Bisoprolol 5mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Bisoprolol fumarate

Доступна с:

Waymade Healthcare Plc

код АТС:

C07AB07

ИНН (Международная Имя):

Bisoprolol fumarate

дозировка:

5mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02040000

тонкая брошюра

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

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol 5 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of bisoprolol fumarate.
Excipient with known effect: Lactose Monohydrate 136 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
The tablets are pale yellow mottled in colour, round and convex with
the
following identification markings: BI centrally above a break-line
with 5 below.
The tablets can be divided into equal halves.
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.
Patients with kidney impairment
In patients with severe renal impairment, (creatinine clearance <
20ml/min) the dose
should not exceed 10 mg once daily._ _This dosage may eventually be
divided into
halves.
Patients with severe liver impairment
No dosage adjustment is required, however careful monitoring is
advised In patients
with severe liver function disorders a daily dose of 10mg bisoprolol
should not be
exceeded._ _
Elderly:
No dosage adjustment is normally required. It is recommended to start
with the
lowest possible dose
Paediatric population:
There is no paediatric experience with this medicine, therefore its
use cannot be
recommended
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 5 mg Tablets are for oral administration.
The tablet should be taken in the morning and be swallowed with a
sufficient amount
of fluid (e.g. one glass of water) .The tablet can be taken with food.
4.3
CONTRAINDICATIONS
•
acute heart failure or during episodes of heart failure decompensation
requi