MEFENAMIC ACID 500MG TABLETS

Active substance: MEFENAMIC ACID

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Braille reads (in Marburg medium font):
MEFENAMIC
ACID
# 500 MG
TABLETS
For proofreading of Braille

Base label (Selfadhesive)
10 mm
Glue

Mefenamic Acid
UK Reg'd T.M.

MA Holder:
TEVA UK Limited
Eastbourne, BN22 9AG.
PL 00289/0235
62230-V

5 01 7007 05 5 1 43

PIP 109-1438

Lot.:

55 mm

500 mg Tablets
Oral Use

500
mg

Exp.:
84

Tablets

12 mm 3
Tab/Glue

45 mm

10 mm
Glue

Each tablet contains 500 mg of mefenamic acid.
Also contains E110.
DOSAGE:
Use as directed by the doctor.
Please read the enclosed package leaflet before use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
UK Reg'd T.M.
Store below 25°C. Store in the original package.

45 mm

Braille placement only
55 mm

45 mm

12 mm 3
Tab/Glue

10 mm
Glue

55 mm

12 mm 3
Tab/Glue

MEFenAMIC
ACID
# 500 mg
tablets

MEFenAMIC
ACID
# 500 mg
tablets

Leaflet outside (Prima)

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 Acid can cause side effects, although not
everybody gets them.
Stop taking the tablets and tell your doctor immediately or go to the
casualty department at your nearest hospital if the following happens:
• an allergic reaction (swelling of the lips, face or neck leading to severe
difficulty in breathing; asthma or worsening of existing asthma, skin
rash or hives)

Stop taking the tablets and seek immediate medical help if the following
happens at any time during your treatment:
• pass blood in your faeces (stools/motions)
• pass loose stools
• pass black tarry stools
• vomit any blood or dark particles that look like coffee grounds.
Stop taking the tablets and tell your doctor if the following happens:
• indigestion or heartburn
• stomach pain or other abnormal stomach symptoms.
The following side effects have also been reported:
Gastro-intestinal:
• loss of appetite, inflammation or ulceration of the mouth e.g. mouth
ulcers or cold sores, peptic ulcer with or without bleeding, oily
appearance of stools, feeling sick, being sick, wind, constipation, chest
pain due to stomach acidity, abdominal pain, worsening of colitis or

Leaflet inside (Sekunda)
12 mm
65 mm
Tab/Glue
Page 1 Front page outside
MEFENAMIC ACID 500 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
1.
2.
3.
4.
5.
6.

IN THIS LEAFLET:
What Mefenamic Acid is and what it is used for
Before you take Mefenamic Acid
How to take Mefenamic Acid
Possible side effects
How to store Mefenamic Acid
Further information

1. WHAT MEFENAMIC ACID IS AND WHAT IT IS USED FOR
Mefenamic Acid is a non-steroidal anti-inflammatory drug (NSAID) which
is used to relieve pain, swelling, and fever.

Crohn’s disease, intestinal inflammatory disease , inflammation of the
stomach and inflammation of the pancreas, which causes severe pain
in the abdomen and back.
Elderly and debilitated patients seem to tolerate bleeding in the digestive
track or ulceration less well than other patients. Greater caution should
be taken when Mefenamic Acid is being taken by this group of patients.
Metabolism and nutritional:
• glucose intolerance in diabetic patients
• low blood levels of sodium which can cause tiredness and confusion,
muscle twitching, fits or coma.
Psychiatric:
• confusion, depression, hallucination, nervousness.
Eye:
• eye irritation, temporary loss of colour vision, problems with sight.
Ear:
• ear pain, ringing in the ears and a feeling of dizziness or “spinning”
.
Respiratory:
• asthma, shortness of breath.

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Mefenamic Acid is used:
• to treat headache, toothache, menstrual pain, muscular pain and to
help reduce excessive menstrual bleeding
• for long-term relief of pain and stiffness in rheumatoid arthritis and
osteoarthritis
• to treat pain after an operation or giving birth.
2. BEFORE YOU TAKE MEFENAMIC ACID
DO NOT take Mefenamic Acid and consult your doctor if you:
• are allergic (hypersensitive) to Mefenamic Acid or any of the other
ingredients of this medicine, aspirin or any other NSAID e.g. ibuprofen
• are taking aspirin or any other NSAID, including
cyclo-oxygenase-2-specific inhibitors
• have severe liver or kidney problems
• have severe heart failure, which can cause shortness of breath or ankle
swelling
• are in the final 3 months of pregnancy
• have or have ever had, peptic ulceration (ulcer in your stomach or
duodenum)
• have or have ever had bleeding in your digestive tract when you have
taken NSAIDs in the past

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Cardiovascular:
• water retention, which may result in swollen ankles, high blood
pressure and heart failure
• medicines such as Mefenamic Acid may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke
• palpitation, low blood pressure.
Kidney:
• kidney problems including inflammation of the kidneys, difficulty in
passing urine or painful urination, presence of blood in urine,
increased amounts of protein in the urine, kidney disease, kidney
toxicity and kidney function failure.
Liver:
• abnormal liver function tests, inflammation of the liver and jaundice
(yellowing of the skin or whites of the eyes), toxicity that damages the
liver, rapid deterioration of kidney function due to liver failure.
Nervous system:
• hazy vision, inflammation of the optic nerve, headaches,
pin-and-needles or numbness, dizziness, fits, tiredness, drowsiness,
difficulty in sleeping and a general feeling of being unwell
• aseptic meningitis (symptoms include stiff neck, headache, nausea,
vomiting, fever and disorientation).

Blood:
• reduction in red blood cells, which may cause paleness or yellowing of
the skin and can also cause weakness or breathlessness (this generally
stops after discontinuation of Mefenamic Acid), reduction in other
blood cell counts, impaired blood cell production which may result in
anaemia and reduced ability to fight infection and bruising or bleeding,
decreased blood platelet counts, decreased white blood cell counts
with a risk of getting infection more easily, infection in the blood
stream, blood disorders, which may be characterised by fever or chills,
sore throat, ulcers in your mouth or throat and blood clotting disorders.
Skin:
• sensitivity to light, swelling of the voice box, red rash, serious illness
with blistering of the skin, mouth and eyes, sweating, itching and
nettle rash.
General:
• tiredness, general feeling of being unwell, multi-organ failure and fever.
Effects on your test result:
• a positive result in certain tests for bile (a digestive juice secreted by
the liver) in the urine of patients receiving Mefenamic Acid has been
demonstrated to be due to the presence of this medicine and not to
the presence of bile.

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• have inflammation of your bowels.
This medicine should not be taken for the treatment of pain after heart
bypass surgery.
Take special care with Mefenamic Acid
Talk to your doctor before you start to take this medicine if you:
• are elderly
• are suffering from or have a history of bronchial asthma
• suffer from high blood pressure
• have heart failure or any other heart or vascular problems
• have mild kidney or liver problems
• suffer from ulcerative colitis or Crohn’s disease
• suffer from systemic lupus erythematosus (inflammation of the
connective tissue) or mixed connective tissue disease
• suffer from epilepsy
• are elderly and suffering from dehydration or kidney problems
• start developing rash, diarrhoea or a blood disorder or blood clotting
problems after taking this medicine, please speak to your doctor
immediately.

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This medicine should be given with caution to patients with internal
brain bleeding or abnormal bleeding disorders.
If this medicine fails to cure your menstrual pain or prolonged heavy
menstrual bleeding please speak to your doctor immediately.
Prolonged use of this medicine for the treatment of headache can make
them worse. Please speak to your doctor if this happens to you.
Medicines such as Mefenamic Acid may be associated with a small 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.
Taking other medicines
DO NOT take Mefenamic Acid in combination with the following:
• aspirin or any other NSAID (e.g. ibuprofen), including
cyclo-oxygenase-2-specific inhibitors (e.g. celecoxib, meloxicam).

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If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MEFENAMIC ACID
Keep out of the reach and sight of children. Store below 25°C. Store in
the original package. Do not transfer them to another container.
Do not use Mefenamic Acid after the expiry date that is stated on the
outer packaging. The expiry date refers to the last day of that month.
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.
6. FURTHER INFORMATION
What Mefenamic Acid Tablets contain:
• The active ingredient is Mefenamic Acid 500 mg
• The other ingredients are microcrystalline cellulose, calcium
phosphate, croscarmellose sodium, povidone, sodium lauryl sulfate
and stearic acid. The coating contains hypromellose, macrogols, and
the colours quinoline yellow (E104), iron oxide yellow (E172), sunset
yellow (E110) and titanium dioxide (E171).

65 mm
(Front page outside)

10 mm
Glue

What Mefenamic Acid Tablets look like and contents of the pack:
• Mefenamic Acid 500 mg Tablets are pale yellow, ovoid,
film-coated tablets. They are engraved ‘3P2’ on one side
and plain on the reverse
• The tablets are available in pack sizes of 7, 10, 14, 21, 28,
30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250,
and 500.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company
responsible for manufacture is TEVA UK Limited, Eastbourne,
BN22 9AG.
This leaflet was last revised: March 2011
PL 00289/0235

Mefenamic Acid

MEFenAMIC
ACID
500
# 500 mg
tablets

500 mg Tablets
Oral Use

mg

84

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65 mm
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Talk to your doctor if you are taking any of the following:
• anticoagulants and antiplatelet agents (medicine used to reduce
and/or prevent blood clots) e.g. warfarin, heparin
• diuretics ('water tablets') and antihypertensives (used to reduce your
blood pressure)
• drugs that stimulate your heart (e.g. digoxin)
• ACE inhibitors and Angiotensin II receptor antagonists (both are used
to treat high blood pressure e.g. enalapril, losartan)
• aminoglycoside (used to treat bacterial infection) e.g. gentamycin
• oral medicines for the treatment of high blood sugar e.g. tolbutamide
• lithium, or SSRI medicines (e.g. fluoxetine, used in the treatment of
depression)
• methotrexate (used to treat cancer)
• ciclosporin or tacrolimus (used to prevent organ transplants being
rejected)
• mifepristone in the last 8-12 days (used to terminate a pregnancy)
• probenecid (used for the treatment of painful inflammation of toes and
feet)
• corticosteroids (e.g. hydrocortisone or prednisolone), or steroids (e.g.
aldosterone)

• quinolone antibiotics (e.g. ciprofloxacin, norfloxacin or levofloxacin)
• zidovudine (used to treat HIV)
• any plasma protein binding medicines (e.g. lipoproteins or globulins).

Important information about some of the ingredients of Mefenamic Acid
• Patients should note that Mefenamic Acid tablets contain Sunset
Yellow (E110), which may cause allergic reactions.

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

3. HOW TO TAKE MEFENAMIC ACID

Pregnancy and breast-feeding
• DO NOT take Mefenamic Acid during the final 3 months of pregnancy
• If you are pregnant ask your doctor for advice before taking this
medicine
• DO NOT take Mefenamic Acid if you are breast-feeding
• Mefenamic Acid may make it more difficult to become pregnant. You
should speak to your doctor if you are planning to become pregnant
or if you have problems becoming pregnant.
Driving and using machines
• Mefenamic Acid may make you feel drowsy, tired, or dizzy and affect
your vision. DO NOT drive or operate machinery if you are affected.

12 mm
Tab

Always take Mefenamic Acid exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
If you are taking Mefenamic Acid for a long period of time your doctor
should be carefully monitoring you and regular blood tests may be
carried out. If you are at higher risk of suffering from intestinal bleeding
e.g. you are taking high doses or are elderly, your doctor may also give
you another medicine to take at the same time to protect your stomach.
Speak to your doctor immediately, if you start to suffer from loose stools
soon after starting this medicine.
If you see another doctor or go into hospital, let him or the staff know
what medicines you are taking.
The tablets should be swallowed with a drink of water, preferably with or
after food. The usual dose is:

Tablets

UK Reg'd T.M.

• serious illness with blistering of the skin, mouth, eyes and genitals.
These are very serious but rare side effects. You may need urgent
medical attention or hospitalisation.

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MA Holder:
TEVA UK Limited
Eastbourne, BN22 9AG.
PL 00289/0235
62230-V

If you forget to take Mefenamic Acid
If you forget to take a tablet, take one as soon as you remember, unless
it is nearly time to take the next one. DO NOT take a double dose to make
up for a forgotten dose. Take the remaining doses at the correct time.

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Each tablet contains 500 mg of mefenamic acid.
Also contains E110.
DOSAGE:
Use as directed by the doctor.
Please read the enclosed package leaflet before use.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Store below 25°C. Store in the original package.

An overdose is likely to cause headache, feeling sick, being sick, stomach
pain, and rarely diarrhoea.
Please take this leaflet, any remaining tablets, and the container with you
to the hospital or doctor so that they know which tablets were consumed.

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PIP 109-1438

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• Adults
500 mg, three times a day.
Excessive menstrual bleeding
Mefenamic Acid should be taken on the first day of excessive
bleeding.
Menstrual pain
Mefenamic Acid should be taken when the pain begins.
In both of these conditions, treatment will be continued according to
your doctor's instructions.
• Elderly (over 65 years)
Your doctor will start you on the lowest effective dose and may
monitor you at the beginning of your treatment for stomach bleeding.
• Children
Mefenamic Acid tablets are not suitable for use in children. An
alternative form of Mefenamic Acid should be used.
If you take more Mefenamic Acid than you should
If you (or someone else) swallow a lot of the tablets all together, or if you
think a child has swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor immediately.

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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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