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Document: leaflet MAH GENERIC_PL 14894-0534 change

• leaflet MAH GENERIC_PL 14894-0534
• leaflet MAH GENERIC_PL 25821-0021

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Package leaflet: Information for the patient

Naproxen EC

250 mg and 500 mg Tablets

What is in this leaflet

1.    What Naproxen EC is and what it is used for

2.    What you need to know before you take Naproxen EC

3.    How to take Naproxen EC

4.    Possible side effects

5.    How to store Naproxen EC

6.    Contents of the pack and other information

1.    What Naproxen EC is and what it is used for

Naproxen EC tablets contain the active substance naproxen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines help to relieve pain and joint inflammation.

Naproxen EC can be used in adults for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (causing pain and stiffness in the back), back pain, neck pain, and swollen or painful tendons. It is also used to treat sprained or strained muscles or painful menstrual periods.

2.    What you need to know before you take Naproxen EC

Do not take Naproxen EC if you:

•    are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).

•    have or ever had a stomach ulcer, or bleeding of the stomach or intestine.

•    have previously experienced bleeding or perforation in your stomach while taking NSAIDs.

•    have ever suffered any allergic reactions after taking aspirin or other NSAIDs or if you have a history of swelling of the tongue or larynx (angioedema), wheeziness (asthma) inflammation of the nose (rhinitis) or nasal polyps (Lumps lumps in nose), hay fever, itchiness or skin rash (urticaria) after taking aspirin or other NSAIDs

•    have severe problems with your kidneys, liver or heart.

•    are in the last three months of pregnancy.

Do not take Naproxen EC if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen EC.

Warnings and precautions

Talk to your doctor or pharmacist before taking Naproxen EC if you:

•    suffer from stomach problems. It is known that bleeding in the stomach or gut can occur in patients taking Naproxen EC. If you find you have black, tarry stools while taking these tablets, you must stop taking them and tell your doctor at once.

•    have asthma, hay fever or allergies as these tablets can cause breathing difficulties (bronchospasm).

•    are having liver or adrenal function tests as taking these tablets can change the results.

•    suffer from any blood clotting disorders or are taking anti-coagulant therapy (blood thinning medicines) e.g. heparin or warfarin, as naproxen decreases the ability of your blood to clot and will increase the length of time you bleed if you get a cut.

•    have heart problems. Occasionally patients have reported swollen feet or hands while taking these tablets and this is more likely in patients who have heart problems.

•    have problems with the blood vessels (arteries) anywhere in your body.

•    have kidney problems. Your doctor may wish to check your kidney function before and during treatment and/or use a lower dose than normal.

•    have liver problems, including alcohol-related disease or other forms of cirrhosis of the liver, as you should then take the least number of tablets needed.

•    are elderly and/or feeling weak (perhaps because of an illness). These patients are more susceptible to side effects of NSAIDs especially bleeding and perforation in the stomach or gut. Long term use of Naproxen in these patients is not recommended.

•    have an autoimmune condition, such as 'systemic lupus erythematosus' (SLE, causes joint pain, skin rashes and fever) and ulcerative colitis or Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen EC.

While taking this medicine if you develop visual disturbances, talk to your doctor and go for ophthalmological examination.

Please note:

Medicines such as Naproxen EC 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 that you might be at risk of these conditions (for example if you have a high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Children and adolescents

Naproxen EC is not recommended for use in children under 16 years of age.

Other medicines and Naproxen EC

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is important because Naproxen EC could alter how other medicines work.

In particular, tell your doctor or pharmacist if you are taking:

•    other NSAIDs such as aspirin (medicines used as a pain killers)

•    a hydantoin (for epilepsy), like phenytoin

•    anti-coagulants (medicine to stop your blood clotting) like warfarin, heparin

•    sulphonylurea (for diabetes) like glimepiride or glipizide

•    sulphonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulphonamide antibiotics (for infections)

•    a 'quinolone antibiotic' (for infections), like ciprofloxacin or moxifloxacin.

•    cardiac glycosides (for heart problems) such as digoxin

•    certain medicines for mental health problems like lithium or 'SSRIs' like fluoxetine or citalopram

•    antihypertensive drugs (medicines used to treat high blood pressure) such as angiotensin-ll receptor antagonists like candesartan or losartan, ACE inhibitors like cilazapril or enalapril, diuretics (water tablet) like furosemide

•    probenecid (medicine used to treat gout)

•    methotrexate (used to treat skin problems, arthritis or cancer)

•    steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone

•    ciclosporin or tacrolimus (for skin problems or after an organ transplant).

•    mifepristone (used to end pregnancy or to bring on labour if the baby has died)

•    zidovudine (used to treat AIDS and HIV infections).

Pregnancy, breast-feeding and fertility

Do not take Naproxen if you are in the last three months of pregnancy, as it can harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacists for advice before taking this medicine.

Talk to your doctor before taking Naproxen if you are up to six months pregnant. Your doctor will then discuss this with you and decide whether you should take this medicine. Naproxen may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

If you are breast feeding you should not take these tablets.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

You should not drive or operate machinery if you are affected by drowsiness, dizziness, tiredness, abnormal vision, have problem with your balance, difficulty in sleeping or depression when taking Naproxen.

3. How to take Naproxen EC

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The number of tablets you should take depends on the type of pain you have.

Do not take more than you are told to, as this increases the chances of side-effects (especially in the elderly).

Adults

For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis The recommended dose is between 500 mg and 1 g each day in two separate doses, 12 hours apart. Where 1 g per day is needed, you can take 500 mg twice each day, or 1 g in one single dose (morning or evening).

In some people, a larger dose of between 750 mg and 1 g per day may be taken to start with to control the pain. This is in patients with:

•    severe night-time pain and/or morning stiffness.

•    if your tablets have recently been changed from a high dose of another treatment for pain.

•    osteoarthritis where pain is your main problem.

For strained or sprained muscles, back pain, neck pain, swollen or painful tendons, and painful periods

The recommended starting dose is 500 mg, followed by 250 mg every 6 to 8 hours as needed. Do not take more than 1250 mg a day after the first day.

Elderly and people with liver and kidney problems

Your doctor will decide your dose; it will usually be lower than that for adults.

Use in children and adolescents

Naproxen EC is not for use in children under 16 years of age.

Medicines such as Naproxen EC may be associated (linked) with a small increased risk of heart attack ('myocardial stroke') 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.

Swallow the tablets whole with a little water, with or after food. Do not crush or chew tablet.

You should make sure that you have enough to drink (stay well hydrated) when you are taking Naproxen EC. This is particularly important for people who have problems with their kidneys.

While you are taking naproxen EC your doctor will want to check you are on the right dose for you and look for any side effects. This is particularly important if you are an elderly.

If you take more Naproxen than you should

If you take too many tablets, you may develop headache, drowsiness, heartburn, abdominal pain, bleeding from the stomach wall, and rarely loose motions, disorientation, excitation, dizziness, ringing or other persistent noise in the ears, fainting, indigestion, feeling or being sick. Contact your doctor, pharmacist or nearest hospital straight away.

If you forget to take Naproxen EC

If you should forget to take your tablets, take the normal dosage as soon as you remember and then wait for the normal interval before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Naproxen EC

Your doctor will advise you when to stop taking the medicine.

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

4. Possible side effects

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

Medicines such as Naproxen may be associated (linked) with a small increased risk of heart attack ('myocardial infarction¹) or stroke.

Important side effects to look out for:

Stop taking Naproxen 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 Crohn's disease, seen as pain, diarrhoea, vomiting and weight loss.

Allergic reactions, signs include:

•    Sudden swelling of your throat, face, hands or feet.

•    Difficulty 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.

•    Skin blistering when exposed to sunlight (porphyria cutanea tarda) seen most on arms face and hands.

•    Redness, hives, bruising, itching, sweating.

•    'Systemic lupus erythematosus' (SLE). Signs include fever, rash, problems with your kidneys and joint pain.

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 and circulation

•    Heart attack, signs include: Chest pain which may spread to your neck and shoulders and down your left arm.

•    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.

•    Swelling of your hands, feet or legs (oedema). This may be with chest pains, tiredness, shortness of breath (cardiac failure).

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 erythematosus¹).

Others

•    Changes in the numbers of blood cells which may present as sudden fever, mouth ulcers, unexplained bruising or bleeding, sore throat, anaemia.

•    Fits or seizures.

•    Blood in your water (urine) or kidney problems.

If you notice any of the serious side effects mentioned above, stop taking this medicine and tell your doctor straight away.

Other possible side effects:

Stomach and gut

•    Heartburn, indigestion, stomachache, feeling sick or being sick, constipation, diarrhoea, wind.

•    Inflammation of the food pipe and stomach.

Mental illness

•    Having difficulty sleeping or changes in your patterns of dreaming.

•    Depression.

•    Confusion or seeing and possibly hearing things that are not there (hallucinations).

Nervous system

•    Headache.

•    Feeling dizzy or light-headed or sleepy.

•    Pins and needles or numbness of your hands and feet.

•    Difficulty with your memory or concentration.

Eyes and ears

•    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

•    A fluttering feeling in your heart (palpitations), slow heart beat or high blood pressure.

Chest

•    Difficulty breathing, including shortness of breath, wheezing or coughing.

•    Pneumonia or swelling of your lungs.

Skin and hair

•    Hair loss

Other

•    Thirst, fever, feeling tired or generally unwell.

•    A sore mouth or mouth ulcers.

•    Muscle pain or weakness.

•    Problems for women in getting pregnant.

Electrolyte imbalance

•    Increased level of potassium in blood (this can be identified by blood test).

Reporting of side effects

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

You can also report 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 Naproxen EC

•    Store below 25°C

•    Keep blister in the outer carton in order to protect from light

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date, which is stated on the label or carton after “EXP”. The expiry date refers to the last day of the month. Consult your pharmacist if you have any doubts about the shelf life

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Naproxen EC contains

-    The active substance is naproxen

Naproxen EC 250 mg tablets contain 250 mg naproxen Naproxen EC 500 mg tablets contain 500 mg naproxen

-    The other ingredients are povidone, colloidal silicon dioxide, microcrystalline cellulose, crosscarmellose sodium, magnesium stearate, triethyl citrate, glycerol monostearate, methacrylic acid copolymer (type C), talc, titanium dioxide (E171).

What Naproxen EC looks like and contents of pack

Naproxen EC 250 mg tablets: round, biconvex, white or almost white, film-coated, smooth surface

Naproxen EC 500 mg tablets: oblong, biconvex, white or almost white, film-coated, smooth surface

Both strengths of Naproxen EC are supplied in blister packs of 56 tablets.

Marketing Authorisation Holder

Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE

Manufacturer

Losan Pharma GmbH Otto-Hahn-Strasse 13,

Neuenburg, D-79395,

Germany

This leaflet was last revised in October 2015.

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