Olanzapine Neopharma 10 mg coated tablets

ATC Code
N05AH03
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About this drug

Admission country
Manufacturer Neopharma Ltd.
Narcotic drug No
Psychotropic No
Anatomical group Nervensystem
Therapeutic group Psycholeptika
Pharmacological group Antipsychotika
Chemical group Diazepine, oxazepine, thiazepine und oxepine
Substance Olanzapin

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All to know

Author

Neopharma Ltd.

What is it?

Olanzapine Neopharma is a medicine containing the active substance olanzapine. It is available as tablets (white and round: 2.5, 5, 7.5 and 10 mg; blue and oval: 15 mg).
Olanzapine Neopharma is a ?generic medicine?. This means that Olanzapine Neopharma is similar to a ?reference medicine? already authorised in the European Union (EU) called Zyprexa. For more information on generic medicines, see the question-and-answer document here.

What is it used for?

Olanzapine Neopharma is used to treat adults with schizophrenia. Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). Olanzapine Neopharma is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Olanzapine Neopharma is also used to treat moderate to severe manic episodes (extremely high mood) in adults. It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
The medicine can only be obtained with a prescription.

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How is it used?

The recommended starting dose of Olanzapine Neopharma depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day. The dose is adjusted depending on how well the patient responds to and tolerates the treatment. The usual dose range is between 5 and 20 mg per day. Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.

How does it work?

The active substance in Olanzapine Neopharma, olanzapine, is an antipsychotic medicine. It is known as an ?atypical? antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ?neurotransmitters?, chemicals that allow nerve cells to communicate with each other. It is thought that olanzapine?s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

How has it been studied?

Because Olanzapine Neopharma is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).

What benefits has it shown during the studies?

Because Olanzapine Neopharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

What is the risk associated?

Because Olanzapine Neopharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Neopharma has been shown to have comparable quality and to be bioequivalent to Zyprexa. Therefore, the CHMP?s view was that, as for Zyprexa, the benefit outweighs the identified risk. The Committee recommended that Olanzapine Neopharma be given marketing authorisation.

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