Emend 80mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Aprepitant

Διαθέσιμο από:

Merck Sharp & Dohme Ltd

Φαρμακολογική κατηγορία (ATC):

A04AD12

INN (Διεθνής Όνομα):

Aprepitant

Δοσολογία:

80mg

Φαρμακοτεχνική μορφή:

Capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: ; GTIN: 5013945196269

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMEND® 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
EMEND, 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 EMEND is and what it is used for
2.
What you need to know before you take or give EMEND
3.
How to take EMEND
4.
Possible side effects
5.
How to store EMEND
6.
Contents of the pack and other information
1.
WHAT EMEND IS AND WHAT IT IS USED FOR
EMEND contains the active substance aprepitant and belongs to a group
of medicines called
“neurokinin 1 (NK
1
) receptor antagonists”. The brain has a specific area that controls
nausea and
vomiting. EMEND works by blocking signals to that area, thereby
reducing nausea and vomiting.
EMEND 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 EMEND
DO NOT TAKE EMEND:
-
if you or the child is allergic to aprepitant or any of the other
ingredients of this medicine
(listed in section 6).
-
with medicines containing pimozide (used to treat psychiatric
illnesses), terfenadine and
astemizole (used for hay fever and other allergic conditions),
cisapride (used for treating
digestive problems). Tell the doctor if you or the

Αρχείο Π.Χ.Π.

OBJECT 1
EMEND 80MG, 125MG HARD CAPSULES
Summary of Product Characteristics Updated 07-Jun-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
EMEND® 125 mg hard capsules
EMEND® 80 mg hard capsules
2. Qualitative and quantitative composition
Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule
contains 80 mg of aprepitant.
Excipient with known effect
Each capsule contains 125 mg of sucrose (in the 125 mg capsule).
Excipient with known effect
Each capsule contains 80 mg of sucrose (in the 80 mg capsule).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
The 125 mg capsule is opaque with a white body and pink cap with
“462” and “125 mg” printed radially
in black ink on the body. The 80 mg capsules are opaque with a white
body and cap with “461” and “80
mg” printed radially in black ink on the body.
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.
EMEND 125 mg/80 mg is given as part of combination therapy (see
section 4.2).
4.2 Posology and method of administration
Posology
_Adults _
EMEND 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.
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
EMEND
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 product
information for the
selected 5-HT
3
antagonist for
appropriate dosing
information
none
none
none
DEXAMETHASONE should be administered 30 minutes prior to chemothe