Itraconazole 100mg capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Itraconazole

Commercializzato da:

Sandoz Ltd

Codice ATC:

J02AC02

INN (Nome Internazionale):

Itraconazole

Dosaggio:

100mg

Forma farmaceutica:

Oral capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05020100; GTIN: 5015915952011

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ITRACONAZOLE 100MG 15 & 60 TABLETS PIL - UK
Black
Profile
BBBA1065
C.Grant
19/07/17
24/07/17
C.Grant
140x540
9pt 8pt in the table
Linconsa
19/07/17
24/07/17
02
ITRACONAZOLE 100MG CAPSULES, HARD
PACKAGE LEAFLET: INFORMATION FOR THE USER
BBBA1065
_continued top of next column_
_continued over page_
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 symptoms
are the same as yours.
• If you get any of the 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 ITRACONAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ITRACONAZOLE CAPSULES
3. HOW TO TAKE ITRACONAZOLE CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ITRACONAZOLE CAPSULES
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT ITRACONAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
Itraconazole capsules are indicated for the
treatment of fungal infections of the vagina,
skin, mouth, eyes, nails and internal organs.
The active substance is itraconazole, a
member of the following pharmaco-
therapeutic class of drugs: Antimycotic for
systemic use, triazole derivatives.
Itraconazole is very effective against a variety
of infections caused by yeasts and

Scheda tecnica

OBJECT 1
ITRACONAZOLE 100 MG CAPSULES
Summary of Product Characteristics Updated 17-Sep-2018 | Sandoz
Limited
•
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
Itraconazole 100 mg Capsules
2. Qualitative and quantitative composition
One capsule contains 100 mg itraconazole.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Opaque green capsule, containing yellowish-beige beads.
4. Clinical particulars
4.1 Therapeutic indications
Itraconazole is indicated for the treatment of the following fungal
infections when thought likely to be
susceptible:
• Vulvovaginal candidiasis.
• Pityriasis versicolor.
• Dermatophytoses caused by organisms susceptible to itraconazole
(Trichophyton spp. Microsporum
spp. Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea
corporis, tinea manuum.
• Oral candidiasis.
• Onychomycosis caused by dermatophytes and/or yeasts.
Consideration should be given to official guidance regarding the
approp