{"id":99677,"date":"2024-10-08T16:30:53","date_gmt":"2024-10-08T16:30:53","guid":{"rendered":"https:\/\/www.mymsd.ch\/it\/?page_id=99677"},"modified":"2026-02-19T17:37:35","modified_gmt":"2026-02-19T17:37:35","slug":"adempas","status":"publish","type":"page","link":"https:\/\/www.mymsd.ch\/it\/succinctstatement\/adempas\/","title":{"rendered":"Abridged prescribing information ADEMPAS\u00ae \/ Adempas junior (riociguat)"},"content":{"rendered":"\n<h1 class=\"wp-block-heading has-border-color has-has-red-border-color-border-color  mhh-mcn-v1-heading mhh-mcn-v1-heading--a3e3a327a280253c6fc82e91c88688ac\"><mark class=\"has-inline-color has-teal-500-color\">Abridged prescribing information ADEMPAS<sup>\u00ae<\/sup> \/ Adempas junior (riociguat)<\/mark><\/h1>\n\n\n\n<p class=\"has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--6d944db359bcdf6e4773dfa68bbfe1d9\"><strong>Adempas\u00ae \/ Adempas junior:<\/strong> <strong>AI:<\/strong> Riociguat; <strong>I:<\/strong> 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; <strong>D:<\/strong> 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 (\u226565y), 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\u201315 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; <strong><em>For further indications and the corresponding dosages for adults and pediatric patients, please refer to the prescribing information;<\/em><\/strong> <strong>CI:<\/strong> 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; <strong>Pr:<\/strong> 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 &lt;18-year-olds with systolic blood pressure &lt;95 mmHg at baseline and 6 to &lt;12-year-olds with systolic blood pressure &lt;90 mmHg, severely impaired liver function, creatinine clearance &lt;15 ml\/min and dialysis patients, in children and adolescents under 18 years with impaired liver or kidney function; Tablets contain lactose; <strong>DDI:<\/strong> 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; <strong>P\/L:<\/strong> Contra-indicated; <strong>UDE:<\/strong> Very common: headache, dizziness, dyspepsia, nausea, diarrhoea, vomiting, peripheral oedema; <strong>P:<\/strong> 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; <strong>C:<\/strong> B; <strong>MAH:<\/strong> Bayer (Switzerland) AG, Uetlibergstrasse 132, 8045 CH-Zurich; (V5.0); CH-ADE-00030.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-gray-300-color has-alpha-channel-opacity has-gray-300-background-color has-background\" \/>\n\n\n\n<p class=\"has-object-object-font-size has-border-color has-has-red-border-color-border-color has-gray-800-color has-text-color has-link-color wp-elements-3e3559538e3eac61449b626360d01a41   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--57bd448d33e2944d6b2498451afd7cd3\"><em>Before prescribing, please consult the full prescribing information, published on the website of Swissmedic (<a href=\"https:\/\/www.swissmedicinfo-pro.ch\/ShowText.aspx?textType=FI&amp;lang=IT&amp;authNr=62903\" target=\"_blank\" rel=\"noreferrer noopener\">www.swissmedicinfo-pro.ch<\/a>).<\/em><\/p>\n\n\n\n<p dir=\"ltr\" lang=\"it-IT\" class=\"has-border-color has-has-red-border-color-border-color   mhh-mcn-v1-paragraph mhh-mcn-v1-paragraph--384674a58c4772b601831ccbed0aaec2\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Abridged prescribing information ADEMPAS\u00ae \/ Adempas junior (riociguat) Adempas\u00ae \/ Adempas junior: AI: Riociguat; I: Adults: improvement in exercise capacity [&hellip;]<\/p>\n","protected":false},"author":73172,"featured_media":0,"parent":99147,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_mhh_sticky_footer_settings":{"entityId":0},"_mhh_sticky_footer_posts":"","_mhh_sticky_footer_expanded":false,"_mhh_mcn_text_direction":"","_mhh_mcn_language":"","_mhh_mcn_left_sidebar_settings":{"entityId":0},"_mhh_mcn_sidebar_settings":{"entityId":0},"mhh_mcn_side_navigation_style":{"fontSize":{"l":"","m":"","s":""},"lineHeight":{"l":1.5,"m":1.5,"s":1.5},"itemColor":"","hoverItemColor":"","currentItemColor":"","borderItemColor":"","backgroundItemHoverColor":"","themeColor":""},"_mhh_mcn_child_page_navigation":{"isActive":false,"isSticky":false},"hide_header":false,"show_top_bar":false,"hide_footer":false,"full_width_layout":false,"icon":null,"job_code":"","primary_tag":1129,"editor_notices":[],"mconnectHideShareThis":false,"footnotes":"","mconnectIsArchiveTemplate":false,"mconnectArchiveFiltersDisabled":false,"mconnectArchiveLockAllPresetFilters":false,"mconnectArchiveHidePageSubmenu":false,"mconnectArchiveShowParentPageOnly":false,"mconnectArchiveDefaultOrder":"DESC","mconnectArchiveDefaultOrderBy":"date","mconnectArchivePostsPerPage":12,"mconnectArchivePostTypes":[],"mconnectArchiveAllowFilterBy":["category","tx-content-type","tx-product","tx-pathology","tx-active-ingredient","tx-therapeutic-area"],"mconnectArchiveTaxonomyOrder":[],"mconnectArchiveFilterSorting":["active","is_keyword","is_date"],"mconnectArchiveContentItemStyle":{"showExcerpt":true,"showImage":true,"showIcon":false,"showPrimaryTag":true,"showBorder":false,"showDates":false,"showCta":true,"isCard":false,"hasBackground":false,"showMetadata":true},"mconnectArchiveLayout":{"type":"list","hasFeatured":false},"mconnectDynamicTaxonomyEntities":[],"mconnectArchiveTerms_category":[],"mconnectArchiveAllowTerms_category":[],"mconnectArchiveTerms_tx-content-type":[],"mconnectArchiveAllowTerms_tx-content-type":[],"mconnectArchiveTerms_tx-product":[],"mconnectArchiveAllowTerms_tx-product":[],"mconnectArchiveTerms_tx-pathology":[],"mconnectArchiveAllowTerms_tx-pathology":[],"mconnectArchiveTerms_tx-active-ingredient":[],"mconnectArchiveAllowTerms_tx-active-ingredient":[],"mconnectArchiveTerms_tx-therapeutic-area":[],"mconnectArchiveAllowTerms_tx-therapeutic-area":[],"mconnectArchiveAllowTerms_dynamic-taxonomy":[],"mconnectArchiveLegacyDefaultTermsApplied":false,"mconnectContentUpdatesPerPage":10,"mconnectContentUpdatesViewMoreUrl":"","mconnectContentUpdatesTerms_tx-content-type":[],"mconnectContentUpdatesTerms_tx-product":[],"mconnectContentUpdatesTerms_tx-pathology":[],"mconnectContentUpdatesTerms_tx-active-ingredient":[],"mconnectContentUpdatesTerms_tx-therapeutic-area":[],"sidebar_toogle":0,"sidebar_toogle_notification_warning":true,"sidebar_toogle_notification_alert":true,"content_expiration_sidebar_date":"","content_expiration_sidebar_expired_post_status":"","content_expiration_sidebar_redirection":""},"categories":[1128],"tags":[1129],"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[501],"ga4_page_businessunit":[506],"ga4_page_campaign":[],"ga4_page_content_purpose":[1072],"ga4_page_customer_journey_stage":[],"ga4_page_customer_specialty":[],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[713],"ga4_page_product":[715],"ga4_page_region":[946],"ga4_page_therapeuticarea":[1001],"tx-therapeutic-area":[344],"tx-product":[343],"tx-pathology":[],"tx-content-type":[1130],"tx-active-ingredient":[],"access":[],"user_status":[],"user_role":[],"class_list":["post-99677","page","type-page","status-publish","hentry","category-kfi","tag-kfi"],"yoast_head":"<!-- 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