Bisoprolol and Aspirin Capsules Hard 10mg/75mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID

Available from:

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

ATC code:

C07FX04

INN (International Name):

BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID

Pharmaceutical form:

HARD CAPSULE

Composition:

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

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Authorised

Authorization date:

2018-12-11

Patient Information leaflet

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1.3.1 PATIENT INFORMATION LEAFLET
TEXT VERSION OF PACKAGE LEAFLET
PATIENT INFORMATION LEAFLET
BISOPROLOL AND ASPIRIN5MG/75 MG CAPSULES, HARD
BISOPROLOL AND ASPIRIN10MG/75 MG CAPSULES, HARD
BISOPROLOL AND ASPIRIN 5MG/100 MG CAPSULES, HARD
BISOPROLOL AND 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 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, heart attack or stroke who were
previously treated with the
individual ingredients. BISOPROLOL AND ASPIRIN
capsules may also be used to prevent
complications following certain types of heart surgeries.
2.

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BISOPROLOL AND ASPIRIN
10mg /75mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg Bisoprolol fumarate and 75 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 10/75, size 1
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
BISOPROLOL AND ASPIRIN
capsules
are indicated for patients that are on stable
treatment at the same dose level
with bisoprolol for
arterial hypertension or
angina pectoris
and with acetyl salicylic acid for
unstable angina pectoris,
secondary prevention of myocardial infarction,
prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG)
or after coronary angioplasty
for secondary prevention of transient ischaemic attacks and ischaemic
cerebrovascular accidents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Capsules for oral administration
One capsule to be taken daily
Special populations
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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
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 ASPIRIN
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 SUDD