BISOPROLOL FUMARATE ACTAVIS 10 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

Actavis Group PTC ehf

ATC code:

C07AB07

INN (International Name):

BISOPROLOL FUMARATE

Dosage:

10 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective

Authorization status:

Authorised

Authorization date:

2010-10-01

Patient Information leaflet

  
Bisoprolol Tablets 5mg and 10mg tablets PIL - Ireland
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TECHNICAL APPROVAL
AAAI9658
4
22.04.16
DR
25.05.16
DR
Niche Generics 
 148x420
9pt
22.04.16
26.04.16 
PACKAGE LEAFLET:  
INFORMATION FOR THE PATIENT
BISOPROLOL FUMARATE ACTAVIS 5 MG TABLETS
BISOPROLOL FUMARATE ACTAVIS 10 MG TABLETS
Bisoprolol fumarate
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, pharmacist or nurse.
•   This medicine has been prescribed for you
only. 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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET 
1
  WHAT BISOPROLOL FUMARATE ACTAVIS IS 
AND WHAT IT IS USED FOR
2
  WHAT YOU NEED TO KNOW BEFORE YOU 
TAKE BISOPROLOL FUMARATE ACTAVIS
3
  HOW TO TAKE BISOPROLOL FUMARATE 
ACTAVIS
4
  POSSIBLE SIDE EFFECTS
5
  HOW TO STORE BISOPROLOL FUMARATE 
ACTAVIS 
6
  CONTENTS OF THE PACK AND OTHER 
INFORMATION
1

WHAT BISOPROLOL FUMARATE ACTAVIS IS 
AND WHAT IT IS USED FOR
Bisoprolol fumarate belongs to a group of
medicinal products called beta-blockers. It is
used to treat:
•   high blood pressure
•   angina pectoris (pain in the chest caused by
blockages in the arteries leading to the heart).
2

 WHAT YOU NEED TO KNOW BEFORE YOU 
TAKE BISOPROLOL FUMARATE ACTAVIS
DO NOT TAKE BISOPROLOL FUMARATE ACTAVIS:
•   if you are ALLERGIC to bisoprolol fumarate or any
of the other ingredients of t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Fumarate Actavis 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet Bisoprolol fumarate Actavis 10 mg contains 8.49 mg bisoprolol equivalent to 10 mg bisoprolol fumarate.
Excipient with known effect
Each tablet contains 130.20 mg of lactose monohydrate per tablet
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Bisoprolol fumarate Actavis 10 mg tablets are mottled beige, round and convex with the following identification
markings: BI centrally above a break-line with 10 below.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be individually adjusted. It is recommended to start with the lowest possible dose. In some patients,
5 mg per day may be adequate. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per
day.
_SPECIAL POPULATIONS_
_Renal or liver impairment_
Adjustment of dose in patients with mild to moderate liver- or kidney impairment is usually not necessary. In patients
with severe renal impairment (creatinine clearance < 20 ml/min) or severe liver impairment, the dose should not exceed
10 mg once daily. This dosage may eventually be divided into halves.
_Elderly_
No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.
_Paediatric population_
Bisoprolol fumarate tablets are not recommended for use in children due to a lack of data (see section 5.3).
_Discontinuation of treatment_
Treatment should not be stopped abruptly (see section 4.4). The dosage should be diminished slowly by a weekly
halving of the dose.
Method o