Nitrolingual 400micrograms/dose pump sublingual spray

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Glyceryl trinitrate

Disponibil de la:

Beaumont Pharma Ltd

Codul ATC:

C01DA02

INN (nume internaţional):

Glyceryl trinitrate

Dozare:

400microgram/1dose

Forma farmaceutică:

Sublingual spray

Calea de administrare:

Sublingual

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02060100; GTIN: 5013675000744 5013837321960 5013675000751

Prospect

Package leaflet: Information for the user
Pump Spray
glyceryl trinitrate
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better.
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 means that you use it 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
®
(listed 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, acute stroke, bleeding in the brain,
a severe head injury or severe anaemia
•
if you have certain unusual heart conditions (such as acute

Caracteristicilor produsului

OBJECT 1
NITROLINGUAL PUMPSPRAY
Summary of Product Characteristics Updated 08-May-2018 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Nitrolingual Pumpspray
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.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment and prophylaxis of angina pectoris and the treatment
of variant angina.
4.2 Posology and method of administration
Posology
_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.
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.
_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, ideal