Ibandronic acid 150mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Ibandronic sodium monohydrate

Prieinama:

Mylan

ATC kodas:

M05BA06

INN (Tarptautinis Pavadinimas):

Ibandronic sodium monohydrate

Dozė:

150mg

Vaisto forma:

Tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06060200; GTIN: 5016695003634 5016695003641

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONIC ACID 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 is and what it is used for
2.
What you need to know before you take Ibandronic Acid
3.
How to take Ibandronic Acid
4.
Possible side effects
5.
How to store Ibandronic Acid
6.
Contents of the pack and other information
1.
WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR
Ibandronic Acid belongs to a group of medicines called
BISPHOSPHONATES
. It contains the active
substance ibandronic acid.
Ibandronic Acid 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
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 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 weig

Prekės savybės

OBJECT 1
IBANDRONIC ACID MYLAN 150 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 31-May-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Ibandronic Acid Mylan 150 mg Film- coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg ibandronic acid (as sodium
monohydrate).
Excipient with known effect:
Contains 171.78 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White film-coated, capsule-shaped, biconvex tablets, with “G” over
“I-150” imprinted in black ink on one
side and plain on other.
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 Mylan 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 Mylan 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 bisp