Skip to Content

UK Edition. Click here for US version.

NAPROXEN TABLETS BP 500MG

Active substance(s): NAPROXEN

View full screen / Print PDF » Download PDF ⇩
Transcript
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
or pharmacist. 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
By reporting side effects you can help provide
more information on the safety of this medicine.
5

Package leaflet:
Information for the patient

Naproxen 250mg and 500mg tablets

How to store

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.

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.
6

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.

Contents of the pack and other
information
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.
What Naproxen tablets look like and
contents of the pack
Naproxen tablets are yellow, uncoated tablets.
Pack size is 28 or 56.

This leaflet was last revised in August 2016

Actavis, Barnstaple, EX32 8NS, UK
AAAJ1831

50905959

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.

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
1

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

•m
 uscle and bone disorders
•p
 ainful periods

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
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

Continued top of next column

Continued over page

page 4

page 1

Naproxen 250mg and 500mg tablets PIL UK

approved for print/date

item no: AAAJ1831

dimensions: 296 x 210 reel fed

print proof no: 04

pharmacode:

origination date: 22-07-2016

min pt size: 9pt body text / 7pt small text

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: MH
revision date: 28-07-2016

Technical Approval

revised by: MH

date sent: N/A

supplier: Actavis UK

technically app. date: N/A

Non Printing Colours
1. Profile
2.
3.

* Please note that only Actavis Global Artwork Studios are 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.

•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).

Naproxen tablets with food and alcohol
Naproxen tablets should preferably be taken
with or after food.

You should refrain from alcohol consumption
while taking NSAIDs.

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.

Pregnancy

Children

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

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
Continued top of next column

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.

Breast-feeding

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

Fertility

Naproxen may make it more difficult to become
pregnant.

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.
Continued over page

3

How to take Naproxen tablets

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.

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Swallow with or after food.

4

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

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.

Stop taking Naproxen tablets and
contact your doctor immediately if you

• 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)
• pass blood in your faeces (stools/motions) or
black tarry looking stools (signs of bleeding and
perforation of the stomach and intestines).
• vomit 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.
•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.
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.

If you take more Naproxen tablets than
you should

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

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.

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 top of next column

Continued over page

page 2

page 3

Naproxen 250mg and 500mg tablets PIL UK

approved for print/date

item no: AAAJ1831

dimensions: 296 x 210 reel fed

print proof no: 04

pharmacode:

origination date: 22-07-2016

min pt size: 9pt body text / 7pt small text

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: MH
revision date: 28-07-2016

Technical Approval

revised by: MH

date sent: N/A

supplier: Actavis UK

technically app. date: N/A

Non Printing Colours
1. Profile
2.
3.

* Please note that only Actavis Global Artwork Studios are 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 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.

Hide