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PATIENT INFORMATION LEAFLET

Tiloket 50mg Capsules

(ketoprofen)

What Tiloket is and what it is used for

The name of this medicine is Tiloket 50mg Capsules (referred to as Tiloket throughout this leaflet) . Tiloket Capsules contains Ketoprofen. This belongs to the group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It works by blocking chemicals in the body that normally cause inflammation. The capsules are effective against pain, inflammation and fever.

Tiloket capsules can be used in the management of

■    rheumatoid arthritis ■ osteoarthritis

■    ankylosing spondylitis (chronic inflammatory disease of the spine and nearby joints)

■    inflammation of the moving parts of the body (joint space, capsule, lining of the joint, muscle insertion), cervical spondylitis

■    low back pain (strain, lumbago, sciatica, inflammation of the fibrous tissue)

■    painful musculoskeletal conditions

What you need to know before you take Tiloket

Do not take Tiloket

■    If you are allergic (hypersensitive) to ketoprofen or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information")

■    If you are allergic to other non-steroidal antiinflammatory drugs (NSAIDs), including aspirin. Signs of an allergic reaction are breathing problems, including asthma, swelling to the face or throat, redness and itching of the skin or an itchy running nose

■    If you have or have ever had an ulcer or bleed in your stomach or intestine (gut) (see Section 2 below 'Please note')

■    If you have severe heart, liver or kidney problems

■    If you bruise more easily than usual and have bleeding that lasts a long time

■    If you are in the last 3 months of pregnancy (see Section 2 "Pregnancy & breast-feeding")

Warnings and precautions

Talk to your doctor before taking Tiloket:

■    If you have kidney or liver problems

■    If you have heart problems (see Section 2 below 'Please note')

■    If you are elderly (see Section 2 below 'Please note')

■    If you are planning to become pregnant or you have problems becoming pregnant (see Section 2 'Pregnancy & breast-feeding')

■    If you use an intrauterine contraceptive device (IUCD), as it may be less effective

■    If you suffer from a disease of the bowel or intestine, such as ulcerative colitis or Crohn's disease

■    If you have an infectious disease as this medicine may mask the usual signs of the disease becoming worse e.g. a fever

■    If you have asthma combined with a chronic runny nose, blocked nose or swellings in the nose, as you have a higher risk of allergy to aspirin or NSAIDs

■    If you have SLE (systemic lupus erythematosis) or any other similar condition with symptoms such as joint pain, skin rash and fever. There may be an increased risk of aseptic meningitis

■    If you are taking other medicines, such as hydrocortisone (oral corticosteroids), warfarin (anticoagulants), citalopram (SSRIs), furosemide (diuretics /water tablets), aspirin or other NSAIDs (see Section 2 "Other medicines and Tiloket")

Please note:

Possible heart problems

Medicines such as Tiloket 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 have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Possible stomach problems

Some evidence suggests that ketoprofen, the active

ingredient of Tiloket, may be associated with a high risk of serious stomach problems, such as bleeding, ulcers or perforation, relative to other NSAIDs. This is more likely if you take a high dose of Tiloket.

Possible side effects can be minimised by using the lowest effective dose for the shortest time necessary.

Other medicines and Tiloket:

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be effected by Tiloket

■    salicylates e.g. aspirin (high dosage) or other NSAIDs e.g. ibuprofen or celecoxib.

You should avoid using these medicines with Tiloket (Tiloket may increase the risk of ulcers or haemorrhages)

■    selective serotonin reuptake inhibitors (SSRIs), used to treat depression e.g. citalopram, paroxetine, fluoxetine or sertraline (Tiloket may increase the risk of stomach bleeding)

■    corticosteroids, used to treat inflammation and allergic conditions e.g. hydrocortisone, betamethasone or prednisolone (Tiloket may increase the risk of stomach bleeding or ulcers)

■    anticoagulants, to stop the blood clotting e.g. warfarin or heparin (Tiloket may increase the effects of these medicines)

■    probenecid, a medicine used to treat gout

■    cyclosporins or tacrolimus, used after an organ transplantation to help prevent rejection

■    mifepristone used to terminate a pregnancy

■    sulphonamides, used to treat bacterial infections e.g. co-trimoxazole

■    cardiac glycosides, used to treat heart failure e.g. digoxin

■    lithium, used to treat some types of mental illness or methotrexate, used to treat psoriasis/skin cancer (Tiloket may increase the toxicity levels of these medicines)

■    quinolone antibiotics, used to treat bacterial infections e.g. ciprofloxacin

■    water tablets (diuretics) e.g. furosemide

■    ticlopidine or clopidogrel, used to prevent excessive blood clotting (Tiloket is not recommended. Bleeding time must be supervised)

■    medicines used to treat high blood pressure e.g. atenolol (beta-blockers) and, if you have kidney problems, medicines e.g. captopril (ACE inhibitors) and candesartan (angiotensin II antagonists)

■    thrombolytics, used to dissolve blood clots such as streptokinase, alteplase or reteplase

■    pentoxifylline, used to help poor blood circulation in limbs

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

You should not take Tiloket if you are trying to become pregnant, unless told to do so by your doctor. This medicine may make it more difficult to become pregnant.

Tiloket should not be taken during the first and second trimester (first 6 months) of pregnancy or whilst trying to conceive, unless your doctor tells you to. If Tiloket is used, the dose should be low and the length of treatment as short as possible.

Tiloket must not be used during the third trimester (last 3 months) of pregnancy.

Breast-feeding

If you are breast-feeding, you should not take Tiloket.

Driving and using machines:

Tiloket may make you feel sleepy or dizzy or you may have a fit (convulsion). If this is experienced, you should not drive or use machines.

Tiloket contains lactose and sulfur dioxide (E220).

These capsules contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. These capsules contains sulfur dioxide (E220), which on rare occasions, may cause severe allergic reactions and diifuculty in breathing or wheezing.

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

■    These capsules are be taken orally

■    You should take the capsules twice daily with food

■    The capsules should be taken early in the morning and late at night

■    Swallow the capsule(s) whole with a glass of water

The recommended dose is:

The dose of Tiloket is different for different patients, depending on the patient's weight and the severity of the symptoms.

■    for a mild chronic disease: start with a low dosage

■    for acute or severe disease: start with a high dosage

The doses stated below are guidelines only. Your doctor will decide on the correct dosage for your condition and symptoms.

Adults:

The usual dose is 100 - 200mg daily, depending on the patient's weight and the severity of the symptoms.

The maximum daily dose is 200mg.

Older people:

Elderly patients are usually advised to begin Tiloket therapy with the lowest dose. Your doctor may need to monitor you regularly for any bleeding from your stomach.

Use in children:

Tiloket is not recommended for children under 15 years of age

If you take more Tiloket than you should

If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take the carton and any remaining capsules with you.

The symptoms of an overdose include: drowsiness, lack of energy, feeling sick, abdominal pain and being sick.

If you forget to take Tiloket

If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Tiloket

Do not stop or change your treatment before talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Stop taking Tiloket and seek medical advice

immediately if you develop the following symptoms:

■    severe abdominal or stomach pain, heartburn or indigestion (symptoms of a peptic ulcer or stomach perforation)

■    vomiting blood or dark particles that look like coffee grounds or bloody or black, tarry stools (symptoms of stomach bleeding)

■    severe allergic reaction which causes difficulty in breathing, dizziness, or shock (anaphylactic reaction)

■    swelling of the face or throat (angiodema)

■    blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome) or blistering of the skin (toxic epidermal necrolysis)

■    eye problems, such as blurred vision

■    lack of energy, shortness of breath or weakness (symptoms of kidney failure) or blood in your urine, a change in the amount of urine you produce or swelling, especially of your legs, ankles or feet (symptoms of serious kidney problems)

Common side effects (may affect up to 1 in 10 people)

■    indigestion

■    feeling or being sick

■    stomach pain

Uncommon side effects (may affects up to 1 in 100

people)

■    headache

■    dizziness

■    feeling sleepy

■    constipation

■    diarrhoea

■    wind (flatulence)

■    pain or discomfort in the upper abdomen (gastritis)

■    rash, itching or skin eruptions

■    slight swelling of feet and hands due to water retention (oedema)

Rare side effects (may affects up to 1 in 10,000

people)

■    pale skin, weakness or breathlessness due to a loss of blood (haemorrhagic anaemia)

■    tingling or numbness in the hands or feet

■    ringing in the ears (tinnitus)

■    coughing, wheezing, shortness of breath or tightness of the chest (asthma)

■    inflammation of the mucous lining of the mouth

■    inflammation of liver (hepatitis), which can cause tiredness, pains in abdomen, muscle and joint aches

■    increase in liver enzymes or bilirubin (detected through blood tests)

■    increased weight

Not known: frequency cannot be estimated from the available data

■    severe reduction in number of white blood cells which makes infections more likely (agranulocytosis)

■    reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

■    tiredness, prone to infections or easily bruised due to bone marrow failure

■    difficulty in getting to sleep (insomnia)

■    mood change

■    fits

■    abnormal taste

■    stiff neck, headache, feeling or being sick, fever or feeling disorientated (symptoms of aseptic meningitis)

■    depression

■    confusion

■    seeing or hearing things that are not real (hallucinations)

■    feeling unwell (malaise)

■    drowsiness

■    feeling of dizziness or "spinning" (Vertigo)

■    visual disturbances

■    painful inflammation of the optic nerve in your eye

■    shortness of breath or ankle swelling (heart failure)

■    high blood pressure

■    reddening of the face (vasodilatation)

■    difficulty in breathing or wheezing

■    runny nose (rhinitis)

■    worsening of abdominal pain or diarrhoea (symptoms of colitis) or diarrhoea and weight loss (symptoms of crohn's disease)

■    increased sensitivity of the skin to sunlight (photosensitivity)

■    loss of hair (alopecia)

■    itchy rash

■    swollen ankles or high blood pressure due to inflammation of the kidney

■    abnormal kidney function tests

■    tiredness

Some anti-inflammatory/pain relieving medicines (particularly at high doses and in long term treatment) may be associated with a small increased risk of heart attack or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Tiloket

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Keep the capsules in the original container.

Do not use this medicine after the expiry date which is stated on the carton/blister after "EXP". The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What Tiloket contains:

Each capsule contains 50mg of ketoprofen.

The other ingredients are: lactose, anhydrous colloidal silica and magnesium stearate.

The capsule shell contains gelatin, sulfur dioxide (E220) and titanium dioxide (E171).

What Tiloket looks like and contents of the pack:

Tiloket capsules are hard, opaque, white, size 4, gelatin capsules containing white powder.

Tiloket is available in:

Tiloket 50mg Capsules are available in blister packs of 28, 56, 84 or 112 capsules.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road,

Eaton Socon, St. Neots,

Cambridgeshire, PE19 8ET, United Kingdom.

Product Licence Number:

Tiloket 50mg capsules: PL 11311/0155

Date of last revision: June 2014

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