Consumer medicine information

Aleve 24 Hour

Naproxen sodium

BRAND INFORMATION

Brand name

Aleve 24 Hour

Active ingredient

Naproxen sodium

Schedule

What is in this leaflet

This leaflet answers some common questions about ALEVE 24 Hour.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your pharmacist or doctor will be able to advise you about the risks and benefits of taking ALEVE 24 Hour.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

What ALEVE 24 Hour is used for

ALEVE 24 Hour belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation.

ALEVE 24 Hour relieves persistent pain and reduces inflammation (swelling, redness and soreness) that may occur in the following:

body pain
back pain
neck and shoulder pain
muscle pain
sprains and strains
osteoarthritis
arthritic and rheumatic conditions
period pain
dental pain
sinus pain
cold and flu

ALEVE 24 Hour can also provide temporary relief of stiffness associated with arthritis.

Aleve 24 Hour should be used if pain is likely to last for longer than 12 hours.

Although ALEVE 24 Hour can relieve the symptoms of pain and inflammation, it will not cure your condition.

Use in children statement:
ALEVE 24 Hour is not recommended for use in children (under the age of 12), as there have been no studies of its effects in children.

ALEVE 24 Hour is not addictive.

It is available from your pharmacist.

Before you take ALEVE 24 Hour

When you must not take it

Do not take ALEVE 24 Hour if you have an allergy to:

any medicine containing naproxen (the active ingredient in ALEVE 24 Hour), aspirin or any other NSAIDs
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 pharmacist.

Some of the symptoms of an allergic reaction may include:

asthma, wheezing, difficulty breathing or shortness of breath
swelling of the face, lips, tongue or other parts of the body which may cause difficulty in swallowing or breathing
hives, itching or rash
fainting

If you are allergic to aspirin or NSAID medicines and take ALEVE 24 Hour, these symptoms may be severe.

Do not take ALEVE 24 Hour if at the present time you have an ulcer (gastric or duodenal) or other stomach disorders, or bleeding from the stomach or bowel. If you take it, your stomach problem may become worse.

Do not take ALEVE 24 Hour if you have impaired kidney function or heart failure.

Do not take ALEVE 24 Hour in the last 3 months of pregnancy. It may affect the baby, and also delay labour and birth.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Do not take this medicine if you are aged 65 years old or over unless your doctor has told you to. Your doctor might tell you to take other lower-dose naproxen tablets instead of Aleve 24 Hour so that you may use the lowest effective dose.

Do not give this medicine to a child under 12 years of age. ALEVE 24 Hour is not recommended for use in children under 12 years of age, as there is not enough information on its use in children under that age.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your pharmacist or doctor if you have any of these health problems/medical conditions at the present time:

heart disease
kidney disease
liver disease
high blood pressure
a tendency to bleed or other blood problems/ such as anaemia
asthma

Your pharmacist or doctor may want to take special precautions if you have any of these conditions.

Tell your pharmacist or doctor if you have or ever have of the following medical conditions:

ulcers (gastric or duodenal)
severe attacks of indigestion or other stomach trouble
diseases of the bowel (e.g. Crohn’s disease, ulcerative colitis)
bleeding from your rectum (back passage)

Tell your pharmacist or doctor if you have an infection at the present time. If you take ALEVE 24 Hour while you have an infection, some of the signs of the infection may be hidden (pain, fever, swelling, redness). You may think, mistakenly, that you are better or that your infection is not serious.

Tell your pharmacist or doctor if you are pregnant, or plan to become pregnant or are breast-feeding. Like most NSAID medicines, ALEVE 24 Hour is not recommended to be used during pregnancy or when breast-feeding. Your pharmacist or doctor will discuss with you the benefits and risks of taking it.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking ALEVE 24 Hour.

Taking other medicines

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

Some medicines and naproxen may interfere with each other. These include:

aspirin, salicylates and other NSAIDs or anti-inflammatory medicines or other medicines for pain relief
phenytoin, a medicine used to treat epilepsy
serotonin reuptake inhibitors, medicines that are often used for the treatment of depression
glucocorticoids, a class of steroid hormones
probenecid, a medicine used to treat gout
medicines used to treat high blood pressure, like beta blockers, ACE-Inhibitors and angiotensin receptor blockers
anticoagulant/antiplatelet medicines e.g. warfarin, coumarins, aspirin
lithium, a medicine used to treat some types of depression
diuretics, also called fluid or water tablets
methotrexate, a medicine used to treat arthritis and some types of cancer
digoxin, a medicine used to treat heart failure
cyclosporin, a medicine used to suppress the immune system
zidovudine, a medicine used to treat HIV infection

Your doctor and pharmacist will have more information on these and other medicines to be careful with or avoid while taking this medicine.

How to take ALEVE 24 Hour

Follow all directions given to you by your pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your pharmacist for help.

How much to take/use

Adults and children from 12 years: Take one tablet every 24 hours as required. Do not take more than one tablet a day.

How to take it

Swallow one tablet whole with a full glass of water or milk. Do not break, crush or chew the tablets.

When to take it

Tablet should be taken with or without food. If you have a sensitive stomach, take with food. If taken with food, the product may take longer to work.

How long to take it

Do not use ALEVE 24 Hour for more than a few days at a time unless your doctor has told you to.

Do not exceed the recommended dose. Excessive use can be harmful.

If symptoms persist or worsen, see your doctor to ensure that they are not due to serious illness. The use of Aleve 24 Hour could mask potentially serious infections.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much ALEVE 24 Hour. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.

If you take/use too much ALEVE 24 Hour, you may feel nausea (feeling sick), vomiting, heartburn, indigestion or cramps.

While you are taking ALEVE 24 Hour

Things you must do

If you become pregnant while taking Aleve 24 Hour, tell your pharmacist or doctor immediately. He/she can discuss with you the risks of taking it while you are pregnant.

If you are about to start using any new medicine, remind your pharmacist or doctor that you are taking Aleve 24 Hour. Take this medicine exactly as directed by your pharmacist or doctor. If you do not follow these instructions, your condition may not improve or you may have unwanted side effects.

If you are going to have surgery, make sure the surgeon and anaesthetist know that you are taking Aleve 24 Hour. NSAID medicines can slow down blood clotting.

If you get an infection while taking Aleve 24 Hour, tell your doctor. This medicine may hide some of the signs of an infection (pain, fever, swelling, redness). You may think, mistakenly, that you are better or the infection is not serious.

Talk to your pharmacist or doctor if you feel that the medicine is not helping. This will help him/her determine the best treatment for you.

Tell any other doctor, dentist or pharmacist who treats you that you are taking ALEVE 24 Hour.

Things you must not do

Do not take any medicines used to treat arthritis while you are taking Aleve 24 Hour without first telling your doctor or pharmacist.

This includes:

aspirin or other salicylates
any NSAID or anti-inflammatory medicine

Do not take ALEVE 24 Hour to treat any other complaints unless your pharmacist or doctor tells you to.

Do not give ALEVE 24 Hour to anyone else, even if they have the same condition as you.

Do not take more than the recommended dose unless your doctor tells you to.

Things to be careful of

Aleve 24 Hour is not recommended if you are aged 65 years old or over unless your doctor has told you to take this medicine.

Taking this medicine may increase the risk of you getting unwanted effects, such as stomach or heart problems.

Be careful driving or operating machinery until you know how ALEVE 24 Hour affects you. This medicine may cause dizziness, drowsiness or blurred vision in some people. If this happens, do not drive, use or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ALEVE 24 Hour.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you get an allergic reaction stop taking and see your doctor immediately.

If you are aged 65 years old or over you may have an increased chance of getting side effects. Report any side effects promptly to your pharmacist or doctor.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

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

stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion, cramps or stomach pain
loss of appetite
diarrhoea, pain in the stomach, wind
dizziness, light-headedness
drowsiness, sleepiness, disorientation
headache
change in mood, e.g. feeling depressed, anxious, irritable or nervous
buzzing or ringing in the ears
sore or dry mouth or tongue
trembling, sleeplessness, nightmares
sore mouth or tongue
altered taste sensation
feeling thirsty
aching muscles, muscle tenderness or weakness, not caused by exercise

The above list includes the more common side effects of your medicine. They are usually mild.

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

severe pain or tenderness in the stomach
signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal, reddish-purplish or blue-black blotches under the skin
signs of anaemia such as tiredness, being short of breath, looking pale
a change in the colour of urine passed, blood in the urine
a change in the amount or frequency of the urine passed, burning feeling when passing urine
signs of a liver problem such as tiredness, lack of energy, itching of the skin, yellowing of the skin and eyes, pain in the abdomen
unusual weight gain, swelling of ankles or legs
get sunburnt more quickly than normal
eye problems such as blurred or double vision , sore red eyes, itching
severe dizziness, spinning sensation
severe or persistent headache
tingling or numbness of the hands or feet
fast or irregular heartbeats, also called palpitations
difficulty hearing, deafness
severe skin rashes

These are serious side effects. You may require medical attention. Serious side effects are rare for low doses of this medicine and when used for a short period of time.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

vomiting blood or what look like coffee grounds
bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea
swelling of the face, lips, tongue which may cause difficulty in swallowing or breathing
asthma, wheezing or shortness of breath
sudden or severe rash, itching or hives on the skin
fainting or seizures (fits)
pain or tightness in the chest

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

Tell your pharmacist or doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

After taking ALEVE 24 Hour

Storage

Keep your tablets in the strip pack until it is time to take them. If you take the tablets out of the strip pack they will not keep well.

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

Do not store ALEVE 24 Hour or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking ALEVE 24 Hour or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

ALEVE 24 Hour tablets are blue, capsule-shaped, film-coated tablet debossed with “BAYER” on one side and “660” on the other. It comes in strip packs of 4, 8, 12 and 16 tablets.

Ingredients

Active ingredient:

Each ALEVE 24 Hour is a bilayer tablet with an immediate release layer containing 264 mg naproxen sodium and an extended release layer containing 396 mg of naproxen sodium.

Inactive ingredients:

povidone
microcrystalline cellulose
purified talc
magnesium stearate
purified water
hypromellose
lactose
silica colloidal anhydrous
titanium dioxide
macrogol 8000
indigo carmine aluminium lake
carnauba wax

ALEVE 24 Hour also contains galactose

ALEVE 24 Hour does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier/Distributor

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073

ALEVE is a Registered Trademark.

Australian Registration Number: AUST R 263421.

This leaflet was prepared in October 2019.

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Aleve 24 Hour

Active ingredient

Naproxen sodium

Schedule

1 Name of Medicine

Naproxen sodium.

2 Qualitative and Quantitative Composition

One Aleve 24 Hour extended release tablet contains 660 mg naproxen sodium, equivalent to 600 mg naproxen.

List of excipients with known effect.

Aleve 24 Hour 660 mg extended release tablet contains lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The Aleve 24 Hour tablet is a bilayer tablet with an immediate release layer containing 264 mg naproxen sodium and an extended release layer containing 396 mg of naproxen sodium.
Aleve 24 Hour tablets are blue, capsule-shaped, film-coated tablet, debossed with "BAYER" on one side and "660" on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Temporary relief of persistent pain and/or inflammation likely to last for more than 12 hours associated with body pain, back pain, neck and shoulder pain, muscle pain, sprains and strains, osteoarthritis, arthritic and rheumatic conditions, period pain, dental pain, sinus pain, cold and flu. Also reduces stiffness in muscles and joints.

4.2 Dose and Method of Administration

Pregnancy.

See Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation.
Unless otherwise prescribed, the following dosage recommendations apply:

Adults and adolescents aged 12 years and over.

Take 1 tablet every 24 hours while symptoms last. The maximum daily dose is 1 tablet (equivalent to 660 mg naproxen sodium).
Aleve 24 Hour is not recommended in patients aged 65 years old and over unless otherwise advised by their physician. Other lower-dose naproxen tablets may be used to achieve the lowest effective dose.
Aleve 24 Hour is swallowed whole with plenty of liquid and can be taken before or during meals.
The tablets should not be chewed, crushed or broken.
Patients with a sensitive stomach are advised to take Aleve 24 Hour during meals. If taken with food, the product may take longer to work.

4.3 Contraindications

Third trimester of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).
Aleve 24 Hour must not be used in the following circumstances:
hypersensitivity to the active substance, naproxen, or to any of the excipients of the medicinal product;
if asthma attacks, inflammation of the nasal mucosa or skin reactions have previously been experienced after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
unexplained haemopoietic disorders;
continuing or repeated past occurrences of peptic ulcers or haemorrhages (evidence of at least two separate episodes of ulcers or bleeding history of stomach ulcer);
a past history of gastrointestinal bleeding or perforation caused by previous therapy with NSAIDs;
cerebrovascular haemorrhages or other active bleedings;
severe impairment of renal or hepatic function;
heart failure or heart problems;
during the last three months of pregnancy;
by children under the age of 12 years since safety in this age group has not been established.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Gastrointestinal safety. 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. 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.
The use of Aleve 24 Hour in combination with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Contraindications can be reduced by using the lowest effective dosage for the shortest period possible for controlling the symptoms.
Gastrointestinal haemorrhages, ulcers or perforations. 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 (see Use in the elderly). Debilitated patients do not seem to withstand ulceration or bleeding as well as others. Most of the fatal gastrointestinal events associated with NSAIDs occurred with the elderly and/or debilitated patients.
The risk of gastrointestinal bleeding, ulceration and perforation rises with increasing doses of the NSAID in patients with a history of ulcers, particularly if the latter occurred in conjunction with bleeding and perforation, and in elderly patients. These patients should be first treated with the lowest possible dose.
Patients with a medical history of gastrointestinal toxicity, in particular older patients, should report any unusual symptoms in the abdominal cavity (above all gastrointestinal haemorrhages), in particular, at the start of treatment.
NSAIDs should be used with caution in patients with a medical history of inflammatory bowel disease such as ulcerative colitis or Crohn's disease as the symptoms may worsen.
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 increases the risk of serious gastrointestinal adverse events.
Patients with risk factors should commence treatment on the lowest dose available.
Caution is advised with patients who are concurrently receiving medicinal products that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulant agents like warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Treatment should be discontinued should patients receiving Aleve 24 Hour treatment experience gastrointestinal bleeding or perforation.
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.
Patients with a medical history of gastrointestinal toxicity, in particular older patients, should report any unusual symptoms in the abdominal cavity (above all gastrointestinal haemorrhages), in particular at the start of treatment (see Use in the elderly).
Cardiovascular and cerebrovascular effects. Caution is called for (discussion with the physician or pharmacist) prior to treating patients with a medical history of hypertension and/or cardiac insufficiency, as fluid retention, hypertension and oedema have been reported in connection with NSAID therapy.
Clinical studies of epidemiological data suggest that the administration of some NSAIDs (in particular, when given in high dosages and over an extended period) may possibly be linked to a slightly increased risk of arterial thrombotic occurrences (for example, myocardial infarction or stroke). Although data suggests that a low risk may be associated with the use of naproxen (1000 mg daily), a risk of this nature cannot be ruled out. Insufficient data is available on the effects of low doses (220 mg - 660 mg naproxen sodium) for any safe conclusions about the possible risks of thrombosis to be drawn.
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.
Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore, caution is advised in patients with fluid retention or heart failure.
Skin reactions. Among patients receiving NSAID therapy, there have been very rare reports of serious skin reactions, some of which have been fatal, including Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN). The highest risk of reactions of this kind appears to be at the beginning of therapy because in most cases, these reactions occurred in the first month of treatment. Administration of Aleve 24 Hour should be discontinued at the first signs of rashes, lesions of the mucous membranes, or other signs of hypersensitivity.

Drug reaction with eosinophilia with systemic symptoms (DRESS).

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 the NSAID and evaluate the patient immediately.
Additional information. Aleve 24 Hour should be used in the following circumstances only after rigorously weighing up the risks and benefits:
in cases of congenital disorder of the porphyrin metabolism (e.g. acute intermittent porphyria);
systemic lupus erythematosus (SLE) and mixed connective tissue disease (see Section 4.8 Adverse Effects (Undesirable Effects)).
Particularly careful medical supervision is needed:
in cases of renal impairment;
hepatic impairment;
immediately after major surgery;
in cases of cardiac impairment;
patients suffering from hay fever, nasal polyps or chronic obstructive airway diseases, as they are at greater risk of allergic reactions. These may appear as asthma attacks (so-called analgesic asthma), angioneurotic oedema or urticaria;
in patients with allergic reactions to other substances, because the use of Aleve 24 Hour also increases the risk of hypersensitivity reactions.
Serious hypersensitivity reactions (for example anaphylactic shock) have very rarely been reported. Therapy should be discontinued as soon as the first signs of a hypersensitivity reaction following the use of Aleve 24 Hour become apparent. Medically necessary measures appropriate to the symptoms must be taken by competent persons.
Naproxen, the active substance of Aleve 24 Hour, may temporarily inhibit the platelet function (platelet aggregation). Patients with coagulation disorders should thus be carefully observed.
Prolonged use of painkillers may lead to headaches that must not be treated with increased doses of the medication.
As a general rule, the habitual use of painkillers, particularly where several painkilling active substances are combined, may lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
The use of NSAIDs and the concomitant consumption of alcohol may enhance the undesirable effects of the active substance, particularly its effects on the gastrointestinal tract and the central nervous system.
Infection. The antipyretic, anti-inflammatory and analgesic effects of naproxen may mask the usual signs and 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 naproxen, although a cause-and-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with Aleve 24 Hour should have an opthalmological examination.

Use in the elderly.

Aleve 24 Hour is not recommended in patients aged 65 years old and over unless otherwise advised by their physician. Other lower-dose naproxen tablets may be used to achieve the lowest effective dose.
Elderly patients, particularly those with a history of gastrointestinal toxicity, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Adverse reactions are frequently observed with NSAID therapy in older patients, above all gastrointestinal haemorrhages and perforations, some of which have been fatal.

Paediatric use.

This product is not recommended for children under the age of 12 years since safety in this age group has not been established.

Effects on laboratory tests.

Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be considered when bleeding times are determined.
Prolonged use of Aleve 24 Hour necessitates regular monitoring of hepatic parameters, renal function and blood count.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Naproxen, like other NSAIDs, should always be used with caution in patients being treated concurrently with the following medicinal products:

Other NSAIDs including salicylates.

Due to a synergistic effect, the concurrent administration of a number of NSAIDs can increase the risk of serious NSAID-related adverse events e.g. gastrointestinal ulcers and haemorrhages. Therefore, concurrent treatment with naproxen and other NSAIDs, including cyclooxygenase-2 (COX-2) selective inhibitors should be avoided.

Digoxin, phenytoin, and lithium.

The concurrent use of Aleve 24 Hour and digoxin, phenytoin, or lithium preparations may increase the serum levels of these medicinal products. As a rule, checks of the serum lithium level, the serum digoxin level and the serum phenytoin level are not necessary under normal conditions of use (up to a maximum of 4 days).

Glucocorticoids.

Increased risk of gastrointestinal ulcers or gastrointestinal haemorrhage (see Section 4.4 Special Warnings and Precautions for Use).

Methotrexate.

The administration of Aleve 24 Hour within 24 hours before or after taking methotrexate may lead to an increased concentration of methotrexate and to an increase in its toxic effect.

Cyclosporin.

The risk of a nephrotoxic effect of cyclosporin is increased by the concurrent administration of particular NSAIDs, including naproxen.

Anticoagulant/antiplatelet agents.

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

Selective serotonin reuptake inhibitors.

There is an increased risk of gastrointestinal bleeding when anti-platelet agents such as acetylsalicylic acid and selective serotonin reuptake inhibitors are combined with NSAIDs.

Protein binding.

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

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-desmethyl naproxen.

Beta-blockers.

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

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.

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

NSAIDs may reduce the effects of diuretics and anti-hypertensives. In patients with renal impairment (e.g. dehydrated patients or elderly patients), concomitant administration of an ACE inhibitor or angiotensin II antagonist with a medicinal product that inhibits cyclo-oxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Thus, a combination of this nature should only be administered with caution, above all with older patients. Patients should be urged to consume adequate amounts of fluids and regular monitoring of renal values should be considered following the start of a combination regimen.
Concurrent administration of Aleve 24 Hour and potassium-sparing diuretics may lead to hyperkalaemia. Naproxen may inhibit the natriuretic effect of frusemide.
The use of an ACE inhibiting drug, an 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.

There is a certain amount of evidence that medicinal products that inhibit cyclo-oxygenase/prostaglandin synthesis may interfere with female fertility by disrupting ovulation. This effect is reversible on ceasing treatment.
(Category C¹)
The inhibition of the prostaglandin synthesis may have a negative influence on pregnancy and/or embryo-foetal development. Data from epidemiological studies suggest an increased risk of birth defects, as well as cardiac malformations and gastroschisis following the use of a prostaglandin inhibitor during early pregnancy. It is believed that the risk increases with the dose and the duration of therapy.
It has been confirmed in animals that the use of a prostaglandin inhibitor leads to increased pre and post-implantation loss and to embryofoetal lethality. In addition, increased incidences of different types of malformations, including cardiovascular ones, have been reported in animals which were given a prostaglandin inhibitor during the organogenesis phase.
During the first and second trimesters of pregnancy, naproxen should only be administered when absolutely necessary. If naproxen is used by a woman who wants to become pregnant, or it is used during the first or second trimester of pregnancy, the dose should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin inhibitors can subject the foetus to the following risks:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
renal impairment, that can lead to neonatal renal failure with oligohydramnios (see Oligohydramnios and neonatal renal impairment);
subject the mother and child, at the end of the pregnancy to the following risks:
possible extension of bleeding time, an antiplatelet effect that may occur even at very low doses;
inhibition of contractions of the uterus, resulting in delayed or prolonged parturition.
Naproxen is therefore contraindicated during the third pregnancy trimester.

Oligohydramnios and neonatal renal impairment.

Use of NSAIDs from about 20 weeks gestation 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, NSAID treatment is necessary from about 20 weeks, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.

Puerperium.

Aleve 24 Hour should not be used in the puerperium on account of the possibility of increased postpartum bleeding.
¹ Pregnancy Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible.
Small amounts of the active substance naproxen and its degradation products pass into breast milk. The use of Aleve 24 Hour while breast-feeding should be avoided as a precaution.

4.7 Effects on Ability to Drive and Use Machines

Central nervous disorders such as fatigue and dizziness may appear as adverse events during the use of higher doses of Aleve 24 Hour. In individual cases, the ability to react and to drive road vehicles and to use machines may be impaired. This is particularly the case in conjunction with alcohol.

4.8 Adverse Effects (Undesirable Effects)

Evaluation of undesirable effects is based on the following frequencies:
Common: ≥ 1/100 to < 1/10; Uncommon: ≥ 1/1,000 to < 1/100; Rare: ≥ 1/10,000 to < 1/1,000; Very rare: < 1/10,000.
The listing of the following undesirable effects includes all side effects of treatment with naproxen that have come to light, including those from high-dose, long-term treatment of patients with rheumatism. The specified frequencies of anything other than very rare reports relate to short-term use at daily doses of up to a maximum of 750 mg naproxen for oral dosage forms.
In the case of the following adverse events, it should be considered that they are primarily dose-dependent and may also vary from patient to patient.
Naproxen causes a moderate dose dependent prolongation of the bleeding time, which is reversible.
The most commonly observed undesirable effects involve the digestive tract. Peptic ulcers, perforations or haemorrhages, sometimes with fatal results, in particular among older patients. Nausea, vomiting, diarrhoea, flatulence, constipation, digestive symptoms, abdominal pain, tarry stools, haematemesis, ulcerative stomatitis, and exacerbation of colitis and Crohn's disease have been reported following use. Gastritis has been less commonly reported.
In particular, the risk of gastrointestinal bleeding is dependent on the dose range and duration of treatment.
Oedema, hypertension and cardiac failure have been reported in connection with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (in particular, at high doses and over long periods of treatment) are possibly linked to a slightly increased risk of arterial thrombotic events, for example myocardial infarction or stroke.

Cardiac disorders.

Very rare: congestive heart failure, hypertension, pulmonary oedema, palpitations.

Blood and lymphatic system disorders.

Very rare: haemopoietic disturbances (leucopenia, thrombocytopenia, agranulocytosis, aplastic anaemia, eosinophilia, haemolytic anaemia).

Nervous system disorders.

Common: dizziness, headache, light-headedness.
Uncommon: drowsiness, insomnia, somnolence.
Very rare: aseptic meningitis, cognitive dysfunction, convulsions.

Eye disorders.

Very rare: visual disturbance, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema.

Ear and labyrinth disorders.

Uncommon: vertigo.
Very rare: hearing impairment, tinnitus and hearing disturbances.

Gastrointestinal disorders.

Common: dyspepsia, nausea, heartburn, abdominal pain.
Uncommon: vomiting, constipation or diarrhoea.
Rare: peptic ulcers without or with bleeding or perforation, gastrointestinal bleeding, haematemesis, melaena.
Very rare: stomatitis, oesophagitis, pancreatitis, colitis, aphthous ulcers, intestinal ulcerations.
Patients should be told that, if reasonably severe upper abdominal pain, melaena or haematemesis occurs, they should stop taking Aleve 24 Hour and should seek medical advice immediately.

Hepatobiliary disorders.

Very rare: hepatitis (including fatal cases), jaundice, icterus.

Immune system disorders.

Very rare: anaphylaxis/anaphylactoid reactions including shock with fatal outcome. Signs of such reactions may be as follows: facial, lingual and laryngeal oedema, dyspnoea, tachycardia, and fall in blood pressure to the point of life-threatening shock.
If such phenomena occur, as may happen on first use of the product, immediate medical assistance is required.

Renal and urinary tract disorders.

Rare: renal impairment.
Very rare: interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, haematuria, proteinuria.

Skin and subcutaneous tissue disorders.

Uncommon: exanthema (rash), pruritus, urticaria.
Rare: angioneutotic oedema.
Very rare: alopecia (usually reversible), photosensitivity, porphyria, exudative erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, skin rashes, Systemic Lupus Erythematosus, photosensitivity reactions including porphyria cutanea tarda ("pseudoporphyria") or epidermolysis bullosa, ecchymoses, purpura, sweating.
Unknown: Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS).

Infections and parasitic diseases.

Very rare: symptoms of aseptic meningitis with severe headache, nausea, vomiting, fever, neck stiffness or clouding of consciousness. Patients with autoimmune diseases (SLE, mixed connective tissue disease) would appear to be predisposed to this undesirable effect.
Very rare: deterioration of infectious diseases (e.g. development of necrotising fasciitis), temporally related to systemic use of NSAIDs has been described. This is possibly linked to the mechanism of action of NSAIDs.
Should signs of infection appear or worsen during use of Aleve 24 Hour, patients are therefore advised to consult a doctor immediately so that the need for anti-infective/antibiotic therapy can be determined.

Pregnancy, puerperium and perinatal conditions.

Very rare: induction of labour.
Unknown: oligohydramnios, neonatal renal impairment.

Congenital disorders.

Very rare: closure of ductus arteriosus.

Reproductive disorders.

Very rare: female - infertility.

Vascular disorders.

Very rare: vasculitis.

Psychiatric disorders.

Very rare: psychiatric disorders, depression, dream abnormalities, inability to concentrate.

Respiratory disorders.

Very rare: dyspnoea, asthma, eosinophilic pneumonitis.

Investigations.

Very rare: raised serum creatinine, abnormal liver function tests, hyperkalaemia.

General disorders and administration site conditions.

Rare: peripheral oedema, particularly in patients with hypertension or kidney failure, pyrexia (including chills and fever).
Very rare: oedema, thirst, malaise.

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 www.tga.gov.au/reporting-problems.

4.9 Overdose

Significant overdose of the medicine may be characterised by dizziness, drowsiness, epigastric pain, abdominal pain or discomfort, heartburn, dyspepsia, indigestion, transient alterations in liver function, hypoprothrombinaemia, renal dysfunction, metabolic acidosis, apnoea, disorientation, nausea or vomiting. The occurrence of gastrointestinal bleeding is also possible.
The following may also occur after an overdose: hypotension, hypertension, acute reversible renal failure, respiratory depression, cyanosis and coma. A few patients have experienced seizures, but it is unclear if these were causally related to naproxen. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs.
It is not known what dose of naproxen would be life-threatening.
In an event of NSAIDs overdose, patients should be managed by symptomatic and supportive care. There are no specific antidotes. Prevention of further absorption (e.g. activated charcoal) may be indicated in symptomatic patients seen within one hour of ingestion or following a large overdose. Forced diuresis, alkalinisation 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.

Naproxen is a non-steroidal anti-inflammatory drug/analgesic that has proved effective by means of inhibition of prostaglandin synthesis in the usual animal models of inflammation. In humans, naproxen reduces pain, swelling and fever.
In addition, naproxen reversibly inhibits platelet aggregation.

Clinical trials.

A clinical trial to assess the analgesic efficacy and safety of the extended release formulation (660 mg naproxen sodium tablets) relative to immediate release formulation (220 mg naproxen sodium tablets) in postsurgical dental pain was conducted. The objective of the trial was to establish the non-inferiority of the extended release formulation administered once in 24 hours versus the immediate release formulation administered every 8 hours, with summed pain intensity differences (SPID) over 24 hours as the primary efficacy variable. The analgesic efficacy of the extended release formulation was not inferior to the immediate release formulation in postsurgical dental pain for the entire 24 hour period. Both the extended release formulation taken once per day and the immediate release formulation three times per day were generally safe and well-tolerated.

5.2 Pharmacokinetic Properties

Absorption.

After oral administration, naproxen sodium is absorbed partially while still in the stomach and then fully in the small intestine.
Peak plasma concentrations are attained within 1 - 2 hours of taking a dose under fasting conditions. When Aleve 24 Hour was taken after food, the time to peak plasma concentration was significantly delayed.
Studies evaluating the effect of food on the PK profile of the naproxen sodium extended release formulation showed that food had no effect on the extent of absorption based on comparable AUC values, but delayed the rate of absorption as shown by longer Tmax value.

Distribution.

The therapeutically effective plasma concentration is over 15 microgram/mL, plasma protein binding is 99% and the volume of distribution is approximately 0.1 L/kg.
Naproxen sodium crosses the placenta and is also secreted in human breast milk (1%). The plasma concentration of unbound naproxen is increased in patients with severely impaired hepatic function.

Metabolism.

Naproxen sodium is metabolised in the liver.

Excretion.

Elimination is predominantly via the renal route. The elimination half-life in healthy subjects and patients with renal impairment is 10 to 18 hours.
Renal excretion of naproxen and its metabolites is reduced in patients with severe renal insufficiency.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, magnesium stearate, purified water, hypromellose, lactose, silica colloidal anhydrous, titanium dioxide, macrogol 8000, indigo carmine and carnauba wax.
See Section 2 Qualitative and Quantitative Composition.

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.

6.5 Nature and Contents of Container

Aleve 24 Hour tablets come in strip packs of 4, 8, 12 and 16 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Naproxen sodium is a white to almost white, hygroscopic, crystalline powder. It is freely soluble in water.
Naproxen sodium is a white to creamy, crystalline solid, freely soluble in water.

CAS number.

CAS 26159-34-2.

7 Medicine Schedule (Poisons Standard)

S3 Pharmacist-Only Medicine.

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