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VALKET 200 RETARD

Active substance(s): KETOPROFEN

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PATIENT INFORMATION LEAFLET

VALKET 200 RETARD
(Ketoprofen 200mg Controlled Release Capsules)
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or your pharmacist.
 This medicine has been prescribed for you personally and you should not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
 If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1
2
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1

What Valket is and what it is used for
Before you take Valket
How to take Valket

4
5
6

What Valket is and what it is used
for

Valket belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is a
painkiller and reduces fever (antipyretic).
Valket works by reducing inflammation and relieving
pain, swelling and stiffness in the joints and muscles.
The capsules may be used by adults to treat the
following conditions:
 acute gout
 period (menstrual) pain
 rheumatic disorders, such as rheumatoid arthritis
and ankylosing spondylitis (arthritis in the spine)
 degenerative joint diseases, such as osteoarthritis
 inflammation within tendons, joints and ligaments,
such as bursitis, capsulitis, synovitis, tendinitis
and fibrositis
 low back pain (lumbago)
 pain in the back and leg associated with a slipped
disc (sciatica)

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attack, some risk is still possible. Do not exceed
the recommended dose or duration of treatment.
If you have heart problems, 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.
Possible stomach problems
Some evidence suggests that ketoprofen, the active
ingredient of Valket, 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 Valket.
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, or any of
the following:


Before you take Valket

Do not take Valket:
 if you are allergic to ketoprofen, any of the other
ingredients in this medicine (these are listed in
section 6) or other NSAIDs, see paragraph below
 if you have taken another non-steroidal antiinflammatory drug before (including aspirin) and
suffered an unpleasant or allergic reaction
including asthma, asthmatic attacks, difficulty
breathing or wheezing, redness and itching of the
skin or an itchy, running nose
 if you have a history of stomach bleeding or
perforation related to previous NSAID treatment
 if you currently have or previously had peptic
ulcers (ulcer in the stomach and upper part of the
intestine) or bleeding in your stomach
 if you suffer from chronic indigestion
 if you have severe kidney, liver or heart problems
 if you have a tendency to bleed
 If you are in the last 3 months of pregnancy (see
'Pregnancy & breast-feeding', section 2)
Take special care with Valket:
 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 a history of problems with your stomach or
bowel including ulcerative colitis or Crohn's disease
 if you have kidney or liver problems
 If you have heart problems including uncontrolled
high blood pressure and mild to moderate heart
failure (see 'Please note' section below, section 2)
 if you have a history of ulcers or you are elderly as
there is an increased risk of stomach bleeding and
perforation
 if you are elderly. You are more at risk of having
side effects
 If you are taking other medicines, such as
hydrocortisone (oral corticosteroids), warfarin
(anticoagulants), citalopram (SSRIs), aspirin or
other NSAIDs (see 'Taking other medicines, section 2)
 if you have an infectious disease as this medicine
may mask the usual signs of the disease becoming
worse e.g. a fever
Tell your doctor if any of the above applies to you.
Please note: It is important that you use the lowest
dose that controls your pain and you should not take
Valket for longer than necessary to control your
symptoms.
Possible heart problems
Some anti-inflammatory pain relieving medicines may
be associated with a small increased risk of heart
attack or stroke, especially when used
at high doses and in long-term treatment.
Valket are controlled release capsules, which means
they are designed to release the ketoprofen more
gradually over the day, compared with a standard
release capsule. Although this helps to reduce the
number of capsules you may need to take each day
and may be associated with a lower risk of heart

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Possible side effects
How to store Valket
Further information


















Other non-steroidal anti-inflammatory drugs
(NSAIDs), such as aspirin, diflusinal, ibuprofen,
naproxen, diclofenac (use with Valket may
increase the risk of ulcers or haemorrhages)
Methotrexate, used to treat psoriasis, rheumatoid
arthritis and cancer
Digoxin, used to treat heart failure
Lithium, used to treat mental illness
Diuretics (water tablets), such as triamterene,
thiazides and frusemide
Medicines used to thin your blood, such as
warfarin, heparin, clopidogrel or ticlopidine
Sulphonamides, used to treat infections, such as
trimethoprim
Hydantoins, used to treat or prevent fits, such as
phenytoin
Medicines used to treat high blood pressure, such
as atenolol (beta-blockers) and, if you have kidney
problems, medicines such as captopril (ACE
inhibitors) and candesartan (angiotensin II
antagonists)
Cyclosporin, used to treat some inflammatory
diseases and after transplants
Mifepristone, used to terminate pregnancy. Valket
should not be used for 8-12 days after mifepristone
has been given
Corticosteroids, used to treat inflammation, such
as prednisolone
Quinolone antibiotics, used to treat bacterial
infections, such as ciprofloxacin
Antidepressants, known as selective serotonin
reuptake inhibitors (SSRIs), such as citalopram
Pentoxifylline, used to help poor blood circulation
in limbs
Probenecid, for gout

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
You should not take this medicine if you are pregnant,
think you may be pregnant or you are trying to become
pregnant, unless told to do so by your doctor. This
medicine may make it more difficult to become
pregnant.
Valket 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 Valket is
used, the dose should be low and the length of
treatment as short as possible.
Valket must not be used during the last three months
of pregnancy.
If you are breast-feeding, you should not take this
medicine, unless told to do so by your doctor.
Driving and using machinery
You should not drive, operate machinery or carry out
other activities requiring full alertness if you feel
confused, dizzy, tired, sick, you have a headache,
eyesight problems or a fit while taking this medicine.
Important Information about the ingredients
These 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.

Phone

continued....

0800 970 6115

for help
Till−Ver.7.2s

3



How to take Valket

Always take Valket exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.
 These capsules are for oral administration
 You should swallow the capsules whole with a
glass of water and with food
Adults:
The usual dose is one 200mg capsule a day, taken
either in the morning or at night.
Your doctor may prescribe a different dose depending
on your condition. You should always follow your
doctor's instructions on taking your medicine. Your
pharmacist may also help if you are not sure.
Elderly:
You should be given the lowest dose that is effective in
order to avoid the risk of developing serious side effects.
Your doctor should monitor you for 4 weeks after
starting treatment for signs of bleeding in your
stomach or gut (gastrointestinal bleeding), such as
black, tarry stools or if you vomit blood.
Patients with kidney, heart or liver problems:
You should be given the lowest dose that is effective
and your kidney function should be monitored by your
doctor.
Children:
This medicine should not be given to children.
If you take more Valket than you should
If you take more Valket than you should, contact your
doctor or nearest hospital emergency department
immediately. The most likely symptoms of overdose
include lack of energy, drowsiness, dizziness and
feeling or being sick. Take the carton and any
remaining capsules with you.
If you forget to take Valket
If you have forgotten to take your medicine, take it as
soon as you remember. If your next dose is due within
4 hours, take a single dose now and skip the next. If
you are concerned, consult your doctor or pharmacist.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Valket
Do not stop taking Valket without talking to your
doctor, even if you feel better. It is important that you
take the full course of Valket prescribed by your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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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.
If any side effect gets serious, or if you notice any
side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Possible side effects

Like all medicines, Valket can cause side effects,
although not everybody gets them.
Very serious side effects - If any of the following
happen, stop taking Valket and tell your doctor
immediately or go to your nearest hospital emergency
department:
 if you have severe stomach pain, heartburn or
indigestion (symptoms of a peptic ulcer or stomach
perforation)
 if you have blood in your stools, pass black, tarry
stools or you vomit any blood or dark particles that
look like coffee grounds (symptoms of stomach
bleeding)
 if you have an allergic reaction causing difficulty in
breathing, dizziness, shock (anaphylactic reaction),
tightness of the chest, swelling of the face, throat
or tongue, sore dry itchy skin, or severe skin rashes
 if you have blistering of the skin, mouth, eyes and
genitals or your skin flakes and falls off
 if you have eye problems, such as blurred vision
 if you feel exhausted, have general swelling (eyes,
hands, ankles and feet), weakness or shortness of
breath (symptoms of kidney failure)
Other possible side effects:
Uncommon side effects (affect less than 1 in 10 people)
 headaches
 dizziness
 drowsiness
 rash or itching
 slight swelling of feet and hands due to water
retention (oedema)
 tiredness
Rare side effects (affect less than 1 in 1,000 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
 increased weight
 coughing, wheezing, shortness of breath or
tightness of the chest (asthma)
 inflammation of the mucous lining of the mouth
 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)
Other side effects (frequency not known)
 severe reduction in number of white blood cells
which makes infections more likely
(agranulocytosis or neutropenia)
 reduction in blood platelets, which increases the
risk of bleeding or bruising (thrombocytopenia)

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tiredness, prone to infections or easily bruised due
to bone marrow failure
severe reduction in blood cells, which can cause
weakness, increase the risk of bleeding or 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)
muscle pain, tenderness or swelling, if you have
kidney disease or an under active thyroid gland
enlargement of the liver
mood change
feeling depressed
feeling confused
seeing or hearing things that are not real
difficulty sleeping
fits
abnormal taste
painful inflammation of the optic nerve in your eye
feeling of dizziness or ’spinning’
shortness of breath or ankle swelling (heart failure)
high blood pressure
reddening of the face
difficulty in breathing or wheezing (bronchospasm)
or breathlessness
runny nose
worsening of abdominal pain or diarrhoea
(symptoms of colitis) or diarrhoea and weight loss
(symptoms of Crohn’s disease)
difficulty having or maintaining an erection (impotence)
general feeling of being unwell
tiredness
increased sensitivity to sunlight
loss of hair (alopecia)
swollen ankles or high blood pressure due to
inflammation of the kidney
abnormal kidney function tests
red patches on the skin (erythema multiforme) or
scaling of the skin (exfoliative dermatitis)
feeling or being sick
constipation
diarrhoea
wind (flatulence)
pain or discomfort in the upper abdomen (gastritis)
indigestion
stomach pain

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How to store Valket

Keep out of the reach and sight of children.
Do not take Valket after the expiry date, which is
shown on the label or carton. The expiry date refers to
the last day of that month.
Do not store these capsules above 25°C.
Keep the capsules in the original container, protected
from sunlight
If you notice any visible signs of deterioration in your
medicine, take it to your pharmacist for advice.
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

Further information

What Valket contains:
Active ingredient: Each capsule contains 200 mg of
ketoprofen BP in a controlled release formulation.
Other ingredients: macrogol, ethylcellulose, purified
stearic acid, talc, polymers of methacrylic acid, acrylic
acid esters and methacrylic acid esters, sucrose and
corn starch.
The capsule shells contain erythrosine (E127) and
titanium dioxide (E171) colours and gelatin.
What Valket looks like and contents of the pack:
Valket 200 Retard are hard gelatin capsules with an
opaque pink cap and natural transparent body.
The capsules are either unmarked or marked 'KZ 200
AB' and contain white to whitish pellets.
Valket 200 Retard is supplied in blister packs
containing 28, 30, 56, 60 or 100 capsules. Not all 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: PL 11311/0460
Date of last revision: May 2012

Phone

0800 970 6115

for help
Till−Ver.7.2s

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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