MEFENAMIC ACID 250 MG CAPSULES

Active substance: MEFENAMIC ACID

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MEFENAMIC ACID PIL - JUN 2012:Layout 1

6/15/12

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Patient Information Leaflet

MEFENAMIC ACID 250 MG B.P

THIS LEAFLET PROVIDES A SUMMARY OF THE INFORMATION
AVAILABLE ON YOUR MEDICINE; PLEASE READ IT CAREFULLY
BEFORE YOU START TO TAKE YOUR MEDICINE. IF YOU HAVE
ANY QUESTIONS OR ARE NOT SURE OF ANYTHING ASK YOUR
DOCTOR OR PHARMACIST.KEEP THIS LEAFLET, YOU MAY NEED
TO READ IT AGAIN.
WHAT IS IN THIS MEDICINE?
Mefenamic Acid capsules 250 mg are blue and brown in colour and printed
with PV and M250 mg. Each capsule contains 250mg of Mefenamic acid,
the active ingredient.
The capsules also contain the inactive ingredients 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.
Pack sizes: 50, 84, 100, 250, 500 and 1000 capsules

WHAT IS MEFENAMIC ACID?
Mefenamic acid is one of a group of medicines called non-steroidal antiinflammatory 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.
M A Holder and Manufacturer:
Pharmvit Limited
177 Bilton Road, Perivale, Greenford, Middx, UB6 7HQ

WHAT IS THIS MEDICINE FOR?
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.
WHAT DO YOU NEED TO KNOW BEFORE TAKING THIS
MEDICINE?
If the answer to any of the following questions is YES, DO NOT take this
medicine without consulting your doctor.

Have you 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 breathing.

Are you allergic to any of the other ingredients? (See ‘WHAT IS IN
THIS MEDICINE?’ above.)

You are in the last three months of pregnancy?

Do you have severe problems with your liver, kidney or heart?

You had a major heart surgery?

Do you have high blood pressure?

Do you suffer from inflammatory bowel disease?

Have you ever had stomach pains, felt like being sick or had
heartburn after taking aspirin or any other medicine used to treat
painful conditions?

Are you presently suffering from dehydration?

Take special care with Mefenamic Acid Capsules and check with your
doctor or pharmacist before taking your medicine if:
If the answer to any of the following questions is YES, tell your doctor or
pharmacist

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

You have, or have ever had, peptic ulceration (ulcer in your stomach
or duodenum) or bleeding in your digestive tract.

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
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.
If you have a urine test, tell the doctor that you are taking Mefenamic acid
because the medicine may affect the result.

If you are elderly you should consult your doctor before taking this
medicine.

ARE YOU TAKING ANY OTHER MEDICINES?
You should consult your doctor BEFORE taking any other medicines,
including medicines obtained without a prescription.

Mefenamic Acid Capsules may affect or be affected by the following
medicines:



















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 Indapamide).
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).

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 PIL - JUN 2012:Layout 1

6/15/12

Important information about some of the ingredients of Mefenamic
Acid Capsules:
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.

HOW MUCH OF THIS MEDICINE SHOULD YOU TAKE?
You should take your medicine as directed by your doctor. 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.
The capsules should be swallowed whole with water. Do not chew them or
break them.
Adults:
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.
Elderly:
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.
Children:
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.

WHAT IF YOU HAVE TAKEN TOO MANY CAPSULES?
If you or anyone else has swallowed a lot of the capsules all together, 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 nearest hospital casualty department or doctor immediately.
Bring the container with any remaining capsules with you.

If you forget to take your Mefenamic Acid Capsules:
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 about these capsules, ask your doctor or
pharmacist.
WHAT UNWANTED EFFECTS CAN THIS MEDICINE HAVE?
Like all medicines Mefenamic Acid 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.
If you suffer from any of the following at any time during your treatment
STOP TAKING the medicine and seek immediate medical help:

Pass blood in your faeces (stools/motions)

Pass black tarry stools

Pass loose stool ( Diarrhoea)

Vomit any blood or dark particles that look like coffee
grounds.

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STOP TAKING the medicine and tell your doctor if you experience:

Indigestion or heartburn

Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.
This medicine, like most other medicines, may cause side effects in some
people.

Medicines such as Mefenamic Acid may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke. If you
experience any of the following STOP taking the capsules and tell your
doctor IMMEDIATELY.

Skin rashes or itching for the first time.

Wheezing or shortness of breath.
Persistent sore throat or high temperature.

Yellowing of your skin or the whites of your eyes.

You should tell your doctor as soon as possible if you notice any of the
following side effects after taking this medicine:
Blurred vision


Sore mouth

Hallucinations

Anaemia

Red urine

Pain in the eyes

Puffiness of the face

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)

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

Headaches

A ringing in the ears

Nausea

Vomiting

Feeling unwell

Pins and needles

Other rare side effects include confusion, depression, dizziness, drowsiness,
vertigo (spinning sensation) and severe skin disorders.

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 experience any of the above or are concerned about anything or you
notice anything unusual contact your doctor.

WARNINGS:
Medicines such as Mefenamic Acid 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.

HOW SHOULD YOU STORE THIS MEDICINE?
This medicine should not be used after the expiry date stated on the pack.
Mefenamic acid capsules should be stored below 30˚C.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

REMEMBER: This medicine has been prescribed for you. Do not give it to
anybody else even if their symptoms appear to be the same as yours, since it
may be harmful to them. 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.
PL 4556/0045

POM

Leaflet last revised in June 2012
Reference: 00450612/OL

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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.

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