Olanzapine Apotex - olanzapine

What is Olanzapine Apotex?

Olanzapine Apotex is a medicine that contains the active substance olanzapine. It is available as white round film-coated tablets (2.5, 5, 7.5, and 10 mg) and yellow orodispersible tablets (5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Olanzapine Apotex is a 'generic medicine'. This means that Olanzapine Apotex is similar to 'reference medicines' already authorized in the European Union (EU) called Zyprexa and Zyprexa Velotab.

What is Olanzapine Apotex used for?

Olanzapine Apotex is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental illness characterized by a number of symptoms, including disorganization of thought and language, hallucinations, suspiciousness and delusions (false beliefs). Olanzapine Apotex is also effective in maintaining clinical improvement in patients who have responded to initial treatment.
Olanzapine Apotex is also used to treat moderate to severe manic episodes (extremely high mood) in adults. It can also be used to prevent such episodes from coming back (relapse) in adults with bipolar disorder (a mental illness characterized by alternating euphoric and depressive phases) who have responded to initial treatment.
The medicine can only be obtained with a prescription.

How is Olanzapine Apotex used?

The recommended starting dosage of Olanzapine Apotex 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. The dosage should be adjusted according to the patient's response and his degree of tolerance of the therapy. The usual dose varies between 5 and 20 mg per day. The orodispersible tablets should be placed on the tongue, where they disperse in saliva, or they can be dissolved in water before taking. The starting 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 Apotex work?

The active ingredient in Olanzapine Apotex, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Although not exactly known, its mechanism of action consists of the bind to a few different receptors on the surface of nerve cells in the brain.This disrupts the signals transmitted between brain cells by "neurotransmitters" - the chemicals that allow nerve cells to communicate with each other. The beneficial effect of olanzapine is thought to be 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 normalization of " brain activity, reducing the symptoms of such diseases.

How has Olanzapine Apotex been studied?

As Olanzapine Apotex is a generic medicine, the patient studies have been limited to trials to demonstrate its bioequivalence to the reference medicines. Medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Olanzapine Apotex?

Since Olanzapine Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks of the medicine are assumed to be the same as those of the latter.

Why has Olanzapine Apotex been approved?

The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Olanzapine Apotex 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 identified risks. The Committee recommended that Olanzapine Apotex be given marketing authorization.

Other information about Olanzapine Apotex

On 10 June 2010, the European Commission issued Apotex Europe B.V. a "Marketing Authorization" for Olanzapine Apotex, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.

For the full version of the EPAR for Olanzapine Apotex click here. For more information about Olanzapine Apotex therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 04-2010.

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