Olanzapine Mylan

What is Olanzapine Mylan?

Olanzapine Mylan is a medicine that contains the active substance olanzapine. It is available as white tablets (round: 2.5, 5, 7.5 and 10 mg; ovals: 15 and 20 mg).

Olanzapine Mylan is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called Zyprexa. For more information on generic medicines, see the questions and answers by clicking here.

What is Olanzapine Mylan used for?

Olanzapine Mylan is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental disorder characterized by a series of symptoms, including thought and language disorders, hallucinations, suspiciousness and fixations. Olanzapine Mylan is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.

Olanzapine Mylan 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 manic 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 Mylan used?

The recommended starting dosage of Olanzapine Mylan tablets 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 medicines, in which case the starting dose can be 10 mg a day. The dosage can be adapted to the patient's response and therapy tolerance. The usual dose varies between 5 and 20 mg a day. 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. The use of Olanzapine Mylan is not recommended in patients under 18 years of age due to the lack of data on safety and efficacy of the product for this age group.

How does Olanzapine Mylan work?

The active substance in Olanzapine Mylan, olanzapine, is an antipsychotic agent. It is known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Although its exact mechanism of action is not known, it is however related to some receptors on the surface of nerve cells in the brain . In this way the signals transmitted between the brain cells are interrupted through neurotransmitters, ie the chemical substances 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.

What studies have been performed on Olanzapine Mylan?

Because Olanzapine Mylan is a generic medicine, studies have been limited to tests to show that the drug is bioequivalent to the reference medicine (ie that the two medicines produce the same levels of the active substance in the body).

What is the risk associated with Olanzapine Mylan?

Because Olanzapine Mylan is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the drug are supposed to be the same.

Why has Olanzapine Mylan been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Olanzapine Mylan 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 Mylan.