SAGALATIN Film-coated tablet Ref.[51087] Active ingredients: Dapagliflozin

Posology

Monotherapy and add-on combination therapy

The recommended dose is 10 mg SAGALATIN once daily for monotherapy and addon combination therapy with other glucose-lowering medicines, including metformin, a thiazolidinedione, a sulfonylurea, a DPP4 inhibitor, or insulin.

When SAGALATIN is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia.

Special populations

Renal impairment

No dosage adjustment for SAGALATIN is indicated for mild renal impairment. The efficacy of SAGALATIN is dependent on renal function. SAGALATIN should not be used in patients with moderate to severe renal impairment (defined as eGFR <60 mL/min/1,73 m² by MDRD or CrCl <60 mL/min by Cockcroft-Gault) or end stage renal failure (see section 4.3, 4.4 and 4.8).

Monitoring of renal function is recommended as follows

• Prior to initiation of SAGALATIN and at least annually, thereafter.
• Prior to initiation of concomitant medicines that may reduce renal function and periodically thereafter.
• For renal function approaching moderate renal impairment, at least 2 to 4 times per year. If renal function falls below CrCl <60 mL/min or eGFR <60 mL/min/1,73 m², SAGALATIN treatment should be discontinued.

Hepatic impairment

No dosage adjustment for SAGALATIN is necessary for patients with mild or moderate hepatic impairment. SAGALATIN is not recommended for patients with severe hepatic impairment. (see section 5.2).

Use in patients at risk for volume depletion

For patients at risk for volume depletion to co-existing conditions or concomitant medicines, such as loop diuretics, a 5 mg starting dose of SAGALATIN may be appropriate. SAGALATIN should be permanently discontinued in patients who develop volume depletion (see section 4.8).

Elderly (≥65 years) patients

No dosage adjustment for SAGALATIN is required based on age.

Paediatric and adolescent

Safety and effectiveness of SAGALATIN in paediatric and adolescent patients have not been established.

Method of administration

SAGALATIN should be taken orally once daily at any time of the day with or without food. Tablets are to be swallowed whole.

In overdose, side effects may be elicited or exacerbated. Appropriate symptomatic and supportive treatment should be initiated as dictated by the patient’s clinical status. The removal of SAGALATIN by haemodialysis has not been studied.

24 months.

This medicine does not require any special storage conditions.

Store at or below 25°C.

Store in the original package.

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.

No special requirements.