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The product codes for this leaflet are: PL 20532/0027, PL 20532/0028

 

Naproxen Tablets BP 250mg/500mg

Company Details

Aurobindo Pharma - Milpharm Ltd.


Odyssey Business ParkAres BlockWest End RoadSouth RuislipMiddlesexHA4 6QD
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Medical Information e-mail:medinfo@aurobindo.com
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Naproxen Tablets BP 250mg

Naproxen Tablets BP 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 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 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

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

Naproxen is one of a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Naproxen reduces inflammation and pain in the joints and muscles.

Naproxen is used for:

  • Treatment of rheumatoid arthritis of other rheumatic or musculoskeletal disorders (aliments that cause pain and stiffness in muscles, bones and joints)
  • Treatment of period pain
  • Treatment of acute gout
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2. Before you take Naproxen Tablets

DO NOT take Naproxen Tablets

  • if you are allergic (hypersensitive) to naproxen or any of the other ingredients of Naproxen Tablets
  • if you are allergic to or have ever had a reaction to aspirin or another NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen or meloxicam
  • if you have stomach ulcer or if you often get stomach ulcers
  • if you have duodenal ulcer (in the first part of the small intestine) or if you often get duodenal ulcers
  • if you have serious liver or kidney disease
  • if you are or have ever suffered from bleeding in the stomach or intestines while taking NSAIDs
  • if you are more than 6 months pregnant or if you are breast-feeding
  • if you have severe heart failure

Take special care with Naproxen Tablets

  • 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
  • if you have problems with how your blood clots
  • if you have ever had bronchial asthma or allergies
  • if you have ever had a stomach ulcer
  • if you have ever had a duodenal ulcer
  • if you have ever had any other problems with your digestive tract
  • if you suffer with localised swelling, high blood pressure or heart failure
  • if you have too much fat (lipid) in your blood (hyperlipidaemia)
  • if you have problems with you kidneys or liver
  • if you have an autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, causes joint pain, skin rashes and fever) and colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).
  • if you suffer from a serious skin reaction your doctor may want to stop/change your medicine

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 to become pregnant. Tell your doctor who will decide what to do.

If you are elderly you may have an increased risk of side effects. Tell your doctor immediately if you suffer with any unusual symptoms of the stomach or bowel.

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

Taking other medicines

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.
  • Medicines that prevent blood clotting such as warfarin, heparin or ticlopidine
  • Diuretics (water tablets) such as furosemide
  • Medicines to treat high blood pressure such as propranolol, enalapril, cilazapril
  • A ‘cardiac glycoside’ used to treat heart problems such as digoxine.
  • A steroid used to treat swelling and inflammation, like hydrocortisone, prednisolone and dexamethasone
  • Probenecid, a medicine to treat gout
  • Certain medicines used to treat mental illness such as lithium
  • Selective serotonin reuptake inhibitors such as Fluoxetine or Citalopram
  • Hydantoin – medicine used to treat epilepsy such as Phenytoin
  • Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics used to treat infections
  • A ‘quinolone antibiotic’ used to treat infections such as ciprofloxacin or moxifloxacin.
  • Ciclosporin or tacrolymus, medicines used to prevent transplant rejection after surgery
  • Methotrexate, a medicine used to treat skin conditions, rheumatoid arthritis and cancer
  • Colestyramine a medicine used to reduce cholesterol
  • Zidovudine, a medicine used to treat AIDS and HIV infections
  • Mifepristone, a medicine 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 Tablets. Please note that the above medicines may be known to you by other names, often the brand names. In this section only the active ingredient or therapeutic group of the medicine is given, and not the brand name. Always thoroughly check the pack and information leaflet of the medicines you are already using for the active ingredient or therapeutic group of that medicine.

It may still be all right for you to take Naproxen tablets and your doctor will be able to decide what is suitable for you.

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

Pregnancy and breast-feeding

Do not take Naproxen Tablets if you are more than 6 months pregnant or if you are breast-feeding. Your doctor may prescribe naproxen for you during early pregnancy if they decide it is suitable.

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

Driving and using machines

The tablets may make your vision blurred or make you feel drowsy or dizzy. If this happens you should not drive or use machines.

Important information about some of the ingredients of Naproxen Tablets

Naproxen Tablets contains 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.

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3. How to take Naproxen Tablets

Always take Naproxen Tablets exactly as your doctor has told you. 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.

Method of administration:

The tablets should be swallowed whole with a glass of water, at mealtime. Take your tablets at the same time each day.

While you are taking Naproxen Tablets 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.

Dosage:

The usual doses are listed below:

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 in two and taken twice a day.

Gout

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

Elderly and patients with liver and kidney problems

The doctor will decide right dose for you, it will usually be lower than for other adults.

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.

If you take more Naproxen Tablets than you should

If you take too much Naproxen Tablets, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Naproxen Tablets

If you have missed a dose, continue in accordance with your doctor’s prescription. Never take a double dose of Naproxen Tablets to make up for a forgotten dose.

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

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4. Possible side effects

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

Serious side effects to look out for:

Stop taking Naproxen and tell your doctor straight away if any of the following side effects happen. You may need urgent medical treatment:

Allergic reactions, signs include:

  • Sudden swelling of your throat, face, hands or feet.
  • Difficulty breathing, tightness in your chest.
  • Skin rashes, blisters or itching.

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.

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 Naproxen and tell your doctor straight away.

Other possible side effects:

  • Heartburn, indigestion, stomach ache, feeling sick or being sick, constipation, diarrhoea, wind.
  • Blood problems, like anaemia or changes to the numbers of white blood cells.
  • Having difficulty sleeping or changes in your patterns of dreaming.
  • Depression.
  • Confusion or seeing and possibly hearing things that are not there (hallucinations).
  • 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.
  • 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.
  • 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.
  • Difficulty breathing, including shortness of breath, wheezing or coughing.
  • Pneumonia or swelling of your lungs.
  • 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.
  • Blood in your urine or kidney problems.
  • 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 leaflet, please tell your doctor or pharmacist.

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5. How to store Naproxen Tablets

Keep out of the reach and sight of children.

Do not use Naproxen Tablets after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last date of that month.

This medicinal product does not require any special storage conditions.

Do not use Naproxen Tablets if you notice any visible signs of deterioration.

Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicin.es no longer required. These measures will help to protect the environment.

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6. Further information

What Naproxen Tablets contains

  • The active substance is naproxen.
  • The other ingredients are lactose, maize starch, povidone (E1201), sodium starch glycollate, magnesium stearate (E470b) and quinoline yellow (E104).

What Naproxen Tablets looks like and contents of the pack

Naproxen Tablets BP 250mg are yellow colored, round shaped, flat beveled edge uncoated tablets with score line between ‘NPY’ and ‘250’ debossed on one side and plain on the other side.

Naproxen Tablets BP 500mg are yellow colored, capsule shaped uncoated tablets with score line between ‘NPY’ and ‘500’ debossed on one side and plain on the other side.

Naproxen Tablets are available in packs of 28, 30, 56, 60, 84, 100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma Limited
Ares
Odyssey Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom

Manufacturers

Aurobindo Pharma Limited
Ares
Odyssey Business Park
West End Road
South Ruislip
HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26 Hal Far Industrial Estate
Hal Far
Birzebbugia
BBG 3000
Malta
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This leaflet was approved in {11/2011}

P1505645


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