Description and Composition
This drug contains Naproxen as its active pharmaceutical ingredient plus other inactive ingredients called excipients. Naproxen is an analgesic in the class of Non-Steroidal Anti-inflammatory Drugs (NSAIDs).
Uses and Indications of Naproxen
As an analgesic, Naproxen is used to treat painful muscles and joints caused by conditions such as rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout and acuto musculoskeletal disorders.
Contraindications of Naproxen
Do not take these tablets if you:
- are allergic to naproxen or its excipients. You should note that different brands of Naproxen have different excipients, so always check the drug leaflet of the particular brand you are taking should you want to know the excipients it contains.
- have had any form of allergic reaction to aspirin, other non- steroidal anti-inflammatory drugs (NSAIDs)
- have a peptic ulcer disease or bleeding, or past medical history of active Ulcer
- have ever had stomach bleeding or perforation caused by tablets
- have severe heart, liver or kidney failure
- are more than 6 months pregnant as it would be harmful to your unborn child
Check with your doctor before taking these if you:
- are elderly or weak, as you may be more likely to suffer side effects
- have, or have ever had asthma as naproxen might bring on an attack, any allergies (like hayfever), swelling of the face, throat, lips, eyes or tongue, blocked or runny nose, or lumps in your nose (polyps)
- have heart, liver or kidney problems
- have problems with the way that your blood clots
- have a history of problems with your stomach or intestines e.g. ulcerative colitis or Crohn’s disease
- have systemic lupus erythematosus (SLE) or mixed connective tissue disorder (an immune system disorder)
- are in the first 6 months of pregnancy, think you may be pregnant or you are breastfeeding.
Drug Interactions with Naproxen (taking other medicines):
Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking:
- medicines to thin the blood prevent clotting (anticoagulants or anti-platelet drugs) such as warfarin, heparin, clopidogrel
- aspirin/ acetylsalicylic acid to prevent blood clots
- paracetamol, aspirin or any other non-steroidal anti-inflammatory drugs
- medicines called hydantoins, used to treat epilepsy e.g. phenytoin
- a sulfonylurea (to treat diabetes) e.g. glipizide
- antibiotic medicines called sulfonamides, often used to treat urinary tract infections
- medicines to treat high blood pressure e.g water tablets (diuretics such as furosemide), propranolol and other beta blockers, or ACE inhibitors e.g. enalapril
- an angiotensin-Ii receptor antagonist e.g. candesartan, losartan (to treat high blood pressure and heart failure)
- lithium, used to treat mental illness
- methotrexate, used to treat mono types of cancer, you are having radiation therapy, or taking any medicines that depress bone marrow
- ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow transplants) oral steroids (used in replacement therapy and to treat mifepristone (used to terminate a pregnancy)
- probenecid, used to treat gout
- medicines to treat heart problems e.g. digoxin
- Oral steroids (used in replacement therapy and to treat inflammation) e.g. hydrocortisone
- selective serotonin reuptake inhibitors (to treat depression e.g. fluoxetine)
- Mifepristone (used to terminate a pregnancy)
- quinolone antibiotics (for infections) eg. ciprofloxacin
- zidovudine (to treat HIV infection)
Other special warnings:
- This medicine is not recommended for children under 16 years of age, except for the treatment of juvenile rheumatoid arthritis in children over 5 years of age.
- This medicine can affect the results of laboratory tests. Before you have any tests, tell your doctor you are taking this. medicine
- 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 а smoker) you should discuss your treatment with your doctor or pharmacist.
- 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.
Naproxen Use During Pregnancy and Breastfeeding
- Do not take this medicine if you are more than 6 months pregnant.
- Check with your doctor before taking if you are in the first 6 months of pregnancy, think you may be pregnant, or you are breast feeding.
Effects on driving or operating machinery:
Naproxen Tablets may make you feel dizzy, tired, drowsy, or depressed or have problems with your eyesight and balance, or have difficulty sleeping. If you think this medicine has affected you do not drive or operate machinery.
Important information about some ingredients of Naproxen Tablets:
Some brands of Naproxen 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. Some brands equally contains the colourant sunset yellow E110 which may cause allergic reactions.
How to take Naproxen Tablets
Swallow the tablets whole with water. Take with or after food. The dose is different for different medical conditions and patients. Always take the medicine exactly as directed by your doctor.
The label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis:
The usual daily dose is 500mg to 1g taken in two doses at 12-hour Intervals, or the dose may be taken all at once.
For attacks of gout
A first dose of 750mg followed by 250mg every 8 hours until the attack has gone.
For acute musculoskeletal disorders:
A first dose of 500mg followed by 250mg at 6-8 hour intervals. After the first day, the maximum daily dose is 1250mg.
Children aged over 5 years:
For Juvenile rheumatoid arthritis only:
The daily dose is calculated by your doctor and is usually 10mg per kg of body weight, taken in two doses at 12-hour intervals.
Elderly patients and people with liver and kidney problems:
Your doctor may have told you to take a lower dose than the usual adult dose stated above. Follow your doctor’s instructions. If you are elderly, your doctor may want to do some tests after you start taking these tablets to check you are not bleeding in your stomach or intestines
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take a dose:
If you miss a dose of this medicine take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES.
Possible side effects of Naproxen
Like all medicines, naproxen can cause side effects, although not everybody gets them. There will be fewer side effects if you take the lowest effective dose for the shortest time necessary you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek IMMEDIATE medical help:
- pass blood in your faeces (stools/motions), pass black tarry stools, vomit any blood or dark particles that look like coffee granules. These may be signs of a stomach ulcer or bleeding in your stomach.
STOP TAKING the medicine and tell your doctor if you experience:
- indigestion or heartburn
- abdominal pain (pains in your stomach) or other abnormal stomach symptoms
- allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering, dizziness, difficulty in breathing, wheezing or shortness of breath, swollen face, throat, lips, hands or fingers
- blistering of skin when exposed to sunlight
- yellowing of your skin or the whites of your eyes and/or pale stools, dark urine, loss of appetite as these may be signs of liver problems
- passing more or less urine than normal, cloudy or foamy urine, blood in urine, pain in the back, swelling (particularly of the ankles) as these may be signs of kidney problems.
If you get any of the following very rare effects stop taking the tablets and tell your doctor as soon as possible:
- inflammation of the pancreas causing severe pain in the abdomen and back
- Stevens Johnson syndrome or toxic epidermal necrolysis (serious illnesses causing blistering of the skin, mouth, eyes and genitals)
Other effects include:
- high blood pressure, oedema (water retention), heart failure (symptoms may include shortness of breath or swollen ankles), feeling your heartbeat
- high levels of blood potassium which can cause abnormal heart rhythm
- feeling or being sick, diarrhoea, constipation, flatulence (wind), sore mouth, mouth ulcers, irritation or swelling of the oesophagus
- worsening of the symptoms of colitis and Crohn’s disease.
- blood disorders including changes in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising or make infections more likely
- hives, sweating, tender red lumps on the shins, itchy swollen rash on the skin or in the mouth, blisters or pimples containing pus, increased sensitivity to light or loss of hair
- headache, confusion forgetfulness and difficulty concentrating, feeling of dizziness or “spinning”, changes to your hearing including ringing in the ear and hearing loss, drowsiness light headedness, fits, eyesight problems (such as blurred, clouded, partial or complete loss of vision, blind spots, halos around lights, eye pain, eye swelling), tingling or numbness in the hands or fet
- difficulty sleeping, changes in your patterns of dreaming, • confusion, depression, hallucinations
- shortness of breath, asthma, or swelling of or fluid in your lungs which may cause breathing problems, cough, coughing up blood, pink frothy sputum, high temperature, excessive awenting, anxiety and pato skin
- systemic lupus erythematosus (SLE). This is an allergic condition which causes joint pain, skin rashes and fever
- muscle pain or weakness, tiredness, looking generally unwell, thirst, fever
- problems for women in getting pregnant
- inflammation of the blood vessels, often with skin rash
- aseptic meningitis (especially in patients with autoImmune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck and back fooling or being sick, skin rash, eyes being very sensitive to bright light, disorientation and muscle pain
- medicines such as naproxen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
How to store Naproxen Tablets
Keep this medicine in the original package and protect from heat, light and moisture. KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Do not take the tablets if the expiry date on the pack has passed, if you have any medicines that are out of date, return them to your pharmacist for safe disposal.