Abridged prescribing information ADEMPAS^® (riociguat)

ADEMPAS®: AI: Riociguat; I: Adults: improvement in exercise capacity in inoperable chronic thromboembolic pulmonary hypertension (CTEPH), persistent/recurrent CTEPH after surgery or in pulmonary arterial hypertension (PAH) in WHO Functional Classes II and III; D: Oral administration, starting dose: 0.5 mg or 1.0 mg 3x/day, gradual dose increase by 0.5 mg up to max. 2.5 mg 3x/day; Special dosage instructions: Caution in elderly patients (≥65y); in patients with moderately severe restriction of liver function (Child Pugh B); in patients with mild, moderately severe and severe restriction of kidney function (creatinine clearance 80-15 ml/min); in patients under stable doses of potent multi-pathway inhibitors of CYP / P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP); in smokers; CI: Nitrates, nitric oxide donors, specific phosphodiesterase 5 inhibitors and non-specific phosphodiesterase inhibitors. Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). Combination with stimulators of soluble guanylate cyclase; Pr: Pulmonary veno-occlusive disease (PVOD). Increased risk of bleeding in general and from the respiratory tract. Vasodilatory effect, lowering of blood pressure possible. Increased risk of osteoporosis. Not investigated: Combination with endothelin receptor antagonists or prostanoids in CTEPH, in cases of systolic blood pressure <95 mmHg at baseline, severely impaired liver function, creatinine clearance <15 ml/min and dialysis patients. Contains lactose; DDI: CYP3A4-inducers, strong multi-pathway inhibitors of CYP and P-gp/BCRP and other strong inhibitors of CYP and P-gp/BCRP, proton pump inhibitors, antacids. Increased risk of bleeding when used with anticoagulants, thrombocyte aggregation inhibitors. Reduced exposure in smokers; P/L: Contra-indicated; UDE: Very common: headache, dizziness, dyspepsia, nausea, diarrhoea, vomiting, peripheral oedema; P: 42 and 84 film-coated tablets with 0.5 mg / 1.0 mg / 1.5 mg / 2.0 mg / 2.5 mg; C: B; MAH: Bayer (Switzerland) AG, Uetlibergstrasse 132, 8045 CH-Zurich; (V3.0); CH-ADE-00030.

Before prescribing, please consult the full prescribing information, published on the website of Swissmedic (www.swissmedicinfo.ch).