The sale of the drug for hypertension has been suspended. The reason is a quality defect

The Main Pharmaceutical Inspector has decided to suspend the series of Sumilar HCT prescription medicine on the territory of the whole country. It is a preparation used for hypertension. The responsible party is Sandoz GmbH.

1. GIF decided to suspend the sale of Sumilar HCT
2. The reason for the recall is suspected quality defect 
3. Check the current list of recalled drugs
4. More information can be found on the Onet homepage

Sumilar HCT suspended from the market – batch number

The Main Pharmaceutical Inspector withdrew the drug from the market throughout the country Sumilar HCT (Ramiprilum + Amlodipinum + Hydrochlorothiazidum) in the form of hard capsules of 5 mg + 5 mg + 12,5 mg. The responsible party is Sandoz GmbH.

What series has been discontinued?

Sumilar HCT with batch number 12574261, expiration date 30.04.2023/XNUMX/XNUMX has been discontinued.

Sumilar HCT – why was it withdrawn?

«The Main Pharmaceutical Inspectorate received information from the Provincial Pharmaceutical Inspectorate in Kielce about the receipt of a notification of a suspected quality defect from the pharmacy for the Sumilar HCT medicinal product, serial number 12574261, due to the identification of abnormal color appearance inside the blister pack.

Due to the suspicion of a quality defect referred to above, the Main Pharmaceutical Inspector decided to suspend the series of the medicinal product in question on the territory of the whole country until explanations are obtained from the responsible entity ”, reads the GIF release.

Sumilar HCT – what is it used for?

Sumilar HCT contains three active substances: ramipril, amlodipine and hydrochlorothiazide.

Ramipryl belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors) and works by:

1. Decreasing your body’s production of substances that could raise your blood pressure
2. reduction of tension and expansion of blood vessels,
3. making it easier for your heart to pump blood to all parts of your body.

Amlodipine belongs to a group of medicines called calcium antagonists and works by:

1. reducing the tension and widening of blood vessels, which facilitates blood flow.

Hydrochlorotiazyd belongs to the group of a thiazide diuretic and works by:

1. increase in the amount of urine excreted, which lowers blood pressure.

As we read in the leaflet, «Sumilar HCT is used to treat high blood pressure (hypertension) in adult patientswith adequate control of blood pressure, o simultaneous administration of the active substances in doses as in the combined drug, but in the form of separate tablets ».