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ORUVAIL 200 CAPSULES

Active substance(s): KETOPROFEN

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Package Leaflet: Information for the user
Oruvail® 200 Capsules
(ketoprofen)
Your medicine is known by the above name, but will be referred to as
Oruvail Capsules throughout this leaflet. Oruvail is also available in another
strength.
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.

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
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.

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.
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.

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 this medicine out of the sight and reach of children.
Do not use after the expiry date printed on the carton label or blister strip.
Oruvail 200 Capsules should be stored below 25°C in a dry place. Protect
from light.
If the capsules become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist.
If your doctor tells you to stop taking the capsules, please take them back to
the pharmacist for safe disposal. Only keep the capsules if your doctor tells
you to.
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 ingredient ketoprofen in a
controlled release formulation.
Oruvail Capsules also contain the following inactive ingredients:
Starch, sucrose, colloidal silicon dioxide, shellac, ethylcellulose, talc,
gelatin, titanium dioxide (E171) and erythrosine (E127)
What Oruvail Capsules look like and contents of the pack
The capsules are opaque white and clear pink hard gelatin capsules printed
'ORUVAIL 200' on each half.
Oruvail Capsules are available as calendar blister packs of 14 capsules.
PL No: 10383/0634

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Aventis Pharma, Dagenham, Rainham
Rd South, Dagenham-Essex RM10 7XS. Procured from within the EU and
repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 10.10.2016
Oruvail is a registered trademark of Sanofi, France.

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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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