Ibandronic acid 50mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Ibandronic sodium monohydrate

Доступна с:

Actavis UK Ltd

код АТС:

M05BA06

ИНН (Международная Имя):

Ibandronic sodium monohydrate

дозировка:

50mg

Фармацевтическая форма:

Tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 06060200; GTIN: 5012617021694

тонкая брошюра

AAAJ1387
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Ibandronic Acid 50mg PIL UK
item no:
print proof no:
origination date:
originated by:
revision date: 11.07.16
revised by: MB
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent:
4/7/16
supplier:
technically app. date:
11.07.16
min pt size:
TECHNICAL APPROVAL
AAAJ1387
4
4/7/16
MB
IL/Synthon ES
160 x 330
8.4pt
_Continued over page_
IBANDRONIC ACID 50MG
FILM-COATED TABLETS
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
symptoms 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.
•
The full name of this medicine is Ibandronic Acid 50mg
Film-coated Tablets but within the leaflet it will be referred
to as Ibandronic acid tablets.
WHAT IS IN THIS LEAFLET:
1 WHAT IBANDRONIC ACID TABLETS ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
3 HOW TO TAKE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT IBANDRONIC ACID TABLETS ARE AND WHAT THEY
ARE USED FOR
Ibandronic acid tablets contain the active substance ibandronic
acid. This belongs to a group of medicines called bisphosphonates.
Ibandronic acid tablets are indicated in adults and prescribed to
you if you have breast cancer that has spread to your bones (called
bone “metastases”).
It helps to prevent your bones from breaking (fractures).
It also helps to prevent other bone problems that may need
surgery or radiotherapy.
Ibandronic acid tablets work by reducing the amount of calcium
that is lost from your bones. This helps to stop your bones from
getting weaker.
2

Характеристики продукта

OBJECT 1
IBANDRONIC ACID ACTAVIS 50MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 24-Aug-2016 | Accord-UK Ltd
1. Name of the medicinal product
Ibandronic Acid Actavis 50mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg of ibandronic acid (as
ibandronic sodium monohydrate).
_Excipients with known effect:_
Each film-coated tablet contains 54 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, 9 mm in
length and debossed with “I9BE“ on
one side and on the other side with “50“.
4. Clinical particulars
4.1 Therapeutic indications
Ibandronic acid is indicated in adults for the prevention of skeletal
events (pathological fractures, bone
complications requiring radiotherapy or surgery) in patients with
breast cancer and bone metastases.
4.2 Posology and method of administration
Ibandronic acid therapy should only be initiated by physicians
experienced in the treatment of cancer.
Posology
The recommended dose is one 50 mg film-coated tablet daily.
_Special populations_
_Patients with hepatic impairment_
No dosage adjustment is required (see section 5.2 ).
_Patients with renal impairment_
No dosage adjustment is necessary for patients with mild renal
impairment (CLcr ≥50 and<80 mL/min).
For patients with moderate renal impairment (CLcr ≥30 and <50
mL/min) a dosage adjustment to one 50
mg film-coated tablet every second day is recommended (see section
5.2).
For patients with severe renal impairment (CLcr <30 mL/min) the
recommended dose is one 50 mg film-
coated tablet once weekly. See dosing instructions, above.
_Elderly population (>65 years)_
No dose adjustment is necessary (see section 5.2).
_Paediatric population_
The safety and efficacy of ibandronic acid in children and adolescents
below the age of 18 years have not
been established. No data are available. .(see section 5.1 and 5.2)
Method of administration
For ora