NITROLINGUAL PUMPSPRAY glyceryl trinitrate 400mcg/metered dose, spray solution, aerosol, pump actuated

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glyceryl trinitrate, Quantity: 0.4 mg/actuation

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Spray, solution

Composition:

Excipient Ingredients: Peppermint Oil; ethanol; sodium lactate; (S)-lactic acid; fractionated coconut oil; purified water; glyceryl caprylate/caprate

Administration route:

Sublingual

Units in package:

13.9 mL

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

The treatment of acute angina pectoris. As well as relieving the pain of an acute attack Nitrolingual Pumpspray may be used prophylactically five to ten minutes prior to engaging in activities which may precipitate an acute attack.

Product summary:

Visual Identification: Plastic bottle with actuator with finger rest, snap on cap, pump body, dip tube with notch and gasket.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-10-19

Patient Information leaflet

NITROLINGUAL
® PUMPSPRAY
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NITROLINGUAL PUMPSPRAY?
Nitrolingual Pumpspray contains the active ingredient Glyceryl
Trinitrate. Nitrolingual Pumpspray is used to treat acute angina.
For more information, see Section 1. Why am I using Nitrolingual
Pumpspray? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NITROLINGUAL PUMPSPRAY?
Do not use if you have ever had an allergic reaction to Glyceryl
trinitrate (the active ingredient) or any of the other ingredients of
Nitrolingual Pumpspray listed at the end of the CMI.
Do not use Nitrolingual Pumpspray if you are pregnant or
breast-feeding unless you and your doctor or pharmacist have discussed
the risks and benefits involved.
For more information, see Section 2. What should I know before I use
Nitrolingual Pumpspray? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Nitrolingual Pumpspray and affect
how it works.
A list of these medicines is in Section 3 What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NITROLINGUAL PUMPSPRAY?
•
Use the exact amount your doctor or pharmacist tells you to.
•
At the first sign of an angina attack, one metered dose should be
sprayed under your tongue. If the pain persists after five
minutes, administer a second metered dose.
•
DO NOT TAKE MORE THAN TWO DOSES DURING AN ANGINA ATTACK.
•
More instructions can be found in Section 4. How do I use Nitrolingual
Pumpspray? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NITROLINGUAL PUMPSPRAY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Nitrolingual Pumpspray.
•
Tell your doctor or pharmacist if you continue to have angina attacks
or if they become more frequent
while you are using Nitrolingual Pumpspray.
THINGS YOU
SHOULD NOT DO
•
Do not

Summary of Product characteristics

nitrolingual-ccdsv8-piv11-09dec21
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION - NITROLINGUAL
®
(GLYCERYL TRINITRATE) PUMPSPRAY
1
NAME OF THE MEDICINE
Glyceryl trinitrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of Nitrolingual Pumpspray delivers 400 micrograms of
glyceryl trinitrate
per spray emission. This product delivers glyceryl trinitrate in the
form of spray droplets
beneath the tongue.
For full list of excipients, see 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Spray solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute angina pectoris.
As well as relieving the pain of an acute attack, Nitrolingual
Pumpspray may be used
prophylactically five to ten minutes prior to engaging in activities
which may precipitate an
acute attack.
4.2
DOSE AND METHOD OF ADMINISTRATION
The spray should not be inhaled and should be kept away from the eyes.
When initiating therapy, especially when changing from another form of
glyceryl trinitrate
administration, patients should be followed closely in order to
determine the minimal effective
dose for each patient.
Reserved for use in adults. Tachyphylaxis (tolerance to treatment) may
occur with chronic
administration (prophylactic treatment of acute angina pectoris).
Except in cases where the
transdermal
route
is
used
as
a
follow-on
treatment
after
another
(e.g.
intravenous)
pharmaceutical form of nitrate treatment, the effective dosage should
be attained gradually,
because of the risk of orthostatic hypotension and/or violent headache
in certain subjects.
At the onset of an attack, initially one metered dose (400 micrograms)
should be sprayed under
the tongue, followed by a second metered dose if pain relief has not
occurred within 5 minutes.
No more than two metered doses are recommended. If chest pain
persists, seek prompt
attention.
nitrolingual-ccdsv8-piv11-09dec21
Page 2 of 11
For the prevention of exercise induced angina or in other
precipitating conditions: one or two
400 microgram metered doses sprayed under the tongue immedia