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ORUVAIL 150MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): KETOPROFEN / KETOPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Oruvail ® 150mg
Prolonged-Release Capsules, Hard
Ketoprofen
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Phone 08453 727101 for help
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 that get 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
The name of your medicine is Oruvail 150mg 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 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, clopidogrel, ticlopidine,
dabigatran, apixaban, rivaroxaban or edoxaban
• 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.
5. How to store Oruvail Capsules
Keep this medicine in a safe place where children cannot see or reach it.
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.
Store the blister packs in a dry place below 25°C. Keep the blister strip in the outer carton in
order to protect from light.
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 of the 150mg capsule contains 150mg of the active substance, ketoprofen
The other ingredients are sugar spheres, colloidal anhydrous silica, shellac, ethylcellulose,
talc, gelatine, titanium dioxide (E171), aerythrosine (E127).
What Oruvail Capsules look like and contents of the pack
Oruvail 150mg Capsules are pink marked with Oruvail 150 in blue. They are supplied in
blister packs of 4 & 28 capsules
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sanofi,
One Onslow Street,
Guildford,
Surrey, GU1 4YS, UK.
Tel: 08453 727101
Email: uk-medicalinformation@sanofi.com
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.,
Avda. Leganés, 62,
Alcorcón 28923
Madrid, Spain.
This leaflet was last revised in 06/2017
© sanofi, 1982-2017

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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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