Ibandronic Acid Sandoz

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ibandronic acid

Available from:

Sandoz GmbH

ATC code:

M05BA06

INN (International Name):

ibandronic acid

Therapeutic group:

Drugs for treatment of bone diseases, Bisphosphonates

Therapeutic area:

Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone

Therapeutic indications:

Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.,

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2011-07-26

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONIC ACID SANDOZ 50 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 Sandoz is and what it is used for
2.
What you need to know before you take Ibandronic acid Sandoz
3.
How to take Ibandronic acid Sandoz
4.
Possible side effects
5.
How to store Ibandronic acid Sandoz
6.
Contents of the pack and other information
1.
WHAT IBANDRONIC ACID SANDOZ IS AND WHAT IT IS USED FOR
Ibandronic acid Sandoz contains the active substance ibandronic acid.
This belongs to a group of
medicines called bisphosphonates.
Ibandronic acid Sandoz tablets is used 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 Sandoz works by reducing the amount of calcium that is
lost from your bones. This
helps to stop your bones from getting weaker.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBANDRONIC ACID SANDOZ
DO NOT TAKE IBANDRONIC ACID SANDOZ
•
if you are allergic to ibandronic acid or any of the other ingredients
of this medicine that are
listed in section 6
•
if you have problems with your food pipe/gullet (oesophagus) such as
narrowing or difficulty
swallowing
•
if you cannot stand or sit upright for at least one hour (60 minutes)
at a time
•
if you have or ev

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ibandronic acid Sandoz 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of ibandronic acid (as
ibandronate sodium monohydrate).
Excipient with known effect
Each film-coated tablet contains 0.86 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White round biconvex tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ibandronic acid Sandoz 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 Sandoz 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_
_Hepatic impairment_
No dose adjustment is required (see section 5.2).
_Renal impairment _
No dose 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 _
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).
3
Method of administration
For oral use.
Ibandronic acid Sandoz tablets should be taken after an overnight fast
(at least 6 hours) and before the
first food or drink of the day. Medicinal products and supplements
(including calcium) should
similarly be avoided prior t