Sporanox 100 mg Capsules

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Itraconazole

Beszerezhető a:

PCO Manufacturing Ltd.

ATC-kód:

J02AC; J02AC02

INN (nemzetközi neve):

Itraconazole

Adagolás:

100 milligram(s)

Gyógyszerészeti forma:

Capsule, hard

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Triazole derivatives; itraconazole

Engedélyezési státusz:

Authorised

Engedély dátuma:

2014-08-22

Betegtájékoztató

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX
® 100 MG 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 signs 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sporanox capsules are and what they are used for
2.
What you need to know before you use Sporanox capsules
3.
How to use Sporanox capsules
4.
Possible side effects
5.
How to store Sporanox capsules
6.
Contents of the pack and other information
1.
WHAT SPORANOX CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Sporanox 100 mg capsules. It is called
‘Sporanox capsules’ in this
leaflet.
Sporanox capsules contain a medicine called itraconazole. This belongs
to a group of medicines
called ‘antifungals’.
Sporanox capsules are used in adults for infections caused by fungi or
yeasts. They are used for:
•
Infections of the mouth or vagina causing ‘thrush’
•
Skin infections
•
Infections affecting other parts of the body
Patches of skin may take a few weeks to completely clear up after you
have finished your treatment
with Sporanox capsules. Finger and toe nails may take several months
to completely clear up. This is
because your skin or nail will only look normal after new skin or nail
has grown, even though the
medicine has killed the fungus that caused the infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX CAPSULES
DO NOT USE SPORANOX CAPSULES:
•
IF YOU ARE ALLERGIC (hypersensitive) to any of the ingredients in
SPORANOX CAPSULES (listed in
section 6)
•
IF YOU ARE PREGNANT, THINK YOU MIGHT BE PREGNANT OR COULD BECO

Termékjellemzők

Health Products Regulatory Authority
30 January 2024
CRN00F1JC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sporanox 100 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains itraconazole 100 mg.
Excipient(s) with known effect: sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
_Product imported from Greece and Poland:_
Capsule (size 0): opaque blue cap and pink transparent body containing
coated beads.
4 CLINICAL PARTICULARS
As per PA22612/012/002
5 PHARMACOLOGICAL PROPERTIES
As per PA22612/012/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Greece:_
_ _
Sugar spheres
Hypromellose
Macrogol
_Capsule shell:_
Gelatin
Titanium dioxide (E171)
Indigotin disulphonate sodium (E132)
Erythrosine (E127)
_Product imported from Poland:_
Sugar spheres (consisting of corn starch, hydrolyzed starch syrup and
sucrose)
Hypromellose
Macrogol
_Capsule shell:_
Gelatin
Titanium dioxide (E171)
Indigotin disulphonate sodium salt (E 132)
Erythrosine sodium (E 127)
Health Products Regulatory Authority
30 January 2024
CRN00F1JC
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Store in the original package in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips each containing 5 or 14 capsules in an outer cardboard
carton.
Pack sizes: 14, 15 or 28 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/400/001
9 DATE OF FIRST AUTHORISATION/RENEWAL