Naproxen 250 mg Tablets

• 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 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

1. What Naproxen Tablet is and what it is used for
2. What you need to know before you take Naproxen Tablet
3. How to take Naproxen Tablet
4. Possible side effects
5. How to store Naproxen Tablet
6. Contents of the pack and other information

• Naproxen or any of the other ingredient of Naproxen Tablet (see listed in section 6).
• Aspirin, other NSAIDs or any other pain relief medicines (such as ibuprofen or diclofenac).

• You have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding.
• You have previously experienced bleeding or perforation in your stomach while taking NSAIDs.
• You have severe problems with your kidneys, liver or heart.
• You are in the last three months of pregnancy.

Do not take Naproxen Tablet if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen Tablet.

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.

Talk to your doctor or pharmacist before taking Naproxen Tablet if any of the following apply to you:

• Asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past.
• A feeling of weakness (perhaps because of an illness) or you are an older person.
• Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis).
• Problems with your kidneys or liver.
• Problems with the way that your blood clots.
• Problems with the blood vessels (arteries) anywhere in your body.
• Too much fat (lipid) in your blood (hyperlipidaemia).
• An autoimmune condition, such as 'systemic lupus erythematosus' (SLE, causes joint pain, skin rashes and fever) and colitis or Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen Tablet.

Serious skin reactions including (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic Symptoms (DRESS) have been reported in association with Naproxen tablets. Stop using Naproxen tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 pain killers, like aspirin, ibuprofen, diclofenac and paracetamol.
• Medicine to stop your blood clotting, like, asprin/ acetylsalicylic acid, warfarin, heparin or clopidogrel.
• A hydantoin (for epilepsy), like phenytoin.
• Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics (for infections).
• A sulfonylurea (for diabetes), like glimepiride or glipizide.
• An 'ACE inhibitor’ or any other medicine for high blood pressure like cilazapril, enalapril or propranolol.
• An angiotensin-II receptor antagonist, like candesartan, eprosartan or losartan.
• A diuretic (water tablet) (for high blood pressure), like furosemide.
• A 'cardiac glycoside' (for heart problems), like digoxin.
• A steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone.
• A 'quinolone antibiotic' (for infections), like ciprofloxacin or moxifloxacin.
• Certain medicines for mental health problems like lithium or 'SSRIs' like fluoxetine or citalopram.
• Probenecid (for gout).
• Methotrexate (used to treat skin problems, arthritis or cancer).
• Ciclosporin or tacrolimus (for skin problems or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (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 Tablet.

• You should not take Naproxen Tablet during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, naproxen tablet can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narro wing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
• Do not take Naproxen Tablet if you are in the last three months of pregnancy, as it can harm your baby. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Naproxen Tablet 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.

Naproxen Tablet may make you tired, drowsy, dizzy, have problems with your eyesight and balance, depressed or have difficulty sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

If you take more Naproxen Tablets than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

• If you forget to take a dose, skip the missed dose. Then take next dose as normal.
• Do not take double dose to make up for a forgotten dose.

Stop taking Naproxen Tablet 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.

Allergic reactions, signs include:

• Sudden swelling of your throat, face, hands or feet.
• Difficulty breathing, tightness in your chest.
• Skin rashes, blisters or itching.

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 (including hepatitis), 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. 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 Tablet and tell your doctor straight away.

Stomach and gut

• Heartburn, indigestion, stomach ache, feeling sick or being sick, constipation, diarrhoea, wind.

Blood

• Blood problems, like anaemia or changes to the numbers of white blood cells.

Mental illness

• Having difficulty sleeping or changes in your patterns of dreaming.
• Depression.
• Confusion or seeing and possibly hearing things that are not there (hallucinations).

Nervous system

• 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.

Eyes and ears

• 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.

Heart and circulation

• 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), 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.

Chest

• Difficulty breathing, including shortness of breath, wheezing or coughing.
• Pneumonia or swelling of your lungs.

Skin and hair

• 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.

Urinary

• Blood in your water (urine) or kidney problems.

Other

• 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 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.

Stop taking Naproxen tablets and immediately contact a doctor if you notice any of the following side effects:

Not known: frequency cannot be estimated from the available data.

• Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS). See also section 2.
• A distinctive cutaneous allergic reaction known as fixed drug eruption, that usually recurs at the same site (s) on re-exposure to the medication and may look like round or oval patches of redness and swelling of the skin, blistering (hives), itching.

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 via the Yellow Card Scheme at: www.mhra. gov.uk/yellowcard. or search for Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance in Naproxen 250 mg and 500 mg Tablets is naproxen. Each tablet contains either 250 mg (milligrams) or 500 mg of naproxen.
• The other ingredients in the tablets are povidone, magnesium stearate, croscarmellose sodium, Colloidal anhydrous silica and Ferric oxide.

• Naproxen 250 mg Tablets are off white to pale yellow, round, flat faced beveled edge uncoated tablets debossed with 'N & 250'seperated by breakline on one side and plain on other side.
• Naproxen 500 mg Tablets are off white to pale yellow, oblong shaped uncoated tablets debossed with 'N500' on one side and breakline on other side.
• Naproxen 250 mg and 500 mg tablets are available in cartons containing Aluminium- PVC clear Blister packs of 14s, 15s, 20s, 21s, 28s, 30s, 42s, 50s, 56s, 60s,70s, 84s, 90s, 100s, 112s, 120s, 140s, 168s, 180s and 250s along with a leaflet inside.
  Not all pack sizes may be marketed.