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NAPROXEN EC 250MG TABLETS

Active substance(s): NAPROXEN / NAPROXEN / NAPROXEN

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Package leaflet: Information for the patient
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. See section 4.

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 in adults for the treatment of 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:
 are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
 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.
 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), wheeziness (asthma) inflammation of
the nose (rhinitis) or nasal polyps (Lumps lumps in nose), hay fever, itchiness or skin rash
(urticaria) after taking aspirin or other NSAIDs
 have severe problems with your kidneys, liver or heart.
 are in the last three months of pregnancy.
Do not take Naproxen EC if any of the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Naproxen EC.
Warnings and precautions
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).
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.
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).

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before you
take Naproxen EC.
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 you are taking, have recently taken or might take any other
medicines. This is important because Naproxen EC could alter how other medicines work.
In particular, tell your doctor or pharmacist if you are taking:
 other NSAIDs such as aspirin (medicines used as a pain killers)
 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) such as angiotensin-II
receptor antagonists like candesartan or losartan, ACE inhibitors like cilazapril or enalapril,
diuretics (water tablet) like furosemide
 probenecid (medicine used to treat gout)
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methotrexate (used to treat skin problems, arthritis or cancer)
steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone
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)
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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacists for advice before taking this medicine.
Talk to your doctor before taking Naproxen if you are up to six months pregnant. 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, have problem with your balance, 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. The number of tablets you should take depends on the type of pain
you have.
Do not take more than you are told to, as this increases the chances of side-effects (especially in the
elderly).
Adults
For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
The recommended dose is between 500 mg and 1 g each day in two separate doses, 12 hours apart.
Where 1 g per day is needed, you can take 500 mg twice each day, or 1 g in one single dose (morning
or evening).
In some people, a larger dose of between 750 mg and 1 g 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, back pain, neck pain, swollen or painful tendons, and painful periods
The recommended starting dose is 500 mg, followed by 250 mg every 6 to 8 hours as needed. Do not
take more than 1250 mg a day after the first day.
Elderly and people with liver and kidney problems
Your doctor will decide your dose; it will usually be lower than that for adults.
Use in children and adolescents
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Naproxen EC is not for use in children under 16 years of age.
Medicines such as Naproxen EC may be associated (linked) with a small increased risk of heart attack
(‘myocardial stroke’) 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.
Swallow the tablets whole with a little water, with or after food. Do not crush or chew tablet.
You should make sure that you have enough to drink (stay well hydrated) when you are taking
Naproxen EC. This is particularly important for people who have problems with their kidneys.
While you are taking naproxen EC your doctor will want to check you are on the right dose for you
and look for any side effects. This is particularly important if you are an elderly.
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 dose.
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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Medicines such as Naproxen may be associated (linked) with a small increased risk of heart attack
(‘myocardial infarction’) or stroke.
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:
 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.
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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.
 Redness, hives, bruising, itching, sweating.
 ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash, problems with your kidneys
and joint pain.
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 and circulation
 Heart attack, signs include: Chest pain which may spread to your neck and shoulders and
down your left arm.
 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.
 Swelling of your hands, feet or legs (oedema). This may be with chest pains, tiredness,
shortness of breath (cardiac failure).
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’).
Others
 Changes in the numbers of blood cells which may present as sudden fever, mouth ulcers,
unexplained bruising or bleeding, sore throat, anaemia.
 Fits or seizures.
 Blood in your water (urine) or kidney problems.
If you notice any of the serious side effects mentioned above, stop taking this medicine and tell your
doctor straight away.
Other possible side effects:
Stomach and gut
 Heartburn, indigestion, stomachache, feeling sick or being sick, constipation, diarrhoea, wind.
 Inflammation of the food pipe and stomach.
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).
Nervous system
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Headache.
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
 A fluttering feeling in your heart (palpitations), slow heart beat or high blood pressure.
Chest
 Difficulty breathing, including shortness of breath, wheezing or coughing.
 Pneumonia or swelling of your lungs.
Skin and hair
 Hair loss
Other





Thirst, fever, feeling tired or generally unwell.
A sore mouth or mouth ulcers.
Muscle pain or weakness.
Problems for women in getting pregnant.

Electrolyte imbalance
 Increased level of potassium in blood (this can be identified by blood test).
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. How to store Naproxen EC





Store below 25ºC
Keep blister in the outer carton in order to protect from light
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 or carton after “EXP”.
The expiry date refers to the last day of the month. Consult your pharmacist if you have any
doubts about the shelf life

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 to protect the environment.
6. Contents of the pack and other information
What Naproxen EC contains
- The active substance is naproxen
Naproxen EC 250 mg tablets contain 250 mg naproxen
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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).
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
Both strengths of Naproxen EC are supplied in blister packs of 56 tablets.
Marketing Authorisation Holder

Focus Farma B.V.
Lagedijk 1-3
1541 KA Koog aan de Zaan
The Netherlands
Manufacturer
Losan Pharma GmbH
Otto-Hahn-Strasse 13,
Neuenburg, D-79395,
Germany
This leaflet was last revised in May 2016

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Expand Transcript

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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