Glytrin, 400 microgram per dosis, sublinguale spray

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NITROGLYCERINE 400 µg/dosis

Beschikbaar vanaf:

Ayrton Saunders (Ireland) Limited 8a Sandyford Business Centre Blackthorn Avenue, Sandyford - DUBLIN 18 (IERLAND)

ATC-code:

C01DA02

INN (Algemene Internationale Benaming):

NITROGLYCERINE 400 µg/dosis

farmaceutische vorm:

Spray voor sublinguaal gebruik

Samenstelling:

ETHANOL ; NORFLURAAN ; PEPERMUNTOLIE,

Toedieningsweg:

Sublinguaal gebruik

Therapeutisch gebied:

Glyceryl Trinitrate

Product samenvatting:

Hulpstoffen: ETHANOL; NORFLURAAN; PEPERMUNTOLIE;

Autorisatie datum:

1998-12-14

Bijsluiter

BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
GLYTRIN, 400 MICROGRAM PER DOSIS, SUBLINGUALE 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, 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
(bra

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glytrin, 400 microgram per dosis, sublinguale spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glyceryl Trinitrate: 400 micrograms per metered dose
Excipient(s) with known effect
Ethanol (alcohol) – 7.5 mg per spray.
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Sublingual spray, solution.
(Sublingual spray)
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
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 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.
_Paediatric population _
Glytrin should not be used in children and adolescents under 18 years.
Method of administration
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.
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
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sprayed under the tongue and th