59.5 mm

59.5 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER_

Naproxen 250mg and 500mg Tablets

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 symptoms are the same as yours.

•    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. See section 4.

What is in this leaflet:

1.    What Naproxen is and what it is used for

2.    What you need to know before you take Naproxen

3.    How to take Naproxen

4.    Possible side effects

5.    How to store Naproxen

6.    Contents of the pack and other information

1. What Naproxen is and what it is used for

Naproxen is a 'Non Steroidal Anti Inflammatory Drug' or NSAID. Naproxen can lessen pain, swelling, redness and heat (inflammation) and is used for:

•    Problems with your muscles, joints and tendons, like strains, gout, ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis.

•    Women, while having period pain.

•    Children over 5 years with rheumatoid arthritis.

2. What you need to know before you take Naproxen Do not take Naproxen if you:

•    Are allergic or (hypersensitive) to Naproxen sodium or any of the other ingredients of Naproxen (see section 6).

•    Have a history of allergy to NSAIDs (e.g. Aspirin, Diclofenac, Ibuprofen), which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose

•    Have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding

•    Have a history of gastrointestinal bleeding or perforation related to the use of NSAIDs.

•    Have severe problems with your kidneys, liver or heart.

•    Are in the last three months of pregnancy (last trimester).

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

Warnings and Precautions

Check with your doctor before taking Naproxen tablets if you:

•    Use other non-steroidal anti-inflammatory medicines

(NSAIDs) or any medication which may cause bleeding or ulcers in the stomach

•    Have a history of gastrointestinal disease e.g. ulcerative colitis, Crohn's disease

•    Smoke

•    Drink alcohol

•    Are elderly

•    Have or have had high blood pressure or any liver, kidney

or heart problems

•    Have or have had bronchial asthma, other breathing problems or nasal polyps

•    Have systemic lupus erythematosus or other connective tissue disorders

•    Have a blood clotting disorder

•    Are a women trying to become pregnant or undergoing investigation of infertility.

Other warnings

•    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 a smoker) you should discuss your treatment with your doctor or pharmacist.

•    If you are elderly or frail, you have a higher risk of getting side effects, especially from the stomach. If you experience any unusual symptoms from the stomach you must tell your doctor about it.

•    Taking a painkiller for headaches too often or for too long can make them worse.

•    Naproxen tablets may hide the symptoms of an infection.

Other medicines and Naproxen

Tell your doctor or pharmacist if you are taking or have recently

taken or might take any other medicines. In particular, tell your

doctor or pharmacist if you are taking:

•    Other pain killers like, aspirin, ibuprofen, diclofenac and paracetamol

•    Medicines which thin the blood or which prevent blood clotting (e.g. heparin or warfarin)

•    A steroid (for swelling and inflammation) like, hydrocortisone, prednisolone and dexamethasone, if needed the doctor will reduce the dose of the steroid slowly and monitor for side effects.

•    A diuretic (water tablet) (for high blood pressure) like, furosemide

•    Medicines to treat high blood pressure (e.g. captopril, ramipril or propranolol, losartan or candesartan)

•    Ciclosporin or tacrolimus (for skin problems or after an organ transplant)

•    Mifepristone (used to end pregnancy or to bring on labour if the baby has died) - do not take NSAIDs 8-12 days after mifepristone

•    Zidovudine (used to treat AIDS and HIV infections)

•    A 'quinolone antibiotic' (for infections) like, ciprofloxacin or moxifloxacin

•    Probenecid (for gout)

•    Methotrexate (used to treat skin problems, arthritis or cancer)

•    Bisphosphonates (used to treat bone diseases)

•    Cholestyramine (used to treat high blood cholesterol levels)-take 1 hour before or 4 to 6 hours after cholestyramine to avoid interference with absorption

•    Certain medicines for mental health problems like, lithium or 'SSRIs' like fluoxetine or citalopram

•    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

•    A 'cardiac glycoside' (for heart problems) like, digoxin

Pregnancy and breast-feeding

•    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.

•    You should not take Naproxen in the first 6 months of pregnancy and must not take Naproxen in the last 3 months of pregnancy or during labour.

•    If you are breast-feeding, you should not take Naproxen tablets

Driving and using machines

Naproxen may make you feel 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.

Tests

If you need any blood or urine tests tell your doctor you are taking Naproxen tablets. The tablets may need to be stopped 48 hours before a test, as they may interfere with the results.

Naproxen Tablets contain Lactose and Sunset yellow (E110)

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Sunset yellow may cause allergic reactions.

|    3. How to take Naproxen    |

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with a drink of water, with or after food. Dose

Your doctor should prescribe as low a dose as possible. This will reduce any side effects you may experience.

Adults

Muscle, joint or tendon problems and period pain

•    The usual starting dose is 500 mg, followed by 250 mg tablet every 6 to 8 hours as needed. Up to a maximum of 1250mg a day may be given after the first day.

Arthritis and ankylosing spondylitis

•    The usual dose is between 500 mg and 1000 mg.

•    The dose can be taken all at once, or split into two doses and can be taken twice a day.

Gout

•    The usual starting dose is 750 mg, followed by a 250 mg tablet _x every 8 hours until the attack has passed.

140 mm

59.5 mm

59.5 mm

The elderly and people with liver and kidney problems

Your doctor will decide your dose, it will usually be lower than that for other adults.

Children over 5 years for juvenile rheumatoid arthritis

10mg per kg of body weight a day, taken in two doses at twelve hourly intervals.

If you take more Naproxen than you should

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

If you forget to take Naproxen

•    If you forget to take a dose, skip the missed dose. Then take your next dose as normal.

•    Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will get them.

Medicines such as Naproxen may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke. Stop taking Naproxen tablets and contact your doctor immediately if you

•    Have indigestion, heartburn, pains in your stomach or other abnormal stomach symptoms, feeling or being sick (you may have an ulcer or inflammation in the stomach or gut)

•    Pass blood in your faeces (stools/motions) or black tarry looking stools (signs of bleeding and perforation of the stomach and intestines).

•    Vomit any blood or dark particles that look like coffee grounds

•    Have an allergic reaction:

•    Swelling of the face, mouth, tongue, airways or body

•    Skin reactions including: hives (pale/red raised skin with severe itching), blistered skin, itchy skin rash, blood spots, bruising or discolouring of the skin, raised purple rashes, red skin patches, a severe rash with reddening, peeling and swelling of the skin that resembles burns, bumpy rashes, blisters, dermatitis (skin shedding, itching, swelling)

•    Difficulty breathing or wheezing, coughing up blood.

Tell your doctor if you notice any of the following side effects

The most commonly observed adverse events are gastrointestinal in nature. Feeling sick, being sick, diarrhoea, wind, constipation and worsening of colitis and Crohn's disease have been reported following administration.

Water retention (may cause swelling in the limbs), high blood pressure and heart failure have been reported in association with NSAID therapy.

Common (may affect up to 1 in 10 people)

•    Confusion, headache

•    Ringing in the ears

•    Changes in vision (you should go for an eye test if you notice changes in vision)

•    Tiredness, drowsiness, dizziness

•    Rashes

Uncommon (may affect up to 1 in 100 people)

•    Depression

•    Irregular heartbeat (palpitations)

•    Abnormal dreams, forgetfulness, difficulty sleeping

•    Difficulty concentrating,

•    Sensitivity of the skin to light (may cause blistering)

Rare (may affect up to 1 in 1,000 people)

•    High blood potassium levels (causing irregular, slow heart beat, feeling sick)

•    Hair loss

•    Jaundice (yellow skin or eyes)

•    Hearing difficulties

•    Inflammation of blood vessels (causing fever, swelling and general unwellness)

•    Worsening of asthma

•    Muscle weakness/pain

•    Ulcers on the inner cheeks, gums and tongue

•    Hepatitis - sometimes fatal (symptoms include feeling tired

•    Loss of appetite, feeling or being sick and pale coloured stools) Very rare (may affect up to 1 in 10,000 people)

•    Changes in the numbers and types of blood cells (if you develop sore throats, nose bleeds or infections consult your doctor)

•    Anaemia (may cause fainting, chest pain, breathlessness)

•    Fits, aseptic meningitis (may cause fever, feeling or being sick, disorientation, headache, neck stiffness and sensitivity to light)

•    Severe skin rash with flushing, blisters or ulcers (Stevens-Johnson syndrome

•    Blisters or sores on the skin

•    Kidney damage or infection (may cause blood in the urine, decrease in amount of urine passed, feeling or being sick)

•    Inflammation of the pancreas; pancreatitis (causing fever, stomach pain, sickness).

•    Medicines such as naproxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Not Known (frequency cannot be estimated from the available data)

•    Low amounts of white cells in the blood (may cause fever or frequent infections)

•    Runny nose

•    Lowered female fertility

•    Sensing things that are not there

•    High blood creatinine levels seen in blood tests

•    Kidney failure

•    Kidney disease (may cause changes in the need to or amount of urine)

•    Thirst, fever

•    Inflammation in the eye (causing eye pain or changes in vision)

•    Tingling or "pins and needles”

•    A spinning sensation

•    Abnormal liver function seen in tests

•    Worsening of Parkinson's disease

•    General feeling of discomfort and illness

•    Swelling of the hands and feet

•    Swelling in the eye (causing headaches or blurred vision).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

•    Keep this medicine out of the sight and reach of children.

•    Store in a cool dry place. Protect from light. Do not store above 25⁰C.

•    Do not use this medicine after the expiry date which is printed on the pack. The expiry date refers to the last day of that month.

•    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 contains

•    The active substance is naproxen. Each tablet contains either 250 mg (milligrams) or 500 mg of naproxen

•    The other ingredients are sodium lauryl sulfate, lactose, maize starch, crospovidone, magnesium stearate and the colours quinoline yellow (E104) and sunset yellow (E110)

What Naproxen looks like and contents of the pack

Naproxen 250 mg tablets: Pale yellow, flat bevelled edge tablets with N breakline 250 on one side and BL on the other.

Naproxen 500 mg tablets: Pale yellow, oblong tablets with N breakline 500 on one side and BL on the other.

Naproxen 250 mg tablets are supplied in containers of 28, 56, 250 tablets and blisters of 28, 56, 84 and 112 tablets.

Naproxen 500 mg tablets are supplied in containers of 28, 56, 100, 500 tablets and blisters of 28, 56, 84 and 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd. Unit 3, Canalside, Northbridge Road,

Berkhamsted, Herts, HP4 1EG, UK

Tel:    0044 (0)1442200922

Fax:    0044 (0)1442873717

e-mail:    info@bristol-labs.co.uk

Naproxen 250mg Tablets; PL 17907/0339

Naproxen 500mg Tablets; PL 17907/0340

This leaflet was last revised in May 2016.

V10 25-05-16 D0

140 mm