Cobisomyl 10mg/25mg film-coated Tablets

Maa: Malta

Kieli: englanti

Lähde: Malta Medicines Authority

Aktiivinen ainesosa:

HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

Saatavilla:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-koodi:

C07BB07

INN (Kansainvälinen yleisnimi):

HYDROCHLOROTHIAZIDE 25 mg BISOPROLOL FUMARATE 10 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

HYDROCHLOROTHIAZIDE 25 mg BISOPROLOL FUMARATE 10 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

BETA BLOCKING AGENTS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2012-03-28

Pakkausseloste

PAGE 1 OF 10
PACKAGE LEAFLET
PAGE 2 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COBISOMYL 5 MG/12.5 MG FILM-COATED TABLETS
COBISOMYL 10 MG/25 MG FILM-COATED TABLETS
Bisoprolol fumarate
Hydrochlorothiazide
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 Cobisomyl is and what it is used for
2.
What you need to know before you take Cobisomyl
3.
How to take Cobisomyl
4.
Possible side effects
5.
How to store Cobisomyl
6.
Contents of the pack and other information
1.
WHAT COBISOMYLIS AND WHAT IT IS USED FOR
Cobisomyl contains the active substances bisoprolol and
hydrochlorothiazide.
Bisoprolol belongs to the family of medicines called beta-blockers and
it is used to decrease blood
pressure.
Hydrochlorothiazide belongs to the family of medicines called thiazide
diuretics (also known as
“water tablets”). This medicine helps to lower blood pressure by
increasing the elimination of urine.
This medicine is recommended in the treatment of high blood pressure
in patients whose blood
pressure is not sufficiently controlled by bisoprolol or
hydrochlorothiazide alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COBISOMYL
DO NOT TAKE COBISOMYL IF YOU:
-
are allergic to bisoprolol, hydrochlorothiazide, other thiazides,
sulphonamides (substances
chemically related to hydrochlorothiazide) or any of the other
ingredients of this medicine
(listed in section 6)
-
suffer from acute weakness of the heart muscle (acute heart failure)
or if your heart muscle
weakness is not under control (decompensated heart failur

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 15
1.
NAME OF THE MEDICINAL PRODUCT
Cobisomyl 5 mg/12.5 mg film-coated tablet
Cobisomyl 10 mg/25 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg/12.5 mg film-coated tablet contains:
5 mg bisoprolol fumarate
12.5 mg hydrochlorothiazide
Each 10 mg/25 mg film-coated tablet contains:
10 mg bisoprolol fumarate
25 mg hydrochlorothiazide
Excipient with known effect:
Each tablet contains:
29.3 mg lactose (anhydrous)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet. Diameter: 7.6 mm.
Cobisomyl 5 mg/12.5 mg film-coated tablet
A pinkish grey, film coated, round, biconvex tablet debossed with
‘BH4’ over ‘M’ on one side and
breakline on the other side of the tablet.
5 mg/12.5 mg only: The score line is only to facilitate breaking for
ease of swallowing and not to
divide into equal doses.
Cobisomyl 10 mg/25 mg film-coated tablet
A reddish grey, film coated, round, biconvex tablet debossed with
‘BH5’ over ‘M’ on one side and
breakline on the other side of the tablet.
10 mg/25 mg only: The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
The fixed-dose combination of bisoprolol fumarate/hydrochlorothiazide
5 mg/12.5 mg or bisoprolol
fumarate/hydrochlorothiazide 10 mg/25 mg is indicated in patients
whose blood pressure cannot be
adequately controlled using bisoprolol or hydrochlorothiazide alone.
Cobisomyl is indicated in adults only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PAGE 3 OF 15
Posology
Individual dose titration with each single component is recommended.
If clinically appropriate, a
direct switch from monotherapy to the fixed combination may be taken
into consideration.
The usual dose is 5 mg bisoprolol and 12.5 mg hydrochlorothiazide once
daily (equivalent to one film-
coated tablet Cobisomyl 5/12.5 mg film-coated tablets or 1/2
film-coated tablet Cobisom