Glytrin 400micrograms/dose aerosol sublingual spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glyceryl trinitrate

Available from:

Aspire Pharma Ltd

ATC code:

C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

400microgram/1dose

Pharmaceutical form:

Sublingual spray

Administration route:

Sublingual

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5000283601852

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, and 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).
•
If you have severe low blood pressure.
•
If you have shock caused by low blood pressure.
•
If you have severe anaemia.
•
If you have constrictive pericarditis (a heart condition).
•
If you have an extremely low heart rate.
•
If you have glucose-6-phosphate-dehydrogenase deficiency
(an inherited enzyme deficiency, mainly affecting men).
•
If you have a brain trauma or cerebral haemorrhage (brain or
head injury, including bleeding).
•
If you have narrowing of the heart valves or arteries or
angina caused by a disease of the heart muscle.
•
If you have circulatory collapse (a failure of blood circulation).
•
If you have toxic pulmonary oedema (lung swelling/ fluid)
•
If you 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 Sildenafil, tildenafil, vardenafil or
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

Summary of Product characteristics

OBJECT 1
GLYTRIN, 400 MICROGRAMS PER METERED DOSE,
SUBLINGUAL SPRAY
Summary of Product Characteristics Updated 28-Jun-2016 | Aspire Pharma
Ltd
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 per metered dose
This product contains small amounts of ethanol (alcohol) less than
100mg per spray.
For full list of excipients, see Section 6.1
3. Pharmaceutical form
Metered dose oromucosal (sublingual) spray solution.
Small aerosol canister
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
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.
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 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 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 t