Bio – Naproxen Tablets

Naproxen, the active ingredient in BIO - NAPROXEN 250 and BIO - NAPROXEN 500, belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles. BIO-NAPROXEN is used to give relieve to some of the symptoms (inflammation, swelling, stiffness and joint pain) of diseases of the joints such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis (form of spinal arthritis). BIO-NAPROXEN is also used to treat acute gout, mild to moderate pain associated painful periods, inflammation in shoulder joint (bursitis) and inflammation of a tendon (tendonitis).

Do not take BIO - NAPROXEN :

• If you are hypersensitive (allergic) to naproxen, naproxen sodium, aspirin, other non-steroidal anti-inflammatory agents or any of the other ingredients of BIO-NAPROXEN (listed in section 6).
• If you are hypersensitive (allergic) to aspirin, other non-steroidal anti-inflammatory medicines or any other pain relief medicines (such as ibuprofen and diclofenac). If these medicines have given you asthma, a runny nose, sac-like growths of inflamed tissue lining of your nose or sinuses or skin hives, you may also experience severe allergic reaction with BIO-NAPROXEN, which can be fatal.
• If you are pregnant or breastfeeding your baby.
• If you have severe heart problems.
• If you have severe kidney problems.
• If you have previously experienced bleeding or perforation in your stomach while taking non-steroidal anti-inflammatory medicines.
• If you have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or any bleeding.
• If you have porphyria.
• If you are a child under the age of 16 years.

Warnings and precautions

Special care should be taken with BIO - NAPROXEN: If you are taking BIO - NAPROXEN for longer than the recommended time or at higher than recommended doses, you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

• 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
• Medicines such as BIO-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 a history of stomach problems such as ulcerative colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss), heart burn or reflux as the condition can be made worse by the use of BIO-NAPROXEN.
• you have a liver/kidney disease or your liver/kidney is not working properly
• If you have a blood clotting disorder.
• If you are an elderly patient (as you will be more likely to experience side effects with BIO-NAPROXEN especially bleeding and perforation of the gut).
• If you have or have had bronchial asthma, or other breathing problems or nasal polyps
• if you have systemic lupus erythematosus
• if you develop any skin rash or other sign of hypersensitivity. You should then immediately stop taking BIO-NAPROXEN.
• if you develop flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• if you are planning to become pregnant.
• if you might have a bleeding problem or problem relating to blood clotting
• Naproxen tablets may hide the symptoms of an infection.
• If you need any blood or urine tests tell your doctor you are taking BIO - NAPROXEN tablets. The tablets may need to be stopped 48 hours before a test, as they may interfere with the results.
• Taking a painkiller for headaches too often or for too long can make them worse
• If you are 20 weeks or later pregnant, the use of BIO-NAPROXEN can cause serious kidney problems in the unborn baby

Children

Do not give BIO-NAPROXEN to children under the age of 16 years.

Other medicines and BIO - NAPROXEN

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

• hydantoins (e.g. phenytoin),
• sulfonamides (e.g. sulfamethoxazole)
• Sulphonylurea antidiabetics such as glimepiride or glipizide
• medicines which thin the blood, or which prevent blood clotting (e.g. heparin or warfarin)
• lithium (medicine for depression)
• diuretics (furosemide) and antihypertensive medicines (medicine used to lower blood pressure)
• probenecid for gout.
• methotrexate (medicine for the treatment of skin problems, cancer or to treat auto-immune diseases)
• cardiac glycosides (medicine used to treat heart failure and certain irregular heartbeats such as digoxin.)
• ciclosporin (medicine that suppress the immune system used after organ transplant)
• mifepristone (medicine used to end pregnancy)
• corticosteroids (such as hydrocortisone, prednisolone and dexamethasone.), if needed the doctor will reduce the dose of the steroid slowly and monitor for side effects
• other NSAIDs including cyclooxygenase-2 inhibitors (medicine such as aspirin, ibuprofen or indomethacin)
• quinolone antibiotics (such as ciprofloxacin, moxifloxacin, norfloxacin, gatifloxacin or levofloxacin to treat bacterial infections)
• anti-platelet medicines (medicine such as aspirin, clopidogrel or prasugrel)
• antidepressants that are known as selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and paroxetine
• tacrolimus (an immunosuppressive drug used mainly in organ transplants)
• Zidovudine
• bisphosphonates
• Antacids used for heartburn or cholestyramine used to bind bile in the stomach.
• aspirin/acetylsalicylic acid to prevent blood clots

BIO - NAPROXEN with food and alcohol

BIO-NAPROXEN should be taken with food.

Pregnancy, breastfeeding and fertility

You should not take BIO-NAPROXEN in the first 6 months of pregnancy and must not take BIO-NAPROXEN in the last 3 months of pregnancy or during labour. Do not use BIO-NAPROXEN if you are breastfeeding your baby. BIO-NAPROXEN may make it more difficult to become pregnant. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking BIO-NAPROXEN.

Do not share medicines prescribed for you with any other person. Always take BIO - NAPROXEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with BIO-NAPROXEN will last. Do not stop treatment early. If you have the impression that the effect of BIO-NAPROXEN is too strong or too weak, tell your doctor or pharmacist. BIO-NAPROXEN should not be used in children under the age of 16 years. Swallow the tablet with a little water, with or after food. You should take the lowest possible dose for the shortest possible duration of treatment.

Adults

Arthritis and ankylosing spondylitis (pain and stiffness in the neck and back): 250 mg (one tablet) to 375 mg (one and a half tablets) taken twice daily, with food.

Acute gout: An initial dose of 750 mg (three tablets) with meals, followed by 250 mg (one tablet) every 8 hours until the attack has subsided.

Muscle, joint or tendon problems and period pain: An initial dose of 500 mg (two tablets) followed by 250 mg (one tablet) every 6 to 8 hours with food.

If you take more BIO - NAPROXEN than you should:

Symptoms of overdose are headache, feeling or being sick, heartburn, diarrhoea, disorientation, bleeding of the stomach or intestines, unconsciousness, drowsiness, dizziness, ringing or buzzing in the ears, fainting, fits and excitation. Patients should be treated symptomatically. Activated charcoal should be given within one hour after taking a potentially toxic amount of BIO- NAPROXEN. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be checked for at least four hours after taking a potentially toxic amounts of BIO- NAPROXEN. Frequent or prolonged convulsions should be treated with intravenous diazepam. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you forget to take BIO - NAPROXEN do not take a double dose to make up for forgotten individual doses.

Not all side effects reported for BIO - NAPROXEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BIO-NAPROXEN, please consult your health care provider for advice. If any of the following happens, stop taking BIO-NAPROXEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing ore breathing,
• rash or itching,
• fainting.

BIO-NAPROXEN, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood. This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness. These are all very serious side effects. If you have them, you may have had a serious reaction to BIO- NAPROXEN. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• haemolytic anaemia (red blood cells are destroyed faster than they can be made).
• granulocyctopenia (low number of granulocytes, a type of white blood cells).
• thrombocytopenia (blood platelets deficiency that causes bleeding into tissues and slow blood clotting after injury).
• agranulocytosis (agranulocytes deficiency (type of white blood cells)).
• leukopenia (a reduction in the number of white cells in the blood, typical of various diseases.)
• neutropenia (abnormal number of neutrophils in the blood)
• eosinophilia (an increase in the number of eosinophils in the blood, occurring in response to some allergens, drugs, and parasites, and in some types of leukaemia).
• anaemias (a condition in which there is a deficiency of red cells or of haemoglobin in the blood, resulting in pallor and weariness)
• aplastic anaemia (deficiency of all types of blood cell caused by failure of bone marrow development)
• damage to your liver
• hyperkalaemia (high potassium levels in your blood)
• convulsions
• aseptic meningitis (inflammation of the linings of the brain)
• worsen of Parkinson’s disease
• palpitations (rapid, strong and irregular heartbeat)
• cardiac failure (Swelling of your hands, feet or legs (oedema), this may include chest pain, tiredness, shortness of breath)
• angioneurotic oedema
• congestive heart failure (chronic progressive condition that affects the pumping power of your heart muscle)
• pericarditis (inflammation of the pericardium, a sac-like structure with two thin layers of tissue that surround the heart)
• inflammation of the blood vessels (vasculitis)
• high blood pressure (hypertension)
• heart attack or stroke due to blood clot that blocks an artery (arterial thrombotic events e.g. myocardial infarction or stroke)
• asthma worsened
• high number of eosinophils (type of white blood cells) (eosinophilic)
• inflammation of the walls of the alveoli in the lungs (pneumonitis)
• difficulty in breathing (dyspnoea)
• spasm of the bronchial smooth muscle (bronchospasm)
• excess fluid in the lungs (pulmonary oedema)
• lesion in the lining (mucosa) of the digestive tract, typically in the stomach or duodenum, caused by the digestive action of pepsin and stomach acid (peptic ulcers)
• holes forming in your stomach or gut (perforation) that leads to bleeding in the gastrointestinal tract.
• worsening of ulcerative colitis or Crohn’s disease, leading to pain, diarrhoea, vomiting and weight loss.
• inflammation of the liver (hepatitis)
• rare, serious disorder of the skin and mucous membranes. It's usually a reaction to medication that starts with flu-like symptoms, followed by a painful rash that spreads and blisters (stevens Johnsons syndrome)
• potentially life-threatening dermatologic disorder characterized by widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes (toxic epidermal necrosis).
• skin disorders that cause the skin to become very fragile. Any trauma or friction to the skin can cause painful blisters (epidermolysis bullosa)
• inflammation of the tiny filters in your kidneys (glomerular nephritis)
• kidney disorder in which the spaces between the kidney tubules become swollen (interstitial nephritis)
• kidney disease, especially when characterized by oedema and the loss of protein from the plasma into the urine due to increased glomerular permeability (nephritic syndrome)
• disorder of the kidneys in which all or part of the renal papillae die. The renal papillae are the areas where the openings of the collecting ducts enter the kidney and where urine flows into the ureter (renal papillary necrosis)
• Impairment of renal functions, renal disease and renal failure

These are all serious side effects. You may need urgent medical attention.

• Store all medicines out of reach of children
• Store at or below 25 °C
• Protect from light
• Store in the original container.
• Return all unused medicine to your pharmacist
• Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).