Information appeal regarding to the drug Amispiron IC

The Pharmacovigilance Risk Assessment Committee EMA (PRAC) recommended temporarily to stop usingdrugs containing fenspiride.

Suspension is a precautionary measure to protect patients during PRAC review of evidence of the risk of prolonged QT interval and torsades de pointes (disturbances in the electrical activity of the heart, which may lead to disturbances in the heart rhythm).

On the basis of PRAC data and in accordance to the legislation of Ukraine, the State Drugs and Medication Central Service of Ukraine temporarily stop the sale and use of all series of drugs which contain the active substance fenspiride,

including,

AMISPIRON ІС, long-acting tablets of 0.08 g №10 and №20, production of "INTERCHEM" SLC, Ukraine,

until the end of the PRAC audit and the decision of the European Medicines Agency (EMA) on the conditions for the continuation or withdrawal of a marketing authorisation for the circulation of medicines containing fenspiride.

According to the State Drugs and Medication Central Service of Ukraine in identifying samples of this medicinal product, the company must take measures to:

• withdrawal from circulation by placing in quarantine;

• informing the territorial body of the State Service on the location regarding the implementation of this order;

• prevent the purchase, sale and use of the medicinal product listed in this order.

Links:

1) https://www.ema.europa.eu/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf

2) http://portal.dls.gov.ua/PublicSite/QLA/Download.ashx?sid=2&fid=40068226796

Information for patients

• While authorities review all the evidence, patients are advised to stop taking this medicines.

• If you are taking a cough medicine containing fenspiride, contact your doctor or pharmacist for

  advice on alternative treatments, if needed.

• If you have any concerns about your medicine, discuss them with your doctor or pharmacist.

Information for healthcare professionals

• As a precaution and while the review is ongoing, healthcare professionals should advise their

  patients to stop taking fenspiride medicines.

• Healthcare professionals will be informed in writing about the suspension, and further information

  will be provided as needed and once the review has concluded.

The authorized person on pharmacovigilance of the company

Margarita Filonenko

050-356-36-56 (round the clock), 097-690-98-50

0482-34-08-04 (Marketing Department)

filonenko@interchem.com.ua