Sedropor tablets film-coated

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.

Kodiċi ATC:

M05BA06

INN (Isem Internazzjonali):

ibandronic acid (ibandronic acid sodium monohydrate)

Dożaġġ:

150mg

Għamla farmaċewtika:

tablets film-coated

Unitajiet fil-pakkett:

(1) in blister

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2019-01-18

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 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 Sedropor is and what it is used for
2. What you need to know before you take Sedropor
3. How to take Sedropor
4. Possible side effects
5. How to store Sedropor
6. Content of the pack and other information
1. WHAT SEDROPOR IS AND WHAT IT IS USED FOR
Sedropor belongs to a group of medicines called
bisphosphonates. It contains the active substance
ibandronic acid. 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
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 HEALTH

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 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.
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).
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 potenti