Firialta 20 mg Film Coated Tablet

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Finerenone

Available from:

Bayer East Africa Limited, KENYA

ATC code:

Aldosterone Antagonists and Other Potassium-Sparin

INN (International Name):

Finerenone

Dosage:

20 mg

Pharmaceutical form:

Film Coated Tablet

Manufactured by:

Bayer AG, GERMANY

Product summary:

Physical description: Yellow, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked "20" on one side and "FI" on the other side; Local technical representative: JD PHARMACY LIMITED (6943)

Authorization status:

Registered/Compliant

Authorization date:

2022-12-05

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Firialta
10
mg
film-coated
tablets
Firialta 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Firialta 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of finerenone.
_Excipient with known effect _
Each film-coated tablet contains 45 mg of lactose (as monohydrate),
see section 4.4.
Firialta 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of finerenone.
_Excipient with known effect _
Each film-coated tablet contains 40 mg of lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet) Firialta
10 mg film-coated tablets
Pink, oval-oblong film-coated tablet with a length of 10 mm and a
width of 5 mm, marked
‘10’ on one side and ‘FI’ on the other side.
Firialta 20 mg film-coated tablets
Yellow, oval-oblong film-coated tablet with a length of 10 mm and a
width of 5 mm,
marked ‘20’ on one side and ‘FI’ on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Firialta is indicated for the treatment of chronic kidney disease
(stage 3 and 4 with
albuminuria) associated with type 2 diabetes in adults.
1
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended target dose is 20 mg finerenone once daily. The
maximum recommended
dose is 20 mg finerenone once daily.
_Initiation of treatment _
Serum potassium and estimated glomerular filtration rate (eGFR) have
to be measured to
determine if finerenone treatment can be initiated and to determine
the starting dose.
If serum potassium ≤ 4.8 mmol/L, finerenone treatment can be
initiated. For monitoring of
serum potassium, see below ‘Continuation of treatment.’
If serum potassium > 4.8 to 5.0 mmol/L, initiation of finerenone
treatment may be
considered with additional serum potassium monitoring within the first
4 weeks based on
patient characteristics and serum potassium levels (see section 4.4).
If serum potassium > 5.0 mmol/L, finer