SPORANOX CAPSULES

Страна: Южна Африка

Език: английски

Източник: South African Health Products Regulatory Authority (SAHPRA)

Предлага се от:

Janssen Pharmaceutica (Pty) Ltd

дозиране:

See ingredients

Лекарствена форма:

CAPSULES

Композиция:

EACH CAPSULE CONTAINS ITRACONAZOLE 100 mg

Статус Оторизация:

Registered

Дата Оторизация:

1991-03-01

Листовка

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPORANOX & TRISPORAL
Strength and Dosage Form: 100 mg itraconazole per capsule
_ _
_ _
_Page 1 of 17 _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
SPORANOX 100 MG CAPSULES
ITRACONAZOLE
Contains sugar: each capsule contains 175.68 mg of sucrose.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN SPORANOX
•
Keep this leaflet. You may need to read it again.
•
SPORANOX has been prescribed for you personally and you should not
share
your medicine with other people. It may harm them, even if their
symptoms are
the same as yours.
•
Ask your health care provider or pharmacist if you need more
information or
advice.
WHAT IS IN THIS LEAFLET
1. What SPORANOX is and what it is used for
2. What you need to know before you take SPORANOX
3. How to take SPORANOX
4. Possible side effects
5. How to store SPORANOX
6. Contents of the pack and other information
Schedule 4
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPORANOX & TRISPORAL
Strength and Dosage Form: 100 mg itraconazole per capsule
_ _
_ _
_Page 2 of 17 _
1. WHAT SPORANOX IS AND WHAT IT IS USED FOR
SPORANOX contains a medicine called itraconazole. This belongs to a
group of medicines
called ‘antifungals’.
SPORANOX is used for treating fungal infections of the vagina, skin,
nails or internal organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPORANOX
DO NOT TAKE SPORANOX
•
If you are hypersensitive (allergic) to itraconazole or any of the
other ingredients of
SPORANOX (listed in section 6).
•
if you are pregnant. If you are of childbearing age and could become
pregnant, you
should take adequate contraceptive precautions to make sure that you
do not become
pregnant while you are taking SPORANOX. As SPORANOX remains in the
body for
some time after you stop taking it, you should continue to use
contraception until your
next period after your treatment with SPORANOX capsules is finished.
•
if you have a condition called heart failure (also called congestive
heart

Данни за продукта

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPORANOX
Strength and Dosage Form:
100 mg itraconazole per capsule
______________________________________________________________________________________
_Page 1 of 51 _
PROFESSIONAL INFORMATION
SCHEDULING STATUS
Schedule 4
1.
NAME OF THE MEDICINE
SPORANOX 100 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of itraconazole in a pellet formulation.
Contains sugar (sucrose): each capsule contains 175.68 mg of sucrose.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule
Pink and blue capsules (size 0) containing white to faintly
cream-coloured beads (pellets).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SPORANOX capsules are indicated for:
1)
Treatment of vulvovaginal candidiasis
2)
Treatment of dermatomycosis, including highly keratinised regions as
in plantar _tinea _
_pedis_ and palmar _tinea manus, _which does not respond to
conventional therapy.
Schedule 4
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPORANOX
Strength and Dosage Form:
100 mg itraconazole per capsule
______________________________________________________________________________________
_Page 2 of 51 _
3)
Onychomycosis caused by dermatophytes and/or yeasts and which does not
respond
to other therapy.
4)
Although proof of efficacy is limited, SPORANOX capsules have been
used in
systemic aspergillosis and candidiasis, histoplasmosis,
sporotrichosis,
paracoccidioidomycosis and blastomycosis. However, due to the
potential of
significant interactions with many medicines, SPORANOX should be used
in cases
resistant to other antifungal medicines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SPORANOX capsules should be taken immediately after a meal for optimal
absorption.
The capsules must be swallowed whole.
Dosage recommendations vary according to the infection treated:
INDICATION
DOSE
MEDIAN TREATMENT
DURATION
•
Treatment of vulvovaginal
candidiasis
200 mg twice daily
or
200 mg once daily
1