Sporanox 100 mg Capsules

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Itraconazole

Disponibbli minn:

Lexon (UK) Ltd

Kodiċi ATC:

J02AC; J02AC02

INN (Isem Internazzjonali):

Itraconazole

Dożaġġ:

100 milligram(s)

Għamla farmaċewtika:

Capsule

Tip ta 'preskrizzjoni:

Not applicable

Żona terapewtika:

Triazole derivatives; itraconazole

Data ta 'l-awtorizzazzjoni:

2012-07-06

Fuljett ta 'informazzjoni

SPORANOX 100MG 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:
What Sporanox capsules are and what they are used for
What you need to know before you use Sporanox capsules
How to use Sporanox capsules
Possible side effects
How to store Sporanox capsules
Contents of the pack and other information
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 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX
CAPSULES
DO NOT USE SPORANOX CAPSULES IF:
*
You are allergic to itraconazole or any of the other ingredients of
this
medicine (listed in section 6)
*
You are pregnant or could become pregnant unless your doctor has told
you to (see ‘Pregnancy and breast-feeding’ below)
*
You have a serious heart condit

Karatteristiċi tal-prodott

Health Products Regulatory Authority
19 November 2018
CRN008KHJ
Page 1 of 3
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: contains sucrose.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from the UK:_
Capsules (size 0): opaque blue cap and pink transparent body
containing coated
beads.
4 CLINICAL PARTICULARS
As per PA0748/009/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/009/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sugar spheres
Hypromellose 2910 5mPa.s
Macrogol 20 000
_Capsule shell_
Gelatin
Titanium dioxide (E171)
Indigotin disulphonate sodium (E132)
Erythrosine (E127)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
19 November 2018
CRN008KHJ
Page 2 of 3
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container
and outer package of the product on the market in the country of
origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store the capsules in their carton to protect from light.
Do not store above 30°C
6.5 NATURE AND CONTENTS OF CONTAINER
Tristar Blister-Plastic foil consisting of three layers.
Polyvinylchloride on the outside, low density polyethylene in the
middle, and
polyvinylidene chloride on the inside. Aluminium foil (thickness
20μm) coated on the
inner side with colourless heatseal lacquer PVC mixed polymers with
acrylates 6
g/m2.
or:
PVC blister consisting of –
Polyvinylchloride 'genotherm' glass clear, thickness 250 μm;
Aluminium foil (thickness
20μm) coated on the inner side with a colourless heat-seal Lacquer:
PVC mixed
polymers with acrylates, 6g/m².
Pack size: 15 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
Lexon (UK) Ltd
Unit 18, Ox