What is Olanzapine Teva?
Olanzapine Teva is a medicine containing the active substance olanzapine, and is available in tablets (white and round: 2.5, 5, 7.5 and 10 mg; blue and oval: 15 mg; pink and oval: 20 mg and as orodispersible tablets round (yellow: 5 and 10; orange: 15; green 20 mg) Orodispersible tablets are tablets that dissolve in the mouth.
Olanzapine Teva is a 'generic medicine'. or a drug similar to "reference drugs", already authorized in the European Union (EU) called Zyprexa and Zyprexa Velotab. For more information on generic drugs, consult the questions and answers by clicking here.
What is Olanzapine Teva used for?
Olanzapine Teva is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental illness characterized by a number of symptoms, including thought and speech disturbances, hallucinations (seeing or hearing things that are not there), suspiciousness and delusions. Olanzapine Teva is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
The drug is also used to treat moderate to severe manic episodes (particularly high mood) in adults. It can also be used to prevent a recurrence of manic episodes (return of symptoms) in adults with bipolar disorder (a disease
characterized by the alternation of manic and depressive phases) in patients who responded to the initial treatment.
The medicine can only be obtained with a prescription.
How is Olanzapine Teva used?
The recommended starting dose of Olanzapine Teva 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 Olanzapine Teva work?
The active substance in Olanzapine Teva, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from older antipsychotic drugs available since the 1950s. While its exact mechanism of action is not known, it is nonetheless not known. connected to some receptors on the surface of nerve cells in the brain. This disrupts the signals transmitted between brain cells through neurotransmitters, which are the chemicals that allow nerve cells to communicate with each other. benefit of olanzapine is due to its ability to block the 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 Olanzapine Teva been studied?
Since Olanzapine Teva is a generic medicine, the studies have limited themselves to showing that the medicine is bioequivalent to the reference medicine (ie that the medicines produce the same levels of the active substance in the body).
What are the benefits and risks of Olanzapine Teva?
Since Olanzapine Teva is a generic medicine and is bioequivalent to the reference medicines, yes
assumes that the benefits and risks of the drug are the same.
Why has Olanzapine Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the required requirements of EU legislation, Olanzapine Teva has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. It is therefore the CHMP's view that, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the identified risks. The Committee recommended that Olanzapine Teva be given a Marketing Authorization.
Other information about Olanzapine Teva
On 12 December 2007, the European Commission granted Teva Pharma BV a "Marketing Authorization" for Olanzapine Teva valid throughout the European Union.
The full version of the EPAR for Olanzapine Teva can be found here.
Full versions of the EPAR for reference medicines can be found on the EMEA website.
Last update of this summary: 09-2008
The information on Olanzapine Teva published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
