What is Zalasta?
Zalasta is a drug 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 drug, or a medicine equivalent to the reference drugs 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 series 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 therapeutic cycle. It can also be used to prevent the recurrence of manic episodes (reappearance of symptoms) in patients with bipolar disorder (a mental illness characterized by the alternation of manic and depressive phases) that have responded to initial treatment. The medicine can only be obtained with a prescription.
How is Zalasta used?
The recommended initial dosage of Zalasta 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 association with other drugs, in which case the starting dose may 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. Orodispersible tablets, which can be administered as an alternative to traditional tablets, must be placed on the tongue, where they are rapidly dispersed in the saliva, or they can be dissolved in the water before being taken. It may be necessary to reduce the starting dose by 5 mg per day in patients over 65 and in subjects 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 old antipsychotic drugs available since the 1950s. Although its exact mechanism of action is not known, it is nevertheless connected 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 carried out on Zalasta?
Since Zalasta is a generic medicine, the studies have been limited to proving that the drug is bioequivalent to the reference medicines (ie that the medicines produce the same levels and 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 drugs, the benefits and risks of the drug are supposed to be the same.
Why has Zalasta been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the 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, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the risks identified. The Committee recommended that Zalasta be given marketing authorization.
More information on ZALASTA
On 27 September 2007, the European Commission issued a marketing authorization for Zalasta, valid throughout the European Union, to KRKA, dd, Novo mesto.
The full EPAR for Zalasta can be found here.
The full EPAR versions for the reference medicines can be consulted on the site
EMEA Internet.
Last update of this summary: 09-2008.
