PACKAGE LEAFLET: INFORMATION FOR THE USER

NAPROXEN TABLETS 250 mg & 500 mg

(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 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 side effect 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 is and what it is used for

2.    Before you take Naproxen

3.    How to take Naproxen

4.    Possible side effects

5.    How to store Naproxen

6.    Further information

1.    WHAT NAPROXEN IS AND WHAT IT IS USED FOR

Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAID). It is a painkiller and antipyretic (reduces fever). Naproxen works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. There are a number of painful conditions that can affect your joints and muscles, which can be helped by taking Naproxen. These conditions include:

•    rheumatoid arthritis including childhood rheumatoid arthritis

•    osteoarthritis

•    ankylosing spondylitis (arthritis in the spine)

•    gout

•    musculo-skeletal disorders such as sprains, strains and other injuries, such as backache or neckache

2.    BEFORE YOU TAKE NAPROXEN

Do not take Naproxen:

•    if you are allergic (hypersensitive) to naproxen or any of the other ingredients in these tablets (these are listed in section 6)

•    if you have taken another non-steroidal antiinflammatory drug before (including Aspirin) and suffered an unpleasant or allergic reaction including asthma, redness and itching of the skin or an itchy, running nose

•    if you have a stomach ulcer or know that you have suffered with ulcers in the past

•    if you have severe heart failure, a disease of the heart that causes shortness of breath and swelling of the feet or legs due to fluid build up.

Take special care with Naproxen:

•    if you suffer from bronchial asthma or from allergies

•    if you have any problems with your stomach or bowel

•    if you have problems with your blood not clotting

•    if you nave problems with your liver or kidneys or have to be careful not to take too much sodium in your diet.

Tell your doctor if any of the above applies to you.

Please note: It is important that you use the lowest dose that controls your pain and you

should not take Naproxen for longer than necessary to control your symptoms. Some anti-inflammatory/pain relieving medicines may be associated with a small increased risk of heart attack or stroke, especially when used at high doses and in long-term treatment. Although Naproxen (1000 mg daily) may be associated with a lower risk, some risk is still possible

•    if you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including "mini-stroke" or transient ischaemic attack "TIA") you should discuss this with your doctor before taking Naproxen.

•    you should also discuss your treatment with your doctor if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. Your doctor will want to ensure that you take the lowest necessary dose of Naproxen for the shortest period necessary.

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, or any of the following:

•    rhenytoin to treat or prevent convulsions, anticoagulants to thin your blood, such as Warfarin or sulphonamides to treat infection, as the levels of all these medicines in your blood may increase when you start taking Naproxen

•    Furosemide or other water tablets, as these may not work as well when you start taking Naproxen

•    Lithium to treat mental illness or Methotrexate, for psoriasis, as your body may not be able to clear these as quickly when you start taking Naproxen

•    medicines to lower your blood pressure or to treat a heart condition

•    Probenecid, for gout, as the dose of Naproxen you will need will be lower than usual

•    antibiotics, to treat infection, as side effects may occur if some antibiotics are taken with Naproxen

•    Digoxin for your heart; corticosteroids such as Ciclosporin and Prendisolone; Mifepristone or if you are already taking other non-steroidal anti-inflammatory druqs.

Taking Naproxen with food and drink -You should swallow Naproxen with a glass of water, preferably with or after food.

Pregnancy and breast-feeding - Tell your doctor if you are pregnant, planning to become pregnant or if you are breast-feeding, as small amounts of Naproxen can pass into breast milk. Ask your doctor or pharmacist for advice before takinp any medicine.

Driving and using machines - Naproxen should not have any effect on your ability to drive or use machines.

Effects on laboratory tests - If you need to have any tests such as blood tests, urine tests, liver function or adrenal function tests tell the doctor that you are taking Naproxen. You may need to stop taking these tablets before you have the test.

Important information about some of the ingredients of Naproxen - Naproxen contains lactose monohycfrate. If you are lactose intolerant, contact your doctor before taking this medicine.

3.    HOWTO TAKE NAPROXEN

Always take Naproxen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage - You should swallow the tablets whole with a glass of water, with or after food. The dose you should take will depend on what you are taking Naproxen for.

Adult's: Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: The usual dose is 500 mg to 1 gram Naproxen daily, divided into two doses and taken 12 hours apart. Alternatively, the whole daily dose may be taken either in the morning or in the evening if your symptoms require this. Your doctor will tell you how to take your tablets.

Gout: The usual dose is 750 mg Naproxen at once when an attack occurs, then 250 mg every 8 hours until the attack has gone. Musculo-Skelefal Disorders (sprains etc): The usual dose is 500 mg to start, then one 250 mg tablet every 6-8 hours as needed, up to a maximum 1250 mg (5 x Naproxen 250 mg tablets) per day after the first day.

Elderly: If you are elderly the close you take will be similar to other adults but should be the lowest dose that is effective. If you notice any signs of bleeding in your stomach or gut (eg. black, tarry stools or if you vomit blood) stop taking Naproxen and tell your doctor straight away. Children: The dose is worked out depending on the weight of your child. The usual dose is 10 mg Naproxen/kg bodyweight/day, divided into two doses (morning and evening).

Children under 16 years old should not take Naproxen for any other use.

If you take more Naproxen than you should - If you take more Naproxen than you should, contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose include drowsiness, heartburn, indigestion, feeling and being sick. Take the container and any remaining tablets with you.

If you forget to take Naproxen - If you forget to take Naproxen 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 Naproxen - Do not

stop taking Naproxen without talking to your doctor, even if you feel better. It is important that ou take the full course of Naproxen prescribed y your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

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

Very serious side effects ■ If any of the following happen, stop taking Naproxen and tell your doctor immediately or go to

your nearest hospital emergency department:

•    if you have severe stomach pain

•    if you pass black, tarry stools

•    if you vomit any blood or dark particles that look like coffee grounds

•    if you have an allergic reaction causing difficulty in breathing, tightness of the chest, swelling of the face, throat or tongue, sore dry itchy skin, or severe skin rashes

•    if you notice sensitivity of the skin to sunlight, red spots or rash on tne skin or unusual

bruising or bleeding of the skin • if your skin or the whites of your eyes become yellow.

Other possible side effects:

Very common (occurring in more than 1 in 10 patients): upset stomach, stomach or abdominal pain and diarrhoea.

Common (occurring in less than 1 in 10 atientsl: feeling or being sick, wind, indigestion, eadache, pins and needles or slight swelling of the hands and feet, feeling dizzy or confused, ringing in the ears and changes in eyesight. Uncommon (occurring in less than 1 in 100 patients): sleeplessness, lack of concentration, sore mouth, effects on the kidneys or liver, feeling generally unwell, hallucinating and depression. Rare or very rare (occurring in less than 1 in 1000 patients): hair loss, bleeding for longer than usual from cuts, loss of hearing and a mild form of meningitis (causing headache, neck stiffness, fever, confusion, reeling or being sick).

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.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOWTO STORE NAPROXEN

Keep out of the reach and sight of children. Do not use Naproxen after the expiry date, which is shown on the label or carton. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the tablets in the original container. Medicines should not be disposed of via wastewater 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 contains - The active substance is naproxen. The other ingredients are lactose monohydrate, maize starch, povidone K29/32, polysorbate 80, sodium starch glycollate, purified talc, magnesium stearate and quinoline yellow (El04).

What Naproxen looks like and contents of the pack - Your medicine comes as yellow tablets containing either 250 mg or 500 mg of naproxen. The 250 mg tablets are marked with "NP" and "250" on one side and "G" on the other. The 500 mg tablets are marked with "NP" and "500" on one side and "G" on the other. Naproxen is available in blisters or plastic bottles of 5, 7, 10, 14, 15, 20,21,25, 28,30, 56,

60, 84, 90, 100, 112, 120, 168 and 180 tablets. Plastic bottles of 250 and 500 tablets and glass bottles of 100, 250 and 500 tablets are also available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder is: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

The Manufacturer is: Gerard Laboratories,

Grange Road, Dublin 13.

Date of revision: March 2007    ITEM CODE