Posaconazole Clonmel 100 mg gastro-resistant tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

POSACONAZOLE

Διαθέσιμο από:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

Φαρμακολογική κατηγορία (ATC):

J02AC04

INN (Διεθνής Όνομα):

POSACONAZOLE 100 mg

Φαρμακοτεχνική μορφή:

GASTRO-RESISTANT TABLET

Σύνθεση:

POSACONAZOLE 100 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTIMYCOTICS FOR SYSTEMIC USE

Περίληψη προϊόντος:

Licence number in the source country: NOT APPLICAPABLE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2020-07-09

Φύλλο οδηγιών χρήσης

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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”

Αρχείο Π.Χ.Π.

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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 myelodysplastic syndromes (MDS) expected to result