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VALKET 200 RETARD

Active substance(s): KETOPROFEN / 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 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 effect 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 Valket is and what it is used for
What you need to know before you take Valket
How to take Valket

What Valket is and what it is
used for

Valket belongs to a group of medicines known as
non-steroidal 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:
 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)
 acute gout
 menstrual pain (dysmenorrhoea)

2

What you need to know before
you take Valket

Do not take Valket:
 if you are allergic to ketoprofen, any of the other
ingredients of this medicine (see Section 6
"Contents of the pack and other information) or
other NSAIDs, see paragraph below
 if you are allergic to other non-steroidal antiinflammatory drug (including aspirin)
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 peptic
ulcers (ulcer in the stomach and upper part of the
intestine), perforation or bleeding in your stomach
 if you suffer from chronic indigestion
 if you have severe kidney, liver or heart 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 Valket:
 
 
 
 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 Section 2 below 'Please note')
 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 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 including COX-2 selective NSAIDs
e.g. celecoxib (see Section 2 "Other medicines and
Valket)
 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
attack, some risk is still possible. Do not exceed
the recommended dose or duration of treatment.

4
5
6

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

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.
Other medicines and Valket
Tell your doctor or pharmacist 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
Valket
 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, (anticoagulants)
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)
 Ciclosporins or tacrolimus, used after an organ
transplantation to help prevent rejection
 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
 Selective serotonin reuptake inhibitors (SSRIs),
used to treat depression such as citalopram,
paroxetine, fluoxetine or sertraline
 Pentoxifylline, used to help poor blood circulation
in limbs
 Probenecid, a medicine used to treat gout
 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 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.
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
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.
Valket contains sucrose. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

If you have heart problems, had a stroke or think that
continued....

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3

How to take Valket

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 for oral administration
 You should swallow the capsules whole with a
glass of water and with food
The recommended dose is:
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.
Older people:
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.
Use in children:
This medicine should not be given to children.
If you take more Valket than you should
If you accidentally take more Valket than you should,
contact your doctor or nearest hospital emergency
department immediately for advice. Remember to
take the carton and any remaining capsules with you.
The most likely symptoms of overdose include lack of
energy, drowsiness, dizziness and feeling or being
sick.
If you forget to take Valket
If you have 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 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.

4

Possible side effects

Like all medicines, Valket can cause side effects,
although not everybody gets them.
Stop taking Valket and seek medical advice
immediately if you develop the following
symptoms
Very serious side effects
 if you have severe stomach pain, heartburn or
indigestion (symptoms of a peptic ulcer or stomach
perforation)
 
 
 
 
 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 (toxic
epidermal necrolysis, stevens-johnson syndrome)
 if you have swelling of the face or throat
(angiodema)
 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)



 
  

 
 
 
 
 
 
 
 
 
 

 
 
 
 
  

 
 

 
 

 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
  
 
 
 
 




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 Valket

Keep this medicine out of the sight and reach of children.
Store in a dry place below 25°C.
Store in the original package in order to protect from light.
Do not take Valket 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

Other possible side effects:
Common side effects (may affect up to 1 in 10
people)
 indigestion
 stomach pain
 feeling or being sick

Contents of the pack and
other information

What Valket contains:
Each capsule contains 200 mg of ketoprofen in a
controlled release formulation.

Uncommon side effects (may affect up to 1 in 100
people)
 
 
 
 
 
 
 
 
  
 
 
Rare side effects (may affect up to 1 in 10,000
people)
 
 
 

 
 
 
  
 
 
 

Hard to Read?

 
 
 
 

The 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),
titanium dioxide (E171) and gelatin.
What Valket looks like and contents of the pack:
Valket 200 Retard are hard gelatin size 1 capsules with
an opaque pink cap and transparent body.
The capsules are either unmarked or marked 'KZ 200
AB' and contain white to whitish controlled release
pellets.
Valket is available in:
Valket 200 Retard is available in blister packs of 28,
30, 56, 60 or 100 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: PL 11311/0460
Date of last revision: June 2015

Phone

0800 970 6115

for help


Expand Transcript

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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