NAPROXEN EC 500MG TABLETS

Active substance: NAPROXEN

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Naproxen EC
250 mg and 500 mg Tablets
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.

What is in this leaflet
1. What Naproxen EC is and what it is used for
2. What you need to know before you take Naproxen EC
3. How to take Naproxen EC
4. Possible side effects
5. How to store Naproxen EC
6. Contents of the pack and other information

1. WHAT NAPROXEN EC IS AND WHAT IT IS USED FOR
Naproxen EC tablets contain the active substance naproxen, which
belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). These medicines help to relieve
pain and joint inflammation.
Naproxen EC can be used to treat rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis (causing pain and stiffness in the back), back
pain, neck pain, and swollen or painful tendons. It is also used to
treat sprained or strained muscles or painful menstrual periods.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN EC
Do not take Naproxen EC if you:
• have or ever had a stomach ulcer, or bleeding of the stomach or
intestine.
• have previously experienced bleeding or perforation in your
stomach while taking NSAIDs.
• are allergic to Naproxen, Naproxen sodium formulations or any of
the other ingredients of this medicine (listed in section 6).
• have had wheeziness (asthma), hay fever, itchiness or skin rash
(urticaria) after taking aspirin or other NSAIDs (non-steroidal
anti-inflammatory drugs).
• suffer from severe kidney, liver or heart failure.
• are in last three months of pregnancy.
Warnings and precautions

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Talk to your doctor or pharmacist before taking Naproxen EC if you
• suffer from stomach problems. It is known that bleeding in the
stomach or gut can occur in patients taking Naproxen EC. If you
find you have black, tarry stools while taking these tablets, you
must stop taking them and tell your doctor at once.
• have asthma, hay fever or allergies as these tablets can cause
breathing difficulties (bronchospasm).
• have ever suffered any allergic reactions after taking aspirin or
other NSAIDs or if you have a history of swelling of the tongue or
larynx (angioedema), asthma, inflammation of the nose (rhinitis),
or nasal polyps (Lumps in nose).
• are having liver or adrenal function tests as taking these tablets
can change the results. suffer from any blood clotting disorders
or are taking anti-coagulant therapy (blood thinning medicines)
e.g. heparin or warfarin, as naproxen decreases the ability of your
blood to clot and will increase the length of time you bleed if you
get a cut.
• have heart problems. Occasionally patients have reported swollen
feet or hands while taking these tablets and this is more likely in
patients who have heart problems.
• have problems with the blood vessels (arteries) anywhere in your
body.
• have kidney problems. Your doctor may wish to check your
kidney function before and during treatment and/or use a lower
dose than normal.
• have liver problems, including alcohol-related disease or other
forms of cirrhosis of the liver, as you should then take the least
number of tablets needed.
• are elderly and/or feeling weak (perhaps because of an illness).
These patients are more susceptible to side effects of NSAIDs
especially bleeding and perforation in the stomach or gut. Long
term use of Naproxen in these patients is not recommended.
• are a women trying to become pregnant or undergoing
investigation of infertility.
• have an autoimmune condition, such as ‘systemic lupus
erythematosus’ (SLE, causes joint pain, skin rashes and fever)
and ulcerative colitis or Crohn’s disease (conditions causing
inflammation of the bowel, bowel pain, diarrhoea, vomiting and
weight loss).
While taking this medicine if you develop visual disturbances, talk to
your doctor and go for ophthalmological examination.

Please note:
Medicines such as Naproxen EC 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 a high blood
pressure, diabetes or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or pharmacist.
Children and adolescents
Naproxen EC is not recommended for use in children under 16 years
of age.
Other medicines and Naproxen EC
Tell your doctor or pharmacist if are taking, have recently taken or
might take any other medicines.
This is important because Naproxen EC could alter how other
medicines work.
• a hydantoin (for epilepsy), like phenytoin
• anti-coagulants(medicine to stop your blood clotting) like
warfarin, heparin
• sulphonylurea (for diabetes) like glimepiride or glipizide
• sulphonamide medicines, like hydrochlorothiazide,
acetazolamide, indapamide and including sulphonamide
antibiotics (for infections)
• a ‘quinolone antibiotic’ (for infections), like ciprofloxacin or
moxifloxacin.
• cardiac glycosides (for heart problems) such as digoxin
• certain medicines for mental health problems like lithium or
‘SSRIs’ like fluoxetine or citalopram
• antihypertensive drugs (medicines used to treat high blood
pressure) like propranolol and other beta-blockers, ACE inhibitors
e.g. cilazapril, diuretic (water tablet) like furosemide
• probenecid (medicine used to treat gout)
• methotrexate (used to treat skin problems, arthritis or cancer)
• steroid (for swelling and inflammation), like hydrocortisone,
prednisolone and dexamethasone other NSAIDs such as aspirin
(medicines used as a pain killers)
• ciclosporin or tacrolimus (for skin problems or after an organ
transplant).
• mifepristone (a drug usually prescribed through hospitals)
• zidovudine (used to treat AIDS and HIV infections).
Pregnancy, breast-feeding and fertility
Do not take Naproxen if you are in the last three months of
pregnancy, as it can harm your baby. Talk to your doctor before
taking Naproxen if you are up to six months pregnant, think you are
pregnant, plan to get pregnant or are breast-feeding. Your doctor
will then discuss this with you and decide whether you should take
this medicine. Naproxen may make it more difficult to become
pregnant. You should tell your doctor if you are planning to become
pregnant or if you have problems becoming pregnant.
If you are breast feeding you should not take these tablets.
Ask your doctor or pharmacist for advice before taking any
medicines.
Driving and using machines
You should not drive or operate machinery if you are affected by
drowsiness, dizziness, tiredness, abnormal vision, difficulty in
sleeping or depression when taking Naproxen.

3. HOW TO TAKE NAPROXEN EC
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
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.
The number of tablets you should take depends on the type of pain
you have.
Read the following section carefully. It tells you how the tablets are
usually taken. Do not take more than you are told to, as this
increases the chances of side-effects (especially in the elderly).
For rheumatoid arthritis, osteoarthritis or ankylosing spondylitis
Take between 500mg and 1g each day in two separate doses, 12
hours apart. Where 1g per day is needed, you can take 500mg twice
each day, or 1g in one single dose (morning or evening).
In some people, a larger dose of between 750mg and 1g per day
may be taken to start with to control the pain. This is in patients with:
• severe night-time pain and/or morning stiffness.
• if your tablets have recently been changed from a high dose of
another treatment for pain.
• osteoarthritis where pain is your main problem.
For strained or sprained muscles or painful periods
Take 500mg to start with, then 250mg every 6 to 8 hours as needed.
Do not take more than 1250mg a day after the first day.

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

If you take more Naproxen than you should
If you take too many tablets, you may develop headache,
drowsiness, heartburn, abdominal pain, bleeding from the stomach
wall, and rarely loose motions, disorientation, excitation, dizziness,
ringing or other persistent noise in the ears, fainting, indigestion,
feeling or being sick. Contact your doctor, pharmacist or nearest
hospital straight away.
If you forget to take Naproxen EC
If you should forget to take your tablets, take the normal dosage as
soon as you remember and then wait for the normal interval before
taking the next dose. Do not take a double dose to make up for a
forgotten one.
If you stop taking Naproxen EC
Your doctor will advise you when to stop taking the medicine.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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Like all medicines, this medicine can cause side effects, although
not everybody gets them.
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:
• 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.
• 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.
• Worsening of ulcerative colitis or Crohn’s disease, seen as pain,
diarrhoea, vomiting and weight loss.
Allergic reactions, signs include:
• Sudden swelling of your throat, face, hands or feet.
• Difficulty breathing, tightness in your chest.
• Skin rashes, blisters or itching.
Severe skin rashes, signs include:
• 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.
• Skin blistering when exposed to sunlight (porphyria cutanea
tarda) seen most on arms face and hands.
Liver problems, signs include:
• 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.
Heart attack, signs include:
• Chest pain which may spread to your neck and shoulders and
down your left arm.
Medicines such as Naproxen may be associated (linked) with a small
increased risk of heart attack (‘myocardial infarction’) or stroke.
Stroke, signs include:
• 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:
• 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’).
If you notice any of the serious side effects mentioned above, stop
taking this medicine and tell your doctor straight away.

Nervous system
• Headache.
• Fits or seizures, feeling dizzy or light-headed or sleepy.
• Pins and needles or numbness of your hands and feet.
• Difficulty with your memory or concentration.
Eyes and ears
• Changes to your eyesight, eye pain.
• Changes to your hearing, including ringing in the ears (tinnitus)
and hearing loss.
• Dizziness that causes problems with your balance.
Heart and circulation
• Swelling of your hands, feet or legs (oedema). This may be with
chest pains, tiredness, shortness of breath (cardiac failure).
• A fluttering feeling in your heart (palpitations), slow heart beat or
high blood pressure.
• Problems with the way your heart pumps blood around the body
or damage to your blood vessels. Signs may include tiredness,
shortness of breath, feeling faint, general pain.
Chest
• Difficulty breathing, including shortness of breath, wheezing or
coughing.
• Pneumonia or swelling of your lungs.
Skin and hair
• Skin rashes including redness, hives, pimples and blisters on
your body and face.
• Bruising, itching, sweating, skin being more sensitive to the sun
or hair loss.
Urinary
• Blood in your water (urine) or kidney problems.
Other
• Thirst, fever, feeling tired or generally unwell.
• A sore mouth or mouth ulcers.
• Muscle pain or weakness.
• Problems for women in getting pregnant.
• ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash,
problems with your kidneys and joint pain.
Electrolyte imbalance
• Abnormal level of potassium in blood (this can be identified by
blood test).
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
5. HOW TO STORE NAPROXEN EC
• Store below 25ºC
• Keep blister in the outer carton in order to protect from light
• Keep pack in a dry place
• Keep this medicine out of the reach and sight of children.
• This medicine must not be used after the date (EXP) printed on
the pack. The expiry date refers to the last day of the month.
Consult your pharmacist if you have any doubts about the shelf life.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measure will help to protect the environment.
6. WHAT NAPROXEN EC CONTAINS
What Naproxen EC contains
- The active substance is naproxen
Naproxen EC 250 mg tablets contain 250 mg naproxen
Naproxen EC 500 mg tablets contain 500 mg naproxen
- The other ingredients are povidone, colloidal silicon dioxide,
microcrystalline cellulose, crosscarmellose sodium, magnesium
stearate, triethyl citrate, glycerol monostearate, methacrylic acid
copolymer (type C), talc, titanium dioxide (E171), as inactive
ingredients.
What Naproxen EC looks like and contents of pack
Naproxen EC 250 mg tablets:
round, biconvex, white or almost white, film-coated, smooth surface
Naproxen EC 500 mg tablets:
oblong, biconvex, white or almost white, film-coated, smooth
surface

Stomach and gut
• Heartburn, indigestion, stomach ache, feeling sick or being sick,
constipation, diarrhoea, wind.
• inflammation of the food pipe and stomach.

Both strengths of Naproxen EC are supplied in blister packs of 56
tablets.

Blood
• Blood problems, like anaemia or changes to the numbers of white
blood cells.

Marketing Authorisation Holder and Manufacturer
Ranbaxy (UK) Limited
Building 4, Chiswick Park
566 Chiswick High Road
London W4 5YE

Mental illness
• Having difficulty sleeping or changes in your patterns of
dreaming.
• Depression.
• Confusion or seeing and possibly hearing things that are not there
(hallucinations).

This leaflet was last revised in November 2011

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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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