What is Ibandronic Acid Teva?
Ibandronic Acid Teva is a medicine that contains the active substance ibandronic acid. It is available as white, capsule-shaped tablets (50 and 150 mg).
Ibandronic Acid Teva is a "generic medicine". This means that Ibandronic Acid Teva is similar to a 'reference medicine' already authorized in the European Union (EU). The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
What is Ibandronic Acid Teva used for?
Ibandronic Acid Teva 50 mg is used to prevent "skeletal events" (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (spread of bone cancer).
Ibandronic Acid Teva 150 mg is used to treat osteoporosis (a disease that makes bones fragile) in post-menopausal women who are at risk of bone fractures. Although the efficacy of the medicine in reducing the risk of fractures of the spine has been demonstrated by some studies, its effectiveness remains to be established with regard to the risk of fractures of the neck of the femur (upper part of the femur).
The medicine can only be obtained with a prescription.
How is Ibandronic Acid Teva used?
For the prevention of skeletal events, one tablet of 50 mg should be taken once a day. The tablets should always be taken after an overnight fast of at least six hours and at least 30 minutes before the first intake of food or drink of the day.
For the treatment of osteoporosis, one 150 mg tablet should be taken orally (by mouth). The tablet should always be taken after an overnight fast, one hour before taking any type of food or drink, with the exception of water. Patients must also take vitamin D and calcium supplements if the diet does not ensure sufficient intake of these substances.
Ibandronic Acid Teva should be taken with a full glass of still water (but not mineral water) in an upright or sitting position and the tablets should not be chewed, sucked or crushed. The patient should not lie down in the hour after taking the tablets.
How does Ibandronic Acid Teva work?
The active substance in Ibandronic Acid Teva, ibandronic acid, is a bisphosphonate. It blocks the action of osteoclasts, the body's cells responsible for breaking down bone tissue, thereby reducing bone loss. Reduced bone loss helps make bones less prone to breakage, with an advantage in terms of preventing fractures in cancer patients with bone metastases and women with osteoporosis.
How has Ibandronic Acid Teva been studied?
Because Ibandronic Acid Teva is a generic medicine, studies in patients have been limited to tests to show that the drug is bioequivalent to the reference medicines. Medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Ibandronic Acid Teva?
Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are considered to be similar to those of the reference medicines.
Why has Ibandronic Acid Teva been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Ibandronic Acid Teva has been shown to have comparable quality and to be bioequivalent to Bondronat and Bonviva. Therefore, the CHMP considered that, as in the case of Bondronat and Bonviva, the benefits outweighed the identified risks. The committee recommended the granting of the marketing authorization for Ibandronic Acid Teva.
More information on Ibandronic Acid Teva
On 17 September 2010, the European Commission issued a marketing authorization for Ibandronic Acid Teva, valid throughout the European Union, to Teva Pharma BV. The marketing authorization is valid for five years, after which it can be renewed.
For the full EPAR version of Ibandronic Acid Teva, see the Agency's website. For more information about treatment with Ibandronic Acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 07-2010.
