Fluconazole 150mg capsules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Fluconazole

Dostępny od:

Milpharm Ltd

Kod ATC:

J02AC01

INN (International Nazwa):

Fluconazole

Dawkowanie:

150mg

Forma farmaceutyczna:

Oral capsule

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 05020100; GTIN: 8901175007493

Ulotka dla pacjenta

FRONT F.I.
BACK F.I.
Format: 160X600MM | Weight: 50GR
RESERVED FOR THE CODE GENERIS FARMACÊUTICA
RESERVED ARTICLE NUMBER GENERIS FARMACÊUTICA
TEXT AREA
40mm
40mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50 MG
CAPSULES, HARD
FLUCONAZOLE 100 MG
CAPSULES, HARD
FLUCONAZOLE 150 MG
CAPSULES, HARD
FLUCONAZOLE 200 MG
CAPSULES, HARD
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 Fluconazole is and what it is used for
2.
What you need to know before you take
Fluconazole
3.
How to take Fluconazole
4.
Possible side effects
5.
How to store Fluconazole
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE IS AND WHAT IT IS
USED FOR
Fluconazole is one of a group of medicines
called “antifungals”. The active substance is
fluconazole.
Fluconazole 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 denture
sore mouth
-
Genital thrush – infection of the vagina or
penis
-
Skin infections - e.g. athlete’s foot,
ringw

Charakterystyka produktu

OBJECT 1
FLUCONAZOLE 150 MG CAPSULES
Summary of Product Characteristics Updated 24-Aug-2022 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Fluconazole 150 mg capsules, hard
2. Qualitative and quantitative composition
Each capsule, hard contains 150 mg fluconazole.
Excipient with known effect: 151.68 mg lactose/hard capsule
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Capsules, hard
Size '1' hard gelatin capsule filled with white to off-white powder
and imprinted with 'FL' on white to off-
white opaque cap and '150' on white to off-white opaque body with
yellow ink.
4. Clinical particulars
4.1 Therapeutic indications
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole is indicated in adults for the treatment of:
• Cryptococcal meningitis (see section 4.4).
• Coccidioidomycosis (see section 4.4).
• Invasive candidiasis.
• Mucosal candidiasis including oropharyngeal