Active ingredient
- glyceryl trinitrate
Legal Category
P: Pharmacy
P: Pharmacy
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL18190/0013 .
Glyceryl Trinitrate 400 micrograms/metered dose, sublingual spray x180
Glyceryl Trinitrate
400 micrograms/metered dose, sublingual spray
Glyceryl trinitrate
Package leaflet: Information for the User
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
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
1 What Glyceryl Trinitrate spray is and what it is used for
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).
2 What you need to know before you use Glyceryl Trinitrate spray
Do not use Glyceryl Trinitrate spray if you:
Warnings and precautions
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.
Children
The use of Glyceryl Trinitrate spray is not recommended for children.
Other medicines and Glyceryl Trinitrate spray
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.
Glyceryl Trinitrate spray with alcohol
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).
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.
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.
Driving and using machines
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.
Glyceryl Trinitrate spray contains small amounts of ethanol (alcohol) and propylene glycol
This product contains 79.2 volume% of ethanol (alcohol). Each dose (spray) contains up to 0.04g of alcohol. This product may be harmful for patients suffering from liver disease, alcoholism, epilepsy, brain injury or disease.
Propylene glycol may cause skin irritation.
3 How to use Glyceryl Trinitrate 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.
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 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.
4 Possible side effects
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.
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.
5 How to store Glyceryl Trinitrate spray
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.
6 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 containing 10g of solution is designed to deliver at least 180 doses.
Appearance: Colourless or almost colourless, clear solution, free from sediments.
Marketing Authorisation Holder
Manufacturer
Distributor
This leaflet was last revised in 11/2019
1010029-P7.2
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148