Bisoprolol 10mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Bisoprolol fumarate

Предлага се от:

Actavis UK Ltd

АТС код:

C07AB07

INN (Международно Name):

Bisoprolol fumarate

дозиране:

10mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 02040000; GTIN: 5012617011411

Листовка

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

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol 10mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Bisoprolol 10 mg tablet contains 8.49 mg bisoprolol equivalent to
10 mg
bisoprolol fumarate.
Excipient with known effect_ _
Each tablet contains 130.20 mg of lactose monohydrate per tablet
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Bisoprolol 10 mg tablets, are mottled beige, round and convex with the
following
identification markings: BI centrally above a break-line with 10
below.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be individually adjusted. It is recommended to start
with the
lowest possible dose. In some patients, 5 mg per day may be adequate.
The usual dose
is 10 mg once daily with a maximum recommended dose of 20 mg per day.
_Special Populations _
_Renal or liver impairment _
Adjustment of dose in patients with mild to moderate liver- or kidney
impairment is
usually not necessary. In patients with severe renal impairment
(creatinine clearance
< 20 ml/min) or severe liver impairment, the dose should not exceed 10
mg once
daily. This dosage may eventually be divided into halves.
_Elderly _
No dosage adjustment is normally required. It is recommended to start
with the lowest
possible dose.
_Paediatric population _
Bisoprolol tablets are not recommended for use in children due to a
lack of data (see
section 5.3).
_Discontinuation of treatment _
Treatment should not be stopped abruptly (see section 4.4). The dosage
should be
diminished slowly by a weekly halving of the dose.
Method of administration
Bisoprolol 10 mg tablets are for oral administration.
The tablet should be swallowed with a sufficient amount of fluid (e.g.
one glass of
water). The tablet can be taken with or without food.
4.3
CONTRAINDICATIONS
Bisoprolol is contraindicated in patients with:
-
hypersensitiv