Relifex 1g Film-Coated Tablets

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1. What Relifex is and what it is used for

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3. How to take Relifex

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Patient Information Leaflet

Relifex 500 mg & 1 g Film-coated Tablets

Nabumetone

Read all of this leaflet carefully before you start taking

this medicine because it contains important information

for you.

• 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 signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• In this leaflet, Relifex 500 mg & 1 g Film-coated Tablets will be called Relifex.

What is in this leaflet:

1. What Relifex is and what it is used for

2. What you need to know before you take Relifex

3. How to take Relifex

4. Possible side effects

5. How to store Relifex

6. Contents of the pack and other information

Relifex belongs to a group of medicines called non-steroidal anti-inflammatory drugs (known as NSAIDs).

It works by reducing the production of some natural chemicals found in the body. These chemicals (prostaglandins) cause the symptoms of inflammation such as pain and swelling.

Relifex is used to treat the pain, stiffness and swelling of joints which are affected by osteoarthritis or rheumatoid arthritis.

2. What you need to know before you take Relifex

Do not take Relifex if:

• You are allergic to nabumetone

• You are allergic to any of the other ingredients of Relifex (see section 6)

• You have ever had an allergic reaction like a rash, itchy, runny or bleeding nose, or become short of breath when you have taken aspirin or other NSAID medicines. Such medicines include ibuprofen, acetylsalicylic acid, diclofenac or naproxen. Some people who have had previous allergic reactions to NSAID medicines have very serious, sometimes fatal reactions if they take this kind of medicine again.

• You have, or have ever had a stomach (peptic) ulcer or any perforation or bleeding (haemorrhage) in your digestive system or if you have or have ever had peptic disease

• You have serious problems with your heart (severe heart failure)

• You are currently receiving treatment for a stroke or other internal bleed

• You have serious problems with your liver (liver cirrhosis)

• You have serious problems with your kidneys (kidney failure)

• You are in the last three months of pregnancy.

• You are breast-feeding

If any of the above applies to you, talk to your doctor or

pharmacist.

Check with your doctor before taking Relifex if:

• You have, or have ever had asthma

• You have, or have ever had stomach problems. This includes Crohn’s disease or ulcerative colitis

• You have kidney problems

• You have liver problems

• You have heart problems

• You have or have ever had high blood pressure (hypertension)

• You have ever had a stroke

• You have any signs of water building up in your body, such as swollen ankles

• You have a condition called systemic lupus erythematosus (SLE or Lupus for short) or any other autoimmune disease

• You are in the first six months of pregnancy

• You are trying to, or planning to become pregnant

• You have diabetes

• You have high cholesterol

• You are a smoker

• You are over 65 years of age

• You have an infection. NSAID medicines such as Relifex may hide the symptoms of infections such as fever and inflammation

Children

Do not give Relifex to children.

Warnings

Medicines such as Relifex 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.

Tell your doctor if you are taking any of the following medicines:

• Anticoagulants such as warfarin (to thin your blood)

• Anticonvulsants such as phenytoin (to prevent fits)

• Antidepressants such as selective serotoninreuptake inhibitors (SSRI’s) (to treat depression)

• Antidiabetics (taken by mouth to control blood sugar levels)

• Antihypertensives such as ACE inhibitors or angiotensin receptor agonists (to control high blood pressure)

• Cardiac glycosides such as digoxin (to manage certain heart conditions)

• Ciclosporin and tacrolimus (to prevent transplanted organs being rejected)

• Corticosteroids (to treat skin conditions)

• Diuretics or ‘water tablets’ (to make you pass more water)

• Lithium (to treat mental problems)

• Methotrexate (to treat arthritis)

• Mifepristone (used by doctors to terminate pregnancies). If you have taken mifepristone within the last two weeks you should not take Relifex

• Non steroidal anti-inflammatory drugs (NSAIDs or COX-2). These include ibuprofen acetylsalicylic acid, diclofenac, naproxen, clopidogrel or aspirin

• Quinolone antibiotics (to treat infections)

• Zidovudine (to treat HIV)

• Protein bound drugs such as sulphonamides, sulphony-lureas, probenecid, sulfinpyrazone or hydantoin (used in medicines to treat bacterial infections, diabetes, oedema, hypertension and gout)

• Bisphosphonates (used in medicines to treat conditions that effect your bones)

• Oxpentifylline (pentoxyfilline) (used in medicines to treat the symptoms of intermittent claudication)

• Any other medicine, including medicines obtained without a prescription.

Taking Relifex with food

You must take this medicine with or after a meal.

Taking Relifex with alcohol

No alcohol should be consumed during treatment with Relifex.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding. Your doctor will decide if taking this medicine at this time is right for you and/or your baby.

Remember: Taking this medicine may make it harder for you to become pregnant. Ask your doctor for advice

Driving and using machines

Whilst taking Relifex you may feel dizzy, tired, drowsy, confused or notice problems with your eye sight. If this happens, do not drive or operate machinery. Your doctor may arrange for you for have an eye examination if your eyesight is affected whilst you are taking this medicine.

Important:

• Only take the amount of this medicine your doctor has prescribed

• Only take this medicine for the treatment time your doctor has prescribed.

This will stop you getting so many side-effects. This will reduce any chance of you having a stroke or heart attack.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Remember: Always take this medicine with or after a meal. Swallow the tablets whole with water. Do not chew the tablets.

Some patients may need to take another medicine at the same time as taking Relifex. Your doctor will prescribe this if you need it.

Relifex tablets come in two strengths - 500 mg and 1 g. The number of tablets you take will therefore depend on which strength of tablet the doctor has prescribed for you.

Adults

• The usual dose is 1 g taken once a day at bedtime (as either two 500 mg tablets or one 1 g tablet).

• The label your pharmacist puts on your medicine will tell you exactly how many tablets to take.

• I f you need to take more, your doctor will explain how much to take and when to take it.

Elderly (65 years and over)

• The usual starting dose is 500 mg taken once a day at bedtime (as either one 500 mg tablet or half a 1 g tablet).

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• The label your pharmacist puts on your medicine will tell you exactly how many tablets to take.

• I f you need to take more, your doctor will explain how much to take and when to take it.

• Never take more than 1 g of Relifex each day (either two 500 mg tablets or one 1 g tablet per day).

Medical check-ups

When you are taking this medicine, your doctor may ask you to come for check-ups which may include:

• Checking your kidneys to make sure they are working properly. Your doctor may want to do some tests before you start taking Relifex and then re-check your kidney function once you have been taking the medicine for a few weeks.

• Checking your liver is working properly

• Checking you are not getting any problems with swelling of any part of your body. Your doctor may want to give you some medicine to help with these symptoms.

• If you are elderly you will need to go for check-ups during the first four weeks of taking the medicine. This is to make sure that the medicine is working properly and that the dose you are taking is right for you.

If you take more Relifex than you should

Do not take more Relifex than you should. If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest hospital casualty department.

Taking too much Relifex may make you feel or be sick, be dizzy or faint, develop a headache or have fits (convulsions).

If you forget to take Relifex

Do not take a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any questions about the use of this medicine ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Relifex can cause side effects, although not everybody gets them.

Stop taking this medicine and seek immediate medical

help if you have any of the following symptoms:

• You have difficulty breathing

• Your face or throat swells

• You have a severe rash which may blister

• You have chest pains or sudden numbness and confusion

• You have blood in your stools. They may look black and tarry

• You vomit blood or dark particles that look like coffee granules.

Stop taking this medicine and tell your doctor if you have any of the following symptoms:

This is especially important if you are elderly.

• You have indigestion or heart burn

• You have severe pains in your stomach

• You have any other abnormal stomach symptoms

The following side effects are common and may affect up to one in 10 people taking Relifex:

• Ringing in your ears or problems with the ears

• Increase in blood pressure (you may feel dizzy and have a headache)

• Diarrhoea, constipation, feeling sick, inflammation of the stomach lining, stomach ache, wind

• Rash, itchy skin

• Fluid retention which causes swelling e.g. swollen ankles

The following side effects are uncommon and may affect up to one in 100 people:

• Confusion, nervousness, problems sleeping

• Tiredness, dizziness, headache, “pins and needles” or tingling feelings, anxiety

• Problems with your sight or with your eyes

• Breathing difficulties, nose bleeds

• Upset stomach, being sick,

• Mouth ulcers, dry mouth

• I ncreased skin sensitivity to sunlight or artificial light, red, raised patches on the skin, sweating

• Problems with your muscles

• Problems with your urinary tract

• Loss of strength or energy, fatigue

• Abnormal liver enzymes

The following side effects are very rare and may affect up to one in 10,000 people:

• Low numbers of blood platelets

• I nflammation of the lungs causing shortness of breath and a dry cough

• Yellowing of your skin and the whites of your eyes (jaundice), liver failure

• Severe skin eruptions where the skin reddens, peels and swells and looks severely burnt, or a severe skin rash with flushing, fever, blisters and ulcers or a widespread skin rash with circular irregular red patches on the hands and feet

• Skin hives, loss of hair

• A disorder called pseudoporphyria which causes skin blisters, stomach pains and nervous system problems

• Kidney problems such as blood in the urine, kidney failure

• Heavy or unusually prolonged periods

The following side effects have also been reported by people taking Relifex although it is not known how many people have these side effects:

• Depression, hallucinations

• Aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) especially in patients who already have an autoimmune disorder such as systemic lupus erythematosus or mixed connective tissue disorder

• Vertigo, drowsiness

• Inflammation of the optic nerve

• Asthma or worsening of existing asthma

• Red or purple skin patches

• A problem with the kidneys known as interstitial nephritis. The symptoms include fever, rash, enlarged kidneys, lower back pain, problems when passing water

• A general feeling of being unwell or “out of sorts”

• Changes in the numbers and types of blood cells. You may get ill more often with a sore throat, fever, chills, anaemia or abnormal bruising

• Worsening of existing stomach conditions such as Crohn’s disease or ulcerative colitis

Important: Medicines such as Relifex may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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 any 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 Relifex

Keep out of the reach and sight of children.

Do not use Relifex after the expiry date on the label or carton. The expiry date refers to the last day of that month. Keep the tablets in their original bottle in order to protect from light.

The blister strips do not require any special storage conditions.

Medicines should not be disposed of via wastewater or in household waste. Return any medicine you no longer need to your pharmacist.

6. Contents of the pack and other Information What Relifex contains

The active substance in Relifex is nabumetone.

• Relifex 500 mg Film-coated Tablets

Each 500 mg tablet contains 500 mg nabumetone.

The other ingredients are sodium starch glycollate, sodium lauryl sulphate, hydroxyl-propyl-methylcellulose (E464), magnesium stearate, microcrystalline cellulose (E460), red carmine (E120), yellow iron oxide (E172), titanium dioxide (E171), talc, polyethylene glycol 400, saccharin sodium, liquid caramel flavour, purified water and carnauba wax.

• Relifex 1 g Film-coated Tablets

Each 1 g tablet contains 1 g nabumetone. The other ingredients are hydroxyl-propyl-methylcellulose (E464), macrogol 6000, sodium lauryl sulphate, sodium starch glycollate, Type A, microcrystalline cellulose (E460) and titanium dioxide (E171).

What Relifex looks like

Relifex 500 mg Film-coated Tablets are red, oblong and marked ‘RELIFEX’ on one side and ‘500’ on the other. The tablets come in plastic bottles containing 56 tablets. Relifex 1 g Film-coated Tablets are white, with a break-line on one side. The tablets come in plastic bottles containing 100 or 200 tablets or in blister strips containing 20 or 100 tablets.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd Skyway House,

Parsonage Road, Takeley,

Bishop‘s Stortford, CM22 6PU, UK.

Manufacturer:

Haupt Pharma Wulfing GmbH,

Bethelner LandstraBe 18,

31028 Gronau, Germany.

This leaflet was last updated January 2015.

If this leaflet is difficult to see or read or you would like it in a different format, please contact Meda Pharmaceuticals, Skyway House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU, UK

225 8511 7 56UK1784132-03

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