Package leaflet: Information for the user

Naproxen 250 mg tablets Naproxen 500 mg tablets

Naproxen

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 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,

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 tablets contain a medicine called naproxen, This is a 'Non Steroidal Anti Inflammatory Drug' or NSAID,

Naproxen can lessen pain, swelling, redness and heat (inflammation) and is used to treat adults 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,

It can also be used in 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 to Naproxen, naproxen sodium or any of the other ingredients of this medicine (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,

•    Severe hepatic failure

•    Severe kidney problems

•    Insufficient strength of the heart to pump blood (severe heart failure)

•    You are in the last three months of pregnancy,

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

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 if any of the following apply to you:

•    If you are an older person

•    Problems with your kidney or liver

•    Problems with the way your blood clots

•    Colitis or Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss)

•    Asthma or allergies (like hayfever) or you have had swelling of the face, lips, eyes or tongue in the past

•    Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis)

In patients with a reduced functioning of the heart the use of this medicine can cause fluid accumulation (swollen ankles, swollen fingers, mild peripheral oedema),

It is better not to use this medicine when you have chicken pox (varicella),

Long-term use of any pain medication against headache, may worsen the headache, If you believe this is the case with you, please contact your doctor for advice,

Children

Naproxen is not recommended for use in children below 5 years of age,

Other medicines and Naproxen

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 warfarin, heparin, ticlopidine 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,

Pregnancy, breast-feeding and fertility

The use of this medicine is not recommended during pregnancy, Do not take this medicine in the last 3 months of pregnancy,

Naproxen is excreted in the breast milk, Therefore it should not be used during the period of breast-feeding,

Naproxen may make it more difficult to get pregnant, You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant,

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,

Driving and using machines

Naproxen can cause drowsiness and dizziness as side effect, If you affected in this way, do not drive or operate machinery,

Naproxen tablets contains lactose monohydrate, If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine,

3. How to take Naproxen

Always take this medicine exactly as your doctor or pharmacist has told you, Check with your doctor or pharmacist if you are not sure,

Medicines such as Naproxen may be associated (linked) with a small increased risk of heart attack ('myocardial infarction') or stroke, Any risk is more likely with higher doses and prolonged (longer term) treatment, Do not exceed (take more than) the recommended dose or duration (length) of treatment. Check with your doctor if you are not sure,

The recommended dose is:

Adults

Muscle, joint or tendon problems and period pain

•    The recommended starting dose is

500 mg, followed by a 250 mg tablet every 6 to 8 hours as needed,

Arthritis and ankylosing spondylitis

•    The recommended dose is between 500 mg and 1000 mg,

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

Gout

Initial dose of 750 mg, then 8 hours later 500 mg, after this 250 mg every 8 hours until the attack has passed

Older people 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 (above 25kg weight), rheumatoid arthritis

The recommended dose is 10 mg/kg body weight each day,

The dose is split into two and given 12 hours apart,

Method of administration:

For oral use, Swallow the tablets whole with a glass of water, with or after food, The tablet can be divided into equal doses

You should make sure that you have enough to drink (stay well hydrated) when you are taking Naproxen, This is particularly important for people who have problems with their kidneys,

While you are taking Naproxen your doctor will want to see you to check you are on the right dose for you and look for any side effects, This is particularly important if you are elderly,

If you take more Naproxen than you should

If you have taken too much, talk to a doctor or go to a hospital straight away, Take the medicine pack with you,

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,

If you have any further questions on the use of this medicine, ask your doctor or pharmacist,

4. Possible side effects

Like all medicines, this medicine also can cause side effects, although not everyone gets them,

Important side effects to look out for:

Stop taking Naproxen 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:

Uncommon (may affect up to 1 in 100 people)

•    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,

Black

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

•    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,

Not known: frequency cannot be estimated from the available data

•    Worsening of ulcerative colitis or Crohn's disease, seen as pain, diarrhoea, vomiting and weight loss,

Allergic reactions, signs include:

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

•    Difficulty breathing, tightness in your chest,

Not known: frequency cannot be estimated from the available data

•    Sudden swelling of your throat, face, hands or feet,

•    Skin rashes, blisters or itching,

Liver problems, signs include:

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

•    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,

Severe skin rashes, signs include:

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

•    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,

Heart attack, signs include:

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

•    Chest pain which may spread to your neck and shoulders and down your left arm,

Stroke, signs include:

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

•    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:

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

•    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'),

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    Prolonged bleeding time

•    Headache, dizziness, drowsiness during the day, light-headedness,

•    Ringing in the ear

•    Heartburn, constipation, abdominal pain, nausea

•    Fluid accumulation (oedema)

•    Shortness of breath

Uncommon: (may affect up to 1 in 100 people)

•    Blurred vision

•    A feeling of dizziness or “spinning”

•    Hearing disorders

•    Palpitations

•    Vomiting

•    Inflammation of the mucous membrane of mouth,

•    Digestive disorder

•    Thirst

•    Acid indigestion,

•    Diarrhoea

•    Bruising

•    Purpura

•    Perspiration

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

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

•    Severe hypersensitivity to certain substances (anaphylactic reaction)

•    Loss of appetite

•    Insomnia

•    Mood changes

•    Having difficulty sleeping or changes in your patterns of dreaming

•    Reduced ability to concentrate

•    Difficulty with your memory

•    Mild depression

•    Infectious disease characterized by inflammation of the cerebral membrane and/or the spinal cord membrane (aseptic meningitis)

•    Repeated attacks of transient itching and fluid accumulation (oedema) of the skin and/or mucous membranes (angioneurotic oedema)

•    Seizures/epileptic fits (convulsions)

•    Eye abnormalities

•    Elevated blood pressure and insufficient pumping strength of the heart (heart failure)

•    Blood count abnormalities, inflammation of a blood vessel (vasculitis)

•    Fluid accumulation in the lungs

•    Dyspnea attacks due to cramping of the muscles and swelling of the mucous membrane of the respiratory tract frequently involving coughing and phlegm (asthma)

•    Pneumonia

•    Oesophagitis

•    Haematemesis

•    Pancreatitis

•    Dry mouth

•    Throat irritation

•    Increased liver enzyme values

•    Reduced liver function

•    Hair loss

•    Skin being more sensitive to the sun

•    Severe skin or mucosal reactions with peeling or blistering (e,g, Stevens-Johnson's syndrome) erythema multiforme, exacerbation of skin diseases (e,g, lichen planus, erythema nodosum)

•    Muscle weakness

•    Reduced renal function,

•    Increased urination (pollakisuria)

•    Blood in your water (urine)

•    Increased serum creatinine

•    Increased potassium level in blood tests

•    Fatigue,

•    Reduction of the body temperature

•    Fever

Not known: frequency cannot be estimated from the available data

•    Allergic reactions

•    gastritis

•    Obstruction

•    Muscle pain

•    Systemic lupus erythematosus' (SLE), Signs include fever, rash, problems with your kidneys and Joint pain,

•    Problems for women in getting pregnant

•    Generally feeling unwell

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 national reporting system listed in Yellow Card Scheme, Website: www.mhra.gov.uk/vellowcard, 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,

Do not use this medicine after the expiry date which is stated on the label, carton and bottle after “EXP”, The expiry date refers to the last day of that month,

This medicinal product does not require any special storage conditions,

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 tablets contains

-    The active ingredient of this product is naproxen,

Each tablet contains 250 mg naproxen,

Each tablet contains 500 mg naproxen,

-    The other ingredients in this product are: lactose monohydrate, maize starch, sodium starch glycolate , povidone (E1201), yellow iron oxide (E172), magnesium stearate (E470b),

What Naproxen looks like and contents of the pack

Tablet

Naproxen 250mg Tablets:

Yellow coloured, mottled, biconvex, beveled edged, round shape, uncoated tablets debossed with 'T' & '18' on either side of breakline on one side and other side plain,

The tablet can be divided into two equal doses,

Naproxen 500mg Tablets:

Yellow coloured, mottled, biconvex, capsule shape, uncoated tablets debossed with 'T' &

'20' on either side of breakline on one side and other side plain,

The tablet can be divided into two equal doses,

Naproxen tablets are available in clear PVC/

PE/ PVdC - aluminium foil blister packs and white opaque HDPE-container closed with white opaque polypropylene stock ribbed closure with wad having induction sealing liner,

Package sizes:

Blister packs: 7, 10, 12, 15, 16, 20, 24, 25, 28, 30, 40, 50, 56, 60, 90, 98, 100, 250 and 500 tablets,

HDPE packs:

Naproxen 250 mg tablets: 30, 100, 250 and 1000 tablets

Naproxen 500 mg tablets: 30, 100 and 500 tablets

Not all pack sizes may be marketed,

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

This leaflet was last revised in 04/2016.

*Pharma code position may change as per supplier’s machine

requirement