Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: MYLAN (PTY) LTD, 4 Brewery Street, Isando, 1600, Republic of South Africa
CONTRAMYL XR 18 mg (prolonged release tablets).
CONTRAMYL XR 27 mg (prolonged release tablets).
CONTRAMYL XR 36 mg (prolonged release tablets).
CONTRAMYL XR 54 mg (prolonged release tablets).
| Pharmaceutical Form |
|---|
|
CONTRAMYL XR 18 mg: Yellowish to yellow, round, biconvex, film-coated tablets. CONTRAMYL XR 27 mg: Yellow, oblong, biconvex, film-coated tablets with break scores on both sides. CONTRAMYL XR 36 mg: White to off-white, oblong, biconvex, film-coated tablets with break scores on both sides. CONTRAMYL XR 54 mg: Reddish to red, oblong, biconvex, film-coated tablets with break scores on both sides. |
Prolonged release tablets containing 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride respectively.
Contains sugar:
CONTRAMYL XR 18 mg: Sucrose 10,013 mg.
CONTRAMYL XR 27 mg: Sucrose 15,024 mg.
CONTRAMYL XR 36 mg: Sucrose 20,027 mg.
CONTRAMYL XR 54 mg: Sucrose 30,040 mg.
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Methylphenidate |
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 |
|---|
|
Active pellets: Hypromellose; sugar spheres; talc EC pellet coating: Ethylcellulose; hydroxypropylcellulose; talc; triethyl citrate HPMC/AS pellet coating: Hypromellose acetate succinate Final blending: Carmellose sodium; cellulose, microcrystalline; magnesium stearate; silica, colloidal anhydrous Tablet coating (API): Opadry II white (Macrogol 3350; polyvinyl alcohol; talc, titanium dioxide); Opadry II yellow (Iron oxide yellow; macrogol 3350; polyvinyl alcohol; talc); Opadry II red (Iron oxide red; macrogol 3350; polyvinyl alcohol; talc} Tablet coating colour 18 mg: Opadry II white; Opadry II yellow Tablet coating colour 27 mg: Opadry II yellow Tablet coating colour 36 mg: Opadry II white Tablet coating colour 54 mg: Opadry II white; Opadry II red |
CONTRAMYL XR tablets are available in white high-density polyethylene (HDPE) bottles with round white, child-resistant, tamper-evident screw caps with three break-points on the tamper-evident ring made of polypropylene and aperture for desiccant insert.
Packs of 30’s.
MYLAN (PTY) LTD, 4 Brewery Street, Isando, 1600, Republic of South Africa
CONTRAMYL XR 18 mg: 49/1.2/1137
CONTRAMYL XR 27 mg: 49/1.2/1138
CONTRAMYL XR 36 mg: 49/1.2/1139
CONTRAMYL XR 54 mg: 49/1.2/1140
05 December 2016
| Drug | Countries | |
|---|---|---|
| CONTRAMYL | South Africa |
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