DAXAS 500 MCG FILM-COATED TABLETS

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

ROFLUMILAST, MICRONIZED

Beschikbaar vanaf:

ASTRAZENECA SDN. BHD.

INN (Algemene Internationale Benaming):

ROFLUMILAST, MICRONIZED

Eenheden in pakket:

30Tablet Tablets; 90Tablet Tablets; 10Tablet Tablets

Geproduceerd door:

Takeda GmbH

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DAXAS
® FILM-COATED TABLETS
_ _
Roflumilast (500 micrograms)
1
WHAT IS IN THIS LEAFLET
1.
What Daxas is used for
2.
How Daxas works
3.
Before you use Daxas
4.
How to use Daxas
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of Daxas
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DAXAS IS USED FOR
Daxas is used for maintenance
treatment of severe chronic
obstructive pulmonary disease
(COPD) in adults who in the past had
frequent worsening of their COPD
symptoms (so-called exacerbations)
and who have chronic bronchitis.
COPD is a chronic disease of the
lungs that results in tightening of the
airways (obstruction) and swelling
and irritation of the walls of the small
air passages (inflammation). This
leads to symptoms such as coughing,
wheezing, chest tightness or difficulty
in breathing. Daxas is to be used in
addition to bronchodilator medicine.
HOW DAXAS WORKS
Daxas contains the active substance
roflumilast, which is an anti-
inflammatory medicine called
phosphodiesterase-4-inhibitor.
Roflumilast reduces the activity of
phosphodiesterase 4, a protein
occurring naturally in body cells.
When the activity of this protein is
reduced, there is less inflammation in
the lungs. This helps to stop
narrowing of airways occurring in
chronic obstructive pulmonary
disease (COPD). Thus, Daxas eases
breathing problems.
BEFORE YOU USE DAXAS
-
_When you must not use it _
Do not take Daxas if:
•
You are allergic to roflumilast or
any of the other ingredients of
this medicine (listed in product
description)
•
You have moderate or severe
liver problems.
-
_Before you start to use it _
Before you take Daxas, tells your
doctor if you:
•
Have severe immunological
disease such as HIV infection,
multiple sclerosis (MS), lupus
erythematosus (LE) or
progressive multifocal
leukoencephalopathy (PML).
•
Have mild liver problems
•
Have severe acute infectious
disease such as tuberculosis, or
viral hepatitis
•
Hav

Productkenmerken

1
1. NAME OF THE MEDICINAL PRODUCT
Daxas 500 micrograms film -coated tablets
2. NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each tablet contains 500 micrograms of roflumilast.
3. PRODUCT DESCRIPTION
Yellow, D -shaped film -coated tablet, embossed with “D” on one side.
4. PHARMACOLOGICAL PROPERTIES
4.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for
obstructive airway diseases, ATC code: R03DX07
Mechanism of action
Roflumilast is a PDE4 inhi bitor, a non -steroid, anti -inflammatory agent designed to target both the
systemic and pulmonary inflammation associated with COPD. The mechanism of action is the
inhibition of PDE4, a major cyclic adenosine monophosphate (cAMP) -metabolizing enzyme found i n
structural and inflammatory cells important to the pathogenesis of COPD. Roflumilast targets the
PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range. The affinity to the
PDE4C splicing variants is 5 to 10 -fold lower. This mecha nism of action and the selectivity also apply
to roflumilast N -oxide, which is the major active metabolite of roflumilast.
Pharmacodynamic effects
Inhibition of PDE4 leads to elevated intracellular cAMP levels and mitigates COPD -related
malfunctions of l eukocytes, airway and pulmonary vascular smooth muscle cells, endothelial and
airway epithelial cells and fibroblasts in experimental models. Upon in vitro stimulation of human
neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress
the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumor necrosis
factor α, interferon γ and granzyme B.
In patients with COPD, roflumilast reduced sputum neutrophils. Furthermore, roflumilast attenuated
influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers.
Clinical efficacy
In two confirmative replicate one -year studies (M2 -124 and M2 -125) and two supplementary six -
month studies (M2 -127 and M2 -