Safety Alerts & Recalls

What does this mean?

This recall for Mirtazapine 15 mg and 45 mg tablets from Ranbaxy (UK) Limited was issued at the wholesale and pharmacy level only. The MHRA and company involved have determined that there is no specific evidence to suggest that the medicines are not safe for patient use. People who have these medicines should continue to take their medicines as directed. If you take mirtazapine and are concerned, you should follow up with your doctor or pharmacist.

If you are experiencing suicidal thoughts and behaviours, the following suicide hotline is available in the UK to help you: 08457 90 90 90 or http://www.samaritans.org/

Pharmacy Level Recall of Several Batches of Mirtazapine 15 mg and 45 mg Tablets

Ranbaxy (UK) Limited is recalling unused stock from select batches of Mirtazapine 15 mg and 45 mg tablets because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency (EMA). Please note, other companies may distribute this medicine under the name mirtazapine or the brand name Zispin, but this recall only applies to select batches of Mirtazapine 15 mg and 45 mg tablets in packs of 28 from Ranbaxy (UK) Limited.

The safety warnings in the PIL for under the section "Before you take Mirtazapine" should state: Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this: - If you have previously had thoughts about killing or harming yourself

- If you are a young adult - information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

For more information and a complete list of recalled batch numbers, please visit: more information here

Source: MHRA
Publication Date: 2010-05-13
Last Updated: 2010-11-08

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