Bisoprolol and Aspirin Capsule 10mg/75mg

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID

Доступна с:

Asa Pharma Public Northbrook Road, Ranelagh Dublin 6, D06 PH32, Ireland

код АТС:

C07FX

ИНН (Международная Имя):

BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID

Фармацевтическая форма:

CAPSULE

состав:

BISOPROLOL FUMARATE 10 milligram(s) ; ACETYLSALICYLIC ACID 75 milligram(s)

Тип рецепта:

POM

Терапевтические области:

BETA BLOCKING AGENTS

Статус Авторизация:

Authorised

Дата Авторизация:

2018-08-16

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BISOPROLOL AND ASPIRIN 5 MG/75 MG CAPSULES
BISOPROLOL AND ASPIRIN 10 MG/75 MG CAPSULES
BISOPROLOL AND ASPIRIN 5MG/100MG CAPSULES
BISOPROLOL AND ASPIRIN 10MG/100MG CAPSULES
BISOPROLOL FUMARATE / ACETYLSALICYLIC ACID
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. 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4
In this leaflet:
1.
What
Bisoprolol and Aspirin
capsules are and what they are used for
2.
What you need to know before you take Bisoprolol and Aspirin
capsules
3.
How to take Bisoprolol and Aspirin
capsules
4.
Possible side effects
5.
How to store Bisoprolol and Aspirin
capsules
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL AND ASPIRIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Bisoprolol and Aspirin
capsules contain two active ingredients, bisoprolol fumarate and
acetylsalicylic acid. Bisoprolol belongs to a group of drugs called
beta blockers. This
medicine works by affecting the body`s response to some nerve
impulses, especially in the
heart and has the effect of reducing blood pressure. Acetylsalicylic
acid has the effect of
preventing the development of blood clots. Acetylsalicylic acid is
also known as Aspirin.
Bisoprolol and Aspirin
capsules are used in the treatment of high blood pressure or in
patients
at risk of heart disease who were previously treated with the
individual ingredients.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL AND ASPIRIN CAPSULES
DO NOT TAKE BISOPROLOL AND ASPIRIN CAPSULES IF YOU:
•
are allergic to bisoprolol fumarate or acetylsalicylic acid or any of
the other
ingredients of this me

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol and Aspirin 10mg /75mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg Bisoprolol fumarate and 75 mg
Acetylsalicylic
acid.
Excipient with known effect: Lecithin (Soya)
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
White capsule printed 10/75, size 1
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension in patients previously stabilised on the
individual
components.
Treatment of angina pectoris in patients previously stabilised on the
individual
components.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Capsules for oral administration.
One capsule to be taken daily
Special populations
Older people: No dosage adjustment is normally required, but 5 mg of
bisoprolol per
day may be adequate in some patients.
Renal or hepatic impairment:
Due to the acetylsalicylic acid component, Bisoprolol and Aspirin 10mg
/75mg
Capsules are contraindicated in patients with severe hepatic or renal
insufficiency
(see section 4.3). Caution should be exercised in patients with mild
or moderate
hepatic or renal insufficiency (see section 4.4 and 5.2).
Paediatric population: The safety and efficacy of Bisoprolol in
children and
adolescents has not been established. Therefore, Bisoprolol and
Acetylsalicylic acid
capsules should not be used in children or adolescents.
DURATION OF THERAPY:
TREATMENT WITH BISOPROLOL IS GENERALLY A LONG-TERM THERAPY.
THE TREATMENT WITH BISOPROLOL MUST NOT BE STOPPED ABRUPTLY SINCE THIS
MIGHT
LEAD TO A TRANSITORY WORSENING OF CONDITION. ESPECIALLY IN PATIENTS
WITH ISCHEMIC
HEART DISEASE, TREATMENT MUST NOT BE DISCONTINUED SUDDENLY. GRADUAL
REDUCTION
OF DAILY DOSE IS RECOMMENDED.
4.3
CONTRAINDICATIONS
This medicine is contraindicated in patients with:
•
hypersensitivity to bisoprolol
•
hypersensitivity to salicylic acid compounds or prostaglandin
synthetase
inhibitors (e.g. certain asthma patients who may suffer an attack or
faint a