PACKAGE LEAFLET: INFORMATION FOR THE USER

NAPROXEN TABLETS BP 250 mg

Read all of this leaflet carefully before you start taking this medicine.

-    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.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

THIS LEAFLET CONTAINS

1.    What Naproxen is for

2.    Before you take Naproxen

3.    How to take Naproxen

4.    Possible side effects

5.    How to store Naproxen

6.    Further information

1. WHAT NAPROXEN IS FOR

Naproxen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by reducing inflammation and pain in joints and muscles.

Naproxen tablets are used to treat:

•    rheumatic disorders, such as rheumatoid arthritis (including juvenile rheumatoid arthritis)

•    muscle and bone disorders, such as strains and sprains, muscular pain and stiffness or inflammation of tendons

•    period pain

•    attacks of gout

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE NAPROXEN

Do not take Naproxen tablets if you:

•    are allergic (hypersensitive) to Naproxen or any of the other ingredients in these tablets (listed in section 6 of this leaflet)

•    are allergic to aspirin or other NSAIDs, (e.g. ibuprofen). You may have developed signs of asthma (wheezing), a runny nose, swelling of the skin or a rash when taking these medicines.

•    have or have had an ulcer or bleeding in the stomach or intestines on more than one occasion

•    have severe liver, kidney, or heart failure

•    are in the last three months of pregnancy

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

Take special care with Naproxen tablets

Tell your doctor before you take this medicine if you:

•    use other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or any medication which may cause ulcers or bleeding in the stomach

•    are elderly or have a history of gastrointestinal disease (e.g. ulcerative colitis or Crohn’s disease), as there is a higher risk of stomach problems such as ulcers or bleeding

•    have blood clotting problems or are taking medicines to stop your blood clotting

•    have or have had any kidney or liver problems

•    have or have had bronchial asthma or allergic disease

•    have systemic lupus erythematosus (a condition where your immune system attacks itself) or other connective tissue disorders

•    are a women trying to become pregnant or undergoing investigation of infertility as Naproxen may make it more difficult to become pregnant

Medicines such as Naproxen tablets may be associated with a small increased risk of heart attack, (‘myocardial infarction’) or stroke. Any risk is more likely with high doses or 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.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect or be affected by how Naproxen tablets work:

•    medicines to treat high blood pressure such as captopril, enalapril (ACE inhibitors), doxazosin, prazosin (alpha-blockers), candesartan, losartan (angiotensin-II receptor antagonists), clonidine, diazoxide, guanethidine, hydralazine, methyldopa, minoxidil, moxonidine or sodium nitroprusside

•    medicines to treat high blood pressure or chest pain such as propranolol, atenolol (beta-blockers), amlodipine, felodipine (calcium-channel blockers), bendroflumethiazide, furosemide (diuretics), glyceryl trinitrate or isosorbide mononitrate (nitrates)

•    other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for pain and inflammation, such as aspirin or ibuprofen

•    medicines to stop your blood clotting such as warfarin, clopidogrel or prasugrel

•    medicines to treat epilepsy such as carbamazepine or phenytoin

•    medicines called quinolone antibiotics, such as ciprofloxacin or norfloxacin, to treat bacterial infections

•    medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs) for depression such as venlafaxine

•    steroids, such as hydrocortisone or prednisolone, to treat swelling and allergies

•    ciclosporin or tacrolimus to suppress the immune system and stop the rejection of organs after transplants

•    digoxin to treat heart failure

•    lithium for mental health problems

•    methotrexate to treat cancer

•    mifepristone to induce labour or abortion

•    probenecid to treat gout

•    zidovudine to treat viral infections

Tests

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

Pregnancy and breast-feeding

Do not take Naproxen tablets if you are in the last three months of pregnancy.

Avoid these tablets if you are in first six months of your pregnancy or if you are breast-feeding unless your doctor has advised you to take them.

Driving and using machines

Naproxen may cause headaches, dizziness, drowsiness, tiredness, problems with your vision, or difficulty sleeping. Make sure you are not affected before you drive or operate machinery.

Important information about some of the ingredients of Naproxen tablets

This medicine contains lactose. If you know you have an intolerance to lactose or other sugars, contact your doctor before taking Naproxen tablets.

3. HOW TO TAKE NAPROXEN

Always take Naproxen tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow these tablets whole with a glass of water, with or after food. Dosage

Your doctor will decide your dose, as it depends on your condition. They will prescribe you the lowest dose of Naproxen possible for the shortest period necessary. This will reduce any side effects you may experience.

Adults:

Rheumatoid disorders - The usual dose is 500-1000 mg a day, split into two doses at 12 hour intervals

Attack of gout - Initially a single dose of 750 mg, then 250 mg every 8 hours until the attack has passed.

Period pain - Initially a single dose of 500 mg, then 250 mg every 6-8 hours

Muscle and bone disorders - Initially a single dose of 500 mg, then 250 mg every 6-8 hours as necessary. Up to a maximum of 1250 mg, (5x 250 mg Naproxen tablets), a day may be given after the first day.

The elderly and patients with kidney problems: Your dosage may be lower than the usual adult dose. This will be decided by your doctor, follow their advice.

Children over 5 years of age:

Juvenile rheumatoid arthritis - The usual dose is 10 mg/kg

bodyweight a day, split into two doses at 12 hour intervals Naproxen tablets should not be used in children under 16 years of age for any other condition

If you take more Naproxen tablets than you should

It is important not to take too many tablets. If you have taken more tablets then you should, contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the medicine pack with you so they know what has been taken.

Symptoms of overdose include; feeling or being sick, upper abdominal pain, heartburn, indigestion, diarrhoea, bleeding of the stomach or intestines, headache, dizziness, ringing or buzzing in the ears, disorientation, drowsiness, fainting, fits, excitation, coma, liver and kidney damage.

If you forget to take Naproxen tablets

If you forget to take your tablets, take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

Effects on the brain and central nervous system: fits, difficulty concentrating and/or sleeping, inflammation of the optic nerve, tingling or ‘pins and needles’, headache, depression, confusion, seeing or hearing things that are not real, dizziness, nervousness, drowsiness

Effects on stomach and intestines: nausea, vomiting, constipation or diarrhoea, gas, indigestion, aches and pains in the stomach area, inflammation of the lining of the stomach

Effects on the liver: abnormal liver function, yellowing of the skin and/or whites of the eyes (jaundice), inflammation of the liver (hepatitis)

Effects on the kidneys: damage to or disease of the kidneys, kidney failure, blood in your urine

Other general effects: tiredness, feeling unwell, a feeling of dizziness or “spinning” (vertigo), hearing disturbances ringing in the ears, visual disturbances, high levels of potassium in the blood, hair loss

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE NAPROXEN

Keep out of the reach and sight of children.

Do not store above 25°C. Store the blister strips in the outer carton to protect from light or store in the original container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Naproxen tablets can cause side effects, although not everybody gets them.

If you get any of the following serious side effects STOP TAKING Naproxen and tell your doctor immediately or go to the nearest hospital emergency department:

•    an allergic reaction to Naproxen, which may cause any kind of skin rash, itching, swelling of the hands, feet, ankles, face, eyelids, lips, tongue or throat, difficulty in swallowing or breathing, asthma, sensitivity to sunlight and a condition which causes joint pain, skin rashes and fever (systemic lupus erythematosus)

•    a serious illness with peeling and blistering of the skin (Stevens Johnson syndrome or toxic epidermal necrolysis)

•    ulcers or bleeding in the stomach or intestines which may cause you to pass black tarry stools or fresh or clotted blood in your stools (faeces). You may also get dark ‘coffee ground’ bits in your vomit.

If you get any of the following side effects, see your doctor straight away:

•    pancreatitis, an inflammation of the pancreas which can cause you to get severe stomach pain that may reach through to your back

•    medicines such as Naproxen tablets may be linked to a small increased risk of heart attack and stroke, the symptoms of which include chest pain or muscle weakness and numbness

•    infection in the fluid of your spine or brain (meningitis), which may cause a stiff neck, headache, nausea, vomiting, fever and disorientation

Tell your doctor or pharmacist if you get any of these side effects:

Effects on blood: reduced numbers of white blood cells, red blood cells or blood platelets, which can increase the risk of bleeding, bruising or infections, make the skin pale or yellow and cause weakness or breathlessness

What Naproxen tablets contain

The active ingredient in Naproxen tablets is Naproxen BP; each tablet contains 250 mg of the active substance.

The other ingredients are; lactose, maize starch, polyvinyl pyrrolidone PVP K30, sodium starch glycollate, magnesium stearate and quinoline yellow E104.

What Naproxen tablets look like and contents of the pack

Naproxen 250 mg tablets are pale yellow, round tablets, marked ‘NAPROXEN 250’ on one side with a break-line on the other.

The tablets come in containers of 14, 15, 21, 28, 42, 56, 70, 84, 100, 250, 500, 1000 tablets and blisters packs of 14, 15, 21, 28, 42, 56, 70, 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

Boumpoulinas 11, 3rd Floor,

Nicosia, PC. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London, SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 12/2013

CL0067/O/PIL/CL1

Product:    Naproxen Tablets BP 250 mg

Printing Colours:    Non-Printing Colours:

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PHARMACEUTICALS