Nintedanib Teva 100 mg, zachte capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NINTEDANIBESILAAT 120,4 mg/stuk SAMENSTELLING overeenkomend met ; NINTEDANIB 100 mg/stuk

INN (Algemene Internationale Benaming):

NINTEDANIBESILAAT 120,4 mg/stuk SAMENSTELLING overeenkomend met ; NINTEDANIB 100 mg/stuk

farmaceutische vorm:

Capsule, zacht

Samenstelling:

GELATINE (E 441) ; GLYCEROL 85 PER CENT (E 422) ; HARD VET ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; KARMIJN (E120) ; POLYGLYCERYL-3 OLEAAT (E 475) ; PROPYLEENGLYCOL (E 1520) ; RODE INKT ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SIMETICON ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
Rvg 131943 EU PIL new MA met NL info clean
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NINTEDANIB TEVA 100 MG, ZACHTE CAPSULES
nintedanib
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 [Product Name] is and what it is used for
2.
What you need to know before you take [Product Name]
3.
How to take [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product Name] contains the active substance nintedanib, a medicine
belonging to the class of
so-called tyrosine kinase inhibitors, and it is used for the treatment
of idiopathic pulmonary fibrosis
(IPF), other chronic fibrosing interstitial lung diseases (ILDs) with
a progressive phenotype and
systemic sclerosis associated interstitial lung disease (SSc-ILD) in
adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a condition in which the tissue in your lungs becomes
thickened, stiff and scarred over time. As
a result, scarring reduces the ability to transfer oxygen from the
lungs into the bloodstream and it
becomes difficult to breathe deeply. This medicine helps to reduce
further scarring and stiffening of
the lungs.
Other chronic fibrosing interstitial lung diseases (ILDs) with a
progressive phenotype
Besides IPF, there are other conditions in which the tissue in your
lungs becomes thickened, stiff, and
scarred over time (lung fibrosis) and keeps worsening (progressive
phenotype). Examples of these
conditions are hypersensitivity pneu

Productkenmerken

1
Rvg 131943_4 EU SPC new MA met NL info clean
SUMMARY OF PRODUCT CHARACTERISTICS
2
Rvg 131943_4 EU SPC new MA met NL info clean
1.
NAME OF THE MEDICINAL PRODUCT
Nintedanib Teva 100 mg, zachte capsules
Nintedanib Teva 150 mg, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_[Product Name] 100 mg soft capsules _
Each soft capsule contains nintedanib esilate equivalent to 100 mg
nintedanib
_[Product Name] 150 mg soft capsules _
Each soft capsule contains nintedanib esilate equivalent to 150 mg
nintedanib
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Soft capsule (capsule)
_[Product Name] 100 mg soft capsules _
Peach, opaque, oblong capsule containing yellow viscous suspension,
imprinted with “NT 100” in red
ink and approximately 16 mm in length.
_[Product Name] 150 mg soft capsules _
Brown, opaque, oblong capsule containing yellow viscous suspension,
imprinted with “NT 150” in red
ink and approximately 17 mm in length.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product Name] is indicated in adults for the treatment of idiopathic
pulmonary fibrosis (IPF).
[Product Name] is also indicated in adults for the treatment of other
chronic fibrosing interstitial lung
diseases (ILDs) with a progressive phenotype (see section 5.1).
[Product Name] is indicated in adults for the treatment of systemic
sclerosis associated interstitial lung
disease (SSc-ILD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by physicians experienced in the
management of diseases for which
[Product Name] is approved.
Posology
_Adults _
The recommended dose is 150 mg nintedanib twice daily administered
approximately 12 hours apart.
The 100 mg twice daily dose is only recommended to be used in patients
who do not tolerate the
150 mg twice daily dose.
If a dose is missed, administration should resume at the next
scheduled time at the recommended dose.
If a dose is missed the patient should not take an additional dose.
The recommended maximum daily
dose of 300 mg should not