Consumer medicine information

1. Why am I using APO-ISOSORBIDE MONONITRATE?

APO-ISOSORBIDE MONONITRATE contains the active ingredient Isosorbide mononitrate. APO-ISOSORBIDE MONONITRATE is used to prevent angina pectoris (heart pain). It is not recommended and should not be taken for the treatment of acute attacks.
For more information, see Section 1. Why am I using APO-ISOSORBIDE MONONITRATE? in the full CMI.

2. What should I know before I use APO-ISOSORBIDE MONONITRATE?

Do not use if you have ever had an allergic reaction to APO-ISOSORBIDE MONONITRATE 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 APO-ISOSORBIDE MONONITRATE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-ISOSORBIDE MONONITRATE 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 APO-ISOSORBIDE MONONITRATE?

• Your Doctor will advise you on how many tablets to take each day.

5. What should I know while using APO-ISOSORBIDE MONONITRATE?

6. Are there any side effects?

Possible side effects include headache (most common), dizziness, nausea, tiredness and disturbed sleep.
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.

1 Name of Medicine

Isosorbide mononitrate.

2 Qualitative and Quantitative Composition

APO-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

APO-Isosorbide Mononitrate 60 mg sustained release tablets. A cream, film-coated oval tablet of 13 mm length, half scored on both sides.

4 Clinical Particulars

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).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Isosorbide mononitrate is a white to pale yellow, crystalline, odourless powder that is freely soluble in water.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSISOMON.gif Chemical Name: 1,4:3,6-dianhydro-D-glucitol 5-nitrate.
Molecular Formula: C₆H₉NO₆.
Molecular Weight: 191.14.
CAS number. 16051-77-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOISMST.gif