Bonviva Film-Coated Tablets 150mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Ibandronate Sodium Monohydrate

Boleh didapati daripada:

DKSH MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Ibandronate Sodium Monohydrate

Unit dalam pakej:

1 Tablets

Dikeluarkan oleh:

PENN PHARMACEUTICAL SERVICES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BONVIVA
® FILM-COATED TABLETS
Ibandronic Acid (150mg)
__________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.
What Bonviva is used for
2.
How Bonviva works
3.
Before you use Bonviva
4.
How to use Bonviva
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Bonviva
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT BONVIVA IS USED FOR
BONVIVA
is a prescription
medicine used to treat
osteoporosis in women after
menopause. Bonviva helps
reduce the chance of having
fracture (break).
HOW BONVIVA WORKS BONVIVA
contains the active ingredient
ibandronic acid. Bonviva
belongs to a group of medicines
called bisphosphonates.
Bonviva reduces bone loss,
with no direct effect on bone
formation and increases bone
mass.
BEFORE YOU USE BONVIVA
-
_When you must not use it,_
_ _
You should not take Bonviva if
you:
•
Are allergic to ibandronic
acid or any of the other
ingredients of this
medicine. (see section
PRODUCT DESCRIPTION).
•
Are pregnant or
breastfeeding.
•
Cannot stand or sit
upright for at least 60
minutes.
•
Have certain problem
with your esophagus.
•
Have low levels of
calcium in your blood.
•
Less than 18 years old.
-
_Before you start to use it _
Before you take Bonviva, tells
your doctor if you:
•
Have problems with
swallowing
•
Have stomach or
digestive problems.
•
Have disturbances of bone
and mineral metabolism.
•
Plan to have dental
surgery or teeth removed.
•
Have severe kidney
problems where creatinine
clearance is <30 mL/min.
•
Plan to become pregnant
or breast-feeding.
•
Have cancer
•
Have other concomitant
therapies, e.g.,
chemotherapy,
radiotherapy,
corticosteroid
•
Have other diseases e.g.,
low red blood cell count
or hemoglobin, impaired
blood clotting, infection,
pre-existing dental
disease.
-
_Taking other medicines _
Tell your doctor if you are
taking any other medicines,
including prescription and
no

Ciri produk

TEXT FREE AREA
TEXT FREE AREA
TEXT FREE AREA
TEXT FREE AREA
MY 735-7197 APIL WM 02
Monthly tablet
Monthly tablet
Monthly tablet
One year data
in study BM 16549
Three year data
in study MF 4411
Bonviva
150 mg
once
monthly
(N=396)
(%)
Bonviva
2.5 mg
daily
(N=395)
(%)
Bonviva
2.5 mg
daily
(N=977)
(%)
Placebo
(N=975)
(%)
System Organ Class/
Adverse drug
reaction
GASTROINTESTINAL SYSTEM
Gastro-oesophageal
reflux disease
Diarrhoea
Abdominal pain
Dyspepsia
Nausea
Flatulence
NERVOUS SYSTEM
Headache
GENERAL DISORDERS
Influenza like illness*
Fatigue
Arthralgia
MUSCULOSKELETAL SYSTEM
Myalgia
Rash
SKIN DISORDERS
0.5
1.0
0.4
0.1
2.5
1.8
1.4
1.0
3.5
2.8
2.1
2.9
3.3
3.3
3.5
5.8
4.3
2.9
1.8
2.3
0.5
1.0
0.4
0.7
0.8
0.8
1.5
0.6
0.3
3.3
0.3
0.2
0.3
0.3
1.0
0.4
1.0
1.0
1.2
0.3
0.4
0.4
0.3
1.5
1.8
0.8
0.8
0.7
Two year cumulative
data in study BM 16549
Three year data
in study MF 4411
Bonviva
150 mg
once
monthly
(N=396)
(%)
Bonviva
2.5 mg
daily
(N=395)
(%)
Bonviva
2.5 mg
daily
(N=977)
(%)
Placebo
(N=975)
(%)
System Organ Class/
Adverse drug
reaction
GASTROINTESTINAL SYSTEM
Gastro-oesophageal
reflux disease
Diarrhoea
Abdominal pain
Dyspepsia
Nausea
Gastritis
NERVOUS SYSTEM
Headache
GENERAL DISORDERS
Influenza like illness*
Muscle cramp
Arthralgia
MUSCULOSKELETAL SYSTEM
Myalgia
Rash
SKIN DISORDERS
4.0
6.3
4.0
2.7
3.0
3.5
1.8
2.3
4.0
3.0
2.1
2.9
2.5
1.0
0.3
2.0
1.4
1.0
0.7
0.5
0.8
1.0
0.5
0.1
0.8
0.8
1.5
0.6
0.3
3.3
0.3
0.2
0.3
1.8
1.5
0.8
1.0
1.0
1.2
0.5
0.4
0.4
1.0
0.5
0.1
0.4
0.8
0.7
Oesophagitis
0
1.0
0.5
0.4
Musculoskeletal
pain
Musculoskeletal
stiffness
1.0
0
0
0
1.0
0.5
0
0
In this leaflet:
PLANNING WHEN TO TAKE LBANDRONIC ACID TABLET
with peel-off stickers for your personal calendar
1. DESCRIPTION
2. CLINICAL PARTICULARS
3. PHARMACOLOGICAL PROPERTIES AND EFFECTS
4. PHARMACEUTICAL PARTICULARS
PLANNING WHEN TO TAKE IBANDRONIC ACID TABLET
The dose of Bonviva 150 mg is one tablet once a month. Choose one day
of
the month that will be easy to remember:
- either the same date (such as the 1st of each
month)
- or the same day (such as t