What is Olanzapine Apotex?
Olanzapine Apotex is a medicine containing the active substance olanzapine. It is available as round white film-coated tablets (2.5, 5, 7.5, and 10 mg) and yellow orodispersible tablets (5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Olanzapine Apotex is a "generic medicine". This means that Olanzapine Apotex is similar to "reference drugs" already authorized in the European Union (EU) called Zyprexa and Zyprexa Velotab.
What is Olanzapine Apotex used for?
Olanzapine Apotex is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental illness characterized by a series of symptoms, including disorganization of thought and language, hallucinations, suspiciousness and delusions (false beliefs). Olanzapine Apotex is also effective in maintaining clinical improvement in patients who have responded to initial treatment.
Olanzapine Apotex is also used for the treatment of manic episodes (particularly euphoric mood) from moderate to severe in adults. It can also be used to prevent the recurrence of such episodes (relapse) in adults with bipolar disorder (a mental illness characterized by the alternation of euphoric phases and depressive phases) that have responded to the initial treatment.
The medicine can only be obtained with a prescription.
How is Olanzapine Apotex used?
The recommended initial dosage of Olanzapine Apotex depends on the disease to be treated: for schizophrenia and the prevention of manic episodes it is 10 mg a day, for the treatment of manic episodes it is 15 mg a day, unless it is used in combination with other drugs, in which case the starting dose may be 10 mg a day. The dosage should be adjusted depending on the patient's response and the degree of tolerance of the therapy. The usual dose varies between 5 and 20 mg a day. The orodispersible tablets must be placed on the tongue, where they are dispersed in the saliva, or they can be dissolved in the water before being taken. The initial dosage may need to be reduced to 5 mg per day in patients over 65 and in patients with liver or kidney problems.
How does Olanzapine Apotex work?
The active substance in Olanzapine Apotex, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Although not exactly known, its mechanism of action is to bind to some different receptors on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells by "neurotransmitters" are interrupted, ie the chemicals that allow nerve cells to communicate with each other. It is believed that the beneficial effect of olanzapine is due to its ability to block receptors for neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Because these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.
How has Olanzapine Apotex been studied?
Because Olanzapine Apotex is a generic medicine, studies in patients have been limited to tests designed to demonstrate its bioequivalence 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 Olanzapine Apotex?
Since Olanzapine Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks of the drug are supposed to be the same as the latter.
Why has Olanzapine Apotex been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Olanzapine Apotex has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. It is therefore the opinion of the CHMP that, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the risks identified. The Committee recommended the granting of a marketing authorization for Olanzapine Apotex.
More information on Olanzapine Apotex
On 10 June 2010, the European Commission issued a marketing authorization valid throughout the European Union to Apotex Europe BV for Olanzapine Apotex. The marketing authorization is valid for five years, after which it can be renewed.
For the full EPAR for Olanzapine Apotex click here. For more information about treatment with Olanzapine Apotex, 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: 04-2010.
