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TILOKET CR 100MG CAPSULES

Active substance(s): KETOPROFEN

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PATIENT INFORMATION LEAFLET

Tiloket CR 100mg and 200mg Capsules
(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, please ask your doctor or your pharmacist.
• 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. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1
2
3

1

What Tilokit is and what it is used for
What you need to know before you take Tiloket
How to take Tiloket

Possible side effects
How to store
Contents of the pack and other information

Possible side effects can be minimised by using the
lowest effective dose for the shortest time necessary.

What Tilokit is and what
it is used for

The name of this medicine is: Tiloket CR Capsules
(referred to as Tiloket throughout this leaflet). It
contains Ketoprofen. These capsules are controlled
release capsules, which mean that the ketoprofen is
released slowly into the blood. This medicine belongs
to the group of medicines known as non−steroidal anti−
inflammatory drugs (NSAIDs). The capsules are
effective against pain, inflammation and fever.
Tiloket can be used in the management of
 rheumatoid arthritis
 osteoarthritis
 ankylosing spondylitis (chronic inflammatory
disease of the spine and nearby joints)
 inflammation of the moving parts of the body (joint
space, capsule, lining of the joint, muscle
insertion), cervical spondylitis
 low back pain (strain, lumbago, sciatica,
inflammation of the fibrous tissue)
 painful musculoskeletal conditions
 severe menstrual pain (dysmenorrhoea)

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What you need to know
before you take Tiloket

Do not take Tiloket:
 If you are allergic to ketoprofen or any of the other
ingredients of this medicine (see Section 6
"Contents of the pack and other information")
 If you are allergic to aspirin, ibuprofen or any other
non−steroidal anti−inflammatory drug (NSAIDs).
Symptoms of an allergic reaction include breathing
problems, swelling of the face or throat, runny nose,
redness of the skin or an itchy skin rash
 If you have or have ever had an ulcer, perforation or
bleed in your stomach or intestine (gut)
 If you have a history of stomach bleeding or
perforation related to previous NSAID treatment
 If you have severe liver, kidney or heart problems
 If you are in the last 3 months of pregnancy (see
section 2 ’Pregnancy & breast−feeding’)
 If you bruise more easily than usual and have
bleeding that lasts a long time
Warnings and precautions
Talk to your doctor before taking Tiloket:
 If you have kidney or liver problems
 If you have asthma combined with a chronic runny
nose, blocked nose or swellings in the nose, as you
have a higher risk of allergy to aspirin or NSAIDs
 If you have SLE (systemic lupus erythematosis) or
any other similar condition with symptoms such as
joint pain, skin rash and fever. There may be an
increased risk of aseptic meningitis
 If you have a history of ulcers or you are elderly as
there is an increased risk of stomach bleeding and
perforation (see Section 2 below ’Please note’)
 If you have a history of suffering from a disease of
the bowel or intestine, such as ulcerative colitis or
Crohn’s disease
 If you are planning to become pregnant or you have
problems becoming pregnant. Tiloket may make it
more difficult to become pregnant (see Section 2
"Pregnancy & breast−feeding’)
 If you are taking other medicines, such as
hydrocortisone (oral corticosteroids), warfarin
(anticoagulants), citalopram (SSRIs), furosemide
(diuretics /water tablets), aspirin or other NSAIDs
including COX−2 selective NSAIDs e.g. celecoxib (see
Section 2 "Other medicines and Tiloket")
 If you have heart problems (see Section 2 below
’Please note’)
 If you have an infectious disease as this medicine
may mask the usual signs of the disease becoming
worse e.g. a fever
Please note:
Possible heart problems
Medicines such as Tiloket may be associated with a
small increased 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.
Possible stomach problems
Some evidence suggests that ketoprofen, the active
ingredient of Tiloket, may be associated with a high
risk of serious stomach problems, such as bleeding,
ulcers or perforation, relative to other NSAIDs. This is
more likely if you take a high dose of Tiloket.

Other medicines and Tiloket:
Tell your doctor if you are taking, have recently taken
or might take any other medicines, including medicines
obtained without a prescription. This includes herbal
medicines.
Medicines which may interact with or be effected by
Tiloket
 salicylates, such as aspirin (high dosage) or other
NSAIDs e.g. ibuprofen or celecoxib. You should
avoid using these medicines with Tiloket (Tiloket
may increase the risk of ulcers or haemorrhages)
 selective serotonin reuptake inhibitors (SSRIs),
used to treat depression e.g. citalopram, paroxetine,
fluoxetine or sertraline (Tiloket may increase the
risk of stomach bleeding)
 corticosteroids, used to treat inflammation and
allergic conditions e.g. hydrocortisone,
betamethasone or prednisolone (Tiloket may
increase the risk of stomach bleeding or ulcers)
 anticoagulants used to stop blood clotting e.g.
warfarin, heparin, ticlopidine or clopidogrel (Tiloket
may increase the effects of these medicines)
 probenecid, a medicine used to treat gout
 methotrexate, used to treat some inflammatory
diseases and cancers
 sulphonamides, used to treat bacterial infections
e.g. co−trimoxazole
 hydantoins, used to treat seizures e.g. phenytoin
 lithium, used to treat depression
 ciclosporin, used to treat some inflammatory
diseases and after an organ transplantation to help
prevent rejection (especially if elderly)
 pentoxifylline, used to help poor blood circulation in
limbs
 mifepristone, used to terminate a pregnancy
 cardiac glycosides, used to treat heart failure
e.g. digoxin
 quinolone antibiotics, used to treat bacterial
infections e.g. ciprofloxacin
 medicines used to treat high blood pressure e.g.
atenolol (beta−blockers) and, if you have kidney
problems, medicines such as captopril (ACE
inhibitors) and candesartan (angiotensin II
antagonists)
 water tablets (diuretics) e.g. amiloride
 medicines used to treat diabetes e.g. gliclazide
 tacrolimus, used to dampen down the body’s
immune response and may be used for severe skin
complaints and following organ transplantation
 zidovudine, used to treat viral infections
 aminoglycosides used to treat bacterial infections
e.g. amikacin
 thrombolytics used to dissolve blood clots such as
streptokinase, alteplase or reteplase
Pregnancy and breast−feeding:
If you are pregnant or breast−feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Pregnancy
You should not take this medicine if you trying to
become pregnant, unless told to do so by your doctor.
This medicine may make it more difficult to become
pregnant.
Tiloket should not be taken during the first and second
trimester (first 6 months) of pregnancy or whilst trying
to conceive, unless your doctor tells you to. If Tiloket is
used, the dose should be low and the length of
treatment as short as possible.
Tiloket must not be used during the last three months
of pregnancy.
Breast−feeding
If you are breast−feeding, you should not take this
medicine, unless told to do so by your doctor.
Driving and using machines:
Tiloket may affect your ability to drive and operate
machinery by causing headaches, fatigue, nausea,
confusion, blurred vision, dizziness, drowsiness. You
may have a fit (convulsion) while taking this medicine.
If you do experience any effects, do not drive or
operate machinery.
Tiloket contains micrograins of sugar and sulfar
dioxide
These capsules contains micrograins of sugar. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
These capsules contains sulphur dioxide, which on
rare occasions, may cause severe allergic reactions
and difficulty in breathing or wheezing.
continued....

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Phone

0800 970 6115

for help
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3

How to take Tiloket

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
 These capsules are to be taken orally
 You should take the capsules twice daily with food
 Swallow the capsule(s) whole with a glass of water
The recommended dose is:
The doses stated below are guidelines only. Your
doctor will decide on the correct dosage for your
condition and symptoms.
Adults:
The usual dose is 100 − 200mg daily, depending on the
patient’s weight and the severity of the symptoms.
The maximum daily dose is 200mg and this must not
be exceeded
Older people:
Your doctor will prescribe the lowest effective dose for
you to take. Your doctor may need to monitor you
regularly for any bleeding from your stomach during
the first four weeks after you start your treatment and
may need to carry out blood tests from time to time.
Use in children:
Tiloket is not recommended for children.
If you take more Tiloket than you should
If you accidently take too many capsules, contact your
doctor, pharmacist or nearest emergency department
immediately for advice. Remember to take the carton
and any remaining capsules with you.
The symptoms of an overdose include: lack of energy,
feeling or being sick, stomach pain, bleeding in the
stomach, diarrhoea (rare), feeling disorientated or
excited, coma, drowsiness, dizziness, ringing in your
ears, fainting and, occasionally, low blood pressure,
difficulty breathing or fits.
If you forget to take Tiloket
If you forget to take a dose, take it as soon as you
remember, unless it is almost time for your next dose.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Tiloket
Do not stop or change your treatment before talking to
your doctor. If you have any further questions on the
use of this medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Tiloket and seek medical advice
immediately if you develop the following
symptoms

Medicines such as ketoprofen may be associated with
a small increased 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."
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the internet at
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

5

 Pass blood in your stools or black, tarry stools,
vomit any blood or dark particles that look like
coffee grounds (possible symptoms of stomach
bleeding)
 Indigestion or heartburn, severe abdominal or
stomach pain or other abnormal stomach symptoms
(possible symptoms of a peptic ulcer or stomach
perforation)
 Allergic reactions: swelling of the hands, face, feet,
eyelids, lips, tongue, throat, difficulty breathing,
itching, dizziness (anaphylactic reaction)
 Blistering of the skin (Toxic Epidermal Necrolysis),
mouth, eyes or genitals (Stevens−Johnson
Syndrome)
 Swelling of the face or throat (angiodema)
 Eye problems, such as blurred vision
 Lack of energy, shortness of breath or weakness
(symptoms of kidney failure) or blood in your urine,
a change in the amount of urine you produce,
swelling, especially of your legs, ankles or feet
(symptoms of serious kidney problems)
Common side effects (may affect up to 1 in 10
people)
 indigestion
 feeling or being sick
 stomach pain

How to Store

Keep this medicine out of the sight and reach of
children.
Do not store above 25°C.
Keep the capsules in the original container.
Do not use this medicine after the expiry date which is
stated on the carton/blister after "EXP". The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer required. These
measures will help to protect the environment.

6

Contents of the pack and
further information

What Tiloket contains:
Each Tiloket CR 100mg capsule contains 100mg of
ketoprofen
Each Tiloket CR 200mg capsule contains 200mg of
ketoprofen
The other ingredients are: povidone, ethylcellulose, talc
and micrograins of sugar and starch.
The 100mg capsule shell contains gelatin, sulfur
dioxide, titanium dioxide, denatured ethanol and black
ink code 1007.

Uncommon side effects (may affect up to 1 in 100
people)
 headache
 dizziness
 tiredness or drowsiness
 constipation
 diarrhoea
 wind (flatulence)
 pain or discomfort in the upper abdomen (gastritis)
 itching with or without a rash (pruritus)
 swelling of parts of the body (oedema)
Rare side effects (may affect up to 1 in 10,000
people)
 pale skin, weakness or breathlessness due to a
loss of blood (haemorrhagic anaemia)
 tingling or numbness in the hands or feet
(paraesthesia)
 ringing in the ears (tinnitus)
 coughing, wheezing, shortness of breath or
tightness of the chest (asthma)
 inflammation of the mucous lining of the mouth
(stomatitis)
 tiredness, pains in abdomen, muscle and joint
aches , yellowing of skin and eyes (inflammation of
the liver [jaundice] hepatitis)
 increase in liver enzymes or bilirubin (detected
through blood tests)
 increased weight
Not known: frequency cannot be estimated from
the available data
 abnormally low level or decrease of white blood
cells in the blood &/or make infections more likely
(neutropenia/agranulocytosis)
 reduction in blood platelets, which increases the risk

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of bleeding or bruising (thrombocytopenia)
 tiredness, prone to infections or easily bruised due
to bone marrow failure
 severe reduction in blood cells which can cause
weakness, bruising or make infections more likely
(aplastic anaemia)
 reduction in red blood cells which can make the skin
pale yellow and cause weakness or breathlessness
(haemolytic anaemia)
 mood change
 fits
 abnormal sense of taste (dysgeusia)
 visual disturbances
 painful inflammation of the optic nerve in your eye
(optic neuritis)
 shortness of breath or ankle swelling (heart failure)
 high blood pressure
 reddening of the face (vasodilatation)
 worsening of asthma or bronchospasm i.e.
coughing, wheezing, shortness of breath or
tightness of the chest
 runny nose (rhinitis)
 worsening of abdominal pain or diarrhoea
(symptoms of colitis) or diarrhoea and weight loss
(symptoms of crohn’s disease)
 increased sensitivity of the skin to sunlight
(photosensitivity)
 loss of hair (alopecia)
 skin rash resulting from bleeding into the skin
(purpura)
 red patches on the skin (erythema multiforme) or
scaling of the skin (exfoliative dermatitis)
 itchy rash
 kidney problems or worsening of existing kidney
problems
 swollen ankles or high blood pressure due to
inflammation of the kidney
 abnormal kidney function tests
 feeling generally unwell

The 200mg capsule shell contains gelatin, sulfur
dioxide, titanium dioxide, the colourings E104
(quinoline yellow), E127 (erythrosine BS), E132 (indigo
carmine), E172 (yellow iron oxide) and E171 (titanium
dioxide) and opacode white (shellac, soya lecithin, IMS
and ethoxy ethanol).
What Tiloket looks like and contents of the pack:
Tiloket CR 100mg capsules: white cap, colourless
body, size 3 capsules, containing homogeneous
creamy white microgranules,printed TILOKET 100mg
CR
Tiloket CR 200mg capsules: red cap, transparent
green body, size 1 capsules, containing homogeneous
creamy white microgranules, printed TILOKET 200mg
CR
Tiloket is available in:
Tiloket CR 100mg Capsules are available in packs of
56 capsules.
Tiloket CR 200mg Capsules are available in packs of
28 capsules.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd.
3 Howard Road, Eaton Socon, St. Neots,
Cambridgeshire, PE19 8ET,
United Kingdom.
Product Licence Number:
Tiloket CR 100mg Capsules: PL 11311/0103
Tiloket CR 200mg Capsules: PL 11311/0104
Date of last revision: April 2014

Phone

0800 970 6115

for help
Till−Ver.4s

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Tiloket CR
100mg & 200mg Capsules
PIL
165 mm x 420 mm
Font SansSerif − Text 8pt
Till−Ver.4s
11/04/2014
Pantone Black CVC

Tillomed Laboratories Ltd, 3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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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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