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LARAFEN CR

Active substance(s): KETOPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Larafen CR® Capsules 200mg
(Ketoprofen BP 200mg)
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 further questions, please 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 Larafen Capsules are and what they
are used for
2. What you need to know before you take
Larafen Capsules
3. How to take Larafen Capsules
4. Possible side effects
5. How to store Larafen Capsules
6. Contents of the pack and other information
1. WHAT LARAFEN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Larafen Capsules belong to a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). Larafen Capsules are used to relieve
symptoms caused by osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis (rheumatism of
the spine) such as swelling, stiffness or joint pain.
It does not cure arthritis and will help you only as
long as you continue to take it. It is also useful to
relieve pain in the back and leg (sciatica), acute
gout and painful periods.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE LARAFEN CAPSULES
Do not take Larafen Capsules if you:
! Are allergic (hypersensitive) to ketoprofen,
other NSAIDs or any of the other ingredients in
Larafen Capsules (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 risk of a bronchospasm
! Have severe liver, kidney or heart failure
! Are in the last three months of pregnancy
! Previously had a stomach or intestinal ulcer,
bleeding or perforation
! Currently have stomach or intestinal ulcer,
bleeding or perforation
! Have or had a history of gastrointestinal
bleeding or perforation associated with NSAID
treatment. You should not take this medicine.
That is those with inflammation of the stomach
or intestines such as ulcerative colitis,
Crohn's disease, gastrointestinal cancers
and diverticulitis (inflamed or infected
pouches/pockets of the colon)
! Have a history of blood disorders where you
bleed for a long time.
If any of these apply to you, you should not be
given Larafen Capsules. Tell your doctor
immediately.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before
taking Larafen Capsules if you:
! Are taking other NSAIDs including COX-2
selective NSAIDs and aspirin, a substance
present in many medicines used to relieve pain
and lower fever (see section Other medicines
and Larafen Capsules)
! Have reduced kidney or liver function, there
may be increased risk of jaundice (see section
4 possible side effects)
! Have recently had or you need to have
surgery
! Have a history of asthma or have previously
shown an allergic reaction to ketoprofen you
are at an increased risk of breathing difficulties
! If you are elderly, your doctor may wish to
minimise treatment duration and to see you
more often while you are taking Larafen
Capsules

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If you 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 Larafen 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
Pregnancy, breastfeeding and fertility).

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 disturbances, 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 Larafen 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 Larafen Capsules
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Especially if you are taking:
! 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
! Serotonin re-uptake inhibitors (SSRIs) e.g
fluoxetine used to treat depression
! Diuretics (water tablets) effect may be
decreased. Potassium-sparing diuretics may
increase the blood levels of potassium
! Ace-inhibitors e.g captopril (medicines used
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 if you are elderly
! Quinolones e.g ciprofloxacin (antibiotics
used 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, breastfeeding and fertility
Ask your doctor or pharmacist for advice before
taking any medicine.
Fertility
Larafen 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.
Pregnancy and breastfeeding
You should not take Larafen Capsules during the
first 6 months of pregnancy unless directed by your
doctor and must not take Larafen Capsules during
the last 3 months of pregnancy as damage to the
baby and reduced labour may occur.
You should only use Larafen Capsules whilst
breastfeeding if advised by your doctor.
Driving and using machines
Some patients may experience side effects such
as dizziness, drowsiness and visual disturbances
which may affect their ability to drive or operate
machinery. Make sure you are not affected before
driving or operating machinery.
Larafen Capsules contain sucrose
Larafen Capsules contain sucrose. 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 LARAFEN CAPSULES
Always take Larafen Capsules exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Larafen Capsules must not be taken long-term,
blood tests should be carried out if taken for more
than a few days.
The capsules must be swallowed whole with a
glass of water, with food.
The usual dose is:
! Adults: One capsule once a day
! Elderly: As adult dose. The lowest effective
dose should be taken and your doctor will need
to monitor you regularly. If you are older then
70 years your doctor may prescribe a lower
daily dose and reduce the duration of treatment
! Children: not recommended.
If you take more Larafen Capsules than you
should
Contact your doctor, local hospital casualty
department or pharmacist if you have taken more
Larafen Capsules than stated in this leaflet or more
than what your doctor has prescribed (and you feel
unwell).
Symptoms of overdose may be gastrointestinal
disorders, feeling or being sick, diarrhoea, kidney
failure, fits, headache, disorientation, excitement,
coma, drowsiness, dizziness, ringing in the ears,
fainting and liver damage.
If you forget to take Larafen Capsules
Do not take a double dose to make up for a
forgotten dose. Continue the treatment as advised
by your doctor.
If you stop taking Larafen Capsules
Changes to dosage or stopping of treatment
should only be as directed by your doctor.

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You have blurred eyesight
You bruise more easily than usual or have
bleeding that lasts a long time. This could be
because of a serious blood problem
You have pale skin and feel tired, faint or dizzy,
you may have anaemia.

Frequency not known
! Worsening of your Crohn's disease or colitis
! Skin reaction to light or sunlamps
(photosensitivity)
! Hair loss
! You may get more infections more easily than
usual. This could be because of a serious blood
disorder
! Fits
! Pain in your eyes
! Your eyes or skin go yellow (jaundice). This may
be a sign of liver problems.
Other side effects
Common (affects less than 1 in 10 people)
! Indigestion (dyspepsia), heartburn, stomach
pain, these are reduced by taking the medicine
with food
! Feeling sick (nausea) or being sick (vomiting).
Uncommon (affects less than 1 in 100 people)
! Constipation, diarrhoea, wind or stomach pain
(cause by inflammation of the stomach lining)
! Rash and itching
! Water retention which may cause swollen arms
or legs
! Headaches, feeling dizzy, feeling sleepy, feeling
tired.
Rare (affects less than 1 in 1,000 people)
! Ringing in your ears (tinnitus)
! Weight gain
! Inflamed mouth
! Changes in liver enzymes (shown by a blood
test) and hepatitis (swelling of the liver).
Very rare (affects less than 1 in 10,000 people)
! Severe stomach or back pain. These could be
signs of pancreatitis.
Frequency not known
! Balance problems (vertigo)
! Being unable to sleep, changes in mood
! High blood pressure
! Changes in the way things taste
! Runny nose, itching, sneezing and stuffy nose
! Flushing
! Depression
! Feeling confused
! You see or hear things that are not there
! Feeling drowsy, feeling unwell
! Breathlessness.
Blood tests
The results of a blood test may show changes in the
way your liver or kidneys are working.
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.

4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LARAFEN CAPSULES
Like all medicines, this medicine can cause side
effects although not everybody gets them.
Stop taking and see your doctor or go to a
hospital straight away if:
Rare (affects less than 1 in 1,000 people)
! You have an asthma attack
! You have a burning, aching pain in your stomach,
with an empty feeling and hunger. This may be
caused by an ulcer in your stomach or gut
! You get swelling of your face, lips or throat which
makes it difficult to swallow, breathe or you may
have wheezing or tightness in the chest, as well
as itching and rashes. This may mean you are
having a severe allergic reaction.
Frequency not known
! You get blistering, peeling or bleeding on any part
of your skin with or without an itchy, lumpy rash.
This includes your lips, eyes, mouth, nose,
genitals, hands or feet. You may also have flu like
symptoms at the same time. You may have a
serious skin problem that needs urgent medical
treatment
! You have blood in your urine, change in the
amount of urine you produce or swelling
especially of your legs, ankles or feet. This may
be caused by serious kidney problems
! You get chest pain or a sudden severe headache.
Medicines such as Larafen Capsules may be
associated with a small increased risk of heart
attack (myocardial infarction) or stroke
! You are vomiting blood, have severe stomach
pains or pass dark, tarry stools
! A form of meningitis (aseptic) causing a
combination of symptoms headache, fever, stiff
neck, tiredness, feeling or being sick and
disorientation.
Tell your doctor as soon as possible if you have
any of the following side effects:
Rare (affects less than 1 in 1,000 people)
! Unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on your
skin (paresthesia)

Keep all medicines out of the sight and reach
of children.
Do not store above 25°C.
Do not use Larafen Capsules after the expiry date
which is stated on the carton. 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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Larafen Capsules contain
The active substance (the ingredient that makes
the capsule work) is ketoprofen.
The other ingredients are polyethylene glycol,
ethylcellulose, purified stearic acid, talc, polymers
of methacrylic acid, acrylic esters and methacrylic
acid esters, sucrose, corn starch, gelatine,
erythrosine (E127) and titanium dioxide (E171).
What Larafen Capsules look like and contents
of the pack
These capsules are supplied in blister packs of 28,
30, 56, 60 and 100.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
The Product Licence number is PL 40147/0053
Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in July 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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