Posaconazole Clonmel 100 mg gastro-resistant tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Posaconazole

Beschikbaar vanaf:

Clonmel Healthcare Ltd

ATC-code:

J02AC; J02AC04

INN (Algemene Internationale Benaming):

Posaconazole

Dosering:

100 milligram(s)

farmaceutische vorm:

Gastro-resistant tablet

Therapeutisch gebied:

Triazole derivatives; posaconazole

Autorisatie-status:

Marketed

Autorisatie datum:

2020-01-10

Bijsluiter

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POSACONAZOLE CLONMEL 100 MG GASTRO-RESISTANT TABLETS
posaconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist, or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Posaconazole Clonmel is and what it is used for
2. What you need to know before you take Posaconazole Clonmel
3. How to take Posaconazole Clonmel
4. Possible side effects
5. How to store Posaconazole Clonmel
6. Contents of the pack and other information
1. WHAT POSACONAZOLE CLONMEL IS AND WHAT IT IS USED FOR
Posaconazole Clonmel contains the active substance posaconazole. This
belongs to a group of medicines
called “antifungals”. It is used to prevent and treat many
different fungal infections.
This medicine works by killing or stopping the growth of some types of
fungi that can cause infections.
Posaconazole Clonmel can be used in adults to treat fungal infections
caused by fungi of the
_Aspergillus_
family.
Posaconazole Clonmel can be used in adults and children from 2 years
of age weighing more than 40 kg
to treat the following types of fungal infections:
•
infections caused by fungi of the Aspergillus family that have not
improved during treatment with
the anti-fungal medicines amphotericin B or itraconazole or when these
medicines have had to be
stopped;
•
infections caused by fungi of the Fusarium family that have not
improved during treatment with
amphotericin B or when amphotericin B has had to be stopped;
•
infections
caused
by
fungi
that
cause
the
conditions
known
as
“chromoblastomycosis”

Productkenmerken

Health Products Regulatory Authority
08 March 2024
CRN00F0X2
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Posaconazole Clonmel 100 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 100 mg of posaconazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Yellow coated, capsule shaped tablet of approximately 17.5 mm length
and 6.7 mm width, debossed with "100P" on one side
and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Posaconazole Clonmel is indicated for use in the treatment of the
following fungal infections in adults (see sections 4.2 and 5.1):

Invasive aspergillosis
Posaconazole Clonmel is indicated for use in the treatment of the
following fungal infections in paediatric patients from 2 years
of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):

Invasive aspergillosis in patients with disease that is refractory to
amphotericin B or itraconazole or in patients who
are intolerant of these medicinal products;

Fusariosis in patients with disease that is refractory to amphotericin
B or in patients who are intolerant of
amphotericin B;

Chromoblastomycosis and mycetoma in patients with disease that is
refractory to itraconazole or in patients who
are intolerant of itraconazole;

Coccidioidomycosis in patients with disease that is refractory to
amphotericin B, itraconazole or fluconazole or in
patients who are intolerant of these medicinal products.
Refractoriness is defined as progression of infection or failure to
improve after a minimum of 7 days of prior therapeutic doses
of effective antifungal therapy_._
_ _
Posaconazole Clonmel is also indicated for prophylaxis of invasive
fungal infections in the following paediatric patients from
2 years of age weighing more than 40 kg and adults (see sections 4.2
and 5.1):

Patients receiving remission-induction chemotherapy for acute
myelogenous leukemia (AML) or