Fluconazol Sandoz 150 mg, harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FLUCONAZOL 150 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J02AC01

INN (Algemene Internationale Benaming):

FLUCONAZOL 150 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

GELATINE (E 441) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Fluconazole

Product samenvatting:

Hulpstoffen: GELATINE (E 441); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2002-09-04

Bijsluiter

Sandoz B.V.
Page 1/10
Fluconazol Sandoz 50 mg, 100 mg, 150 mg, 200 mg, harde
capsules
RVG 26719-20-21-22
1313-v22a
1.3.1.3 Bijsluiter
Augustus 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCONAZOL SANDOZ 50 MG, HARDE CAPSULES
FLUCONAZOL SANDOZ 100 MG, HARDE CAPSULES
FLUCONAZOL SANDOZ 150 MG, HARDE CAPSULES
FLUCONAZOL SANDOZ 200 MG, HARDE CAPSULES
fluconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is one of a group of medicines called
“antifungals”. The active substance
is fluconazole.
[Nationally completed name] is used to treat infections caused by
fungi and may also be used to stop
you from getting a candidal infection. The most common cause of fungal
infections is a yeast called
_Candida_
.
ADULTS
You might be given this medicine by your doctor to treat the following
types of fungal infections:
-
Cryptococcal meningitis - a fungal infection in the brain
-
Coccidioidomycosis - a disease of the bronchopulmonary system
-
Infections caused by
_Candida _
and found in the blood stream, body organs (e.g. heart, lungs) or
urinary tract
-
Mucosal thrush - infection affecting the lining of the mouth, throat
and dentu

Productkenmerken

Sandoz B.V.
Page 1/25
Fluconazol Sandoz 50 mg, 100 mg, 150 mg, 200 mg,
harde capsules
RVG 26719-20-21-22
1311-v20b
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluconazol Sandoz 50 mg, harde capsules
Fluconazol Sandoz 100 mg, harde capsules
Fluconazol Sandoz 150 mg, harde capsules
Fluconazol Sandoz 200 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of fluconazole.
Excipient with known effects:
Each hard capsule also contains 37 mg of lactose.
Each hard capsule contains 100 mg of fluconazole.
Excipient with known effects:
Each hard also capsule contains 74 mg of lactose.
Each hard capsule contains 150 mg of fluconazole.
Excipient with known effects:
Each hard capsule also contains 110 mg of lactose.
Each hard capsule contains 200 mg of fluconazole.
Excipient with known effects:
Each hard capsule also contains 147 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
[Nationally completed name] 50 mg: white/light blue, opaque hard
capsule, no. 4
[Nationally completed name] 100 mg: white/blue, opaque hard capsule,
no. 2
[Nationally completed name] 150 mg: white, opaque hard capsule, no. 1
[Nationally completed name] 200 mg: light blue/blue, opaque hard
capsule, no. 0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated in the following fungal
infections (see section 5.1).
[Nationally completed name] is indicated in adults for the treatment
of:
Sandoz B.V.
Page 2/25
Fluconazol Sandoz 50 mg, 100 mg, 150 mg, 200 mg,
harde capsules
RVG 26719-20-21-22
1311-v20b
1.3.1.1 Samenvatting van de Productkenmerken
September 2023
•
Cryptococcal meningitis (see section 4.4).
•
Coccidioidomycosis (see section 4.4).
•
Invasive candidiasis.
•
Mucosal candidiasis including oropharyngeal, oesophageal candidiasis,
candiduria and chronic
mucocutaneous candidiasis.
•
Chronic oral atrophic candidiasis (denture sor