Dapagliflozin Polpharma
On the Bulgarian pack: Дапаглифлозин Полфарма 10 mg филмирани таблетки
10 mg film-coated tablets 30 · film-coated tablets
- Prescription only
- Digestion, stomach, diabetes and nutrition
- Active substance
- Dapagliflozin
- Made by
- Zaklady Farmaceutyczne POLPHARMA SA
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet read the official leaflet for this product. The exact uses and dose are in the leaflet inside the pack. Open the official leaflet
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dapagliflozin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Dapagliflozin is an inhibitor of SGLT2.
The metabolism of dapagliflozin is primarily mediated by UGT1A9; CYP-mediated metabolism is a minor clearance pathway in humans.
Dapagliflozin and related metabolites are primarily eliminated via the renal pathway.
Administration of dapagliflozin with a high-fat meal decreases its C max by up to 50% and prolongs T max by approximately 1 hour but does not alter AUC as compared with the fasted state.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-08
Safety of the active substance
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dapagliflozin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
- Dapagliflozin is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in dapagliflozin.
- Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin [see Adverse Reactions ( 6.1 )].
- History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in dapagliflozin.
The most frequently reported genital mycotic infections were vulvovaginal mycotic infections in females and balanitis in males.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Zaklady Farmaceutyczne POLPHARMA SA · Poland |
|---|---|
| Active substance | Dapagliflozin |
| Used in | Digestion, stomach, diabetes and nutrition |
| Strength | 10 mg film-coated tablets 30 |
| Form | film-coated tablets |
| Pack sizes | 30 |
| Classification | A10BK01 · Digestion, stomach, diabetes and nutrition |
| Name in the register | Дапаглифлозин Полфарма 10 mg филмирани таблетки |
| Reg. no. | 20230137 |
Source: Bulgarian Drug Agency register · 2026-08-01 · not reviewed by a clinician
Източник: Изпълнителна агенция по лекарствата (ИАЛ). The publisher’s terms do not grant reproduction, so text is shortened and linked. Publisher’s terms.
Other strengths and forms
8 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- film-coated tablets8 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.