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NAPROSYN EC 500 MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN / NAPROXEN / NAPROXEN

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New code 10167432

GB 723-1400-APIL

Size: 148 x 420 mm PL 43252/0006-7-8

PAGE 1 of 2

Date: 20.04.15 Version 6 B/code:
Update: 27.05.15 10.07.15 22.09.15 16.11.15

Information: Naprosyn EC 250 / 375 / 500 mg tablets
Pharma code:

Notes: Special instructions:
Laetus: 325
Type size: 9pt.

Colour PMS

Previous ref:

UPDATED TEXT

Date:.......................
Signed:...................
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10160045 GB

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

Technical approval

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

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GB 723-1400-APIL 10167432 GB-DIV (LE)

Naprosyn® EC

250 mg, 375 mg and 500 mg
Gastro-Resistant Tablets
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.

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.

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).

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.

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.

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

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.

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.

325

325

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
What is in this leaflet:
infections).
1. What Naprosyn EC is and what it is used for
• A sulfonylurea (for diabetes), like glimepiride
2. What you need to know before you take
or glipizide.
Naprosyn EC
• An ‘ACE inhibitor’ or any other medicine for
3. How to take Naprosyn EC
high blood pressure like cilazapril, enalapril
4. Possible side effects
or propranolol.
5. How to store Naprosyn EC
• An angiotensin-II receptor antagonist, like
6. Contents of the pack and other information
candesartan, eprosartan or losartan.
• A diuretic (water tablet) (for high blood
pressure), like furosemide.
1. What Naprosyn EC is and
• A ‘cardiac glycoside’ (for heart problems),
what it is used for
like digoxin.
• A steroid (for swelling and inflammation),
Naprosyn EC contains a medicine called
like hydrocortisone, prednisolone and dexamnaproxen. This is a ‘Non Steroidal Anti
ethasone.
Inflammatory Drug’ or NSAID.
• A ‘quinolone antibiotic’ (for infections),
like ciprofloxacin or moxifloxacin.
Naprosyn EC can lessen pain, swelling, redness
• Certain medicines for mental health problems
and heat (inflammation) and is used to treat adults
like lithium or ‘SSRIs’ like fluoxetine or
for:
citalopram.
• Problems with your muscles, joints and
• Probenecid (for gout).
tendons, like strains, back pain, ankylosing
• Methotrexate (used to treat skin problems,
spondylitis (pain and stiffness in the neck and
arthritis or cancer).
back) or arthritis.
• Ciclosporin or tacrolimus (for skin problems
• Women, while having period pain.
or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV
infections).
2. What you need to know before • Mifepristone (used to end pregnancy or to
bring on labour if the baby has died).
you take Naprosyn EC

325

Naproxen

The recommended dose is:

325

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.

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.

Children and adolescents
Naprosyn EC is not recommended for use in
children under 16 years of age.
1

Please turn over

New code 10167432

GB 723-1400-APIL

Size: 148 x 420 mm PL 43252/0006-7-8

PAGE 2 of 2

Date: 20.04.15 Version 6 B/code:
Update: 27.05.15 10.07.15 22.09.15 16.11.15

Information: Naprosyn EC 250 / 375 / 500 mg tablets
Pharma code:

Notes: Special instructions:
Laetus: 325
Type size: 9pt.

Colour PMS

Previous ref:

UPDATED TEXT

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

10160045 GB

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

Technical approval

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

Black

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

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.

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.

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.

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.

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

4. Possible side effects

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.

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.

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

Important side effects to look out for:

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.

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.

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

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.

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.

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.

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

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.

Other possible side effects:

Naprosyn EC 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’).

Stomach and gut
• Heartburn, indigestion, stomach ache, feeling
sick or being sick, constipation, diarrhoea,
wind.

Marketing Authorisation Holder
Atnahs Pharma UK Limited
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.

Manufacturer

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

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).

November 2015

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

GB 723-1400-APIL 10167432 GB-DIV (LE)

Expand Transcript

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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