{"id":241,"date":"2022-07-14T08:39:41","date_gmt":"2022-07-14T07:39:41","guid":{"rendered":"https:\/\/vip-organon-connect-com-develop.go-vip.net\/fr-fr\/?post_type=article&#038;p=241"},"modified":"2023-07-31T11:44:19","modified_gmt":"2023-07-31T10:44:19","slug":"information-medicale-sinemet-lp","status":"publish","type":"article","link":"https:\/\/organonpro.com\/fr-fr\/article\/information-medicale-sinemet-lp\/","title":{"rendered":"Information m\u00e9dicale : SINEMET\u00ae LP"},"content":{"rendered":"\n<p><strong>A la suite d\u2019un changement d\u2019usine de fabrication, la nouvelle pr\u00e9sentation des comprim\u00e9s de SINEMET\u00ae LP 200 mg\/50 mg, est distribu\u00e9e \u00e0 compter du 31 mars 2021 apr\u00e8s \u00e9puisement de l\u2019ancienne pr\u00e9sentation au printemps 2019. Les modifications portent sur la composition et l\u2019apparence des comprim\u00e9s.<\/strong><\/p>\n\n\n\n<p><strong>Les substances actives (l\u00e9vodopa\/carbidopa) restent identiques, ainsi que la dose et le nombre de comprim\u00e9s \u00e0 utiliser. L\u2019efficacit\u00e9 et la tol\u00e9rance de ce m\u00e9dicament sont inchang\u00e9es. Si toutefois les patients observent une diff\u00e9rence, ils doivent se rapprocher de leur m\u00e9decin ou pharmacien.<\/strong><\/p>\n\n\n\n<p>Un document d\u2019information \u00e0 destination des patients a \u00e9t\u00e9 \u00e9labor\u00e9 par l\u2019ANSM en lien avec les repr\u00e9sentants de patients et les professionnels de sant\u00e9. Il sera remis par les m\u00e9decins lors de la consultation et\/ou par les pharmaciens lors de la dispensation des nouvelles boites de SINEMET\u00ae LP.<br>Ces nouvelles boites seront&nbsp;\u00e9tiquet\u00e9es les 6 premiers mois de commercialisation avec la mention : <em>\u00ab Nouvelles composition et pr\u00e9sentation \u2013 Demandez la fiche d\u2019information \u00e0 votre pharmacien \/ m\u00e9decin \u00bb.<\/em><\/p>\n\n\n\n<p>Un courrier a \u00e9galement \u00e9t\u00e9 adress\u00e9 par l\u2019ANSM aux professionnels de sant\u00e9 afin de les informer de ces modifications.<\/p>\n\n\n\n<p><strong><u>Contexte :<\/u><\/strong><\/p>\n\n\n\n<p>Le laboratoire MSD a d\u00e9cid\u00e9 d\u2019arr\u00eater la fabrication aux Etats-Unis des comprim\u00e9s de SINEMET\u00ae LP 200 mg\/25 mg compte-tenu de difficult\u00e9s de production \u00e0 l\u2019origine de fr\u00e9quentes ruptures de stock. La fabrication est d\u00e9sormais assur\u00e9e en Italie, l\u00e0 o\u00f9 SINEMET\u00ae LP \u00e9taient fabriqu\u00e9s jusqu\u2019en 2012. Les \u00e9quipements de la nouvelle usine ont n\u00e9cessit\u00e9 une modification du proc\u00e9d\u00e9 de fabrication et donc de la composition des comprim\u00e9s.<\/p>\n\n\n\n<p>Cette modification a \u00e9t\u00e9 autoris\u00e9e en France et au Portugal.<\/p>\n\n\n\n<p>Les nouveaux comprim\u00e9s sont les m\u00eames que ceux d\u00e9j\u00e0 utilis\u00e9s par des milliers de patients europ\u00e9ens pour lesquels la fabrication n\u2019avait pas \u00e9t\u00e9 transf\u00e9r\u00e9e aux Etats-Unis (Allemagne, Irlande, Espagne, Italie et au Royaume-Uni).<\/p>\n\n\n\n<p><strong>Ce qui change<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>La composition en excipients, sans que cela ne modifie l\u2019efficacit\u00e9 et la tol\u00e9rance du m\u00e9dicament :<\/strong>\n<ul class=\"wp-block-list\">\n<li>3 excipients ont \u00e9t\u00e9 supprim\u00e9s (hypromellose, carmin d\u2019indigo (E132) et rouge allura AC (E129)).<\/li>\n\n\n\n<li>3 excipients ont \u00e9t\u00e9 ajout\u00e9s (copolym\u00e8re d&#8217;ac\u00e9tate de polyvinyl et d&#8217;acide crotonique, laque aluminique de jaune de quinol\u00e9ine, et oxyde de fer rouge). Il s\u2019agit d\u2019excipients sans effet notoire.<\/li>\n\n\n\n<li>La quantit\u00e9 de l\u2019excipient hydroxypropylcellulose a \u00e9t\u00e9 diminu\u00e9e.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>L\u2019apparence des comprim\u00e9s :<\/strong>\n<ul class=\"wp-block-list\">\n<li>Ils comportent d\u00e9sormais une barre sur une face. Il ne s\u2019agit pas d\u2019une barre de s\u00e9cabilit\u00e9. Les comprim\u00e9s ne sont donc pas s\u00e9cables et le patient doit imp\u00e9rativement les avaler sans les m\u00e2cher, ni les \u00e9craser, ni les couper, afin de ne pas alt\u00e9rer les propri\u00e9t\u00e9s du m\u00e9dicament.<\/li>\n\n\n\n<li>Leur <strong>couleur est modifi\u00e9e<\/strong> : elle passe de violet tachet\u00e9 \u00e0 p\u00eache.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Les conditions de conservation :<\/strong>\n<ul class=\"wp-block-list\">\n<li>Les comprim\u00e9s sont d\u00e9sormais \u00e0 conserver dans l\u2019emballage d\u2019origine \u00e0 l\u2019abri de la lumi\u00e8re et de l\u2019humidit\u00e9 et \u00e0 une temp\u00e9rature ne d\u00e9passant pas 30\u00b0C.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><strong><br>Ce qui ne change pas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Les substances actives<\/strong> (l\u00e9vodopa et carbidopa) <strong>sont identiques et dans les m\u00eames quantit\u00e9s ;<\/strong><\/li>\n\n\n\n<li><strong>La dose \/ le nombre de comprim\u00e9s \u00e0 utiliser sont les m\u00eames ;<\/strong><\/li>\n\n\n\n<li><strong>Le code CIP est inchang\u00e9 : 34009 335 693 8 9 (Boite de 30 comprim\u00e9s).<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Pour plus d\u2019informations, vous pouvez t\u00e9l\u00e9charger la lettre aux professionnels de sant\u00e9 ainsi que la fiche \u00e0 destination des patients mises \u00e0 disposition par l\u2019ANSM ci-dessous.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/organonpro.com\/fr-fr\/wp-content\/uploads\/sites\/3\/2022\/07\/Sinemet_LP_200-50_Fiche_patient_finale.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Fiche d&#8217;information pour les patients (15\/03\/2021)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/organonpro.com\/fr-fr\/wp-content\/uploads\/sites\/3\/2022\/07\/SINEMET_LP_200mg-50mg-courrier_PDS_signe_ANSM-1.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Lettre aux professionnels de sant\u00e9 (15\/03\/2021)<\/a><\/li>\n<\/ul>\n\n\n\n<p>Pour d\u00e9clarer tout effet ind\u00e9sirable : <a href=\"https:\/\/solidarites-sante.gouv.fr\/soins-et-maladies\/signalement-sante-gouv-fr\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.signalement-sante.gouv.fr<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A la suite d\u2019un changement d\u2019usine de fabrication, la nouvelle pr\u00e9sentation des comprim\u00e9s de SINEMET\u00ae LP 200 mg\/50 mg, est distribu\u00e9e \u00e0 compter du 31 mars 2021 apr\u00e8s \u00e9puisement de l\u2019ancienne pr\u00e9sentation au printemps 2019. Les modifications portent sur la composition et l\u2019apparence des comprim\u00e9s. Les substances actives (l\u00e9vodopa\/carbidopa) restent identiques, ainsi que la dose [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":4208,"parent":0,"menu_order":3,"template":"","meta":{"_acf_changed":false},"tags":[26],"article_categories":[],"class_list":["post-241","article","type-article","status-publish","has-post-thumbnail","hentry","tag-nexplanon"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.11 (Yoast SEO v26.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Information m\u00e9dicale : SINEMET\u00ae LP Organon Pro - France<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/organonpro.com\/fr-fr\/article\/information-medicale-sinemet-lp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Information m\u00e9dicale : SINEMET\u00ae LP\" \/>\n<meta property=\"og:description\" content=\"A la suite d\u2019un changement d\u2019usine de fabrication, la nouvelle pr\u00e9sentation des comprim\u00e9s de SINEMET\u00ae LP 200 mg\/50 mg, est distribu\u00e9e \u00e0 compter du 31 mars 2021 apr\u00e8s \u00e9puisement de l\u2019ancienne pr\u00e9sentation au printemps 2019. Les modifications portent sur la composition et l\u2019apparence des comprim\u00e9s. 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