Aprepitant 80mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aprepitant

Available from:

Viatris UK Healthcare Ltd

ATC code:

A04AD12

INN (International Name):

Aprepitant

Dosage:

80mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5016695008431

Patient Information leaflet

Myriad Pro
12 pt
12 pt
Aprepitant_80mg_125mg_5x1_2x1_1x1
Leaflet
1718048
N/A
1718048
PL 04569/1798, PL 04569/1799,
PL 04569/1800
TBC
TBC
TBC
N/A
101985468/0120
3
United Kingdom
157x315 BDM-2-v1
N/A
1
157 x 315 mm
Black
1 / 2
N/A
v3/Jul 2017
Colours
Non-Print
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22:30
18 Mar 19
•
slow heartbeat, heart and blood
vessel disease,
•
lowering of white blood cells,
low sodium levels in the blood,
weight loss.
REPORTING OF SIDE EFFECTS
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. You
can also report side effects directly
via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google
Play or Apple App Store. By reporting
side effects you can help provide
more information on the safety of this
medicine.
5. HOW TO STORE APREPITANT
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the
expiry date which is stated on the
carton after EXP. The expiry date refers
to the last day of that month.
This medicine does not require any
special storage conditions.
Do not remove the capsule from its
blister until you are ready to take it.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT APREPITANT CONTAINS
The active substance is aprepitant. Each
capsule contains 80 mg or 125 mg of
aprepitant.
The other ingredients are:
Capsule content:
hydroxypropylcellulose, sodium
laurilsulfate, sucrose, cellu

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aprepitant Mylan 80 mg + 125 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 size 1 capsule and has an opaque pink cap and an
opaque
white body printed with “125 mg” in black ink.
The 80 mg capsule is size 2 capsule and has an opaque white cap and an
opaque
white body printed with “80 mg” in black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention nausea and vomiting associated with highly and moderately
emetogenic cancer
chemotherapy in adults and adolescents from the age of 12.
Aprepitant Mylan 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 Mylan 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
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 product
information for
the selected 5-
HT
3
antagonist
for appropriate
dosing
information
none
none
none
DEXAMETHASONE should be administered 30 minutes prior to chemotherapy
treatment on
Day 1 and in the morning on Days 2 to 4. The dose of dexamethasone
acco