Skip to Content

UK Edition. Click here for US version.

NAPROXEN TABLETS 250MG

Active substance(s): NAPROXEN

View full screen / Print PDF » Download PDF ⇩
Transcript
59.5 mm

59.5 mm

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 symptoms are the same
as yours.
• 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.
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 is a ‘Non Steroidal Anti Inflammatory Drug’ or NSAID.
Naproxen can lessen pain, swelling, redness and heat (inflammation)
and is used 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.
• 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 or (hypersensitive) to Naproxen sodium or any of the
other ingredients of Naproxen (see section 6).
• Have a history of allergy to NSAIDs (e.g. Aspirin, Diclofenac,
Ibuprofen), which includes attacks of asthma, swelling of the
nose and throat, skin rashes or a runny nose
• Have now or have ever had any problems with your stomach or
gut (intestine) like an ulcer or bleeding

• Have a history of gastrointestinal bleeding or perforation related to
the use of NSAIDs.
• Have severe problems with your kidneys, liver or heart.
• Are in the last three months of pregnancy (last trimester).
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
Check with your doctor before taking Naproxen tablets if you:
• Use other non-steroidal anti-inflammatory medicines
(NSAIDs) or any medication which may cause bleeding or ulcers
in the stomach
• Have a history of gastrointestinal disease e.g. ulcerative
colitis, Crohn’s disease
• Smoke
• Drink alcohol
• Are elderly
• Have or have had high blood pressure or any liver, kidney
or heart problems
• Have or have had bronchial asthma, other breathing
problems or nasal polyps
• Have systemic lupus erythematosus or other connective
tissue disorders
• Have a blood clotting disorder
• Are a women trying to become pregnant or undergoing
investigation of infertility.
Other warnings
• Medicines 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.
• If 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.
Other medicines and Naproxen
Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines. In particular, tell your
doctor or pharmacist if you are taking:
• Other pain killers like, aspirin, ibuprofen, diclofenac and paracetamol
• Medicines which thin the blood or which prevent blood clotting
(e.g. heparin or warfarin)
• A steroid (for swelling and inflammation) like, hydrocortisone,
prednisolone and dexamethasone, if needed the doctor will reduce
the dose of the steroid slowly and monitor for side effects.
• A diuretic (water tablet) (for high blood pressure) like, furosemide
• Medicines to treat high blood pressure (e.g. captopril, ramipril or
propranolol, losartan or candesartan)
• Ciclosporin or tacrolimus (for skin problems or after an organ
transplant)
• Mifepristone (used to end pregnancy or to bring on labour if the
baby has died) – do not take NSAIDs 8-12 days after mifepristone
• Zidovudine (used to treat AIDS and HIV infections)
• A ‘quinolone antibiotic’ (for infections) like, ciprofloxacin or
moxifloxacin
• Probenecid (for gout)
• Methotrexate (used to treat skin problems, arthritis or cancer)
• Bisphosphonates (used to treat bone diseases)
• Cholestyramine (used to treat high blood cholesterol levels)-take
1 hour before or 4 to 6 hours after cholestyramine to avoid
interference with absorption
• Certain medicines for mental health problems like, lithium or ‘SSRIs’
like fluoxetine or citalopram
• 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
• A ‘cardiac glycoside’ (for heart problems) like, digoxin
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.

430 mm

• 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.
• If you are breast-feeding, you should not take Naproxen tablets
Driving and using machines
Naproxen may make you feel 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.
Tests
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.
Naproxen Tablets contain Lactose and Sunset yellow (E110)
• If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
• Sunset yellow may cause allergic reactions.
140 mm

Naproxen 250mg and 500mg Tablets

3. How to take Naproxen
Always take this medicine exactly as your doctor has told you. If
you are not sure, check with your doctor or pharmacist.
Swallow the tablets whole with a drink of water, with or after food.
Dose
Your doctor should prescribe as low a dose as possible. This will
reduce any side effects you may experience.
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. Up to a maximum of 1250mg a
day may be given after the first day.
Arthritis and ankylosing spondylitis
• The usual dose is between 500 mg and 1000 mg.
• The dose can be taken all at once, or split into two doses and can
be taken twice a day.
Gout
• The usual starting dose is 750 mg, followed by a 250 mg tablet
every 8 hours until the attack has passed.

IXXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

59.5 mm

59.5 mm

• 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 (Stevens-Johnson
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
• 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, 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. By reporting side effects you can
help provide more information on the safety of this medicine.

• Store in a cool dry place. Protect from light. Do not store above
25 0 C.
• Do not use this medicine after the expiry date which is printed on
the pack. 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. Contents of the pack and other information
What Naproxen contains
• The active substance is naproxen. Each tablet contains either
250 mg (milligrams) or 500 mg of naproxen
• The other ingredients are sodium lauryl sulfate, lactose, maize
starch, crospovidone, magnesium stearate and the colours
quinoline yellow (E104) and sunset yellow (E110)
What Naproxen looks like and contents of the pack
Naproxen 250 mg tablets: Pale yellow, flat bevelled edge tablets
with N breakline 250 on one side and BL on the other.
Naproxen 500 mg tablets: Pale yellow, oblong tablets with N breakline
500 on one side and BL on the other.
Naproxen 250 mg tablets are supplied in containers of 28, 56, 250
tablets and blisters of 28, 56, 84 and 112 tablets.
Naproxen 500 mg tablets are supplied in containers of 28, 56, 100,
500 tablets and blisters of 28, 56, 84 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd. Unit 3, Canalside, Northbridge Road,
Berkhamsted, Herts, HP4 1EG, UK
Tel:
0044 (0)1442200922
Fax:
0044 (0)1442873717
e-mail:
info@bristol-labs.co.uk
Naproxen 250mg Tablets; PL 17907/0339
Naproxen 500mg Tablets; PL 17907/0340
This leaflet was last revised in May 2016.

5. How to store Naproxen
• Keep this medicine out of the sight and reach of children.

430 mm

V10 25-05-16 D0

140 mm

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everyone will get them.
Medicines such as Naproxen may be associated with a small
increased risk of heart attack (‘myocardial infarction’) or stroke.
Stop taking Naproxen tablets and contact your doctor
immediately if you
• Have 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)
• 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:
• Swelling of the face, mouth, tongue, airways or body
• Skin 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)

• Difficulty breathing or wheezing, coughing up blood.
Tell your doctor if you notice any of the following side effects
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.
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 sleeping
• Difficulty concentrating,
• Sensitivity of the skin to light (may cause blistering)
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 up to 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)

IXXXXX

The elderly 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 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 than you should
If you take more Naproxen than you should, talk to your doctor or go
to the hospital straight away. Take the original pack with you.
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.
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.

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