Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Office Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
EMERDYNE 10 mg (film-coated tablets).
EMERDYNE 20 mg (film-coated tablets).
| Pharmaceutical Form |
|---|
|
Film-coated tablet. EMERDYNE 10 mg: A white to off white, circular, biconvex, film-coated tablet having “ML 60” debossed on one side, break line on opposite side and having notches on either ends of break line. EMERDYNE 20 mg: A white to off white, circular, biconvex, film-coated tablet having “ML 61” debossed on one side, break line on opposite side and having notches on either ends of break line. |
Each film-coated tablet contains:
EMERDYNE 10 mg (film-coated tablets): Escitalopram oxalate corresponding to 10 mg escitalopram. Contains sugar. (104.33 mg of lactose monohydrate).
EMERDYNE 20 mg (film-coated tablets): Escitalopram oxalate corresponding to 20 mg escitalopram. Contains sugar. (208.67 mg of lactose monohydrate).
Excipients:
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Escitalopram |
Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity. |
| List of Excipients |
|---|
|
Croscarmellose sodium |
EMERDYNE 10 mg.
EMERDYNE 20 mg.
Blister pack:
Tablets are packed in cold form laminate, 25 µm OPA/45 µm Aluminum foil/60 µm PVC as the forming material and plain 25 micron, aluminum foil, 6-8 gsm HSL, as the lidding material.
Aluminium blister pack of 3 × 10 (30) tablets. The blisters are placed in an outer carton.
Macleods Pharmaceuticals SA (Pty) Ltd, Office Block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext. 12, Alberton, South Africa
EMERDYNE 10 mg: 45/1.2/0881
EMERDYNE 20 mg: 45/1.2/0882
10 October 2013
| Drug | Countries | |
|---|---|---|
| EMERDYNE | South Africa |
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