PERCUTOL Ointment Ref.[7282] Active ingredients: Glyceryl trinitrate

In the elderly the development of postural hypotension may be more pronounced especially on sudden rising.

Caution should be exercised in patients with arterial hypoxaemia, due to severe anaemia, patients with hypoxaemia or other ventilation and perfusion abnormalities, susceptibility to angle-closure glaucoma.

Caution should be exercised in patients suffering from hypothyroidism, malnutrition, severe renal or hepatic impairment, hypothermia, recent history of myocardial infarction and ischaemic heart failure due to obstruction.

As with other vasodilators chronic therapy should not be discontinued abruptly. The frequency of application and the dosage should gradually be reduced (over a period of 4 to 6 weeks).

This formulation contains lanolin which may cause skin irritations and skin reactions (e.g. contact dermatitis).

If the ointment is not used as indicated (see Section 4.2) tolerance to the medication could develop.

Concomitant use of glyceryl trinitrate with other vasodilating agents (hydralazine, moxonidine, sodium nitroprusside), alcohol, alprostadil, anti-hypertensive agents including alpha-blockers, beta-adrenergic blocking agents, ACE inhibitors, angiotensin 2 receptor antagonists, clonidine, calcium channel blocking agents, diazoxide, diuretics, dopaminergics, methyldopa, monoamine oxidase inhibitors (MAOIs) and major tranquillisers including phenothiazines, anxiolytics and hypnotics, adrenergic neurone blocking agents, aldesleukin, moxysylite, muscle relaxants (baclofen and tinazidine) or general anaesthetics, may cause additive hypotensive effects.

The hypotensive effect of nitrates are potentiated by concurrent administration of phosphodiesterase inhibitors, e.g. sildenafil, tadalafil, vardenafil, alprostadil (see section 4.3).

If administered concurrently, the ointment may increase the blood level of dihydroergotamine and lead to coronary vasoconstriction.

The possibility that ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory drugs might diminish the therapeutic response to the ointment cannot be excluded.

The safety of Percutol in pregnancy is not established. The product should therefore be given during pregnancy, only if clearly needed. It is not known whether glyceryl trinitrate is excreted in human milk, therefore caution should be exercised when administered to a nursing mother.

Glyceryl trinitrate may cause dizziness. In consequence until the effect of treatment is known, patients should be warned not to take charge of vehicles or machinery.

Adverse reactions are ranked in descending order of frequency, as follows: Very common (=1/10); common (=1/100-<1/10); uncommon (=1/1000-<1/100); rare (=1/10,000-<1/1,000); very rare (<1/10,000), including isolated reports.

Nervous system disorder

Very Common: Headache

Common: Dizziness

Uncommon: Syncope, burning sensation

Cardiac disorders

Rare: Tachycardia, bradycardia (in the presence of syncope)

Vascular disorders

Uncommon: Hypotension, circulatory collapse

Rare: Flushing

Skin disorders

Uncommon: Allergic skin disorders including, eczema, dermatitis, pruritus, urticaria and non-specific rashes.

Gastro-intestinal System disorders

Common: Nausea, vomiting

Very Rare: Heartburn

Immune System disorders

Rare: Hypersensitivity reactions and anaphylaxis

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 (www.mhra.gov.uk/yellowcard).

None stated.