Dyzantil 300mg prolonged-release tablets - Risk Management Materials - (emc)

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Dyzantil 300mg prolonged-release tablets ${equilateral_black_triangle}$

Active Ingredient:

sodium valproate, valproic acid

Company:

Aspire Pharma Ltd See contact details

ATC code:

N03AG01

About Medicine

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL) Risk Materials Letters to HCPs HCP Med Info

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Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

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Valproate - Annual Risk Acknowledgement Form for females GB & NI 2023 - aRMM

Further to the National Patient Safety Alert issued on 28 November 2023, the purpose of this letter is to notify you of an important restriction of indication for new male patients and all female patients aged under 55 years, along with updated contraindications, warnings, and measures to prevent valproate exposure during pregnancy, as well as the availability of revised educational materials to support discussions with patients.

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Valproate - Annual Risk Acknowledgement Form for males GB & NI 2023 - aRMM

Further to the National Patient Safety Alert issued on 28 November 2023, the purpose of this letter is to notify you of an important restriction of indication for new male patients and all female patients aged under 55 years, along with updated contraindications, warnings, and measures to prevent valproate exposure during pregnancy, as well as the availability of revised educational materials to support discussions with patients.

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Valproate - Poster-Dispensary-Pregnancy Prevention Programme

FOR DISPENSARY USE ONLY Dispensary A4 Poster for Pharmacy with key information about the Pregnancy Prevention Programme.

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Valproate- “White Box” Warning Labels

FOR DISPENSARY USE ONLY Warning Labels with Valproate Pregnancy Pictogram for Pharmacy to use with white box dispensing of these products.

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Valproate- Patient Guide- Pregnancy prevention programme

Educational material for girls and women of childbearing potential about the Pregnancy Prevention Programme.

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Valproate- Patient Card-Contraception and Pregnancy Prevention

Educational material for girls and women of childbearing potential about the Pregnancy Prevention Programme.

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Valproate- Healthcare professionals (HCPs) Guide Pregnancy prevention programme

Educational material for Healthcare Professionals (HCPs) about the Pregnancy Prevention Programme.

Address

4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK

WWW

http://www.aspirepharma.co.uk

Telephone

+44 (0)1730 231148

Medical Information Direct Line

+44 (0)1730 231148

Customer Care direct line

+44 (0)1730 231148