Bisocombimyl 2.5mg/6.25mg film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

Available from:

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

ATC code:

C07BB07

INN (International Name):

HYDROCHLOROTHIAZIDE 6.25 mg BISOPROLOL FUMARATE 2.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 6.25 mg BISOPROLOL FUMARATE 2.5 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Authorised

Authorization date:

2012-01-06

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOCOMBIMYL 2.5 MG/6.25 MG FILM-COATED TABLETS
BISOCOMBIMYL 5 MG/6.25 MG FILM-COATED TABLETS
BISOCOMBIMYL 10 MG/6.25 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 of pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Bisocombimyl is and what it is used for
2.
What you need to know before you take Bisocombimyl
3.
How to take Bisocombimyl
4.
Possible side effects
5.
How to store Bisocombimyl
6.
Contents of the pack and other information
1.
WHAT BISOCOMBIMYL IS AND WHAT IT IS USED FOR
The active substances are 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 product helps to lower blood pressure by
increasing the elimination of urine.
This medicine is recommended for the treatment of mild to moderate
high blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOCOMBIMYL
DO NOT TAKE BISOCOMBIMYL 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 severe asthma
-
have heart failure which is not controlled by treatment, or
cardiogenic shock (a serious cardiac
disorder causing a drop in blood pressure and circulatory failure)
-
ha

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Bisocombimyl 2.5 mg/6.25 mg film-coated tablets
Bisocombimyl 5 mg/6.25 mg film-coated tablets
Bisocombimyl 10 mg/6.25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg/6.25 mg film-coated tablet contains:
2.5 mg bisoprolol fumarate
6.25 mg hydrochlorothiazide
Each 5 mg/6.25 mg film-coated tablet contains:
5 mg bisoprolol fumarate
6.25 mg hydrochlorothiazide
Each 10 mg/6.25 mg film-coated tablet contains:
10 mg bisoprolol fumarate
6.25 mg hydrochlorothiazide
Excipient with known effect:
Each tablet contains:
29.3 mg lactose and 0.7 mg macrogol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet. Diameter: 7.6 mm.
BISOCOMBIMYL 2.5 MG/6.25 MG FILM-COATED TABLET
A yellow, film coated, round, biconvex tablet debossed with ‘BH1’
on one side and ‘M’ on the other
side of the tablet.
BISOCOMBIMYL 5 MG/6.25 MG FILM-COATED TABLET
A light pink, film coated, round, biconvex tablet debossed with
‘BH2’ on one side and ‘M’ on the
other side of the tablet.
BISOCOMBIMYL 10 MG/6.25 MG FILM-COATED TABLET
A white, film coated, round, biconvex tablet debossed with ‘BH3’
on one side and ‘M’ on the other
side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate arterial hypertension.
Bisocombimyl is indicated in adults only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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Dose titration of each active ingredient to the individual patient is
recommended. If clinically
appropriate patients can be transferred from monotherapy to the fixed
combination therapy.
In order to individually adjust the posology, Bisocombimyl is
available in the following dosages:
Bisocombimyl 2.5 mg/6.25 mg, film-coated tablets
Bisocombimyl 5 mg/6.25 mg, film-coated tablets
Bisocombimyl 10 mg/6.25 mg, film-coated tablets
The low dose 2.5 mg/6.25 mg may be used for dose titration if in the
judgement of the clinician this is
required fo