ACTOS TABLET 15 MG [SIN12441P]

Product Info

ACTOS TABLET 15 MG

[SIN12441P]

INDICATIONS
actos® is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

actos® is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or sulphonylurea :

• In combination with metformin particularly in overweight patients

• In combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated

DOSAGE AND ADMINISTRATION
actos® should be taken orally once daily with or without food.
Dosage in Adults
actos® may be initiated at 15 mg or 30mg once daily. The dose may be increased to up to a maximum dose of 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.

In combination with metformin, the current metformin dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of metformin should be decreased.

In combination with sulphonylurea, the current sulphonylurea dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of sulphonylurea should be decreased.

The dose of actos® should not exceed 45 mg once daily in monotherapy or in combination with metformin or sulphonylurea.

Elderly
No dosage adjustment is necessary for elderly patients.

Patients with renal impairment
No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4ml/min). No information is available from dialysed patients therefore pioglitazone should not be used in such patients.

Patients with hepatic impairment
Pioglitazone should not be used in patients with hepatic impairment.

Children and adolescents
There are no data available on the use of pioglitazone in patients under 18 years of age, and therefore its use is not recommended in this age group.

CONTRAINDICATIONS
actos® is contraindicated in patients with the following conditions:

• known hypersensitivity to pioglitazone or to any of the excipients of the tablet

• cardiac failure or history of cardiac failure (NYHA stages I to IV)

• hepatic impairment

• active or history of bladder cancer

• uninvestigated macroscopic haematuria

actos® is also contraindicated for use in combination with insulin.