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While you are taking Naproxen Other possible side effects: Tablets your doctor will want to • heartburn, indigestion, constipation, stomach see you to check you are on ache, feeling sick or being sick, gaseous bowels the right dose for you and look • blood problems, like anaemia or changes to the for any side effects. This is numbers of white blood cells particularly important if you are • high levels of blood potassium which can cause elderly. abnormal heart rhythm • difficulty sleeping or changes in your patterns of The recommended doses are: dreaming Adults Muscle, joint or • depression tendon problems and period • confusion or seeing and possibly hearing things pain that are not there (hallucinations) The usual starting dose is • headache 500 mg, followed by one • fits or seizures, feeling dizzy, light-headed or 250 mg tablet every 6 to 8 sleepy hours as needed. • pins and needles or numbness of your hands and feet Arthritis and ankylosing spondylitis • difficulty with your memory or concentration The usual dose is between 500 mg and 1000 mg. • changes to your eyesight, eye pain The dose can be taken all at once, or half the • changes to your hearing, including ringing in the dose may be taken twice a day. ears (tinnitus) and hearing loss Gout • dizziness that causes problems with your balance The usual starting dose is 750 mg, followed by • Swelling of your hands, feet or legs (oedema), one 250 mg tablet every 8 hours as needed. this may be with chest pains, tiredness, shortness of breath (cardiac failure). Elderly and patients with liver and kidney • a fluttering feeling in your heart (palpitations), problems slow heart beat or high blood pressure The doctor will decide the right dose for you, it • Problems with the way your heart pumps blood will usually be lower than for other adults. around the body or damage to your blood vessels. Signs may include tiredness, shortness Children over 5 years, rheumatoid arthritis of breath, feeling faint, general pain. The usual dose is 10 mg per kilogram of body • Difficulty breathing, including shortness of breath, weight each day. wheezing or coughing. The total daily dose is split into two doses, to be • pneumonia or swelling of your lungs given 12 hours apart. • bruising, itching, sweating, skin being more If you take more Naproxen Tablets than you sensitive to the sun or hair loss should • blood in your urine or kidney problems If you take too many Naproxen Tablets, talk to • thirst, fever, feeling tired or generally unwell your doctor or go to a hospital straight away. Take • a sore mouth or mouth ulcers the medicine pack with you. • muscle pain or weakness • problems for women in getting pregnant If you forget to take Naproxen Tablets • ‘Systemic lupus erythematosus’ (SLE). Signs If you have missed a dose, continue in include fever, rash, problems with your kidneys accordance with your doctor’s prescription. Never and joint pain. take a double dose of Naproxen Tablets to make Reporting of side effects up for a forgotten dose. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects If you have any further questions on the use of not listed in this leaflet. You can also report side this product, ask your doctor or pharmacist. effects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA 4. Possible side effects Yellow Card in the Google Play or Apple App Store. Like all medicines, Naproxen Tablets can cause By reporting the side effects you can help provide side effects, although not everybody gets them. more information on the safety of this medicine Medicines such as Naproxen may be associated with a small increased risk of heart attack 5. How to store Naproxen Tablets ('myocardial infarction') or stroke. Keep this medicine out of the sight and reach of Serious side effects: children Do not use Naproxen Tablets after the expiry date, Stop taking Naproxen and tell your doctor which is stated on the carton after EXP. The expiry straight away if any of the following side date refers to the last date of that month. effects happen. You may need urgent medical treatment: This medicinal product does not require any special Allergic reactions, signs include: storage conditions. • sudden swelling of your throat, face, hands or Do not use Naproxen Tablets if you notice any visible feet signs of deterioration. • difficulty breathing, tightness in your chest • skin. rashes, blisters or itching. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw Serious stomach or gut problems, signs away medicines you no longer use. These measures include: will help protect the environment. • bleeding from the stomach, seen as vomit which has blood in it, or bits that look like 6. Contents of the pack and other information coffee grounds • bleeding from your back passage (anus), What Naproxen Tablets contain seen as passing black sticky bowel motions - The active substance in Naproxen 250 mg and (stools) or bloody diarrhoea Naproxen 500 mg Tablets is naproxen. • ulcers or holes forming in your stomach or Each Naproxen 250 mg tablet contains 250 mg gut, seen as upset stomach, stomach pain, (milligrams) of naproxen. fever, feeling or being sick Each Naproxen 500 mg tablet contains 500 mg • problems with your pancreas, seen as severe (milligrams) of naproxen. stomach pain which spreads to your back - The other ingredients are lactose, maize starch, • worsening of ulcerative colitis or Crohn’s povidone (E1201), sodium starch glycollate, disease, seen as pain, diarrhoea, vomiting magnesium stearate (E470b) and quinoline and weight loss. yellow (E104). Severe skin rashes, signs include: What Naproxen Tablets look like and contents of • a severe rash that develops quickly, with the pack blisters or peeling of your skin and possibly Naproxen Tablets BP 250 mg are yellow coloured, blisters in your mouth, throat or eyes. Fever, round shaped, flat bevelled edge uncoated tablets headache, cough and aching body may with score line between ‘NPY’ and ‘250’ embossed happen at the same time on one side and plain on the other side. • blistering of skin when exposed to sunlight (porphyria cutanea tarda) seen most on arms, Naproxen Tablets BP 500 mg are yellow coloured, face and hands. capsule shaped uncoated tablets with score line between ‘NPY’ and ‘500’ embossed on one side and Liver problems, signs include: plain on the other side. • yellowing of your skin or the whites of your eyes (jaundice) Naproxen Tablets are available in packs of 28, 30, • feeling tired, loss of appetite, feeling or being 56, 60, 84, 100, 250, 500 and 1000 tablets. sick and pale coloured stools (hepatitis) and Not all pack sizes may be marketed. problems, shown in blood tests. Marketing Authorisation Holder Heart attack, signs include: Milpharm Limited • chest pain which may spread to your neck Ares, Odyssey Business Park, and shoulders and down your left arm. West End Road, Stroke, signs include: South Ruislip, HA4 6QD, • muscle weakness and numbness, which may United Kingdom only be on one side of your body Manufacturers • a sudden altered sense of smell, taste, Milpharm Limited hearing, vision or confusion. Ares, Odyssey Business Park, Meningitis, signs include: West End Road, • fever, feeling or being sick, a stiff neck, South Ruislip, HA4 6QD, headache, sensitivity to bright light and United Kingdom confusion. Most likely in people with APL Swift Services (Malta) Limited autoimmune conditions such as ‘systemic Hf26 Hal Far Industrial Estate, lupus erythematosus.’
Hal Far, Birzebbugia, If you notice any of the serious side effects BBG 3000, mentioned above, stop taking Naproxen and tell Malta your doctor straight away. This leaflet was last revised in 09/2020.
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