What you need to know before you take it

e It is not recommended to drive or use machinery when Glyceryl Trinitrate spray you start using this product as the hypotensive (blood Do not use Glyceryl Trinitrate spray if you: pressure lowering) effect may lead to dizziness and/or feeling faint or unwell. After you have got used to the

• Are allergic to glyceryl trinitrate, to other nitrates, spray, it may be that you have no problems and are able or any of the other ingredients of this medicine (listed in section 6) (you have previously had swelling to drive safely. of the face, extremities, lips, inside of the mouth, Glyceryl Trinitrate spray contains ethanol (alcohol) tongue, glottis and/or larynx while using any of the and propylene glycol nitrate preparations). This medicine contains 39.6mg of ethanol (alcohol) in
• Have marked hypotension (low blood pressure with each dose (spray). The amount in dose of this medicine a systolic pressure below 90mmHg). is equivalent to less than 1mL of beer or 1mL of wine.
• Have too little circulating blood (due to blood loss The small amount of alcohol in this medicine will not or dehydration). have any noticeable effects.
• Suffer from conditions where your heart is unable to Propylene glycol may cause skin irritation. supply enough oxygenated blood to the rest of your body (cardiac shock or left sided heart failure).

How to take it

Glyceryl Trinitrate spray

• Have angina pectoris caused by hypertrophic, Always use this medicine exactly as your doctor or obstructive cardiomyopathy (abnormal heart growth). pharmacist has told you. Check with your doctor or
• Have constrictive pericarditis (an inflammation of the pharmacist if you are not sure. smooth membrane that surrounds the heart). Follow the instruction below to take off the cap:
• Have pericardial tamponade (an accumulation of When using the aluminium canister, the cap can easily fluid in the sac that surrounds the heart). be removed (see Figure 1.).
• Have aortic and mitral stenosis (heart valve disease). Figure 1. • Suffer from primary pulmonary hypertension Removal of the cap from the aluminium canister (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. Warnings and precautions Talk to your doctor or pharmacist before using Glyceryl Trinitrate spray. Before using the spray for the first time, check that the
• If you are prone to postural hypotension (low blood pump is working by pressing the pump button a few pressure) which can lead to dizziness and/or fainting times until it produces a fine mist of liquid. Practice on sitting up or standing up. aiming the spray onto a tissue or similar item so that
• If you suffer from narrow angle glaucoma (increased you will be able to aim it correctly under the tongue pressure in the eye), or migraine. (sublingual use) when you need to use it. If you do not
• If you suffer from liver disease, alcoholism, epilepsy, need to use the spray very often, remember to check cerebral trauma and other nervous system diseases the pump regularly to see that it still works properly. (the spray contains small amounts of alcohol and may If possible, sit down before using your spray. Rest or sit be harmful to patients with the above conditions). quietly, as you may feel faint or dizzy otherwise,
• If you suffer from a disease of the blood vessels particularly if you are elderly. Take off the plastic cap supplying the brain (cerebrovascular disease). and hold the spray bottle upright. There is no need to
• If you suffer from lung disease or lung disease shake the canister before dosing. related heart disease. The spray outlet should then be placed close to the
• If you had a recent heart attack mouth. Hold your breath for a moment to avoid (myocardial infarction). breathing in the spray, then open your mouth and spray a dose under your tongue by pressing down on the If your dose is increased, you may become tolerant to pump button then letting go. The mouth should be this medicine (where you need to use higher doses to closed immediately after each dose (spray). The spray prevent or relieve the symptoms of an angina attack) should not be breathed in. It is useful to become aware or to other medicines containing nitrates. of the position of the spray outlet so that its using at If this medicine does not work, it may be an early sign night can be easily achieved. of a myocardial infarction (heart attack). If this occurs, At the onset of an attack use one or two doses you should see your doctor immediately or go to the (sprays) under your tongue, and then immediately casualty department. close your mouth before breathing normally through Tell your doctor or nurse that you are using this your nose again. medicine if you are having blood or urine tests, as it If symptoms do not resolve, this dose may be may affect the results. repeated at five minute intervals for a total of three Children doses (sprays). The use of Glyceryl Trinitrate spray is not recommended If symptoms have not resolved after a total of three for children. doses (sprays), seek prompt medical attention. Other medicines and Glyceryl Trinitrate spray For the prevention of an attack use one or two doses Tell your doctor or pharmacist if you are taking, have (sprays) immediately before the event. recently taken or might take any other medicines. 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 more Glyceryl Trinitrate spray than you should 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Reporting of side effects 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.

Possible side effects

Store below 25°C, in the original package in order to protect from light and radiant heat. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the base of the canister. This medicinal product is flammable, explosive. Storage and application near open fire and while smoking are forbidden. Do not use it near to anyone that is smoking; or spray the product into a naked flame or onto a hot surface. Do not pierce or burn the canister after use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people are more sensitive to the effects of glyceryl trinitrate than others. If you experience one of the following side effects, stop using the spray and consult your doctor immediately:

• Allergic skin reactions or in some cases hypersensitivity reactions and exfoliative dermatitis (itchy, scaling skin rash) may appear.
• Worsened angina pectoris symptoms (increase of chest pain). In cases where there is a large fall in blood pressure, this medicine may make the symptoms of angina worse (may affect up to 1 in 100 people).
• Cyanosis (blue or purple coloration of the skin or mucous membranes due to the tissues near the skin surface being low on oxygen) (may affect up to 1 in 100 people).
• Methaemoglobinaemia (a blood disorder where oxygen cannot be released effectively to parts of your body) causes bluish skin colouring, headache, tiredness and lack of energy or shortness of breath (may affect up to 1 in 10,000 people).
• Decreased blood flow to the brain (may affect up to 1 in 10,000 people). The following side effects have also been reported: Very common (may affect more than 1 in 10 people)
• Headache Common (may affect up to 1 in 10 people)
• Dizziness
• Drowsiness
• Fast heart beat
• Decreased blood pressure*
• Fall of blood pressure when standing up or sitting up*
• Weakness Uncommon (may affect up to 1 in 100 people)
• Syncope (loss of consciousness)
• Slow heart beat
• Facial flushing
• Circulatory collapse (failure of the blood circulation)
• Nausea (feeling sick)
• Vomiting (being sick) Very rare (may affect up to 1 in 10,000 people)
• Restlessness
• Heartburn
• Bad breath
• Difficulty breathing
• Skin rash
• Particularly upon initiation of therapy and following an increase in dose. The first dose, or the first higher dose, may cause a blood pressure drop and/or postural hypotension (fainting or feeling faint when standing up or getting out of bed), tachycardia (your heart may seem to speed up), dizziness and weakness. The following side effects may also occur in approximately 30-40% of patients: taste disturbance (metallic taste), mild burning or stinging sensation in the mouth or tongue, and palpitations (feeling your heartbeat). These are usually mild and disappear within a few minutes. Headache may occur at the beginning of the treatment. Sometimes the heart rate may slow and even lead to feeling faint or actually fainting.

Contents of the pack and other information

What Glyceryl Trinitrate spray contains 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. What Glyceryl Trinitrate spray looks like and contents of the pack 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. Marketing Authorisation Holder Egis Pharmaceuticals UK Ltd. 127 Shirland Road, London, W9 2EP United Kingdom Manufacturer Egis Pharmaceuticals PLC Mátyás Király út 65. Körmend, 9900 Hungary Distributor Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road, Petersfield Hampshire, GU32 3QG United Kingdom This leaflet was last revised in 07/2022 1010030-P8.4