Ibandronic Acid 150 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ibandronate sodium monohydrate

Boleh didapati daripada:

Accord Healthcare Ireland Ltd.

Kod ATC:

M05BA; M05BA06

INN (Nama Antarabangsa):

Ibandronate sodium monohydrate

Dos:

150 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Kawasan terapeutik:

Bisphosphonates; ibandronic acid

Status kebenaran:

Marketed

Tarikh kebenaran:

2011-01-21

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONIC ACID 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 150 MG IS AND WHAT IT IS USED FOR.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBANDRONIC ACID 150 MG.
3 HOW TO TAKE IBANDRONIC ACID 150 MG.
4 POSSIBLE SIDE EFFECTS.
5 HOW TO STORE IBANDRONIC ACID 150 MG.
6 CONTENTS OF THE PACK AND OTHER INFORMATION.
1 WHAT IBANDRONIC ACID 150 MG IS AND WHAT IT IS USED FOR
Ibandronic acid 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.
IBANDRONIC ACID 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 drinking too muc

Ciri produk

Health Products Regulatory Authority
15 December 2022
CRN00D987
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid 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.
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 tr