Aprepitant Rontis Capsules Hard 80mg & 125mg

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

APREPITANT

Saadav alates:

Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece

ATC kood:

A04AD12

INN (Rahvusvaheline Nimetus):

APREPITANT 80 mg APREPITANT 125 mg

Ravimvorm:

HARD CAPSULE

Koostis:

APREPITANT 80 mg APREPITANT 125 mg

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIEMETICS AND ANTINAUSEANTS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2018-04-24

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
APREPITANT RONTIS 80 MG HARD CAPSULES
APREPITANT RONTIS 125 MG HARD CAPSULES
APREPITANT RONTIS 125 MG HARD CAPSULES + APREPITANT RONTIS 80 MG HARD
CAPSULES
aprepitant
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. IF YOU ARE THE PARENT OF A CHILD TAKING
APREPITANT RONTIS, PLEASE READ THIS
INFORMATION CAREFULLY.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask the doctor, pharmacist, or
nurse.
-
This medicine has been prescribed for you or the child only. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same.
-
If you or the child gets 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 Aprepitant Rontis is and what it is used for
2.
What you need to know before you take or give Aprepitant Rontis
3.
How to take Aprepitant Rontis
4.
Possible side effects
5.
How to store Aprepitant Rontis
6.
Contents of the pack and other information
1.
WHAT APREPITANT RONTIS IS AND WHAT IT IS USED FOR
Aprepitant Rontis contains the active substance aprepitant and belongs
to a group of medicines called
"neurokinin 1 (NK1) receptor antagonists". The brain has a specific
area that controls nausea and
vomiting. Aprepitant Rontis works by blocking signals to that area,
thereby reducing nausea and
vomiting. Aprepitant Rontis capsules are used in adults and
adolescents from the age of 12 years IN
COMBINATION WITH OTHER MEDICINES to prevent nausea and vomiting caused
by chemotherapy (cancer
treatment)
that
are
strong
and
moderate
triggers
of
nausea
and
vomiting
(such
as
cisplatin,
cyclophosphamide, doxorubicin or epirubicin).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE APREPITANT RONTIS
DO NOT TAKE APREPITANT RONTIS:
-
if you or the child is allergic to aprepitant or any of the other
ingredients of this medicine (lis

Toote omadused

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Aprepitant Rontis 80 mg hard capsules
Aprepitant Rontis 125 mg hard capsules
Aprepitant Rontis 125 mg hard capsules + Aprepitant Rontis 80 mg hard
capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Aprepitant Rontis 80 mg hard capsules _
Each hard capsule contains 80 mg of aprepitant.
Excipient with known effect
Each capsule contains 80 mg of sucrose (in the 80 mg capsule).
_Aprepitant Rontis 125 mg hard capsules _
Each hard capsule contains 125 mg of aprepitant.
Excipient with known effect
Each capsule contains 125 mg of sucrose (in the 125 mg capsule).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
_Aprepitant Rontis 80 mg hard capsules _
Opaque, size 2 hard gelatin capsules with a white body and cap,
containing white to off-white pellets.
_Aprepitant Rontis 125 mg hard capsules _
Opaque, size 1 hard gelatin capsules with a white body and pink cap,
containing white to off-white
pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention
of
nausea
and
vomiting
associated
with
highly
and
moderately
emetogenic
cancer
chemotherapy in adults and adolescents from the age of 12.
Aprepitant Rontis 125 mg/80 mg is given as part of combination therapy
(see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Aprepitant Rontis is given for 3 days as part of a regimen that
includes a corticosteroid and a 5-HT
3
antagonist. The recommended dose is 125 mg orally once daily one hour
before start of chemotherapy on
Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning.
Page 2 of 18
The following regimens are recommended in adults for the prevention of
nausea and vomiting associated
with emetogenic cancer chemotherapy:
_Highly Emetogenic Chemotherapy Regimen_
Day 1
Day 2
Day 3
Day 4
Aprepitant
125 mg orally
80 mg orally
80 mg orally
none
Dexamethasone
12 mg orally
8 mg orally
8 mg orally
8 mg orally
5-HT
3
antagonists
Standard dose of
5-HT
3
antagonists.
See the