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KETOPROFEN CAPSULES BP 50MG

Active substance(s): KETOPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketoprofen Capsules 50mg and 100mg
(Ketoprofen)
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 or nurse.
! 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.
What is in this leaflet:
1. What Ketoprofen Capsules are and what
they are used for
2. What you need to know before you take
Ketoprofen Capsules
3. How to take Ketoprofen Capsules
4. Possible side effects
5. How to store Ketoprofen Capsules
6. Contents of the pack and other information
1. WHAT KETOPROFEN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Ketoprofen Capsules contain a medicine called
Ketoprofen. This belongs to a group of medicines
called 'non-steroidal anti-inflammatory drugs'
(NSAIDs).
Ketoprofen Capsules are used to relieve
symptoms of rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis, fibrositis, cervical
spondylitis, low back pain, painful musculoskeletal
conditions and period pain.
Ketoprofen reduces joint pain and inflammation,
and facilitates an increase in mobility and
functional independence.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE KETOPROFEN CAPSULES
Do not take Ketoprofen Capsules if you:
! Are allergic (hypersensitive) to Ketoprofen,
other NSAIDs or any of the other ingredients in
this medicine (see Section 6)
! Suffer from asthma, hives or a runny nose
caused by an allergy to salicylates (e.g. aspirin)
or other NSAIDs such as ibuprofen as it may
increase the risk of bronchospasm
! Have severe liver, kidney or heart failure
! Are in the last three months of pregnancy
! Previously have had a stomach or intestinal
ulcer, bleeding or perforation
! Currently have a stomach or intestinal ulcer,
bleeding or perforation
! Currently have or have a history of
gastrointestinal disorders (inflammation of
the stomach or intestines) that predispose to
bleeding disorders such as ulcerative colitis,
Crohn's disease, gastrointestinal cancers,
diverticulitis (inflamed or infected
pouches/pockets of the colon)
! Bruise more easily than usual and have
bleeding that lasts a long time.
Ketoprofen Capsules should not be used in
children.
If any of these apply to you, you should not be
given Ketoprofen Capsules. Tell your doctor
immediately.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before
taking Ketoprofen Capsules if you:
! Are taking other NSAIDs including COX-2
selective NSAIDs and acetylsalicylic acid, a
substance present in many medicines used to
relieve pain and lower fever (see section Other
medicines and Ketoprofen Capsules)
! Have reduced kidney or liver function, there
may be an increased risk of jaundice (see
section 4 Possible side effects)
! Have recently had or you need to have
surgery
! Are elderly, your doctor may wish to minimise
treatment duration and to see you more often
while you are taking this medicine
! Are elderly, or taking other medicines like
corticosteroids or certain drugs for depression
called selective serotonin reuptake inhibitors

!
!
!

!
!
!

(SSRIs), or aspirin to prevent blood clotting,
your doctor may like to prescribe you, together
with Ketoprofen Capsules, a medicine for
protecting your stomach and intestines
Suffer from liver porphyria (disorder of the red
blood pigment)
Suffer from SLE (systemic lupus erythema) or
other connective tissue disorders
Have heart problems, have had a 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.
Have been treated with diuretics for water
retention
Are being treated for high blood pressure
Are trying to get pregnant (See section on
Pregnancy and Breast-feeding).

If you notice any of the following symptoms
then you should talk to your doctor
immediately as you may need to stop taking
the capsules immediately:
Visual distrubances, skin rashes or signs of an
allergic reaction such as swollen face, tongue or
throat, or suddenly feeling faint and breathing
difficulties, symptoms such as stiff neck, headache,
fever, tiredness and feeling disorientated as these
may be signs of meningitis, indigestion or
heartburn, stomach pains, vomiting, blood in your
faeces, yellowing of the skin or eyes.
Medicines such as Ketoprofen Capsules may
cause a small increased risk of heart attack
(“myocardial infarction”) or stroke. Any risk is
more likely with high doses and prolonged
treatment. Do not take more than the
recommended dose or use for longer than
recommended.
Other medicines and Ketoprofen Capsules
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Remember to take your medicine with you if you
have to go to hospital.
In particular tell your doctor or pharmacist if you
are taking any of the following:
! Aspirin or other non-steroidal antiinflammatory drugs for pain relief
! Corticosteroids (e.g. hydrocortisone) given
to treat a variety of conditions such as allergies
and hormone imbalances
! Anticoagulants such as warfarin to prevent
blood clots as there is an increased risk of
bleeding. If co-administration is unavoidable
you will be closely monitored by your doctor
! Lithium (medicine to treat depression) or
digoxin (medicine to treat impaired heart
function) - increase in blood levels of these
medicines
! Selective serotonin re-uptake inhibitors
(SSRIs) e.g. fluoxetine used to treat depression
! Diuretics (water tablets) - the effect may be
decreased. Potassium-sparing diuretics may
increase the blood levels of potassium
! ACE-inhibitors e.g.captopril (medicines to
treat high blood pressure). Blood pressure
lowering effect may be reduced
! Ciclosporin or tacrolimus (medicines used to
prevent rejection after a transplant) - may harm
kidney function especially in elderly patients
! Quinolones e.g. ciprofloxacin (antibiotics to
treat infections) - may cause fits
! Medicines to treat diabetes e.g. metformin - a
dose adjustment of these medicines may be
necessary as blood sugar may drop too low
! Methotrexate (to treat psoriasis, rheumatoid
arthritis and certain tumours)
! Mifepristone - (used to induce abortion)
NSAIDs should not be used for 8-12 days after
taking mifepristone as NSAIDs can reduce
mifepristone's effectiveness
! Cardiac glycosides such as digoxin (used for
some heart conditions) - may worsen heart
failure
! Probenecid used to treat gout.
Laboratory tests
Regular liver and kidney function tests and
monitoring of blood counts are necessary during
long-term treatment.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
you are pregnant, might become pregnant or are
breast-feeding.

Ketoprofen Capsules may make it more difficult for
you to become pregnant. You should talk to your
doctor if you are planning on becoming pregnant or
if you have any problems becoming pregnant.
You should not take Ketoprofen Capsules during
the first six months of pregnancy unless directed
by your doctor. You must not take Ketoprofen
Capsules during the last 3 months of pregnancy as
damage to the baby and reduced labour may
occur.
You should not take Ketoprofen Capsules if you
are breast-feeding. This is because small amounts
may pass into mother's milk.
Ask your doctor or pharmacist for advice before
taking any medicines if you are pregnant or breastfeeding.
Driving and using machines
You may feel sleepy, dizzy, faint, have eyesight
problems or you may have a fit while taking this
medicine.
Ketoprofen Capsules contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
3. HOW TO TAKE KETOPROFEN CAPSULES
Always take Ketoprofen Capsules exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Ketoprofen Capsules should be swallowed whole
with a glass of water, with food.
Adults:
1-2 capsules (50-100mg), twice a day.
This dose may be altered by your doctor.
For dysmenorrhoea:
1 capsule (50mg), up to three times a day.
Treatment is usually for 3-4 days from the onset of
menstruation.
Elderly:
As adult dose. The lowest effective dose should be
given.
Your doctor will monitor you regularly.
Children:
Ketoprofen Capsules should not be used in
children under 12 years of age.
If you take more Ketoprofen Capsules than you
should
Contact your doctor, casualty department or
pharmacist immediately if you have taken more
Ketoprofen Capsules than is stated in this leaflet,
or more than prescribed to you by your doctor.

STOP TAKING your capsules and tell your
doctor if you experience:
! Indigestion or heartburn
! Abdominal pain (pains in your stomach) or
other abdominal stomach symptoms
! Yellowing of the skin and eyes which may
indicate jaundice
! Blurred vision
! Stevens-Johnson Syndrome (severe skin rash
with flushing, fever, blisters and ulcers) or
Lyell's syndrome (severe rash with reddening,
peeling and swelling of skin that looks like
severe burns), hair loss, sensitivity to light.
Medicines such as Ketoprofen Capsules may be
associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.
The most common side effects are:! Indigestion, heartburn, stomach pain or
cramps, feeling or being sick, diarrhoea,
flatulence, loss of appetite, constipation, mouth
ulcers, worsening of ulcerative colitis or
Crohn's disease, inflammation of the pancreas
or tongue
! Skin rash, itching, skin eruptions, eczema,
Erythema multiforme (round, red patches on
skin).
Other less common side effects are:! Changes in kidney function, blood or protein in
the urine
! Changes in liver function causing yellowing of
your skin or the whites of the eyes or increased
liver enzyme levels in the body
! Blood disorders including anaemia
! Palpitations, chest pain, high blood pressure,
heart failure
! Headache, dizziness, 'spinning' sensation,
drowsiness or tiredness, disturbances of
sensation, 'pins and needles', memory
disturbance, disorientation, disturbance of
vision, sleeplessness, impaired hearing, ringing
in the ears, irritability, convulsions, depression,
anxiety, nightmares, confusion, hallucinations,
tremor, psychotic reactions or taste alteration
disorders, impotence.
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 KETOPROFEN
CAPSULES
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
package. Protect from moisture.

Symptoms of overdose may include stomach pain,
feeling or being sick, diarrhoea, drowsiness, kidney
failure, fits, headache, disorientation, ringing in the
ears, excitement, coma, fainting and liver damage.

Do not use Ketoprofen Capsules after the expiry
date which is stated on the carton. The expiry date
refers to the last day of that month.

If you forget to take Ketoprofen Capsules
If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for the next
dose, skip the missed dose. Do not take a double
dose to make up for a forgotten dose.

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.

Continue treatment as advised by your doctor.
If you stop taking Ketoprofen Capsules
Do not stop taking Ketoprofen Capsules without
talking to your doctor.
If you have any further questions on the use of this
product, ask your doctor, nurse or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine, may cause you
some problems, although not everybody gets
them.
If you experience any of the following side effects
with Ketoprofen Capsules at any time during your
treatment, STOP TAKING your capsules and
seek immediate medical help:
! Passing blood in your faeces (stools / motions)
! Passing black tarry stools
! Vomiting any blood or dark particles that look
like coffee grounds
! An allergic reaction such as itching, swelling
of the face, lips, tongue, mouth and throat,
which may cause shortness of breath or
difficulty swallowing
! A form of meningitis (aseptic) causing a
combination of symptoms such as headache,
fever, stiff neck, tiredness, feeling or being sick
and disorientation.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Ketoprofen Capsules 50mg and 100mg
contain:
Ketoprofen Capsules 50mg contain 50mg of the
active ingredient ketoprofen.
The other ingredients are: magnesium stearate
and lactose. The capsule shell contains gelatin,
erythrosine (E127), indigotine (E132), titanium
dioxide (E171) and quinoline yellow (E104).
Ketoprofen Capsules 100mg contain 100mg of the
active ingredient ketoprofen.
The other ingredients are: magnesium stearate
and lactose. The capsule shell contains gelatin,
red iron oxide (E172) and titanium dioxide (E171).
What Ketoprofen Capsules 50mg and 100mg
look like and contents of the pack
Ketoprofen Capsules 50mg and 100mg
Available in amber glass bottles in pack sizes of
28, 30, 56, 60, 84, 90, 100, 112 and 500.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in November 2014.

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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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