Glyceryl trinitrate 400 micrograms/metered dose sublingual spray, suspension – patient leaflet, side effects, dosage

1. What Glyceryl Trinitrate Sublingual Spray is and what it is used for

Glyceryl Trinitrate Sublingual Spray is a sublingual spray which means that you use it under your tongue. The active ingredient is called glyceryl trinitrate or GTN for short. GTN is one of a group of medicines called ‘nitrates’. These relax the muscles around the blood vessels and make it easier for the heart to do its work.

Glyceryl Trinitrate Sublingual Spray helps stop the pain of angina (pain in your chest, arms or neck especially when you exert yourself). You can also use this medicine immediately before doing things which you know will cause you angina pain.

2. What you need to know before you use Glyceryl Trinitrate Sublingual Spray

Do not use Glyceryl Trinitrate Sublingual Spray:

• if you are allergic to glyceryl trinitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6).
• if you are very ill because of very low blood pressure, severe blood loss, bleeding in the brain, a severe head injury or severe anaemia.
• if you have certain heart disorders (such as acute circulatory shock /where there is insufficient blood flow reaching the body’s tissues/, this can include hypovolaemic shock (as a result of low blood volume) and uncontrolled cardiogenic shock (as a result of decreased output from the heart), severe mitral stenosis (a narrowing of the opening to the heart mitral valve) or hypertrophic obstructive cardiomyopathy (a disease of the heart muscle causing obstruction of blood flow), which your doctor will have told you about.
• if you are taking sildenafil, vardenafil or tadalafil for the treatment of erectile dysfunction or high blood pressure of arterial lung vessels. If you take these medicines and Glyceryl Trinitrate Sublingual Spray, a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal.

Warnings and precautions

Talk to your doctor or pharmacist before using Glyceryl Trinitrate Sublingual Spray:

• if you are in the early stages of an eye condition called glaucoma (where there is raised pressure within the eye)
• While taking this medicine, tell your doctor if the spray does not stop the pain; or if the spray usually works, but this time the pain lasts longer (half an hour or more), or feels different or worse than usual
• if you have aortic and/or mitral stenosis (a narrowing of the opening to the heart aortic or mitral valve)
• if you feel dizzy when you sit or stand upright suddenly
• if you have cerebrovascular disease (brain disorders relating to disease of the blood vessels supplying the brain)
• if you have pericardial tamponade (compression of the heart caused by blood or fluid accumulation in the space between the heart muscle and the outer covering of the heart)
• if you have constrictive pericarditis (inflammation and swelling of the covering of the heart)
• low blood oxygen in lung disease or pulmonary heart disease (enlargement of the right ventricle of the heart)
• if you have had a heart attack
• if you have left ventricular hypertrophy (thickening of the muscle of the left ventricle of the heart) associated with aortic stenosis (narrowing of the opening of the aortic heart valve)

Children

This medicine is not intended for use in children.

Other medicines and Glyceryl Trinitrate Sublingual Spray

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

This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.

Your doctor may need to take special care or change the dose. This is especially important for:

• medicines for the treatment of erectile dysfunction or high blood pressure of arterial lung vessels (see ‘Do not take Glyceryl Trinitrate Sublingual Spray’)
• other medicines which can lower blood pressure, such as beta-blockers, calcium channel blockers and neuroleptics, vasodilators, anti-hypertensives, diuretics, tricyclic antidepressants, sapropterin
• anti-blood-clotting medicines such as heparin
• N-acetyl-cysteine (used for breathing difficulties caused by too much mucus in the lungs and airways)

If you use Glyceryl Trinitrate Sublingual Spray very often or if you regularly use other nitrates, the pain relief you receive may be less.

During use with dihydroergotamine (DHE) (used to treat migraines), Glyceryl Trinitrate Sublingual Spray may lead to an increase in DHE levels, thereby increasing blood pressure.

Glyceryl Trinitrate Sublingual Spray with alcohol

If you drink alcohol before using Glyceryl Trinitrate Sublingual Spray, you may feel dizzy or faint due to low blood pressure. Do not drink alcoholic beverages during the use of this medicine.

Pregnancy and breast-feeding

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.

You should use Glyceryl Trinitrate Sublingual Spray only after discussing with your doctor the potential benefits to you versus any potential risks to your unborn child.

It is not known whether glyceryl trinitrate passes into human breast milk. You should ask your doctor for advice if you are breast-feeding.

There is no sign of a harmful effect with respect to fertility.

Driving and using machines

You should wait at least five minutes after using the spray before driving or using machinery. If you feel faint, dizzy or unwell, wait until you feel better. You should be particularly careful if you have just started using Glyceryl Trinitrate Sublingual Spray, if you have changed your dosage or if you drink alcohol.

Glyceryl Trinitrate Sublingual Spray contains alcohol

This medicine contains 9.2 mg of alcohol (ethanol) in each metered dose (puff). The amount in dose 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.

3. How to take Glyceryl Trinitrate Sublingual Spray

Always use this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

This spray is meant for use under your tongue and is not meant to be inhaled.

It is recommended to spray one or two puffs under your tongue. If symptoms do not resolve, you can repeat this at 5-minute intervals for a maximum of three puffs. If, after that, your symptoms have still not resolved, please seek immediate medical attention. The spray should work quickly and last about half an hour.

Method of administration

You should press the pump 7 times for first activation. Before you use a new bottle of Glyceryl Trinitrate Sublingual Spray, spray the first puff into the air to get the pump working properly. You may also spray one puff into the air if you have not used the pump for 1 week or more.

1. 1. Rest or sit quietly, as you may feel faint or dizzy otherwise, particularly if you are elderly.
2. 2. Remove the cap before use.
3. 3. Hold the bottle upright with your finger on the button. You don’t need to shake the bottle.
4. 4. Open your mouth and put the bottle vertically to your chin with the spray nozzle facing your mouth.

1. 5.

   Press the button firmly so that the puff of medicine goes under your tongue.

   Close your mouth.

2. 6. Do not breathe in while you are taking the puff of medicine.
3. 7. Replace the cap after use.

Always keep the spray with you. Through the side of the bottle, you can see how much spray you have left. Make sure that you get a new spray before the old one runs out. Always keep a spare.

Talk with your doctor about how long you should keep using Glyceryl Trinitrate Sublingual Spray.

If you use more Glyceryl Trinitrate Sublingual Spray than you should

If you use too many puffs you may notice more severe and pronounced side effects (see section 4), for example, you may get a bad headache, blurred vision, feel flushed or feel that your heart is beating more slowly. You may also feel faint, sweaty, breathless, weak, restless and feel sick or be sick, or notice a bluish tinge to your lips or a bluish colouration of the skin. In very rare cases you may develop methaemoglobinaemia (a disorder of the red blood cells). If any of these effects persist, contact your doctor or pharmacist.

If you forget to use Glyceryl Trinitrate Sublingual Spray

Do not use a double dose to make up for a forgotten dose.

If you stop taking Glyceryl Trinitrate Sublingual Spray

Do not stop using Glyceryl Trinitrate Sublingual Spray without the advice of your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Headache

Common (may affect up to 1 in 10 people)

• Decreased blood pressure, which can also occur on standing up
• Weakness
• Dizziness
• Drowsiness
• Increased heart rate
• Facial flushing

Uncommon (may affect up to 1 in 100 people)

• Fainting
• Worsened angina symptoms
• Slowing heart rate
• Bluish colouration of the skin
• Circulatory collapse (failure of the blood circulation)
• Nausea
• Vomiting
• Allergic skin rash

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

• Cerebral ischaemia (decreased blood flow to the brain)
• Methaemoglobinemia (a disorder of the red blood cells)
• Restlessness
• Difficulty breathing
• Skin rash

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

• Tongue swelling (due to an allergic reaction) • Tongue blistering

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 <To be completed nationally>. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Glyceryl Trinitrate Sublingual Spray

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date.

Store below 25 °C.

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.

6. Contents of the pack and other information

What Glyceryl Trinitrate Sublingual Spray contains

• The active substance is glyceryl trinitrate. Each puff of sublingual spray contains 400 micrograms of glyceryl trinitrate.
• The other ingredients are triglycerides, medium-chain, ethanol, anhydrous, glycerol monocaprylocaprate, peppermint oil.

What Glyceryl Trinitrate Sublingual Spray looks like and contents of the pack

Blue coated glass bottle is equipped with a metered dosing valve and a transparent protective cap, in a carton box. Each bottle is designed to deliver at least 180 or 200 doses.

Marketing Authorisation Holder

EGIS Pharmaceuticals UK Ltd.

127 Shirland Road

London

W9 2EP

United Kingdom

Manufacturer

Egis Pharmaceuticals PLC

65 Matyas kiraly Street

Kormend

H-9900

Hungary

This leaflet was last revised in September 2026.