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TILOKET CAPSULES 50MG

Active substance(s): KETOPROFEN

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PATIENT INFORMATION LEAFLET

Tiloket 50mg 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, ask your doctor or 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 Tiloket is and what it is used for
What you need to know before you take Tiloket
How to take Tiloket

What Tiloket is and what it is
used for

The name of this medicine is Tiloket 50mg Capsules
(referred to as Tiloket throughout this leaflet) . Tiloket
Capsules contains Ketoprofen. This belongs to the
group of medicines called non−steroidal anti−
inflammatory drugs (NSAIDs). It works by blocking
chemicals in the body that normally cause inflammation.
The capsules are effective against pain, inflammation
and fever.
Tiloket capsules 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

2

What you need to know before
you take Tiloket

Do not take Tiloket
 If you are allergic (hypersensitive) 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 other non−steroidal anti−
inflammatory drugs (NSAIDs), including aspirin. Signs
of an allergic reaction are breathing problems,
including asthma, swelling to the face or throat,
redness and itching of the skin or an itchy running
nose
 If you have or have ever had an ulcer or bleed in your
stomach or intestine (gut) (see Section 2 below
’Please note’)
 If you have severe heart, liver or kidney problems
 If you bruise more easily than usual and have
bleeding that lasts a long time
 If you are in the last 3 months of pregnancy (see
Section 2 "Pregnancy & breast−feeding")
Warnings and precautions
Talk to your doctor before taking Tiloket:
 If you have kidney or liver problems
 If you have heart problems (see Section 2 below
’Please note’)
 If you are elderly (see Section 2 below
’Please note’)
 If you are planning to become pregnant or you have
problems becoming pregnant (see Section 2
’Pregnancy & breast−feeding’)
 If you use an intrauterine contraceptive device
(IUCD), as it may be less effective
 If you suffer from a disease of the bowel or intestine,
such as ulcerative colitis or Crohn’s disease
 If you have an infectious disease as this medicine
may mask the usual signs of the disease becoming
worse e.g. a fever
 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 are taking other medicines, such as
hydrocortisone (oral corticosteroids), warfarin
(anticoagulants), citalopram (SSRIs), furosemide
(diuretics /water tablets), aspirin or other
NSAIDs (see Section 2 "Other medicines and
Tiloket")
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

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4
5
6

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

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.
Possible side effects can be minimised by using the
lowest effective dose for the shortest time necessary.
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 e.g. 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, to stop the blood clotting e.g. warfarin
or heparin (Tiloket may increase the effects of these
medicines)
 probenecid, a medicine used to treat gout
 cyclosporins or tacrolimus, used after an organ
transplantation to help prevent rejection
 mifepristone used to terminate a pregnancy
 sulphonamides, used to treat bacterial infections e.g.
co−trimoxazole
 cardiac glycosides, used to treat heart failure e.g.
digoxin
 lithium, used to treat some types of mental illness or
methotrexate, used to treat psoriasis/skin cancer
(Tiloket may increase the toxicity levels of these
medicines)
 quinolone antibiotics, used to treat bacterial
infections e.g. ciprofloxacin
 water tablets (diuretics) e.g. furosemide
 ticlopidine or clopidogrel, used to prevent excessive
blood clotting (Tiloket is not recommended. Bleeding
time must be supervised)
 medicines used to treat high blood pressure e.g.
atenolol (beta−blockers) and, if you have kidney
problems, medicines e.g. captopril (ACE inhibitors)
and candesartan (angiotensin II antagonists)
 thrombolytics, used to dissolve blood clots such as
streptokinase, alteplase or reteplase
 pentoxifylline, used to help poor blood circulation in
limbs
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 Tiloket if you are 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 third trimester (last
3 months) of pregnancy.
Breast−feeding
If you are breast−feeding, you should not take Tiloket.
Driving and using machines:
Tiloket may make you feel sleepy or dizzy or you may
have a fit (convulsion). If this is experienced, you
should not drive or use machines.
Tiloket contains lactose and sulfur dioxide (E220).
These capsules contains lactose. 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 sulfur dioxide (E220), which on
rare occasions, may cause severe allergic reactions and
diifuculty in breathing or wheezing.

Phone

continued....

0800 970 6115

for help
Till−Ver.5.1s

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 be taken orally
 You should take the capsules twice daily with food
 The capsules should be taken early in the morning
and late at night
 Swallow the capsule(s) whole with a glass of water
The recommended dose is:
The dose of Tiloket is different for different patients,
depending on the patient’s weight and the severity of the
symptoms.
 for a mild chronic disease: start with a low dosage
 for acute or severe disease: start with a high dosage
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.
Older people:
Elderly patients are usually advised to begin Tiloket
therapy with the lowest dose. Your doctor may need to
monitor you regularly for any bleeding from your
stomach.
Use in children:
Tiloket is not recommended for children under 15 years
of age
If you take more Tiloket than you should
If you accidentally take too many capsules, contact your
doctor or nearest hospital emergency department
immediately for advice. Remember to take the carton
and any remaining capsules with you.
The symptoms of an overdose include: drowsiness, lack
of energy, feeling sick, abdominal pain and being sick.
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:
 severe abdominal or stomach pain, heartburn or
indigestion (symptoms of a peptic ulcer or stomach
perforation)
 vomiting blood or dark particles that look like coffee
grounds or bloody or black, tarry stools (symptoms of
stomach bleeding)
 severe allergic reaction which causes difficulty in
breathing, dizziness, or shock (anaphylactic
reaction)
 swelling of the face or throat (angiodema)
 blistering of the skin, mouth, eyes and genitals
(Stevens−Johnson syndrome) or blistering of the skin
(toxic epidermal necrolysis)
 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 or
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
Uncommon side effects (may affects up to 1 in 100
people)
 headache
 dizziness
 feeling sleepy
 constipation
 diarrhoea
 wind (flatulence)
 pain or discomfort in the upper abdomen (gastritis)
 rash, itching or skin eruptions
 slight swelling of feet and hands due to water
retention (oedema)
Rare side effects (may affects 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
 ringing in the ears (tinnitus)
 coughing, wheezing, shortness of breath or tightness
of the chest (asthma)
 inflammation of the mucous lining of the mouth

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 inflammation of liver (hepatitis), which can cause
tiredness, pains in abdomen, muscle and joint aches
 increase in liver enzymes or bilirubin (detected
through blood tests)
 increased weight
Not known: frequency cannot be estimated from the
available data
 severe reduction in number of white blood cells which
makes infections more likely (agranulocytosis)
 reduction in blood platelets, which increases risk of
bleeding or bruising (thrombocytopenia)
 tiredness, prone to infections or easily bruised due to
bone marrow failure
 difficulty in getting to sleep (insomnia)
 mood change
 fits
 abnormal taste
 stiff neck, headache, feeling or being sick, fever or
feeling disorientated (symptoms of aseptic meningitis)
 depression
 confusion
 seeing or hearing things that are not real
(hallucinations)
 feeling unwell (malaise)
 drowsiness
 feeling of dizziness or "spinning" (Vertigo)
 visual disturbances
 painful inflammation of the optic nerve in your eye
 shortness of breath or ankle swelling (heart failure)
 high blood pressure
 reddening of the face (vasodilatation)
 difficulty in breathing or wheezing
 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)
 itchy rash
 swollen ankles or high blood pressure due to
inflammation of the kidney
 abnormal kidney function tests
 tiredness
Some anti−inflammatory/pain relieving medicines
(particularly at high doses and in long term treatment)
may be associated with a small increased risk of heart
attack or stroke.
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

How to Store Tiloket

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 other
information

What Tiloket contains:
Each capsule contains 50mg of ketoprofen.
The other ingredients are: lactose, anhydrous colloidal
silica and magnesium stearate.
The capsule shell contains gelatin, sulfur dioxide (E220)
and titanium dioxide (E171).
What Tiloket looks like and contents of the pack:
Tiloket capsules are hard, opaque, white, size 4, gelatin
capsules containing white powder.
Tiloket is available in:
Tiloket 50mg Capsules are available in blister packs of
28, 56, 84 or 112 capsules.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd.
3 Howard Road,
Eaton Socon, St. Neots,
Cambridgeshire, PE19 8ET, United Kingdom.
Product Licence Number:
Tiloket 50mg capsules: PL 11311/0155
Date of last revision: June 2014

Phone

0800 970 6115

for help
Till−Ver.5.1s

Expand view ⇕

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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