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NAPROSYN 500MG TABLETS

Active substance(s): NAPROXEN

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New code 10167428

GB 723-1335-APIL

Size: 148 x 420 mm

PL 43252/0004-5

PAGE 1 of 2

Date: 17.04.15 Version 10 B/code:
Update: 16.06.15 03.07.15 13.07.15 22.09.15 16.11.15

Information: Naprosyn 250 / 500 mg tablets
Pharma code:

Notes: Special instructions:
Laetus: 380
Type size: 9pt.

Colour PMS

Previous ref:

Technical approval
Date:.......................
Signed:...................
‘OK for printing PDF’

10160046 GB

Date:.......................

Miles Gray Road, Basildon,
Essex. SS14 3FR United Kingdom © 2015

Black U

Package leaflet: Information for the patient

Signed:...................

GB 723-1335-APIL 10167428 GB DIV (LE)

Naprosyn

®

250 mg & 500 mg Tablets

● 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.

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

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.

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 medicine.
● 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.

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 diclofenac).

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:
● 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 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.
The recommended dose is:
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.

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.

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.

380

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
(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).

Gout
● 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.
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.

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

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.

Other medicines and Naprosyn
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.

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.
1

Please turn over

380

380

1. What Naprosyn is and what it
is used for

380

Naproxen

New code 10167428

GB 723-1335-APIL

Size: 148 x 420 mm

PL 43252/0004-5

PAGE 2 of 2

Date: 17.04.15 Version 10 B/code:
Update: 16.06.15 03.07.15 13.07.15 22.09.15 16.11.15

Information: Naprosyn 250 / 500 mg tablets
Pharma code:

Notes: Special instructions:
Laetus: 380
Type size: 9pt.

Colour PMS

Previous ref:

Date:.......................
Signed:...................
‘OK for printing PDF’

10160046 GB

Miles Gray Road, Basildon,
Essex. SS14 3FR United Kingdom © 2015

Technical approval

Date:.......................

Black U

Signed:...................

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.

● 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.

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.
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.

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.

Urinary
• Blood in your water (urine) or kidney problems.

Important side effects to look out for:
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 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.

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
● 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.

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. Contents of the pack and
other information

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 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).

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.

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.

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’).

Naprosyn tablets are supplied in blister packs
containing 56 tablets.

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

Marketing Authorisation Holder
Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road,
Basildon, Essex SS14 3FR
United Kingdom.

Other possible side effects:
Stomach and gut
● Heartburn, indigestion, stomach ache, feeling
sick or being sick, constipation, diarrhoea, wind.

Manufacturer
Waymade Plc.
Sovereign House, Miles Gray Road,
Basildon, Essex SS14 3FR
United Kingdom.

Blood
● Blood problems, like anaemia or changes to the
numbers of white blood cells.

T
November 2015

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.
2

GB 723-1335-APIL 10167428 GB-DIV (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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