Bisoprolol and Aspirin 5mg /100mg Capsules

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID

Доступна з:

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

Код атс:

C07FX04

ІПН (Міжнародна Ім'я):

BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID

Фармацевтична форма:

CAPSULE

Склад:

BISOPROLOL FUMARATE 5 milligram(s) ; ACETYLSALICYLIC ACID 100 milligram(s)

Тип рецепту:

POM

Терапевтична области:

BETA BLOCKING AGENTS

Статус Авторизація:

Authorised

Дата Авторизація:

2018-08-16

інформаційний буклет

1.3.1 Patient Information Leaflet
TEXT VERSION OF PACKAGE LEAFLET
PATIENT INFORMATION LEAFLET
BISOPROLOL & ASPIRIN 5MG/100 MG CAPSULES, HARD
BISOPROLOL & ASPIRIN 10MG/100 MG CAPSULES, HARD
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 & ASPIRIN capsules are and what they are used for
2.
What you need to know before you take BISOPROLOL & ASPIRIN capsules
3.
How to take BISOPROLOL & ASPIRIN capsules
4.
Possible side effects
5.
How to store BISOPROLOL & ASPIRIN capsules
6.
Contents of the pack and other information.
1. WHAT BISOPROLOL & ASPIRIN CAPSULES ARE AND WHAT THEY ARE USED FOR
BISOPROLOL & 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 & 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 & ASPIRIN CAPSULES
DO NOT TAKE
BISOPROLOL & ASPIRIN
CAPSULES IF YOU:
•
are allergic to Bisoprolol fumarate, Acetylsalicylic acid or any of
the other ingredients in this
medicine (listed in section 6).
•
have ever ha

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol and Aspirin 5mg /100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 5 mg Bisoprolol fumarate and 100 mg
Acetylsalicylic
acid.
Excipient(s) with known effect: Lecithin (Soya)
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
White capsule printed 5/100, 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 5mg
/100mg
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