Ibandronic Acid Clonmel 150 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibandronic acid

Available from:

Clonmel Healthcare Ltd

ATC code:

M05BA; M05BA06

INN (International Name):

Ibandronic acid

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:

2011-01-28

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONIC ACID CLONMEL 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 Clonmel 150 mg is and what it is used for
2. What you need to know before you take Ibandronic acid Clonmel 150
mg
3. How to take Ibandronic acid Clonmel 150 mg
4. Possible side effects
5. How to store Ibandronic acid Clonmel 150 mg
6. Contents of the pack and other information
1. WHAT IBANDRONIC ACID CLONMEL 150 MG IS AND WHAT IT IS USED FOR
Ibandronic acid Clonmel 150 mg belongs to a group of medicines called
BISPHOSPHONATES
. It contains the
active substance ibandronic acid. Ibandronic acid Clonmel 150 mg 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 Clonmel 150 mg 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 CLONMEL 150 MG 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

Summary of Product characteristics

Health Products Regulatory Authority
30 November 2022
CRN00D69Z
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid Clonmel 150 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic
acid sodium monohydrate).
_ _
_Excipient(s) with known effect_
Each film-coated tablet contains 162.77 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 optim