Patient Leaflet Updated 04-Apr-2023 | Aspire Pharma Ltd
Glyceryl Trinitrate 400 micrograms/metered dose, sublingual spray x180
Glyceryl Trinitrate
400 micrograms/metered dose, sublingual spray
glyceryl trinitrate
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
Glyceryl Trinitrate spray is a smooth muscle relaxant. The walls of many of the body’s veins and arteries are made of smooth muscle, and so glyceryl trinitrate helps to widen these vessels.
When you spray Glyceryl Trinitrate spray under your tongue it is quickly absorbed in the bloodstream. The action of Glyceryl Trinitrate spray allows blood to flow more quickly and more easily. This means that your heart does not need to work so hard. The greater blood flow through the heart also means that the heart works more efficiently. These actions of glyceryl trinitrate bring relief in an attack of angina and can prevent an attack coming on.
Glyceryl Trinitrate spray is for the relief and prevention of angina attacks (chest pains).
Talk to your doctor or pharmacist before using Glyceryl Trinitrate spray.
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:
Take care when using Glyceryl Trinitrate spray with:
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.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Follow the instruction below to take off the cap:
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
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:
The following side effects have also been reported:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people)
*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.
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.
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.
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 10 grams of solution and is designed to deliver at least 180 doses.
Appearance: Colourless or almost colourless, clear solution, free from sediments.
This leaflet was last revised in 07/2022
1010029-P8.4
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
http://www.aspirepharma.co.uk
+44 (0)1730 231148
+44 (0)1730 231148
