Sedropor 150mg film-coated tablets

Country: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

ibandronic acid (ibandronic acid sodium monohydrate)

Disponibbli minn:

Pharmathen S.A.

INN (Isem Internazzjonali):

ibandronic acid (ibandronic acid sodium monohydrate)

Dożaġġ:

150mg

Għamla farmaċewtika:

tablets film-coated

Tip ta 'preskrizzjoni:

Prescription

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEDROPOR 150 MG FILM-COATED TABLETS
Ibandronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• 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. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor.
IN THIS LEAFLET:
1. What Sedropor is and what it is used for
2. Before you take Sedropor
3. How to take Sedropor
4. Possible side effects
5. How to store Sedropor
6. Further information
1. WHAT SEDROPOR IS AND WHAT IT IS USED FOR
Sedropor belongs to a group of medicines called bisphos-
phonates (used in the treatment of osteoporosis). It
contains ibandronic acid. It does not contain hormones.
Sedropor 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. Sedropor may help lower the chances of
breaking bones (fractures). This reduction in fractures was
shown for the spine but not for the hip.
SEDROPOR IS PRESCRIBED TO YOU TO TREAT 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
Many people with osteoporosis have no symptoms. If you
have no symptoms you may not know if you have the

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
SEDROPOR 150 MG FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Sedropor 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as
ibandronate sodium
monohydrate).
_Excipients: _
Each film-coated tablet contains a small amount of lactose monohydrate
in the film-
coating of the tablet. For a 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.
Sedropor 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
Sedropor 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).
_Special populations _
_ _
_Patients with renal impairment_
No
dosage
adjustment
is
necessary
for
patients
with
mild
or
moderate
renal
impairment where creatinine clearance