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Active substance(s): NAPROXEN

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Package leaflet: Information for the patient

10164854 GB LE

Naprosyn® 250 mg & 500 mg
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
● 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.

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
● 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
● Mifepristone (used to end pregnancy or to
bring on labour if the baby has died).

What is in this leaflet:
1. What Naprosyn is and what it is used for
2. What you need to know before you take
3. How to take Naprosyn
4. Possible side effects
5. How to store Naprosyn
6. Contents of the pack and other information

1. What Naprosyn is and what it
is used for
Naprosyn contains a medicine called naproxen.
This is a ‘Non Steroidal Anti Inflammatory
Drug’ or NSAID.
Naprosyn can lessen pain, swelling, redness
and heat (inflammation) and is used to treat
adults for:
● Problems with your muscles, joints and
tendons, like strains, gout, ankylosing
spondylitis (pain and stiffness in the neck
and back) or arthritis.
● Women, while having period pain.
It can also be used in children over 5 years
with rheumatoid arthritis.

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

2. What you need to know before
you take Naprosyn
Do not take Naprosyn if you are allergic
(hypersensitive) to:
● Naproxen, naproxen sodium or any of the
other ingredients of Naprosyn (see listed
in section 6).
● Aspirin, other NSAIDs or any other pain
relief medicines (such as ibuprofen or

Pregnancy, breast-feeding and fertility.
● Do not take Naprosyn 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

Do not take Naprosyn 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

Driving and using machines:
Naprosyn 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.

● Naprosyn 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.

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

3. How to take Naprosyn
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

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.

The recommended dose is:
Muscle, joint or tendon problems and
period pain
● The usual starting dose is 500 mg,
followed by a 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.

Talk to your doctor or pharmacist before
taking Naprosyn 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
● An autoimmune condition, such as
‘systemic lupus erythematosus’ (SLE,
causes joint pain, skin rashes and fever)
and colitis or Crohn’s disease (conditions
causing inflammation of the bowel, bowel
pain, diarrhoea, vomiting and weight loss).

● The usual starting dose is 750 mg,
followed by a 250 mg tablet every 8 hours
as needed.
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.
Children over 5 years, rheumatoid arthritis
● The usual dose is 10 mg/kg body weight
each day.
● The dose is split into two and given
12 hours apart.

If any of the above apply to you, or if you are
not sure, talk to your doctor or pharmacist
before you take Naprosyn.
Other medicines and Naprosyn
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

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Medicines such as Naprosyn 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.

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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.
You should make sure that you have enough
to drink (stay well hydrated) when you are
taking Naprosyn. This is particularly important
for people who have problems with their
While you are taking Naprosyn 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 elderly.
If you take more Naprosyn than you should
If you take more Naprosyn 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
● 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 will get them.
Medicines such as Naprosyn may be
associated with a small increased risk of heart
attack (‘myocardial infarction’) or stroke.

Important side effects to look out
Stop taking Naprosyn 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
● 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.
● Blistering of skin when exposed to
sunlight (porphyria cutanea tarda) seen
most on arms, face and hands.

● 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
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
Heart and circulation
● Swelling of your hands, feet or legs
(oedema), this may be with chest pains,
tiredness, shortness of breath (cardiac
● 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.
● 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.
● Blood in your water (urine) or kidney
● Thirst, fever, feeling tired or generally
● 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:
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Naprosyn

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.

● Keep this medicine out of the sight and
reach of children.
● Store in original package in order to
protect from light. Store below 30 °C.
● Do not use Naprosyn Tablets 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.

Heart attack, signs include:
● Chest pain which may spread to your neck
and shoulders and down your left arm.

6. Contents of the pack and other

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 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 problems, like anaemia or changes
to the numbers of white blood cells.
Mental illness
● Having difficulty sleeping or changes in
your patterns of dreaming.

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What Naprosyn contains
The active substance in Naprosyn 250 mg
and 500 mg Tablets is naproxen. Each tablet
contains either 250 mg (milligrams) or
500 mg of naproxen. The other ingredients
in the tablets are povidone, magnesium
stearate, croscarmellose sodium, water and
iron oxide (E172).
What Naprosyn looks like and contents of
the pack
● Naprosyn 250 mg Tablets are round,
yellow and marked with NPR LE 250 on
one side and a breakline on the other.
● Naprosyn 500 mg Tablets are oblong,
yellow and marked with NPR LE 500 on
one side and a breakline on the other.
Naprosyn tablets are supplied in blister packs
containing 56 tablets.
Marketing Authorisation Holder and
Roche Products Limited,
6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom
This leaflet was last revised in May 2015
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04.05.2015 10:34:51

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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.