NAPROXEN 250MG TABLETS

Active substance: NAPROXEN

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Module 1 Administrative
1.3.1 Labeling

Athlone Pharmaceuticals Limited

Naproxen 250mg & 500mg Tablets

1.3.1

PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET
Naproxen 250mg Tablets
Naproxen 500mg Tablets

Read all of this leaflet carefully before you start taking this medicine.
o Keep this leaflet. You may need to read it again.
o If you have any further questions, ask your doctor or pharmacist.
o 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.
o 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.
In this leaflet
1. What Naproxen Tablets are and what they are used for
2. Before you take Naproxen Tablets
3. How to take Naproxen Tablets
4. Possible side effects
5. How to store Naproxen Tablets
6. Further information
1. WHAT NAPROXEN TABLETS ARE AND WHAT THEY ARE USED FOR
Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines help relieve pain and joint inflammation.
Naproxen Tablets can be used to treat:
o arthritis
o gout
o ankylosing spondylitis (causing pain and stiffness in the back)
o muscle, joint and tendon pain caused by injury (e.g. strains and sprains)
o period pain
o juvenile rheumatoid arthritis in children over 5 years of age
2. BEFORE YOU TAKE NAPROXEN TABLETS
DO NOT take Naproxen Tablets if you:
o are allergic to naproxen or any other ingredients contained in these tablets (see section 6, Further
information)
o have suffered any allergic reactions or if you have had wheezing (asthma), hay fever, itchiness or
skin rash (urticaria) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs),
such as aspirin or ibuprofen
o have now or have ever had a stomach ulcer, or bleeding of the stomach or intestine
o have had bleeding or perforation in your stomach while taking other NSAIDs
o have severe problems with your kidneys, liver or heart
o are in the last three months of pregnancy

Athlone Pharmaceuticals Limited

Naproxen 250mg & 500mg Tablets

Module 1 Administrative
1.3.1 Labeling

Take special care with Naproxen Tablets if you:
o are already taking another non-steroidal anti-inflammatory drug (NSAID), such as aspirin or
ibuprofen
o suffer bleeding in the stomach or gut while taking naproxen. If you have black, tarry stools or
notice specks like coffee grounds when you vomit while taking this medicine, you must stop
taking it and tell your doctor at once.
o have other stomach or bowel problems such as colitis or Crohn‟s disease (conditions causing
inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss)
o are elderly – you may be more likely to suffer side effects and your doctor may prescribe a lower
dose along with a protective agent (e.g. a proton pump inhibitor)
o suffer from asthma, hay fever or allergies (swelling of face, lips, eyes or tongue) as these tablets
can cause breathing difficulties
o suffer from nasal polyps (growths inside the nose)
o suffer from any blood clotting disorders or are taking medicines which may increase the risk of
bleeding (for example, warfarin, aspirin, serotonin reuptake inhibitors)
o take steroid medication and it is reduced/stopped during naproxen treatment – you should be
observed for signs of side effects or worsening of your condition
o have heart problems or high blood pressure – you may be at greater risk of developing swelling in
feet or hands
o have kidney problems or are taking diuretics. Your doctor may wish to check your kidney
function before and during treatment and/or use a lower dose than normal
o have liver problems, including alcohol-related disease
o have lupus (an autoimmune condition that causes joint pain, skin rashes and fever)
o are attempting to become pregnant
o have an intolerance to some sugars as this medicine contains lactose
Tell your doctor if any of the above applies to you.
SPECIAL WARNING:
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, high cholesterol or are a smoker) you should discuss
your treatment with your doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines
including medicines obtained without a prescription, or herbal remedies or any of the following:
o hydantoins such as phenytoin (to treat epilepsy)
o anticoagulants such as warfarin and heparin and antiplatelet agents such as clopidogrel (to thin
your blood)
o sulphonamide and quinolone antibiotics, e.g. ciprofloxacin
o sulphonylureas such as gliclazide (anti-diabetic drugs)
o medicines used for heart problems: diuretics (water tablets), e.g. furosemide and drospirenone;
cardiac glycosides, e.g. digoxin; ACE inhibitors, e.g. ramipril
o probenecid (for gout)
o lithium and serotonin reuptake inhibitors (SSRIs), such as fluoxetine (to treat depression)
o other NSAIDs or pain killers such as aspirin, ibuprofen, diclofenac or paracetamol
o mifepristone (used to end pregnancy)
o erlotinib (used to treat certain types of cancer)

Athlone Pharmaceuticals Limited

Naproxen 250mg & 500mg Tablets
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1.3.1 Labeling

ciclosporin or tacrolimus (for preventing organ transplant rejection)
methotrexate (used to treat psoriasis, arthritis and some cancers)
corticosteroids (for swelling or inflammation), e.g. hydrocortisone
penicillamine (for arthritis)
baclofen (used to treat muscle tightness)
pentoxyifylline (used to treat poor blood circulation)
zidovudine (for the treatment of AIDs)

Effects on laboratory tests
You should tell your doctor if you are having certain hormone tests or certain cancer diagnostic tests as
these tablets can interfere with the results.
Pregnancy and breast-feeding
Do not take Naproxen Tablets if you are in the last three months of pregnancy, as it can harm your baby.
You must tell your doctor if you are pregnant, or if you think you may be pregnant. Your doctor will
decide whether you should take this medicine. If you are breast-feeding you should not take this
medicine. As with other NSAIDs, naproxen may make it more difficult to become pregnant as it may
reduce fertility. You should inform your doctor if you are attempting to become pregnant or if you have
problems becoming pregnant
Driving and using machines
If you are affected by dizziness, tiredness, abnormal vision or depression when taking Naproxen Tablets
you should not drive or operate machinery.
Important information about some of the ingredients of Naproxen Tablets
Naproxen Tablets contain lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE NAPROXEN TABLETS
These tablets should be taken with a glass of water, with or after food.
Always take Naproxen Tablets exactly as your doctor has told you to. The number of tablets you should
take will depend on the type of pain you have.
Read the following section carefully. If you are not sure ask your doctor or pharmacist.
While you are taking this medicine 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.
Dosage
Adults:
The usual dose is prescribed below:
 For arthritis and ankylosing spondylitis:
Take between 500mg to 1000mg. The dose can be taken all at once or split into two separate doses
given 12 hours apart.
 For muscle, joint or tendon pain and for period pain:
Take 500mg at the start and then take 250mg every 6 to 8 hours as needed. Do not take more than
1250mg a day after the first day.
 For gout:
Take 750mg and then 250mg every eight hours.

Athlone Pharmaceuticals Limited

Naproxen 250mg & 500mg Tablets

Module 1 Administrative
1.3.1 Labeling

Children over 5 years with rheumatoid arthritis:
 The usual dose is 10mg/kg of body weight per day, split into 2 doses and given 12 hours apart.
Elderly people and people with liver or kidney problems:
Your doctor will usually prescribe a lower dose than for other adults.
If you take more of your medicine than you should
If you take too many tablets, or someone accidentally takes your medicine, contact your doctor or
pharmacist or nearest hospital straight away.
If you forget to take your medicine:
If you forget to take your medicine, take it as soon as you remember unless it is almost time for your next
dose. Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like most other medicines, Naproxen Tablets may cause side effects in some people.
Medicines such as naproxen may be associated with a small increased risk of heart attack (“myocardial
infarction”) or stroke.
STOP taking Naproxen Tablets and tell your doctor immediately if you experience any of the
following side effects:
o Bleeding from the stomach – seen as vomit which has blood in it or bits that look like coffee
grounds or black, tarry stools
o Inflammation, ulcers or holes forming in your stomach or gut. Signs include upset stomach,
stomach pain, fever, feeling or being sick.
o Problems with your pancreas. Signs include severe stomach pain which spreads to your back.
o Worsening of ulcerative colitis or Crohn‟s disease, seen as pain, diarrhoea, vomiting and weight
loss.
o Allergic reactions – signs may include sudden swelling of your throat, face, hands or feet
o Difficulty breathing, tightness in your chest, skin rashes, itching, damage to blood vessels causing
reddening of skin
o Severe blistering or peeling of the skin
o Jaundice (yellowing of the skin and whites of the eyes), hepatitis (life-threatening)
o Kidney problems – signs may include painful urination or blood in the urine
If you notice any of the following side effects, tell your doctor as soon as possible:
Indigestion, feeling or being sick, constipation, diarrhoea, stomach upset
 Headache, drowsiness, dizziness, convulsions
 Pins and needles
 Unusual bruising or bleeding, anaemia (may make you look pale and feel tired), lowered
immunity resulting in sore throats or mouth ulcers (due to changes in numbers of blood cells)
 Eyesight problems or eye pain – if you notice this you may need to have an eye examination
 Ringing in your ears, vertigo
Hyperkalaemia (high blood potassium)
Heart problems – may result in breathlessness, trouble breathing, tiredness, swelling of the feet
and hands, high blood pressure, palpitations
Asthma, coughing
Sleeping difficulties, depression, hallucinations
Confusion, difficulty concentrating, forgetfulness

Athlone Pharmaceuticals Limited

Naproxen 250mg & 500mg Tablets

Module 1 Administrative
1.3.1 Labeling

Meningitis (symptoms may include stiff neck, vomiting and fever) – especially in patients
suffering from lupus, an auto-immune disease
Hair loss
Sweating
Feeling thirsty
Increased skin sensitivity to the sun
Muscle weakness
Female infertility
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.
5. HOW TO STORE NAPROXEN TABLETS
Do not use the tablets after the expiry date shown on the label or carton.
KEEP ALL MEDICINES OUT THE OF REACH AND SIGHT OF CHILDREN.
Store this medicine below 25oC in a dry place and protect from light.
Keep the tablets in the original container. 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. FURTHER INFORMATION
What your medicine contains
Each tablet contains the active ingredient naproxen. The tablets also contain the inactive ingredients
lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate and quinoline yellow
(E104).
What your medicine looks like and contents of the pack
Naproxen 250mg Tablets are yellow, flat, circular bevel-edged uncoated tablets marked with „SP/N250‟
on one side and are available in packs of 60, 100 and 250 tablets.
Naproxen 500mg Tablets are yellow, capsule-shaped uncoated tablets marked with „SP/N500‟ on one side
and are available in packs of 60, 100 and 250 tablets.
Marketing Authorisation Holder and Manufacturer:
The marketing authorisation holder is:
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This product is manufactured by:
Sussex Pharmaceuticals Limited, Charlwoods Road, East Grinsted, West Sussex, RH19 2HL, U.K.
Naproxen 250mg Tablets: PL 30464/0003
Naproxen 500mg Tablets: PL 30464/0004
This leaflet was last revised in January 2013.

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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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