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 (Ireland) Limited

ATC code:

C01DA; C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

0.7%w/w percent weight/weight

Pharmaceutical form:

Sublingual spray, solution

Therapeutic area:

Organic nitrates; glyceryl trinitrate

Authorization status:

Not marketed

Authorization date:

1990-11-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYTRIN
400 MICROGRAMS PER METERED DOSE, SUBLINGUAL SPRAY
glyceryl trinitrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If
you
get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Glytrin is and what it is used for
2.
What you need to know before you use Glytrin
3.
How to use Glytrin
4.
Possible side effects
5.
How to store Glytrin
6.
Contents of the pack and other information
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 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.
•
Hav

Summary of Product characteristics

Health Products Regulatory Authority
02 June 2023
CRN00DHZR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glytrin 400 micrograms per metered dose Sublingual Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose delivers 8.8 mg of solution containing 400
micrograms of glyceryl trinitrate
Excipient(s) with known effect
Ethanol (alcohol) – 7.5 mg per metered dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual spray, solution
Pressurised 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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Sublingual 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 the breath is held. If
symptoms do not resolve, this may be repeated at five-minute
intervals for a total of three sprays (maximum of 1.2mg 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
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 inst