NAPROSYN 250MG TABLETS

Active substance: NAPROXEN

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KAU-Nr.

1314

Genisys-No.

10142743

Printing Colour:

Pantone Black

Format:

148x420 mm

Folding Format:

-

Leatus Code

219

Type Size

9 pt

Drawing Norm

PR003/20 18.11.2009

make-up Code

GB

COE/CMO

LE

Checked and
approved

Date

Signature

10142743 GB
LE.1210.1078

Patient Information Leaflet

Naprosyn®
250 mg & 500 mg Tablets
Naproxen

Taking other medicines

Please 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
troublesome, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist.

Tell your doctor or pharmacist if you are taking
or have recently taken 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).

In this leaflet:
1. What Naprosyn is and what it is used for
2. Before you take Naprosyn
3. How to take Naprosyn
4. Possible side effects
5. How to store Naprosyn
6. Further 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 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.
● 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.
Pregnancy and breast-feeding

2. Before you take Naprosyn
Do not take Naprosyn if you are allergic
(hypersensitive) to:

● Do not take Naprosyn if you are in the last
three months of pregnancy, as it can harm
your baby.
● Talk to your doctor before taking Naprosyn
if you are up to six months pregnant, think
you are pregnant, plan to get pregnant or are
breast-feeding. Your doctor will decide if
you should take Naprosyn.
● 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.

● Naproxen, naproxen sodium or any of the
other ingredients of Naprosyn (see Section 6).
● Aspirin, other NSAIDs or any other pain
relief medicines (such as ibuprofen or
diclofenac).

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
pregnancy.

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.

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
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. 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 kidneys.
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.

Take special care with Naprosyn

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.
Check with 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 elderly.
● 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 colitis or
Crohn’s disease (conditions causing
inflammation of the bowel, bowel pain,
diarrhoea, vomiting and weight loss).

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.

Adults
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.

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

Arthritis and ankylosing spondylitis
● The usual dose is between 500 mg and
1000 mg.
1

10142743 PR003 148x420 mm.indd 1

Please turn over

25.02.2013 13:24:47

KAU-Nr.

1314

Genisys-No.

10142743

Printing Colour:

Pantone Black

Format:

148x420 mm

Folding Format:

-

Leatus Code

219

Type Size

9 pt

Drawing Norm

PR003/20 18.11.2009

make-up Code

GB

COE/CMO

LE

Checked and
approved

Date

Signature

Eyes and ears

● The dose can be taken all at once, or split in
two and taken twice a day.

● 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.

Gout

● The usual starting dose is 750 mg, followed
by a 250 mg tablet every 8 hours as needed.

The elderly and people with liver and
kidney problems

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.

Your doctor will decide your dose, it will
usually be lower than that for other adults.

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.

Chest

● Difficulty breathing, including shortness of
breath, wheezing or coughing.
● Pneumonia or swelling of your lungs.

4. Possible side effects
Like all medicines Naprosyn can cause side
effects, although not everyone will get them.
Medicines such as Naprosyn may be associated
with a small increased risk of heart attack
(‘myocardial infarction’) or stroke.

Skin and hair

Important side effects to look out for:

Urinary

● 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
problems.

Stop taking Naprosyn and tell a doctor
straight away if any of the following side
effects happen. You may need urgent
medical treatment:

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.

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.

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.

5. How to store Naprosyn
● Naprosyn Tablets should be kept in their
original packaging to protect them from
light. Store below 30 °C.
● Keep out of the reach and sight of children.
● Do not use Naprosyn Tablets after the expiry
date printed on the pack.
● Return any left over tablets to your
pharmacist to be disposed of carefully.
Only keep them if your doctor tells you to.

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.

6. Further information
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. Other ingredients in the tablets are
povidone, magnesium stearate, croscarmellose
sodium and iron oxide (E172).

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.

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 oval,
yellow and marked with NPR LE 500 on
one side and a breakline on the other.

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.

Naprosyn tablets are supplied in blister packs
containing 56 tablets.

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’).

Marketing Authorisation Holder and
Manufacturer
Roche Products Limited,
6 Falcon Way, Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

If you notice any of the serious side effects
mentioned above, stop taking Naprosyn and tell
your doctor straight away.

This leaflet was last revised in
February 2013

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.
2

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10142743 GB
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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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