Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Glyceryl trinitrate
Ayrton Saunders Ltd
C01DA; C01DA02
Glyceryl trinitrate
0.7%w/w percent weight/weight
Sublingual spray
Product subject to prescription which may be renewed (B)
Organic nitrates; glyceryl trinitrate
Marketed
1990-11-29
1. WHAT GLYTRIN IS AND WHAT IT IS USED 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, exposure to cold, etc. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLYTRIN DO NOT USE GLYTRIN AND TALK TO YOUR DOCTOR IF YOU: • Are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6). • 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 (an • 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 • 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). DO NOT USE if you are taking: • RIOCIGUAT to treat pulmonary hypertension • or other similar phospho- diesterase inhibitors used to treat male erectile dysfunction (impotence). GLYTRIN 400 MICROGRAMS PER METERED DOSE, SUBLINGUAL SPRAY Glyceryl Trinitrate 400 micrograms per metered dose WARNINGS AND PRECAUTIONS Talk to your doctor before using Glytrin if any of the following apply to you: • Fluid around the heart (pericardial tamponade). • • Problems controlling your blood pressure. • Any disease that increases pressure on the brain. • Glauc Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glytrin 400 micrograms per metered dose Sublingual Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Glyceryl Trinitrate: 400 micrograms/metered dose (One metered dose with 8.8 mg solution contains 400 micrograms glyceryl trinitrate). Excipients with known effect: This product contains ethanol 13.2% w/w For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sublingual Spray, Solution Metered dose aerosol canister containing a colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute angina pectoris. Prevention of inducible angina (e.g. physical effort, emotional stress, exposure to cold). ROUTE OF ADMINISTRATION Oromucosal (Sublingual). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION OROMUCOSAL DOSAGE ADULTS INCLUDING THE ELDERLY At the onset of an attack: one or two metered doses (400 to 800 micrograms glyceryl trinitrate) to be sprayed under the tongue for the relief of anginal pain while the breath is held. No more than three doses are recommended at any one time. For the prevention of inducible angina (e.g. physical effort, emotional stress, exposure to cold) one or two 400 microgram metered doses sprayed under the tongue within 2-3 minutes of the event starting. CHILDREN Glytrin Spray is not recommended for children. ADMINISTRATION 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document