Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist.
  This includes any possible side effects not listed in this leaflet.

1. What Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion is and what it is used for
2. What you need to know before you are given Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion
3. How to use Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion
4. Possible Side Effects
5. How to store Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion
6. Contents of the pack and other information

• You are allergic to isosorbide dinitrate or any other medication containing nitrate, mononitrate or dinitrate or any of the other ingredients listed in this medicine (listed in section 6)
• You have ever had a ruptured blood vessel in your brain (cerebral haemorrhage)
• You have had a head injury (head trauma) or raised intracranial pressure (high pressure within your skull)
• You suffer from anaemia (reduced number of red blood cells or iron level)
• You have low blood pressure
• Your blood has stopped circulating around your body properly (circulatory failure)
• You have cardiogenic shock (your heart is not delivering enough oxygen around your body)
• You have constrictive pericarditis (inflammation of the sack-like covering of the heart)
• You have cardiac tamponade or hypertrophic obstructive cardiomyopathy (conditions which affect the ability of your heart to function as a pump)
• You have aortic or mitral valve stenosis (narrowing of the heart valves)
• You have a low blood volume because of injury or another reason
• You have an eye disease called glaucoma
• You have been taking sildenafil or any other phosphodiesterase inhibitor

If any of the above applies to you talk to your doctor or pharmacist.

Talk to your doctor or pharmacist before using Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion if:

• You are pregnant or breastfeeding
• You have hypothyroidism (an underactive thyroid gland which can cause tiredness or weight gain)
• You are malnourished (severely underfed)
• You suffer from hypothermia (a very low body temperature)
• You suffer from liver or kidney disease
• You have other heart problems or a family history of heart problems
• You suffer from orthostatic syndrome (where you may have a rapid heart rate and light-headedness on standing)

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

You should not be given Isosorbide Dinitrate with phosphodiesterase inhibitors such as Sildenafil (“Viagra”) used for impotence. Using Isosorbide Dinitrate with these medicines could cause your blood pressure to fall to a dangerously low level.

It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines to lower your blood pressure. They could increase the effect of Isosorbide Dinitrate and lower your blood pressure too much.
• Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety). These may also increase the effect of Isosorbide Dinitrate.
• Dihydroergotamine (used to treat migraine). This could increase your blood pressure too much.
• Any other medicine, including medicines obtained without a prescription.
• Sapropterin used for phenylketonuria (PKU).

Do not drink alcohol. It could increase the effect of Isosorbide Dinitrate and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before being given Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion. Your doctor will decide whether you should be given this medicine.

Isosorbide Dinitrate may give you a headache, or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.

This medicine contains less than 1mmol sodium (23mg) per 1mg per 1mL, that is to say it is essentially ‘sodium-free’.

Adults

This medicine 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, although sometimes as much as 20mg per hour is necessary. The normal dose for direct injection into the coronary artery is 1mg. Further doses may be given if your doctor thinks it necessary.

The injection is for single use only, so once the ampoule or vial is opened the medicine should be used immediately and any unused medicine discarded.

As this medicine is used in hospital, your heartbeat (pulse) and blood pressure will be carefully monitored whilst you are being given Isosorbide Dinitrate. This is to make sure that your medicine is working properly and that the dose you are taking is right for you.

Use in Children

This medicine is not suitable for children. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Product Characteristics.

An overdose of Isosorbide Dinitrate may cause your blood pressure to be too low resulting in paleness, sweating, weak pulse, fast heartbeat, light-headedness on standing, headache, weakness, dizziness, feeling sick, being sick and diarrhoea. If you have any concerns about this tell your doctor or nurse.

The dose should be given as soon as it is remembered. The next dose should be given at the usual time. Do not take a double dose to make up for a forgotten dose.

• Swelling of the face, lips or throat which makes it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of severe allergic reaction.
• Fainting which is sometimes accompanied by a slowing heartbeat
• Swelling of the face or blistering of the skin, mouth, eyes or genitals (Stevens-Johnson syndrome)

• Headache
• Drowsiness
• Weakness
• Nausea
• Feeling faint or dizzy as this may be caused by a reduced blood flow to the brain and heart
• Skin rash or flushing
• Dizziness
• Increased heartbeat
• Light-headedness on standing
• Vomiting
• Worsening symptoms of angina (chest pain)
• Heartburn

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.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is isosorbide dinitrate at a strength of 1mg in 1mL.
• The other ingredients are sodium chloride and Water for Injections.

This medicine is a clear and colourless solution. This medicine comes in 10mL single use ampoules and 50mL single use vials. The medicine is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.