Therapeutic indications

For the treatment and prophylaxis of angina pectoris and the treatment of variant angina.

Posology and method of administration
Adults and the Elderly:

At the onset of an attack or prior to a precipitating event: one or two 400 microgram metered doses sprayed under the tongue.  It is recommended that no more than three metered-doses are taken at any one time and that there should be a minimum interval of 15 minutes between consecutive treatments.

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.


Children:

Nitrolingual Pumpspray is not recommended for use.


Administration:

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.



Contraindications
Hypersensitivity to nitrates or any constituent of the formulation.  Hypotension, hypovolaemia, severe anaemia, cerebral haemorrhage and brain trauma, mitral stenosis and angina caused by hypertrophic obstructive cardiomyopathy.  Concomitant administration of phosphodiesterase inhibitors used for the treatment of erectile dysfunction


Special warnings and precautions for use
Any lack of effect may be an indicator of early myocardial infarction.

As with all glyceryl trinitrate preparations, use in patients with incipient glaucoma should be avoided.


Interaction with other medicinal products and other forms of interaction
Tolerance to this drug and cross tolerance to other nitrates may occur.  Alcohol may potentiate any hypotensive effect.

The hypotensive effects of nitrates are potentiated by concurrent administration of phosphodiesterase inhibitors used for the treatment of erectile dysfunction.  A severe and possibly dangerous fall in blood pressure may occur.  This can result in collapse, unconsciousness and may be fatal.  Such use is therefore contra-indicated (section 4.3)

If a patient treated with these drugs for erectile dysfunction needs a rapidly effective nitrate, he/she should be closely monitored.


Undesirable effects
Headache, dizziness, postural hypotension, flushing, tachycardia and paradoxical bradycardia have been reported