failure. You should be under regular supervision by your doctor while taking this medicine.
As a general principle, the smallest effective dose should be used.

Mefenamic acid 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 Capsules than you should
If you or a child accidentally takes too many Capsules, contact your nearest hospital casualty
department or doctor immediately. Bring the container with any remaining capsules with you.

Signs of an overdose include 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.
If you forget to take a dose
If you forget to take a dose, take it as soon as you remember, unless it is nearly time to take the next
one. Never take two doses together. Then go on as before.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Mefenamic Acid Capsules can cause side effects, although not everybody gets
STOP taking the capsules and seek medical help immediately if you have any of the following
allergic reactions:

sudden wheeziness, difficulty breathing or swallowing, swelling of the face, lips, tongue or

severe itching of the skin (especially affecting your whole body), 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

passing blood in your stools (faeces/motions)

passing black tarry stools

pass loose stool (Diarrhoea)

vomiting any blood or dark particles that look like coffee grounds

indigestion or heartburn

abdominal pain (pains in your stomach) or other abnormal stomach symptoms

persistent sore throat or high temperature
yellowing of your skin or the whites of your eyes
Other Side Effects
You should tell your doctor as soon as possible if you notice any of the following side effects after
taking this medicine:

blurred vision, pain in the eyes

sore mouth and/or lips, puffiness of the face

hallucinations, anaemia, red urine

your skin may become more sensitive to light

bruising or bleeding easily

protein in the urine (your doctor may test for this from time to time)

change in your urine output or appearance, possibly accompanied by kidney pain
The following side effects are often mild and may wear off after a few days’ treatment. If they are
severe or last more than a few days, tell your doctor.

stomach discomfort, nausea (feeling sick), vomiting

headaches, a ringing in the ears

feeling unwell, pins and needles
Other rare side effects include confusion, depression, dizziness, drowsiness, vertigo (spinning
sensation) and severe skin disorders.
Medicines such as Mefenamic Acid may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke (see section 2- Warnings and precautions).

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
By reporting side effects you can help provide more information on the safety of this medicine.

Keep all medicines out of the sight and reach of children

Do not use the Capsules after the expiry date stated on the label after ‘EXP’. The expiry date
refers to the last day of that month.

Do not store above 30˚C.

Keep container tightly closed.

Store in original container.
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.

What Mefenamic Acid Capsules contain
Mefenamic Acid 250mg Capsules:

The active substance is Mefenamic Acid. Each capsule contains 250mg of Mefenamic acid.

The other ingredients are lactose monohydrate, gelatine, sodium starch glycollate and sodium
laurylsulphate. The capsule shell contains gelatine and the colours patent blue (E131),
erythrosine (E127), yellow iron oxide (E172) and titanium dioxide (E171). Each capsule
contains 450 micrograms of sodium.
See end of section 2 for further information on lactose.
What Mefenamic Acid looks like and contents of the pack

Mefenamic Acid 250mg Capsules are blue and brown in colour and printed with P
V and M250 mg.
Mefenamic Acid 250mg Capsules are available in packs containing 50, 84, 100, 250, 500 and
1000 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
0208 997 5433
To request a copy of this leaflet in large print or audio format or additional copies, please contact the
licence holder at the address (or telephone, fax) above.
PL 04556 / 0045
Reference: 00450814/02
The leaflet was last revised in August 2014

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.