Bisoprolol and Aspirin 5mg /100mg capsules, hard

Maa: Malta

Kieli: englanti

Lähde: Malta Medicines Authority

Saatavilla:

Athena Pharmaceutiques SAS 12 Rue Georges Blandon 78430 Louveciennes, France

ATC-koodi:

C07FX04

INN (Kansainvälinen yleisnimi):

BISOPROLOL FUMARATE 5 mg ACETYLSALICYLIC ACID 100 mg

Lääkemuoto:

HARD CAPSULE

Koostumus:

BISOPROLOL FUMARATE 5 mg ACETYLSALICYLIC ACID 100 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

BETA BLOCKING AGENTS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-12-11

Pakkausseloste

Page 1 of 9
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
In this leaflet:
1.
What BISOPROLOL AND ASPIRINcapsules 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.
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 medicine (listed in Section 6)
•
have ever had an asthma attack or swelling of some parts of the body
e.g. face, lips,
throat or tongue (angioedema) after taking any other non-steroidal
anti-inflammatory
drugs (NSAIDs)
•
have severe heart failure or cardiac shock causing breathlessness and
circulatio

Valmisteyhteenveto

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BISOPROLOL AND ASPIRIN
5mg /100mg capsules, hard
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
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
Page 2 of 17
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