DALIRESP 500 MCG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

ROFLUMILAST

Διαθέσιμο από:

RAFA LABORATORIES LTD

Φαρμακολογική κατηγορία (ATC):

R03DX07

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

ROFLUMILAST 500 MCG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TAKEDA GMBH, GERMANY

Θεραπευτική ομάδα:

ROFLUMILAST

Θεραπευτική περιοχή:

ROFLUMILAST

Θεραπευτικές ενδείξεις:

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..

Ημερομηνία της άδειας:

2017-10-31

Φύλλο οδηγιών χρήσης

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
DALIRESP 500 MCG
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet of Daliresp 500 mcg contains:
Roflumilast 500 mcg.
For the list of the additional ingredients, see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
The medicine is not indicated for treatment of children and
adolescents under 18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is indicated for maintenance treatment of severe COPD
(Chronic Obstructive
Pulmonary Disease) accompanied by chronic bronchitis, in adults with a
prior history of recurring
flare-ups, in addition to bronchodilators treatment.
THERAPEUTIC GROUP:
Phosphodiasterase 4 inhibitor (PDE-4 inhibitor), a type of
anti-inflammatory medicine.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
•Do not use if you are sensitive (allergic) to the active ingredient
or to any of the other ingredients
the medicine contains (for a list of the other ingredients, see
section 6).
• Do not use if you suffer from moderate to severe liver disease.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
Sudden attack of breathlessness: Daliresp is not intended for the
treatment of a sudden attack of
breathlessness (acute bronchospasm). Therefore it is very important
that your doctor provide you
with another medicine to be available to you at all times and to
assist you in treating these
attacks.
•
Body weight: During the course of treatment with Daliresp, you should
check your body weight on a
regular basis. If, while taking this medicine, you observe an
unintentional loss of body weight (not
related to a diet o

Αρχείο Π.Χ.Π.

DOCTOR LEAFLET
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 about 199 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow, D-shaped film-coated tablet, 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 one tablet of 500 micrograms roflumilast once
daily.
Daliresp may need to be taken for several weeks to achieve its full
effect (see section 5.1 and 5.2).
Daliresp has been studied in clinical trials for up to one year, and
is intended for maintenance treatment.
Special populations
_ _
_Elderly (65 years and older) _
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.
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
(under 18 years) in the indication of
COPD.
Method of administration
For oral use.
The tablet should be swallowed with water and taken at the same time
every day. The tablet can be taken
with or without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipie