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MEFENAMIC ACID 500 MG FILM-COATED TABLETS

Active substance(s): MEFENAMIC ACID

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Mefenamic acid 500 mg Film-coated Tablets
Your medicine is known by the above name but will be referred to as Mefenamic Tablets throughout this leaflet.

Read all of this leaflet carefully before you start using 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.

In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is and what it is used for
Mefenamic Tablets contain mefenamic acid which is a nonsteroidal 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
• painful or heavy periods.

2. Before you take
Do NOT take Mefenamic Tablets if you:
• are allergic to mefenamic acid, to any other anti-inflammatory
medicines (such as aspirin, ibuprofen, celecoxib), or to any of
the other ingredients (see Section 6)
• have, or have ever had, stomach or intestinal conditions such
as peptic ulcer, bleeding in the stomach or severe gastritis
• have an inflammatory bowel disease (e.g. ulcerative colitis,
Crohn’s disease)
• have severe heart, liver or kidney problems
• have just had heart bypass surgery
• are more than 6 months pregnant.
If any of the above apply to you, speak to your doctor or
pharmacist.
Take special care with Mefenamic Tablets
Before taking the tablets, tell your doctor if you:
• are taking any other NSAIDs (e.g. ibuprofen, diclofenac)
• are taking any other anti-inflammatory medicines including
steroids (e.g. prednisolone)
• are taking aspirin or medicines that thin the blood (e.g. warfarin,
clopidogrel)
• are taking antidepressants called selective serotonin re- uptake
inhibitors (SSRIs) (e.g. paroxetine)
• have kidney or liver problems. Your doctor may check your
kidney or liver function before and during treatment
• are elderly (see Section 3)
• are trying to become pregnant (see Section on Fertility)
• 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
Tablets
• have a bleeding disorder or if you are going to have a major
operation. Mefenamic Tablets can affect the clotting of your
blood. It can make you bleed more and for longer than usual
• have asthma, or a history of asthma, as this medicine may
cause breathing difficulties
• have a connective tissue disorder, e.g. Systemic Lupus
Erythematosus (SLE)
• have epilepsy
• are dehydrated (thirsty with dry skin, dark urine, dry mouth,
headache)
• 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 Tablets 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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription, and herbal preparations.
Some medicines may be affected by Mefenamic Tablets or they
may affect how well Mefenamic Tablets 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).
Blood tests
Your doctor may test your blood during treatment.
Pregnancy and breast feeding
Pregnancy
Mefenamic acid will be passed to your unborn baby. It is not
known how much it will affect your unborn baby in the first 6
months of pregnancy.
DO NOT take the tablets in the last 3 months of pregnancy as
they may delay the onset of labour and prolong its duration. They
may also increase the likelihood of bleeding in the mother and in
the baby.
If you need to take these tablets, your doctor can help you
decide whether or not to take them during the first 6 months of
pregnancy.
Breast-feeding
Mefenamic acid passes into breast milk and can affect the baby.
You should not take the tablets while breast-feeding unless advised
by your doctor.
Fertility
DO NOT take the tablets 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.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Mefenamic Tablets 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.
Important information about some of the ingredients of
Mefenamic Tablets
• lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
• sunset yellow
This may cause allergic reactions.

Continued over page

3. How to take
Always take Ponstan Forte tablets exactly as your doctor has told you
and always read the label. Your doctor will decide on the appropriate
dose to suit your condition. Ask your doctor or pharmacist if you are
not sure.

• Take the tablets with or immediately after a meal.
• Do NOT drink alcohol while taking Mefenamic Tablets.
Alcohol and smoking can irritate the stomach and make some
of the side effects worse.
Doses
Adults and the elderly: the usual dose is 1 tablet three times
a day.
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.
Children: this medicine is NOT suitable for children under 12
years.
If you take more than you should
If you take more tablets than you should you may harm your
stomach, kidneys and you may get seizures (fits).
1. Tell your doctor, pharmacist or nearest hospital casualty
department immediately.
2. Take the container and any remaining tablets with you so
that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
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 use a double dose to make up for a missed dose.
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 Tablets 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 tablets 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.

Tell your doctor if you get any of the following side effects:
head-spins (vertigo)
depression
fatty stools
inability to sleep
sweating
hallucinations
rapid heartbeat (palpitations)
nervousness
mental confusion
ear pain
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i
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.
Medicines such as Mefenamic Tablets may be associated with a
small increased risk of heart attack or stroke. (See Section 2 - end of
‘Take special care’).
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 or pharmacist. This
includes any possible side effects not listed on 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
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Do not use your tablets after the expiry date which is stated on the

carton and blister. The expiry date refers to the last day of the
month.
If your tablets become discoloured or show signs of deterioration
seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are
no longer required. This will help to protect the environment.

6. Further information
What Mefenamic Tablets contain
Each tablet contains the active ingredient mefenamic acid 500 mg.
Also includes lactose monohydrate, pregelatinised maize starch,
maize starch, povidone, silicon dioxide, talc, magnesium stearate,
croscarmellose sodium type A, sodium laurilsulfate.
The film-coating contains hypromellose, titanium dioxide (E171),
lactose monohydrate, macrogol 4000, vanillin, quinoline yellow
(E104), sunset yellow (E110).
The polish contains purified water, beeswax, carnauba wax yellow,
polysorbate 20 and sorbic acid (E200).
(See end of Section 2 for further information on lactose and sunset
yellow).
What Mefenamic Tablets look like and contents of the pack
Yellow, film-coated tablets marked ‘PONSTAN FORTE’ on one side
and plain on the reverse.
Supplied as 30 tablet pack size.
Manufactured by: Dales Pharmaceuticals Ltd, Snaygill Industrial
Estate, Keighley Road, Skipton, BD23 2RW, UK.
Procured from within the EU and Repackaged by PL holder:
PilsCo Ltd, 10-16 Colvilles Place, East Kilbride, G75 0SN.
PL 39467/0335 Mefenamic acid 500 mg Film-coated Tablets
Leaflet date: 01/02/2018

POM

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