Binosto 70mg effervescent tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

alendronic acid

Available from:

Internis Pharmaceuticals Ltd

ATC code:

M05BA04

INN (International Name):

alendronic acid

Dosage:

70mg

Pharmaceutical form:

Effervescent Tablet

Administration route:

Oral use

Units in package:

Packs with 4, 12 or 24 effervescent tablets.

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Temmler Pharma GmbH & Co. KG

Therapeutic group:

Drugs affecting bone structure and mineralisation, bisphosphonates

Therapeutic indications:

Treatment of postmenopausal osteoporosis. Binosto 70 mg reduces the risk of vertebral and hip fractures.

Authorization status:

Authorised

Authorization date:

2015-09-16

Patient Information leaflet

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SUBMISSION REQUIRED
Yes
C
niallmcateer-lee
587379
12126
New product introduction
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Leaflet
4's
25408601
195 x 396mm
3
30.07.2015
Process Black
Keyline (Does not print)
Binosto 70mg Effervescent Tablets 
Internis
Arial
Helvetica Neue LT Std
P
C
P
 H
EAD
ER
 B
O
X 
APP
RO
VE
D B
Y   

  D
ATE

O
P
ER
ATOR

A
RT
W
O
RK
 N
O 

C
R
N

FI
X

R
EA
SO
N
 F
SU
F
O
R 
C
HA
N
G
E 

ISSU
ED 
B
Y 

D
ATE

M
H
R
A/IMB
SUBMISSION REQUIRED
Yes
C
niallmcateer-lee
587379
12126
New product introduction
M
H
R
A
 H
EA
D
ER
 B
O
X  
P
RO
D
UCT

 T
IT
LE 
C
FONTS USED
O
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U
RS
 U
SE
D 
C
OMP
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N
ENT

P
AC
K 
SI
ZE

IG
 CODE
D
IM
ENS
IO
N
S 
P
RO
O
F N
O.

D
AT
E 
Leaflet
4's
25408601
195 x 396mm
3
30.07.2015
Process Black
Keyline (Does not print)
Binosto 70mg Effervescent Tablets 
Internis
Arial
Helvetica Neue LT Std
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS  
MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR 
YOU, EVEN IF THIS IS A REPEAT PRESCRIPTION.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor or pharma-
cist or nurse.
•  This medicine has been prescribed for you. 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, or
pharmacist 
or nurse. This includes any possible si

Summary of Product characteristics

Binosto 70 mg effervescent tablets
Summary of Product Characteristics Updated 16­Sep­2015 | Internis Pharmaceuticals Ltd
1. Name of the medicinal product
Binosto 70 mg effervescent tablets
2. Qualitative and quantitative composition
Each effervescent tablet contains 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate.
Excipients: each effervescent tablet contains 602.54 mg of sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Effervescent Tablet
White to off­white round effervescent tablets of 25 mm diameter, flat faced with bevelled edges. After dissolution the
solution has a pH of 4.8 – 5.4
4. Clinical particulars
4.1 Therapeutic indications
Treatment of postmenopausal osteoporosis. Binosto 70 mg reduces the risk of vertebral and hip fractures.
4.2 Posology and method of administration
Posology
The recommended dose is one 70 mg effervescent tablet once weekly.
Patients should be instructed that if they miss a dose of Binosto 70 mg, they should take one effervescent tablet on the
morning after they remember.
They should not take two effervescent tablets on the same day but should return to taking one effervescent tablet once
a week, as originally scheduled on their chosen day.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued
treatment should be re­evaluated periodically based on the benefits and potential risks of Binosto on an individual
patient basis, particularly after 5 or more years of use.
_Use in the elderly:_
In clinical studies there was no age related difference in the efficacy or safety profiles of alendronate. Therefore no
dosage adjustment is necessary for the elderly.
_Use in renal impairment:_
No dosage adjustment is necessary for patients with�