What is Ibandronic Acid Sandoz?
Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid. It is available in the form of white tablets (50 mg).
Ibandronic Acid Sandoz is a 'generic medicine', which means that it is similar to a 'reference medicine' already authorized in the European Union (EU). The reference medicine for Ibandronic Acid Sandoz is Bondronat.
What is Ibandronic Acid Sandoz used for?
Ibandronic Acid Sandoz is used to prevent 'skeletal events' (bone fractures or complications that require treatment) in patients with breast cancer and bone metastases (spread of cancer to the bone).
The medicine can only be obtained with a prescription.
How is Ibandronic Acid Sandoz used?
The recommended dose is one tablet once a day. The tablets should always be taken after an overnight fast of at least six hours and at least 30 minutes after the first intake of food or drink of the day.
Ibandronic Acid Sandoz should be taken with a full glass of still (but not mineral) water in an upright or sitting position; the tablets should not be chewed, sucked or crushed. Also, patients should not lie down for the hour after taking the tablets.
How does Ibandronic Acid Sandoz work?
The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate. It works by blocking the action of osteoclasts, the body's cells responsible for breaking down bone tissue, and thus reducing bone loss. This reduction contributes to make bones less prone to breakage, with an advantage in terms of fracture prevention in cancer patients with bone metastases.
How has Ibandronic Acid Sandoz been studied?
As Ibandronic Acid Sandoz is a generic medicine, the patient studies have been limited to tests to show that the medicine is bioequivalent to the reference medicine. Medicinal bioequivalents are defined as producing the same levels of active ingredient in the body.
What are the benefits and risks associated with Ibandronic Acid Sandoz?
Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Ibandronic Acid Sandoz been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP considered that, as in the case of Bondronat, the benefits outweigh the identified risks. The Committee recommended the granting of a marketing authorization for Ibandronic Acid Sandoz.
More information about Ibandronic Acid Sandoz
On 26 July 2011, the European Commission granted SANDOZ PHARMACEUTICALS GMBH a "marketing authorization" for Ibandronic Acid Sandoz, valid throughout the EU. The "marketing authorization" is valid for five years, after which can be renewed.
For more information on Ibandronic Acid Sandoz therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 03-2011.
The information on Ibandronic Acid Sandoz published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
