Ibandronic acid 150mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Ibandronic sodium monohydrate

Disponible desde:

Actavis UK Ltd

Código ATC:

M05BA06

Designación común internacional (DCI):

Ibandronic sodium monohydrate

Dosis:

150mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 06060200; GTIN: 5012617021670 5012617021687

Información para el usuario

Ibandronic Acid 150mg Tablets PIL - UK (Arrow)
item no: AAAJ1353
print proof no: 3
origination date: 30.06.16
originated by: S.Anson
revision date: 07.07.16
revised by: S.Anson
dimensions: 170 x 330
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. Code area
2.
3.
date sent: 30.06.16
supplier: Specifar S.A.
technically app. date: 06.07.16
min pt size: 8.5
TECHNICAL APPROVAL
_ 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 weight-bearing exercise
•
a family history of osteoporosis
A HEALTHY LIFESTYLE will also
help you to get the most
benefit from your treatment.
This includes eating a
balanced diet rich in calcium
and vitamin D; walking or any
other weight-bearing exercise;
not smoking; and not drinking
too much alcohol.
_ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBANDRONIC _
_ACID_
DO NOT TAKE IBANDRONIC ACID
•
If you are allergic to ibandronic acid, or to any of the other
ingredients of this me

Ficha técnica

OBJECT 1
IBANDRONIC ACID 150 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Sep-2016 | Accord-UK Ltd
1. Name of the medicinal product
Ibandronic acid 150 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg of ibandronic acid (as sodium
monohydrate).
Excipients with known effect:
Contains 108 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Ibandronic acid tablets are white, oblong, biconvex film coated
tablets, with dimensions of approximately
15.3 x 6.6mm.
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
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. Th