Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 1 Company Reg. No.: 1990/001979/07
MEFEDINEL 18 (prolonged release tablets).
MEFEDINEL 27 (prolonged release tablets).
MEFEDINEL 36 (prolonged release tablets).
MEFEDINEL 54 (prolonged release tablets).
| Pharmaceutical Form |
|---|
|
MEFEDINEL 18: prolonged release tablets. Light yellow, round, film-coated tablet with a delivery orifice on one side. MEFEDINEL 27: prolonged release tablets. Light grey, round, film-coated tablet with a delivery orifice on one side. MEFEDINEL 36: prolonged release tablets. White, round, film-coated tablet with a delivery orifice on one side. MEFEDINEL 54: prolonged release tablets. Red, round, film-coated tablet with a delivery orifice on one side. |
Each MEFEDINEL 18 (prolonged release tablet) contains 18 mg methylphenidate hydrochloride.
Each MEFEDINEL 27 (prolonged release tablet) contains 27 mg methylphenidate hydrochloride.
Each MEFEDINEL 36 (prolonged release tablet) contains 36 mg methylphenidate hydrochloride.
Each MEFEDINEL 54 (prolonged release tablet) contains 54 mg methylphenidate hydrochloride.
MEFEDINEL 18 contains sugar (6,31 mg lactose monohydrate per tablet).
MEFEDINEL 27 contains sugar (8,17 mg lactose monohydrate per tablet).
MEFEDINEL 36 contains sugar (8,43 mg lactose monohydrate per tablet).
MEFEDINEL 54 contains sugar (6,76 mg lactose monohydrate per tablet).
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space. |
| List of Excipients |
|---|
|
Polyethylene oxide In addition: MEFEDINEL 18, 54: Iron oxide yellow MEFEDINEL 27: Iron oxide black |
MEFEDINEL 18, 27, 36, 54: HDPE bottles closed with a child-resistant, tamper evident PP screw cap with drying plug.
Pack sizes of 28, 30, 50, 56, 60, 98, 100 or 120 prolonged-release tablets.
Not all pack sizes may be marketed.
Sandoz SA (Pty) Ltd1, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090
1 Company Reg. No.: 1990/001979/07
MEFEDINEL 18: 48/1.2/0092
MEFEDINEL 27: 48/1.2/0093
MEFEDINEL 36: 48/1.2/0094
MEFEDINEL 54: 48/1.2/0095
Date of first authorisation: 02 February 2021
| Drug | Countries | |
|---|---|---|
| MEFEDINEL | South Africa |
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