Giotrif 50mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Afatinib dimaleate

Dostupné s:

Boehringer Ingelheim Ltd

ATC kód:

L01XE13

INN (Mezinárodní Name):

Afatinib dimaleate

Dávkování:

50mg

Léková forma:

Tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 08010500; GTIN: 5012816099005

Informace pro uživatele

GIOTRIF® 50 MG
FILM-COATED
TABLETS
afatinib
abcd
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 or pharmacist.
- 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 any of these side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist. See
section 4.
WHAT IS IN THIS LEAFLET
1. What GIOTRIF is and what it is used for
2. What you need to know before you take
GIOTRIF
3. How to take GIOTRIF
4. Possible side effects
5. How to store GIOTRIF
6. Contents of the pack and other information
1. WHAT GIOTRIF IS AND WHAT IT IS USED FOR
GIOTRIF is a medicine which contains the active
substance afatinib. It works by blocking the
activity of a group of proteins called the ErbB
family (including EGFR [epidermal growth factor
receptor or ErbB1], HER2 [ErbB2], ErbB3 and
ErbB4). These proteins are involved in the growth
and spread of cancer cells, and can be affected by
changes (mutations) in the genes that produce
them. By blocking the activity of these proteins
this medicine can inhibit growth and spread of
cancer cells.
This medicine is used on its own to treat adult
patients with a specific type of cancer of the lung
(non-small cell lung cancer):
• that is identified by a change (mutation) in the
gene for EGFR. GIOTRIF can be prescribed to
you as your first treatment or if prior
chemotherapy treatment has been insufficient.
• of squamous type if prior chemotherapy
treatment has been insufficient.
IF YOU STOP TAKING GIOTRIF
Do not stop taking this medicine without first
consulting your doctor. It is important to take this
medicine every day, as long as your doctor
prescribes it for you. If you do not take this
medicine as prescribed by your doctor your cancer
may grow again.
If y

Charakteristika produktu

OBJECT 1
GIOTRIF 20 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 01-Jun-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
GIOTRIF 20 mg film-coated tablets
GIOTRIF 30 mg film-coated tablets
GIOTRIF 40 mg film-coated tablets
GIOTRIF 50 mg film-coated tablets
2. Qualitative and quantitative composition
GIOTRIF 20 mg film-coated tablets
One film-coated tablet contains 20 mg afatinib (as dimaleate).
_Excipient with known effect _
One film-coated tablet contains 118 mg lactose (as monohydrate).
GIOTRIF 30 mg film-coated tablets
One film-coated tablet contains 30 mg afatinib (as dimaleate).
_Excipient with known effect _
One film-coated tablet contains 176 mg lactose (as monohydrate).
GIOTRIF 40 mg film-coated tablets
One film-coated tablet contains 40 mg afatinib (as dimaleate).
_Excipient with known effect _
One film-coated tablet contains 235 mg lactose (as monohydrate).
GIOTRIF 50 mg film-coated tablets
One film-coated tablet contains 50 mg afatinib (as dimaleate).
_Excipient with known effect _
One film-coated tablet contains 294 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
GIOTRIF 20 mg film-coated tablets
White to yellowish, round, biconvex and bevel-edged film-coated tablet
debossed with the code “T20” on
one side and the Boehringer Ingelheim company logo on the other.
GIOTRIF 30 mg film-coated tablets
Dark blue, round, biconvex and bevel-edged film-coated tablet debossed
with the code “T30” on one side
and the Boehringer Ingelheim company logo on the other.
GIOTRIF 40 mg film-coated tablets
Light blue, round, biconvex and bevel-edged film-coated tablet
debossed with the code “T40” on one side
and the Boehringer Ingelheim company logo on the other.
GIOTRIF 50 mg film-coated tablets
Dark blue, oval, biconvex film-coated tablet debossed with the code
“T50” on one side and the
Boehringer Ingelheim company logo on the other.
4. Clinical particulars
4.1 Therapeutic indications