Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray

Each metered dose contains 400 micrograms glyceryl trinitrate.

Excipients: contains 9.6 mg anhydrous ethanol per metered dose.

For a full list of excipients, see section 6.1.

Sublingual spray.

A clear, colourless to slightly yellow solution.

For the treatment and prophylaxis of angina pectoris and the treatment of variant angina, and for the emergency treatment of pulmonary oedema secondary to acute left ventricular failure until appropriate intravenous therapy can be instituted.

Adults and the Elderly:

Angina

At the onset of an attack: one or two 400 microgram metered-doses sprayed under the tongue. No more than three metered-doses are generally recommended at any one time.

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.

Left ventricular failure

Two 400 microgram metered doses sprayed under the tongue, as quickly as possible. This may be repeated as necessary.

Children:

Nitrolingual spray 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.

Angina: 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.

Left ventricular failure: patients should be maintained in an upright position during administration of the spray.

Hypersensitivity to nitrates or to any of the excipients. Hypotensive shock, severe anaemia, cerebral haemorrhage and brain trauma, mitral stenosis, arterial hypoxaemia, uncorrected hypovolaemia and angina caused by hypertrophic obstructive cardiomyopathy. Concomitant administration of phosphodiesterase inhibitors used for the treatment of erectile dysfunction or pulmonary arterial hypertension (see section 4.5).

This medicinal product contains small amounts of ethanol (alcohol); less than 10mg per metered dose (puff)

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 or pulmonary arterial hypertension. 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 (see section 4.3).

If a patient treated with these drugs for erectile dysfunction or pulmonary arterial hypertension need a rapidly effective nitrate, he/she should be closely monitored.

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

Only as a result of hypotension.

The following convention is used to classify the frequency of adverse reactions: Very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to 1/100); rare ( 1/10,000 to 1/1000); very rare ( 1/10,000); not known (cannot be estimated from the available data).

The most serious, although uncommon, adverse reaction observed is a pronounced drop in blood pressure, in the worst case leading to circulatory collapse, occasionally accompanied by bradycardia. Headache occurs very commonly at the start of treatment but usually subsides with continued use.

The following table summarises adverse reactions by system organ class and frequency:

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.

Pharmacotherapeutic group: Vasodilators used in cardiac disease,

ATC code: C01DA02.

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.

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.

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Medium-chain triglycerides (fractionated coconut oil), anhydrous ethanol, medium-chain partial glycerides, peppermint oil.

Not applicable.

3 years.

Do not store above 25°C.

Red plastic coated glass bottle (colourless type III glass) fitted with metering pump. Each bottle contains 4.9, 10.3, 11.2 or 14.2g solution (equivalent to about 75, 180, 200 or 250 doses).

No special requirements.

Merck Serono Ltd

Bedfont Cross, Stanwell Road,

Feltham, Middlesex,

TW14 8NX, UK

PA 654/20/1

Date of first authorisation: 8^th May 1996

Date of last renewal: 8^th May 2011

29 June 2011