Ibandronic acid Pinewood 150 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibandronic acid

Available from:

Pinewood Laboratories 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:

2010-12-03

Patient Information leaflet

Front
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 Pinewood is and what it is used for
2. What you need to know before you take Ibandronic acid Pinewood
3. How to take Ibandronic acid Pinewood
4. Possible side effects
5. How to store Ibandronic acid Pinewood
6. Content of the pack and other information
1. What Ibandronic acid Pinewood is and what it is used for
Ibandronic acid Pinewood belongs to a group of medicines called
bisphosphonates. It contains the
active substance ibandronic acid. Ibandronic acid Pinewood may reverse
bone loss by stopping
more loss of bone and increasing bone mass in most women who take it,
even though they will not
be able to see or feel a difference. Ibandronic acid Pinewood 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 Pinewood 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 much alcohol
• not enough walking or other weight-beari

Summary of Product characteristics

Health Products Regulatory Authority
23 October 2019
CRN009CQ3
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibandronic acid Pinewood 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:_
Contains 2,56 mg anhydrous lactose (equivalent to 2,7 mg lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round biconvex tablets.
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 Pinewood 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 Pinewood 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