• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

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

• Are allergic to glyceryl trinitrate, to other nitrates, or any of the other ingredients of this medicine (listed in section 6) (you have previously had swelling of the face, extremities, lips, inside of the mouth, tongue, glottis and/or larynx while using any of the nitrate preparations).
• Have marked hypotension (low blood pressure with a systolic pressure below 90mmHg).
• Have too little circulating blood (due to blood loss or dehydration).
• Suffer from conditions where your heart is unable to supply enough oxygenated blood to the rest of your body (cardiac shock or left sided heart failure).
• Have angina pectoris caused by hypertrophic, obstructive cardiomyopathy (abnormal heart growth).
• Have constrictive pericarditis (an inflammation of the smooth membrane that surrounds the heart).
• Have pericardial tamponade (an accumulation of fluid in the sac that surrounds the heart).
• Have aortic and mitral stenosis (heart valve disease).
• Suffer from primary pulmonary hypertension (an increased resistance to blood flow through the lungs).
• Have had a heart attack with low blood supply to the heart.
• Are very anaemic.
• Take sildenafil, tadalafil or vardenafil (these drugs are used for the treatment of male impotence).
• Suffer from any condition with possible raised pressure within your head including that caused by an accident.

Talk to your doctor or pharmacist before using Glyceryl Trinitrate spray.

• If you are prone to postural hypotension (low blood pressure) which can lead to dizziness and/or fainting on sitting up or standing up.
• If you suffer from narrow angle glaucoma (increased pressure in the eye), or migraine.
• If you suffer from liver disease, alcoholism, epilepsy, cerebral trauma and other nervous system diseases (the spray contains small amounts of alcohol and may be harmful to patients with the above conditions).
• If you suffer from a disease of the blood vessels supplying the brain (cerebrovascular disease).
• If you suffer from lung disease or lung disease related heart disease.
• If you had a recent heart attack (myocardial infarction).

If your dose is increased, you may become tolerant to this medicine (where you need to use higher doses to prevent or relieve the symptoms of an angina attack) or to other medicines containing nitrates.

If this medicine does not work, it may be an early sign of a myocardial infarction (heart attack). If this occurs, you should see your doctor immediately or go to the casualty department.

Tell your doctor or nurse that you are using this medicine if you are having blood or urine tests, as it may affect the results.

The use of Glyceryl Trinitrate spray is not recommended for children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Never use Glyceryl Trinitrate spray with:

• Sildenafil, vardenafil or tadalafil containing erectile dysfunction medicines. The blood-pressure lowering effect of Glyceryl Trinitrate spray may be increased, possibly resulting in collapse, unconsciousness and even death.

Take care when using Glyceryl Trinitrate spray with:

• Medicines with blood pressure lowering effect, such as vasodilators and other antihypertensive agents, neuroleptics (used to treat mental illness), drugs used to treat depression (e.g. tricyclic antidepressants), sapropterin (used to treat phenylketonuria) and N-acetylcysteine (amino acid supplement). Any one of these medicines could increase the blood pressure lowering effect of glyceryl trinitrate.
• Dihydroergotamine containing medicines for the treatment of abnormal bleeding from the female reproductive system as the effect of this drug can be increased by glyceryl trinitrate.
• Heparin containing blood-thinning medicines (the effectiveness of heparin may decrease).

You may need a higher dose of glyceryl trinitrate if you have been previously treated with long-acting nitrates (e.g. isosorbide-dinitrate, isosorbide mononitrate).

If your doctor has prescribed tablets to be placed under the tongue for your angina, you should not use your spray for the same attack.

Consumption of alcoholic beverages during the use of this medicine is strictly forbidden as some of the side effects may be worse than usual (see section 4).

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

Glyceryl Trinitrate spray should only be used in women during pregnancy or breast-feeding, if the doctor considers that the benefit for the mother exceeds any possible risk to the baby.

It is not recommended to drive or use machinery when you start using this product as the hypotensive (blood pressure lowering) effect may lead to dizziness and/or feeling faint or unwell. After you have got used to the spray, it may be that you have no problems and are able to drive safely.

This medicine contains 39.6mg of ethanol (alcohol) in each dose (spray). The amount in dose of this medicine is equivalent to less than 1mL of beer or 1mL of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Propylene glycol may cause skin irritation.

When using the aluminium canister, the cap can easily be removed (see Figure 1.).

Figure 1. -

Removal of the cap from the aluminium canister

Before using the spray for the first time, check that the pump is working by pressing the pump button a few times until it produces a fine mist of liquid. Practice aiming the spray onto a tissue or similar item so that you will be able to aim it correctly under the tongue (sublingual use) when you need to use it. If you do not need to use the spray very often, remember to check the pump regularly to see that it still works properly.

If possible, sit down before using your spray. Rest or sit quietly, as you may feel faint or dizzy otherwise, particularly if you are elderly. Take off the plastic cap and hold the spray bottle upright. There is no need to shake the canister before dosing.

The spray outlet should then be placed close to the mouth. Hold your breath for a moment to avoid breathing in the spray, then open your mouth and spray a dose under your tongue by pressing down on the pump button then letting go. The mouth should be closed immediately after each dose (spray). The spray should not be breathed in. It is useful to become aware of the position of the spray outlet so that its using at night can be easily achieved.

At the onset of an attack use one or two doses (sprays) under your tongue, and then immediately close your mouth before breathing normally through your nose again.

If symptoms do not resolve, this dose may be repeated at five minute intervals for a total of three doses (sprays).

If symptoms have not resolved after a total of three doses (sprays), seek prompt medical attention.

For the prevention of an attack use one or two doses (sprays) immediately before the event.

Put the cap back on the spray bottle.

If you are not sure how to use the spray, ask your pharmacist to show you.

If you use too many sprays some of the side effects (see below) may be worse than usual.

In this case you should see your doctor immediately.

If you get any side effects, talk to your doctor 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 (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 400 micrograms glyceryl trinitrate per spray.

The other ingredients are ethanol and propylene glycol and a particle-free solution in a CFC-free pump spray.

The aluminium canister is equipped with a metered dose valve and a protective cap. Each canister contains 11 grams of solution and is designed to deliver at least 200 doses.

Appearance: Colourless or almost colourless, clear solution, free from sediments.