Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA Company Contact Details: Phone: +27 21 943 4200 Customer Care: 080 222 6662
SAGALATIN 5 mg FILM COATED TABLET.
SAGALATIN 10 mg FILM COATED TABLET.
| Pharmaceutical Form |
|---|
|
Film coated tablet. SAGALATIN 5 mg: Pink, biconvex, round, film-coated tablets with C388" engraved on one side and plain on the other side. SAGALATIN 10 mg: Pink, biconvex, diamond-shaped, film-coated tablets with “C389” engraved on one side and plain on the other side. |
SAGALATIN 5 mg: Each tablet contains the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol.
Contains sugar: lactose anhydrous 25 mg/tablet.
SAGALATIN 10 mg: Each tablet contains the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol.
Contains sugar: anhydrous lactose 50 mg/tablet.
For a full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Dapagliflozin |
Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion. |
| List of Excipients |
|---|
|
Anhydrous lactose |
SAGALATIN 5 mg is packed in 50 cc white high-density polyethylene (HDPE) bottle with 33 mm blue child resistant (CRC) cap with heat seal 130-20 liner containing 30 tablets and 1 silica gel bag of 2 g.
SAGALATIN 10 mg is packed in 50 cc white high-density polyethylene (HDPE) bottle with 33 mm blue child resistant (CRC) cap with heat seal 130-20 liner containing 30 tablets and 1 silica gel bag of 2 g.
CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA
Company Contact Details:
Phone: +27 21 943 4200
Customer Care: 080 222 6662
SAGALATIN 5 mg: To be allocated.
SAGALATIN 10 mg: To be allocated.
Date of first authorisation: To be allocated.
| Drug | Countries | |
|---|---|---|
| SAGALATIN | South Africa |
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