Consumer medicine information

Chemmart Isosorbide Mononitrate Sustained-Release Tablets

Isosorbide mononitrate

BRAND INFORMATION

Brand name

Chemmart Isosorbide Mononitrate

Active ingredient

Isosorbide mononitrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemmart Isosorbide Mononitrate Sustained-Release Tablets.

What is in this leaflet

This leaflet answers some of the common questions people ask about isosorbide mononitrate. It does not contain all the information that is known about this medicine. It does not take place of talking to your doctor or pharmacist.

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

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

Keep this leaflet with the medicine. You may need to read it again.

What this medicine is used for

Isosorbide mononitrate sustained-release tablets are used to prevent angina.

Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or the neck and sometimes to the shoulders and back. This is caused by too little blood and oxygen getting to the heart.

The pain of angina is usually brought on by exercise or stress.

How it works

Isosorbide mononitrate belongs to a group of medicines called nitrates. It works by relaxing the blood vessels, letting more blood and oxygen reach the heart.

It is not recommended that isosorbide mononitrate be taken for the treatment of acute attacks.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

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

There is not enough information to recommend the use of this medicine in children.

Before you take this medicine

When you must not take it

Do not take this medicine if you have any allergy to:

  • isosorbide mononitrate
  • food containing nitrates
  • nitrites
  • any ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • muscle or joint pain, tenderness
  • rash, itching or hives on the skin.

Do not take this medicine if you are intolerant or allergic to lactose. These tablets contain lactose.

Do not take isosorbide mononitrate if you have or have had any of the following medical conditions:

  • extremely low blood pressure
  • shock, including when caused by low blood pressure or heart failure
  • pericarditis (swelling around the heart)
  • weakened muscle of the heart.

You must not use isosorbide mononitrate whilst taking sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®).

Do not use this medicine to treat acute angina.

Do not take isosorbide mononitrate tablets if you are pregnant, plan to become pregnant or are breastfeeding. It is not known whether it is safe to take isosorbide mononitrate whilst you are pregnant or breast-feeding. It may affect your baby. Ask your doctor about the risks and benefits involved.

Do not use 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.

If you are not sure whether you should take this medicine, talk to your doctor.

Before you start to take it

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

Tell your doctor if you have any of the following medical conditions:

  • liver or kidney problems
  • low blood pressure
  • heart and blood vessel problems

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist 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 isosorbide mononitrate may interfere with each other. These include:

  • medicines used to treat male impotence e.g. (sildenafil, vardenafil, tadalafil)
  • medicines used to treat high blood pressure and heart conditions (e.g. verapamil)
  • medicines used to treat liver disease (e.g. propranolol)

These medicines may be affected by this medicine or may affect how well isosorbide mononitrate works. You may need different amounts of your medicines, or you may need to take different medicines.

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

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ to the information contained in this leaflet.

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

How much to take

Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether you are taking any other medicines.

The usual dose is one tablet taken once a day. This may be increased by your doctor if necessary to two tablets taken once a day.

How to take it

Swallow the tablets whole with water. Do not halve, chew or crush the tablets. Chemmart Isosorbide mononitrate sustained-release tablets are designed to let the drug out over several hours. If they are crushed or chewed they won't work properly.

The tablets are composed of a waxy substance that does not dissolve in the body. You may find the outer shell of the tablets in your bowel motions. The medication in them has already been absorbed by the body.

When to take it

Take this medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you to remember when to take it.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition but does not cure it. It is important to keep taking your medicine even if you feel well.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, as long as it is not more than 8 hours late. If it is more than 8 hours after you should have taken your dose, wait until the right time the next day to take it.

Do not double the dose. You may find that you will need to use the tablets or spray that your doctor has given you to use during angina attacks if you miss a dose.

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

If you take too much (overdose)

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

Symptoms of an overdose include a pulsing headache, feeling excited, flushed, cold sweats, nausea or vomiting.

While you are taking this medicine

Things you must do

If you are started on any new medicines, remind your doctor and pharmacist that you are taking this one.

Tell any other doctors, dentists and pharmacists who are treating you that you are taking isosorbide mononitrate.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Take this medicine regularly once every day. If you miss doses, you will be more likely to get attacks of angina.

Tell your doctor if you continue to get angina attacks, or they become more frequent, while you are taking isosorbide mononitrate.

Things you must not do

Do not take this medicine to relieve acute attacks of angina. Your doctor will have given you other tablets or spray to use when you get attacks of angina.

Do not take this medicine for any other complaints unless your doctor tells you to.

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

Do not stop taking this medicine or change the dosage without checking with your doctor.

Things to be careful of

Speak to your doctor about starting any new physical activities while on this medicine.

You will probably feel better and more active when you start taking this medicine, but you may need time to improve your physical fitness.

Be careful driving or operating machinery until you know how this medicine affects you. Isosorbide mononitrate may cause dizziness and fainting in some patients, especially when you first start to take it. Make sure you know how you feel when you are taking this medicine before you drive a car, operate machinery, or do anything else that could be dangerous.

Be careful when drinking alcohol while you are using this medicine. If you drink alcohol while you are taking this medicine, your blood pressure may drop, making you feel dizzy or faint.

Side effects

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

Isosorbide mononitrate helps most people with angina, but it may have unwanted side effects in a few people. All medicines may have some unwanted side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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 or pharmacist if you notice any of the following and they worry you:

  • headache (usually goes away after a few days)
  • dizziness, light-headedness or feeling faint
  • stomach complaints, such as nausea, vomiting, heartburn, diarrhoea
  • rapid heart beat
  • poor appetite
  • rash, itching
  • tiredness or sleep disturbances
  • muscle tenderness or weakness, not caused by exercise.

The above list includes the more common side effects of isosorbide mononitrate.

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

Storage and disposal

Storage

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

Keep it in a cool dry place, protected from light and where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or near a windowsill. Heat and dampness can destroy some medicines.

Keep it where young 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any tablets left over.

Product description

What it looks like

Cream, film-coated oval tablets of 13mm length and half scored on both sides.

Available in blister packs of 30 tablets. AUST R 75239.

Ingredients

Each tablet contains 60 mg of isosorbide mononitrate as the active ingredient.

They also contain the following:

  • stearic acid
  • carnauba wax
  • hypromellose
  • lactose monohydrate
  • magnesium stearate
  • purified talc
  • titanium dioxide
  • purified siliceous earth
  • macrogol 4000
  • iron oxide yellow CI77492

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

Chemmart is a registered trademark of Symbion Pty Ltd.

This leaflet was prepared in December 2018.

Published by MIMS April 2019

BRAND INFORMATION

Brand name

Chemmart Isosorbide Mononitrate

Active ingredient

Isosorbide mononitrate

Schedule

S4

 

1 Name of Medicine

Isosorbide mononitrate.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

16051-77-7.
Isosorbide mononitrate is a white to pale yellow, crystalline, odourless powder that is freely soluble in water.
Chemical Name: 1,4:3,6-dianhydro-D-glucitol 5-nitrate. Molecular Formula: C6H9NO6. Molecular Weight: 191.14.

2 Qualitative and Quantitative Composition

Chemmart Isosorbide Mononitrate Sustained Release Tablets contain 60 mg isosorbide mononitrate.

Excipients with known effect.

Lactose monohydrate.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets:
A cream, film-coated oval tablet of 13 mm length, half scored on both sides.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Isosorbide mononitrate is an active metabolite of isosorbide dinitrate and exerts qualitatively similar effects. Isosorbide mononitrate reduces the workload of the heart by producing venous and arterial dilatation. By reducing the end diastolic pressure and volume, isosorbide mononitrate lowers intramural pressure, hence leading to an improvement in the sub-endocardial blood flow. The net effect when administering isosorbide mononitrate is therefore a reduced workload for the heart and an improvement in the oxygen supply/demand balance of myocardium.
Nitrates are highly effective in the prophylaxis of symptomatic and asymptomatic myocardial ischaemia. Nitrates dilate coronary arteries not only in pre- and post-stenotic vessels, but also in eccentric lesions. The natural initiator of vascular relaxation is thought to be endothelium derived relaxing factor (EDRF), which has both the clinical and biological characteristics of nitric oxide. Organic nitrates are metabolised to nitric oxide in the muscle cell via a sulfhydryl dependent mechanism. They are therefore thought to be the physiological substitute for EDRF.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Isosorbide mononitrate has an elimination half-life of around 5 hours. Isosorbide Mononitrate 60 mg Sustained Release Tablets provide a sustained release presentation of isosorbide mononitrate, with approximately 85% bioavailability. The release mechanism in Chemmart Isosorbide Mononitrate comprises active drug distributed within a hydrophobic cellulose matrix with release occurring by diffusion. Drug particles close to the tablet surface are released relatively rapidly, but those incorporated more deeply are released more slowly. Administration of isosorbide mononitrate 60 mg Sustained Release Tablets results in a gradual, non-pH dependent release of the active substance, which is completed after approximately 10 hours. Compared to ordinary tablets, the absorption phase is prolonged and the duration of effect is extended. The absorption of isosorbide mononitrate 60 mg Sustained Release Tablets has been shown not to be influenced by food intake.
After repeated once daily administration of isosorbide mononitrate 60 mg Sustained Release Tablets, the maximum plasma level (about 3000 nanomol/L) of isosorbide mononitrate is achieved at about 4 hours. The plasma concentration remains above 1400 to 1500 nanomol/L for approximately 10 hours, dropping to under 500 nanomol/L by the end of the dosage interval (24 hours after dose). This nitrate low period minimises the possibility of nitrate tolerances developing during prolonged treatment with isosorbide mononitrate 60 mg Sustained Release Tablets.
Isosorbide mononitrate is less than 5% plasma protein bound. The distribution volume of isosorbide mononitrate is about 0.6 L/kg, indicating that it is mainly distributed into total body water. Elimination takes place predominantly by hydrolysis of the nitrate and conjugation in the liver. The metabolites are excreted mainly via the kidneys, with only about 2% of the dose being excreted intact.
In placebo controlled studies, isosorbide mononitrate sustained release tablets have been shown to significantly increase exercise capacity in patients with angina pectoris taking no other chronic treatment, as well as in patients taking concomitant β-blocker therapy.
It is known that the clinical effects may be attenuated during repeated administration with nitrates in high doses and/or frequent administration. However, the pharmacokinetic characteristics of isosorbide mononitrate 60 mg Sustained Release Tablets produce a nitrate low period following once daily dosage. No development of tolerance with respect to antianginal effect has been detected when isosorbide mononitrate Sustained Release Tablets are given at a dose of one or two tablets (60 or 120 mg) once daily. The drug is not recommended for twice daily administration.
There is insufficient evidence to show that one halved tablet of Chemmart Isosorbide Mononitrate delivers exactly half the dose of one full tablet, or whether the rate of release is the same. In vitro dissolution testing showed that dissolution was slightly faster with halved isosorbide mononitrate sustained release tablets than with whole tablets.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Prophylactic treatment of angina pectoris.Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets are not recommended for the management of acute attacks of angina pectoris (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Known hypersensitivity to nitrates or to any of the components in Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets.
Shock (including cardiogenic shock), hypotension, obstructive hypertrophic cardiomyopathy and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis and severe anaemia.
Phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) are contraindicated and must not be given to patients already receiving isosorbide mononitrate therapy.
Concomitant administration of isosorbide mononitrate and Phosphodiesterase type 5 inhibitors can potentiate the vasodilatory effect of isosorbide mononitrate with the potential result of serious side effects such as syncope or myocardial infarction.
Severe cerebrovascular insufficiency or hypotension are relative contraindications to the use of Isosorbide Mononitrate 60 mg Sustained Release Tablets.
Acute angina. Isosorbide Mononitrate 60 mg Sustained Release Tablets are not indicated for the relief of acute attacks of angina; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.

4.4 Special Warnings and Precautions for Use

Note.

There is a risk of developing tolerance to haemodynamic and antianginal effects if higher doses (more than 120 mg/day) and/or more frequent doses (e.g. twice daily) of isosorbide mononitrate 60 mg Sustained Release tablets are administered. It is therefore important that isosorbide mononitrate 60 mg Sustained Release Tablets are administered once a day in order to ensure that intervals with low nitrate concentrations are achieved each day, reducing the risk of the development of tolerance.

Cerebral arteriosclerosis or mitral stenosis.

Caution should be observed if isosorbide mononitrate is administered to patients with severe cerebral arteriosclerosis or pronounced mitral stenosis.

Acute myocardial infarction and congestive cardiac failure.

The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive cardiac failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, the medicine is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical and haemodynamic monitoring is necessary to avoid the hazards of hypotension and tachycardia.

Hypotension.

Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. Hypotension and lightheadedness on standing may be more frequent in patients who have consumed alcohol. The drug should be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.

Industrial workers.

Tolerance develops in industrial workers who have had long-term exposure to high doses of organic nitrates. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.

Check the following before use.

Caution should be observed isosorbide mononitrate 60 mg Sustained Release Tablets are administered to patients with: severe cerebral arteriosclerosis, pronounced mitral stenosis, hypertrophic cardiomyopathy, hypotension or cardiogenic shock.

Use with caution in the following circumstances.

Use in renal impairment.

The elimination of isosorbide mononitrate following administration of an immediate release tablet but not a sustained release tablet, has been investigated in patients with severe renal impairment, but not using the sustained release tablet. Renal impairment makes no therapeutically important difference to the pharmacokinetics of isosorbide mononitrate administered as an immediate release tablet, although two single dose studies did indicate a prolonged half-life in these patients with severe renal impairment. One of these studies also showed a higher plasma concentration. In view of the lack of data regarding the use of the tablet presentation in patients with severe renal impairment, the possibility of accumulation should be borne in mind when administering isosorbide mononitrate 60 mg Sustained Release Tablets to such patients, in whom a reduced dosage may be appropriate.

Use in hepatic impairment.

Isosorbide mononitrate has been shown to cause a significant decrease in portal pressure in patients with cirrhosis and portal hypertension during long-term therapy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Propranolol).

Abrupt withdrawal.

Although no clear cut rebound phenomena were seen upon abrupt withdrawal of isosorbide mononitrate sustained release tablets, such withdrawal is not recommended because of the possibility of severe exacerbation of anginal symptoms.

Paediatric use.

Due to lack of data, the use of isosorbide mononitrate 60 mg Sustained Release Tablets cannot be recommended in children.

Use in the elderly.

No dose reduction is necessary in elderly patients unless they have severe renal impairment.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Phosphodiesterase type 5 inhibitors.

Concomitant administration of isosorbide mononitrate and phosphodiesterase type 5 inhibitors can potentiate the vasodilatory effect of isosorbide mononitrate with the potential result of serious side-effects such as syncope or myocardial infarction. Therefore, phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) must not be given to patients already receiving isosorbide mononitrate therapy.

Sulfhydryl containing compounds.

The metabolism of organic nitrates to nitric oxide is dependent on the presence of sulfhydryl groups in the muscle. The combination of oral N-acetylcysteine and a single dose of sustained release isosorbide mononitrate 60 mg significantly prolonged the total exercise time in patients with angina pectoris and angiographically proven significant coronary artery disease, when compared with isosorbide mononitrate alone. Concomitant administration of other exogenous sources of sulfhydryl groups such as methionine and captopril may produce a similar interaction.

Phenylalkylamine calcium antagonists.

The addition of a calcium channel blocker of the verapamil type, such as gallopamil 75 mg, has been shown to further improve left ventricular functional parameters when given in combination with isosorbide mononitrate in a sustained release formulation.

Propranolol.

The addition of isosorbide mononitrate to propranolol treatment in patients with cirrhosis and portal hypertension caused a marked fall in portal pressure, a reduction in hepatic blood flow, cardiac output and mean arterial blood pressure, but no additional change in azygos blood flow. The additional effect of isosorbide mononitrate was especially evident in patients whose portal pressure was not reduced by propranolol.

Calcium antagonists (general).

Marked symptomatic orthostatic hypotension has been reported when calcium antagonists and organic nitrates were used in combination. Dose adjustments of either class of agent may be necessary.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
The safety of isosorbide mononitrate in pregnancy has not been established. In the absence of Segment I and III studies with isosorbide mononitrate, the drug should only be administered to pregnant women if, in the opinion of the physician, the clinical benefits outweigh the potential risks.

At present there is no documentation about the passage of isosorbide mononitrate into breast milk, therefore its use in women who are breastfeeding is not recommended.

4.8 Adverse Effects (Undesirable Effects)

Adverse effects associated with the vascular activity of the drug are common and as expected with all nitrate preparations. They occur mainly in the early stages of treatment. Headache predominates (up to 30%), but the incidence reduces rapidly as treatment continues. Only 2-3% of patients withdrew during clinical trials due to this adverse effect.
Hypotension (4%) with symptoms such as dizziness and nausea have been reported. These symptoms generally disappear during long-term treatment.
The adverse reactions which follow have been reported in studies with isosorbide mononitrate.

Very common.

Headache (up to 30%) necessitating withdrawal of 2-3% of patients.

Common.

Tiredness, sleep disturbances (6%) and gastrointestinal disturbances (6%) have been reported during clinical trials with isosorbide mononitrate modified release tablets, but at a frequency no greater than for placebo. Hypotension (4 to 5%), poor appetite (2.5%), nausea (1%).
Adverse effects associated with the clinical use of the drug are as expected with all nitrate preparations. They occur mainly in the early stages of treatment.

Very common.

Headache predominates (up to 30%), but the incidence reduces rapidly as treatment continues.

Common.

Hypotension (4%) with symptoms such as dizziness and nausea have been reported. These symptoms generally disappear during long-term treatment.
Other reactions that have been reported with isosorbide mononitrate modified release tablets include: tachycardia, vomiting, diarrhoea, vertigo, fainting, poor appetite, nausea, heartburn, rash and pruritus.
The following adverse events have been observed in the post-marketing period (definitions of frequency: common 1 - 9.9%; uncommon 0.1 - 0.9%; rare 0.01 - 0.09%; very rare < 0.01%).

Central nervous system.

Common: dizziness.

Musculoskeletal.

Very rare: myalgia.

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 http://www.tga.gov.au/reporting-problems and contact Apotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.2 Dose and Method of Administration

Dosage.

One (1) tablet once daily. That dose may be increased to two (2) tablets daily, both tablets taken at the same time.
Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets should not be administered twice daily.
There is insufficient evidence to show that one halved tablet of Chemmart Isosorbide Mononitrate delivers exactly half the dose of one full tablet, or whether the rate of release is the same. In-vitro dissolution testing showed that dissolution was slightly faster with halved Chemmart Isosorbide Mononitrate Sustained Release Tablets than with whole tablets.
Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets should not be chewed or crushed, and should be swallowed whole with half a glass of fluid.

4.7 Effects on Ability to Drive and Use Machines

Patients may develop dizziness when first using isosorbide mononitrate. Patients should be advised to determine how they react before they drive or operate machinery.

4.9 Overdose

Symptoms.

The most common symptom of overdose is a pulsing headache. More serious symptoms are excitation, flushing, cold sweats, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.

Treatment.

Activated charcoal may reduce absorption of the drug if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. In patients with severe hypotension, place patient in supine position with the legs raised. If necessary, further symptomatic treatment should be given, including intravenous fluid administration.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hypromellose, carnauba wax, stearic acid, lactose monohydrate, purified siliceous earth, magnesium stearate, purified talc, titanium dioxide, iron oxide yellow C177492, macrogol.

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 25 degrees. Protect from moisture. Protect from light.

6.5 Nature and Contents of Container

Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets: 30's. AUST R 75239.
Chemmart is a registered trade mark of Symbion Pty Ltd.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes