Summary of Product Characteristics (SmPC) - Sustac tablets 6.4 mg
1 NAME OF THE MEDICINAL PRODUCT
SUSTAC TABLETS 6.4MG
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains glyceryl trinitrate 6.4mg (as Diluted Nitroglycerin USP)
3 PHARMACEUTICAL FORM
Prolonged release tablets for oral administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The prophylaxis of angina pectoris
4.2 Posology and method of administration
Adults and Elderly Patients:
Dosage should be tailored to the requirements of the individual patient but will usually be 1 or 2 tablets taken three times daily.
Children:
Not recommended.
For oral administration. Sustac tablets must be swallowed whole and not chewed. They are not for sublingual administration. Tablets should be taken between meals.
4.3 Contraindications
As for glyceryl trinitrate. Sustac should not be used in patients with marked anaemia, head trauma, cerebral haemorrhage or incipient glaucoma.
Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.
4.4 Special warnings and precautions for use
As with other drugs for the treatment of angina pectoris, abrupt discontinuation of therapy may lead to exacerbation of symptoms. When discontinuing long term treatment, the dosage should be reduced gradually over several days, and the patient carefully monitored.
4.5 Interaction with other medicinal products and other forms of interaction
May enhance the effects of peripheral vasodilators. The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.
4.6 Pregnancy and lactation
There is no evidence relating to the safety of nitrates in pregnancy and lactation.
Nitrates should not be administered to pregnant women and nursing mothers unless considered essential by the physician.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Side-effects include facial flushing and headache. Toxic effects of glyceryl trinitrate include vomiting, restlessness, cyanosis, methaemoglobinaemia and syncope.
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
In the event of accidental or deliberate overdosage toxic effects of glyceryl trinitrate include vomiting, restlessness, cyanosis, methaemoglobinaemia, tachycardia and syncope. Patients should receive gastric aspiration and lavage and be given respiratory and circulatory support.
The physician should be aware that tablets in the intestine will release their content over several hours.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glyceryl trinitrate is a potent coronary vasodilator. It also reduces venous return and thus left ventricular work.
5.2 Pharmacokinetic properties
Following oral administration glyceryl trinitrate is rapidly metabolised to glyceryl 1,2 dinitrate and glyceryl 1,3 dinitrate. Although less potent the metabolites probably provide the predominant pharmacological effect. Studies with Sustac 2.6mg and 6.4mg demonstrate a tmax for both metabolites of approximately 1 hour and an apparent t½ of approximately 2 hours. There is evidence of activity extending over 6 hours or more.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to safety data already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Compressible Sugar
E127
Magnesium stearate
Ethyl Cellulose
Castor Oil
Shellac
Lactose
Sucrose
Corn Starch
Talc
Ethanol
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Plastic container with plastic lid containing 30, 60, 90, 120 or 180 tablets.
Sustac 10mg: Plastic containers or amber glass bottles with metal screw cap with white lined newsboard extrusion coated one side with polyethylene containing 30, 60 or 90 tablets.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
CHEMIDEX PHARMA LIMITED
TRADING AS ESSENTIAL GENERICS 8A CRABTREE ROAD
EGHAM
SURREY
TW20 8RN
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 17736/0110
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/11/1987 / 16/06/2010
10 DATE OF REVISION OF THE TEXT
27/03/2026