GLYTRIN Sublingual spray, solution Ref.[27718] Active ingredients: Glycerol

Posology

Oromucosal dosage.

Adults including the elderly

At the onset of an attack: one or two metered doses (400 to 800 micrograms glyceryl trinitrate) to be sprayed under the tongue for the relief of anginal pain while the breath is held. No more than three doses are recommended at any one time.

For the prevention of inducible angina (e.g. physical effort, emotional stress, exposure to cold) one or two 400 microgram metered doses sprayed under the tongue within 2-3 minutes of the event starting.

Paediatric population

Glyceryl Trinitrate Spray should not be used in children and adolescents under 18 years.

Method of administration

Before using Glyceryl Trinitrate Spray for the first time, the patient should check that the spray is working by pressing the pump button a few times until it produces a fine mist of liquid. The patient should practice aiming the spray onto a tissue or similar item so that they will be able to aim it correctly under the tongue when they need to use it. If the patient does not need to use Glyceryl Trinitrate Spray very often, the spray should be checked regularly to see that it still works properly.

During application the patient should rest, ideally in the sitting position. The canister should be held vertically with the valve head uppermost and the spray orifice 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 top of the valve, in order to facilitate orientation for the administration at night.

Signs and symptoms

Flushing, severe headache, vertigo, tachycardia, a feeling of suffocation, hypotension, fainting 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 methylthioninium chloride and/or toluidine blue. Symptomatic treatment should be given for respiratory and circulatory defects in more serious cases.

3 years.

Do not store above 25°C. Do not refrigerate or freeze.

Glyceryl Trinitrate Spray is an aerosol spray and contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the aluminium container (canister), even when empty.

It should not be sprayed at a naked flame or any incandescent material.

Patients, especially those who smoke should be warned not to use Glyceryl Trinitrate Spray near a naked flame.

Internally lacquered monobloc aluminium pressurised container (canister) sealed with a metered spray valve. The product is presented in packs with one container.

Each container contains either 1760.0 mg of solution (according to 11400.0 mg of solution and propellant) providing 200 single metered doses, or 1584.0 mg of solution (according to 10260.0 mg of solution and propellant) providing 180 metered doses.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.