Consumer medicine information

Imdur Durules

Isosorbide mononitrate

BRAND INFORMATION

Brand name

Imdur

Active ingredient

Isosorbide mononitrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Imdur Durules.

SUMMARY CMI

IMDUR®

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 IMDUR®?

IMDUR contains the active ingredient isosorbide mononitrate. Imdur is used to prevent angina.

For more information, see Section 1. Why am I using IMDUR? in the full CMI.

2. What should I know before I use IMDUR®?

Do not use if you have ever had an allergic reaction to IMDUR 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 IMDUR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with IMDUR 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 IMDUR®?

  • Take one IMDUR modified release tablet every day, at about the same time.
  • If your doctor tells you to take two 60mg IMDUR modified release tablets each day, take both tablets at the same time.

More instructions can be found in Section 4. How do I use IMDUR? in the full CMI.

5. What should I know while using IMDUR®?

Things you should do
  • Take IMDUR modified release tablets regularly once every day
  • Remind any doctor, dentist or pharmacist visit that you are using IMDUR.
Things you should not do
  • Do not stop using this medicine suddenly
  • Do not use IMDUR modified release tablets to relieve acute attacks of angina.
Driving or using machines
  • Be careful driving or operating machinery until you know how IMDUR affects you.
  • IMDUR may cause dizziness and fainting in some patients
Drinking alcohol
  • Be careful when drinking alcohol while you are using IMDUR
  • If you drink alcohol while you are taking IMDUR, you may feel dizzy or faint.
Looking after your medicine
  • Keep it in a cool dry place where the temperature stays below 30°C.
  • Keep your IMDUR modified release tablets in the blister pack until it is time to take them

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

6. Are there any side effects?

Headache is the most common side effect while taking IMDUR. You may also experience feeling faint, dizziness, fatigue, and muscle tenderness or weakness.

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

IMDUR®

Active ingredient(s): Isosorbide mononitrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using IMDUR. You should also speak to your doctor or pharmacist if you would like further information or if youhave any concerns or questions about using IMDUR.

Where to find information in this leaflet:

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

1. Why am I using IMDUR®?

IMDUR contains the active ingredient Isosorbide mononitrate. IMDUR is belongs to a group of medicines called nitrates.

IMDUR is 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.

IMDUR works by relaxing the blood vessels, letting more blood and oxygen reach the heart.

Your doctor will have explained why you are being treated with IMDUR and told you what dose to take.

2. What should I know before I use IMDUR®?

Warnings

Do not use IMDUR if:

  • You are allergic to isosorbide mononitrate or food containing nitrates or nitrites or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • You have one of the following conditions:
    - Low blood pressure
    - Shock including those caused by low blood pressure or failing heart
    - Pericarditis (swelling around the heart)
    - Weakened muscle of the heart
  • You are taking sildenafil (Viagra), vardenafil (Levitra), tadalafil (Cialis).

Check with your doctor if you:

  • Have any allergies to any medicine, foods, preservatives or dyes.
    - If you have an allergic reaction you may get a skin rash, hayfever, asthma or feel faint.
  • Have any of these medical conditions:
    - any illness affecting your liver or kidneys
    - low blood pressure (this can make you feel faint, weak or dizzy, especially when you stand up suddenly)
    - heart and blood vessel problems

It may not be safe for you to take IMDUR if you have any of these conditions.

Do not use IMDUR to treat acute angina.

IMDUR modified release tablets must be taken once daily. Do not stop taking it abruptly.

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

Do not use IMDUR if you are pregnant or breast feeding unless your doctor says it is safe.

Check with your doctor if you are pregnant or intend to become pregnant.

It is not know if it is safe for you to take it while you are pregnant. It may affect your baby.

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

It is not known if your baby can take in IMDUR from breast milk if you are breast feeding.

Ask your doctor about the risks and benefits involved.

Use in children

Do not give IMDUR to children.

There is no specific information about use in children, so IMDUR is not recommended for use in children. Always ask your doctor before giving medicines to children.

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 IMDUR and affect how it works.

  • Phosphodiesterase inhibitors such as sildenafil (Viagra*), vardenafil (Levitra=), tadalafil (Cialis+) can result in serious side-effects such as syncope or myocardial infarction
  • Calcium antagonists, which can cause orthostatic hypotension

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect IMDUR.

4. How do I use IMDUR®?

How much to take

  • Take one IMDUR modified release tablet every day, at about the same time.
  • If your doctor tells you to take two 60mg IMDUR modified release tablets each day, take both tablets at the same time.
  • Taking IMDUR modified release tablets at 24-hour intervals makes sure they keep working properly.
  • Swallow IMDUR modified release tablets whole, with half a glass of water or other liquid e.g. fruit juice, milk. Do not chew or crush the tablets.
  • The 60mg modified release tablet can be broken in half if care is taken not to crumble them.
  • IMDUR modified release tablets are designed to let the drug out over a number of hours. If they are crushed or chewed they won't work properly.
  • IMDUR modified release 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
  • Follow the instructions provided and use IMDUR until your doctor tells you to stop.

If you forget to take IMDUR

If you forget to take a dose, take it as soon as you remember, as long as it is not more than eight (8) hours late.

If it is more than eight (8) hours after you should have taken IMDUR, 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 of IMDUR.

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

If you take too much IMDUR

If you think that you have taken too much IMDUR, you may need urgent medical attention.

If you take too many IMDUR modified release tablets you will have a pulsing headache. You may also feel excited, flushed, have cold sweats, nausea (feeling sick) and vomit.

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 IMDUR®?

Things you should do

Take IMDUR regularly once every day.

If you don't you will be more likely to get attacks of angina.

Call your doctor straight away if you:

  • Continue to get angina attacks, or they become more frequent, while you are taking IMDUR.

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

Things you should not do

  • Do not use IMDUR to relieve acute attacks of angina.
    Your doctor will have given you other tablets or a spray to use when you get attacks of angina.
  • Do not take medicines known as phosphodiesterase type 5 inhibitor used to treat impotence (or erectile dysfunction) whilst on IMDUR.
  • Do not stop taking IMDUR unless you have discussed it with your doctor.
  • Do not use IMDUR 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.

Things to be careful of

You will probably feel better when you start taking IMDUR but be careful not to overdo physical activities straight away.

You will need time to improve your physical fitness.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how IMDUR affects you.

IMDUR 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 IMDUR before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.

Drinking alcohol

Tell your doctor if you drink alcohol.

If you drink alcohol while you are taking IMDUR, your blood pressure may drop, making you feel dizzy or faint.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

Looking after your medicine

  • Keep your IMDUR modified release tablets in the blister pack until it is time to take them.
  • If you take IMDUR out of the blister pack it will not keep well.
  • Keep it in a cool dry place where the temperature stays below 30°C.
  • Keep it where young children cannot reach it.

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.

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. 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.

Side effects

Side effectsWhat to do
Heart related
  • Hypotension
  • Tachycardia
Head and body related
  • Headache
  • Vertigo
  • Fainting
  • Fatigue
  • Muscle tenderness or weakness, not caused by exercise.
Stomach related
  • Poor appetite
  • Nausea
  • Vomiting
  • Diarrhoea
  • Heartburn
Skin related
  • Rash
  • Pruritus
Speak to your doctor if you have any of these side effects and they worry you.

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.

What IMDUR contains

Active ingredient
(main ingredient)		Isosorbide mononitrate 60mg or 120mg
Other ingredients
(inactive ingredients)		Aluminium sodium silicate
Synthetic paraffin
Magnesium stearate
Hyprolose
Hypromellose
Colloidal anhydrous silica
Macrogol 6000
Titanium dioxide
Iron oxide yellow (60 mg only)

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

What IMDUR looks like

IMDUR 60mg modified release tablets (AUST-R 46390) are yellow, oval tablets, scored on both sides, marked A/ID.

IMDUR 120mg modified release tablets (AUST-R 62795) are whitish, oval tablets marked A/IF

Who distributes IMDUR

Clinect Pty Ltd,
120-132 Atlantic Drive,
Keysborough, VIC 3173,
Australia
Free Call Australia: 1800 899 005

This leaflet was prepared 10 June 2022

Published by MIMS August 2022

BRAND INFORMATION

Brand name

Imdur

Active ingredient

Isosorbide mononitrate

Schedule

S4

 

1 Name of Medicine

Isosorbide mononitrate.

2 Qualitative and Quantitative Composition

Imdur modified release tablets containing isosorbide mononitrate 60 mg or 120 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Imdur (modified release tablets) 60 mg: Yellow, oval, biconvex tablets, scored on both sides, engraved A/ID.
Imdur (modified release tablets) 120 mg: White to off-white, oval, biconvex tablets, engraved A/IF.

4 Clinical Particulars

4.1 Therapeutic Indications

Imdur is indicated for prophylactic treatment of angina pectoris.
Imdur is not recommended for the management of acute attacks of angina pectoris (see Section 4.4 Special Warnings and Precautions for Use).

4.2 Dose and Method of Administration

One 60 mg Imdur Durule once daily. The dose may be increased to 120 mg once daily.
Imdur should not be administered twice daily.
If headache occurs, the initial dose may be reduced to half a 60 mg tablet daily until the headache disappears. Patients with severe renal impairment may require dosage reduction to half a tablet given once daily.
Imdur should not be chewed or crushed, and should be swallowed whole with half a glass of fluid. If care is taken to avoid crushing or chewing the tablet, half doses of the 60 mg tablet may be administered without affecting the modified release properties of Imdur. The 120 mg tablet is not scored and should not be administered in half doses.

4.3 Contraindications

Known hypersensitivity to nitrates or to any of the components in Imdur.
Shock (including cardiogenic shock), hypotension, obstructive hypertrophic cardiomyopathy and pericarditis.
Phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) must not be given concomitantly with Imdur.

4.4 Special Warnings and Precautions for Use

Please 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 Imdur is administered. It is therefore important that Imdur is 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.
Caution should also be observed if Imdur is administered to patients with severe cerebral arteriosclerosis, pronounced mitral stenosis, hypotension.

Acute angina.

Imdur is not indicated for the relief of acute attacks of angina.

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.

Abrupt withdrawal.

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

Use in renal impairment.

The elimination of isosorbide mononitrate following administration of an immediate release (IR) tablet has been investigated in patients with severe renal impairment, but not using the modified release Durule. Renal impairment makes no therapeutically important difference to the pharmacokinetics of isosorbide mononitrate administered as an IR 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 Imdur Durule presentation in patients with severe renal impairment, the possibility of accumulation should be borne in mind when administering Imdur 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).

Paediatric use.

Due to lack of data, the use of Imdur cannot be recommended in children.

Use in the elderly.

No dose reduction is necessary in the elderly unless they have severe renal impairment (see Section 4.4 Special Warnings and Precautions for Use).

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) should not be given to patients already receiving isosorbide mononitrate therapy.

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.

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 modified 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 modified 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.

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 undertaken 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 breast feeding is not recommended.

4.7 Effects on Ability to Drive and Use Machines

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

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 following adverse reactions have been reported in studies with isosorbide mononitrate.

Cardiovascular.

Hypotension (4-5%), tachycardia.

Central nervous system.

Headache, vertigo, fainting.

Gastrointestinal.

Poor appetite (2.5%), nausea (1%), vomiting, diarrhoea, heartburn.

Skin.

Rash, pruritus.
Tiredness, sleep disturbances (6%) and gastro-intestinal disturbances (6%) have been reported during clinical trials with Imdur, but at a frequency no greater than for placebo.
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 reactions.

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

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.

Management.

Administer activated charcoal. In patients with severe hypotension, first place in the 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 13 11 26 (Australia).

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 the intramural pressure, hence leading to an improvement in the subendocardial 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 the myocardium.
Nitrates are highly effective in the prophylaxis of symptomatic and asymptomatic myocardial ischaemia. Nitrates dilate coronary arteries not only in pre- and poststenotic 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 (NO). Organic nitrates are metabolised to NO 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

Absorption.

Administration of Imdur 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. Drug particles close to the tablet surface are released relatively rapidly but those incorporated more deeply are released more slowly. The absorption of Imdur has been shown not to be influenced by food intake.
After repeated once daily administration of Imdur 60 mg, the maximum plasma level (about 3000 nanomol/L) of isosorbide mononitrate is achieved at about 4 hours. The plasma concentration remains above 1400-1500 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 tolerance developing during prolonged treatment with Imdur.

Distribution.

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.

Metabolism and excretion.

Isosorbide mononitrate has an elimination half-life of around five hours. Imdur provides a sustained release presentation of isosorbide mononitrate, with approximately 85% bioavailability.
Elimination takes place predominantly by denitrification and conjugation in the liver. The metabolites are excreted mainly via the kidneys, with only about 2% of the dose being excreted intact.

Special populations.

In placebo-controlled studies, Imdur has been shown to significantly increase exercise capacity in patients with angina pectoris taking no other chronic treatment, as well as in patients taking concomitant beta-blocker therapy.
It is known that the clinical effects may be attenuated during repeated administration with nitrates in high doses and/or during frequent administration. However, the pharmacokinetic characteristics of Imdur produces a nitrate low period following once daily dosage. No development of tolerance with respect to antianginal effect has been detected when Imdur is given at a dose of one or two tablets (60 mg or 120 mg) once daily. The drug is not recommended for twice daily administration.
Pharmacokinetic studies suggest that absorption of Imdur is slower in some patients with acute myocardial infarction compared to healthy volunteers. At steady state, absorption of Imdur is similar in patients with acute myocardial infarction and in healthy volunteers. The steady state elimination half-life is longer in patients with acute myocardial infarction compared to healthy volunteers (see Section 4.4 Special Warnings and Precautions for Use, Acute myocardial infarction and congestive cardiac failure).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Imdur contains the active drug embedded in a porous inert matrix consisting of paraffin-synthetic, aluminium sodium silicate, magnesium stearate, hydroxypropylcellulose and silica - colloidal anhydrous. In addition, the tablet coating contains hypromellose, macrogol, titanium dioxide, hydrogen peroxide, paraffin-synthetic and water-purified.

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

Imdur 60 mg: blister packs of 7^, 10^, 15^, 30.
Imdur 120 mg: blister packs of 7^, 30.
^ Currently not marketed.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

The chemical name is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate. Molecular formula C6H9NO6; m.w. 191.14. Isosorbide mononitrate is a white to pale yellow crystalline powder and is freely soluble in water.

Chemical structure.

The chemical structure of isosorbide mononitrate is:

CAS number.

CAS 16051-77-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes