Certain “serious adverse effects”: a medical prescription will soon be required for this medication

Certain “serious adverse effects”: a medical prescription will soon be required for this medication
Certain “serious adverse effects”: a medical prescription will soon be required for this medication

Since the announcement of the prescription requirement for pseudoephedrine-based drugs, sales of Sinutab and similar products have seen a spectacular increase.

It is one of the most popular medications for stuffy noses or headaches. “It works well, it is efficient”assures a patient has been taking it for several years.

And yet, from November 1, sinutab will be withdrawn from over-the-counter sale in pharmacies like around ten other similar drugs.

The reason: it contains an active ingredient, pseudo-ephedrine, known to cause potentially dangerous side effects. “There is already one that is very annoying, it is tachycardia, which means that it will increase the heart rate”explains pharmacist Amandine. “All patients who have heart problems, hypertension, etc., it is really contraindicated. And if you take it every day, you have an addiction that develops.”

According to the Federal Medicines Agency, 32 patients have had to be treated over the last 5 years for adverse effects, high blood pressure or even kidney failure. 11 of them had to be hospitalized. “11 notifications meet the definition of serious adverse reactions”says Ann Eeckhout, spokesperson for the Federal Medicines Agency. “Each case is one case too many and we want more responsible use and controlled by doctors.”

Since the withdrawal announcement, sales of Sinutab in pharmacies have increased by 30% on average. Many pharmacists advise patients on more appropriate medications to try to overcome the symptoms associated with winter illnesses.

This increase comes after the Federal Agency for Medicines and Health Products (FAMHP) decided to subject these medicines to mandatory prescription to count from November 1, 2024.

According to Febelco, 30% of Sinutab’s usual monthly volumes have already been sold since October 1. On Thursday, October 3, daily sales were six times the October sales average.

Sinutab Forte also saw strong demand with 34% of usual volumes sold in three days.

medicine Belgian health company Sinutab

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