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NAPROXEN 375MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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Rare (affects 1 to 10 users in 10,000)
high blood potassium levels (causing
irregular, slow heart beat, feeling sick),
hair loss, jaundice (yellow skin or eyes),
hearing difficulties, inflammation of blood
vessels (causing fever, swelling and general
unwellness), worsening of asthma, muscle
weakness/pain, ulcers on the inner cheeks,
gums and tongue, hepatitis - sometimes
fatal (symptoms include feeling tired, loss
of appetite, feeling or being sick and pale
coloured stools).

You can also report side effects directly 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

Very rare (affects less than 1 user in 10,000)
changes in the numbers and types of blood
cells (if you develop sore throats, nose
bleeds or infections consult your doctor),
anaemia (may cause fainting, chest pain,
breathlessness), fits, aseptic meningitis
(may cause fever, feeling or being sick,
disorientation, headache, neck stiffness
and sensitivity to light), severe skin rash
with flushing, blisters or ulcers (StevensJohnson syndrome), blisters or sores on
the skin, kidney damage or infection
(may cause blood in the urine, decrease
in amount of urine passed, feeling or
being sick), inflammation of the pancreas;
pancreatitis (causing fever, stomach pain,
sickness). Medicines such as naproxen may
be associated with a small increased risk of
heart attack (myocardial infarction) or stroke.
Not Known (frequency cannot be estimated
from the available data)
low amounts of white cells in the blood
(may cause fever or frequent infections),
runny nose, lowered female fertility (see
section 2), sensing things that are not there,
high blood creatinine levels seen in blood
tests, kidney failure, kidney disease (may
cause changes in the need to or amount
of urine), thirst, fever, inflammation in the
eye (causing eye pain or changes in vision),
tingling or “pins and needles”, a spinning
sensation, abnormal liver function seen
in tests, worsening of Parkinson’s disease,
general feeling of discomfort and illness,
swelling of the hands and feet, swelling
in the eye (causing headaches or blurred
vision).
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.
Continued top of next column

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Naproxen GR Tablets
250,375 & 500mg x 56’s (UK)

How to store

Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the
original package.
Do not use Naproxen GR tablets after the
expiry date stated on the label/carton/
bottle. The expiry date refers to the last day
of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

Naproxen 250mg, 375mg and
500mg Gastro-resistant
tablets

Further information

What Naproxen GR tablets contain

• The active substance (the ingredient that
makes the medicine work) is 250mg,
375mg or 500mg of naproxen.
• The other ingredients are methacrylic
acid-ethylacrylate copolymer (1:1),
lactose, magnesium stearate, maize
starch, crospovidone, propylene glycol,
shellac glaze, sodium hydroxide, triethyl
citrate, titanium dioxide (EI71), iron oxide
black (E172), potassium sorbate (E202),
sodium citrate (E331), xanthan gum (E415),
hydroxypropyl cellulose (E463), purified talc
(E553), beeswax.

What Naproxen GR tablets look like
and contents of the pack
250mg tablets are white, round, biconvex,
enteric-coated tablets.
375mg and 500mg tablets are white, oval,
biconvex, enteric-coated tablets.
Pack sizes: 56 tablets
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS
This leaflet was last revised in March 2014

Actavis, Barnstaple, EX32 8NS, UK
AAAG6625 50778110

Read all of this leaflet carefully before
you start taking this medicine.
• K
 eep 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 get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

2

Do not take Naproxen GR tablets if
you:

• a re allergic to naproxen or to any of the
other ingredients in Naproxen GR tablets
(see section 6)
• a re allergic to aspirin or other nonsteroidal anti-inflammatory medicines
(NSAIDs), or you have developed signs of
asthma (wheezing), runny nose, swelling
of the skin or rash when taking these
medicines
•h
 ave or have had stomach or duodenum
(gut) ulcers, bleeding in the stomach or
intestines (gastrointestinal bleeding) or
have had two or more episodes of peptic
ulcers, stomach bleeding or perforation
• a re in the last three months of pregnancy
or if you are breast feeding
• have severe liver, kidney or heart failure.

In this leaflet
1 What Naproxen GR tablets are
and what they are used for
2 B
 efore you take Naproxen GR
tablets
3 How to take Naproxen GR tablets
4 Possible side effects
5 How to store
6 Further information
1

If you are not sure about any of the above
conditions, please ask your doctor.

Check with your doctor before taking
Naproxen GR tablets if you:

• a re on a low potassium diet, as this
product contains potassium sorbate.
High blood levels of potassium can cause
stomach upset and diarrhoea
•u
 se other non-steroidal antiinflammatory medicines (NSAIDs) or any
medication which may cause bleeding or
ulcers in the stomach
•h
 ave a history of gastrointestinal disease
e.g. ulcerative colitis, Crohn’s disease
• smoke
• drink alcohol
• are elderly
•h
 ave or have had high blood pressure or
any liver, kidney or heart problems
•h
 ave or have had bronchial asthma, other
breathing problems or nasal polyps
•h
 ave systemic lupus erythematosus or
other connective tissue disorders

 hat Naproxen GR tablets are
W
and what they are used for

Naproxen belongs to a group of medicines
called non-steroidal anti-inflammatory
drugs (NSAIDs), which are used to reduce
inflammation and pain in joints and muscles.
Naproxen GR tablets are used to treat:
•d
 iseases of joints such as rheumatoid
arthritis (including in children),
osteoarthritis and ankylosing
spondylitis. Naproxen GR tablets
cannot cure arthritis but are used to give
relief of some of the symptoms such as
inflammation, swelling, stiffness and joint
pain.
• attacks of gout
• muscle and bone disorders
• painful periods.

Continued top of next column

page 4

B
 efore you take Naproxen GR
tablets

Continued over page

page 1

Naproxen 250mg, 375mg & 500mg PIL - UK

colours/plates:
1. Black

item no: AAAG6625

dimensions: 296 x 210 Reel Fed

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

print proof no: 3

pharmacode:

origination date: 13.03.14

min pt size: 9

Pharmacode: 14336

originated by: S.Anson

JDE No.:

50778110

Date Sent:
04/03/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

approved for print/date

2.
3.
4.
5.
6.

revision date: 26.03.14

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

• have a blood clotting disorder
• a re a woman trying to become pregnant
or undergoing investigation of infertility.

Other warnings

•M
 edicines such as naproxen may be
associated with a small increased risk of
heart attack (myocardial infarction) or
stroke. Any risk is more likely with high
doses and prolonged treatment. Do not
exceed the recommended dose or duration
of treatment.
• 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.
• I f you are elderly or frail, you have
a higher risk of getting side effects,
especially of the stomach. If you experience
any unusual symptoms from the stomach
you must tell your doctor about it.
• Taking a painkiller for headaches too
often or for too long can make them worse.
•N
 aproxen GR tablets may hide the
symptoms of an infection.

Pregnancy and breast-feeding

Naproxen may make it more difficult to
become pregnant. You should inform
your doctor if you are planning to become
pregnant or if you have problems becoming
pregnant.
You should not take Naproxen GR in the
first 6 months of pregnancy and must not
take Naproxen GR in the last 3 months of
pregnancy or during labour.
If you are breast-feeding, you should not
take Naproxen GR tablets.

Please tell your doctor or pharmacist if you
are taking or have recently taken, any other
medicines, including medicines obtained
without a prescription. Especially:
•o
 ther NSAIDs such as aspirin or COX II
inhibitors
•m
 edicines which thin the blood or which
prevent blood clotting (e.g. heparin or
warfarin)
• c orticosteroids (e.g. prednisolone), if
needed the doctor will reduce the dose
of the steroid slowly and monitor for side
effects.
•d
 iuretics (‘water tablets’) such as
furosemide
•m
 edicines to treat high blood pressure (e.g.
captopril, ramipril or propranolol, losartan
or candesartan)
• ciclosporin or tacrolimus
•m
 ifepristone – do not take NSAIDs 8-12
days after mifepristone
• SSRI antidepressants
• zidovudine
• quinolones (e.g. ciprofloxacin)
• probenecid
• methotrexate

Naproxen GR Tablets
250,375 & 500mg x 56’s (UK)

If you take more Naproxen GR tablets
than you should
It is important not to take too many tablets.
Contact your doctor, pharmacist or nearest
hospital casualty department immediately
if you have taken more tablets than you
should.
Symptoms of an overdose are headache,
feeling or being sick, heartburn, diarrhoea,
disorientation, bleeding of the stomach or
intestines, unconsciousness, drowsiness,
dizziness, ringing or buzzing in the ears,
fainting, fits and excitation.

Sugar intolerance

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine, as it contains lactose.

Tests

If you need any blood or urine tests tell your
doctor you are taking Naproxen GR tablets.
The tablets may need to be stopped 48
hours before a test, as they may interfere
with the results.

Continued top of next column

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Elderly with kidney disease
Dosage may be reduced in the elderly.

Naproxen GR tablets may cause dizziness,
drowsiness or affect your vision. Make sure
you are not affected before you drive or
operate machinery.

3

Your doctor should prescribe as low a dose
as possible. This will reduce any side effects
you may experience.

Continued over page

The most commonly observed adverse
events are gastrointestinal in nature.
Feeling sick, being sick, diarrhoea, wind,
constipation and worsening of colitis
and Crohn’s disease have been reported
following administration.

Water retention (may cause swelling in the
limbs), high blood pressure and heart failure
have been reported in association with
NSAID therapy.

If you forget to take your tablets, take your
forgotten dose as soon as you remember,
unless it is nearly time for your next dose. Do
not take a double dose to make up for one
you have missed.

Always take Naproxen GR tablets exactly as
your doctor has told you. If you are not sure,
check with your doctor or pharmacist.

Dose

Tell your doctor if you notice any of
the following side effects

If you forget to take Naproxen GR
tablets

How to take Naproxen GR tablets

Swallow whole with or after food with
water, do not crush or break them.

•h
 ave indigestion, heartburn, pains in your
stomach or other abnormal stomach
symptoms, feeling or being sick (you
may have an ulcer or inflammation in the
stomach or gut)
•p
 ass blood in your faeces (stools/motions)
or black tarry looking stools (signs of
bleeding and perforation of the stomach
and intestines).
• v omit any blood or dark particles that look
like coffee grounds
•h
 ave an allergic reaction:
- s welling of the face, mouth, tongue,
airways or body
- s kin reactions including: hives (pale/red
raised skin with severe itching), blistered
skin, itchy skin rash, blood spots, bruising
or discolouring of the skin, raised purple
rashes, red skin patches, a severe rash with
reddening, peeling and swelling of the
skin that resembles burns, bumpy rashes,
blisters, dermatitis (skin shedding, itching,
swelling)
-d
 ifficulty breathing or wheezing, coughing
up blood.

Children over 5 years for juvenile
rheumatoid arthritis
10mg per kg of body weight a day, taken in
two doses at twelve hourly intervals.

Driving and using machines

Taking other medicines

Stop taking Naproxen tablets and
contact your doctor immediately if
you

Adults
•R
 heumatoid arthritis, osteoarthritis and
ankylosing spondylitis
500mg-1g a day in two doses at twelve
hourly intervals. If 1g a day is needed this
can be given as two 500mg doses or as a
single dose.
•A
 ttack of gout
Initially 750mg as a single dose then
250mg every 8 hours until the attack has
passed.
•M
 uscle and bone disorders and painful
periods
Initially 500mg as a single dose then
250mg every 6-8 hours as necessary. Up to
a maximum of 1250mg a day may be given
after the first day.

• bisphosphonates
• c olestyramine (take naproxen 1 hour
before or 4 to 6 hours after colestyramine
to avoid interference with absorption)
• lithium
• hydantoins (e.g. phenytoin)
• sulphonamides (e.g. sulfamethoxazole)
• s ulphonylureas (e.g. glibenclamide or
gliclazide)
• c ardiac glycosides (e.g. digoxin)

4

Common (affects 1 to 10 users in 100)
confusion, headache, ringing in the ears,
changes in vision (you should go for an
eye test if you notice changes in vision),
tiredness, drowsiness, dizziness, rashes.

Possible side effects

Like all medicines, Naproxen GR tablets can
cause side-effects, although not everybody
gets them. If any of the side effects get
worse, or if you notice any not listed in this
leaflet, please tell your doctor or pharmacist.

Uncommon (affects 1 to 10 users in 1,000)
depression, irregular heartbeat
(palpitations), abnormal dreams,
forgetfulness, difficulty concentrating,
sensitivity of the skin to light (may cause
blistering), difficulty sleeping.

Continued top of next column

Continued over page

page 2

page 3

Naproxen 250mg, 375mg & 500mg PIL - UK

colours/plates:
1. Black

item no: AAAG6625

dimensions: 296 x 210 Reel Fed

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

print proof no: 3

pharmacode:

origination date: 13.03.14

min pt size: 9

Pharmacode: 14336

originated by: S.Anson

JDE No.:

50778110

Date Sent:
04/03/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

approved for print/date

2.
3.
4.
5.
6.

revision date: 26.03.14

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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