Posology : מינונים

4.2    Posology and method of administration

Posology
Adults with normal renal function (GFR ≥ 90 mL/min)

The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day).
Competact 15mg/850mg MF 05/2019 Certification

Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Competact.

When clinically appropriate, direct change from metformin monotherapy to Competact may be considered.

Special populations

Elderly
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4).

Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).

Renal impairment
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.

The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.
If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination.

GFR mL/min Metformin                                      Pioglitazone 
60-89               Maximum daily dose is 3,000 mg.
Dose reduction may be considered in relation to declining renal function.                            No dose adjustment.
45-59               Maximum daily dose is 2,000 mg.      Maximum daily dose is 45 mg
The starting dose is at most half of the maximum dose.
30-44               Maximum daily dose is 1,000 mg.
The starting dose is at most half of the maximum dose.
< 30                Metformin is contra-indicated

Hepatic impairment
Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).

Paediatric population
The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established. No data are available.

Method of administration


Competact 15mg/850mg MF 05/2019 Notification
Tablets should be swallowed with a glass of water. Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin.