Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glyceryl trinitrate

Available from:

G Pohl-Boskamp GmbH & Co. KG

ATC code:

C01DA02

INN (International Name):

Glyceryl trinitrate

Dosage:

400 microgram(s)

Pharmaceutical form:

Sublingual spray, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

glyceryl trinitrate

Authorization status:

Marketed

Authorization date:

1996-05-08

Patient Information leaflet

1
PACKAGE LEAFLET
2
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 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
–
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

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2021
CRN00C5D0
Page 1 of 6
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._
During application for angina the patient should rest, ideally in the
sitting position because of the risk of symptomatic postural
hypotension. During administrati