Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using PROXEN SR?
PROXEN SR contains the active ingredient naproxen. PROXEN SR is used to relieve pain
and reduces inflammation (swelling, redness and soreness) that may occur in different
types of arthritis including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
For more information, see Section
1. Why am I using PROXEN SR? in the full CMI.
2. What should I know before I use PROXEN SR?
Do not use if you have ever had an allergic reaction to naproxen, aspirin or any other
NSAID medicines, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use PROXEN SR? in the full CMI.
3. What if I am taking other medicines?
4. How do I use PROXEN SR?
Your doctor will tell you how many PROXEN SR tablets to take each day. The usual dose
is one tablet once a day.
5. What should I know while using PROXEN SR?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using PROXEN SR.
Tell your doctor if you get an infection while using PROXEN SR.
Tell your doctor if you feel the tablets are not helping your condition.
Call your doctor straight away if you become pregnant while taking PROXEN SR.
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Things you should not do
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Do not give PROXEN SR to anyone else, even if they have the same condition as you.
Do not use PROXEN SR to treat other complaints unless your doctor tells you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how PROXEN
SR affects you.
PROXEN SR may cause dizziness or light-headedness in some people. If this occurs,
do not drive.
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Drinking alcohol
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Tell your doctor if you drink alcohol. If you drink alcohol, dizziness or light-headedness
may be worse.
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Looking after your medicine
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Keep the tablets in a cool dry place away from moisture, heat or sunlight. Store below
30°C.
Do not keep your tablets in the refrigerator.
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6. Are there any side effects?
Tell your doctor immediately if you notice any of the following serious side effects:
difficulty hearing, deafness, severe or persistent headache, yellowing of the skin,
bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin, fast or irregular heartbeats, eye problems such as blurred vision, yellowing
of the eyes, unusual weight gain, swelling of ankles or legs. Call your doctor straight
away or go straight to the Emergency Department at your nearest hospital if you notice
any of the following very serious side effects: vomiting blood or what looks like
coffee grounds, bleeding from the back passage (rectum), black sticky bowel motions
(stools) or bloody diarrhoea, severe dizziness, spinning sensation, severe pain or
tenderness in any part of the stomach, swelling of the face, lips or tongue which
may cause difficulty in swallowing, difficulty breathing, wheezing or shortness of
breath, sudden or severe itching, skin rash or hives, fainting, seizures or fits,
pain or tightness in the chest, flu-like symptoms with a rash on the face then an
extended rash with a high temperature and enlarged lymph nodes. For more information,
including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient: naproxen
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PROXEN SR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using PROXEN SR.
Where to find information in this leaflet:
1. Why am I using PROXEN SR?
PROXEN SR contains the active ingredient naproxen. PROXEN SR belongs to a group of medicines called Non-Steroidal Anti-Inflammatory
Drugs (or NSAIDs).
PROXEN SR is used to relieve pain and reduces inflammation (swelling, redness and
soreness) that may occur in different types of arthritis including rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis.
As the active ingredient in PROXEN 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.
Although PROXEN SR can relieve the symptoms of pain and inflammation, it will not
cure your condition.
Your doctor may have prescribed PROXEN SR for another reason.
Ask your doctor if you have any questions why PROXEN SR has been prescribed for you.
2. What should I know before I use PROXEN SR?
Warnings
Do not use PROXEN SR if:
you are allergic to naproxen, aspirin or any other NSAID medicine, or any of the ingredients
listed at the end of this leaflet. 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 doctor or pharmacist. If you are
allergic to aspirin or NSAID medicines and use PROXEN SR, these symptoms may be severe.
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
Always check the ingredients to make sure you can use this medicine.
you are vomiting blood or material that looks like coffee grounds
you are bleeding from the rectum (back passage), have black sticky bowel motions (stools)
or bloody diarrhoea
you currently have a peptic ulcer (i.e. stomach or duodenal ulcer), or have had peptic
ulcers before
you have severe liver disease
you have recently had or are about to have heart bypass surgery
you are taking other medications which contain naproxen or naproxen sodium (e.g. Naprosyn®, Naprogesic®, Anaprox® or Inza®)
you have severe heart failure
you are in the 3rd trimester of pregnancy
Do not give PROXEN SR to a child under the age of 2 years. The safety and effectiveness of PROXEN SR in children under 2 years of age has not
been established.
If you are not sure if you should start taking PROXEN SR, contact your doctor.
Check with your doctor if you:
have allergies to any other substances, such as foods, preservatives or dyes
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
currently have an infection. If you take PROXEN SR while you have an infection, the
signs may be hidden (e.g. pain, fever). This may make you think, mistakenly, that
you are better or that it is not serious.
you plan to have surgery. PROXEN SR can prolong bleeding.
If you have not told your doctor about any of the above, tell them before you take
any PROXEN SR.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become pregnant.
PROXEN SR may affect your developing baby if you take it during pregnancy. If it is
necessary for you to take PROXEN SR, your doctor will discuss the risks and benefits
of taking it during pregnancy.
PROXEN SR may impair fertility and is not recommended in women attempting to conceive.
Tell your doctor if you are breast-feeding or intend to breast-feed.
PROXEN SR passes into breast milk. The effect on the baby is not known.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with PROXEN SR and affect how it works. 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
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 PROXEN 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PROXEN SR.
4. How do I use PROXEN SR?
How much to take
Take PROXEN SR exactly as your doctor has prescribed.
Your doctor will tell you how many PROXEN SR tablets to take each day. The usual dose
is one tablet once a day.
Follow the instructions provided and use PROXEN SR until your doctor tells you to
stop. They may differ from the information contained in this leaflet.
How to take PROXEN SR
Swallow PROXEN SR whole with a glass of water or milk. Do not chew them.
When to take PROXEN SR
Take the tablets with or straight after food with a full glass of water or milk. This
may help reduce the possibility of an upset stomach.
How long to take PROXEN SR
Do not take PROXEN SR for longer than your doctor says.
If you are taking PROXEN SR for arthritis, it will not cure your condition but it
should help to control pain, swelling and stiffness. If you have arthritis, PROXEN
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 PROXEN SR for.
If you forget to take PROXEN SR
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 continue
taking it as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much PROXEN SR
If you take too much PROXEN SR, you may experience drowsiness, pain or tenderness
in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn,
indigestion or cramps. If you think that you have used too much PROXEN SR, you may
need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using PROXEN SR?
Things you should do
Ask your doctor or pharmacist before you start taking any new medicines.
Tell your doctor you are taking PROXEN SR if you are going to have surgery.
Tell you doctor or pharmacist before you start taking any new medicines.
Tell your doctor you are taking PROXEN SR if you are going to have any laboratory
tests. PROXEN SR can affect the results of some of these tests.
Tell your doctor if you get an infection while using PROXEN SR. PROXEN 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, swelling
and 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.
Call your doctor straight away if you:
become pregnant while taking PROXEN SR.
Remind any doctor, dentist or pharmacist you visit that you are using PROXEN SR.
Things you should not do
Do not give PROXEN SR to anyone else, even if they have the same condition as you.
Do not use PROXEN SR to treat other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PROXEN
SR affects you.
As with other NSAID medicines, PROXEN SR may cause dizziness or light-headedness in
some people. If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
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 keep your tablets in the refrigerator.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. PROXEN SR helps most people with pain due to
inflammation, but it may have unwanted side effects in a few people.
If you do experience any side effects, most of them are minor and temporary. However,
some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Less serious side effects
Serious side effects
Very serious side effects
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Very serious side effects
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What to do
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Gastrointestinal or gut related:
vomiting blood or what looks like coffee grounds
bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody
diarrhoea
Head related:
severe dizziness, spinning sensation
Pain related:
severe pain or tenderness in any part of the stomach
Allergic reaction related:
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
difficulty breathing, wheezing or shortness of breath
sudden or severe itching, skin rash or hives
fainting, seizures or fits
pain or tightness in the chest
flu-like symptoms with a rash on the face then an extended rash with a high temperature,
increased levels of liver enzymes seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph nodes.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects. You may need
urgent medical attention or hospitalisation. These very serious side effects are rare.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
PROXEN SR is not addictive.
What PROXEN SR contains
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Active ingredient
(main ingredient)
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each PROXEN SR 750 tablet contains 750 mg naproxen
each PROXEN SR 1000 tablet contains 1000 mg naproxen.
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Other ingredients
(inactive ingredients)
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hypromellose
magnesium stearate [470]
the colour, Sunset Yellow
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Potential allergens
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PROXEN SR tablets does not contain sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What PROXEN SR looks like
PROXEN SR tablets are available in two strengths.
PROXEN SR 750 is a peach coloured oval tablet marked "NPR SR-750" on one side (Aust
R 259113).
PROXEN SR 1000 is a peach coloured oval tablet marked "NPR SR-1000" on one side (Aust
R 259112).
PROXEN SR 750 and 1000 come in blister packs of 28 tablets.
Who distributes PROXEN SR
PROXEN SR is supplied in Australia by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Customer enquiries: 1 800 899 005
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street,
SYDNEY, NSW, 2000, Australia
This leaflet was prepared June 2023.