Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glyceryl trinitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Your medicine is called Glytrin. 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. Glytrin 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, and exposure to cold, etc.
e Glytrin Do not use Glytrin and talk to your doctor:
•
sildenafil, tadalafil, vardenafil or other similar phospho-diesterase inhibitors used to treat male erectile dysfunction (impotence).
Warnings and precautions Talk to your doctor before using Glytrin if any of the following apply to you:
Continuous use warning Continuous use of Glytrin and other nitrates may reduce effectiveness at relieving your symptoms, so high continuous doses should be avoided.
Glytrin 1. Glytrin is not recommended for children. 2. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 3. Learn how to use Glytrin 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 Glytrin if you are near a naked flame, e.g. a cigarette. 6. Before using Glytrin for the first time, check that the spray 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 when you need to use it. If you do not need to use Glytrin very often, remember to check the spray regularly to see that it still works properly. 7. To use Glytrin
Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience one of the following rare serious side effects (may affect up to 1 in 1,000 people unless specified), stop taking Glytrin immediately and consult your doctor:
Other known side effects are: Very common (may affect more than 1 in 10 people): Common (may affect up 1 in 10 people): Uncommon (may affect up to 1 in 100 people): Rare (may affect up to 1 in 1,000 people): Very rare (may affect up to 1 in 10,000 people):
Headache Vertigo (spinning sensation), dizziness, nausea, facial flushing, weakness Burning sensation, stinging sensation Severe fall in blood pressure, heart rhythm change Flaking or peeling skin
Reporting of side effects If you get any side effects, talk to your doctor. 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.
Glytrin • • • • •
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 the container label after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate or freeze. Glytrin is an aerosol spray and contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister, even when empty. Do not spray at or use near a naked flame. 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.
What Glytrin contains
Glytrin, 400 micrograms per metered dose, sublingual spray comes as spray containing 400mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Glytrin, 400 micrograms per metered dose, sublingual spray is glyceryl trinitrate.
Medicines with the same active substance, strength and form include: Glyceryl Trinitrate 400 micrograms/metered dose, sublingual spray (PL18190/0013), Glyceryl Trinitrate 400 micrograms/metered dose, sublingual spray x200, Glyceryl Trinitrate Spray 400 micrograms/metered dose, sublingual spray. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Glytrin, 400 micrograms per metered dose, sublingual spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of acute angina pectoris.
Prevention of inducible angina (e.g. physical effort, emotional stress, exposure to cold).
Posology
Oromucosal Dosage
Adults including the elderly
At the onset of an attack, one or two metered sprays (400 to 800 micrograms glyceryl trinitrate) to be sprayed under the tongue for the relief of anginal pain while breath is held. If symptoms do not resolve, this may be repeated at five-minute intervals for a total of three sprays (maximum of 1.2 mg taken within 15 minutes). If symptoms have not resolved after a total of three sprays, immediate medical attention should be sought.
For the prevention of inducible angina (e.g. due to physical effort, emotional stress, exposure to cold), one or two metered sprays (400 to 800 micrograms glyceryl trinitrate) to be sprayed under the tongue 2 to 3 minutes prior to activity likely to cause angina.
Paediatric population
Glytrin should not be used in children and adolescents under 18 years.
Method of administration
Before using Glytrin for the first time, the patient should check that the spray is working by pressing the pump button a few times until it produces a fine mist of liquid. The patient should practice aiming the spray onto a tissue or similar item so that they will be able to aim it correctly under the tongue when they need to use it. If the patient does not need to use Glytrin very often, the spray should be checked regularly to see that it still works properly.
During application the patient should rest, ideally in the sitting position. The canister should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should be sprayed under the tongue and the mouth should be closed immediately after each dose. The spray should not be inhaled. Patients should be instructed to familiarise themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation, for administration at night.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Severe hypotension (systolic blood pressure lower than 90 mm Hg)
• Hypotensive shock
• Severe anaemia
• Constrictive pericarditis
• Extreme bradycardia
• Cerebral haemorrhage and brain trauma
• Aortic and/or mitral stenosis
• Angina caused by hypertrophic obstructive cardiomyopathy
• Circulatory collapse
• Cardiogenic shock, unless a sufficiently high left ventricular end diastolic pressure is assured by intra-aortic balloon pump counterpulsation therapy or positive inotropic drugs
• Toxic pulmonary oedema
• Concomitant use with phosphodiesterase inhibitors, such as sildenafil, tadalafil, or vardenafil
• Concomitant use with the soluble guanylate cyclase stimulator riociguat (see section 4.5).
Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia (including G6PD deficiency induced forms).
Tolerance to this drug and cross-tolerance to other nitrates may occur.
Glytrin should be administered with particular caution in:
• Pericardial tamponade
• Low filling pressures (e.g. acute myocardial infarction, left ventricular failure)
• Tendency to dysregulation of orthostatic blood pressure
• Diseases accompanied by an increase in intracranial pressure (so far further pressure has been observed solely in high doses of glyceryl trinitrate).
Alcohol should be avoided because of the hypotensive effect and medical controls of the intraocular pressure of glaucoma patients are advisable.
Particular caution should also be exercised when using Glytrin in patients with volume depletion from diuretic therapy, severe hepatic or renal impairment and hypothyroidism.
This medicine contains 7.5 mg of alcohol (ethanol) in each spray. The amount in one spray 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.
• Alcohol may potentiate the hypotensive effect.
• Vasodilators, antihypertensives, β-blockers, calcium antagonists, neuroleptics, tricyclic antidepressants and diuretics can increase nitrate-induced hypotension.
• The hypotensive effects of nitrates are potentiated by the concurrent administration of phosphodiesterase inhibitors, such as sildenafil, tadalafil, or vardenafil.
• The use of a soluble guanylate cyclase stimulator such as riociguat is contraindicated (see section 4.3) since concomitant use can cause hypotension.
• The bioavailability of dihydroergotamine may be increased by concomitant use of Glytrin, which can result in vasoconstriction since dihydroergotamine can antagonise the effects of glyceryl trinitrate.
• The concomitant administration of Glytrin and heparin can reduce the antithrombotic effect of heparin. Regular monitoring of coagulation parameters and adjustment of the heparin dose may be necessary.
• In patients pre-treated with organic nitrates a higher dose of glyceryl trinitrate may be necessary to achieve the desired haemodynamic effect.
Pregnancy
The safety of glyceryl trinitrate in human pregnancy, especially during the first trimester has not been established.
Breastfeeding
It is not known whether glyceryl trinitrate is excreted into human breast milk. Glytrin should be used only after weighing the benefit for the mother against possible risks for the child. Nursing should be discontinued during treatment with this product.
Fertility
Preclinical data reveal no special hazard for humans based on conventional studies of toxicity to reproduction (see section 5.3).
The ability to react may be diminished because of the side effects or interactions due to the nitrates. This effect is potentiated by alcohol consumption. Therefore, driving and/or using machines should be avoided during treatment with Glytrin.
The following adverse reactions have been reported:
System Organ Class
Very common
(≥ 1/10)
Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1,000 to < 1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
Very Rare
(< 1/10,000)
Nervous System Disorders
Headache
Vertigo
Dizziness
Syncope
Skin and Subcutaneous Tissue Disorders
Allergic dermatitis *
Exfoliative dermatitis
Vascular Disorders
Facial flushing
Orthostatic hypotension
Circulatory collapse
General Disorders and Administration Site Conditions
Asthenia
Application site discomfort including Burning sensation and Stinging
Gastrointestinal Disorders
Nausea
Tongue blistering
Cardiac Disorders
Tachycardia
Bradycardia
Angina pectoris aggravated
Investigations
Blood pressure decreased
* symptoms which are known in conjunction with hypersensitivity reactions
Use of Glytrin may give rise to transient hypoxaemia and, in patients with coronary heart disease, ischaemia as a result of a relative redistribution of the bloodstream, which is to hypoventilated alveolar areas.
Tolerance development and the occurrence of crossed tolerance of other nitro compounds have been found in chronic, continuous treatment using high doses. To avoid a decrease in efficacy or a loss of efficacy, high continuous doses should be avoided.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions 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.
Signs and symptoms
Flushing, severe headache, vertigo, tachycardia, a feeling of suffocation, hypotension, fainting and rarely cyanosis and methaemoglobinaemia may occur. In a few patients, there may be a reaction comparable to shock with nausea, vomiting, weakness, sweating and syncope.
Treatment
Recovery often occurs without special treatment. Hypotension may be corrected by elevation of the legs to promote venous return. If methaemoglobinaemia is suspected, it should be confirmed, assessed and treated in accordance with local guidance and best practice. Treatment includes supplemental oxygen and intravenous methylthioninium chloride, as indicated. Symptomatic treatment should be given for respiratory and circulatory defects in more serious cases.
Ask anything about Glytrin, 400 micrograms per metered dose, sublingual spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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