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NAPROXEN TABLETS BP 250MG

Active substance(s): NAPROXEN / NAPROXEN / NAPROXEN

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Rare (may affect up to 1 in 1,000 people)
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).
Very rare (may affect 1 in 10,000 people)
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.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard

5

JDE No.:

6

Contents of the pack and other
information

What Naproxen tablets look like and
contents of the pack
Naproxen tablets are yellow, uncoated tablets.

What is in this leaflet:
1 What Naproxen tablets are and
what they are used for
2 What you need to know before
you take Naproxen tablets
3 How to take Naproxen tablets
4 Possible side effects
5 How to store Naproxen tablets
6 Content of the pack and other
information

Pack size is 28 or 56.

1

What Naproxen tablets contain

• T he active substance (the ingredient that
makes the medicine work) is naproxen. Each
tablet contains either 250mg or 500mg of the
active substance.
• T he other ingredients are lactose, magnesium
stearate, maize starch, polyvidone, E172, E463.

Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.

Actavis, Barnstaple, EX32 8NS, UK
BBBA0696

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

2

 hat you need to know before
W
you take Naproxen tablets
Do not take Naproxen tablets if you:

• a re in the last three months of pregnancy or
if you are breast-feeding
• a re allergic to naproxen or to any of the other
ingredients of this medicine (listed in section 6)
• a re allergic to aspirin or other non-steroidal
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
• h ave severe liver, kidney or heart failure.
If you are not sure about any of the above
conditions, please ask your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Naproxen tablets if you:
• u se other non-steroidal anti-inflammatory
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
• s moke
•d
 rink alcohol
• a re 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
• h ave a blood clotting disorder
• a re a women trying to become pregnant or
undergoing investigation of infertility.

 hat Naproxen tablets are and
W
what they are used for

Continued top of next column

page 4

Continued over page

page 1

Naproxen 250 and 500mg tablets, PIL, UK
approved for print/date

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

Date Sent:
24/04/17
Technologist: R.Wrey

•m
 uscle and bone disorders
•p
 ainful periods.

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

This leaflet was last revised in May 2017

50931831

Pharmacode: 4154

Read this leaflet carefully before you
start taking this medicine because it
contains important information for you.
•  K eep this leaflet. You may need to read
it again.
•  If you have any further questions, ask
your doctor or pharmacist.
•  T his 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.

How to store
Keep this medicine out of the sight and reach
of children.
Store below 25ºC in a dry place. Protect from
light.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Do not throw away 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.

50931831

Naproxen Tablets
all strengths x All sizes (UK)

Naproxen 250mg and 500mg tablets

By reporting side effects you can help provide
more information on the safety of this medicine.

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),
wind, constipation, water retention (may cause
swelling in the limbs), high blood pressure and
heart failure.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Package leaflet:
Information for the patient

Proof Round

03

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0696

Originator:
Origination Date:
Revision Date:
Revised By:

C.Grant
25/04/17
26/05/17
C.Grant

Dimensions:
296x210
Min Body Text Size: 9pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
N/A
Date received:

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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

Children

•q
 uinolones (e.g. ciprofloxacin)
• probenecid
• methotrexate
• bisphosphonates
• c olestyramine (take naproxen 1 hour before
or 4 to 6 hours after colestyramine to avoid
interference with absorption)
• lithium
• h ydantoins (e.g. phenytoin)
• s ulphonamides (e.g. sulphamethoxazole)
• s ulphonylureas (e.g. glibenclamide or
gliclazide)
• c ardiac glycosides (e.g. digoxin).

Other medicines and Naproxen tablets.

Tell your doctor or pharmacist if you are taking,
or have recently taken or might take any other
medicines, including medicines obtained
without a prescription. Especially:
• other NSAIDs such as aspirin or COX II
inhibitors
• medicines which thin the blood or which
prevent blood clotting (e.g. heparin or
warfarin)
• corticosteroids (e.g. prednisolone), if needed
the doctor will reduce the dose of the steroid
slowly and monitor for side effects
• diuretics (“water tablets”) (e.g. furosemide)
• medicines to treat high blood pressure (e.g.
captopril, ramipril or propranolol, losartan or
candesartan)
• ciclosporin or tacrolimus
• mifepristone – do not take NSAIDs 8-12 days
after mifepristone
• SSRI antidepressants
• zidovudine

Naproxen Tablets
all strengths x All sizes (UK)
JDE No.:

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

4

Stop taking Naproxen tablets and
contact your doctor immediately if you

• h ave indigestion, heartburn, pains in your
stomach or other abnormal stomach
symptoms, feeling or being sick, diarrhoea,
worsening of colitis and Crohn’s disease (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
• have 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.

•A
 ttack of gout
Initially 750mg as a single dose then 250mg
every 8 hours until the attack has passed.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you
may be pregnant, are planning to have a baby
or if you have problems becoming pregnant
ask your doctor or pharmacist for advice before
taking this medicine.

•M
 uscle, 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.

You should not take Naproxen in the first
6 months of pregnancy and must not take
Naproxen in the last 3 months of pregnancy or
during labour.

Elderly
Dosage may be reduced in the elderly.
Use in children and adolescents
Children over 5 years for juvenile
rheumatoid arthritis
10mg per kg of body weight a day, taken in two
doses at twelve hourly intervals.

Breast-feeding

If you are breast-feeding, you should not take
Naproxen tablets.

Fertility

If you take more Naproxen tablets than
you should

Naproxen may make it more difficult to become
pregnant.

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 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.

Driving and using machines

Naproxen may make you feel dizzy, drowsy or
tired and may cause blurred vision. Make sure
you are not affected before you drive or operate
machinery.

Naproxen tablets contain lactose

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.

Tell your doctor if you notice any of the
following side effects
Common (may affect up to 1 in 10 people)
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.
Uncommon (may affect up to 1 in 100 people)
depression, irregular heartbeat (palpitations),
abnormal dreams, forgetfulness, difficulty
concentrating, sensitivity of the skin to light
(may cause blistering), difficulty sleeping.

If you forget to take Naproxen tablets
If you forget to take your tablets, take your
forgotten dose as soon as you remember,

Continued over page

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

Adults
•R
 heumatoid arthritis, osteoarthritis and
ankylosing spondylitis
500mg-1g a day in two doses at twelve hour
intervals. If 1g is needed this can be given as
two 500mg doses or as a single dose.

You should refrain from alcohol consumption
while taking NSAIDs.

Continued top of next column

page 2

Continued over page

page 3

Naproxen 250 and 500mg tablets, PIL, UK
approved for print/date

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

Date Sent:
24/04/17
Technologist: R.Wrey

unless it is nearly time for your next dose. Do
not take a double dose to make up for one you
have missed.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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

Naproxen tablets should preferably be taken
with or after food.

50931831

Pharmacode: 4154

Swallow with or after food.

Naproxen tablets with food and alcohol

Continued top of next column

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

Pregnancy

Do not give this medicine to children under
5 years old.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

3

Proof Round

03

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0696

Originator:
Origination Date:
Revision Date:
Revised By:

C.Grant
25/04/17
26/05/17
C.Grant

Dimensions:
296x210
Min Body Text Size: 9pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
N/A
Date received:

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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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