Ibandroninezuur STADA 150 mg, filmomhulde tabletten

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Δραστική ουσία:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Διαθέσιμο από:

Stada Arzneimittel AG

Φαρμακολογική κατηγορία (ATC):

M05BA06

INN (Διεθνής Όνομα):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

Φαρμακοτεχνική μορφή:

Filmomhulde tablet

Σύνθεση:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Οδός χορήγησης:

Oraal gebruik

Θεραπευτική περιοχή:

Ibandronic Acid

Περίληψη προϊόντος:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); LACTOSE 1-WATER; MACROGOL 3350; NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Ημερομηνία της άδειας:

2010-12-31

Φύλλο οδηγιών χρήσης

1
NL PL Ibandronic acid(Tbl) NL1834 150 mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONINEZUUR STADA 150 MG, FILMOMHULDE TABLETTEN
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 Ibandroninezuur STADA 150 mg is and what it is used for
2. What you need to know before you take Ibandroninezuur STADA 150 mg
3. How to take Ibandroninezuur STADA 150 mg
4. Possible side effects
5. How to store Ibandroninezuur STADA 150 mg
6. Content of the pack and other information
1. WHAT IBANDRONINEZUUR STADA 150 MG IS AND WHAT IT IS USED FOR
Ibandroninezuur STADA 150 mg belongs to a group of medicines called
bisphosphonates. It
contains the active substance ibandronic acid. Ibandroninezuur STADA
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.
Ibandroninezuur STADA 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.
Ibandroninezuur STADA 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 i

Αρχείο Π.Χ.Π.

1
NL SmPC Ibandronic acid(Tbl) NL1834 150 mg
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur STADA 150 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
150 mg
ibandronic
acid
(as
ibandronic
acid
sodium
monohydrate).
_ _
Excipient(s) with known effect_ _
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 treatment for osteoporosis has