Kefort 150mg Film-Coated Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Ibandronic acid

Mevcut itibaren:

Laboratorios LICONSA, S.A.

ATC kodu:

M05BA; M05BA06

INN (International Adı):

Ibandronic acid

Doz:

150 milligram(s)

Farmasötik formu:

Film-coated tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Bisphosphonates; ibandronic acid

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2010-11-12

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
KEFORT
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 KEFORT IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KEFORT
3. HOW TO TAKE KEFORT
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE KEFORT
6. CONTENT OF THE PACK AND OTHER INFORMATION
1.
WHAT KEFORT IS AND WHAT IT IS USED FOR
Kefort belongs to a group of medicines called BISPHOSPHONATES. It
contains the active substance
ibandronic acid. Kefort 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. Kefort may help lower the chances of breaking bones
(fractures). This reduction in
fractures was shown for the spine but not for the hip.
KEFORT 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-bearing exercise
-
a family history of osteoporosis
A HEALTHY LIFESTYLE will also help you to get

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kefort 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.
Kefort 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
Kefort 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 based on the benefits and
potential
risks of Kefort