NITROLINGUAL PUMPSPRAY

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

GLYCERYL TRINITRATE

Dostupné s:

PCO Manufacturing

ATC kód:

C01DA02

INN (Mezinárodní Name):

GLYCERYL TRINITRATE

Dávkování:

400 Microgram

Léková forma:

Sublingual Spray

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

glyceryl trinitrate

Stav Autorizace:

Authorised

Datum autorizace:

2013-01-11

Informace pro uživatele

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.
- 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 knowbefore 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®
-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.
- 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 HEAR

Charakteristika produktu

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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual spray.
_Product imported from the UK:_
A clear colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
As per PA0654/020/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0654/020/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Coconut oil
Ethanol Anhydrous
Medium chain partial Triglycerides
Peppermint oil
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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6.5 NATURE AND CONTENTS OF CONTAINER
Red plastic-coated glass bottle (colourless type III glass) fitted
with metering pump. Each bottle contains 11.2g solution
(equivalent to about 200 doses).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE