Zalasta - olanzapine

What is Zalasta?

Zalasta is a medicine containing the active substance olanzapine, and is available in yellow and round tablets (2.5, 5, 7.5, 10, 15 and 20 mg) or in yellow and round orodispersible tablets (5, 7, 5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth. Zalasta is a generic medicine, which is a medicine equivalent to the reference medicines already authorized in the European Union (EU), called Zyprexa and Zyprexa Velotab. For more information on generic medicines, see the questions and answers by clicking here.

What is Zalasta used for?

Zalasta is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental illness characterized by a range of symptoms, including thought and speech disorders, hallucinations, suspiciousness and delusions. Zalasta is also effective in maintaining improvement in patients who have responded positively to an initial course of therapy. It can also be used to prevent manic episodes from returning (symptoms returning) in patients with bipolar disorder (a mental illness characterized by alternating manic and depressive phases) who have responded to initial treatment. The medicine can only be obtained with medical prescription.

How is Zalasta used?

The recommended starting dose of Zalasta depends on the disease being treated: for schizophrenia and the prevention of manic episodes it is 10 mg per day, for the treatment of manic episodes it is 15 mg per day, unless used in combination with other drugs, in which case the starting dose may be 10 mg per day. Dosage can be adapted to patient response and therapy tolerance. The usual dose varies between 5 and 20 mg per day. The orodispersible tablets, which can be administered as an alternative to traditional tablets, must be placed on the tongue, where they rapidly disperse in saliva, or they can be dissolved in water before being taken. It may be necessary to reduce the initial dosage by 5 mg per day. day in patients over the age of 65 and in people with liver or kidney problems.

How does Zalasta work?

The active substance in Zalasta, olanzapine, is an antipsychotic drug, known as an atypical antipsychotic, as it differs from the older antipsychotic drugs available since the 1950s. While its exact mechanism of action is not known, it is nevertheless linked. to some receptors on the surface of nerve cells in the brain. This disrupts the signals transmitted between brain cells through neurotransmitters - the chemicals that allow nerve cells to communicate with each other. Olanzapine's beneficial effect is thought to be due to its ability to block receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are implicated in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.

How has Zalasta been studied?

Since Zalasta is a generic medicine, the studies have limited themselves to showing that the medicine is bioequivalent to the reference medicines (ie that the medicines produce the same levels of active substances in the body).

What are the benefits and risks of Zalasta?

Since ZALASTA is a generic medicine and is bioequivalent to the reference medicines, the benefits and risks of the medicine are assumed to be the same.

Why has Zalasta been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the required requirements of EU legislation, Zalasta 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, like in the case of Zyprexa and Zyprexa Velotab the benefits outweigh the identified risks. The Committee recommended that Zalasta be given a marketing authorization.

Other information about ZALASTA

On 27 September 2007, the European Commission granted KRKA, d.d., Novo mesto a "marketing authorization" for Zalasta, valid throughout the European Union.
For the full version of Zalasta's EPAR click here.
The full versions of the EPAR for the reference medicines can be consulted on the website
EMEA Internet.

Last update of this summary: 09-2008.

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