Bisoprolol 5mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Bisoprolol fumarate

Prieinama:

Accord-UK Ltd

ATC kodas:

C07AB07

INN (Tarptautinis Pavadinimas):

Bisoprolol fumarate

Dozė:

5mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02040000; GTIN: 5060149318850

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOPROLOL FUMARATE
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 any of the side effects talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4. WHAT IS IN THIS LEAFLET
1.
What Bisoprolol is and what it is used for
2.
What you need to know before you take Bisoprolol
3.
How to take Bisoprolol
4.
Possible side effects.
5.
How to store Bisoprolol
6.
Contents of the pack and other information
The name of this medicine is Bisoprolol 5mg Tablets or Bisoprolol 10mg
Tablets referred to as Bisoprolol throughout this leaflet.
Bisoprolol belongs to a group of medicines commonly called
‘beta-blockers’ which work by blocking the transmission of certain
nerve
impulses. Bisoprolol is used to help treat:

angina pectoris (chest pain)

hypertension (high blood pressure).
DO NOT TAKE BISOPROLOL IF YOU:

are allergic (hypersensitive) to bisoprolol or any of the other
ingredients in this medicine (listed in Section 6)

are in acute heart failure or if you require injection of inotropic
drugs (drugs which increase the force of contraction of the heart)

have had cardiogenic shock (a condition in which your heart is unable
to pump enough blood to your body)

suffer from heart block

suffer from low heart rate or your heart rate is abnormal because of a
condition known as sick sinus syndrome

have very poor circulation or Raynaud’s Syndrome

have unusually low blood pressure

have a tumour of the adrenal gland (phaeochromocytoma)

suffer from severe asthma or have severe breathing difficulties

suffer from metabolic acidosis (a d

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol 5mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Bisoprolol 5mg tablets are round, film-coated, ivory coloured tablets
with a break-
line on one side and ‘5’ embossed on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of stable chronic heart failure with reduced systolic left
ventricular
function in addition to ACE inhibitors, and diuretics, and optionally
cardiac
glycosides (for additional information see section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor
blocker in case of intolerance to ACE inhibitors), a beta-blocker,
diuretics, and when
appropriate cardiac glycosides. Patients should be stable (without
acute failure) when
bisoprolol treatment is initiated.
It is recommended that the treating physician should be experienced in
the
management of chronic heart failure. Transient worsening of heart
failure,
hypotension, or bradycardia may occur during the titration period and
thereafter.
Posology
Titration phase
The treatment of stable chronic heart failure with bisoprolol requires
a titration phase.
The treatment with bisoprolol is to be started with a gradual
uptitration according to
the following steps:
-
1.25mg once daily for 1 week, if well tolerated increase to
-
2.5mg once daily for a further week, if well tolerated increase to
-
3.75mg once daily for a further week, if well tolerated increase to
-
5mg once daily for the 4 following weeks, if well tolerated increase
to
-
7.5mg once daily for the 4 following weeks, if well tolerated increase
to
-
10mg once daily for the maintenance therapy
The maximum recommended dose is 10mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and
symptoms of
worsening heart failure is recommended during the titration