pronounced nap-row-sin S-R

contains the active ingredient naproxen

Consumer Medicine Information

This leaflet answers some common questions about NAPROSYN SR tablets.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits.Your doctor has weighed the risks of you taking NAPROSYN SR tablets against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

NAPROSYN SR belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

NAPROSYN SR relieves pain and reduces inflammation (swelling, redness and soreness) that may occur in different types of arthritis including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Although NAPROSYN SR can relieve the symptoms of pain and inflammation, it will not cure your condition.

As the active ingredient in NAPROSYN SR, is released slowly into the bloodstream during the day, the tablets are not suitable for use in conditions where rapid pain relief is needed e.g. migraine attacks or in conditions needing only short term pain relief.

Your doctor may have prescribed NAPROSYN SR for another purpose.

Ask your doctor if you have any questions why NAPROSYN SR has been prescribed for you.

This medicine is available only with a doctor’s prescription.

NAPROSYN SR is not addictive.

Do not take NAPROSYN SR if you have an allergy to:

NAPROSYN SR or any ingredients listed at the end of this leaflet

aspirin or any other NSAID medicine

Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist.

Symptoms of an allergic reaction to these medicines may include:

asthma, wheezing or shortness of breath

swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing

hives, itching or skin rash

fainting

If you are allergic to aspirin or NSAID medicines and take NAPROSYN SR, these symptoms may be severe.

1.you are vomiting blood or material that looks like coffee grounds

2.you are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea

3.you have a peptic ulcer (i.e. stomach or duodenal ulcer), or have had peptic ulcers before

4.you have severe liver disease

5.you have recently had or are about to have heart bypass surgery

6.you are taking other medications which contain naproxen or naproxen sodium (e.g. Naprosyn®, Naprogesic®, Anaprox® or Inza®)

7.you have severe heart failure

Do not give NAPROSYN SR to a child under the age of 2 years

The safety and effectiveness of NAPROSYN SR in children under the age of 2 years has not been established.

Do not take NAPROSYN SR if the packaging is torn or shows signs of tampering.

Do not take NAPROSYN SR if the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should start taking NAPROSYN SR, contact your doctor.

Tell your doctor if:

1.you have any allergies to:

any other medicines including aspirin or other NSAID medicines

any other substances, such as foods, preservatives or dyes

2.you are pregnant or intend to become pregnant

NAPROSYN SR may impair fertility and is not recommended in women attempting to conceive. NAPROSYN SR may affect your developing baby if you take it during pregnancy.

If it is necessary for you to take NAPROSYN SR, your doctor will discuss the risks and benefits of taking it during pregnancy.

3.you are breast-feeding, or intend to breast-feed

NAPROSYN SR passes into breast-milk. The effect on the baby is not known.

4.you have or have had any medical conditions, especially the following:

heartburn, indigestion, stomach ulcers or other stomach problems

vomiting blood or bleeding from the back passage

bowel or intestinal problems such as ulcerative colitis

kidney or liver disease

heart failure

high blood pressure or heart problems

swelling of the ankles or feet

a tendency to bleed or other blood problems, such as anaemia

5.you currently have an infection

If you take NAPROSYN SR while you have an infection, the tablets may hide some of the signs of an infection (eg pain, fever). This may make you think, mistakenly, that you are better or that it is not serious.

6.you plan to have surgery

NAPROSYN SR can prolong bleeding.

If you have not told your doctor about any of the above, tell them before you take any NAPROSYN SR.

Tell your doctor if you are taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with NAPROSYN SR. These include:

antacids, medicines used to treat heartburn and indigestion

aspirin, salicylates or other NSAID medicines

cholestyramine, a medicine used to treat high cholesterol levels

diuretics, also called fluid or water tablets

lithium, a medicine used to treat some types of depression

probenecid, a medicine used to treat gout

phenytoin, a medicine used to treat epilepsy

methotrexate, a medicine used to treat arthritis and some cancers

sucralfate, a medicine used to treat and prevent stomach ulcers

warfarin, a medicine used to prevent blood clots

heparin, a medicine used to prevent blood clots

medicines used to treat high blood pressure including ACE inhibitors, angiotensin receptor antagonists and beta-blockers.

some medicines used to treat diabetes

selective serotonin reuptake inhibitors, also known as SSRIs, medicines used to treat some types of depression

steroids, medicines used to treat inflammation

zidovudine, a medicine used to treat HIV infection

sodium bicarbonate, a medicine used to treat stomach upset or ulcers

These medicines may be affected by NAPROSYN SR, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking NAPROSYN SR.

Ask your doctor of pharmacist if you are not sure about this list of medicines.

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet

Take NAPROSYN SR exactly as your doctor has prescribed.

Your doctor will tell you how many NAPROSYN SR tablets to take each day.

The usual dose is one tablet once a day.

Swallow NAPROSYN SR whole with a glass of water. Do not chew them.

Take the tablets with or straight after food with a full glass of water.

This may help reduce the possibility of an upset stomach.

Do not take NAPROSYN SR for longer than your doctor says.

If you are taking NAPROSYN SR for arthritis, it will not cure your condition but it should help to control pain, swelling and stiffness. If you have arthritis, NAPROSYN SR should be taken every day for as long as your doctor prescribes.

Ask your doctor if you are not sure how long to take NAPROSYN SR for.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you are not sure what to do, ask your doctor or pharmacist.

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much NAPROSYN SR. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much NAPROSYN SR, you may experience drowsiness, pain or tenderness in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps.

If you become pregnant while taking NAPROSYN SR, tell your doctor immediately.

Tell all doctors, dentists and pharmacists who are treating you that you are taking NAPROSYN SR.

Ask your doctor or pharmacist before you start taking any new medicines.

If you are going to have surgery tell your doctor you are taking NAPROSYN SR.

If you are going to have any laboratory tests, tell your doctor that you are taking NAPROSYN SR.

NAPROSYN SR can affect the results of some of these tests.

If you get an infection while using NAPROSYN SR, tell your doctor.

NAPROSYN SR may hide some of the signs of an infection and may make you think, mistakenly, that you are better or that it is not serious.Signs of an infection may include fever, pain, swellingand redness.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Do not give NAPROSYN SR to anyone else, even if they have the same condition as you.

Do not use NAPROSYN SR to treat other complaints unless your doctor tells you to.

Be careful driving or operating machinery until you know how NAPROSYN SR affects you.

As with other NSAID medicines, NAPROSYN SR may cause dizziness or light-headedness in some people. Make sure you know how you react to NAPROSYN SR before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.If this occurs do not drive.If you drink alcohol, dizziness or light-headedness may be worse.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NAPROSYN SR.

NAPROSYN SR helps most people but it may have unwanted side effects in a few people.

All medicines can have side effects.Sometimes they are serious, most of the time they are not.You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

stomach upset including nausea (feeling sick), heartburn, indigestion

constipation, diarrhoea, pain in the stomach

loss of appetite

dizziness, light-headedness

headache, drowsiness

buzzing or ringing in the ears

dry mouth

aching muscles, muscle tenderness or weakness, not caused by exercise

These side effects of NAPROSYN SR are usually mild.

Tell your doctor immediately if you notice any of the following:

bleeding or bruising more easily than normal, reddish or purplish blotches under the skin

eye problems such as blurred vision

severe or persistent headache

fast or irregular heartbeats, also called palpitations

difficulty hearing, deafness

unusual weight gain, swelling of ankles or legs

yellowing of the skin or eyes

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you experience any of the following:

vomiting blood or material that looks like coffee grounds

bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea

severe pain or tenderness in any part of the stomach

difficulty breathing, wheezing or shortness of breath

swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing

sudden or severe itching, skin rash, hives

fainting, seizures or fits

pain or tightness in the chest

severe dizziness, spinning sensation

These are very serious side effects. You may need urgent medical attention or hospitalisation.These side effects are rare.

This is not a complete list of all possible side effects. Others may occur in some people, and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects.You may not experience any of them.

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they will not keep well.

Keep the tablets in a cool dry place where the temperature stays below 30°C.

Do not store NAPROSYN SR or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not keep your tablets in the refrigerator.

If your doctor tells you to stop taking NAPROSYN SR, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

NAPROSYN SR tablets are available in two strengths.

NAPROSYN SR 750 is a peach coloured oval tablet marked “NPR SR 750” on one side.

NAPROSYN SR 1000 is a peach coloured oval tablet marked “NPR SR 1000” on one side.

NAPROSYN SR 750 and 1000 come in blister packs of 28 tablets.

Active ingredient:

naproxen

each NAPROSYN SR 750 tablet contains 750 mg naproxen

each NAPROSYN SR 1000 tablet contains 1000 mg naproxen.

Inactive ingredients:

hypromellose

magnesium stearate [470]

the colour, Sunset Yellow

NAPROSYN SR does not contain sucrose, gluten, tartrazine or any other azo dyes.

Atnahs Pharma Australia Pty Ltd

Level 10

10 Shelley Street,

SYDNEY, NSW, 2000, Australia

NAPROSYN SR is supplied in Australia by:

Clinect Pty Ltd

120 – 132 Atlantic Drive

Keysborough VIC 3173

Australia

Customer enquiries: 1 800 899 005

Please check with your pharmacist for the latest Consumer Medicine Information.

Australian Registration Numbers:

NAPROSYN SR 750 tablets

AUST R 10174

NAPROSYN SR 1000 tablets

AUST R 10173

This leaflet was prepared November 2016.