Ketovail 100 and Ketovail 200 Capsules

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 doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

IN THIS LEAFLET:

1. What Ketovail is and what it is used for
2. Before you take Ketovail
3. How to take Ketovail
4. Possible side effects
5. How to store Ketovail
6. Further information

What Ketovail is

The name of your medicine is Ketovail 100 or 200 Capsules (called Ketovail throughout this leaflet). Ketovail contains a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-Inflammatory Drugs’ (NSAID’s).

How Ketovail works

It works by blocking chemicals in your body that normally cause inflammation.

Ketovail can be used to

Ketovail is 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
• Dysmenorrhoea (painful periods). Pain and inflammation after an operation
• Other painful inflammatory joint, tendon or muscle problems
• Gout (painful, red, swollen joints).

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 Ketovail 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 often get severe indigestion or heartburn
• 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 taking Ketovail.

Take special care with Ketovail and check with your doctor or pharmacist before taking Ketovail:

• 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 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 Ketovail 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 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 Ketovail.

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 Ketovail.

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 Ketovail can affect the way some other medicines work. Also some medicines can affect the way Ketovail 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, wafarin, clopidogrel or 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 Ketovail Capsules are not used 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 use this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Ketovail may make it more difficult to become pregnant. Speak to your doctor if you are planning to become pregnant or you have problems becoming pregnant.

You should not breast-feed if you are taking Ketovail. 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 or your 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 Ketovail

Ketovail Capsules contain sugar. Take this into account if you have diabetes.

Taking this medicine

• Swallow the capsules whole with a drink of water
• Take the capsules with food
• Do not crush or chew the capsules.

How much to take

Adults

• The usual dose is 100 mg to 200 mg each day.

The elderly

• You are more likely to get side effects while using Ketovail. Your doctor may lower the number of capsules that you use.

Children

• Ketovail is not recommended for children.

If you take more Ketovail than you should

If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take any remaining capsules and the medicine pack with you. This is so the doctor knows what you have used.

The following effects may happen: feeling drowsy, faint, dizzy, excited or disorientated, stomach pains, feeling or being sick, diarrhoea, difficulty breathing, blood in your stools, headache, ringing in your ears, fits or damage to your liver.

If you forget to take Ketovail

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not use a double dose to make up for a forgotten dose.

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 Ketovail 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)

• Ringin in your ears (tinnitus)
• Weight gain
• Inflamed mouth.

Very rare (affects less than 1 in 10,000 people)

• Severe stomach or back pains. These could be signs of pancreatitis.

Frequency not known

• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep, changes in mood
• Hight 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.

What Ketovail contains

• Each 100 mg capsule contains 100 mg of the active substance, ketoprofen.
• Each 200 mg capsule contains 200 mg of the active substance, ketoprofen.

The other ingredients are sugar spheres, colloidal anhydrous silica, shellac, ethylcellulose, talc, erythrocine (E127), gelatine and titanium dioxide (E171). Ketovail 100 mg Capsules also contain patent blue V (E131).

What Ketovail looks like and contents of the pack

• Ketovail 100 Capsules are half pink and half purple marked with KET 100 in black. They are supplied in blister packs containing 56 capsules.
• Ketovail 200 Capsules are half pink and half white marked with KET 200 in black. They are supplied in blister packs containing 28 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer