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CLZ-2022-0103 May 2023

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Clozaril is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics.

Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration.

Clozaril is also indicated in psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed.

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Reporting of adverse reactions:

UK: Please continue to report suspected side effects to the MHRA through the Yellow Card Scheme. Please report all suspected side effects that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason. It is easiest and quickest to report side effects online via the Yellow Card website – https://yellowcard.mhra.gov.uk/ or via the Yellow Card app available from the Apple App Store or Google Play Store. Alternatively, prepaid Yellow Cards for reporting are available by writing to FREEPOST YELLOW CARD (no other address details necessary); by emailing yellowcard@mhra.gov.uk; at the back of the British National Formulary (BNF); by telephoning the Commission on Human Medicines (CHM) free phone line: 0800-731-6789; or by downloading and printing a form from the Yellow Card website.

Ireland: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system HPRA Pharmacovigilance, Website: www.hpra.ie.

Adverse reactions/events should also be reported to the marketing authorisation holder at email address: CPMS@Viatris.com

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