Abridged prescribing information ADEMPAS^® / Adempas junior (riociguat)

Adempas® / Adempas junior: 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; Children and adolescents: PAH in WHO Functional Classes II and III; D: Oral administration: tablet or granules for preparing a suspension; Adults: 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; For further indications and the corresponding dosages for adults and pediatric patients, please refer to the prescribing information; CI: Pregnancy and breastfeeding; combination with: nitrates, nitric oxide donors, specific phosphodiesterase 5 inhibitors and non-specific phosphodiesterase inhibitors, stimulators of soluble guanylate cyclase; Pulmonary hypertension associated with idiopathic interstitial pneumonias; Pr: Pulmonary veno-occlusive disease; 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 adults and 12 to <18-year-olds with systolic blood pressure <95 mmHg at baseline and 6 to <12-year-olds with systolic blood pressure <90 mmHg, severely impaired liver function, creatinine clearance <15 ml/min and dialysis patients, in children and adolescents under 18 years with impaired liver or kidney function; Tablets contain 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; Granules for preparing an oral suspension: glass bottle with 10.5 g granules with water syringe and dosing syringes; C: B; MAH: Bayer (Switzerland) AG, Uetlibergstrasse 132, 8045 CH-Zurich; (V5.0); CH-ADE-00030.

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