Nycopren Tablets 500mg
PACKAGE LEAFLET:
INFORMATION FOR THE USER
NAPROXEN N50 mg & 500 mg
GASTRO-&ESISTANT TABTSTS
/-----<.
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 sise effects n ot listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Naproxen is for
2. Before you take Naproxen 13. How to take Naproxen
4. PossiblA side effects
5. How to store Naproxen
6. Further informxtion
1. WHAT NAPROXEN IS FOR
Naproxen is a Non-Steroidal Anti-Inflammatory Drug (NSAID) used to reduce pain and swelling in joiut, bone or muscle diseases (e.g. rheumatoid arthritis, osteoarthritis, gout, ankylosing spondylitis ar musculoskeletal disorders).
If you are not sure wtiy you have been prescribed thesu tobl ets then please ask your doctor.
2. BEFORE YOU TAKE NAPROXEN
Do not take Naproxen Gastro-resistant tablets
• If you are allergic to Eap roxen or any of the other ingredients in the tablets (listed in section 6 ef this leaflet)
• If you are al lergi c to other NSAIDs (e.g. ibuprofen, aspirin)
• If you have or h ave had a serious heart condition
• If you are in the last three months of your pregn ancy
• If you have or have had repeated ulcers or bleoPiig ie the stomach or intes)ines
• If yeu have or have had proniems with your Iiver or kidneys.
Take special care with Naproxen Gastro-
resistant tablets
Tall your doctor befo re you take this medi cine ifyoe
• are planning a pregnancy er are hav^ laroblems becoming pregnant, as tois medicine may makert more difficug to be come pregnant
• nre elderly, have ulcerative colitis ur Crohn's bisease, as there is a higher risk of stomach troblems (e.g. ulcers or bleeding)
• have blood clooting problems or care taking medicioes ta stop your blood dotting
• have asthma or have had a skin rash, e^cial 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 Naproxen Gkotro-feoiotknt tablets may be linked to a omkiMnsrekObd risk of heart attack or stroke. Any risk is rohre likely with high dolbl srprolongbd treatment. Do not exceed the recsmmbndbd dsob or duration oe treatment.
If sou have heart problems, previous stroke or think that sou might be at risk of these cond^on! (e.g1 if Sou have high blood pressure, diabetes or high cholesterol or are a smoker) sou should discuss sour treatment with sour doctor or pharmacist. Taking other medicines Tell your doctor or pharmacist ff you are taking, or have recently taken, any other medicines, even medicines bought without a prescription.
In particular tell your doctor or pharmacist ff you are aaking any of the foilowing medicineSi as they may affect how this medicine werks:
• 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 Tacroliruss or steroid Sormnbes
• Medicines called Sulphonamides or Quinolone antibiotics to treat bacterial i nteations
• Zidovudine to treat viral infections
• Lithium for mental health problems
• Medicines called Selective Serotonin Re-upaake Inhibitors (SSRIs) for depressio n
• Phenytoin for epilepsy
• Mediates to increase urine production
• Mifepristono for aborti on.
If you go into hospital or have treatment for other conditions, tell the doctor that you are takieg Naproxen Gastro-resistant tablets.
Taking Naproxen Gastro-resistant tablets with fo od and drink
You can take these tablets with or after food.
Pregnancy and breast-feeding
Do not toke this medicine if you are in the last three months rf your pregnancy. Avoto these tablets ff you are in fi rst six months of your pregnancy or if you are breast-feeding unless your dodor has ack/ised you to take them. Driving und using machines Naproxen Gastro-resistant tab lets may cause headaches, tiredness, problemswith eoua vision or difficu,ty sleeping, if affected do not drive or operate machinery.
Important information about some of the ingredients of this medic ine
If you know you have an intolerance to lactose contact your doctor before taking this medicine.
3. HOW TO TAKE NAPROXEN
Always take this medicine exactly as your doctor has told you. Do not crush or chew the tablets. Swallow them whole with a glass of water.
wDaotesra. ge
Your doctor will decide your dose, as it depends on your condition.
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis - Typical doseis 500-1000 mg daily, taken in two divide d doses at 12 hourigtenvals.
Severo night-time pain and morning stiffness -
Typical dose is 750-1000 mg per day.
(Bout - Typical doseis 750 mg then 250 mg every 8 hours untiil the attack has passed . Musculoskeletal disorders - Typical dose is 500 mg then 250 mg evefy8 hours. Maximum daily doseis 1250 mg.
Elderly and patients with kidney problems:
Require smaller doses.Follow ynur doctor’s advice. Children over 50 kg:
Rheumatoid a rth ritis - Typical dose is 500-1000 mg daily, taken in two divide d doses at 12 hourintetvals.
If you take more Naproxen Gastro-resistant tablets than you should
Coktant your doctor or pharmacist immediately. Show them tee pack age.
If yoh forget to take Naproxen Gastro-resistant tablets
Don't worry, just taee oour eext scheduled oose at the correct time;. Do riot taVv a dubble oose to make up for the one you have missed.
Liver disease, which may cause yellowing of the skin and whites of tee eyes (jaundice).
Infection in the fluid of your spine or brain (meningitis), which may cause stiff neck; headache; vomiting; nausea; feveri depression; disorientation; confusion; nervousness; ringing in tee ears; mouth ulcersi an inflamed pancreas err diffinultd breathing, noknvnttatikg err sleeping. Reduction in red blood cells jakavmia), which can make tee skin pale and cause weakness or
bbrreeaaththlelessssnneessss..
Vey 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 effectc 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 n ot store above 25°C. Store in the original conterner an d kvvv the container tightly dosed. Dn not use these tablets attn the expiry date, which is steted on the pankagv. Th e expiry date refers to tee last d ay of that month.
Medicines should not be disposed of via wasteweter or household wastes Ask your pharmanist how to diaposv of medicines uo lotger required. These measures will help to protect the environment.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine cen cau se side effe cts, alth ough not eve rybody gets them. Medicines such as Naproxen Gaston-resistant tablets may belinked te a small increased risk of heart attack or stroke.
Common side effccts : headache; dizziness; vomiting; nausea; aches and pains in tee stomach area ; constipation err diarrhoea; aas or heartburn; ulcers err bleeding in hie stomach err intestines.
If you vomi t blood err avve blood i n your stools, soop taking tee tablets and tellyour doctor.
Rare side effects
Allergic reactions, which may cause asthma; diffinuity breathing; itching; rashes ; blistering or skin peeling; swelling of eyelide, lips, throat, hands, feet or ank les ; or sen sito v/ity to sun l tolit.
Stop taking this mediciNe and kvvk medical help immediately tfyou have an altergic reaction.
What this medicine contains
The active ingredieet in this medicine is
naproxen. The otoer iNgrsdionts are l actose, potato sterch, povidone^lycerol, sodiu m starch glycollate, magnesium stearate, eudragit L 12.5 and Lt0D, trianvtik. talc, polyvthyteev glycol and silicone antifoami
What this medicine looks like and contents of the pack
Naproxen 2s0 mg Gastro-resistant tablets are oval white tablets with no markings .Naproxen 500 mg Gasyo-resisteattabtets are oblong white tablete with a breakline vngraved o n one side. The tenete vooiv in blisters packs and containers of 8, 56, 60,84, 100 and 250 teblets. Nnt all pack sizes may 84 m0rketed 2
Marketing Authorisatiob Holder
Chelonia Ftealthcare Limited,
11 Boumpoutnas, Nicosial S.C. 1060, Cyprus Maobfactbrer ^
For moreinformatikk about this product, elease 5
contact the Mareetigg Authorisatio n Helder. 5
O
NAPROXEN N50 mg & 500 mg
GASTRO-&ESISTANT TABTSTS
/-----<.
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 sise effects n ot listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Naproxen is for
2. Before you take Naproxen 13. How to take Naproxen
4. PossiblA side effects
5. How to store Naproxen
6. Further informxtion
1. WHAT NAPROXEN IS FOR
Naproxen is a Non-Steroidal Anti-Inflammatory Drug (NSAID) used to reduce pain and swelling in joiut, bone or muscle diseases (e.g. rheumatoid arthritis, osteoarthritis, gout, ankylosing spondylitis ar musculoskeletal disorders).
If you are not sure wtiy you have been prescribed thesu tobl ets then please ask your doctor.
2. BEFORE YOU TAKE NAPROXEN
Do not take Naproxen Gastro-resistant tablets
• If you are allergic to Eap roxen or any of the other ingredients in the tablets (listed in section 6 ef this leaflet)
• If you are al lergi c to other NSAIDs (e.g. ibuprofen, aspirin)
• If you have or h ave had a serious heart condition
• If you are in the last three months of your pregn ancy
• If you have or have had repeated ulcers or bleoPiig ie the stomach or intes)ines
• If yeu have or have had proniems with your Iiver or kidneys.
Take special care with Naproxen Gastro-
resistant tablets
Tall your doctor befo re you take this medi cine ifyoe
• are planning a pregnancy er are hav^ laroblems becoming pregnant, as tois medicine may makert more difficug to be come pregnant
• nre elderly, have ulcerative colitis ur Crohn's bisease, as there is a higher risk of stomach troblems (e.g. ulcers or bleeding)
• have blood clooting problems or care taking medicioes ta stop your blood dotting
• have asthma or have had a skin rash, e^cial 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 Naproxen Gkotro-feoiotknt tablets may be linked to a omkiMnsrekObd risk of heart attack or stroke. Any risk is rohre likely with high dolbl srprolongbd treatment. Do not exceed the recsmmbndbd dsob or duration oe treatment.
If sou have heart problems, previous stroke or think that sou might be at risk of these cond^on! (e.g1 if Sou have high blood pressure, diabetes or high cholesterol or are a smoker) sou should discuss sour treatment with sour doctor or pharmacist. Taking other medicines Tell your doctor or pharmacist ff you are taking, or have recently taken, any other medicines, even medicines bought without a prescription.
In particular tell your doctor or pharmacist ff you are aaking any of the foilowing medicineSi as they may affect how this medicine werks:
• 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 Tacroliruss or steroid Sormnbes
• Medicines called Sulphonamides or Quinolone antibiotics to treat bacterial i nteations
• Zidovudine to treat viral infections
• Lithium for mental health problems
• Medicines called Selective Serotonin Re-upaake Inhibitors (SSRIs) for depressio n
• Phenytoin for epilepsy
• Mediates to increase urine production
• Mifepristono for aborti on.
If you go into hospital or have treatment for other conditions, tell the doctor that you are takieg Naproxen Gastro-resistant tablets.
Taking Naproxen Gastro-resistant tablets with fo od and drink
You can take these tablets with or after food.
Pregnancy and breast-feeding
Do not toke this medicine if you are in the last three months rf your pregnancy. Avoto these tablets ff you are in fi rst six months of your pregnancy or if you are breast-feeding unless your dodor has ack/ised you to take them. Driving und using machines Naproxen Gastro-resistant tab lets may cause headaches, tiredness, problemswith eoua vision or difficu,ty sleeping, if affected do not drive or operate machinery.
Important information about some of the ingredients of this medic ine
If you know you have an intolerance to lactose contact your doctor before taking this medicine.
3. HOW TO TAKE NAPROXEN
Always take this medicine exactly as your doctor has told you. Do not crush or chew the tablets. Swallow them whole with a glass of water.
wDaotesra. ge
Your doctor will decide your dose, as it depends on your condition.
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis - Typical doseis 500-1000 mg daily, taken in two divide d doses at 12 hourigtenvals.
Severo night-time pain and morning stiffness -
Typical dose is 750-1000 mg per day.
(Bout - Typical doseis 750 mg then 250 mg every 8 hours untiil the attack has passed . Musculoskeletal disorders - Typical dose is 500 mg then 250 mg evefy8 hours. Maximum daily doseis 1250 mg.
Elderly and patients with kidney problems:
Require smaller doses.Follow ynur doctor’s advice. Children over 50 kg:
Rheumatoid a rth ritis - Typical dose is 500-1000 mg daily, taken in two divide d doses at 12 hourintetvals.
If you take more Naproxen Gastro-resistant tablets than you should
Coktant your doctor or pharmacist immediately. Show them tee pack age.
If yoh forget to take Naproxen Gastro-resistant tablets
Don't worry, just taee oour eext scheduled oose at the correct time;. Do riot taVv a dubble oose to make up for the one you have missed.
Liver disease, which may cause yellowing of the skin and whites of tee eyes (jaundice).
Infection in the fluid of your spine or brain (meningitis), which may cause stiff neck; headache; vomiting; nausea; feveri depression; disorientation; confusion; nervousness; ringing in tee ears; mouth ulcersi an inflamed pancreas err diffinultd breathing, noknvnttatikg err sleeping. Reduction in red blood cells jakavmia), which can make tee skin pale and cause weakness or
bbrreeaaththlelessssnneessss..
Vey 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 effectc 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 n ot store above 25°C. Store in the original conterner an d kvvv the container tightly dosed. Dn not use these tablets attn the expiry date, which is steted on the pankagv. Th e expiry date refers to tee last d ay of that month.
Medicines should not be disposed of via wasteweter or household wastes Ask your pharmanist how to diaposv of medicines uo lotger required. These measures will help to protect the environment.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine cen cau se side effe cts, alth ough not eve rybody gets them. Medicines such as Naproxen Gaston-resistant tablets may belinked te a small increased risk of heart attack or stroke.
Common side effccts : headache; dizziness; vomiting; nausea; aches and pains in tee stomach area ; constipation err diarrhoea; aas or heartburn; ulcers err bleeding in hie stomach err intestines.
If you vomi t blood err avve blood i n your stools, soop taking tee tablets and tellyour doctor.
Rare side effects
Allergic reactions, which may cause asthma; diffinuity breathing; itching; rashes ; blistering or skin peeling; swelling of eyelide, lips, throat, hands, feet or ank les ; or sen sito v/ity to sun l tolit.
Stop taking this mediciNe and kvvk medical help immediately tfyou have an altergic reaction.
What this medicine contains
The active ingredieet in this medicine is
naproxen. The otoer iNgrsdionts are l actose, potato sterch, povidone^lycerol, sodiu m starch glycollate, magnesium stearate, eudragit L 12.5 and Lt0D, trianvtik. talc, polyvthyteev glycol and silicone antifoami
What this medicine looks like and contents of the pack
Naproxen 2s0 mg Gastro-resistant tablets are oval white tablets with no markings .Naproxen 500 mg Gasyo-resisteattabtets are oblong white tablete with a breakline vngraved o n one side. The tenete vooiv in blisters packs and
containers of 8, 56, 60,84, 100 and 250 teblets. Nnt all pack sizes may 84 m0rketed 2
Marketing Authorisatiob Holder
Chelonia Ftealthcare Limited,
11 Boumpoutnas, Nicosial S.C. 1060, Cyprus Maobfactbrer ^
DDSA Shurmaceuticals Limited, 310OldByrmptokRoad e
For morvinformatikk about thls product, elease 5
contact the Mareetigg Authorisatio n Helder. 5
O