Glyceryl Trinitrate Spray
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine is for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Do not use if you are taking sildenafil, tildenafil, vardenafil or similar phospho-diesterase inhibitors used to treat male erectile dysfunction (impotence).
In this leaflet:
1. What GTN Spray is & what it is used for
2. Before you use GTN Spray
3. How to use GTN Spray
4. Possible side effects
5. How to store GTN Spray
6. Further information
Your medicine is called Glyceryl Trinitrate Spray. It will be referred to throughout this leaflet as GTN Spray.
It is a sublingual (under the tongue) aerosol spray that contains the active ingredient glyceryl trinitrate. Glyceryl trinitrate belongs to a group of medicines called nitrates that relax the muscle walls of the blood vessels and reduce the workload of the heart.
GTN Spray is used to treat angina at the onset of an attack. It is also used for the prevention of angina, which can be brought on from physical effort, emotional stress, exposure to cold, etc.
• Are hypersensitive (allergic) to any of the ingredients, including glyceryl trinitrate, or to any other nitrates.
• Have severe low blood pressure.
• Have shock caused by low blood pressure.
• Have severe anaemia.
• Have constrictive pericarditis (a heart condition).
• Have an extremely low heart rate.
• Have glucose-6-phosphate-dehydrogenase deficiency (an inherited enzyme deficiency, mainly affecting men).
• Have a brain trauma or cerebral haemorrhage (brain or head injury, including bleeding).
• Have narrowing of the heart valves or arteries or angina caused by a disease of the heart muscle.
• Have circulatory collapse (a failure of blood circulation).
• Have toxic pulmonary oedema (lung swelling/fluid).
• 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).
Take special care with GTN Spray and tell your doctor 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.
Using with other medicines:
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Talk to your doctor before using GTN Spray if you
are taking or have recently taken any of the following:
• Medicines treating 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 migrane 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).
Using with alcohol:
Be careful about drinking alcohol as GTN Spray may effect you more than usual. Both alcohol and GTN Spray may lower your blood pressure and slow down your reactions.
Pregnancy and breast-feeding:
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.
Driving and using machines:
Your reactions may slow down. Therefore you should avoid driving and using machinery whilst taking GTN Spray.
Important information about some of the ingredients of GTN Spray:
This product contains small amounts of ethanol (alcohol), less than 10Omg per spray.
Continuous use warning:
Continuous use of GTN Spray and other nitrates may reduce effectiveness at relieving your symptoms, so high continuous doses should be avoided.
1 .GTN Spray is not recommended for children.
2. Always use this spray exactly as explained in this leaflet. You should check with your doctor or pharmacist if you are not sure.
3. Learn howto use this spray before the onset of an angina attack, as you may need to use it in a hurry, or in the dark. Familiarise yourself with the spray button, which has a finger rest to help you direct the spray.
4. Keep a spare handy at all times as it can be difficult to tell how many doses are left in the canister.
5. Do not use GTN Spray if you are near a naked flame, e.g. a cigarette.
• Transient hypoxaemia (deprived oxygen supply).
• Patients with coronory 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 (more than 1 in 10 patients) |
headache |
|
Common (less than 1 in 10 patients) |
vertigo (spinning sensation), dizziness, nausea, facial flushing, weakness |
|
Uncommon (less than 1 in 100 patients) |
burning sensation stinging sensation |
|
Rare (less than 1 in 1000 patients) |
severe fall in blood pressure heart rhythm change |
|
Very Rare (less than 1 in 10000 patients) |
flaking or peeling skin |
If any side effect becomes serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.
imminent attack:
• Sit down.
• Hold the canister upright and near your mouth.
• Hold your breath.
• Aim the spray under your tongue.
• Press down the button firmly, once only.
• Close your mouth immediately.
• Do not inhale the spray.
7. The usual dose is one or two sprays. No more than three doses are recommended at any one time.
8. After using GTN Spray, rest for a while. When you stand up, rise slowly, as you may feel faint.
If you use more GTN Spray than you should:
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.
• Keep out of the reach and sight of children.
• Do not use GTN Spray after the expiry date which is stated on the carton and the canister base after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Do not refrigerate or freeze.
• GTN Spray is an aerosol spray and contains a pressurised liquid. Do not expose to temperatures higher than 50°C, and do not pierce the canister, even when empty.
• Ask your pharmacist how to dispose of GTN Spray, as it should not be put in your household waste.
What GTN Spray contains:
• The active ingredient is glyceryl trinitrate. Each spray of product contains 400 micrograms of glyceryl trinitrate.
• The other ingredients are peppermint oil, ethanol and 1,1,1,2 tetrafluoroethane (the propellant).
4. POSSIBLE SIDE EFFECTS
Like all medicines, as well as benefits, GTN Spray can cause side effects, although not everybody gets them.
If you experience one of the following rare serious side effects (affecting less than 1 in 1000 patients unless specified), stop taking GTN Spray immediately and consult your doctor:
• An allergic skin reaction (with or without rash).
• Tongue blistering (less than 1 in 100 patients).
• Fainting due to a low heart rate and a severe fall in blood pressure. This may be accompanied by a worsening of the original angina symptoms.
What GTN Spray looks like and contents of the pack:
• GTN Spray is a colourless spray presented in a printed aluminium aerosol canister, with a metered dose spray nozzle, and a cap.
• Each canister contains enough product tbr75 or 200 sprays.
Marketing Authorisation Holder and Manufacturer:
PL 16431/0023
Marketing Authorisation Holder: Ayrton Saunders Ltd. 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK. medicalinformation@ps-nw.co.uk
Manufacturer: Pharmasol Limited,
North Way, Andover, SP10 5AZ, UK.
This leaflet was last approved in May 2011.
MP00760