DUFORZIG Tablet Ref.[50498] Active ingredients: Dapagliflozin

Type 2 diabetes mellitus

Monotherapy and add-on combination therapy

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

Use with medicines known to cause hypoglycaemia:

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

Heart failure

The recommended dose of DUFORZIG is 10 mg taken orally once daily at any time of the day regardless of meals. DUFORZIG can be used in conjunction with other heart failure therapies.

Special Populations

Renal impairment

Treatment of diabetes mellitus:

No dosage adjustment is required based on renal function.

As glycaemic efficacy is dependent on renal function (see sections 4.4 and 4.8), DUFORZIG is not recommended to improve glycaemic control in the treatment of diabetes in patients where eGFR is below 45 mL/min/1,73 m².

Monitoring of renal function is recommended as follows:

• Prior to initiation of DUFORZIG 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 eGFR <45 mL/min/1,73 m², DUFORZIG treatment should be discontinued (See sections 4.3).

Treatment of heart failure

No dosage adjustment is required based on renal function.

Hepatic impairment

No dosage adjustment for DUFORZIG is necessary for patients with mild or moderate hepatic impairment. DUFORZIG is not recommended for patients with severe hepatic impairment as efficacy has not been established. (See section 5.2).

Elderly

No dosage adjustment for DUFORZIG is required based on age. (See section 4.4).

Paediatric population

Safety and effectiveness of DUFORZIG in paediatric and adolescent patients have not been established. No data is available.

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 DUFORZIG by haemodialysis has not been studied.

24 months Bristol-Myers Squibb.
36 Months AstraZeneca Pharmaceuticals.

Store at or below 30°C.

This medicine does not require any special storage conditions.

Silver aluminium/aluminium foil blister packs of 14, 28, 30, 90 and 98 tablets packed in a carton.

Not all pack sizes may be marketed.

No special requirements. Do not dispose of unused medicine in drains or sewerage
systems (e.g. toilets).