TRISPORAL CAPSULES

Држава: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Доступно од:

Janssen Pharmaceutica (Pty) Ltd

Дозирање:

See ingredients

Фармацеутски облик:

CAPSULES

Састав:

EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg

Статус ауторизације:

Registered

Датум одобрења:

2006-06-10

Информативни летак

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
TRISPORAL & TRISPORAL
Strength and Dosage Form: 100 mg itraconazole per capsule
_ _
_ _
_Page 1 of 17 _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
TRISPORAL 100 MG CAPSULES
ITRACONAZOLE
Contains sugar: each capsule contains 175.68 mg of sucrose.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN TRISPORAL
•
Keep this leaflet. You may need to read it again.
•
TRISPORAL 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 TRISPORAL is and what it is used for
2. What you need to know before you take TRISPORAL
3. How to take TRISPORAL
4. Possible side effects
5. How to store TRISPORAL
6. Contents of the pack and other information
Schedule 4
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
TRISPORAL & TRISPORAL
Strength and Dosage Form: 100 mg itraconazole per capsule
_ _
_ _
_Page 2 of 17 _
1. WHAT TRISPORAL IS AND WHAT IT IS USED FOR
TRISPORAL contains a medicine called itraconazole. This belongs to a
group of medicines
called ‘antifungals’.
TRISPORAL is used for treating fungal infections of the vagina, skin,
nails or internal organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRISPORAL
DO NOT TAKE TRISPORAL
•
If you are hypersensitive (allergic) to itraconazole or any of the
other ingredients of
TRISPORAL (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 TRISPORAL. As TRISPORAL 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 TRISPORAL capsules is finished.
•
if you have a condition called heart failure (also called

Карактеристике производа

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
TRISPORAL
Strength and Dosage Form:
100 mg itraconazole per capsule
______________________________________________________________________________________
_Page 1 of 51 _
PROFESSIONAL INFORMATION
SCHEDULING STATUS
Schedule 4
1.
NAME OF THE MEDICINE
TRISPORAL 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
TRISPORAL 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:
TRISPORAL
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, TRISPORAL 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, TRISPORAL should be used
in cases
resistant to other antifungal medicines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TRISPORAL 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 d