Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530, Customer care number: 080 222 6662
EPITEC 25 mg, tablets.
EPITEC 50 mg, tablets.
EPITEC 100 mg, tablets.
EPITEC 200 mg, tablets.
| Pharmaceutical Form |
|---|
|
EPITEC 25: Yellow, round, circular tablets with 25 debossed on one side and breakline on the other side. EPITEC 50: White, round, circular tablets with 50 debossed on one side and breakline on the other side. EPITEC 100: White, round, circular tablets with 100 debossed on one side and breakline on the other side. EPITEC 200: Yellow, capsule-shaped, biconvex tablets with 200 debossed on one side and plain on the other side. |
EPITEC 25: Each tablet contains lamotrigine 25 mg. Contains sugar: lactose monohydrate 52,50 mg per tablet.
EPITEC 50: Each tablet contains lamotrigine 50 mg. Contains sugar: lactose monohydrate 105,50 mg per tablet.
EPITEC 100: Each tablet contains lamotrigine 100 mg. Contains sugar: lactose monohydrate 211,00 mg per tablet.
EPITEC 200: Each tablet contains lamotrigine 200 mg. Contains sugar: lactose monohydrate 420,00 mg per tablet.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 |
|---|
|
Lactose monohydrate |
Patient ready packs, closures, wadding, desiccant.
Clear, colouless, transparent non-toxic PVC film/printed aluminium foil blister strips of 10 tablets packed in 60’s in a carton.
(this applies to all 4 strengths)
CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530, Customer care number: 080 222 6662
EPITEC 25: A38/2.5/0571
EPITEC 50: A38/2.5/0572
EPITEC 100: A38/2.5/0573
EPITEC 200: A38/2.5/0574
Namibia: NS2
EPITEC 25: 06/2.5/0092
EPITEC 50: 06/2.5/0091
EPITEC 100: 06/2.5/0090
EPITEC 200: 06/2.5/0089
Botswana: S2
EPITEC 25: BOT0700978
EPITEC 50: BOT0700977
EPITEC 100: BOT0700976
EPITEC 200: BOT0700975
First authorisation:18 March 2005
Latest renewal: Not applicable
| Drug | Countries | |
|---|---|---|
| EPITEC | South Africa |
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