ILD/pneumonitis: Patients should be monitored for pulmonary symptoms indicative of pneumonitis. ALECENSA should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified*

Hepatotoxicity: Liver function, including ALT, AST and total bilirubin should be monitored before starting ALECENSA and then at every 2 weeks during the first 3 months of treatment. Thereafter, monitoring should be performed periodically, since events may occur later than 3 months, with more frequent testing in patients who develop aminotransferase and bilirubin elevations. Based on the severity of the adverse drug reaction, ALECENSA should be withheld and resumed at a reduced dose, or permanently discontinued*

Severe myalgia and CPK elevation: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness. CPK levels should be assessed every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of CPK elevations, ALECENSA should be withheld, then resumed or the dose reduced*

Bradycardia: Heart rate and blood pressure should be monitored as clinically indicated. ALECENSA dose modification is not required in case of asymptomatic bradycardia. If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and treatment with ALECENSA adjusted*

Haemolytic anaemia: If haemoglobin concentration is below 10 g/dL and haemolytic anaemia is suspected, ALECENSA should be withheld, and appropriate laboratory testing should be initiated. If haemolytic anaemia is confirmed, ALECENSA should be resumed at a reduced dose upon resolution*

Gastrointestinal perforation: Discontinuation of ALECENSA in patients who develop gastrointestinal perforation should be considered. Patients should be informed of the signs and symptoms of gastrointestinal perforations and advised to consult rapidly in case of occurrence*

Photosensitivity: Patients should be advised to avoid prolonged sun exposure while taking ALECENSA, and for at least 7 days after discontinuation of treatment. Patients should be advised to use a broad-spectrum ultraviolet A/ultraviolet B sunscreen and lip balm (sun protection factor ≥50) to help protect against potential sunburn*

Sodium content: ALECENSA contains 48 mg sodium per daily dose (1200 mg), which is equivalent to 2.4% of the World Health Organization recommended maximum daily intake of 2 g sodium for an adult

Women of child-bearing potential: ALECENSA may cause foetal harm when administered to a pregnant woman. Female patients of child-bearing potential receiving ALECENSA must use highly effective contraceptive methods during and for at least 3 months following the last dose of ALECENSA. Please refer to the full SmPC for additional information on fertility, pregnancy and lactation*

Lactose intolerance: ALECENSA contains lactose. Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take ALECENSA