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MEFENAMIC ACID SUSPENSION 50MG/5ML

Active substance(s): MEFENAMIC ACID

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Mefenamic Acid Suspension 50 mg/5 ml
Mefenamic acid

ethanol (alcohol)
Mefenamic Acid suspension contains small amounts of
ethanol (alcohol), less than 100 mg per 5 ml.
3/L/e/8 F1317

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 Acid suspension contains mefenamic acid
which is a non-steroidal anti-inflammatory drug (NSAID).
This product is intended for children but may be given to
adults.
It can help to relieve:
symptoms of inflammation, such as redness and
swelling
pain and discomfort caused by arthritis, muscular or
rheumatic disorders
headache or toothache
pain after operations, trauma
fever in children
painful or heavy periods in girls.

2. Before you take
Do NOT take Mefenamic Acid suspension 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 Acid suspension
Before taking the suspension, 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 Acid
have a bleeding disorder or if you are going to have
a major operation. Mefenamic Acid 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 Acid 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 Acid or
they may affect how well Mefenamic Acid 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 suspension in the last 3 months of
pregnancy as it may delay the onset of labour and
prolong its duration. It may also increase the likelihood
of bleeding in the mother and in the baby.
If you need to take this suspension, your doctor can
help you decide whether or not to take it 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 suspension while
breast-feeding unless advised by your doctor.
Fertility
DO NOT take the suspension if you are trying to
become pregnant, as it 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 Acid 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 Acid suspension
sucrose
Each 5 ml suspension contains 1 g sucrose.
This should be taken into account in patients with
diabetes mellitus.
sorbitol
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
Sorbitol may have a mild laxative effect and can cause
an upset stomach and diarrhoea.
Each 5 ml of suspension contains 0.68 g sorbitol.
Calorific value 2.6 kcal/g sorbitol.
sodium
Each 5 ml suspension contains 14.3 mg sodium per 5 ml.
This should be taken into consideration by patients on
a controlled sodium diet.
Continued over page

3. How to take
Always take Mefenamic Acid suspension 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.
Shake the bottle before taking the medicine.
Take the suspension with or immediately after a meal.
After taking the suspension, rinse the mouth - this
medicine contains sucrose which may be harmful to the
teeth if taken for more than 2 weeks.
Do not drink alcohol while taking Mefenamic Acid
suspension. Alcohol and smoking can irritate the
stomach and make some of the side effects worse.
Doses
Adults and the elderly: this medicine is intended for
children. Contact your doctor for dosage advice if you
are an adult taking this suspension.
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: the usual dose may be given up to 3 times
per day.
Age
6 months to 2 years
2 years to 5 years
5 years to 9 years
9 years to 12 years

Usual Dose
5 ml
10 ml
15 ml
20 ml

Do NOT take for more than 7 days unless advised to
do so by your doctor.
If you take more than you should
If you take more of the suspension 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 bottle and any remaining suspension 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 take 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.

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
low body temperature (below 35ºC), feeling cold with
pale-looking skin, especially in children.
Tell your doctor if you get any of the following side
effects:
head-spins (vertigo)
depression
inability to sleep
hallucinations
nervousness
rapid heartbeat (palpitations)
sweating
mental confusion
fatty stools
constipation or bloating
loss of appetite
blurred vision, eye irritation
ear pain
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 Acid 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,
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
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store

4. Possible side effects
Like all medicines, Mefenamic Acid suspension 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 suspension 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,
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

3/L/e/8 F1317

FRONT
REVERSE

Keep out of the reach and sight of children.
Do not take after the expiry date which is stated on the
bottle label and on the carton. The expiry date refers to
the last day of that month.
Store below 30ºC.
Do not throw it away with your household waste or in
water. Return all the unwanted medicine to your
pharmacist. This will help to protect the environment.

6. Further information
What Mefenamic Acid suspension contains
The active ingredient is mefenamic acid
(50 mg per 5 ml).
The other ingredients are:
aluminium magnesium silicate, povidone, sodium
hydroxide, glucono delta lactone, hydrochloric
acid, sorbitol (E420), sodium benzoate, saccharin
sodium, sucrose, carmellose sodium, ethanol
(alcohol), banana flavour, anise mint, chocolate
flavour and purified water.
(See end of Section 2 for further information on
sucrose, sorbitol, sodium, and ethanol).
What Mefenamic Acid suspension looks like and
contents of the pack
Mefenamic Acid suspension is an off-white or very pale
pink suspension. It is available in an amber glass bottle
of 30 ml and 125 ml. Not all bottles may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as Essential Generics,
7 Egham Business Village, Crabtree Road, Egham,
TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate,
Keighley Road, Skipton BD23 2RW.
This leaflet was last revised in
April 2015

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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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