Ofev 100mg capsules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Nintedanib esilate

Dostępny od:

Boehringer Ingelheim Ltd

Kod ATC:

L01XE31

INN (International Nazwa):

Nintedanib esilate

Dawkowanie:

100mg

Forma farmaceutyczna:

Capsule

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 08010500; GTIN: 5012816099234

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OFEV 100 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 Ofev is and what it is used for
2.
What you need to know before you take Ofev
3.
How to take Ofev
4.
Possible side effects
5.
How to store Ofev
6.
Contents of the pack and other information
1.
WHAT OFEV IS AND WHAT IT IS USED FOR
Ofev contains the active substance nintedanib and it is used for the
treatment of 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. Ofev helps to reduce scarring and
stiffening of the lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OFEV
_ _
DO NOT TAKE OFEV:
-
if you are allergic to nintedanib, peanut or soya, or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ofev,
-
if you have or ever had liver problems,
-
if you have or ever had bleeding problems,
-
if you take blood-thinning medicines (such as warfarin, phenprocoumon
or heparin) to prevent
blood clotting,
-
if you have or ever had problems with

Charakterystyka produktu

OBJECT 1
OFEV 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
Ofev 100 mg soft capsules
Ofev 150 mg soft capsules
2. Qualitative and quantitative composition
One capsule contains 100 mg nintedanib (as esilate)
One capsule contains 150 mg nintedanib (as esilate)
Excipient(s) 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).
Ofev 100 mg soft capsules are peach-coloured, opaque, oblong
soft-gelatin capsules imprinted on one
side in black with the Boehringer Ingelheim company symbol and
“100“.
Ofev 150 mg soft capsules are brown-coloured, opaque, oblong
soft-gelatin capsules imprinted on one
side in black with the Boehringer Ingelheim company symbol and
“150“.
4. Clinical particulars
4.1 Therapeutic indications
Ofev is indicated in adults for the treatment of Idiopathic Pulmonary
Fibrosis (IPF).
4.2 Posology and method of administration
Treatment with Ofev should be initiated by physicians experienced in
the diagnosis and treatment of IPF.
Posology
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 be exceeded.
_Dose adjustments_
In addition to symptomatic treatment if applicable, the management of
adverse reactions to Ofev (see
se