Oruvail® 200 mg Prolonged-Release    ¹¹-^mi6[31

Capsules, Hard

(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.

This medicine is available using the above name but will be referred to as Oruvail Capsules throughout the following. Also available in 100 mg 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

Oruvail Capsules contain a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-Inflammatory Drugs'

(NsAlD'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 out of the sight and reach of children.

Do not store above 30°C. Store in a dry place.

Store in the original package to protect from light and moisture.

Do not use this medicine after the expiry date stated on the box.

If the capsules become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6.    FURTHER INFORMATION What Oruvail Capsules contain

The active substance is ketoprofen.

Each capsule contains 200 mg ketoprofen.

The other ingredients are sucrose, maize starch, silica, shellac, ethyl cellulose, talc, gelatin, erythrosine (E 127) and titanium dioxide (E171).

What Oruvail Capsules look like and contents of the pack

Oruvail Capsules are half pink, half white capsules marked ‘ORUDIS SR 200' in blue. They are supplied in bottle packs of 100 capsules.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Famar Health Care Services Madrid S.A.U., Avda. Leganes, 62, Alcorcon 28923 Madrid, Spain. Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

PL 20636/2914

Leaflet revision and issue date (Ref) 11.10.16[3]

Oruvail is a trademark of Sanofi.

To request a copy of this leaflet in Braille or large print please call: 020 8423 2111