SOUTH DEV O N

HEALTHCARES

ISOSORBIDE DINITRATE 0.1% CONCENTRATE FOR SOLUTION FOR INJECTION

Patient Information Leaflet

PLEASE READ THIS LEAFLET CAREFULLY. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.

1.    WHAT ISOSORBIDE DINITRATE 0.1% CONCENTRATE FOR SOLUTION FOR INJECTION IS AND WHAT IS IT USED FOR?

Isosorbide Dinitrate, the active ingredient, belongs to a group of medicines called vasodilators used in the treatment of heart disease. It works by widening the arteries and veins so decreasing the resistance to blood flow and lowering blood pressure.

Isosorbide Dinitrate 0.1% is a concentrated solution for injection and is used for the treatment of heart problems. It is specifically used for:

•    Treatment of severe chest pain (angina) which may start suddenly and gets increasingly worse

•    Treatment of heart failure, which may have occurred after a heart attack

•    Surgical procedures treating narrowing of heart arteries

2.    BEFORE USING ISOSORBIDE DINITRATE 0.1% CONCENTRATE FOR SOLUTION FOR INJECTION

Please tell your doctor if you are taking any other medication.

Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection should NOT BE USED:

•    If you are allergic to isosorbide dinitrate or any other medication containing nitrate, mononitrate or dinitrate

•    If you have ever had a ruptured blood vessel in your brain (cerebral haemorrhage)

•    If you suffer from anaemia (reduced number of red blood cells or iron level)

•    If you have low blood pressure

•    If you have a low blood volume because of injury or another reason

•    If you have been taking sildenafil

Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection should be used with caution in patients who:

•    Are taking any other medication

•    Are pregnant or breastfeeding

•    Suffer from glaucoma (a type of eye disease)

•    Suffer from thyroid problems

•    Suffer from malnutrition or hypothermia (low body temperature)

•    Suffer from liver or kidney disease

Taking other medicines:

This medicine may not be suitable for you to take; please tell your doctor if you:

•    are taking medicines to treat depression

•    are taking medicines to make you sleep such as hypnotics or sedatives

•    are taking medicines to reduce high blood pressure

•    drink alcohol

Check with your doctor if you are concerned about any of the above.

3.    HOW TO USE ISOSORBIDE DINITRATE 0.1% CONCENTRATE FOR SOLUTION FOR INJECTION

The doctor will decide what dose of Isosorbide Dinitrate Concentrate for Solution for Injection you should take. Check the label carefully. If you are not sure, ask your doctor, nurse or pharmacist.

Isosorbide Dinitrate Concentrate for Solution for Injection must be diluted before use with Sodium Chloride Injection BP or Glucose Injection BP. It should never be used undiluted. Isosorbide Dinitrate Concentrate for Solution for Injection is either given by infusion into a vein or by direct injection into the coronary artery. Doses will be adjusted by your doctor, but the usual dose is between 2mg and 12mg per hour. The normal dose for direct injection into the coronary artery is 1mg.

The injection is for single dose use only, so once the ampoule or bottle is opened the product should be used immediately and any unused drug discarded.

If you forget to take a dose of Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection - take that dose as soon as you remember. Take the next dose at the usual time. Do not take a double dose.

If you take more Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection than you should - tell your doctor immediately. If you are a medical practitioner administering this medicine please refer to the Summary of Product Characteristics.

4.    POSSIBLE SIDE EFFECTS

As with all medicines, there may be some side effects with Isosorbide Dinitrate Concentrate for Solution for Injection although not everyone gets them.

The most common side effects that may occur during administration are:

•    headache

•    nausea

•    increased heart beat

•    drop in blood pressure when given the medicine

Your pulse and blood pressure may be monitored during administration (because of these effects).

Tell your doctor, nurse or pharmacist immediately, if you think you have any of these or other problems.

5.    HOW TO STORE ISOSORBIDE DINITRATE 0.1% CONCENTRATE FOR SOLUTION FOR INJECTION

The medicine has an expiry date printed on the ampoule or bottle (vial) and carton label. Before use the doctor or nurse will check the medicine has not passed this date and that the injection does not show any sign of deterioration.

Do not use Isosorbide Dinitrate Concentrate for Solution for Injection 0.1% if visible particles are present.

The injection is for single dose use only, so once the ampoule or bottle is opened the product should be used immediately and any unused drug discarded.

After the expiry date, return any unused medicine to a pharmacy.

Store this medicine in a safe place where children cannot see or reach it.

Keep the container in the outer carton to protect it from light.

6.    FURTHER INFORMATION

The injection contains Isosorbide Dinitrate at a strength of 1.0mg per 1ml. It is available in 10ml single use ampoules and 50ml single use vials. It also contains the following inactive substances:

•    Sodium Chloride

•    Water for Injections

The manufacturer and marketing authorisation holder is:

South Devon Healthcare NHS Foundation Trust, Torbay PMU, Long Road, Paignton, Devon, TQ4 7TW

The leaflet was revised in: 01/2013

PL 13079/0003