This information is intended for use by health professionals

1. Name of the medicinal product

Percutol Ointment.

2. Qualitative and quantitative composition

The active ingredient of Percutol is glyceryl trinitrate 2 %w/w.

3. Pharmaceutical form

A homogeneous cream coloured ointment.

4. Clinical particulars
4.1 Therapeutic indications

Prophylaxis of angina pectoris.

4.2 Posology and method of administration

Topical application.

Adults (including elderly):

The usual dose is 1 to 2 inches squeezed from the tube, although some patients may require more. This dose may be repeated every 3 to 4 hours as required.

The dose may be titrated to individual patients' needs by finding the dose that causes headache and then reducing this dose by half an inch. Half an inch of ointment should be applied on the first day, one inch on the second, etc. increasing by half an inch per day until headache occurs and then reducing by half an inch. If several applications per day are required the dose may need to be reduced.

The ointment may be conveniently measured and applied using the paper “Applirules” enclosed in the carton. After squeezing the required length of ointment onto the “Applirule” it should be pressed on to any convenient area of skin (e.g. chest, thigh, or arm) until the ointment is spread in a thin layer under the paper. The ointment should not be rubbed in. The “Applirule” may be secured in place with surgical tape.

Children:

The safety and efficacy of Percutol in children has not been established.

4.3 Contraindications

Contra-indicated in patients with marked anaemia, or raised intra cranial pressure (e.g. cerebral haemorrhage or head trauma) or inadequate cerebral circulation, cerebrovascular disease. Should not be employed in patients with hypersensitivity to nitrates or any of the excipients.

Also contraindicated in severe hypotension and hypovolaemia. Myocardial insufficiency due to valvular or left ventricular outflow tract obstruction, aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy, cardiac tamponade, constrictive pericarditis as well as closed-angle glaucoma or toxic pulmonary oedema.

Phosphodiesterase inhibitors, e.g. sildenafil, tadalafil, vardenafil, alprostadil have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contra-indicated.

Percutol is not indicated for the immediate treatment of acute angina attacks.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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.

4.8 Undesirable effects

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

System Organ Class

Frequency

Adverse Reaction

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).

4.9 Overdose

A hypotensive headache is a sign of overdosage. High doses of glyceryl trinitrate may cause marked hypotension and collapse, however topical application reduces the likelihood of overdosage and the effect can be quickly terminated by washing the ointment off the skin.

5. Pharmacological properties
5.1 Pharmacodynamic properties

The active ingredient relaxes smooth muscle and reduces blood pressure. Its use as a vasodilator in the prophylaxis and treatment of angina pectoris is well established.

5.2 Pharmacokinetic properties

In human volunteers the mean absorption of glyceryl trinitrate from 1 inch of ointment was 0.8mg/hour.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Percutol also contains lanolin anhydrous, purified water, white petroleum, and lactose monhydrate.

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Collapsible aluminium tube containing 60g.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Aspire Pharma Limited

Unit 4 Rotherbrook Court

Bedford Road

Petersfield

Hampshire

GU32 3QG

United Kingdom

8. Marketing authorisation number(s)

PL 35533/0020

9. Date of first authorisation/renewal of the authorisation

25/11/2010

10. Date of revision of the text

02/02/2017