News Local Medicines containing active ingredient Valsartan withdrawn

Medicines containing active ingredient Valsartan withdrawn

The Pharmaceutical Services of the Ministry of Health have withdrawn products containing Valsartan. This comes after an announcement from the European Medicine Agency regarding the discovery of contamination in Valsartan, an active ingredient, in particular batches of pharmaceutical products .

The following products are being withdrawn:

Vapress 40mg Film Coated Tablets                           all batches
Vapress 80mg Film Coated Tablets                           all batches
Vapress 160mg Film Coated Tablets                         all batches
Sartovan 80mg Film Coated Tablets                         all batches
Sartovan 160mg Film Coated Tablets                        all batches
Troval 80mg Film Coated Tablets                              15361 / 16273
Troval 160mg Film Coated Tablets                            15362 / 16274
Cotroval 160/12.5mg Film Coated Tablets               15133
Cotroval 160/25mg Film Coated Tablets                  15134
Valsartan Zentiva 40mg Film Coated Tablets          all batches
Valsartan Zentiva 160mg Film Coated Tablets        all batches

The active incredient Valsatran which was used for these batches was found to include the toxic by-product N-Nitrosodimethylamine (NDMA) which is highly toxic and a known carcinogen.

Valsartan is an angiotensin II receptor blocker mainly used for treatment of high blood pressure and congestive heart failure.

Patients who are in possession of any of the above affected batches should discontinue use and return the product to the pharmacy from which it had been purchased as soon as possible. They should contact their doctor for alternative treatment methods.

The following pharmaceutical products in the Cypriot market contain the active ingredient Valsartan (often in conjunction with other active ingredients):

Diovan Film Coated Tablets 40mg (Valsartan)
Diovan Film Coated Tablets 80mg (Valsartan)
Diovan Film Coated Tablets 160mg (Valsartan)
Co-Diovan Film Coated Tablets 80/12,5mg (Valsartan/Hydrochlorothiazide)
Co-Diovan Film Coated Tablets 160/12,5mg (Valsartan/Hydrochlorothiazide)
Co-Diovan Film Coated Tablets 160/25mg (Valsartan/Hydrochlorothiazide)
Entresto Film Coated Tablets (24+26) mg (Valsartan/Sacubitril)
Entresto Film Coated Tablets (49+51) mg (Valsartan/Sacubitril)
Entresto Film Coated Tablets (97+103) mg (Valsartan/Sacubitril)
Exforge Film Coated Tablets 80/5mg (Valsartan/Amlodipine Besylate)
Exforge Film Coated Tablets 160/5mg (Valsartan/Amlodipine Besylate)
Exforge Film Coated Tablets 160/10mg (Valsartan/Amlodipine Besylate)
Exforge HCT Film Coated Tablets 160/5/12,5mg (Valsartan/Amlodipine Besylate)
Exforge HCT Film Coated Tablets 160/5/25mg (Valsartan/Amlodipine Besylate/Hydrochlorothiazide)

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