NITROLINGUAL PUMP SPRAY 400 Microgram Sublingual Spray

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

GLYCERYL TRINITRATE

Disponível em:

Merck Serono Limited

Código ATC:

C01DA02

DCI (Denominação Comum Internacional):

GLYCERYL TRINITRATE

Dosagem:

400 Microgram

Forma farmacêutica:

Sublingual Spray

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Organic nitrates

Status de autorização:

Authorised

Data de autorização:

2010-07-02

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
NITROLINGUAL® PUMPSPRAY
400 micrograms per metered dose, sublingual spray
GLYCERYL TRINITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or
nurse.
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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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Nitrolingual® is and what it is used for
2. What you need to know before you take Nitrolingual®
3. How to take Nitrolingual®
4. Possible side effects
5. How to store Nitrolingual®
6. Contents of the pack and other information
1.
WHAT NITROLINGUAL® IS AND WHAT IT IS USED FOR
Nitrolingual® is a sublingual spray which you use under your tongue.
The active ingredient is
called glyceryl trinitrate or GTN for short. GTN is one of a group of
medicines called ‘nitrates’.
These relax the muscles around the blood vessels and make it easier
for the heart to do its work.
Nitrolingual® helps stop the pain of angina (pain in your chest, arms
or neck especially when you
exert yourself). You can also use the medicine immediately before
doing things which you know
will cause you angina pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROLINGUAL®
DO NOT TAKE NITROLINGUAL®
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if you are ALLERGIC (hypersensitive) to NITRATES or ANY OF THE OTHER
INGREDIENTS of
Nitrolingual® (see list of ingredients in section 6). An allergic
reaction may include rash,
itching, difficulty breathing or swelling of the face, lips, throat or
tongue.
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if you are VERY ILL BECAUSE OF VERY LOW BLOOD PRESSURE, SEVERE BLOOD
LOSS, A STROKE,
BLEEDING IN THE BRAIN, A SEVERE HEAD INJURY OR SEVERE ANAEMIA
-
if you have certain UNUSUAL

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 400 micrograms glyceryl trinitrate.
Excipients: contains 9.6 mg anhydrous ethanol per metered dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual spray.
A clear colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment and prophylaxis of angina pectoris and the treatment of variant angina, and for the emergency
treatment of pulmonary oedema secondary to acute left ventricular failure until appropriate intravenous therapy can be
instituted.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults including Older people_
_Angina_
At the onset of an attack or prior to a precipitating event: one or two 400 microgram metered doses sprayed under the
tongue. If symptoms do not resolve, this may be repeated at five minute intervals for a total of three doses. If symptoms
have not resolved after a total of three doses, the patient should seek prompt medical attention.
For the prevention of exercise induced angina or in other precipitating conditions: one or two 400 microgram metered
doses sprayed under the tongue immediately prior to the event.
_Left ventricular failure_
Two 400 microgram metered doses sprayed under the tongue, as quickly as possible.
This may be repeated as necessary.
_Older people_
Hypotension and syncope can be a particular problem with the use of nitrates in the older people.
_Paediatric population_
No data are available on the use of glyceryl trinitrate in children.
Method of Administration
_Precautions to be taken before handling or administering the medicinal product._