ORUVAIL 200MG CAPSULES

Active substance: KETOPROFEN

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Ref: 0198/190413/1/F

®

Oruvail 200mg Capsules
(ketoprofen)
Patient Information Leaflet
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.
Your medicine is called Oruvail 200mg Capsules, however throughout the
rest of the leaflet it will be referred to as Oruvail Capsules. This medicine is
available in other strengths.
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
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 spondilitis)
* 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

Ref: 0198/190413/1/B

®

Oruvail 200mg Capsules
(ketoprofen)
Patient Information Leaflet (continued)
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.

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

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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.

Blood tests
The results of a blood test may show changes in the way your liver or kidney
is working.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

These side effects may go away during treatment as your body gets used to
the medicine.

4

Possible side effects

Tell your doctor or pharmacist if any of the side effects get serious or
last longer than a few days. Also tell them if you notice any side effects
not listed in this leaflet.

Like all medicines, Oruvail Capsules can cause side effects, although not
everybody gets them.
5
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.

How to store this medicine

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused capsules to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your capsules become discoloured or
show any other signs of deterioration, consult your pharmacist who will tell
you what to do.
Storing your medicine
* Keep this medicine out of the sight and reach of children.
* Do not store above 25°C. Store in a dry place. Protect from light.
* Do not take your capsules out of the blister strip until it is time to take your
dose.

6

Further information

What this medicine contains:
Each capsule contains 200mg ketoprofen as the active ingredient.
The capsule shell contains the following ingredients: gelatin, erythrosine
(E127), blue printing ink (E131), and titanium dioxide (E171).
The granules inside the capsules contain the active ingredient ketoprofen
together with sugar spheres, colloidal silicon dioxide, shellac, ethyl cellulose,
and talc.
What this medicine looks like and contents of the pack
They are capsules with a translucent pink body and opaque white cap
marked 'ORUVAIL 200' on both the head and the body of the capsule.
Each calendar blister pack contains 14 capsules or 28 capsules.
Manufacturer and Licence Holder
The capsules are manufactured by Sanofi-Aventis S.A., Avenida de Leganes
62, 28925 Alcorcon, Madrid, Spain and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PLPI - 15184/0198

Oruvail is a registered trademark of May & Baker Ltd.
Revision date: 19/04/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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