Naproxen 500mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Naproxen 250mg and 500mg Tablets Naproxen
(Refer to as Naproxen Tablets in this leaflet)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again while you are
receiving your treatment.
- If you have any further questions, please ask your doctor or
nurse.
- This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get 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
1. What Naproxen Tablets are and what they are used for
Naproxen belongs to a group of medicines called nonsteroidal 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
• juvenile rheumatoid arthritis
• osteoarthritis
• ankylosing spondylitis (arthritis in the spine)
• acute gout
• musculo-skeletal disorders such as sprains, back pains and fibrositis
2. Before you take Naproxen Tablets Do not take Naproxen Tablets:
• 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 anti-inflammatory 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 serious problems with your liver, kidney or heart
• if you are in the last three months of pregnancy
• if you are taking another non-steroidal anti-inflammatory drug (NSAID)
Take special care with Naproxen Tablets:
• if you have any problems with your stomach or bowel
• if you have problems with your liver or kidneys
• if you have haemophilia or problems with your blood not clotting
• if you have heart trouble or high blood pressure
• if you are elderly
• if you have asthma or if you suffer from a connective tissue disorder (such as lupus).
Tell your doctor if any of the above applies to you.
Medicines such as Naproxen Tablets 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.
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:
• Phenytoin to treat or prevent convulsions, anticoagulants to thin your blood, such as warfarin, heparin, clopidogrel and ticlopidine or some antibiotics such as ciprofloxacin and sulphonamides to treat infection, as the levels of all these medicines in your blood may increase when you start taking Naproxen
• Furosemide, amiloride, triampterene or other water tablets, as these may not work as well when you start taking Naproxen
• Lithium or moclobemide to treat mental illness, as your body may not be able to clear these as quickly when you start taking Naproxen
• methotrexate (for rheumatoid arthritis)
• cardiac glycosides (e.g. digoxin), used to treat heart problems, and other drugs (e.g. disopyramide) used to control_heart rhythm
•probenecid, for gout, as the dose of Naproxen you will need will be lower than usual
• certain drugs used to treat diabetes - chlorpropamide, glibenclamide, gliclazide and tolbutamide
• drugs for high blood pressure including ACE inhibitors (e.g. lisinopril), beta-blockers (e.g. propranolol) and angiotensin II antagonists (e.g. losartan)
• ritonavir, used to treat viral infections
• oxipentifylline, used for poor circulation
• drugs used to lower cholesterol (e.g. colestyramine)
• corticosteroids (e.g. prednisolone), used to treat allergic conditions and inflammation
• mifepristone (used in abortions)
• ciclosporin and tacrolimus (used after transplant surgery)
There may be some problems when naproxen is taken with alcohol, including bleeding of the stomach and stomach ulcers.
Taking Naproxen Tablets with food and drink - You
should swallow Naproxen Tablets 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 taking any medicine.
Driving and using machines
Do not drive or operate machinery if you feel drowsy or have blurred vision after taking Naproxen Tablets.
Important information about some of the ingredients of Naproxen Tablets
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium - free’.
3. How to take Naproxen Tablets
Always take Naproxen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
These tablets should be taken as instructed after meals. The dose you should take will depend on what you are taking Naproxen for.
Dosage
Adults: Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: 250mg or 500mg twice a day.
|
Product name |
Reference number |
|
Naproxen 250mg Tablets |
29831/0150 |
|
Naproxen 500mg Tablets |
29831/0149 |
Acute gout: 750mg is taken at once then 250mg every eight hours until the attack has passed.
Musculo-Skeletal Disorders (sprains etc): the usual dose is 500mg followed by 250mg every six to eight hours, up to a maximum 1250 mg (5 x Naproxen 250 mg tablets) per day after the first day.
Elderly: If you are elderly the dose you take will be similar to other adults but should be the lowest dose that is effective.
Children: In children over 5 years with juvenile rheumatoid arthritis 10mg/kg bodyweight per day is usually given, in divided doses.
If you take more Naproxen Tablets than you should
If you take more Naproxen Tablets 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 Tablets
If you forget to take Naproxen Tablets 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 Tablets
Do not stop taking Naproxen Tablets without talking to your doctor, even if you feel better. It is important that you take the full course of Naproxen prescribed by 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 Tablets can cause side effects, although not everybody gets them.
Very serious side effects - If any of the following happen, stop taking Naproxen Tablets 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 the skin or unusual bruising or bleeding of the skin
• if your skin or the whites of your eyes become yellow.
Naproxen Tablets can make colitis and Crohn’s disease worse. Occasionally stomach ulcers may develop.
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 patients): feeling or being sick, wind, indigestion, heartburn, mouth ulcers, headache, pins and needles or slight swelling of the hands and feet, feeling dizzy or confused, hearing problems, ringing in the ears and changes in eyesight.
Uncommon (occurring in less than 1 in 100 patients): sleeplessness, lack of concentration, 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, a mild form of meningitis (causing headache, neck stiffness, fever, confusion, feeling or being sick), pneumonia, giddiness, drowsiness, tiredness, blood in the urine, fluid in the tissues. Blood disorders (which may cause fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding or bruising).
Taking naproxen late in pregnancy can cause delayed or prolonged labour and may cause bleeding problems, kidney problems and problems with the circulation of the blood in newborn babies.
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. 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 shown on the label or carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Tablets contain
The active substance is naproxen.
Other ingredients are lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, yellow lake CLF 3076 which consists of E104 (quinoline yellow aluminium lake) and E172 (iron oxide).
What Naproxen Tablets look like and contents of the pack
The tablets are available in two strengths of 250mg and 500mg.
Naproxen 250mg Tablets are yellow, circular, flat faced tablets marked NXN 250 with a breakline on one face and CP on the reverse.
Naproxen 500mg Tablets are yellow capsule shaped tablets marked NXN 500 with a breakline on one face and CP on the reverse.
Naproxen Tablets are available in blister packs of 28 tablets in cartons.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
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