Relifex Suspension

Relifex 500 mg/5 ml Oral Suspension

Nabumetone

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.


• In this leaflet, Relifex 500 mg/ 5 ml Oral Suspension will be called Relifex suspension.

In this leaflet:

• 1. What Relifex suspension is for


• 2. Before you take Relifex suspension


• 3. How to take Relifex suspension


• 4. Possible side effects


• 5. How to store Relifex suspension


• 6. Further information

What Relifex suspension is for

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

Before you take Relifex suspension

Do not take Relifex suspension if:

• You are allergic to nabumetone


• You are allergic to any of the other ingredients of Relifex suspension (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, diclofenac or naproxen


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


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


• 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.

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

Check with your doctor before taking Relifex suspension if:

• You have, or have ever had asthma


• You have, or have ever had stomach problem. 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.

Do not give Relifex suspension to children.

Warnings

Medicines such as Relifex suspension 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 serotonin-reuptake inhibitors (SSRI’s) (to treat depression)


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


• Antihypertensives (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 suspension


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


• Quinolone antibiotics (to treat infections)


• Zidovudine (to treat HIV)


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

Taking Relifex suspension with food

You must take this medicine with or after a meal.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding.

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 suspension you may feel dizzy, tired, drowsy or notice problems with your eye sight.

If this happens, do not drive or operate machinery.

Warnings about the ingredients in Relifex suspension

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Relifex suspension

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.

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

Adults

• The usual dose is 10 ml solution (1 g) taken once a day at bedtime.


• If 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 5 ml (500 mg) taken once a day at bedtime.


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


• Never take more than 10 ml (1 g) each 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



• Checking you are not getting problems with swelling of any parts of your body



• If you are elderly, you will need to go for check-ups during the first four weeks of taking the medicine. These are 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 suspension than you should

Do not take more Relifex suspension 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 suspension may make you feel or be sick, be dizzy or faint, develop a headache or have fits (convulsions).

If you forget to take Relifex suspension

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

Simply take the next dose as planned.

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

Relifex Suspension Side Effects

Like all medicines Relifex suspension 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 that 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 heartburn


• You have severe pains in your stomach


• You have any other abnormal stomach symptoms.

Other possible side effects

• Rash


• Fever


• Diarrhoea


• Headache


• Confusion


• Dry mouth


• Loss of hair


• Depression


• Hallucinations


• Swollen ankles


• Pins and needles


• Ringing in your ears


• Ulcers in your mouth


• Feeling or being sick


• Constipation or wind


• Tiredness or drowsiness


• Problems with your sight


• Trouble sleeping (insomnia)


• Worsening of your asthma


• Difficulty breathing, or wheezing


• Feeling that the room is spinning


• Your skin is more sensitive to sunlight


• Abnormally heavy or long menstrual periods


• Dizziness and headache (you may have high blood pressure)


• Problems passing water and back pain (you may have problems with your kidneys)


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


• Yellowing of your skin and the whites of your eyes (you may have problems with your liver)


• Back pain often with diarrhoea, that may come as an attack after eating (you may have problems with your pancreas)


• Symptoms similar to meningitis, including a stiff neck or fever. This is more likely if you already have an autoimmune disease such as Lupus


• You get ill more often with a sore throat, fever, chills, anaemia or abnormal bruising (you may have problems with your blood).

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

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.

How to store Relifex suspension

Keep out of the reach and sight of children.

Do not use Relifex suspension after the expiry date on the bottle or carton. The expiry date refers to the last day of that month.

Keep the solution in the original bottle. Protect from light.

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

Further Information

What Relifex suspension contains

• The active substance in Relifex suspension is nabumetone.


• Each 5 ml of solution contains 500 mg nabumetone.


• The other ingredients are methylcellulose (E461), xanthan gum (E415), sorbitol (E420), sodium benzoate (E211), liquid vanilla flavour, liquid buttermint flavour, monoammonium glycyrrhizinate, glycerin, dilute hydrochloric acid (E507) and purified water.

What Relifex suspension looks like

Relifex 500 mg/ 5 ml Oral Suspension is a white to off-white suspension. The suspension comes in plastic bottles, each containing 300 ml of solution.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd

trading as Meda Pharmaceuticals

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

Manufacturer:

Pharmasol Ltd.

North Way

Walworth Industrial Estate

Andover

Hampshire

SP10 5AZ

UK

This leaflet was last updated October 2008

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