Bisoprolol 10mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Bisoprolol fumarate

Saadav alates:

Sandoz Ltd

ATC kood:

C07AB07

INN (Rahvusvaheline Nimetus):

Bisoprolol fumarate

Annus:

10mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02040000; GTIN: 5050650035841

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOL 5 MG AND 10 MG TABLETS
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, pharmacist or
nurse.
-
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, 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 TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS
3.
HOW TO TAKE BISOPROLOL TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BISOPROLOL TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT BISOPROLOL TABLETS ARE AND WHAT THEY ARE USED FOR
Bisoprolol fumarate belongs to a group of medicines called
beta-blockers. It is used to treat:
-
high blood pressure
-
angina pectoris (pain in the chest caused by blockages in the arteries
leading to the heart).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS
DO NOT TAKE BISOPROLOL TABLETS
-
if you are
ALLERGIC
to Bisoprolol tablets or any of the other ingredients of this medicine
(listed
in section 6)
-
if you suffer from
SEVERE ASTHMA
or from other
SEVERE
breathing difficulties
-
if you have acute
HEART FAILURE
or are in shock caused by heart problems
-
if you suffer with
HEART
CONDUCTION
or
RHYTHM PROBLEMS
(2nd or 3rd degree AV-block, sick
sinus syndrome or sinoatrial block)
-
if you have a
SLOW HEART RATE
of less than 60 beats per minute before starting treatment.
-
if you have
LOW BLOOD PRESSURE
-
if you suffer from severely
BLOCKED BLOOD VESSELS
, including
BLOOD CIRCULATION PROBLEMS
(which may cause your fingers and toes to tingle or turn pale or blue)
-
if you suffer from
INCREASED ACIDITY OF THE BLOOD
(metabol

Toote omadused

OBJECT 1
BISOPROLOL FUMARATE 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 01-Nov-2016 | Sandoz
Limited
1. Name of the medicinal product
Bisoprolol Fumarate 10 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 10 mg bisoprolol fumarate
Excipients with known effects:
Each tablet contains lactose (as lactose monohydrate 2.48 mg)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
apricot, round tablet with a cross score on one side and encoded "BIS
10" on the other side
The tablet can be divided into equal quarters.
4. Clinical particulars
4.1 Therapeutic indications
Hypertension
Angina pectoris
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
Posology
HYPERTENSION/ANGINA PECTORIS
_Adults_
The dosage should be individually adjusted, in particular according to
the pulse rate and therapeutic
success.
It is recommended to start with 5 mg per day. The usual dose is 10 mg
once daily with a maximum
recommended dose of 20 mg once daily.
_Elderly_
It is recommended to start with the lowest possible dose.
Renal or liver impairment
In patients with liver or kidney function disorders of mild to
moderate severity, no dosage adjustment is
normally required. In patients with severe renal impairment
(creatinine clearance < 20 ml/min) and in
patients with severe liver function disorders it is recommended that a
daily dose of 10 mg is not exceeded.
Experience with the use of bisoprolol in renal dialysis patients is
limited. However, there is no evidence
that the dosage regime needs to be altered.
Discontinuation of treatment:
Treatment must not be stopped abruptly (see section 4.4). The dosage
should be diminished slowly by a
weekly halving of the dose.
STABLE CHRONIC HEART FAILURE
Standard treatment of CHF consists of an ACE i