Naproxen 500mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Naproxen 500mg Tablets
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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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What Naproxen 500mg Tablets are and what they are used for
2. What you need to know before you take Naproxen 500mg Tablets
3. How to take Naproxen 500mg Tablets
4. Possible side effects
5. How to store Naproxen 500mg Tablets
6. Contents of the pack and other information
1. What Naproxen 500mg 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 or other rheumatic or musculoskeletal disorders (ailments that cause pain and stiffness in muscles, bones and joints)
• period pain
• acute gout
2. What you need to know before you take Naproxen 500mg Tablets DO NOT take Naproxen 500mg Tablets
• if you are allergic (hypersensitive) to naproxen or any of the other ingredients of Naproxen 500mg Tablets (listed in section 6)
• if you are allergic (hypersensitive) to or have ever had a reaction to aspirin or another NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen or meloxicam or you have developed signs of asthma (wheezing), runny nose, lumps in your nose or swelling of the skin or rash when taking these medicines.
• if you have a stomach ulcer or if you often get stomach ulcers
• if you have a 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 suffering or have ever suffered two or more episodes of ulcers or bleeding from in the stomach or intestines while taking NSAIDs
• if you are more than 6 months pregnant or if you are breast-feeding (see section 2 “Pregnancy and breast-feeding”)
• if you have severe heart failure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naproxen 500mg Tablets if you:
• have heart problems, have previously had a 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)
• have problems with how your blood clots
• have ever had bronchial asthma or allergies
• suffer from localised swelling, high blood pressure or heart failure
• have too much fat (lipid) in your blood (hyperlipidaemia)
• have problems with your kidneys or liver
• have an autoimmune condition, such as ‘systemic lupus erythematosus’ that causes joint pain, skin rashes and fever
• have colitis or Crohn's disease, the symptoms are inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss
Naproxen may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems getting pregnant. Tell your doctor, who will decide what to do (see section 2 “Pregnancy and breast-feeding").
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 500mg Tablets
Other medicines and Naproxen 500mg Tablets
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 painkillers, like aspirin, ibuprofen, diclofenac and paracetamol
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• 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 digoxin
• 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
• medicines used to treat epilepsy, such as phenytoin and hydantoin
• sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and sulfonamide antibiotics used to treat infections
• a ‘quinolone antibiotic’ used to treat infections, such as ciprofloxacin or moxifloxacin
• ciclosporin or tacrolimus, 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 reducec 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 500mg 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 500mg Tablets and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
Do not take Naproxen 500mg Tablets if you are more than 6 months pregnant or if you are breast-feeding (see section 2 "DO NOT take Naproxen 500mg Tablets"). Your doctor may prescribe Naproxen 500mg Tablets 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
Naproxen 500mg Tablets may make you tired, drowsy, dizzy, cause blurred vision, difficulty in sleeping or make you feel depressed. Talk to your doctor if any of these happen to you and do not drive or use machines.
Naproxen 500mg Tablets contain 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.
3. How to take Naproxen 500mg Tablets
Always take Naproxen 500mg Tablets exactly as your doctor has told you. Medicines such as Naproxen 500mg Tablets may be linked with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses and long term treatment. Do not take more than the recommended dose or exceed the length of the treatment. Check with your doctor or pharmacist if you are not sure.
Method of administration:
Naproxen Tablets should be swallowed whole with a glass of water, with food. Take your tablets at the same time each day.
While you are taking Naproxen 500mg 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.
The recommended doses are:
Adults Period pain
The usual starting dose is 500 mg, followed by one 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 half the dose may be taken twice a day Gout
The usual starting dose is 750 mg, followed by one 250 mg tablet every 8 hours as needed.
Elderly and patients with liver and kidney problems
The doctor will decide the 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 per kilogram of body weight each day.
The total daily dose is split into two doses, to be given 12 hours apart.
If you take more Naproxen 500mg Tablets than you should
If you take too many Naproxen 500mg Tablets, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.
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If you forget to take Naproxen 500mg Tablets
If you have missed a dose, continue in accordance with your doctor's prescription. Never take a double dose of Naproxen 500mg Tablets to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Naproxen 500mg Tablets can cause side effects, although not everybody gets them.
Serious side effects:
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, seen as upset stomach, stomach pain, fever, feeling or being sick
• problems with your pancreas, seen as 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, 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, which may only be on one side of your body
• a sudden altered sense of smell, taste, hearing, vision or 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, constipation, gaseous bowels
• blood problems, like anaemia or changes to the numbers of white blood cells
• high levels of blood potassium which can cause abnormal heart rhythm
• 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, 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
• 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
• pneumonia or swelling of your lungs
• 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaftet.
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 500mg Tablets
Keep this medicine out of the sight and reach of children Do not use Naproxen 500mg Tablets after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last date of that month
Do not store above 25°C. Store in the original package in order to protect from light and moisture
Do not use Naproxen 500mg Tablets if you notice any visible signs of deterioration.
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 500mg Tablets contain
• 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 look like and contents of the pack
Naproxen Tablets 500 mg are yellow coloured, capsule shaped uncoated tablets with score line between 'NPY' and '500' embossed on one side and plain on the other side.
Naproxen 500mg Tablets are available in packs of 28, 30, 56, 60, 84, 100, 250, 500 and 1000 tablets.
(Not all pack sizes may be marketed).
This leaflet was last revised in September 2015
Marketing Authorization Holder:
_ NOUMED LIFE SCIENCES
5 Cattle Market, Hexham, Northumberland NE46 1NJ, United Kingdom
Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
Naproxen 500mg Tablets - PL 44041/0026
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