NAPROSYN 250MG TABLETS

Active substance: NAPROXEN

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KAU-Nr. Genisys-No. Printing Colour: Format: Folding Format: Leatus Code Type Size Drawing Norm make-up Code COE/CMO

1314 10142743 Pantone Black 148x420 mm 219 9 pt PR003/20 18.11.2009 GB LE
Checked and approved Date Signature

Patient Information Leaet

10142743 GB LE.1210.1078

Naprosyn
250 mg & 500 mg Tablets
Naproxen

Please read all of this leaet carefully before you start taking this medicine. Keep this leaet. 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 of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Naprosyn is and what it is used for 2. Before you take Naprosyn 3. How to take Naprosyn 4. Possible side effects 5. How to store Naprosyn 6. Further information

Taking other medicines

1. What Naprosyn is and what it is used for
Naprosyn contains a medicine called naproxen. This is a Non Steroidal Anti Inammatory Drug or NSAID. Naprosyn can lessen pain, swelling, redness and heat (inammation) and is used for: Problems with your muscles, joints and tendons, like strains, gout, ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis. Women, while having period pain. Children over 5 years with rheumatoid arthritis.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking: Other pain killers, like aspirin, ibuprofen, diclofenac and paracetamol. Medicine to stop your blood clotting, like warfarin, heparin or clopidogrel. A hydantoin (for epilepsy), like phenytoin. Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics (for infections). A sulfonylurea (for diabetes), like glimepiride or glipizide. An ACE inhibitor or any other medicine for high blood pressure like cilazapril, enalapril or propranolol. An angiotensin-II receptor antagonist, like candesartan, eprosartan or losartan. A diuretic (water tablet) (for high blood pressure), like furosemide. A cardiac glycoside (for heart problems), like digoxin. A steroid (for swelling and inammation), like hydrocortisone, prednisolone and dexamethasone. A quinolone antibiotic (for infections), like ciprooxacin or moxioxacin. Certain medicines for mental health problems like lithium or SSRIs like uoxetine or citalopram. Probenecid (for gout). Methotrexate (used to treat skin problems, arthritis or cancer). Ciclosporin or tacrolimus (for skin problems or after an organ transplant). Zidovudine (used to treat AIDS and HIV infections). Mifepristone (used to end pregnancy or to bring on labour if the baby has died).

2. Before you take Naprosyn
Do not take Naprosyn if you are allergic (hypersensitive) to:
Naproxen, naproxen sodium or any of the other ingredients of Naprosyn (see Section 6). Aspirin, other NSAIDs or any other pain relief medicines (such as ibuprofen or diclofenac).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naprosyn. Pregnancy and breast-feeding

Do not take Naprosyn if:

You have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding. You have previously experienced bleeding or perforation in your stomach while taking NSAIDs. You have severe problems with your kidneys, liver or heart. You are in the last three months of pregnancy. Do not take Naprosyn if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naprosyn.

Do not take Naprosyn if you are in the last three months of pregnancy, as it can harm your baby. Talk to your doctor before taking Naprosyn if you are up to six months pregnant, think you are pregnant, plan to get pregnant or are breast-feeding. Your doctor will decide if you should take Naprosyn. Naprosyn may make it more difcult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Naprosyn may make you tired, drowsy, dizzy, have problems with your eyesight and balance, depressed or have difculty sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

Driving and using machines:

3. How to take Naprosyn
Medicines such as Naprosyn may be associated (linked) with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses and prolonged (longer term) treatment. Do not exceed (take more than) the recommended dose or duration (length) of treatment. Check with your doctor if you are not sure. Swallow the tablets whole with a little water, with or after food. You should make sure that you have enough to drink (stay well hydrated) when you are taking Naprosyn. This is particularly important for people who have problems with their kidneys. While you are taking Naprosyn your doctor will want to see you to check you are on the right dose for you and look for any side effects. This is particularly important if you are elderly.

Take special care with Naprosyn

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. Check with your doctor or pharmacist before taking Naprosyn if any of the following apply to you: Asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past. A feeling of weakness (perhaps because of an illness) or you are elderly. Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis). Problems with your kidneys or liver. Problems with the way that your blood clots. Problems with the blood vessels (arteries) anywhere in your body. Too much fat (lipid) in your blood (hyperlipidaemia). An autoimmune condition, such as systemic lupus erythematosus (SLE, causes joint pain, skin rashes and fever) and colitis or Crohns disease (conditions causing inammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss). If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naprosyn.

Children over 5 years, rheumatoid arthritis

The usual dose is 10 mg/kg body weight each day. The dose is split into two and given 12 hours apart.

Adults Muscle, joint or tendon problems and period pain Arthritis and ankylosing spondylitis
The usual dose is between 500 mg and 1000 mg. 1

The usual starting dose is 500 mg, followed by a 250 mg tablet every 6 to 8 hours as needed.

Please turn over

10142743 PR003 148x420 mm.indd 1

25.02.2013 13:24:47

KAU-Nr. Genisys-No. Printing Colour: Format: Folding Format: Leatus Code Type Size Drawing Norm make-up Code COE/CMO

1314 10142743 Pantone Black 148x420 mm 219 9 pt PR003/20 18.11.2009 GB LE
Checked and approved Date Signature

The dose can be taken all at once, or split in two and taken twice a day.

Eyes and ears

Gout

The usual starting dose is 750 mg, followed by a 250 mg tablet every 8 hours as needed.

The elderly and people with liver and kidney problems
Your doctor will decide your dose, it will usually be lower than that for other adults.

Changes to your eyesight, eye pain. Changes to your hearing, including ringing in the ears (tinnitus) and hearing loss. Dizziness that causes problems with your balance.

Heart and circulation

If you take more Naprosyn than you should

If you take more Naprosyn than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Naprosyn

If you forget to take a dose, skip the missed dose. Then take your next dose as normal. Do not take a double dose to make up for a forgotten dose.

Swelling of your hands, feet or legs (oedema), this may be with chest pains, tiredness, shortness of breath (cardiac failure). A uttering feeling in your heart (palpitations), slow heart beat or high blood pressure. Problems with the way your heart pumps blood around the body or damage to your blood vessels. Signs may include tiredness, shortness of breath, feeling faint, general pain.

Chest

4. Possible side effects
Like all medicines Naprosyn can cause side effects, although not everyone will get them. Medicines such as Naprosyn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Important side effects to look out for:

Difculty breathing, including shortness of breath, wheezing or coughing. Pneumonia or swelling of your lungs.

Skin and hair

Skin rashes including redness, hives, pimples and blisters on your body and face. Bruising, itching, sweating, skin being more sensitive to the sun or hair loss.

Urinary

Stop taking Naprosyn and tell a doctor straight away if any of the following side effects happen. You may need urgent medical treatment:
Serious stomach or gut problems, signs include: Bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds. Bleeding from your back passage (anus), seen as passing black sticky bowel motions (stools) or bloody diarrhoea. Ulcers or holes forming in your stomach or gut. Signs include upset stomach, stomach pain, fever, feeling or being sick. Problems with your pancreas. Signs include severe stomach pain which spreads to your back. Worsening of ulcerative colitis or Crohns disease, seen as pain, diarrhoea, vomiting and weight loss. Allergic reactions, signs include: Sudden swelling of your throat, face, hands or feet. Difculty breathing, tightness in your chest. Skin rashes, blisters or itching. Severe skin rashes, signs include: A severe rash that develops quickly, with blisters or peeling of your skin and possibly blisters in your mouth, throat or eyes. Fever, headache, cough and aching body may happen at the same time. Blistering of skin when exposed to sunlight (porphyria cutanea tarda) seen most on arms, face and hands. Liver problems, signs include: Yellowing of your skin or the whites of your eyes (jaundice). Feeling tired, loss of appetite, feeling or being sick and pale coloured stools (hepatitis) and problems (including hepatitis), shown in blood tests. Heart attack, signs include: Chest pain which may spread to your neck and shoulders and down your left arm. Stroke, signs include: Muscle weakness and numbness. This may only be on one side of your body. A suddenly altered sense of smell, taste, hearing or vision, confusion. Meningitis, signs include: Fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion (most likely in people with autoimmune conditions such as systemic lupus erythematosus). If you notice any of the serious side effects mentioned above, stop taking Naprosyn and tell your doctor straight away. Other possible side effects:

Blood in your water (urine) or kidney problems.

Other

Thirst, fever, feeling tired or generally unwell. A sore mouth or mouth ulcers. Muscle pain or weakness. Problems for women in getting pregnant. Systemic lupus erythematosus (SLE). Signs include fever, rash, problems with your kidneys and joint pain. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.

5. How to store Naprosyn
Naprosyn Tablets should be kept in their original packaging to protect them from light. Store below 30 C. Keep out of the reach and sight of children. Do not use Naprosyn Tablets after the expiry date printed on the pack. Return any left over tablets to your pharmacist to be disposed of carefully. Only keep them if your doctor tells you to.

6. Further information
What Naprosyn contains
The active substance in Naprosyn 250 mg and 500 mg Tablets is naproxen. Each tablet contains either 250 mg (milligrams) or 500 mg of naproxen. Other ingredients in the tablets are povidone, magnesium stearate, croscarmellose sodium and iron oxide (E172).

What Naprosyn looks like and contents of the pack
Naprosyn 250 mg Tablets are round, yellow and marked with NPR LE 250 on one side and a breakline on the other. Naprosyn 500 mg Tablets are oval, yellow and marked with NPR LE 500 on one side and a breakline on the other.

Naprosyn tablets are supplied in blister packs containing 56 tablets.

Marketing Authorisation Holder and Manufacturer
Roche Products Limited, 6 Falcon Way, Shire Park Welwyn Garden City, AL7 1TW United Kingdom

This leaet was last revised in February 2013

Stomach and gut

Heartburn, indigestion, stomach ache, feeling sick or being sick, constipation, diarrhoea, wind.

Blood

Blood problems, like anaemia or changes to the numbers of white blood cells.

Mental illness

Having difculty sleeping or changes in your patterns of dreaming. Depression. Confusion or seeing and possibly hearing things that are not there (hallucinations).

Nervous system

Headache. Fits or seizures, feeling dizzy or light-headed or sleepy. Pins and needles or numbness of your hands and feet. Difculty with your memory or concentration. 2
10142743 GB LE.1210.1078

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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