Glytrin 400 micrograms per metered dose Sublingual Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glyceryl trinitrate

Available from:

Ayrton Saunders Ltd

ATC code:

C01DA; C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

0.7%w/w percent weight/weight

Pharmaceutical form:

Sublingual spray

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Organic nitrates; glyceryl trinitrate

Authorization status:

Marketed

Authorization date:

1990-11-29

Patient Information leaflet

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

Summary of Product characteristics

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.
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