BICOL 12.5MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

CARVEDILOL

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Φαρμακολογική κατηγορία (ATC):

C07AG02

INN (Διεθνής Όνομα):

CARVEDILOL

Δοσολογία:

12.5MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

CARVEDILOL (0072956093) 12,5MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

CARVEDILOL

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (300034605) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

COMPARATIVE TABLE ENGLISH VS GREEK PIL
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BICOL 12,5 MG FILM-COATED TABLETS
BICOL 25 MG FILM-COATED TABLETS
carvedilol
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 Bicol is and what it is used for
2.
What you need to know before you take Bicol
3.
How to take Bicol
4.
Possible side effects
5.
How to store Bicol
6.
Contents of the pack and other information
1.
WHAT BICOL IS AND WHAT IT IS USED FOR
Bicol contains the active substance carvedilol. It belongs to a group
of
medicines called ‘beta–blockers’.
Bicol tablets are used to treat the following:
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΑΣΘΕΝΉ BICOL 12,5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
BICOL 25 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ
ΔΙΣΚΊΑ
καρβεδιλόλη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ
ΝΑ
ΠΑΊΡΝΕΤΕ
ΑΥΤΌ
ΤΟ
ΦΆΡΜΑΚΟ,
ΔΙΌΤΙ
ΠΕΡΙΛΑΜΒΆΝΕΙ
ΣΗΜΑΝΤΙΚΈΣ
ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το
διαβάσετε ξανά.

Εάν έχετε περαιτέρω απορίες, ρωτήστε
τον γιατρό ή τον φαρμακοποιό
σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλ�

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Bicol 12,5 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 12,5 mg carvedilol.
Excipient(s) with known effect: each film-coated tablet contains
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, oval, scored on both sides and marked “12.5” on one side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjunctive therapy for the treatment of symptomatic congestive heart
failure to reduce morbidity and
increase patient well-being.
Treatment of hypertension.
Long term management of stable angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be taken with fluid. For Congestive Heart Failure
(CHF) patients Bicol should be
given with food
to slow the rate of absorption and reduce the incidence of orthostatic
effects.
SYMPTOMATIC CONGESTIVE HEART FAILURE
The dosage must be titrated to individual requirements and monitored
during up-titration.
For those patients receiving diuretics and/or digoxin and/or ACE
inhibitors, dosing of these other
drugs should be stabilised prior to initiation of Bicol treatment.
ADULTS
1
SUMMARY OF PRODUCT CHARACTERISTICS
The recommended dose for the initiation of therapy is 3,125 mg twice a
day for two weeks. If this
dose is tolerated, the dosage should be increased subsequently, at
intervals of not less than two weeks,
to 6,25 mg twice daily, followed by 12,5 mg twice daily and thereafter
25 mg twice daily. Dosing
should be increased to the highest level tolerated by the patient.
The recommended maximum daily dose is 25 mg given twice daily in
patients weighing less than
85kg (187 lbs) and 50 mg twice daily in patients weighing more than
85kg.
Before each dose increase the patient should be evaluated by the
physician for symptoms of
worsening heart failure or vasodilation. Transient worsening of heart
failure, vasodilation or fluid
retention may be treated with inc