Itraconazol Actavis 100mg, hard capsules
Kraj: Malta
Język: angielski
Źródło: Medicines Authority
Ulotka dla pacjenta
(PIL)
16-05-2024
Charakterystyka produktu
(SPC)
16-05-2024
Składnik aktywny:
ITRACONAZOLE
Dostępny od:
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
Kod ATC:
J02AC02
INN (International Nazwa):
ITRACONAZOLE 100 mg
Forma farmaceutyczna:
HARD CAPSULE
Skład:
ITRACONAZOLE 100 mg
Typ recepty:
POM
Dziedzina terapeutyczna:
ANTIMYCOTICS FOR SYSTEMIC USE
Status autoryzacji:
Withdrawn
Data autoryzacji:
2006-08-03
Ulotka dla pacjenta
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ITRACONAZOL ACTAVIS 100 MG, HARD CAPSULES
ITRACONAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 sign 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.
WHAT IS IN THIS LEAFLET:
1.
What Itraconazol Actavis is and what it is used for
2.
What you need to know before you take Itraconazol Actavis
3.
How to take Itraconazol Actavis
4.
Possible side effects
5.
How to store Itraconazol Actavis
6.
Contents of the pack and further information
1.
WHAT ITRACONAZOL ACTAVIS IS AND WHAT IT IS USED FOR
Itraconazol Actavis contains itraconazole which is an
anti-fungal agent. It prevents the fungus from
building up a
normal cell wall. Without a functional cell wall the fungus will die.
Itraconazol Actavis is used to
treat fungal infections in the vagina, mouth, skin and nails.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOL ACTAVIS
DO NOT TAKE ITRACONAZOL ACTAVIS
-
if you are allergic (hypersensitive) to itraconazole
or any of the other ingredients of this medicine
(see section 6)
-
if you are pregnant. See also
under Pregnancy and breast-feeding.
-
if you are also taking any medicines containing the
following ingredients:
- terfenadine, astemizole or mizolastine (medicines used
in the treatment of allergies)
- cisapride (used in treating some digestive d
Przeczytaj cały dokument
Charakterystyka produktu
Page 1 of 14
S
UMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE MEDICINAL PRODUCT
Itraconazol Actavis 100 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 100mg of itraconazole.
Excipient with known effect: Each capsule, hard
contains 224.31mg sucrose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Hard gelatine capsules, opaque green cap and body, containing yellowish-beige spherical
microgranules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Itraconazole is indicated for the treatment of the following fungal infections verified by direct
microscopy and /or cultures where systemic treatment is considered
necessary:
Vulvovaginal candidiasis, oral candidiasis, pityriasis versicolor, dermatomycoses, onychomycoses
(caused by dermatophytes and yeasts).
Consideration should be given to the official guidelines on the
appropriate use of antifungal agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Itraconazol Actavis capsules are for oral use
The capsules should be taken immediately after meals
The capsules should be swallowed whole.
_Adults:_
_Vulvovaginal candidiasis. _
200 mg in the morning and 200 mg in the evening for 1 day.
_Oral candidiasis:_
100 mg once daily for 2 weeks.
_Pityriasis versicolor_:
200 mg once daily for 1 week.
_ _
_ _
Page 2 of 14
_Tinea corporis/cruris: _
100 mg once daily for 2 week_S_.
_ _
_Tinea pedis/manus: _
100 mg twice daily for 4 weeks.
_ _
_Onychomycoses: _
_Pulse treatment: _
_ _
_Toenail infection with or without fingernail infection: _
200 mg twice daily for 7 days, followed by a treatment-free_ _interval of 3 weeks,
3 times in t
Przeczytaj cały dokument
