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Sandoz Limited

200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Telephone: +44 (0) 1276 698020
Fax: +44 (0) 1276 698324
WWW: http://www.sandoz.com
Medical Information e-mail: sandoz@professionalinformation.co.uk
Medical Information Fax: +44 (0) 1276 698468

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/10/2011
SPC Bisoprolol Fumarate 7.5 mg Film-coated Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 18/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Amendments shown in red

4.5 Interaction with other medicinal products and other forms of interaction

Combinations not recommended

Class I antiarrhythmic medicinal products (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone) (Deleted: in patients with chronic heart failure): Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect increased.


4.8 Undesirable effects

Ear and labyrinth disorders

Rare: hearing disorders

Vascular disorders

Common: feeling of coldness or numbness in the extremities, hypotension (especially in patients with heart failure)

 
Updated on 17/06/2011 and displayed until 18/10/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   07-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Additions made in red.

4.2 Posology and method of administration

Duration of treatment

Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.

The treatment with bisoprolol must not be stopped abruptly since this might lead to a transitory worsening of condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. Gradual reduction of the daily dose is recommended.


Children and adolescents

There is no experience with bisoprolol in children and adolescents, therefore its use cannot be recommended for children.

4.4 Special warnings and precautions for use

The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase (see section 4.2).

Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition (see section 4.2).

The initiation of treatment of stable chronic heart failure with bisoprolol necessitates regular monitoring. For the posology and method of administration please refer to section 4.2.

4.6 Pregnancy and lactation

Lactation:

There are no data on the excretion of bisoprolol in human breast milk or the safety of bisoprolol exposure in infants. Therefore, breastfeeding is not recommended during administration of bisoprolol.
Updated on 04/03/2011 and displayed until 17/06/2011
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  bisoprolol fumarate