Daxas

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

roflumilast

Available from:

AstraZeneca AB

ATC code:

R03DX07

INN (International Name):

roflumilast

Therapeutic group:

Drugs for obstructive airway diseases,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive

Therapeutic indications:

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.,

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2010-07-05

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAXAS 250 MICROGRAMS TABLETS
roflumilast
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 Daxas is and what it is used for
2.
What you need to know before you take Daxas
3.
How to take Daxas
4.
Possible side effects
5.
How to store Daxas
6.
Contents of the pack and other information
1.
WHAT DAXAS IS AND WHAT IT IS USED FOR
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.
Daxas is used for maintenance treatment of severe 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 bronchodilators.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAXAS
DO NOT TAKE DAXAS
-
if you are allergic to roflumilast or any of the other ingredients of
this medicine (listed in s

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Daxas 250 micrograms tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 micrograms of roflumilast.
Excipient with known effect:
Each tablet contains 49.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round tablet, 5 mm in diameter, embossed with
“D” on one side and “250” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daxas is indicated for maintenance treatment of severe chronic
obstructive pulmonary disease (COPD)
(FEV
1
post-bronchodilator less than 50% predicted) associated with chronic
bronchitis in adult
patients with a history of frequent exacerbations as add on to
bronchodilator treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Starting dose_
The recommended starting dose is one tablet of 250 micrograms
roflumilast to be taken once daily, for
28 days.
This starting dose is intended to reduce adverse reactions and patient
discontinuation when initiating
therapy, but it is a sub-therapeutic dose. Therefore, the 250
micrograms dose should be used only as a
starting dose (see sections 5.1 and 5.2).
_Maintenance dose_
After 28 days of treatment with the 250 micrograms starting dose,
patients must be up-titrated to one
tablet of 500 micrograms roflumilast, to be taken once daily.
Roflumilast 500 micrograms may need to be taken for several weeks to
achieve its full effect (see
sections 5.1 and 5.2). Roflumilast 500 micrograms has been studied in
clinical trials for up to one year,
and is intended for maintenance treatment.
Special populations
_Elderly_
No dose adjustment is necessary.
3
_Renal impairment_
No dose adjustment is necessary.
_Hepatic impairment_
The clinical data with roflumilast in patients with mild hepatic
impairment classified as Child-Pugh A
are insufficient to recommend a dose adjustment (see section 5.2) and
therefore Daxas should be used
with caution in these patient