Coronal 5

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

bisoprolol (bisoprolol fumarate)

Dostupné s:

Zentiva a.s.

INN (Mezinárodní Name):

bisoprolol (bisoprolol fumarate)

Dávkování:

5mg

Léková forma:

tablets film-coated

Druh předpisu:

Prescription

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coronal 5
Coronal 10
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Coronal 5: bisoprololi fumarate 5 mg in 1 film-coated tablet.
Coronal 10: bisoprololi fumarate 10 mg in 1 film-coated tablet.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Coronal 5: light yellow, lenticular, round scored tablets
Coronal 10: light pink, lenticular, round scored tablets
4.
CLINICAL DATA
4.1_ _
THERAPEUTIC INDICATIONS
•
hypertension
•
ischemic heart disease (angina pectoris)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
For both indications the dose is 5 mg bisoprolol fumarate once daily.
If necessary, the dose
can be increased to 10 mg bisoprolol fumarate once daily. The maximum
recommended daily
dose is 20 mg. The dose is always adjusted individually, based on
heart rate and effectiveness
of the therapy.
Treatment duration
The treatment with Coronal is generally long-term.
The treatment with Coronal must not be stopped abruptly, as it can
lead to a transient
aggravation of the condition. Especially in patients with ischemic
heart disease the treatment
must not be interrupted abruptly. A gradual reduction of doses is
recommended.
Special populations
_ _
_Renal or hepatic impairment _
1
120307
In patients with mild to moderate hepatic or renal impairment, no dose
adjustment is usually
required. In patients with severe renal impairment (creatinine
clearance
<
20 ml/min) and
severe hepatic impairment, doses higher than 10 mg bisoprolol fumarate
daily should not be
used.
There is limited experience with the use of bisoprolol in patients on
dialysis; however, no data
on dosing scheme is available.
_Elderly _
No dosage adjustment is required.
_Children _
There is no experience with bisoprolol in children, therefore its use
cannot be recommended
for children.
Method of administration
Coronal tablets should be taken in the morning with or without food.
The tablets should be
swallowed whole with a drink and should not be che