Ibandronic Acid Mylan 150 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibandronic sodium monohydrate

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

M05BA; M05BA06

INN (International Name):

Ibandronic sodium monohydrate

Dosage:

150 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bisphosphonates; ibandronic acid

Authorization status:

Marketed

Authorization date:

2010-07-02

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONIC ACID MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Ibandronic Acid Mylan
3.
How to take Ibandronic Acid Mylan
4.
Possible side effects
5.
How to store Ibandronic Acid Mylan
6.
Contents of the pack and other information
1.
WHAT IBANDRONIC ACID MYLAN IS AND WHAT IT IS USED FOR
Ibandronic Acid Mylan belongs to a group of medicines called
BISPHOSPHONATES
. It contains the active
substance ibandronic acid. Ibandronic Acid Mylan 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 Mylan 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 MYLAN 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 vitamin D in the diet
•
smoking, or

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2023
CRN00DCVL
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid Mylan 150 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as sodium
monohydrate)
Excipient with known effect:
Contains 171.78 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White film-coated tablet, capsule-shaped, biconvex tablets, with
“G” over “I-150” imprinted in black ink on one side and plain
on the other.
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 Mylan 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 Mylan 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