Glyceryl Trinitrate Spray 400 micrograms/metered dose, sublingual spray

• 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

• If you are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6).
• If you have severe low blood pressure.
• If you have shock caused by low blood pressure.
• If you have severe anaemia.
• If you have constrictive pericarditis (a heart condition).
• If you have an extremely low heart rate.
• If you have a brain trauma or cerebral haemorrhage (brain or head injury, including bleeding).
• If you have narrowing of the heart valves or arteries or angina caused by a disease of the heart muscle.
• If you have circulatory collapse (a failure of blood circulation).
• If you have toxic pulmonary oedema (lung swelling/ fluid)
• If you have cardiogenic shock (a serious heart condition caused by very low blood pressure, which may result in the following symptoms: dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness or loss of consciousness).

Talk to your doctor before using GTN Spray if any of the following apply to you:

• Fluid around the heart (pericardial tamponade).
• Low filling pressures (e.g. acute myocardial infarction).
• Problems controlling your blood pressure.
• Any disease that increases pressure on the brain.
• Glaucoma (a condition in which the pressure in the eye may be high).
• Liver or kidney problems.
• An underactive thyroid gland.

Please consult your doctor, even if these statements were applicable to you at any time in the past. You may need to be more closely supervised during treatment.

Do not give this medicine to children and adolescents under 18 years.

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

• Riociguat, used to treat pulmonary hypertension.
• Sildenafil, tadalafil, vardenafil or other similar phospho-diesterase inhibitors used to treat male erectile dysfunction (impotence).

• Medicines to treat blood pressure or heart problems, such as vasodilators, antihypertensives, betablockers and calcium channel blockers.
• Tricyclic anti-depressants or neuroleptics, used to treat mental health conditions.
• Diuretics (water tablets to increase amount of urine produced).
• Dihydroergotamine, used to treat migraine headaches.
• Heparin, a blood thinner used to prevent blood clots. Your doctor will need to monitor you more closely.
• Organic nitrates (other acute angina treatments).

Be careful about drinking alcohol as GTN Spray may affect you more than usual. Both alcohol and GTN Spray may lower your blood pressure and slow down your reactions.

If you are, or think you might be pregnant, ask your doctor for advice before taking this medicine. GTN Spray should not be used if you are breastfeeding.

Your reactions may slow down. Therefore, you should avoid driving and using machinery whilst using GTN Spray.

This medicine contains 7.5 mg of alcohol (ethanol) in each spray. The amount in one spray of this medicine is equivalent to less than 1 ml beer or 1 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

Continuous use of GTN Spray and other nitrates may reduce effectiveness at relieving your symptoms, so high continuous doses should be avoided.

Special treatment is not normally required. Overdose symptoms are usually the same as the stated side effects. Some people may experience a reaction similar to shock, with nausea, weakness and sweating. If you feel faint sit down and raise your legs. Contact your doctor if your symptoms do not improve. Rarely a bluish colour to lips/fingers may occur (cyanosis or methaemoglobinaemia). If this happens contact your doctor immediately.

• An allergic skin reaction (with or without rash).
• Tongue blistering (may affect up to 1 in 100 people).
• Fainting.
• A severe fall in blood pressure on standing up.
• Worsening of the original angina symptoms.
• Failure of the blood circulation (decrease in blood pressure, may be followed by loss of consciousness and collapse)
• Transient hypoxaemia (deprived oxygen supply) (bluish colouration of the lips, hands or feet, may be followed by loss of consciousness)
• Patients with coronary heart disease may experience a restriction in blood supply.

Continuous use may result in a tolerance to GTN Spray, reducing its effectiveness. If symptoms are not relieved, medical advice should be sought immediately.

Other known side effects are:

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

Common (may affect up to 1 in 10 people) Vertigo (spinning sensation), dizziness, nausea, facial flushing, weakness

Uncommon (may affect up to 1 in 100 people) Burning sensation, stinging sensation

Rare (may affect up to 1 in 1,000 people) Severe fall in blood pressure, heart rhythm change

Very rare (may affect up to 1 in 10,000 people) Flaking or peeling skin

If you get any side effects, talk to your doctor. 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 glyceryl trinitrate. Each spray contains 400 micrograms of glyceryl trinitrate.
• The other ingredients are peppermint oil, ethanol and 1,1,1,2 tetrafluoroethane (the propellant).

• GTN Spray is a colourless spray presented in an aluminium container (canister), with a metered dose spray nozzle, and a cap.
• Each container contains enough product for 180 or 200 sprays.

Marketing Authorisation Holder:

Manufacturer:

For information in large print, audio CD or braille please contact the Marketing Authorisation Holder.