Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
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Each metered dose contains 400 micrograms glyceryl trinitrate.
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For the treatment and prophylaxis of angina pectoris and the treatment of variant angina.
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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.
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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 or pulmonary arterial hypertension (section 4.5).
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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.
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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 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 or pulmonary arterial hypertension needs a rapidly effective nitrate, he/she should be closely monitored.
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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.
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Only as a result of hypotension.
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Headache, dizziness, postural hypotension, flushing, tachycardia and paradoxical bradycardia have been reported.
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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.
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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.
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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.
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Fractionated coconut oil, ethanol (absolute), medium chain partial glycerides, peppermint oil.
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Red plastic coated glass bottle 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). Nitrolingual Pumpspray Duo pack contains a 4.9g and a 14.2g bottle.
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See 'Administration' section.
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Merck Serono Ltd
Bedfont Cross
Stanwell Road
Feltham
Middlesex
TW14 8NX
UK
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