2018

Medicinal products containing hydrochlorothiazide

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Medicinal products containing hydrochlorothiazide

Information letter for healthcare professionals on the increased risk of non-melanoma skin cancer (basal cell and squamous cell carcinoma) with the use of high cumulative doses of hydrochlorothiazide, with recommendations on monitoring patients' skin. compiled automatically

Medicinal products containing valproate

Informational materials for healthcare professionals and patients on new contraindications and pregnancy prevention measures when using medicinal products containing valproate, due to the risk of congenital malformations and developmental disorders. generated automatically

Abactal®, Moxifloxacin Sandoz®

Information letter to healthcare professionals on the addition of a new warning about the risk of aortic aneurysm and dissection with the use of systemic and inhaled fluoroquinolones, in particular in patients at risk. Contains a description of risk factors, recommendations on assessing the benefit-risk balance and a call to report adverse reactions. generated automatically

Flemoxin Solutab®, Flemoclav Solutab®, Vilprafen Solutab, Suprax Solutab® and Unidox Solutab®

Information letter for healthcare professionals on a change in the method of administration of five antibacterial medicinal products in the form of dispersible tablets. It contains a recommendation to dissolve the tablet in water before taking it, due to a reported case of a serious adverse event. generated automatically

REFORTAN®, REFORTAN®130, REFORTAN® N HES 10%, REFORTAN® N HES 6%, REFORTAN® PLUS, STABISOL

Information letter for healthcare professionals on restrictions on the use of hydroxyethyl starch solutions due to the risks of renal failure, bleeding and mortality, as well as on contraindications and conditions for safe use. generated automatically

Enbrel®LIO

A reminder card for patients using Enbrel® LIO (etanercept), with key safety information during treatment. Contains warnings about the risk of infections, tuberculosis and heart failure, as well as fields for recording patient data, the doctor and examination results. generated automatically

Enbrel®

Xarelto®

Patient information leaflet and recommendations for healthcare professionals on the use of an anticoagulant medicinal product: how to take it, what to tell the doctor, which bleeding symptoms require immediate medical attention, as well as dosing in atrial fibrillation and renal impairment. generated automatically

Esmya

Information letter to health care professionals on updated EMA recommendations on measures to minimize the risk of rare but serious liver injury with ulipristal acetate for the treatment of uterine fibroids, including liver function monitoring and restrictions on use. generated automatically