Ibandronic Acid Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ibandronic acid

Available from:

Teva Pharma B.V.

ATC code:

M05BA06

INN (International Name):

ibandronic acid

Therapeutic group:

Drugs for treatment of bone diseases

Therapeutic area:

Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal

Therapeutic indications:

Ibandronic acid 50mgIbandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.Ibandronic acid 150mgTreatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Product summary:

Revision: 12

Authorization status:

Authorised

Authorization date:

2010-09-17

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONIC ACID TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Ibandronic Acid Teva
3.
How to take Ibandronic Acid Teva
4.
Possible side effects
5.
How to store Ibandronic Acid Teva
6.
Contents of the pack and other information
1.
WHAT IBANDRONIC ACID TEVA IS AND WHAT IT IS USED FOR
Ibandronic Acid Teva contains the active substance ibandronic acid.
This belongs to a group of
medicines called bisphosphonates.
Ibandronic Acid Teva 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 Teva 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 TEVA
DO NOT TAKE IBANDRONIC ACID TEVA
•
if you are allergic to ibandronic acid or any of the other ingredients
of this medicine (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 ever had low calcium in your blood.
Do

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ibandronic Acid Teva 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg ibandronic acid (as sodium
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex, capsule-shaped film-coated tablets, engraved “50”
on one side and plain on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ibandronic Acid Teva 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 Teva 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 population (> 65 years) _
No dose adjustment is necessary (see section 5.2).
_Paediatric population _
The safety and efficacy of Ibandronic Acid Teva in children and
adolescents below the age of 18 years
have not been established. No data are available. (see sections 5.1
and 5.2).
Method of administration
3
For oral use.
Ibandronic Acid Teva 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 to t