Ibandronic Acid Aurobindo 150mg film-coated Tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

IBANDRONIC ACID

MAH:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC_code:

M05BA06

INN:

IBANDRONIC ACID 150 mg

pharmaceutical_form:

FILM-COATED TABLET

composition:

IBANDRONIC ACID 150 mg

prescription_type:

POM

therapeutic_area:

DRUGS FOR TREATMENT OF BONE DISEASES

authorization_status:

Authorised

authorization_date:

2014-01-31

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONIC ACID AUROBINDO 150 MG FILM-COATED TABLETS
ibandronic acid
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 only. 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 Ibandronic Acid Aurobindo is and what it is used for
2.
What you need to know before you take Ibandronic Acid Aurobindo
3.
How to take Ibandronic Acid Aurobindo
4.
Possible side effects
5.
How to store Ibandronic Acid Aurobindo
6.
Contents of the pack and other information
1.
WHAT IBANDRONIC ACID AUROBINDO IS AND WHAT IT IS USED FOR
Ibandronic Acid Aurobindo belongs to a group of medicines called
bisphosphonates. It contains the
active substance ibandronic acid. Ibandronic Acid Aurobindo 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 Aurobindo may help lower the
chances of breaking bones
(fractures). This reduction in fractures was shown for the spine but
not for the hip.
IBANDRONIC ACID AUROBINDO IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL
OSTEOPOROSIS BECAUSE
YOU HAVE AN INCREASED RISK OF FRACTURES.
Osteoporosis is a thinning and weakening of the bones,
which is common in women after the menopause. At the menopause, a
woman’s ovaries stop
producing the female hormone, oestrogen, which helps to keep her
skeleton healthy.
The earlier a woman reaches the menopause, the greater her risk of
fractures in osteoporosis.
Other things that can increase the risk of fractures include:
-
not enough calcium and vita

SPC

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid Aurobindo 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of ibandronic acid (as sodium
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated, caplet shaped, biconvex tablets
debossed with ‘X’ on one side and
‘78’ 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 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 Aurobindo 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 Aurobindo 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.
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. The need
for continued treatment should be re-evaluated periodically based on
the benef