Reporting adverse event or adverse drug reaction

Reporting adverse event or adverse drug reaction
The following information, appearing in Polish, refers to the reporting adverse event of adverse drug reaction only on territory of Poland. For more information in English please contact us: +48 22 56 62 630

Komtur Polska Sp. z o.o. makes a kind request to report all information on suspected adverse event or adverse drug reaction after the following medicinal products:

Marketing Authorisation Holder: Riemser Pharma GmbH:

  • Aldactone (Kalii canrenoas) 20 mg/ml, solution for injection

Marketing Authorisation Holder: Cheplapharm Arzneimittel GmbH:

  • Atacand (Candesartanum) 8 mg; 16 mg; tablets
  • Biosotal 40; Biosotal 80; (Sotalolum) 40 mg; 80 mg; tablets
  • Cymevene (Ganciclovirum) 500 mg, powder for solution for injection
  • Dilatrend (Carvedilolum) 6,25 mg; 12 mg; 25 mg; tablets
  • Ditropan (Oxybutyninum) 5 mg, tablets
  • Dormicum (Midazolamum) 7,5 mg; 15 mg, film-coated tablets
  • Ebrantil 25 (Urapidili hydrochloridum) 5 mg/ml, solution for injection
  • Exacyl (Acidum tranexamicum) 500 mg; film-coated tablets
  • Exacyl (Acidum tranexamicum) 100 mg/ml; solution for injection
  • Exacyl (Acidum tranexamicum) 100 mg/ml; oral solution
  • Fungizone (Amphotericinum B) 50 mg, powder for solution for injection
  • Gutron (Midodrini hydrochloridum) 2,5 mg, tablets
  • Heminevrin (Clomethiazolum) 300 mg, capsules hard
  • Inhibace (Cilazaprilum) 1 mg; 2,5 mg; 5 mg; film-coated tablets
  • Inhibace Plus (Cilazaprilum + Hydrochlorothiazidum) 5 mg + 12,5 mg; film-coated tablets
  • Lexotan (Bromazepamum) 3 mg; 6 mg, tablets
  • Locoid (Hydrocortisoni butyras) 1 mg/ml, solution for use on the skin
  • Locoid (Hydrocortisoni butyras) 1 mg/g, cream
  • Locoid Crelo (Hydrocortisoni butyras) 1 mg/ml, emulsion
  • Locoid Lipocream (Hydrocortisoni butyras) 1 mg/g, cream
  • Lokren 20 (Betaxololi hydrochloridum) 20 mg; film-coated tablets
  • Losec (Omeprazolum) 20 mg, capsules
  • Pimafucin (Natamycinum) 100 mg, vaginal globules
  • Pimafucin (Natamycinum) 20 mg/g, cream
  • Ubretid (Distigmini bromidum) 5 mg, tablets
  • Vesanoid (Tretinoinum) 10 mg, capsules soft
  • Visudyne (Verteporfinum) 15 mg, powder for solution for infusion
  • Xenical (Orlistatum) 120 mg, capsules hard

Marketing Authorisation Holder: Zambon S.p.A.

  • Fluimucil Forte (Acetylocysteinum) 600 mg; effervescent tablets
  • Fluimucil Muko (Acetylocysteinum) 200 mg; granules for oral solution
  • Fluimucil Muko Junior (Acetylocysteinum) 100 mg; granules for oral solution