Vargatef 150mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Nintedanib esilate

Disponible depuis:

Boehringer Ingelheim Ltd

Code ATC:

L01XE31

DCI (Dénomination commune internationale):

Nintedanib esilate

Dosage:

150mg

forme pharmaceutique:

Capsule

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 08010500; GTIN: 5012816099227

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VARGATEF 150 MG SOFT CAPSULES
Nintedanib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vargatef is and what it is used for
2.
What you need to know before you take Vargatef
3.
How to take Vargatef
4.
Possible side effects
5.
How to store Vargatef
6.
Contents of the pack and other information
1.
WHAT VARGATEF_ _IS AND WHAT IT IS USED FOR
Vargatef capsules contain the active substance nintedanib. Nintedanib
blocks the activity of a group of
proteins which are involved in the development of new blood vessels
that cancer cells need to supply
them with food and oxygen. By blocking the activity of these proteins,
nintedanib can help stop the
growth and spread of the cancer.
This medicine is used in combination with another cancer medicine
(docetaxel) to treat a cancer of the
lung called non-small cell lung cancer (NSCLC). It is for adult
patients whose NSCLC is of a certain
type (“
_adenocarcinoma_
”) and who had already received one treatment with another medicine
to treat
this cancer but whose tumour started to grow again.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARGATEF
_ _
DO NOT TAKE VARGATEF:
-
if you are allergic to nintedanib, to peanut or soya, or any of the
other ingredients of this
medicine (listed in section 6).

Résumé des caractéristiques du produit

OBJECT 1
VARGATEF 100 MG SOFT CAPSULES
Summary of Product Characteristics Updated 01-Jun-2018 | Boehringer
Ingelheim Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Vargatef 100 mg soft capsules
Vargatef 150 mg soft capsules
2. Qualitative and quantitative composition
Each capsule contains 100 mg nintedanib (as esilate).
Each capsule contains 150 mg nintedanib (as esilate).
Excipients with known effect:
Each capsule contains 1.2 mg of soya lecithin.
Each capsule contains 1.8 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Soft capsule (capsule)
Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one
side in black with the Boehringer
Ingelheim company symbol and “100”.
Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one
side in black with the Boehringer
Ingelheim company symbol and “150”.
4. Clinical particulars
4.1 Therapeutic indications
Vargatef is indicated in combination with docetaxel for the treatment
of adult patients with locally
advanced, metastatic or locally recurrent non-small cell lung cancer
(NSCLC) of adenocarcinoma tumour
histology after first-line chemotherapy.
4.2 Posology and method of administration
Treatment with Vargatef should be initiated and supervised by a
physician experienced in the use of
anticancer therapies.
Posology
The recommended dose of nintedanib is 200 mg twice daily administered
approximately 12 hours apart,
on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Vargatef must not be taken on the same day of docetaxel chemotherapy
administration (= day 1). If a dose
of nintedanib is missed, administration should resume at the next
scheduled time at the recommended
dose. The individual daily doses of nintedanib should not be increased
beyond