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NAPROSYN EC 375 MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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Package leaflet: Information for the patient

10164857 GB LE

Naprosyn® EC
250 mg, 375 mg and 500 mg
Gastro-Resistant 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 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.
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).
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.

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

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 lightheaded 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 this medicine out of the sight and
reach of children.
● Store in original package in order to
protect from light. Store below 30ºC.
● Do not use Naprosyn EC after the expiry
date printed on the pack. The expiry date
refers to the last day of that month.
● Do not throw 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 Naprosyn EC contains
The active substance in Naprosyn EC 250 mg,
375 mg and 500 mg Tablets is naproxen.
Each tablet contains either 250 mg (milligrams),
375 mg or 500 mg of naproxen.
The other ingredients in the tablets are povidone,
magnesium stearate, water, croscarmellose
sodium, methacrylic acid – ethyl acrylate
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 250 mg Tablets are round,
white and marked with NPR EC 250 on
one side.
● Naprosyn EC 375 mg Tablets are oval, white
and marked with NPR EC 375 on one side.
● 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.
Marketing Authorisation Holder and
Manufacturer
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom
This leaflet was last revised in May 2015
10164857 GB LE

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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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