Glyceryl trinitrate 400micrograms/dose aerosol sublingual spray

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Glyceryl trinitrate

Доступна з:

Aspire Pharma Ltd

Код атс:

C01DA02

ІПН (Міжнародна Ім'я):

Glyceryl trinitrate

Дозування:

400microgram/1dose

Фармацевтична форма:

Sublingual spray

Адміністрація маршрут:

Sublingual

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 02060100; GTIN: 5060479360161 5060479360178

інформаційний буклет

1.
WHAT GLYCERYL TRINITRATE SPRAY IS AND WHAT IT IS USED FOR
Your medicine is called Glyceryl Trinitrate Spray. It will be referred
to
throughout this leaflet as GTN Spray.
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.
GTN Spray 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
GLYCERYL
TRINIT
R
ATE SPRAY
Do not use GTN Spray 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:
•
riociguat to treat pulmonary hypertension
•
sildenafil, tildenafil, vardenafil or other similar phospho-
diesterase inhibitors used to treat male erectile dysfunction
(impotence).
Glyceryl Trinitrate S

Характеристики продукта

OBJECT 1
GLYCERYL TRINITRATE SPRAY 400
MICROGRAMS/METERED DOSE, SUBLINGUAL SPRAY
Summary of Product Characteristics Updated 13-Jul-2017 | Aspire Pharma
Ltd
1. Name of the medicinal product
Glyceryl Trinitrate Spray 400 micrograms/metered dose, sublingual
spray.
2. Qualitative and quantitative composition
Active Ingredient
Glyceryl Trinitrate: 400 micrograms/metered dose
Excipients with known effect:
This product contains small amounts of ethanol (alcohol) less than
100mg per spray.
For the 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 Glyceryl Trinitrate Spray 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 Glyceryl Trinitrate Spray
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 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
Glyceryl Trinitrate Spray is not recommended for children.
Administration
During application the patient should rest, ideally in the sitt