Sporanox-Pulse 100mg capsules

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Itraconazole

から入手可能:

Janssen-Cilag Ltd

ATCコード:

J02AC02

INN（国際名）:

Itraconazole

投薬量:

100mg

医薬品形態:

Oral capsule

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 05020100; GTIN: 5012674436028

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX
®
-
PULSE
Itraconazole
Sporanox is a registered trademark
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. Do not pass it on to
others. It
may harm them, even if their symptoms 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 Sporanox-Pulse is and what it is used for
2. What you need to know before you use Sporanox-Pulse
3. How to use Sporanox-Pulse
4. Possible side effects
5. How to store Sporanox-Pulse
6. Contents of the pack and other information
1. WHAT SPORANOX-PULSE IS AND WHAT IT IS USED FOR
Sporanox-Pulse contains a medicine called itraconazole. This belongs
to a
group of medicines called ‘antifungals’.
Sporanox-Pulse is used for infections caused by fungi or yeasts. It is
used for:
•
Nail infections
•
Skin infections of the hands or feet
Patches of skin may take a few weeks to completely clear up after you
have
finished your treatment with Sporanox-Pulse. This is because your skin
will
only look normal after new skin has grown, even though the medicine
has
killed the fungus that caused the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX-PULSE
DO NOT USE SPORANOX-PULSE IF:
•
You are allergic to anything in Sporanox-Pulse (listed in section 6
below)
•
You are pregnant or could become pregnant (see ‘Pregnancy and
breast-
feeding’ below)
Do not use this medicine if any of the above applies to you. If you
are not sure,
talk to your doctor or pharmacist before using Sporanox-Pulse.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before using this medicine if:
•
You have ever had kidney problems. Your dose of Sporanox-Pulse may
have to be c

製品の特徴

OBJECT 1
SPORANOX-PULSE
Summary of Product Characteristics Updated 23-Apr-2013 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Sporanox-Pulse
2. Qualitative and quantitative composition
Itraconazole 100 mg.
For excipients, see 6.1.
3. Pharmaceutical form
Capsule (Size 0): opaque blue cap and pink transparent body containing
coated beads.
4. Clinical particulars
4.1 Therapeutic indications
Onychomycosis caused by dermatophytes and/or yeasts.
Tinea pedis and/or tinea manuum.
4.2 Posology and method of administration
Sporanox-Pulse is for oral administration and must be taken
immediately after a meal for maximal
absorption. The capsules must be swallowed whole.
Treatment schedules in adults are as follows:
Indication
Dose
Remarks
Tinea pedis and/or tinea manuum
1 pulse treatment
A pulse treatment consists of 200
mg bd. for 7 days.
Onychomycosis – fingernails
2 pulse treatments
Pulse treatments are separated by
a 3-week
Onychomycosis – toenails
3 pulse treatments
drug-free interval
Impaired absorption in AIDS and neutropenic patients may lead to low
itraconazole blood levels and lack
of efficacy. In such cases, blood level monitoring is indicated.
_Use in children_
Clinical data on the use of Sporanox-Pulse in paediatric patients are
limited. The use of Sporanox-Pulse in
paediatric patients is not recommended unless it is determined that
the potential benefit outweighs the
potential risks. See section 4.4 _Special warnings and precautions for
use_.
_In Elderly_
Clinical data on the use of Sporanox-Pulse in elderly patients are
limited. It is advised to use Sporanox-
Pulse in these patients only if it is determined that the potential
benefit outweighs the potential risks. In
general, it is recommended that the dose selection for an elderly
patient should be taken into
consideration, reflecting the greater frequency of decreased hepatic,
renal, or cardiac function, and of
concomitant disease or other drug therapy. See section 4.4 _Special
warnings and precautions for use_.
_Renal impairment_
Limited data are ava