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PACKAGE LEAFLET: INFORMATION FOR THE USER

NAPROXEN TABLETS 250mg and 500mg

[naproxen]

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, health care provider 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.

In this leaflet:

1.    What Naproxen Tablets are and what they are used for

2.    Before you take Naproxen Tablets

3.    How to take Naproxen Tablets

4.    Possible side effects

5.    How to store Naproxen Tablets

6.    Further information

1.    What Naproxen Tablets are and what they are used for

Naproxen is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Naproxen can relieve pain, stiffness and inflammation caused by: rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis (arthritis of the spine and pelvis) and juvenile rheumatoid arthritis.

It is also used to treat acute gout and acute musculoskeletal disorders such as sprains, strains, trauma, lower back pain, neck pain and inflammation of tendons and muscles.

2.    Before you take Naproxen Tablets

Do not take if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Pass blood in your faeces (stools/motions)

•    Pass tarry black stools

•    Vomit any blood or dark particles that look like coffee grounds

•    STOP TAKING the medicine and tell your doctor if you experience: indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Do not take Naproxen tablets and tell your doctor if you:

•    Have a history of stomach bleeding or perforation which may be related to the use of NSAIDs (Mefenamic acid, ibuprofen, diclofenac) or aspirin.

•    Are hypersensitive (allergic) to Naproxen or any other ingredients in this medicine (See section 6. Further information)

•    Have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose

•    Have inflammatory bowel disease

•    Suffer from severe kidney, heart or liver disease

•    Are in the last trimester of your pregnancy

•    Are taking medicines for blood clots (for example warfarin).

If you go into hospital or to see a doctor or dentist, tell them you are taking Naproxen tablets.

Take special care with Naproxen tablets and tell your doctor if you:

•    Suffer from asthma

•    Are elderly

•    Have ulcerative colitis or Crohn's disease

•    You have Systemic Lupus Erythematous (SLE or ‘Lupus') or connective tissue disorders

•    If you develop problems with your vision, contact your doctor immediately.

Naproxen tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Medicines such as Naproxen 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 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Especially:

•    Diuretics (water tablets)

•    Medicines for high blood pressure

•    Warfarin to thin the blood

•    Digoxin for heart conditions

•    Lithium or SSRIs (Selective Serotonin Reuptake Inhibitors) such as fluoxetine or paroxetine used for treatment of depression

•    Prednisolone a steroid treatment for inflammation

•    Methotrexate used to treat rheumatoid arthritis

•    Ciclosporin, tacrolimus which are medicines used to suppress the immune system

•    Ciprofloxacin, sulphonamides such as sulphamethoxazole, antibiotics used to treat bacterial infections

•    Mifepristone used in pregnancy terminations (at any time within the last 12 days)

•    Zidovudine used for the treatment of AIDS and HIV infections

•    Anti-inflammatory pain killers such as ibuprofen or ibuprofen preparations that can be bought without a prescription

•    Phenytoin used to treat epilepsy

•    Gliclazide or glibenclamide (sulphonylureas) used to treat diabetes

•    Probenecid used to treat gout

•    Aspirin, clopidogrel, ticlopidine, dipyridamole which are anti-platelet agents used to prevent blood clots

•    Colestyramine used to treat high levels of cholesterol in the blood.

Taking Naproxen with food and drink

Naproxen tablets should only be taken by mouth.

Always take the tablets with plenty of water, preferably with food.

Try to take them at the same time every day.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning on becoming pregnant or are breast-feeding.

Naproxen does pass into the mother's milk; therefore breastfeeding should be avoided if taking Naproxen tablets.

Driving and using machines

Undesirable effects such as dizziness, drowsiness and tiredness and visual disturbances are possible after taking NSAIDs. If you are affected do not drive or operate machinery.

Important information about some of the ingredients of Naproxen tablets

Naproxen tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine also contains sunset yellow (E110) which may cause allergic reactions.

3. How to take Naproxen Tablets

Always take Naproxen tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The lowest effective dose should be used for the shortest possible time.

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The usual doses of this medicine are given below. Check with your doctor if you are not sure why you have been prescribed this medicine.

For rheumatoid arthritis, osteoarthrosis and ankylosing spondylitis:

250-500mg taken at 12 hour intervals.

Acute musculoskeletal disorders: 500mg to start with, followed by 250mg every 6-8 hours. Do not take more than 1250mg (i.e. five 250mg tablets) in any 24 hour period.

Acute gout: 750mg to start with, followed by 250mg every 8 hours until the attack has passed.

The elderly:

Elderly patients are more likely to experience side effects. Therefore treatment should be started on the lowest possible dose for the shortest possible duration. Your doctor should monitor your condition regularly.

Children over 5 years of age:

If Naproxen tablets are prescribed for a child make sure that the tablets are taken as instructed by the doctor. Naproxen is not recommended for children under 16 years of age for use other than in the treatment of juvenile rheumatoid arthritis. For juvenile rheumatoid arthritis a dose of 10mg per kg body weight per day should be given in two doses, once every 12 hours.

If you take more Naproxen tablets than you should

If you accidently take too many Naproxen tablets, tell your doctor at once. If you can't do this, go to the nearest casualty department. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take Naproxen tablets

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

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

4. Possible side effects

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

Serious side effects:

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

-    Pass blood in your faeces (stools/motions)

-    Pass black tarry stools

-    Vomit any blood or dark particles that look like coffee grounds

-    STOP TAKING the medicine and tell your doctor if you experience: Indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

Medicines such as Naproxen Tablets may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke.

If you experience any of the following stop taking Naproxen Tablets and contact your doctor immediately:

•    All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eye lids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body)

•    Severe painful skin disorder with blisters and peeling skin. You may also have flu-like symptoms such as fever or sore throat (Steven Johnson Syndrome)

•    Diarrhoea

•    Rash or sensitivity to light

•    Jaundice or hepatitis (yellowing of the skin and/or eyes)

•    Blurred vision

•    Meningitis (inflammation of the meninges which line the brain); symptoms may be stiff neck, fever, or disorientation

•    Persistent sore throat or high temperature

•    Anaemia (feeling tired after exercising, giddiness, looking pale)

•    Swollen feet or ankles

•    High blood pressure

•    Chest pain.

The following side effects have also been reported, if they become troublesome contact your doctor:

The following side effects are common:

•    Diarrhoea, flatulence (wind), constipation

•    Nausea, vomiting

•    Headache

•    Pins and needle

•    Drowsiness or tiredness

•    Ringing in the ears.

Other side effects:

•    Sleeping problems, dizziness, inability to concentrate, confusion, depression, hallucinations blood disorders, feeling unwell vasculitis (inflammation of a blood vessel) liver and kidney problems, blood in urine hair loss sore mouth.

If any of the side effects gets serious or if you notice any side effects or symptoms not mentioned in this leaflet, please tell your doctor or pharmacist

5.    How to store Naproxen Tablets

Keep out of the reach and sight of children.

Keep the tablets in a dry place at normal room temperature (below 25° C) in the packaging they come in.

Do not use Naproxen tablets 250mg and 500mg after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Naproxen tablets 250mg and 500mg if you notice visible signs of deterioration.

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

6.    Further information

What Naproxen tablets contains

The active substance(s) is The other ingredients are:

Naproxen

Lactose Monohydrate Maize Starch Sodium lauryl sulphate Crospovidone Magnesium Stearate Quinoline yellow (E104) Sunset yellow (E110)

What Naproxen tablets look like and contents of the pack

Description:

Naproxen tablets 250 mg: Pale yellow flat tablet with a breakline on one side and plain on the reverse.

Naproxen tablets 500 mg: Pale yellow oblong tablet with a breakline on one side and plain on the reverse.

Contents of pack: Tubes

Naproxen tablets 250 mg: Packs of 28, 56 or 250 tablets Naproxen tablets 500 mg: Packs of 28, 56, 100 or 500 tablets

Marketing Authorisation Holder and Manufacturer

Co-Pharma Limited Unit 4, Metro Centre,

Tolpits Lane, Watford,

Herts.

UK, WD18 9SS Tel: 01923 255580 Fax: 01923 255581

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-fc.

CO

This leaflet was last revised in January 2015

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