Naproxen 500mg Tablets
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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 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.
In this leaflet:
1. What are Naproxen Tablets 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 ARE NAPROXEN TABLETS AND WHAT ARE THEY USED FOR
Naproxen Tablets belong to a group of medicines called non-steroid anti-inflammatory drugs (NSAID’s). These medicines reduce pain and inflammation, and bring down a high temperature. These tablets are used to reduce pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and acute gout. They may also be used in the management of acute musculo-skeletal disorders such as sprains, strains, low back pain, inflammation of tendon and muscle sheaths and various soft tissue injuries.
2. BEFORE YOU TAKE NAPROXEN TABLETS DO NOT take Naproxen Tablets if:
• You know that you are allergic to naproxen, naproxen sodium, or any of the other ingredients in these tablets (listed at the end of this leaflet).
• You are allergic to aspirin or other NSAIDs, or you have developed signs of asthma (wheezing), runny nose, swelling of the skin or rash when taking these medicines.
• You have or previously have had a peptic ulcer which is an ulcer in your stomach, or intestines, or have had two or more episodes of peptic ulcers.
• You have a history of gastrointestinal bleeding or perforation related to the use of NSAIDs.
. You have severe problems with your kidneys, liver or heart.
. You are in the last 3 months of pregnancy.
Do not take Naproxen Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen.
Take special care with Naproxen Tablets and check with your doctor or pharmacist before taking your medicine if:
•You are pregnant or if you are breast-feeding, 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.
•You have had an ulcer or some other problem affecting your stomach, or intestines like colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).
• You have asthma or allergies such as hay fever (or if you have had asthma, wheezing or swelling of the face, lips, eyes or tongue in the past),
• You have any liver or kidney problems
• You are using other similar anti inflammatory medicines
• You are elderly or have a feeling of weakness (perhaps because of an illness)
• If you have excessive fluid loss (e.g. through vomiting or diarrhoea), salt restriction or heart failure
• You suffer from haemophilia (a blood clotting disease) or any other bleeding disorder
• You suffer from an autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, causes joint pain, skin rashes and fever) or other connective tissue disorders.
• You have lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis).
•You have problems with the blood vessels (arteries) anywhere in your body.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.
Naproxen tablets may affect or be affected by the following medicines
• Anticoagulants (to prevent blood clots, e.g. warfarin , heparin, clopidogrel)
• Antihypertensives (for the treatment of high blood pressure) e.g 'ACE inhibitors' like lisinopril, enalapril, ramipril )
• Diuretics (to make you pass more water e.g furosemide)
• Lithium (for depression)
• Medicines for the treatment of heart failure (e.g. digoxin)
• Antibiotics (for an infection, e.g. quinolone, ciprofloxacin, moxifloxacin)
• Any other NSAID (for painful or inflammatory conditions e.g. aspirin, ibuprofen, diclofenac)
• Medicines for the treatment of diabetes e.g. sulphonyl urea like glimepiride or glipizide.
• Mifepristone (used to terminate pregnancies)
• A corticosteroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone.
• Antacids
•Colestyramine (to reduce the amount of cholesterol in the blood)
• Methotrexate (which can be used to treat certain tumours and other diseases including psoriasis and rheumatoid arthritis)
• Ciclosporin or tacrolimus (used to suppress the body’s immune system, e.g. following transplants or in diseases such as psoriasis and rheumatoid arthritis)
• Hydantoin drugs (such as phenytoin for epilepsy)
•Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics (for infections)
• Probenecid (for gout or to prolong the effects of some antibiotics)
• Zidovudine (an anti-viral drug used to treat AIDS and HIV infections)
• SSRIs such as fluoxetine or sertaline (for treating depression)
Pregnancy and breast feeding
Do not take Naproxen tablets if you are in the last three months of pregnancy, as it can harm your baby. Talk to your doctor before taking Naproxen tablets if you are in your first six months of pregnancy, think you are pregnant, plan to get pregnant or are breast-feeding. Your doctor will decide if you should take Naproxen tablets. Naproxen tablets 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Naproxen tablets may make you tired, drowsy, dizzy, have problems with your eyesight and balance, depressed or have difficulty in sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.
Important information about some of the ingredients of Naproxen Tablets
This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Taking Naproxen Tablets with food and drink
It is best to take Naproxen Tablets with or after food. The tablets should be swallowed whole with a large glass of water. Do not chew or suck the tablets.
3. HOW TO TAKE NAPROXEN TABLETS
Make sure you take your tablets exactly as directed by your doctor. The instructions will be written on the label. You should check with your doctor or pharmacist if you are not sure.
Swallow each tablet whole with a little water, preferably at mealtimes.
Adults: For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, the usual dose is 500mg to 1,000mg daily, taken in two divided doses every 12 hours. Your doctor may decide to prescribe a larger initial dose of 750mg to 1,000mg per day to treat the acute phase in the following cases
(i) If there is severe night-time pain and/or morning stiffness.
(ii) If high-dose treatment with another anti-rheumatic drug is being replaced with naproxen.
(iii) In osteoarthritis where pain is the predominant symptom.
This larger initial dose will be taken in two divided doses every 12 hours and your doctor will adjust the size of the morning and evening doses to suit your requirements.
In acute gout, the usual dosage is 750mg to be taken at once, followed by 250mg every 8 hours until the attack subsides.
For acute musculo- skeletal disorders, the usual dosage is 500mg initially, followed by 250mg every 6 to 8 hours, with a maximum daily dose of 1,250mg after the first day.
Elderly: If you are elderly, your doctor may want to reduce the usual adult dose and check that the medicine is suiting you, especially during the first four weeks of treatment. Make sure to follow your doctor’s instructions carefully and to keep your appointments.
Children:
Naproxen tablets may be used to treat children over 5 years old with 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 (or someone else) takes too many of these tablets (more than four tablets of either strength), contact your doctor, or hospital immediately for advice. Bring the container with any remaining tablets with you.
If you forget to take your Naproxen Tablets:
If you miss a dose, leave it out and take the next dose whenever it is due. After that, just carry on as before.
If you have any further questions about these tablets, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Naproxen Tablets can cause side effects, although not everybody gets them.
If you are having any blood or urine tests, tell your doctor that you are taking Naproxen as it may interfere with some laboratory tests.
If you are having a medical examination, tell the doctor that you taking Naproxen tablets as they reduce the signs of fever and inflammation which would otherwise be noticed.
Medicines such as naproxen may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke.
All medicines can cause allergic reactions although serious allergic reactions are rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
Naproxen may, like other N.S.A.I.Ds cause unwanted effects in some patients.
Important side effects to look out for:
Stop taking Naproxen tablets 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.
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 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, enlarged liver and abnormal liver function 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 including anaemia, increased tendency to bruise/bleed more easily, changes to the numbers of white blood cells in the blood.
. 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) 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 water (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.
.Blood tests with raised potassium levels
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.
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 label. This medicine should be stored in a cool dry place. Do not store above 25°C (Securitainers) and do not store above 30°C (Blisters). Store in original containers/package to protect from light and moisture. 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.
Remember:
This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.
6. FURTHER INFORMATION What Naproxen Tablets contain
The active substance is naproxen, 250mg or 500mg.
The other ingredients in these tablets are lactose, maize starch, sodium starch glycolate, povidone, magnesium stearate and quinoline yellow E104.
What Naproxen Tablets look like and contents of the pack
Naproxen Tablets 250mg are round yellow tablets scored and marked “N/250” on one side with the company logo on the reverse.
Naproxen Tablets 500mg are oblong yellow tablets marked “N/500” on one side and scored on the reverse.
The pack sizes are:
250mg Tablets Blister Packs of 28 and securitainers of 100 and 250 tablets.
500mg Tablets Blister Packs of 28 and securitainers of 100 tablets.
Marketing Authorisation Holder & Manufacturer:
Mercury Pharmaceuticals Ltd.,
No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK This leaflet was last revised in March 2012