Bisoprolol Viatris

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Bisoprolol fumarate 5mg

Dostupné z:

Viatris Limited

INN (Medzinárodný Name):

Bisoprolol fumarate 5 mg

Dávkovanie:

5 mg

Forma lieku:

Film coated tablet

Zloženie:

Active: Bisoprolol fumarate 5mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Stear-o-wet m or Ligamed MF BLS-MB (Magnesium stearate/Sodium Lauryl Sulphate (94/6)) Iron oxide yellow Lactose Microcrystalline cellulose Opadry Yellow 40C82321

Typ predpisu:

Prescription

Výrobca:

Unichem Laboratories Ltd

Terapeutické indikácie:

Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, PVC/Aluminium - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/Aluminium - 90 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, white HDPE 70 cc with white opaque PP CRC closure - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture

Dátum Autorizácia:

2016-07-13

Príbalový leták

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BISOPROLOL VIATRIS
_BISOPROLOL FUMARATE FILM COATED TABLETS 2.5, 5 & 10 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Bisoprolol
Viatris.
This leaflet answers some common
questions about Bisoprolol Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Bisoprolol
Viatris against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BISOPROLOL
VIATRIS IS USED FOR
Bisoprolol Viatris is used:
•
to treat stable chronic heart
failure (CHF) in combination
with other medicines
suitable for this condition.
•
In treatment of coronary
heart disease and chest
pain (angina pectoris)
caused by shortage of
oxygen in the heart muscle
•
to treat essential
hypertension (high blood
pressure)
Bisoprolol Viatris contains the active
ingredient bisoprolol fumarate. It
belongs to a group of medicines
called beta blockers.
These medicines work by affecting
the body’s response to some nerve
impulses, especially in the heart. As
a result, bisoprolol slows down the
heart rate and makes the heart
more efficient at pumping blood
around the body.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
BISOPROLOL VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE BISOPROLOL VIATRIS IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
bisoprolol fumarate
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, to

Súhrn charakteristických

Page 1 of 11
NEW ZEALAND DATA SHEET
BISOPROLOL VIATRIS
1. PRODUCT NAME
Bisoprolol Viatris, 2.5 mg, 5 mg, and 10 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 2.5 mg, 5 mg or 10 mg of bisoprolol
fumarate.
Excipient(s) with known effect: lactose.
Allergen declaration: sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Bisoprolol Viatris 2.5 mg – Grey, oval, biconvex film coated tablets
with side notches and debossed
with ‘BL & M’ on either side of the scoreline on one side and
‘2.5’ on the other side.
Bisoprolol Viatris 5 mg – Pale yellow, oval, biconvex film coated
tablets with side notches and
debossed with ‘BL & M’ on either side of the scoreline on one side
and ‘5’ on the other side.
Bisoprolol Viatris 10 mg – Pale orange to light orange, oval,
biconvex film coated tablets with side
notches and debossed with ‘BL & M’ on either side of the scoreline
on one side and ‘10’ on the other
side.
The 2.5 mg, 5 mg and 10 mg tablets can be divided into equal halves.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Treatment of stable chronic heart failure (CHF) with reduced systolic
left ventricular function in
addition to ACE inhibitors, and diuretics, and optionally cardiac
glycosides (see section 5.1).
Treatment of chronic, stable angina pectoris.
Treatment of essential hypertension.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
STABLE CHRONIC HEART FAILURE
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker in case
of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when
appropriate cardiac glycosides.
Patients should be stable (without acute failure) when bisoprolol
treatment is initiated.
Page 2 of 11
It is recommended that the treating physician should be experienced in
the management of chronic
heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may
occur during the titration
period and thereafter.
_T