SUMMARY OF PRODUCT CHARACTERISTICS

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 t/ 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.

6.1 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.

Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

CHEMIDEX PHARMA LIMITED

TRADING AS ESSENTIAL GENERICS

7 EGHAM BUSINESS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

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

18/12/2015