Nifiden 100 mg soft capsules

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta

ATC code:

L01EX09

INN (International Name):

NINTEDANIB 100 mg

Pharmaceutical form:

SOFT CAPSULE

Composition:

NINTEDANIB 100 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2024-01-04

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIFIDEN 100 MG SOFT 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 Nifiden is and what it is used for
2.
What you need to know before you take Nifiden
3.
How to take Nifiden
4.
Possible side effects
5.
How to store Nifiden
6.
Contents of the pack and other information
1.
WHAT NIFIDEN IS AND WHAT IT IS USED FOR
Nifiden 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 NIFIDEN
_ _
DO NOT TAKE NIFIDEN
-
if you are allergic to nintedanib or any of the other ingredients of
this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Nifiden if you:
-
have or had liver problems, if you have or had bleeding problems,
particularly recent
bleeding in the lung
-
have or have had probl

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Nifiden 100 mg soft capsules
Nifiden 150 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Nifiden 100 mg soft capsules _
Each soft capsule contains nintedanib esilate equivalent to 100 mg
nintedanib.
_Nifiden 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).
_Nifiden 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.
_Nifiden 150 mg soft capsules _
Brown, opaque, oblong capsules containing yellow viscous suspension,
imprinted with
“NT 150” in red ink and approximately 17 mm in length.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nifiden 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 Nifiden 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.
Nifiden 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
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be increased beyond the recommended dose to make up for missed doses.
The recommended
maximum daily dose of 400 mg should not be exceeded.
Patients may continue therapy with nintedanib after discontinuation of
docetaxel for as long
as clinical benefit is observed or until unaccep