What is Olanzapine Glenmark?
Olanzapine Glenmark is a medicine containing the active substance olanzapine. It is available as round yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg).
Olanzapine Glenmark is a "generic medicine". This means that it is similar to a "reference drug" already authorized in the European Union (EU) called Zyprexa.
What is Olanzapine Glenmark used for?
Olanzapine Glenmark is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental disorder characterized by a series of symptoms, including disorders of thought and language, hallucinations (hearing or seeing things that do not exist), suspiciousness and fixations (false convictions). Olanzapine Glenmark is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olanzapine Glenmark is also used for the treatment of moderate to severe manic episodes (particularly euphoric mood) 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 Olanzapine Glenmark used?
The recommended initial dosage of Olanzapine Glenmark varies according to the type of disorder to be treated: 10 mg per day for schizophrenia and prevention of manic episodes, 15 mg per day for the treatment of manic episodes, 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 according to 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 initial dosage may need to be reduced to 5 mg per day in patients over 65 years of age and in patients with liver or kidney problems.
How does Olanzapine Glenmark work?
The active substance in Olanzapine Glenmark, 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 olanzapine is not known, it binds to different types of receptors 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 Olanzapine Glenmark been studied?
Since Olanzapine Glenmark is a generic medicine, the studies have been limited to providing evidence to show that the drug is bioequivalent to the reference medicine, Zyprexa. Medicines are said to be bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Olanzapine Glenmark?
Because Olanzapine Glenmark is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the drug are supposed to be the same as those of the reference medicine.
Why has Olanzapine Glenmark been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of Community legislation, Olanzapine Glenmark has been shown to have comparable quality and to be bioequivalent to Zyprexa. It is therefore the opinion of the CHMP that, as in the case of Zyprexa, the benefits outweigh the identified risks. The committee recommended the granting of a marketing authorization for Olanzapine Glenmark.
More information on Olanzapine Glenmark
On 3 December 2009, the European Commission granted a marketing authorization valid throughout the European Union to Glenmark Generics (Europe) Limited for Olanzapine Glenmark. The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR of Olanzapine Glenmark, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009.
