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

Tolerance to this drug and cross-tolerance to other nitrates may occur.

Glyceryl Trinitrate Spray should be administered with particular caution in:

• Pericardial tamponade
• Low filling pressures (e.g. acute myocardial infarction, left ventricular failure)
• Tendency to dysregulation of orthostatic blood pressure
• Diseases accompanied by an increase in intracranial pressure (so far further pressure increase has been observed solely in high doses of glyceryl trinitrate).

Alcohol should be avoided because of the hypotensive effect.

Medical controls of the intraocular pressure of glaucoma-patients are advisable.

Particular caution should also be exercised when using Glyceryl Trinitrate Spray in patients with volume depletion from diuretic therapy, severe hepatic or renal impairment and hypothyroidism.

This medicine contains 7.5 mg of alcohol (ethanol) in each spray. The amount in one spray of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

• Alcohol may potentiate the hypotensive effect.
• Vasodilators, antihypertensives, ß-blockers, calcium antagonists, neuroleptics, tricyclic antidepressants and diuretics can increase nitrate induced hypotension.
• The hypotensive effects of nitrates are potentiated by the concurrent administration of phosphodiesterase inhibitors, such as Sildenafil, Tadalafil or Vardenafil.
• The use of a soluble guanylate cyclase stimulator such as riociguat is contraindicated (see section 4.3) since concomitant use can cause hypotension.
• The bioavailability of dihydroergotamine may be increased by concomitant use of Glyceryl Trinitrate Spray, which can result in vasoconstriction since dihydroergotamine can antagonise the effects of glyceryl trinitrate.
• The concomitant administration of Glyceryl Trinitrate Spray and heparin can reduce the antithrombotic effect of heparin. Regular monitoring of coagulation parameters and adjustments of the heparin dose may be necessary.
• In patients pretreated with organic nitrates a higher dose of glyceryl trinitrate may be necessary to achieve the desired haemodynamic effect.

Pregnancy

The safety of glyceryl trinitrate in human pregnancy, especially during the first trimester has not been established.

Breastfeeding

It is not known whether glyceryl trinitrate is excreted into human breast milk. Glyceryl Trinitrate Spray should only be used after weighing the benefit for the mother against possible risks for the child. Nursing should be discontinued during treatment with this product.

Fertility

Preclinical data reveal no special hazard for humans based on conventional studies of toxicity to reproduction (see section 5.3).

The ability to react may be diminished because of the side effects or interactions due to the nitrates. This effect is potentiated by alcohol consumption. Therefore, driving and/or using machines should be avoided during treatment with Glyceryl Trinitrate Spray.

The following adverse reactions have been reported:

^* symptoms which are known in conjunction with hypersensitivity reactions

Use of Glyceryl Trinitrate Spray may give rise to transient hypoxaemia and, in patients with coronary heart disease, ischaemia as a result of a relative redistribution of the bloodstream, which is to hypoventilated alveolar areas.

Tolerance development and the occurrence of crossed tolerance of other nitro compounds have been found in chronic, continuous treatment using high doses. To avoid a decrease in efficacy or a loss of efficacy, high continuous doses should be avoided.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.