ANAPROX®

ANAPROX®

Active ingredient: naproxen sodium

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Consumer Medicine Information (CMI)

This leaflet provides important information about using ANAPROX. 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 ANAPROX.

Where to find information in this leaflet:

1. Why am I using ANAPROX?
2. What should I know before I use ANAPROX?
3. What if I am taking other medicines?
4. How do I use ANAPROX?
5. What should I know while using ANAPROX?
6. Are there any side effects?
7. Product details

1. Why am I using ANAPROX?

ANAPROX contains the active ingredient naproxen sodium. ANAPROX belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs).

ANAPROX 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
• in muscle and bone injuries such as sprains, strains, lower back pain (lumbago), rheumatism and tendonitis, such as tennis elbow
• from swelling and pain after setting broken or dislocated bones
• with menstrual cramps (period pain)
• due to migraine headache
• following surgery
• due to dental pain

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

Your doctor may have prescribed ANAPROX for another reason.

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

2. What should I know before I use ANAPROX?

Warnings

Do not use ANAPROX if:

• you have an allergy to naproxen sodium, 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 ANAPROX, 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 one 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 sodium or naproxen sodium (e.g. Naprogesic^®, Naprosyn^®, Crysanal or Inza^®)
• you have severe heart failure
• you are in the 3rd trimester of pregnancy

Do not give ANAPROX to a child under the age of 2 years. The safety and effectiveness of ANAPROX in children under 2 years of age has not been established.

If you are not sure if you should start taking ANAPROX, talk to 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 ANAPROX 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. ANAPROX can prolong bleeding.
• You are on a strict salt (or sodium) restricted diet. ANAPROX contains a small amount of sodium.

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

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.

ANAPROX may affect your developing baby if you use it during pregnancy. If it is necessary for you to be given ANAPROX, your doctor will discuss the risks and benefits of receiving it during pregnancy.

ANAPROX may impair fertility and is not recommended in women attempting to conceive.

Tell your doctor if you are breastfeeding or intend to breastfeed.

ANAPROX passes into breast milk. The effect on the baby is not known.

Use in children

• There is no specific information available to recommend the use of ANAPROX in children under 5 years.

Use in people over 65 years

• Older people may be at more risk of developing stomach ulcers and hence your doctor may prescribe a lower dose.

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 ANAPROX and affect how it works. These include:

• antacids, medicines used to treat indigestion and heartburn
• aspirin, salicylates or other NSAID medicines
• 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
• 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
• certain antibiotics called sulphonamides
• some medicines used to treat diabetes
• steroids, medicines used to treat inflammation
• serotonin reuptake inhibitors, also known as SSRIs, medicines used to treat some types of depression
• zidovudine, a medicine used to treat HIV infection
• sodium bicarbonate, a medicine used to treat stomach upset or ulcers

You may need to use different amounts of your medicine, or you may need to use 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 ANAPROX.

4. How do I use ANAPROX?

How much to take

• Take ANAPROX exactly as your doctor has prescribed.
• Your doctor will tell you how many ANAPROX tablets to take each day.
• The dose your doctors recommends depends on both the type and severity of pain and/or inflammation you have.
• Follow the instructions provided and use ANAPROX until your doctor tells you to stop. They may differ from the information contained in this leaflet.

Sprains, strains, and period pain

The recommended dose is 550 mg (one tablet) given initially, then 275 mg (half-a-tablet) every 6 to 8 hours as needed. The total dose in one day should not be more than 1375 mg (two and a half tablets).

Migraine headache

The recommended dose is 825 mg (one and a half tablets) taken at the first sign of a migraine. An additional dose of 275 mg (half a tablet) to 550 mg (one tablet) can be taken at least one hour after the initial dose, if required. The total dose in one day should not be more than 1375 mg (two and a half tablets).

Different types of arthritis

The recommended dose is 550 mg (one tablet) to 1100 mg (two tablets) a day (divided in two doses).

Your doctor may recommend lower doses than these, it is always best to use the lowest effective dose for your condition.

When to take ANAPROX

• Take the tablets during or immediately after food with a full glass of water or milk. This may help reduce the possibility of an upset stomach.

How long to take ANAPROX

• Do not take ANAPROX for longer than your doctor says.
• Depending on your condition, you may need to use ANAPROX, only once, for a few days, a few weeks or for longer periods.
• For sprains and strains, ANAPROX is usually only needed for a few days.
• As with other NSAID medicines, if you are taking ANAPROX for arthritis, it will not cure your condition but it should help to control pain, swelling and stiffness. If you have arthritis, ANAPROX should be taken every day for as long as your doctor prescribes.
• For menstrual cramps (period pain), ANAPROX is usually taken during each period as soon as the cramps begin and continued for a few days until the pain goes away.
• Ask your doctor if you are not sure how long to take ANAPROX for.

If you forget to take ANAPROX

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 ANAPROX

If you take too much ANAPROX, 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 ANAPROX, 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 ANAPROX?

Things you should do

• Ask your doctor or pharmacist before you start taking any new medicines.
• Tell your doctor you are taking ANAPROX if you are going to have surgery
• Tell your doctor you are taking ANAPROX if you are going to have any laboratory tests. ANAPROX can affect the results of some of these tests.
• Tell your doctor if you get an infection while using ANAPROX. ANAPROX 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 ANAPROX

Remind any doctor, dentist or pharmacist you visit that you are using ANAPROX.

Things you should not do

• Do not give ANAPROX to anyone else, even if they have the same condition as you.
• Do not use ANAPROX 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 ANAPROX affects you.

As with other NSAID medicines, ANAPROX 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. ANAPROX 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

Less serious side effects	What to do
Gut related: stomach upset including nausea (feeling sick) and heartburn loss of appetite constipation, diarrhoea, pain in the stomach Head related: dizziness, light-headedness headache, drowsiness buzzing or ringing in the ears sore or dry mouth or tongue feeling thirsty Skin related: itching or mild skin rashes Other: fluid retention or shortness of breath	Speak to your doctor if you have any of these less serious side effects and they worry you. These side effects of ANAPROX are usually mild.

Serious side effects

Serious side effects

What to do

Head related: difficulty hearing, deafness severe or persistent headache Skin related: yellowing of the skin Bleeding related: bleeding or bruising more easily than normal, reddish or purplish blotches under the skin Heart related: fast or irregular heartbeats, also called palpitations Eye related: eye problems such as blurred vision yellowing of the eyes Other: unusual weight gain, swelling of ankles or legs

Tell your doctor immediately if you notice any of these serious side effects. You may need urgent medical attention. Serious side effects are rare.

Very serious side effects

Very serious side effects

What to do

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.

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.

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.

ANAPROX is not addictive.

What ANAPROX contains

Active ingredient (main ingredient)	each ANAPROX 550 tablet contains 550mg of naproxen sodium
Other ingredients (inactive ingredients)	Microcrystalline cellulose Magnesium stearate Purified water Povidone Purified talc Opadry Blue YS-1R-4216 ARTG PI No. 3174
Potential allergens	ANAPROX tablets are lactose and gluten free

Do not take this medicine if you are allergic to any of these ingredients.

What ANAPROX looks like

ANAPROX 550 is a dark blue capsule-shaped tablet with ‘NPS 550’ on one side.

ANAPROX comes in packs of 50 tablets (Aust R 66544).

Who distributes ANAPROX

ANAPROX 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 in June 2023.