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NAPROXEN EC 500MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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Ref: 1441/080316/1/F

Naprosyn ® EC 500mg Gastro-Resistant Tablets
(naproxen)
Patient Information Leaflet
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.
Your medicine is called Naprosyn EC 500mg Gastro-Resistant Tablets but
will be referred to as Naprosyn EC throughout this leaflet.
Please note that the leaflet also contains information about other strengths
of the medicine, Naprosyn EC 250mg Gastro-Resistant Tablets and
Naprosyn EC 375mg Gastro-Resistant Tablets
What is in this leaflet
1 What Naprosyn EC is and what it is used for
2 What you need to know before you take Naprosyn EC
3 How to take Naprosyn EC
4 Possible side effects
5 How to store Naprosyn EC
6 Contents of the pack and other information

1

What Naprosyn EC is and what it is used for

Naprosyn EC contains a medicine called naproxen. This is a ‘Non Steroidal
Anti Inflammatory Drug’ or NSAID.
Naprosyn EC can lessen pain, swelling, redness and heat (inflammation)
and is used to treat adults for:
* Problems with your muscles, joints and tendons, like strains, back pain,
ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis.
* Women, while having period pain.

2

What you need to know before you take
Naprosyn EC

Do not take Naprosyn EC if you are allergic (hypersensitive) to:
* Naproxen, naproxen sodium or any of the other ingredients of Naprosyn
EC (listed in section 6).
* Aspirin, other NSAIDs or any other pain relief medicines (such as
ibuprofen or diclofenac).
Do not take Naprosyn EC if:
* 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.
* You have severe problems with your kidneys, liver or heart.
* You are in the last three months of pregnancy.
Do not take Naprosyn EC if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Naprosyn EC.
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.

Other medicines and Naprosyn EC
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 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 Naprosyn EC.
Pregnancy, breast-feeding and fertility.
* Do not take Naprosyn EC if you are in the last three months of pregnancy,
as it can harm your baby.
* 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.
* Naprosyn EC may make it more difficult to become pregnant. You should
tell your doctor if you are planning to become pregnant or if you have
problems becoming pregnant.
Driving and using machines:
Naprosyn EC may make you 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.

3

How to take Naprosyn EC

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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.
Arthritis and ankylosing spondylitis
* The usual 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.
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.

Talk to your doctor or pharmacist before taking Naprosyn EC if any of the
following apply to you:
* Asthma or allergies (like hayfever) or have had swelling of the face, lips,
eyes or tongue in the past.
* A feeling of weakness (perhaps because of an illness) or you are an older
person.
* Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked,
or itchy nose (rhinitis).
* Problems with your kidneys or liver.
* Problems with the way that your blood clots.
* Problems with the blood vessels (arteries) anywhere in your body.
* Too much fat (lipid) in your blood (hyperlipidaemia).
* An autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE,
causes joint pain, skin rashes and fever) and ulcerative colitis or Crohn’s
disease (conditions causing inflammation of the bowel, bowel pain,
diarrhoea, vomiting and weight loss).

Use in children and adolescents
Naprosyn EC is not for use in children under 16 years of age.

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

While you are taking Naprosyn EC 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 an older person.

Children and adolescents
Naprosyn EC is not recommended for use in children under 16 years of age.

Medicines such as Naprosyn EC 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.
Swallow the tablets whole with a little water, with or after food. Do not crush
or chew the tablets.
You should make sure that you have enough to drink (stay well hydrated)
when you are taking Naprosyn EC. This is particularly important for
people who have problems with their kidneys.

If you take more Naprosyn EC than you should
If you take more Naprosyn EC than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
If you forget to take Naprosyn EC
* 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.

Ref: 1441/080316/1/B

Naprosyn ® EC 500mg Gastro-Resistant Tablets
(naproxen)
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines this medicine can cause side effects, although not
everybody gets them.
Medicines such as Naprosyn EC may be associated with a small increased
risk of heart attack (‘myocardial infarction’) or stroke.
Important side effects to look out for:
Stop taking Naprosyn EC 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:
* 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.
* 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.
* Worsening of ulcerative colitis or Crohn’s disease, seen as pain, diarrhoea,
vomiting and weight loss.
Allergic reactions, signs include:
* Sudden swelling of your throat, face, hands or feet.
* Difficulty breathing, tightness in your chest.
* Skin rashes, blisters or itching.
Severe skin rashes, signs include:
* 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.
* Skin blistering when exposed to sunlight (porphyria cutanea tarda) seen
most on arms, face and hands.
Liver problems, signs include:
* 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.
Heart attack, signs include:
* Chest pain which may spread to your neck and shoulders and down your
left arm.
Stroke, signs include:
* 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:
* 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’).
If you notice any of the serious side effects mentioned above, stop taking
Naprosyn EC and tell your doctor straight away.
Other possible side effects:
Stomach and gut
* Heartburn, indigestion, stomach ache, feeling sick or being sick,
constipation, diarrhoea, wind.
Blood
* Blood problems, like anaemia or changes to the numbers of white blood
cells.
Mental illness
* Having difficulty sleeping or changes in your patterns of dreaming.
* Depression.
* Confusion or seeing and possibly hearing things that are not there
(hallucinations).
Nervous system
* Headache.
* Fits or seizures, feeling dizzy or light-headed or sleepy.
* Pins and needles or numbness of your hands and feet.
* Difficulty with your memory or concentration.
Eyes and ears
* Changes to your eyesight, eye pain.
* Changes to your hearing, including ringing in the ears (tinnitus) and
hearing loss.
* Dizziness that causes problems with your balance.
Heart and circulation
* Swelling of your hands, feet or legs (oedema). This may be with chest
pains, tiredness, shortness of breath (cardiac failure).
* A fluttering feeling in your heart (palpitations), slow heart beat or high
blood pressure.
* Problems with the way your heart pumps blood around the body or
damage to your blood vessels. Signs may include tiredness, shortness of
breath, feeling faint, general pain.

Chest
* Difficulty breathing, including shortness of breath, wheezing or coughing.
* Pneumonia or swelling of your lungs.
Skin and hair
* Skin rashes including redness, hives, pimples and blisters on your body
and face.
* Bruising, itching, sweating, skin being more sensitive to the sun or hair
loss.
Urinary
* Blood in your water (urine) or kidney problems.
Other
* Thirst, fever, feeling tired or generally unwell.
* A sore mouth or mouth ulcers.
* Muscle pain or weakness.
* Problems for women in getting pregnant.
* ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash, problems
with your kidneys and joint pain.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects 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 Naprosyn EC

Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package. Protect from light.
Do not use this medicine after the date shown by the six numbers following
EXP on the blister. The first two numbers indicate the month; the last four
numbers indicate the year. This medicine expires at the end of the month
shown.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Naprosyn contains
The active substance in Naprosyn EC is naproxen. Each tablet contains
500 mg of naproxen.
Other ingredients are: povidone, magnesium stearate, croscarmellose
sodium, methylacrylic acid copolymer, purified talc, sodium hydroxide,
triethyl citrate, iron oxide black, shellac and propylene glycol.
What Naprosyn EC looks like and contents of the pack
Naprosyn EC 500 mg Tablets are capsule shaped, white and marked with
NPR EC 500 on one side.
Naprosyn EC Tablets are supplied in blister packs containing 56 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Roche Pharma AG, Emil-Barrell-Str.1,
D-79639 Grenzach-Wyhle, Germany and procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1441

Naprosyn is a registered trademark of F. Hoffmann-La Roche AG.
Revision date: 08/03/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon UK Limited
Tel: 01527 505414 for help.

Ref: 1441/080316/2/F

Naproxen EC 500mg Gastro-Resistant Tablets
Patient Information Leaflet
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.
Your medicine is called Naproxen EC 500mg Gastro-Resistant Tablets but
will be referred to as Naproxen EC throughout this leaflet.
Please note that the leaflet also contains information about other strengths
of the medicine, Naproxen EC 250mg Gastro-Resistant Tablets and
Naproxen EC 375mg Gastro-Resistant Tablets
What is in this leaflet
1 What Naproxen EC is and what it is used for
2 What you need to know before you take Naproxen EC
3 How to take Naproxen EC
4 Possible side effects
5 How to store Naproxen EC
6 Contents of the pack and other information

1

What Naproxen EC is and what it is used for

Naproxen EC contains a medicine called naproxen. This is a ‘Non Steroidal
Anti Inflammatory Drug’ or NSAID.
Naproxen EC can lessen pain, swelling, redness and heat (inflammation)
and is used to treat adults for:
* Problems with your muscles, joints and tendons, like strains, back pain,
ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis.
* Women, while having period pain.

2

What you need to know before you take
Naproxen EC

Do not take Naproxen EC if you are allergic (hypersensitive) to:
* Naproxen, naproxen sodium or any of the other ingredients of Naproxen
EC (listed in section 6).
* Aspirin, other NSAIDs or any other pain relief medicines (such as
ibuprofen or diclofenac).
Do not take Naproxen EC if:
* 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.
* You have severe problems with your kidneys, liver or heart.
* You are in the last three months of pregnancy.
Do not take Naproxen EC if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Naproxen EC.
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.

Other medicines and Naproxen EC
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 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 EC.
Pregnancy, breast-feeding and fertility.
* Do not take Naproxen EC if you are in the last three months of pregnancy,
as it can harm your baby.
* 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.
* Naproxen EC may make it more difficult to become pregnant. You should
tell your doctor if you are planning to become pregnant or if you have
problems becoming pregnant.
Driving and using machines:
Naproxen EC may make you 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.

3

How to take Naproxen EC

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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.
Arthritis and ankylosing spondylitis
* The usual 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.
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.

Talk to your doctor or pharmacist before taking Naproxen EC if any of the
following apply to you:
* Asthma or allergies (like hayfever) or have had swelling of the face, lips,
eyes or tongue in the past.
* A feeling of weakness (perhaps because of an illness) or you are an older
person.
* Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked,
or itchy nose (rhinitis).
* Problems with your kidneys or liver.
* Problems with the way that your blood clots.
* Problems with the blood vessels (arteries) anywhere in your body.
* Too much fat (lipid) in your blood (hyperlipidaemia).
* An autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE,
causes joint pain, skin rashes and fever) and ulcerative colitis or Crohn’s
disease (conditions causing inflammation of the bowel, bowel pain,
diarrhoea, vomiting and weight loss).

Use in children and adolescents
Naproxen EC is not for use in children under 16 years of age.

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

While you are taking Naproxen EC 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 an older person.

Children and adolescents
Naproxen EC is not recommended for use in children under 16 years of age.

Medicines such as Naproxen EC 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.
Swallow the tablets whole with a little water, with or after food. Do not crush
or chew the tablets.
You should make sure that you have enough to drink (stay well hydrated)
when you are taking Naproxen EC. This is particularly important for
people who have problems with their kidneys.

If you take more Naproxen EC than you should
If you take more Naproxen EC than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
If you forget to take Naproxen EC
* 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.

Ref: 1441/080316/2/B

Naproxen EC 500mg Gastro-Resistant Tablets
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines this medicine can cause side effects, although not
everybody gets them.
Medicines such as Naproxen EC may be associated with a small increased
risk of heart attack (‘myocardial infarction’) or stroke.
Important side effects to look out for:
Stop taking Naproxen EC 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:
* 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.
* 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.
* Worsening of ulcerative colitis or Crohn’s disease, seen as pain, diarrhoea,
vomiting and weight loss.
Allergic reactions, signs include:
* Sudden swelling of your throat, face, hands or feet.
* Difficulty breathing, tightness in your chest.
* Skin rashes, blisters or itching.
Severe skin rashes, signs include:
* 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.
* Skin blistering when exposed to sunlight (porphyria cutanea tarda) seen
most on arms, face and hands.
Liver problems, signs include:
* 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.
Heart attack, signs include:
* Chest pain which may spread to your neck and shoulders and down your
left arm.
Stroke, signs include:
* 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:
* 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’).
If you notice any of the serious side effects mentioned above, stop taking
Naproxen EC and tell your doctor straight away.
Other possible side effects:
Stomach and gut
* Heartburn, indigestion, stomach ache, feeling sick or being sick,
constipation, diarrhoea, wind.
Blood
* Blood problems, like anaemia or changes to the numbers of white blood
cells.
Mental illness
* Having difficulty sleeping or changes in your patterns of dreaming.
* Depression.
* Confusion or seeing and possibly hearing things that are not there
(hallucinations).
Nervous system
* Headache.
* Fits or seizures, feeling dizzy or light-headed or sleepy.
* Pins and needles or numbness of your hands and feet.
* Difficulty with your memory or concentration.
Eyes and ears
* Changes to your eyesight, eye pain.
* Changes to your hearing, including ringing in the ears (tinnitus) and
hearing loss.
* Dizziness that causes problems with your balance.
Heart and circulation
* Swelling of your hands, feet or legs (oedema). This may be with chest
pains, tiredness, shortness of breath (cardiac failure).
* A fluttering feeling in your heart (palpitations), slow heart beat or high
blood pressure.
* Problems with the way your heart pumps blood around the body or
damage to your blood vessels. Signs may include tiredness, shortness of
breath, feeling faint, general pain.

Chest
* Difficulty breathing, including shortness of breath, wheezing or coughing.
* Pneumonia or swelling of your lungs.
Skin and hair
* Skin rashes including redness, hives, pimples and blisters on your body
and face.
* Bruising, itching, sweating, skin being more sensitive to the sun or hair
loss.
Urinary
* Blood in your water (urine) or kidney problems.
Other
* Thirst, fever, feeling tired or generally unwell.
* A sore mouth or mouth ulcers.
* Muscle pain or weakness.
* Problems for women in getting pregnant.
* ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash, problems
with your kidneys and joint pain.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects 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 EC

Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package. Protect from light.
Do not use this medicine after the date shown by the six numbers following
EXP on the blister. The first two numbers indicate the month; the last four
numbers indicate the year. This medicine expires at the end of the month
shown.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Contents of the pack and other information

What Naproxen EC contains
The active substance in Naproxen EC is naproxen. Each tablet contains
500 mg of naproxen.
Other ingredients are: povidone, magnesium stearate, croscarmellose
sodium, methylacrylic acid copolymer, purified talc, sodium hydroxide,
triethyl citrate, iron oxide black, shellac and propylene glycol.
What Naproxen EC looks like and contents of the pack
Naproxen EC 500 mg Tablets are capsule shaped, white and marked with
NPR EC 500 on one side.
Naproxen EC Tablets are supplied in blister packs containing 56 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Roche Pharma AG, Emil-Barrell-Str.1,
D-79639 Grenzach-Wyhle, Germany and procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1441

Revision date: 08/03/16

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Tel: 01527 505414 for help.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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