59.5 mm

59.5 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER Naproxen 250mg and 500mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

What is in this leaflet:

1.    What Naproxen is and what it is used for

2.    What you need to know before you take Naproxen

3.    How to take Naproxen

4.    Possible side effects

5.    How to store Naproxen

6.    Contents of the pack and other information

1. What Naproxen is and what it is used for

Naproxen is a ‘Non Steroidal Anti Inflammatory Drug' or NSAID. Naproxen can lessen pain, swelling, redness and heat (inflammation) 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._

2. What you need to know before you take Naproxen

Do not take Naproxen if you:

•    are allergic or (hypersensitive) to Naproxen sodium or any of the other ingredients of Naproxen (see section 6).

•    have a history of allergy to NSAIDs (e.g. Aspirin, Diclofenac, Ibuprofen), which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose

•    have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding

•    have a history of gastrointestinal bleeding or perforation related to the use of NSAIDs.

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

•    are in the last three months of pregnancy (last trimester).

Do not take Naproxen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen. Warnings and Precautions

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 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 Naproxen if you have had or if you are suffering from any of the following conditions.

•    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 your blood clots.

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

•    A history of gastrointestinal disease e.g. ulcerative colitis, Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).

•    Hyperlipidaemia (too much fat (lipid) in your blood).

•    An autoimmune condition such as, ‘systemic lupus erythematosus' (SLE). SLE causes joint pain, skin rashes and fever and mixed connective tissue disorders.

•    Naproxen 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.

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

Other medicines and Naproxen

Tell your doctor or pharmacist if you are taking or have

recently taken or might take any other 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 anatgonist, 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 inflammation) like, hydrocortisone, prednisolone and dexamethasone.

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

•    Certain medicines for mental health problems like, lithium or ‘SSRIs' like fluoxetine 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).

If any of the above apply to you, or if you are not sure, talk to your

doctor or pharmacist before you take Naproxen

Pregnancy and breast-feeding

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

•    Talk to your doctor before taking Naproxen 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 Naproxen.

•    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.

Driving and using machines

Naproxen may make you feel tired, drowsy, dizzy, have problems

with your eyesight and balance, depressed or have difficulty sleeping.

Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

Naproxen Tablets contain Lactose and Sunset yellow

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

•    Sunset yellow may cause allergic reactions.

3. How to take Naproxen

Medicines such as Naproxen 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.

While you are taking Naproxen, your doctor will want to see you to check whether you are on the right dose and look for any side effects. This is particularly important if you are elderly.

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

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

Arthritis and ankylosing spondylitis

•    The usual dose is between 500 mg and 1000 mg.

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

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.

If you take more Naproxen than you should

If you take more Naproxen than you should, talk to your doctor or go to the hospital straight away. Take the original pack with you.

140 mm

59.5 mm

59.5 mm

If you forget to take Naproxen

•    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.

4. Possible side effects

Like all medicines Naproxen can cause side effects, although not everyone will get them.

Medicines such as Naproxen may be associated with a small increased risk of heart attack (‘myocardial infarction') 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 in 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 (Stevens Johnson Syndrome or Toxic epidermal necrolysis)

•    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 Naproxen and tell your doctor straight away.

Other possible side effects:

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 difficulty in sleeping or change 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.

•    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

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

•    A fluttering 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

•    Difficulty in 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

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

•    Naproxen Tablets should be kept in their original packaging to protect them from light. Store below 25⁰C.

•    Keep out of the sight and reach of children.

•    Do not use Naproxen Tablets after the expiry date which is printed on the pack. The expiry date refers to the last day of that month.

•    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 protect the environment

6. Contents of the pack and other information

What Naproxen contains

•    The active substance is naproxen. Each tablet contains either 250 mg (milligrams) or 500 mg of naproxen

•    The other ingredients are sodium lauryl sulphate, lactose, maize

starch, crospovidone, magnesium stearate and the colours quinoline yellow (E104) and sunset yellow (E110)

What Naproxen looks like and contents of the pack

Naproxen 250 mg tablets: Pale yellow, flat bevelled edge tablets with N breakline 250 on one side and BL on the other.

Naproxen 500 mg tablets: Pale yellow, oblong tablets with N breakline 500 on one side and BL on the other.

Naproxen 250 mg tablets are supplied in Securitainers of 28, 56, 250 tablets and blisters of 28, 56, 84 and 112 tablets.

Naproxen 500 mg tablets are supplied in Securitainers of 28, 56, 100, 500 tablets and blisters of 28, 56, 84 and 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Special Concept Development (UK) Limited, Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufacturer

Bristol Laboratories Ltd. Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, UK

Naproxen 250mg Tablets; PL 36722/0052 Naproxen 500mg Tablets; PL 36722/0053 This leaflet was last revised in January 2015.

140 mm