Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, First floor, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
GIROTEC 25 mg TABLETS (tablet).
GIROTEC 50 mg TABLETS (tablet).
GIROTEC 100 mg TABLETS (tablet).
GIROTEC 200 mg TABLETS (tablet).
| Pharmaceutical Form |
|---|
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GIROTEC TABLETS 25 mg: White to off–white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘80’ on flat side. GIROTEC TABLETS 50 mg: White to off–white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘79’ on flat side. GIROTEC TABLETS 100 mg: White to off–white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘78’ on flat side. GIROTEC TABLETS 200 mg: White to off–white, rounded square shaped uncoated tablets debossed with ‘H’ on multifaceted side and ‘77’ on flat side. |
GIROTEC 25 mg TABLETS: Each uncoated tablet contains lamotrigine 25 mg. Contains sweetener: sucralose 2.0 mg.
GIROTEC 50 mg TABLETS: Each uncoated tablet contains lamotrigine 50 mg. Contains sweetener: sucralose 4.0 mg.
GIROTEC 100 mg TABLETS: Each uncoated tablet contains lamotrigine 100 mg. Contains sweetener: sucralose 8.0 mg.
GIROTEC 200 mg TABLETS: Each uncoated tablet contains lamotrigine 200 mg. Contains sweetener: sucralose 16.0 mg.
The other ingredients are black currant flavour; cellulose, microcrystalline; magnesium carbonate; magnesium stearate; polacrilin potassium and povidone.
| Active Ingredient | Description | |
|---|---|---|
| Lamotrigine |
Lamotrigine is a use and voltage dependent blocker of voltage gated sodium channels. It inhibits sustained repetitive firing of neurons and inhibits release of glutamate (the neurotransmitter which plays a key role in the generation of epileptic seizures). |
| List of Excipients |
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1) Blister Pack:
Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.
Each blister contains 10 tablets.
Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.
2) HDPE Container Pack:
Tablets are packed in 40 ml white opaque HDPE containers with white opaque polypropylene closures with induction sealing wad, containing cotton coil.
Each container contains 60 tablets.
Pack size: 60’s – One HDPE container contains 60 tablets.
1) Blister Pack:
Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.
Each blister contains 10 tablets.
Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.
2) HDPE Container Pack:
Tablets are packed in 40 ml white opaque HDPE containers with white opaque polypropylene closures with
induction sealing wad, containing cotton coil.
Each container contains 60 tablets.
Pack size: 60’s – One HDPE container contains 60 tablets.
1) Blister Pack:
Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.
Each blister contains 10
tablets.
Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.
2) HDPE Container Pack:
Tablets are packed in 60 ml white opaque HDPE containers with white opaque polypropylene closures with
induction sealing wad, containing cotton coil.
Each container contains 60 tablets.
Pack size: 60’s – One HDPE container contains 60 tablets
1) Blister Pack:
Tablets are packed in clear PVC laminated with aclar and printed aluminium foil.
Each blister contains 10 tablets.
Pack size: 60’s – Each carton contains 6 blisters of 10 tablets each.
2) HDPE Container Pack:
Tablets are packed in 120 ml white opaque HDPE containers with white opaque polypropylene closures with
induction sealing wad, containing cotton coil.
Each container contains 60 tablets.
Pack size: 60’s – One HDPE container contains 60 tablets.
Aurogen South Africa (Pty) Ltd, Woodhill Office Park, First floor, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
GIROTEC 25 mg TABLETS: 43/2.5/0047
GIROTEC 50 mg TABLETS: 43/2.5/0048
GIROTEC 100 mg TABLETS: 43/2.5/0049
GIROTEC 200 mg TABLETS: 43/2.5/0050
Date of registration: 26 November 2015
| Drug | Countries | |
|---|---|---|
| GIROTEC | South Africa |
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