Posaconazole Teva 100 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Posaconazole

Available from:

Teva B.V.

ATC code:

J02AC04

INN (International Name):

Posaconazole

Dosage:

100 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

posaconazole

Authorization status:

Marketed

Authorization date:

2019-11-22

Patient Information leaflet

Posaconazole, DE/H/6052/001, 28-9-2023
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POSACONAZOLE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Posaconazole Teva
3.
How to take Posaconazole Teva
4.
Possible side effects
5.
How to store Posaconazole Teva
6.
Contents of the pack and other information
1.
WHAT POSACONAZOLE TEVA IS AND WHAT IT IS USED FOR
Posaconazole Teva 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 Teva can be used in adults to treat fungal infections
caused by fungi of the
_Aspergillus_
family.
Posaconazole Teva 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 antifungal 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
“chromoblastomyco

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2024
CRN00DXYG
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Posaconazole Teva 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 Teva is indicated for use in the treatment of the
following fungal infections in adults (see sections 4.2 and 5.1):

Invasive aspergillosis
Posaconazole Teva 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 Teva 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 leukaemia (AML) or myelodysp