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Naproxen 500 Mg Gastro-Resistant Tablets

Informations for option: Naproxen 500 Mg Gastro-Resistant Tablets, show other option
Document: leaflet MAH BRAND 2_PL 33414-0145 change

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.

-    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.


PACKAGE LEAFLET: INFORMATION FOR THE USER NYCOPREN 250 mg & 500 mg GASTRO-RESISTANT TABLETS

Naproxen

THIS LEAFLET CONTAINS

1.    What Nycopren is for

2.    Before you take Nycopren

3.    How to take Nycopren

4.    Possible side effects

5.    How to store Nycopren

6.    Further information

1. WHAT NYCOPREN IS FOR

The name of this medicine is Nycopren. Nycopren contains the active substance naproxen. Naproxen is a NonSteroidal Anti-Inflammatory Drug (NSAID) used to reduce pain and swelling in joint, bone or muscle diseases (e.g. rheumatoid arthritis, osteoarthritis, gout, ankylosing spondylitis or musculoskeletal disorders).

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

2. BEFORE YOU TAKE NYCOPREN

Do not take Nycopren

•    If you are allergic to naproxen or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    If you are allergic to other NSAIDs (e.g. ibuprofen, aspirin)

•    If you have or have had a serious heart condition

•    If you are in the last three months of your pregnancy

•    If you have or have had repeated ulcers or bleeding in the stomach or intestines

•    If you have or have had problems with your liver or kidneys.

Take special care with Nycopren

Tell your doctor before you take this medicine if you

•    are planning a pregnancy or are having problems becoming pregnant, as Nycopren may make it more difficult to become pregnant

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

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

•    have asthma or have had a skin rash, facial swelling or a blocked or runny nose after taking another NSAID

•    have been told that you have Systemic Lupus Erythematosus (a condition where your immune system attacks itself).

Medicines such as Nycopren may be linked to a small increased risk of heart attack 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 (e.g. 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 how Nycopren works:

•    Aspirin or other NSAIDs for pain and swelling or Probenecid to treat gout

•    Methotrexate to treat cancer

•    Medicines to stop your blood clotting

•    Medicines for high blood pressure or heart failure

•    Medicines to suppress the immune system such as Tacrolimus or steroid hormones

•    Medicines called Sulphonamides or Quinolone antibiotics to treat bacterial infections

•    Zidovudine to treat viral infections

•    Lithium for mental health problems

•    Medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs) for depression

•    Phenytoin for epilepsy

•    Medicines to increase urine production

•    Mifepristone for abortion.

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Nycopren.

Taking Nycopren with food and drink

You can take these tablets with or after food.

Pregnancy and breast-feeding

Do not take Nycopren if you are in the last three months of your 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

Nycopren may cause headaches, tiredness, problems with your vision or difficulty sleeping. If affected do not drive or operate machinery.

Important information about some of the ingredients of Nycopren

If you know you have an intolerance to lactose contact your doctor before taking Nycopren.

3. HOW TO TAKE NYCOPREN

Always take Nycopren exactly as your doctor has told you. Do not crush or chew the tablets. Swallow them whole with a glass of water.

Dosage

Your doctor will decide your dose, as it depends on your condition.

Adults:

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis - Typical dose is 500-1000 mg daily, taken in two divided doses at 12 hour intervals.

Severe night-time pain and morning stiffness - Typical dose is 750-1000 mg per day.

Gout - Typical dose is 750 mg then 250 mg every 8 hours until the attack has passed.

Musculoskeletal disorders - Typical dose is 500 mg then 250 mg every 8 hours. Maximum daily dose is 1250 mg.

Elderly and patients with kidney problems: Require smaller doses. Follow your doctor's advice.

Children over 50 kg:

Rheumatoid arthritis - Typical dose is 500-1000 mg daily, taken in two divided doses at 12 hour intervals.

If you take more Nycopren than you should

Contact your doctor or pharmacist immediately. Show them the package.

If you forget to take Nycopren

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS

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

Medicines such as Nycopren may be linked to a small increased risk of heart attack or stroke.

Common side effects: headache; dizziness; vomiting; nausea; aches and pains in the stomach area; constipation or diarrhoea; gas or heartburn; ulcers or bleeding in the stomach or intestines.

If you vomit blood or have blood in your stools, stop taking the tablets and tell your doctor.

Rare side effects

Allergic reactions, which may cause asthma; difficulty breathing; itching; rashes; blistering or skin peeling; swelling of eyelids, lips, throat, hands, feet or ankles; or sensitivity to sunlight.

Stop taking NAPROXEN EC and seek medical help immediately if you have an allergic reaction.

Kidney disease, which may cause swelling of the face and ankles; or blood in your urine.

Liver disease, which may cause yellowing of the skin and whites of the eyes (jaundice).

Infection in the fluid of your spine or brain (meningitis), which may cause stiff neck; headache; vomiting; nausea; fever; depression; disorientation; confusion; nervousness; ringing in the ears; mouth ulcers; an inflamed pancreas or difficulty breathing, concentrating or sleeping.

Reduction in red blood cells (anaemia), which can make the skin pale and cause weakness or breathlessness.

Very rare side effects:

Inflammation of the pancreas, which can cause severe pain in the stomach area and back.

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 NYCOPREN

Keep out of the reach and sight of children.

Do not store above 25°C. 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. 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

What Nycopren contains

The active ingredient in Nycopren is naproxen. The other ingredients are lactose, potato starch, povidone, glycerol, sodium starch glycollate, magnesium stearate, eudragit L 12.5 and L30D, triacetin, talc, polyethylene glycol and silicone antifoam.

What Nycopren looks like and contents of the pack

Nycopren 250 mg is an oval white tablet with no markings.

Nycopren 500 mg is an oblong white tablet with a break line engraved on one side.

The tablets come in blisters packs and containers of 8, 56, 60, 84, 100 and 250 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited 11 Boumpoulinas Nicosia P.C. 1060, Cyprus

Manufacturer

Haupt Pharma Berlin GmbH MoosrosenstraBe 7 12347 Berlin, Germany

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 amended in 10/2014

CL0144-0145/O/PIL1 -Br2/CL1 CL0144-0145/O/PIL2-Br2/CL1