Forxiga F.C Tab 5mg as propanediol monohydrate 5 mg

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Dapagliflozin as propanediol monohydrate 5 mg

Available from:

مستودع ادوية شاوي و رشيدات و مسنات - Shawi & Rushedat Drug Store

ATC code:

A10BX09

INN (International Name):

Dapagliflozin as propanediol monohydrate 5 mg

Dosage:

as propanediol monohydrate 5 mg

Units in package:

28

Manufactured by:

AstraZeneca Pharmaceuticals LP (امريكا)

Product summary:

21.68 :سعر الجمهور + الضريبة

Patient Information leaflet

1
FORXIGA
TM
(DAPAGLIFLOZIN)
FILM-COATED TABLETS
NAME OF THE MEDICINAL PRODUCT
Forxiga 5 mg film-coated tablets
Forxiga 10 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains dapagliflozin propanediol monohydrate
equivalent to
5 mg dapagliflozin.
Each 10 mg tablet contains dapagliflozin propanediol monohydrate
equivalent to
10 mg dapagliflozin.
Excipient with known effect:
Each 5 mg tablet contains 25 mg of lactose anhydrous.
Each 10 mg tablet contains 50 mg of lactose anhydrous.
For the full list of excipients, see List of excipients.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
5 mg tablet: Yellow, biconvex, 0.7 cm diameter round, film-coated
tablets with “5”
engraved on one side and “1427” engraved on the other side.
10 mg tablet: Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally
diamond-shaped, film-coated tablets with “10” engraved on one side
and “1428”
engraved on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Type 2 diabetes mellitus
Forxiga is indicated in adults for the treatment of insufficiently
controlled type 2
diabetes mellitus as an adjunct to diet and exercise,
-
as monotherapy when metformin is considered inappropriate due to
intolerance.
-
in addition to other medicinal products for the treatment of type 2
diabetes.
2
For study results with respect to combination of therapies, effects on
glycaemic
control and cardiovascular events, and the populations studied, see
Special
warnings and precautions for use, Interaction with other medicinal
products and
other forms of interaction and Pharmacodynamic properties.
Heart failure
Forxiga is indicated in adults for the treatment of symptomatic
chronic heart
failure with reduced ejection fraction.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Type 2 diabetes mellitus
The recommended dose is 10 mg dapagliflozin once daily. When
dapagliflozin is
used in combination with insulin or an insulin secretagogue, such as a
sulphonylurea, a lower dose of insulin or insulin secretagogue m