Percutol Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
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 light yellow 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 coadministration 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, non-steroidal anti-inflammatory drugs, oestrogens and corticosteroids 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. Pre-clinical 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 monohydrate.
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 Content of Container
Collapsible aluminium tube containing 60g.
6.6. Instructions for Use, Handling and Disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Aspire Pharma Limited Bellamy House Winton Road Petersfield Hampshire GU32 3HA
8 MARKETING AUTHORISATION NUMBER(S)
PL 35533/0020
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/11/2010
10
DATE OF REVISION OF THE TEXT
03/02/2015