Abridged Prescribing Information:

Description: NITROCONTIN” tablets for oral administration contain 2.6/6.4 mg of Nitroglycerin USP in a CONTINUS TM controlled release system. Each tablet is pink, flat and beveled.

Indication: Nitroglycerin is indicated for the management of angina pectoris. The onset of action is not sufficiently rapid for this form to be useful in aborting an acute angina episode. Dosage &

Administration: Dosage should always to adjusted according to the requirement and response obtained by the individual patient and the severity of the anginal pain.

Adults: One NITROCONTIN” CONTINUS TM tablets 2.6 mg in morning and evening. The tablets should be taken empty stomach. If the symptoms have not been adequately controlled after a week on this regimen, the dosage should be increased to one 6.4 mg tablet morning and evening.

Children: Not recommended. Elderly: Normal adult dose. The tablets should be swallowed whole & not chewed. Side Efiects: Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the results of nitroglycerin’s activity as a vasodilator. Headache is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. However, such side-effects are virtually absent or substantially diminished with NITROCONTIN” CONTINUS TM tablets therapy due to the controlled release system.

Presentation:

NITROCONTIN” 2.6: Polypropylene bottle of 30 tablets.

NITROCONTIN” 6.4: Polypropylene bottle of 30 tablets