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ORUVAIL 200MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): KETOPROFEN / KETOPROFEN

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Package Leaflet: Information for the User

Oruvail® 200mg Prolonged-Release Capsules, Hard
(ketoprofen)
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 any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
 This medicine is also available in another strength.
In this leaflet:
1. What Oruvail Capsules are and what they are used for
2. Before you take Oruvail Capsules
3. How to take Oruvail Capsules
4. Possible side effects
5. How to store Oruvail Capsules
6. Further information
1. What Oruvail Capsules are and what they are used for
What Oruvail Capsules are and how they work
The name of your medicine is Oruvail 200mg Prolonged-Release
Capsules, Hard (called Oruvail Capsules in this leaflet). Oruvail Capsules
contain a medicine called ketoprofen. This belongs to a group of
medicines called ‘Non-Steroidal Anti-Inflammatory Drugs’ (NSAID’s). It
works by blocking chemicals in your body that normally cause
inflammation.
What Oruvail Capsules are used for
Oruvail Capsules are used to treat the swelling, pain, heat, redness and
stiffness in your joints and muscles in the following:
 Rheumatoid arthritis (inflammation of your joints)
 Osteoarthritis (where the cushioning (cartilage) between your bone
joints is damaged)
 Pain due to problems with your spine (such as ankylosing spondylitis)
 Lower back pain
 Sprains and strains
 Painful periods
 Pain and inflammation after an operation
 Other painful inflammatory joint, tendon, nerve or muscle problems
 Gout (painful, red, swollen joints)
2. Before you take Oruvail Capsules
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to:
 ketoprofen
 aspirin
 any other Non-Steroidal Anti-Inflammatory Drug (NSAID) such as
ibuprofen or indometacin
 any of the other ingredients of Oruvail Capsules (listed in Section 6
below)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
 You have or have ever had an ulcer or bleed in your stomach or
intestine (gut)
 You have severe heart problems
 You have severe liver or kidney problems
 You bruise more easily than usual and have bleeding that lasts a long
time
 You are pregnant (see ‘Pregnancy and breast-feeding’ below)
Do not take this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before using Oruvail Capsules.
Take special care with Oruvail Capsules
Check with your doctor or pharmacist before taking your medicine
if:
 You are asthmatic
 You have ulcerative colitis or Crohn’s disease
 You have a disease affecting the skin, joints or kidneys called
‘Systemic Lupus Erythematosus’ (SLE)
 You are 65 years of age or older
 You are planning to become pregnant or you have problems becoming
pregnant. Oruvail Capsules may make it more difficult to become
pregnant.
 You have heart problems, previous stroke or think that you might be at
risk of these conditions (if you have high blood pressure, diabetes or
high cholesterol or are a smoker).
Medicines such as Oruvail Capsules 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 are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Oruvail Capsules.

Your doctor may need to keep a close check on you or give you a
shorter course of treatment if:
 You have high cholesterol or blood fats
 You are diabetic
 You smoke
 You have kidney or liver problems
 You are taking water tablets (diuretics)
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Oruvail Capsules.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Oruvail
Capsules can affect the way some other medicines work. Also some
medicines can affect the way Oruvail Capsules work.
In particular, tell your doctor if you are taking any of the following:
 Other Non-Steroidal Anti-Inflammatory Drugs such as aspirin or
ibuprofen
 Water tablets (diuretics)
 Medicines for high blood pressure or heart failure
 Digoxin - used for controlling heart rate or helping in heart failure
 Medicines to stop your blood clotting such as heparin, warfarin or
clopidogrel, ticlopidine
 Medicines to dissolve blood clots such as streptokinase, alteplase,
reteplase or tenecteplase
 Medicines for infections (antibiotics) such as ciprofloxacin, levofloxacin
or ofloxacin
 Medicines for depression such as fluoxetine, sertraline, citalopram or
paroxetine
 Corticosteroids - used for inflammation such as hydrocortisone,
betamethasone or prednisolone
 Ciclosporin - used after an organ transplantation to help prevent
rejection
 Mifepristone – used to terminate a pregnancy. It is important that
Oruvail Capsules are not taken for 8-12 days after taking Mifepristone
 Lithium – used for some types of mental illness
 Methotrexate – used for some types of cancer or psoriasis
 Pentoxifylline - used to help poor blood circulation in limbs
 Tacrolimus - used after an organ transplant
 Probenecid - used for gout
 Zidovudine – used for HIV
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, might become pregnant, or
think you may be pregnant.
You should not breast-feed if you are using Oruvail Capsules. This is
because small amounts may pass into mothers’ milk.
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.
Driving and using machines
You may feel sleepy, dizzy, faint, your eyesight may be affected or you
may have a fit while taking this medicine. If this happens, do not drive or
use any tools or machines.
Important information about some of the ingredients of Oruvail
capsule
Oruvail Capsules contain sugar. Take this into account if you have
diabetes.
3. How to take Oruvail Capsules
Always take Oruvail Capsules exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Taking this medicine
 Take this medicine by mouth
 Swallow the capsules whole with a drink of water
 Take with or after food
 Do not crush or chew your capsules
 The dose will depend on your body weight and how severe your pain is
 If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor
 These are slow release capsules so you will feel the effects for up to
16 hours
How much to take
Adults
The usual dose is one capsule each day.
Children
Oruvail Capsules are not recommended for children.
The elderly
You are more likely to get side effects while taking Oruvail Capsules.
Your doctor may start you on the lowest strength.

If you take more Oruvail Capsules than you should
If you take more capsules than you should, tell a doctor or go to a
hospital casualty department straight away. Take the medicine pack with
you. This is so the doctor knows what you have taken.
The following effects may happen, feeling drowsy, stomach pains, being
sick, feeling faint due to low blood pressure, difficulty breathing,
wheezing, tightness in the chest or blood in your stools.
If you forget to take Oruvail Capsules
If you forget a dose, take it as soon as you remember. However, if it is
nearly time for the next dose, skip the missed dose. Do not take a double
dose to make up for a forgotten capsule.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

Frequency not known
 Balance problems (vertigo), feeling dizzy
 Feeling sleepy or 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
Blood tests
The results of a blood test may show changes in the way your liver or
kidney is working.
These side effects may go away during treatment as your body gets used
to the medicine.

4. Possible side effects
Like all medicines, Oruvail Capsules 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.
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
Oruvail Capsules may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke
 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
 You are vomiting blood, have severe stomach pains or pass dark, tarry
stools
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 (paraesthesia)
 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
 You have blurred eyesight
 Your eyes or skin go yellow (jaundice). This may be a sign of liver
problems.
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
Other side effects
Common (affects less than 1 in 10 people)
 Indigestion, 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 or wind
 Rash and itching
 Water retention which may cause swollen arms or legs
 Headaches, feeling dizzy, feeling drowsy or sleepy, feeling tired or
unwell
Rare (affects less than 1 in 1,000 people)
 Ringing in your ears (tinnitus)
 Weight gain
 Inflamed mouth
Very rare (affects less than 1 in 10,000 people)
 Severe stomach or back pain. These could be signs of pancreatitis.

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.
5. How to store Oruvail Capsules
 Keep out of the sight and reach of children.
 Do not take Oruvail Capsules after the expiry date which is stated on
the carton and blister after EXP. The expiry date refers to the last day
of that month.
 Do not store above 30°C.
 Keep the blister strip in the outer carton in order to protect from light
and moisture.
 If your capsules become discoloured or show any sign of deterioration,
return them to your pharmacist.
 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 Oruvail Capsules contain
 Each capsule contains 200mg of the active substance, ketoprofen.
 The other ingredients are: sucrose, corn starch, colloidal silica dioxide,
shellac, ethylcellulose and talc.
Capsule shell: gelatin, quinoline yellow (E104), erythrosine (E127) and
titanium dioxide (E171).
What Oruvail Capsules look like and contents of the pack
Oruvail 200mg Capsules are half orange and half transparent marked
‘PROFENID 200’ in black. The capsules contain off-white to cream
spherical pellets.
They are supplied in blister packs of 14 or 28 capsules.
Manufactured by Aventis Pharma SA, Alcorcon (Madrid), Spain.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0676

POM

Leaflet dated 24th January 2017
Leaflet coded XXXXXXXXXXX
Oruvail® is a registered trademark of SANOFI.
Profenid® is a registered trademark of Aventis Pharma.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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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