Nitrolingual Pump Spray

1. Name Of The Medicinal Product

Nitrolingual Pumpspray

2. Qualitative And Quantitative Composition

Each metered dose contains 400 micrograms glyceryl trinitrate.

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

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.

4.3 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 (section 4.5).

4.4 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.

4.5 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 paradoxical myocardial ischaemia 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.

4.6 Pregnancy And Lactation

Nitrolingual Pump spray is not generally recommended and should be used only if its potential benefit justifies any potential risk to the foetus or neonate.

4.7 Effects On Ability To Drive And Use Machines

Only as a result of hypotension.

4.8 Undesirable Effects

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

4.9 Overdose

Signs and symptoms:

Flushing, severe headache, a feeling of suffocation, hypotension, fainting, restlessness, blurred vision, impairment of respiration, bradycardia and rarely, cyanosis and methaemoglobinaemia may occur. In a few patients there may be a reaction comparable to shock with nausea, vomiting, weakness, sweating and syncope.

Treatment:

Recovery often occurs without special treatment. Hypotension may be corrected by elevation of the legs to promote venous return. Methaemoglobinaemia should be treated by intravenous methylene blue.

Symptomatic treatment should be given for respiratory and circulatory defects in more serious cases.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glyceryl trinitrate relieves angina pectoris by reduction of cardiac work and dilation of the coronary arteries. In this way, not only is there a lessening in arterial oxygen requirement but the amount of oxygenated blood reaching the ischaemic heart is increased.

5.2 Pharmacokinetic Properties

The pharmacokinetics of glyceryl trinitrate are complex; venous plasma levels of the drug show wide and variable fluctuations and are not predictive of clinical effect. In a human pharmacodynamic study, pharmacological activity had commenced one minute after dosing and was obvious by two minutes.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Fractionated coconut oil, ethanol (absolute), medium chain partial glycerides, peppermint oil.

6.2 Incompatibilities

Not known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Red plastic coated glass bottle fitted with metering pump. Each bottle contains 4.9, 11.2 or 14.2g solution (equivalent to about 75, 200 or 250 doses). Nitrolingual Pumpspray Duo pack contains a 4.9g and a 14.2g bottle.

6.6 Special Precautions For Disposal And Other Handling

See 'Administration' section.

7. Marketing Authorisation Holder

Merck Serono Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX

UK

8. Marketing Authorisation Number(S)

PL 11648/0082

9. Date Of First Authorisation/Renewal Of The Authorisation

28 November 2005

10. Date Of Revision Of The Text

22^nd January 2010

LEGAL CATEGORY Pharmacy