NITROLINGUAL SPRAY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLYCERYL TRINITRATE

Available from:

MEGAPHARM LTD

ATC code:

C05AE01

Pharmaceutical form:

SOLUTION

Composition:

GLYCERYL TRINITRATE 0.4 MG/DOSE

Administration route:

SUBLINGUAL

Prescription type:

Required

Manufactured by:

G.POHL-BOSKAMP GmbH & CO.,GERMANY

Therapeutic group:

GLYCERYL TRINITRATE

Therapeutic area:

GLYCERYL TRINITRATE

Therapeutic indications:

Relief of angina pectoris attacks, angina pectoris prophylaxis.

Authorization date:

2021-10-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
NITROLINGUAL SPRAY
COMPOSITION
ACTIVE INGREDIENT:
Each dose contains:
0.4 mg Glyceryl Trinitrate
Each dose contains 9.600 mg ethanol.
For a list of inactive and allergenic ingredients in the preparation,
see section
6 “Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, consult your physician or pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to
others. It may harm them even if it seems to you that their medical
condition is
similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
MEDICAL ACTIVITY: Relief of angina pectoris attacks, angina pectoris
prophylaxis.
THERAPEUTIC GROUP: Nitrates, vasodilators.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are sensitive (allergic) to the active ingredient Glyceryl
Trinitrate,
nitrates or any of the additional ingredients contained in the
medicine
(see section 6 "Additional information").
An allergic reaction may include a rash, itchiness, breathing
difficulties
or swelling of the face, lips, throat or tongue.

You suffer from: a severe circulatory problem, very low blood pressure
(below 90
mm of mercury) or severe loss of blood; if you had an acute
cerebrovascular
accident, cerebral hemorrhage, severe head trauma or acute anemia.

You suffer from UNUSUAL HEART CONDITIONS such as acute circulatory
shock
(where there is impaired blood flow to the body’s tissues), this can
include
hypovolemic shock (as a result of low blood volume), uncontrolled
cardiogenic
shock (as a result of decreased cardiac output), severe mitral
stenosis
(narrowing of the opening of the mitral valve in the heart) or
obstructive
cardiomyopathy (a disease of the heart muscle causing obstruction of
blood
flow).

If you are taking VIAGRA (sildenafil) or

Summary of Product characteristics

1/3
1.
NAME OF THE MEDICINAL PRODUCT
NITROLINGUAL SPRAY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 400 micrograms glyceryl trinitrate.
Excipients: contains 9.600 mg anhydrous ethanol per metered dose. For
the full list of excipients, see
section 6.1
3.
PHARMACEUTICAL FORM
Sublingual spray.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of angina pectoris attacks, angina pectoris prophylaxis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
P osology
_Adults and older people:_
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.
_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:_
The bottle should be held vertically with the valve head uppermost. If
the pump is new, or has not
been used for a week or more, the first actuation should be released
into the air. The spray orifice
should then be placed as close to the mouth as possible. The dose
should be sprayed under the
tongue and the mouth should be closed immediately after each dose. The
spray should not be
inhaled.
Patients should be instructed to familiarise themselves with the
position of the spray orifice, which
can be identified by the finger rest on the top of the valve, in order
to facilitate orientation for
administration at night. During application the patient should rest,
ideally in the sitting position
because of the risk of symptomatic postural hypotension. Hypotension
and syncope can be a
particular problem with the use of nitrates in the elderly.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance, other nitrates or to any of
the excipients listed in section
6.1.
-
Acute circula