What is Olazax Disperzi?
Olazax Disperzi is a medicine containing the active substance olanzapine. It is available as yellow orodispersible circular tablets (5, 7.5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Olazax Disperzi is a "generic medicine". This means that it is similar to "reference drugs", already authorized in the European Union (EU) called Zyprexa and Zyprexa Velotab.
What is Olazax Disperzi used for?
Olazax Disperzi is used to treat adults with schizophrenia. Schizophrenia is a mental disorder characterized by a series of symptoms, including thought and speech disorders, hallucinations (seeing or hearing non-existent things), suspiciousness and fixations (false beliefs). Olazax Disperzi is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olazax Disperzi is equally used for the treatment of manic episodes (particularly euphoric mood) from moderate to severe in adults. The medicine can also be used to prevent the recurrence of such episodes (relapse) in adults with bipolar disorder (a mental disorder characterized by the alternation of euphoric phases and depressive phases) that have responded positively to the initial treatment.
The medicine can only be obtained with a prescription.
How is Olazax Disperzi used?
The recommended initial dosage of Olazax Disperzi varies according to the type of disorder being 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 may vary 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 some water before being taken. The initial dosage may need to be reduced to 5 mg daily in patients over 65 and in patients with liver or kidney problems.
How does Olazax Disperzi work?
The active substance in Olazax Disperzi, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the traditional antipsychotic drugs available since the 1950s. Although the exact mechanism of action of olanzipine is not known, it attaches itself to different types of different receptors present on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells are disturbed through the "neurotransmitters", 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 Olazax Disperzi been studied?
Because Olazax Disperzi is a generic medicine, the studies have been limited to providing evidence to establish that the drug is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab. Two medicines are said to be bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits associated with Olazax Disperzi?
Since Olazax Disperzi is a generic medicine and is bioequivalent to the reference drugs, the benefits and risks of the drug are supposed to be the same as the reference medicines.
Why has Olazax Disperzi been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of Community legislation, Olazax Disperzi 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 therefore recommended that Olazax Disperzi be given marketing authorization.
More information on Olazax Disperzi
On 10 December 2009 the European Commission issued to Glenmark Pharmaceuticals sro. a marketing authorization for Olazax Disperzi, valid throughout the European Union. The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR of Olazax Disperzi, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009
