Glyceryl Trinitrate 1mg/ml solution for 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Glyceryl Trinitrate 1 mg/ml solution for infusion, which will be referred to as Glyceryl Trinitrate throughout this leaflet.

1. What Glyceryl Trinitrate is and what it is used for
2. What you need to know before you receive Glyceryl Trinitrate
3. How you will be given Glyceryl Trinitrate
4. Possible side effects
5. How to store Glyceryl Trinitrate
6. Contents of the pack and other information

• you are allergic to glyceryl trinitrate or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to any other nitrates
• you are taking a medicine for the treatment of erectile dysfunction (e.g. sildenafil (Viagra), vardenafil, tadalafil). If you take Glyceryl Trinitrate concomitantly with such medicines a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. You should not take such medicines whilst on Glyceryl Trinitrate treatment.
• you are in shock (a life-threatening medical condition where insufficient blood flow reaches the body tissues)
• you have severe anaemia (lack of red blood cells)
• you have low blood pressure
• you have low blood volume
• you have low blood oxygen (this can make you feel fatigued and short of breath) and angina caused by a heart disease where the muscle mass of the left heart ventricle is enlarged
• you have fluid accumulation in the lung
• you have ever had a serious head injury, cerebral haemorrhage (bleeding in the brain) or a disease which is accompanied by increased pressure on the brain
• you have or had heart conditions
• you are using riociguat, a medicine used in treating pulmonary hypertension.

Talk to your doctor or nurse before being given Glyceryl Trinitrate if:

• you have acute left-sided heart failure - providing that systolic blood pressure (the blood pressure when the heart is contracting) is over 90 mmHg
• you have had an acute myocardial infarction (heart attack) - providing that systolic blood pressure is over 90 mmHg
• you have severe liver or kidney problems
• you have an under active thyroid
• your body temperature is lower than normal (hypothermia)
• you are pregnant or breastfeeding.

This medicine is not recommended in children.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines as they may interact with your Glyceryl Trinitrate:

• Medicines for the treatment of erectile dysfunction (e.g. Viagra (sildenafil), vardenafil, tadalafil). Use of Glyceryl Trinitrate with these medicines could cause a severe drop in blood pressure and could lead to collapse and unconsciousness, and may be fatal.
• Medicines which lower blood pressure (e.g. other vasodilators, beta-blockers, calcium channel blockers, ACE inhibitors, monoamine oxidase inhibitors)
• Tricyclic anti-depressants (e.g. amitriptyline, nortriptyline, clomipramine, imipramine)
• Certain very strong pain killers which are similar to morphine (opioids e.g. alfentanil)
• Neuroleptics (medicines used to treat anxiety)
• Sapropterin containing medicines
• Non-steroidal anti-inflammatory drugs (NSAIDs) except acetyl salicylic acid.

Do not drink alcohol whilst using Glyceryl Trinitrate as it can cause your blood pressure to drop. This may make you feel dizzy or faint.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before being given this medicine.

This medicine is used in hospitalised patients. Therefore if you have any concerns ask your doctor or nurse.

This medicine is not recommended for use in children.

• The usual dose is between 10 micrograms and 200 micrograms per minute, but sometimes as much as 400 micrograms per minute may be needed
• The exact dose that the doctor will give you depends on the condition you are being treated for. As a guide:

To control high blood pressure during surgery:

• 25 micrograms per minute will be given as a starting dose
• This may be increased by 25 micrograms per minute at 5 minute intervals until your blood pressure is stabilised
• Doses up to 400 micrograms per minute may occasionally be needed.

To control myocardial ischaemia during and after cardiovascular surgery:

• 15-20 micrograms per minute will be given as a starting dose.
• Depending on your response, the dose may be increased by increments of 10-15 micrograms per minute until the desired effect is obtained.

To treat unstable angina:

• 10 micrograms per minute will be given as a starting dose
• Depending on your response, the dose may be increased or decreased by 10 micrograms every 30 minutes until the desired effect is achieved.

Treat heart failure following a heart attack:

• 20-25 micrograms per minute will be given as a starting dose
• Depending on your needs, the doctor may decrease the dose by 10 micrograms per minute or give you a further 20-25 micrograms per minute until the required effect is obtained.

While you are being given Glyceryl Trinitrate, the doctor may monitor your heart rate and breathing to make sure that the medicine is working properly.

Since Glyceryl Trinitrate will be administered to you by a doctor or nurse, it is unlikely that you will be given too much. In the event of overdose following signs or symptoms can occur vomiting, restlessness, fall in blood pressure, coldness of the skin, breathing difficulties, mental illness, blue discolouration of the skin, slow heart rate of less than 60 beats per minute, a temporary loss of consciousness and posture and a very rare blood disorder where the blood is unable to carry oxygen to cells in the body.

These symptoms may be readily reversed by discontinuing your treatment, therefore please tell your doctor or nurse immediately if one or more of these symptoms occur.

Very common (may affect more than 1 in 10 people):

• headache

Common (may affect up to 1 in 10 people):

• sleepiness
• low blood pressure (hypotension) and light-headedness upon standing which you may experience as dizziness, drowsiness, rapid heartbeat (reflex tachycardia) and a feeling of weakness at the start of treatment or when the dosage is increased.

Uncommon (may affect up to 1 in 100 people):

• feeling sick (nausea)
• being sick (vomiting)
• collapse sometimes with a slow heartbeat and fainting
• very low blood pressure (severe hypotension) where you may be sick, feel sick, feel restless, have pale skin and sweat a great deal. This may lead to a worsening of the chest pain you often get with angina
• temporary low oxygen level in the blood (temporary hypoxaemia). For people with heart disease this may lead to low oxygen level in the tissue surrounding the heart (myocardial hypoxia)
• Allergic skin rash, which may be severe

Very rare (may affect up to 1 in 10,000 people):

• Heartburn

Not known (frequency cannot be estimated from the available data)

• irregular heart beat (palpitations)
• flushing
• low blood pressure
• very red skin with scaling and thickened itchy skin (exfoliative dermatitis)
• heart rate increase
• rash

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 glyceryl trinitrate. 1 ml solution for infusion contains 1 mg glyceryl trinitrate.
• The other ingredients are water for injections, glucose monohydrate and hydrochloric acid.

The product is a clear and colourless solution for infusion. This solution is packed in boxes containing:

• 10 ampoules with 5 ml
• 10 ampoules with 10 ml
• 10 ampoules with 25 ml
• 1 vial with 50 ml
• 10 vials with 50 ml
• 25 vials with 50 ml

Vials are closed with bromobutyl rubber stoppers.

Not all pack sizes may be marketed.