Ibandronic Acid Liconsa 150 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibandronic acid

Available from:

Laboratorios LICONSA, S.A.

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:

Not marketed

Authorization date:

2010-11-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONIC ACID LICONSA
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 LICONSA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBANDRONIC ACID LICONSA
3. HOW TO TAKE IBANDRONIC ACID LICONSA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE IBANDRONIC ACID LICONSA
6. CONTENT OF THE PACK AND OTHER INFORMATION
1.
WHAT IBANDRONIC ACID LICONSA IS AND WHAT IT IS USED FOR
Ibandronic acid Liconsa belongs to a group of medicines called
BISPHOSPHONATES. It contains
the active substance ibandronic acid. Ibandronic acid Liconsa 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 Liconsa
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 LICONSA 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
-

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid Liconsa 150mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as
ibandronate sodium hydrate).
Excipients with known effect:
Each film-coated tablet contains 88.60 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White film-coated tablets of oblong shape and scored “LC” on one
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 Liconsa 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 Liconsa 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