FLUCONAZOLE
As listed in the register: FLUCONAZOLE
50 mg · tablet
- Prescription only
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Fluconazole
- Made by
- Sivem Pharmaceuticals Ulc
- 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 retrieved and stored the official label for this product, so none of its text is shown here. 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 (fluconazole). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Fluconazole is a highly selective inhibitor of fungal cytochrome P450 dependent enzyme lanosterol 14-α-demethylase.
This enzyme functions to convert lanosterol to ergosterol.
About 11% of the dose is excreted in the urine as metabolites.
The C max and AUC data from a food-effect study involving administration of fluconazole tablets to healthy volunteers under fasting conditions and with a high-fat meal indicated that exposure to the drug is not affected by food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-22
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 (fluconazole). It describes the substance, not this Bulgarian product — its uses and doses can differ.
- Fluconazole tablets are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients.
- There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents.
- Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles.
- Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole (see CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS ).
The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%).
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
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo 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 | Sivem Pharmaceuticals Ulc |
|---|---|
| Active substance | Fluconazole |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 50 mg |
| Form | tablet |
| Classification | J02AC01 · Antibiotics, antivirals and antifungals taken into the body |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02534886 |
| DPD drug code | 102377 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
7 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- tablet4 products
50 mg2
50 mg · 2 companies
- Sanis Health Inc
- Sivem Pharmaceuticals Ulc · this page
100 mg2
100 mg · 2 companies
- capsule3 products
150 mg3
150 mg · 3 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.