Skip to Content

NAPROXEN 250 MG TABLETS

Active substance(s): NAPROXEN

View full screen / Print PDF » Download PDF ⇩
Transcript
Naproxen 250 mg tablets
Naproxen 500 mg tablets
Naproxen
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 Naproxen is and what it is used for
2. What you need to know before you take
Naproxen
3. How to take Naproxen
4. Possible side effects
5. How to store Naproxen
6. Contents of the pack and other information.
1. What Naproxen is and what it is used for
Naproxen tablets contain a medicine called
naproxen. This is a ‘Non Steroidal Anti
Inflammatory Drug’ or NSAID.
Naproxen 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.
2. What you need to know before you take
Naproxen
Do not take Naproxen if:
You are allergic to Naproxen, naproxen
sodium or any of the other ingredients of this
medicine (listed in section 6). Aspirin, other
NSAIDs or any other pain relief medicines
(such as ibuprofen or diclofenac).
• 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.
• Severe hepatic failure
• Severe kidney problems
• Insufficient strength of the heart to pump
blood (severe heart failure)
• You are in the last three months of
pregnancy.
Do not take Naproxen if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking Naproxen.
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.
Talk to your doctor or pharmacist before taking
Naproxen if any of the following apply to you:
• If you are an older person
• Problems with your kidney or liver
• Problems with the way your blood clots
• Colitis or Crohn’s disease (conditions
causing inflammation of the bowel, bowel
pain, diarrhoea, vomiting and weight loss)
• Asthma or allergies (like hayfever) or you
have had swelling of the face, lips, eyes or
tongue in the past
• Lumps in your nose (polyps) or you sneeze
a lot or have a runny, blocked, or itchy nose
(rhinitis)
In patients with a reduced functioning of the
heart the use of this medicine can cause fluid
accumulation (swollen ankles, swollen fingers,
mild peripheral oedema).
It is better not to use this medicine when you
have chicken pox (varicella).
Long-term use of any pain medication against
headache, may worsen the headache. If you
believe this is the case with you, please contact
your doctor for advice.
Children
Naproxen is not recommended for use in
children below 5 years of age.
Other medicines and Naproxen
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, ticlopidine 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.

Black

• 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 Naproxen.
Pregnancy, breast-feeding and fertility
The use of this medicine is not recommended
during pregnancy. Do not take this medicine in
the last 3 months of pregnancy.
Naproxen is excreted in the breast milk.
Therefore it should not be used during the
period of breast-feeding.
Naproxen may make it more difficult to get
pregnant. You should inform your doctor if you
are planning to become pregnant or if you have
problems becoming pregnant.
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.
Driving and using machines
Naproxen can cause drowsiness and dizziness
as side effect. If you affected in this way, do not
drive or operate machinery.
Naproxen tablets contains lactose
monohydrate. If you have been told by your
doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
3. How to take Naproxen
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Medicines such as Naproxen 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.
The recommended dose is:
Adults
Muscle, joint or tendon problems and period
pain
• The recommended starting dose is
500 mg, followed by a 250 mg tablet every
6 to 8 hours as needed.
Arthritis and ankylosing spondylitis
• The recommended 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.
Gout
Initial dose of 750 mg, then 8 hours later
500 mg, after this 250 mg every 8 hours until
the attack has passed
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 (above 25kg weight),
rheumatoid arthritis
The recommended dose is 10 mg/kg body
weight each day.
The dose is split into two and given 12 hours
apart.
Method of administration:
For oral use. Swallow the tablets whole with a
glass of water, with or after food. The tablet can
be divided into equal doses
You should make sure that you have enough to
drink (stay well hydrated) when you are taking
Naproxen. This is particularly important for
people who have problems with their kidneys.
While you are taking Naproxen 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.
If you take more Naproxen than you should
If you have taken too much, talk to a doctor
or go to a hospital straight away. Take the
medicine pack with you.
If you forget to take Naproxen
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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine also can cause
side effects, although not everyone gets them.
Important side effects to look out for:
Stop taking Naproxen 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:
Uncommon (may affect up to 1 in 100 people)
• 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.

P15XXXXX

Package leaflet: Information for the user

Rare (may affect up to 1 in 1,000 people)
• 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.
Not known: frequency cannot be estimated from
the available data
• Worsening of ulcerative colitis or Crohn’s
disease, seen as pain, diarrhoea, vomiting
and weight loss.
Allergic reactions, signs include:
Rare (may affect up to 1 in 1,000 people)
• Difficulty breathing, tightness in your
chest.
Not known: frequency cannot be estimated from
the available data
• Sudden swelling of your throat, face,
hands or feet.
• Skin rashes, blisters or itching.
Liver problems, signs include:
Rare (may affect up to 1 in 1,000 people)
• 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.
Severe skin rashes, signs include:
Rare (may affect up to 1 in 1,000 people)
• 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.
Heart attack, signs include:
Rare (may affect up to 1 in 1,000 people)
• Chest pain which may spread to your neck
and shoulders and down your left arm.
Stroke, signs include:
Rare (may affect up to 1 in 1,000 people)
• 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.
Meningitis, signs include:
Rare (may affect up to 1 in 1,000 people)
• 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’).
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Prolonged bleeding time
• Headache, dizziness, drowsiness during
the day, light-headedness.
• Ringing in the ear
• Heartburn, constipation, abdominal pain,
nausea
• Fluid accumulation (oedema)
• Shortness of breath
Uncommon: (may affect up to 1 in 100
people)
• Blurred vision
• A feeling of dizziness or “spinning”
• Hearing disorders
• Palpitations
• Vomiting
• Inflammation of the mucous membrane of
mouth,
• Digestive disorder
• Thirst
• Acid indigestion,
• Diarrhoea
• Bruising
• Purpura
• Perspiration

P15XXXXX

Rare: (may affect up to 1 in 1,000 people)
• Blood problems, like anaemia or changes to
the numbers of white blood cells
• Severe hypersensitivity to certain
substances (anaphylactic reaction)
• Loss of appetite
• Insomnia
• Mood changes
• Having difficulty sleeping or changes in your
patterns of dreaming
• Reduced ability to concentrate
• Difficulty with your memory
• Mild depression
• Infectious disease characterized by
inflammation of the cerebral membrane
and/or the spinal cord membrane (aseptic
meningitis)
• Repeated attacks of transient itching and
fluid accumulation (oedema) of the skin
and/or mucous membranes (angioneurotic
oedema)
• Seizures/epileptic fits (convulsions)
• Eye abnormalities
• Elevated blood pressure and insufficient
pumping strength of the heart (heart failure)
• Blood count abnormalities, inflammation of a
blood vessel (vasculitis)
• Fluid accumulation in the lungs
• Dyspnea attacks due to cramping of the
muscles and swelling of the mucous
membrane of the respiratory tract frequently
involving coughing and phlegm (asthma)
• Pneumonia
• Oesophagitis
• Haematemesis
• Pancreatitis
• Dry mouth
• Throat irritation
• Increased liver enzyme values
• Reduced liver function
• Hair loss
• Skin being more sensitive to the sun
• Severe skin or mucosal reactions with
peeling or blistering (e.g. StevensJohnson’s syndrome) erythema multiforme,
exacerbation of skin diseases (e.g. lichen
planus, erythema nodosum)
• Muscle weakness
• Reduced renal function,
• Increased urination (pollakisuria)
• Blood in your water (urine)
• Increased serum creatinine
• Increased potassium level in blood tests

• Fatigue,
• Reduction of the body temperature
• Fever
Not known: frequency cannot be estimated
from the available data
• Allergic reactions
• gastritis
• Obstruction
• Muscle pain
• Systemic lupus erythematosus’ (SLE). Signs
include fever, rash, problems with your
kidneys and joint pain.
• Problems for women in getting pregnant
• Generally feeling unwell
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 national
reporting system listed in Yellow Card Scheme,
Website: 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 Naproxen
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label, carton and bottle
after “EXP”. The expiry date refers to the last
day of that month.
This medicinal product does not require any
special storage conditions.
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. Contents of the pack and other
information.
What Naproxen tablets contains
- The active ingredient of this product is
naproxen.
Each tablet contains 250 mg naproxen.
Each tablet contains 500 mg naproxen.
- The other ingredients in this product are:
lactose monohydrate, maize starch, sodium
starch glycolate , povidone (E1201), yellow
iron oxide (E172), magnesium stearate
(E470b).
What Naproxen looks like and contents of
the pack
Tablet
Naproxen 250mg Tablets:
Yellow coloured, mottled, biconvex, beveled
edged, round shape, uncoated tablets
debossed with ‘T’ & ‘18’ on either side of
breakline on one side and other side plain.
The tablet can be divided into two equal doses.
Naproxen 500mg Tablets:
Yellow coloured, mottled, biconvex, capsule
shape, uncoated tablets debossed with ‘T’ &
‘20’ on either side of breakline on one side and
other side plain.
The tablet can be divided into two equal doses.
Naproxen tablets are available in clear PVC/
PE/ PVdC - aluminium foil blister packs and
white opaque HDPE-container closed with white
opaque polypropylene stock ribbed closure with
wad having induction sealing liner.
Package sizes:
Blister packs: 7, 10, 12, 15, 16, 20, 24, 25, 28,
30, 40, 50, 56, 60, 90, 98, 100, 250 and 500
tablets.
HDPE packs:
Naproxen 250 mg tablets: 30, 100, 250 and
1000 tablets
Naproxen 500 mg tablets: 30, 100 and 500
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 04/2016.

*Pharma code position may change as per supplier’s machine
requirement

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