Osbonelle 150mg film-coated Tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

IBANDRONIC ACID

Dostupno od:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC koda:

M05BA06

INN (International ime):

IBANDRONIC ACID 150 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

IBANDRONIC ACID 150 mg

Tip recepta:

POM

Područje terapije:

DRUGS FOR TREATMENT OF BONE DISEASES

Status autorizacije:

Withdrawn

Datum autorizacije:

2012-11-28

Uputa o lijeku

dimensions:
pharmacode:
date sent:
TECHNICAL APPROVAL
min pt size:
[e-mail]
print proof no:
origination date:
originated by:
revision date:
supplier:
technically app. date*:
* Please note the technical approval is provided by the supplier and
is valid on the date indicated.
Any technical changes made by the supplier after approval are not the
responsibility of the Artwork Studio.
Non Printing Colours
colours/plates
revised by:
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2.
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black
1
9 pt
160x440 mm
30.01.2017
30.01.2017
KM
Synthon ES
Item No: AAAJ5941
Ibandronic acid 150 mg, Film-coated tablets, PIL, Malta
approved for print/date
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
or pharmacist.
•
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. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Osbonelle 150 mg is and what it is used for.
2. What you need to know before you take
Osbonelle 150 mg.
3. How to take Osbonelle 150 mg.
4. Possible side effects.
5. How to store Osbonelle 150 mg.
6. Contents of the pack and other information.
1 WHAT OSBONELLE 150 MG IS AND WHAT IT IS USED
FOR
Osbonelle belongs to a group of medicines
called BISPHOSPHONATES. It contains the active
substance ibandronic acid. Ibandronic acid may
reverse bone loss by stopping more loss of bone
and increasing bone mass in most women who
take it, even though they won’t be able to see or
feel a difference. Ibandronic acid may help lower
the chances of breaking bones (fractures). This
reduction in fractures was shown for the spine but
not for the hip.
OSBONELLE IS PRESCRIBED TO YOU TO TREAT
POSTMENOPAUSAL OSTEOPOROSIS BECAUSE YOU HAVE
AN INCREASED RISK OF F

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Osbonelle 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as sodium
monohydrate).
_ _
Excipients with known effect
Each film-coated tablet contains 163 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oblong, biconvex film-coated tablets, 14 mm in
length and debossed with “I9BE”
on one side and on the other side with “150”
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
has not been established.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The recommended dose is one 150 mg film-coated tablet once a month.
The tablet should preferably be
taken on the same date each month.
Ibandronic acid should be taken after an overnight fast (at least 6
hours) and 1 hour before the first food
or drink (other than water) of the day (see section 4.5) or any other
oral medicinal products or
supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one
ibandronic acid 150 mg tablet the
morning after the tablet is remembered, unless the time to the next
scheduled dose is within 7 days.
Patients should then return to taking their dose once a month on their
originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait
until their next dose and then continue
taking one tablet once a month as originally scheduled.
Patients should not take two tablets within the same week.
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Patients should receive supplemental calcium and / or vitamin D if
dietary intake is inadequate (see
section 4.4 and section 4.5).
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established