Bisoprolol and Aspirin 10mg /100mg Capsules.

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Bisoprolol fumarate, Acetylsalicylic acid

Available from:

ASA Pharma PLC

ATC code:

C07AB57

INN (International Name):

Bisoprolol fumarate, Acetylsalicylic acid

Dosage:

10mg /100mg

Pharmaceutical form:

Capsule, hard

Administration route:

Oral use

Units in package:

Pack sizes: 7,10,14,20, 28, 30, 50, 56, 84, 98 and 100 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Pharmaceutical Works Polpharma S.A

Therapeutic group:

beta blocking agents; bisoprolol combination

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.

Authorization status:

Authorised

Authorization date:

2015-03-04

Patient Information leaflet

PREGNANCY AND BREAST FEEDING
Please let the doctor know if you are pregnant, think 
you might be pregnant, are planning to become 
pregnant or are breast-feeding. Bisoprolol and 
Aspirin capsules are not recommended during 
pregnancy unless absolutely necessary, as the 
possible risks to the baby are not known. Your 
doctor will be able to advise you.
It is unknown if bisoprolol is excreted in the breast 
milk, however, acetylsalicylic acid may be present 
in breast milk. Breast-feeding during the use of this 
medicinal product is therefore not recommended.
Ask your doctor or pharmacist for advice before 
taking any medicine.
DRIVING AND USING MACHINES
Bisoprolol and Aspirin capsule should not usually 
affect your ability to drive or use machines. If they 
make you feel tired or dizzy wait until the symptoms 
have worn off before driving or using machines.
3. HOW TO TAKE BISOPROLOL AND 
ASPIRIN CAPSULES
Bisoprolol and Aspirin capsules should be 
swallowed whole with water.
The normal dose for adults is one daily taken at 
about the same time each day. Your doctor will 
decide on the most suitable dose for you.
Bisoprolol and Aspirin capsules are not suitable for 
children. 

OLDER PATIENTS 
In general an adjustment of the dose is not needed. 
It is recommended to start with the lowest possible 
dose.
PATIENTS WITH A SEVERELY REDUCED KIDNEY & LIVER 
FUNCTION 
Patients should not take this product if they suffer 
from severe kidney or liver disease. For patients 
with mild or moderate kidney or liver function, 
special care should be taken. 

Treatment with bisoprolol is usually long-term. If 
you have to stop treatment entirely, your doctor will 
usually advise you to reduce the dose gradually, as 
otherwise your condition may become worse.
IF YOU TAKE MORE BISOPROLOL AND ASPIRIN 
CAPSULES THAN YOU SHOULD
If you have accidentally taken more than the 
prescribed dose, tell your doctor/pharmacist 
immediately. Take any remaining tablets or this 
leaflet with you so the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Bisoprolol and Aspirin 10mg /100mg Capsules. 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each hard capsule contains 10 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 10/100, 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
is 
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.