Daliresp

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:

Daliresp 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: 9

Authorization status:

Withdrawn

Authorization date:

2011-02-28

Patient Information leaflet

23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DALIRESP 500 MICROGRAMS FILM-COATED TABLETS
Roflumilast
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 Daliresp is and what it is used for
2.
What you need to know before you take Daliresp
3.
How to take Daliresp
4.
Possible side effects
5.
How to store Daliresp
6.
Contents of the pack and other information
1
WHAT DALIRESP IS AND WHAT IT IS USED FOR
Daliresp 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 Daliresp eases breathing problems.
Daliresp 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
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
Daliresp 500 micrograms film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms of roflumilast.
Excipient with known effect:
Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow, D-shaped film-coated tablet of 9 mm, embossed with “D” on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daliresp 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
The recommended dose is 500 micrograms (one tablet) roflumilast once
daily.
Daliresp may need to be taken for several weeks to achieve its effect
(see section 5.1). Daliresp has been
studied in clinical trials for up to one year.
Special populations
_Elderly_
No dose adjustment is necessary.
_Renal impairment _
No dose adjustment is necessary.
_Hepatic impairment _
The clinical data with Daliresp in patients with mild hepatic
impairment classified as Child-Pugh A are
insufficient to recommend a dose adjustment (see section 5.2) and
therefore Daliresp should be used
with caution in these patients.
Medicinal product no longer authorised
3
Patients with moderate or severe hepatic impairment classified as
Child-Pugh B or C must not take
Daliresp (see section 4.3).
_Paediatric population _
There is no relevant use of Daliresp in the paediatric population
(