Bonviva Tablet 150 mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Ibandronic acid (Ibandronate form)

Commercializzato da:

DKSH SINGAPORE PTE. LTD.

Codice ATC:

M05BA06

Dosaggio:

168.75 mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

Ibandronic acid (Ibandronate form) 168.75 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

PENN PHARMACEUTICAL SERVICES LTD

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2006-06-19

Foglio illustrativo

Umschlag-Aussenseite

®
FILM-COATED TABLET 
150 MG

PLANNING WHEN TO TAKE BONVIVA 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 1
st
 of each month)
- or the same day (such as the first Sunday of each month)
Use the peel-off stickers below to mark the dates on your calendar.
Once you've taken your tablet, put a tick in the box on the sticker.
2 
   PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR
   Monthly tablet                      Monthly tablet  
                  Monthly tablet 
It is important to keep taking Bonviva tablet 150 mg every month.
Remember to contact your doctor when you need a new prescription.
  3
4 
IN THIS   PLANNING WHEN TO TAKE BONVIVA TABLET              
               PAGE
LEAFLET:  with peel-off stickers for your personal calendar      

  2         

1. NAME OF THE MEDICINAL PRODUCT 

    6                                        

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

  6

3. PHARMACEUTICAL FORM                                

  7

4. CLINICAL PARTICULARS 

  7

5. PHARMACOLOGICAL PROPERTIES                          

38

6. PHARMACEUTICAL PARTICULARS                          
                      67
  5 
1. NAME OF THE MEDICINAL PRODUCT 
Bonviva 150 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 150 mg ibandronic acid 
(as ibandronic sodium monohydrate). 

®
FILM-COATED TABLET

150 MG

6 
_Excipients _
Each film-coated tablet contains 162.75 mg lactose monohydrate. For a
full list of 
excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
White to off white film-coated tablets,

Scheda tecnica

281
Guides
Text
free
One year data
in study BM 16549
Three year data
in study MF 4411
Bonviva
150mg 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
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
0.8
0.7
Two year cumulative
data in study BM 16549
Three year data
in study MF 4411
Bonviva
150mg 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
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
Oesophagitis
0
1.0
0.5
0.4
GENERAL DISORDERS
Influenza like illness*
0.3
3.3
0.3
0.2
Myalgia
0.3
1.5
1.8
0.8
FILM-COATED TABLET
SG 704-3722 PIL WM 04
FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT
Bonviva 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic
sodium
monohydrate)
Excipients
Each film-coated tablet contains 162.75 mg lactose monohydrate. For
full list of
excipients, see section 6.1. 3. PHARMACEUTICAL FORM
White to off white film-coated tablets, of oblong shape marked
“BNVA” on one side, and
“150” on the other side. 4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fracture (see
section 5.1). A reduction in the risk of vertebral fractures has been
demonstrated,
efficacy on femoral neck fractures