Consumer medicine information

ANAPROX

Naproxen sodium

BRAND INFORMATION

Brand name

Anaprox 550

Active ingredient

Naproxen sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using ANAPROX.

SUMMARY CMI

ANAPROX®

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 ANAPROX?

ANAPROX contains the active ingredient naproxen sodium. ANAPROX is used to relieve pain and reduces inflammation (swelling, redness and soreness) that may occur with different types of arthritis, in muscle and bone injuries, after setting broken or dislocated bones, with menstrual cramps (period pain), due to migraine headache, following surgery, or due to dental pain, migraines, after surgery, or dental pain. For more information, see Section 1. Why am I using ANAPROX? in the full CMI.

2. What should I know before I use ANAPROX?

Do not use if you have ever had an allergic reaction to naproxen sodium, 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 ANAPROX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ANAPROX and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ANAPROX?

  • Take ANAPROX exactly as your doctor has prescribed. Your doctor will tell you how many ANAPROX tablets to take each day. More instructions can be found in Section 4. How do I use ANAPROX? in the full CMI.

5. What should I know while using ANAPROX?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using ANAPROX.
  • Tell your doctor if you get an infection while using ANAPROX.
  • 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.
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.
  • 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 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.

For more information, see Section 5. What should I know while using ANAPROX? in the full CMI.

6. Are there any side effects?

Tell your doctor immediately if you notice any of these serious side effects: difficulty hearing, deafness, severe or persistent headache, yellowing of the skin or eyes, bleeding or bruising more easily than normal, reddish or purplish blotches under the skin, fast or irregular heartbeats, eye problems such as blurred vision, 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 these very serious side effects: vomiting blood or what looks like coffee grounds, bleeding from the back passage, black sticky bowel motions 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.



FULL CMI

ANAPROX®

Active ingredient: naproxen sodium


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

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 totake 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 effectsWhat 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 effectsWhat 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 effectsWhat 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 allergensANAPROX 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 September 2021.

Published by MIMS November 2021

BRAND INFORMATION

Brand name

Anaprox 550

Active ingredient

Naproxen sodium

Schedule

S4

 

1 Name of Medicine

Naproxen sodium.

2 Qualitative and Quantitative Composition

Anaprox 550 is available as a film-coated tablet containing 550 mg of naproxen sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

List of excipients with known effect.

Each film-coated tablet contains 50 mg of sodium.

3 Pharmaceutical Form

Film-coated tablet.
Anaprox 550 is supplied as an oblong, dark blue film-coated tablet engraved "NPS 550" on one side, with a break-line on both faces.

4 Clinical Particulars

4.1 Therapeutic Indications

Anaprox 550 is indicated as an analgesic in acute migraine attacks, for the treatment of gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and for the relief of acute and/or chronic pain states in which there is an inflammatory component.

4.2 Dose and Method of Administration

After assessing the risk/ benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.

Acute migraine headache.

The recommended dose is 825 mg at the first symptom of an impending headache. An additional 275 mg to 550 mg dose can be given at least an hour after the initial dose, if necessary. The total daily dose should not exceed 1375 mg.

Acute pain states with an inflammatory component.

The recommended dose is 550 mg initially followed by 275 mg every six to eight hours as required. The total daily dose should not exceed 1375 mg.

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and chronic pain states with an inflammatory component.

The dosage range of naproxen sodium is 550 mg to 1100 mg daily in two divided doses. The starting dose should not be less than 550 mg daily. The dose may be increased gradually up to 1100 mg daily, depending on the needs of the patient.
Patients on long-term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.

Pregnancy.

See Section 4.6 Fertility, Pregnancy and Lactation.

4.3 Contraindications

Anaprox 550 is contraindicated in patients:
who are hypersensitive to naproxen or naproxen sodium, or in whom acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory/ analgesic agents induce allergic manifestations, e.g. asthma, nasal polyps, rhinitis and urticaria. Severe anaphylactic-like reactions to naproxen have been reported in such patients;
with either active, or a history of, peptic or gastrointestinal ulceration, chronic dyspepsia or active gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;
with active or history of recurrent peptic ulcer/ haemorrhage (two or more distinct episodes of proven ulceration or bleeding) unrelated to previous NSAIDs therapy;
less than 2 years of age since safety in this age group has not been established;
with severe heart failure;
undergoing treatment of perioperative pain in setting of coronary artery surgery (CABG);
with severe hepatic impairment.

4.4 Special Warnings and Precautions for Use

Cardiovascular thrombotic events.

Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk. To minimise the potential risk of an adverse cardiovascular event in patients taking an NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration (see Section 4.2 Dose and Method of Administration).
Physicians and patients should remain alert for such CV events even in the absence of previous CV symptoms. Patients should be informed about signs and/or symptoms of serious CV toxicity and the steps to take if they occur.
There is no consistent evidence to suggest that concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and long-term treatment) may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

Hypertension.

NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension and patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.

Heart failure.

Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore, caution is advised in patients with fluid retention or heart failure.

Gastrointestinal.

All NSAIDs can cause gastrointestinal discomfort and, rarely, serious, potentially fatal, gastrointestinal effects such as ulcers, irritation, bleeding and perforation, which may increase with dose or duration of use, but can occur at any time without warning symptoms. Upper gastrointestinal ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious gastrointestinal event at some time during the course of therapy. However, even short-term therapy is not without risk.
Caution is advised in patients with risk factors for gastrointestinal events who may be at greater risk of developing serious gastrointestinal events, e.g. elderly, debilitated patients, those with a history of serious gastrointestinal events, smoking and alcoholism.
NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated. Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. When gastrointestinal bleeding or ulceration occurs in patients receiving NSAIDs, treatment should be withdrawn immediately. Physicians should warn patients about the signs and symptoms of serious gastrointestinal toxicity.
Studies to date have not identified any subset of patients not at risk of developing peptic ulcer and bleeding. However, the elderly have an increased frequency of adverse effects to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal. Debilitated patients do not seem to tolerate ulceration or bleeding as well as others. Most of the fatal gastrointestinal events associated with NSAIDs occurred with the elderly and/or debilitated patients.
In patients with active peptic ulcer or inflammatory disease of the gastrointestinal tract and active rheumatoid arthritis, an attempt might be made to treat the arthritis with a non-ulcerogenic drug.
Caution is advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). The concurrent use of aspirin and NSAIDs also increase the risk of serious gastrointestinal adverse effects.
Patients with risk factors should commence treatment on the lowest dose available.

Haematological.

Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are being determined (see Section 4.4 Special Warnings and Precautions for Use, Effects on laboratory tests).
Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if Anaprox 550 is administered. Patients at high risk of bleeding and those on anticoagulation therapy (e.g. heparin or dicoumarol derivatives) may be at increased risk of bleeding if given Anaprox 550 concurrently. Therefore, benefits of prescribing Anaprox 550 should be weighed against these risks.
Patients with initial haemoglobin values of 10 grams or less, and who are to receive long-term therapy should have haemoglobin values determined frequently.
Patients on other drugs such as hydantoins, sulfonamides, sulfonylureas or methotrexate should be observed for increased effect or toxicity (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Severe skin reactions.

NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) and toxic epidermal necrolysis (TEN), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their physician at the first appearance of a skin rash or other sign of hypersensitivity.
DRESS has been reported in patients taking NSAIDs. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue NSAID and evaluate the patient immediately.

Anaphylactic reactions.

Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin or other NSAIDs or naproxen-containing products. They may also occur in individuals with a history of angioedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
Bronchospasm may be precipitated in patients suffering from, or with a history of, asthma or allergic disease or aspirin sensitivity.

Infection.

The antipyretic, anti-inflammatory and analgesic effects of naproxen may mask the usual signs or symptoms of infection.

Ocular events.

Adverse ophthalmological effects have been observed with NSAIDs. In rare cases, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilloedema have been reported in users of NSAIDs including Anaprox 550, although a cause-and-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with Anaprox 550 should have an ophthalmological examination.

Sodium.

A 550 mg tablet of Anaprox 550 contains approximately 50 mg of sodium. This should be considered in patients whose overall intake of sodium must be markedly restricted.

Fluid retention and oedema.

Peripheral oedema has been observed in some patients taking Anaprox 550 or other NSAIDs. Although sodium retention has not been reported in metabolic studies, it is possible that patients with compromised cardiac function may be at greater risk when taking naproxen. For this reason, naproxen should be used with caution in patients with fluid retention, hypertension or heart failure.

Use in hepatic impairment.

As with other NSAIDs, elevations of one or more liver function tests may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged or may resolve with continued therapy. The ALT test is probably the most sensitive indicator of liver dysfunction. Meaningful elevations (three times the upper limit of normal) of ALT or AST occurred in controlled clinical trials in less than 1% of patients. Physicians and patients should remain alert for hepatotoxicity. Patients should be informed about the signs and/or symptoms of hepatotoxicity. A patient with symptoms and/or signs suggesting hepatic dysfunction (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and flu-like symptoms), or in whom an abnormal hepatic test has occurred, should be evaluated for evidence of the development of more severe hepatic reactions while on therapy with Anaprox 550.
Hepatic abnormalities may be the result of hypersensitivity or direct toxicity.
Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported with naproxen sodium as with other NSAIDs. Cross reactivity has been reported. Although such reactions are rare, if abnormal hepatic tests persist or worsen, if clinical signs and symptoms consistent with hepatic disease develop or if systemic manifestations occur (e.g. eosinophilia, rash, etc.), Anaprox 550 should be discontinued.
Chronic alcoholic hepatic disease and potentially other forms of cirrhosis reduce the total plasma concentration of naproxen; however, the plasma concentration of unbound naproxen is increased. The implication of this finding for naproxen dosing is unknown.
In patients with impaired hepatic function, the lowest effective dose is recommended.

Use in renal impairment.

There have been reports of impaired renal function, renal failure, acute interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and occasionally nephritic syndrome associated with Anaprox 550.
Anaprox 550 should not be given to patients with creatinine clearance less than 30 mL/minute because accumulation of naproxen metabolites has been seen in such patients.
As with other NSAIDs, Anaprox 550 should be used with caution in patients with impaired renal function or a history of kidney disease because naproxen is an inhibitor of prostaglandin synthesis. Caution should be observed in patients with conditions leading to a reduction in blood volume and/or renal blood flow as prostaglandins have a supportive role in the maintenance of renal perfusion. In these patients, administration of Anaprox 550 or other NSAIDs may cause a dose-dependent reduction in renal prostaglandin formation and may precipitate overt renal decompensation or failure. Patients at greatest risk are those with impaired renal function, hypovolaemia, heart failure, liver dysfunction, salt depletion, those taking diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers and the elderly. Discontinuation of Anaprox 550 is usually followed by recovery to the pre-treatment state; however, serious adverse events may persist. Anaprox 550 should be used with great caution in such patients and the monitoring of serum creatinine and/or creatinine clearance is advised and patients should be adequately hydrated. A reduction of daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.
Haemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding.

Use in the elderly.

The lowest effective dose is recommended in elderly patients.
Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly.

Paediatric use.

Anaprox 550 is not recommended in children under 5 years of age as the safety and efficacy in this population has not been established.

Effects on laboratory tests.

Naproxen sodium decreases platelet aggregation and prolongs bleeding time. This effect should be considered when bleeding times are determined.
Anaprox 550 may artefactually interfere with some tests for 17-ketogenic steroid and may interfere with some urinary assays for 5-hydroxy-indoleacetic acid (5HIAA). 17-hydroxycorticosteroid measurements (Porter/ Silber test) do not appear to be altered.
Naproxen sodium therapy should be temporarily discontinued for at least 72 hours before testing adrenal function.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant administration of sucralfate or cholestyramine can delay the absorption of naproxen, but does not affect its extent. Antacids have a variable effect on absorption.

Other NSAIDs.

Combination of naproxen containing products and other NSAIDs, including cyclooxygenase-2 (COX-2) selective inhibitors, is not recommended because of the risk of inducing serious NSAID related adverse events.

Protein binding.

Naproxen sodium is highly bound to plasma albumin; thus, naproxen sodium has a theoretical potential for interaction with other albumin bound drugs, for example warfarin or bishydroxycoumarin, may be displaced and induce excessively prolonged prothrombin times. Similarly, patients receiving hydantoins, sulfonamides or sulfonylureas should be observed for increased effect or toxicity (see Section 4.4 Special Warnings and Precautions for Use, Haematological).

Warfarin.

The concurrent use of NSAIDs and warfarin has been associated with severe, sometimes fatal, haemorrhage. The exact mechanism of the interaction between NSAIDs and warfarin is unknown, but may involve enhanced bleeding from NSAID induced gastrointestinal ulceration, or an additive effect of anticoagulation by warfarin and inhibition of platelet function by NSAIDs. Anaprox 550 should be used in combination with warfarin only if absolutely necessary, and patients taking this combination of drugs should be closely monitored.

Anticoagulants/ antiplatelet agents.

Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen sodium is administered. Patients on full anticoagulation therapy (e.g. heparin or dicoumarol derivatives) may be at increased risk of bleeding if given naproxen sodium concurrently. Thus, the benefits should be weighed against these risks.
There is an increased risk of gastrointestinal bleeding when anti-platelet agents are combined with NSAIDs.

Selective serotonin reuptake inhibitors (SSRIs).

There is an increased risk of gastrointestinal bleeding when SSRIs are combined with NSAIDs.

Steroids.

If steroid dosage is reduced or eliminated during Anaprox 550 therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of underlying disease.

Probenecid.

Probenecid significantly prolongs the half-life of naproxen (from 14 to 37 hrs). This is associated with a decrease in conjugated metabolites and an increase in 6-O-desmethylnaproxen.

Methotrexate.

Concomitant administration of naproxen sodium and methotrexate should be administered with caution because naproxen has been reported, among other NSAIDs, to reduce the tubular secretion of methotrexate in animal models, and thus possibly increasing the toxicity of methotrexate.

Beta-blockers.

Naproxen sodium and other NSAIDs can reduce the anti-hypertensive effect of beta-blockers, angiotensin converting enzyme inhibitors (ACE inhibitors), and angiotensin receptor blockers (ARBs).

Diuretics.

As with other NSAIDs, naproxen sodium may inhibit the natriuretic effect of frusemide.

Lithium.

Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has been reported.

Sodium bicarbonate.

Sodium bicarbonate may enhance the rate of naproxen absorption.

Zidovudine.

In vitro studies have shown that naproxen may interfere with the metabolism of zidovudine, resulting in higher zidovudine plasma levels. Therefore, to avoid the potential side effects associated with increased zidovudine plasma levels, dose reduction should be considered.

ACE inhibitors.

Concomitant use of NSAIDs with ACE inhibitors or angiotensin receptor blockers may increase the risk of renal dysfunction, especially in patients with pre-existing poor renal function (see Section 4.4 Special Warnings and Precautions for Use).

Combination use of ACE inhibitors or angiotensin receptor antagonists, anti-inflammatory drugs and thiazide diuretics.

The use of an ACE inhibiting drug (ACE inhibitor or angiotensin receptor antagonist), an anti-inflammatory drug (NSAID or COX-2 inhibitor) and a thiazide diuretic at the same time (triple whammy) increases the risk of renal impairment. This includes use in fixed combination products containing more than one class of drug. Combined use of these medications should be accompanied by increased monitoring of serum creatinine, particularly at the initiation of the combination. The combination of drugs from these three classes should be used with caution particularly in elderly patients or those with pre-existing renal impairment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The use of Anaprox 550, as with any drug known to inhibit cyclooxygenase/ prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation of infertility, withdrawal of naproxen should be considered.
(Category C)
NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause premature closure of the foetal ductus arteriosus (see Premature closure of foetal ductus arteriosus), foetal renal dysfunction leading to oligohydramnios and neonatal renal impairment (see Oligohydramnios and neonatal renal impairment), prolong labour and delay birth. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Continuous treatment with NSAIDs during the last month of pregnancy should only be given when clearly indicated.
Anaprox 550 should only be administered during pregnancy if the benefit justifies the potential risk.
Data from epidemiological studies suggest an increased risk of miscarriage after the use of a prostaglandin synthesis inhibitor in early pregnancy.

Premature closure of foetal ductus arteriosus.

Naproxen may cause premature closure of the foetal ductus arteriosus. Avoid use of naproxen in pregnant women starting at about 30 weeks of gestation (third trimester) and later. Naproxen increases the risk of premature closure of the foetal ductus arteriosus at approximately this gestational age.

Oligohydramnios and neonatal renal impairment.

Use of NSAIDs from about 20 weeks gestation or later in pregnancy may cause foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If, after careful consideration of alternative treatment options for pain management, Anaprox 550 treatment is necessary from about 20 weeks, limit Anaprox 550 use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Anaprox 550 treatment extends beyond 48 hours. Discontinue treatment with Anaprox 550 if oligohydramnios occurs and follow up according to clinical practice.
Naproxen has been found in the milk of lactating mothers at a concentration approximately 1% of that found in plasma. As the effect of naproxen in the newborn is not known, the use of Anaprox 550 in lactating mothers is not recommended.

4.7 Effects on Ability to Drive and Use Machines

Some patients may experience drowsiness, dizziness, vertigo, insomnia or depression with the use of Anaprox 550. If patients experience these or similar undesirable effects, they should exercise caution in carrying out activities that require alertness.

4.8 Adverse Effects (Undesirable Effects)

Adverse effects reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis and osteoarthritis are listed below. In general, these effects were reported 2 to 10 times more frequently than they were in studies of 962 patients treated for mild to moderate pain.

Incidence between 3% and 9%.

Gastrointestinal.

The most frequently reported adverse effects were related to the gastrointestinal tract. These were: constipation, heartburn, abdominal pain, nausea.

Central nervous system.

Headache, dizziness, drowsiness.

Dermatologic.

Itching (pruritus), skin eruption, ecchymoses.

Special senses.

Tinnitus.

Cardiovascular.

Oedema, dyspnoea.

Incidence between 1% and less than 3%.

Gastrointestinal.

Dyspepsia, diarrhoea, stomatitis.

Central nervous system.

Lightheadedness, vertigo.

Dermatologic.

Sweating, purpura.

Special senses.

Hearing disturbances, visual disturbances.

Cardiovascular.

Palpitations.

General.

Thirst.

Incidence less than 1%.

Probable causal relationship.

The following adverse effects were reported less frequently than 1% during controlled clinical trials and in post-marketing reports. A causal relationship probably exists between naproxen sodium and these adverse effects.

Gastrointestinal.

Abnormal liver function tests, gastrointestinal bleeding, haematemesis, jaundice, melaena, peptic ulceration with bleeding and/or perforation, non-peptic gastrointestinal ulceration, vomiting, ulcerative stomatitis, colitis, fatal hepatitis.

Renal.

Glomerular nephritis, haematuria, interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal disease, hyperkalaemia, renal failure.

Haematologic.

Eosinophilia, granulocytopenia, leucopenia, thrombocytopenia.

Central nervous system.

Depression, dream abnormalities, inability to concentrate, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis.

Dermatologic.

Porphyria cutanea tarda, epidermolysis bullosa, alopecia, skin rashes, epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome (SJS), photosensitivity reactions including rare cases in which the skin resembles porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa.

Special senses.

Hearing impairment.

Cardiovascular.

Vasculitis, congestive heart failure.

General.

Menstrual disorders, pyrexia (chills and fever), eosinophilic pneumonitis, anaphylactoid reactions (see Section 4.4 Special Warnings and Precautions for Use, Anaphylactic reactions).

Causal relationship unknown.

Other reactions have been reported in circumstances in which a causal relationship could not be established. Although rarely reported, the physician should be alerted to these.

Haematologic.

Agranulocytosis, aplastic anaemia, haemolytic anaemia.

Central and peripheral nervous system.

Cognitive dysfunction, convulsions, paraesthesia.

Dermatologic.

Urticaria, photosensitivity.

Mouth and throat.

Sore throat.

General.

Angioneurotic oedema, hyperglycaemia, hypoglycaemia.

Reproductive.

Female infertility.

Post-marketing experience.

The following adverse effects have been reported with Anaprox 550.

Gastrointestinal.

Inflammation, peptic ulcers, ulceration, perforation and obstruction of the upper and lower gastrointestinal tract, gastrointestinal bleeding (sometimes fatal, particularly in the elderly), heartburn, nausea, oesophagitis, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, non-peptic gastrointestinal ulceration, melaena, haematemesis, stomatitis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, pancreatitis, gastritis.

Infection.

Aseptic meningitis.

Blood and lymphatic system disorders.

Agranulocytosis, aplastic anaemia, eosinophilia, haemolytic anaemia, leucopenia, thrombocytopenia.

Immune system disorders.

Anaphylactoid reactions.

Metabolic and nutrition disorders.

Hyperkalaemia.

Psychiatric disorders.

Depression, dream abnormalities, insomnia.

Nervous system disorders.

Dizziness, drowsiness, headache, lightheadedness, retrobulbar optic neuritis, convulsions, cognitive dysfunction, inability to concentrate.

Eye disorders.

Visual disturbances, corneal opacity, papillitis, papilloedema.

Ear and labyrinth disorders.

Hearing impairment, hearing disturbances, tinnitus, vertigo.

Cardiac disorders.

Palpitations, cardiac failure, congestive heart failure.

Vascular disorders.

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders.

Dyspnoea, pulmonary oedema, asthma, eosinophilic pneumonitis.

Hepatobiliary disorders.

Hepatitis, jaundice.

Skin and subcutaneous tissue disorders.

Ecchymoses, itching (pruritus), purpura, skin eruptions, sweating, alopecia, epidermal necrolysis, very rarely toxic epidermal necrolysis (TEN), erythema multiforme, bullous reactions (including SJS, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)), erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, skin rashes, systemic lupus erythematosus (SLE), urticaria, photosensitivity reactions including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa or angioneurotic oedema.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and patient monitored.

Musculoskeletal and connective tissue disorders.

Myalgia, muscle weakness.

Renal and urinary disorders.

Haematuria, interstitial nephritis, nephritic syndrome, renal disease, renal failure, renal papillary necrosis.

Pregnancy, puerperium and perinatal conditions.

Oligohydramnios, neonatal renal impairment.

Reproductive system.

Female infertility.

General disorders.

Oedema, thirst.

Investigations.

Abnormal liver function tests, raised serum creatinine.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Significant overdose of the medicine may be characterised by dizziness, drowsiness, epigastric pain, abdominal discomfort, indigestion, transient alterations in liver function, hypoprothrombinaemia, renal dysfunction, metabolic acidosis, apnoea, disorientation, nausea or vomiting. A few patients have experienced seizures but it is unclear if these were causally related to naproxen. It is not known what dose of naproxen sodium would be life threatening.
Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs and may occur following an overdose.
Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes. Prevention of further absorption (e.g. activated charcoal) may be indicated in symptomatic patients seen within 4 hours of ingestion or following a large overdose. Forced diuresis, alkalinization of urine, haemodialysis or haemoperfusion may not be useful due to high protein binding.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Anaprox 550 dissociates into the naproxen anion and sodium in vivo at physiological pH.
Naproxen has been shown to have anti-inflammatory properties when tested in human clinical studies. In addition, it has analgesic and antipyretic actions. It exhibits its anti-inflammatory effects even in adrenalectomised animals, indicating that its action is not mediated through the pituitary axis. It inhibits prostaglandin synthetase, as do other NSAIDs, however, the exact mechanism of its anti-inflammatory action is not known.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

In humans, naproxen sodium is completely absorbed from the gastrointestinal tract after oral administration. Concomitant administration of food can delay the absorption of naproxen sodium, but does not affect its extent.
After oral administration of Anaprox 550, because of rapid and complete absorption, clinically significant plasma levels and pain relief are obtained in patients within 30 minutes of administration. Peak plasma levels are attained in 1-2 hours, depending on food intake.

Distribution.

Naproxen has a relatively small volume of distribution (0.09 ± 0.03 L/kg), which corresponds to about 10% of the bodyweight in humans. At therapeutic levels naproxen is greater than 99% albumin bound.
The plasma concentration of naproxen increases proportionally with doses up to 500 mg twice daily. Larger doses result in a less than proportional increase due to accelerated renal clearance of disproportionately increased amounts of non-protein bound drug. However, whether this effect increases or decreases the toxicity of naproxen has not been established.
Steady-state plasma levels of naproxen are reached after 4 to 5 doses.
Naproxen enters synovial fluid and crosses the placenta. It has been found in the milk of lactating mothers at a concentration approximately 1% of that found in plasma.

Metabolism.

Naproxen is metabolised in the liver to 6-O-desmethylnaproxen (approximately 28% of an IV dose).

Elimination.

Approximately 95% of the naproxen is excreted in the urine, primarily as naproxen (10%), 6-O-desmethylnaproxen (5%) or their conjugates. The rate of excretion of metabolites and conjugates has been found to coincide closely with the rate of naproxen clearance from the plasma. Small amounts, 5% or less, are excreted in the faeces.
The elimination half-life of naproxen is approximately 14 hours.

Pharmacokinetics in special populations.

Children.

The pharmacokinetic profile of naproxen in children aged 5-16 years is similar to that in adults.

Renal impairment.

Given that naproxen and its metabolites are primarily excreted by the kidney, the potential exists for accumulation in the presence of renal insufficiency. Elimination of naproxen is decreased in patients with severe renal impairment (creatinine clearance < 20 mL/min), in whom there is higher clearance of naproxen than estimated from the degree of renal impairment alone (see Section 4.4 Special Warnings and Precautions for Use, Use in renal impairment).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, magnesium stearate, purified water, povidone, purified talc, Opadry Blue YS-1R-4216 ARTG PI No. 3174.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

Anaprox 550 is available in PVC/aluminium blister packs of 50 tablets.

6.6 Special Precautions for Disposal

The release of medicines into the environment should be minimised. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Unused or expired medicine should be returned to a pharmacy for disposal.

6.7 Physicochemical Properties

Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties.
Naproxen sodium is a propionic acid derivative related to the arylacetic acid class of drugs. It is unrelated to salicylates and the corticosteroid hormones. The chemical name of naproxen sodium is (+)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid, sodium salt. It has a molecular formula of C14H13NaO3 and a molecular weight of 252.2. Naproxen sodium is an odourless, white to off-white crystalline substance. It is soluble in water.

Chemical structure.


CAS number.

26159-34-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes