Ibandronic Acid Sandoz

Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid. It is available as tablets (50 mg).

Ibandronic Acid Sandoz is a ‘generic medicine’. This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine’ already authorised in the European Union (EU). The reference medicine for Ibandronic Acid Sandoz is Bondronat.

Ibandronic Acid Sandoz is used to prevent ‘skeletal events’ (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).

The medicine can only be obtained with a prescription.

The recommended dose is one tablet taken once a day. The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.

Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed. The patient must also not lie down for one hour after taking the tablets.

The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate. It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine. Medicines are bioequivalent when they produce the same levels of the active substance in the body.

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.

The CHMP 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’s view was that, as for Bondronat, the benefit outweighs the identified risk. The Committee recommended that Ibandronic Acid Sandoz be given marketing authorisation.

A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ibandronic Acid Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.

The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011.

For more information about treatment with Ibandronic Acid Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.