JALRAMET Film-coated tablet Ref.[50538] Active ingredients: Metformin Vildagliptin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090

Product name and form

JALRAMET 50 mg/850 mg tablet.

JALRAMET 50 mg/1000 mg tablet.

Pharmaceutical Form

JALRAMET 50 mg/850 mg: yellow, ovaloid bevelled edge, film-coated tablet imprinted with “NVR” on one side and “SEH” on the other side.

JALRAMET 50 mg/1000 mg: dark yellow, ovaloid bevelled edge, film-coated tablet imprinted with “NVR” on one side and “FLO” on the other side.

Qualitative and quantitative composition

JALRAMET 50 mg/850 mg: Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride.

JALRAMET 50 mg/1000 mg: Each tablet contains 50 mg vildagliptin and 1 000 mg metformin hydrochloride.

Active Ingredient Description
Metformin

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

Vildagliptin

Vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion by increasing the endogenous levels of these incretin hormones. The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).

List of Excipients

JALRAMET 50 mg/850 mg: Hydroxypropyl cellulose, hypromellose, iron oxide yellow, magnesium stearate, polyethylene glycol, talc, titanium dioxide.

JALRAMET 50 mg/1000 mg: Hydroxypropyl cellulose, hypromellose, iron oxide yellow, magnesium stearate, polyethylene glycol, talc, titanium dioxide.

Pack sizes and marketing

10, 30, 60, 120, 180 or 360’s tablets in PA / AI / PVC (polyamide / aluminium / polyvinylchloride) blisters with an aluminium foil backing.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090

Marketing authorization dates and numbers

JALRAMET 50 mg/850 mg tablet: 48/21.2/0729
JALRAMET 50 mg/1000 mg tablet: 48/21.2/0730

Namibia:

JALRAMET 50 mg/850 mg: 20/21.2/0126 NS2
JALRAMET 50 mg/1000 mg: 20/21.2/0127 NS2

Date of Registration of medicine: May 2019

Drugs

Drug Countries
JALRAMET South Africa

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