{"id":19868,"date":"2022-03-19T11:20:33","date_gmt":"2022-03-19T11:20:33","guid":{"rendered":"https:\/\/zeepedia.com\/?p=19868"},"modified":"2022-03-21T11:28:09","modified_gmt":"2022-03-21T11:28:09","slug":"opsumit","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/opsumit\/","title":{"rendered":"Opsumit &#8211; Macitentan uses, dose and side effects"},"content":{"rendered":"\n<p>10 mg&nbsp;film-coated tablets<br>macitentan<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Opsumit is and what it is used for<\/h2>\n\n\n\n<p>Opsumite contains the active substance macitentan and belongs to a group of medicines called &#8220;endothelin receptor antagonists&#8221;.<\/p>\n\n\n\n<p>Opsumite is used for the long-term treatment of\u00a0pulmonary\u00a0arterial\u00a0hypertension (PAH) in adults.\u00a0It can be used alone or in combination with other drugs<\/p>\n\n\n\n<p>for PAH.\u00a0PAH is high\u00a0blood pressure\u00a0in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries).\u00a0In people with PAH, these\u00a0arteries\u00a0become narrower and the heart has to work harder to pump blood through them.\u00a0It makes you feel tired, dizzy, and out of breath.<\/p>\n\n\n\n<p>Opsumite dilates the pulmonary arteries and makes it easier for the heart to pump blood through them.&nbsp;Blood pressure&nbsp;is lowered, symptoms are relieved and the disease develops more favorably.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you take Opsumit<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Opsumit:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to macitentan, soy or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are pregnant, planning to become pregnant or could become pregnant because you are not using a reliable contraceptive.&nbsp;See section \u201cPregnancy and breast-feeding\u201d.<\/li><li>if you are breast-feeding.&nbsp;See section \u201cPregnancy and breast-feeding\u201d.<\/li><li>if you have liver disease or if you have very high levels of liver enzymes in your blood.&nbsp;Talk to your doctor, who will decide if this medicine is right for you.<\/li><\/ul>\n\n\n\n<p>Tell your doctor if any of these apply to you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before taking Opsumit.<\/p>\n\n\n\n<p><strong><u>Your doctor will decide on certain blood tests:<\/u><\/strong><\/p>\n\n\n\n<p>Blood samples will be taken before and after treatment with Opsumit to check<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have&nbsp;anemia&nbsp;(decreased&nbsp;red blood cell count&nbsp;)<\/li><li>if your liver function is normal<\/li><\/ul>\n\n\n\n<p>The following may be signs of&nbsp;anemia&nbsp;(ie decreased&nbsp;red blood cell count&nbsp;):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>dizziness<\/li><li>fatigue \/ feeling of illness \/ weakness<\/li><li>fast&nbsp;pulse&nbsp;, palpitations<\/li><li>pallor<\/li><\/ul>\n\n\n\n<p>If you notice any of these signs,&nbsp;<strong>tell your doctor.<\/strong><\/p>\n\n\n\n<p>Signs that your liver may not be functioning normally may be:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>nausea<\/li><li>vomiting<\/li><li>fever<\/li><li>abdominal \/ abdominal pain<\/li><li>yellowing of the skin and whites of the eyes (jaundice)<\/li><li>dark-colored urine<\/li><li>itchy skin<\/li><li>unusual fatigue or exhaustion (hibernation or fatigue)<\/li><li>flu-like symptoms&nbsp;(joint and muscle pain with fever)<\/li><\/ul>\n\n\n\n<p>If you notice any of these signs,&nbsp;<strong>tell your doctor immediately.<\/strong><\/p>\n\n\n\n<p>If you have kidney problems, talk to your doctor before using Opsumit.&nbsp;Macitentan may lead to a further decrease in&nbsp;blood pressure&nbsp;and a decrease in&nbsp;hemoglobin&nbsp;in patients with kidney problems.<\/p>\n\n\n\n<p>In patients with venous occlusive lung disease (\u00a0obstruction\u00a0of the pulmonary veins), the use of drugs against PAHs, e.g.\u00a0Opsumite, leads to\u00a0pulmonary edema.\u00a0If you get signs of\u00a0pulmonary edema\u00a0while using Opsumit, e.g.\u00a0sudden and severe shortness of breath and lack of oxygen,\u00a0tell your doctor immediately.\u00a0The doctor can do more tests and then decide which treatment is best for you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Do not give this medicine to children or adolescents under 18 years of age.&nbsp;Opsumit has not been tested in children.<\/p>\n\n\n\n<p><strong>Older<\/strong><\/p>\n\n\n\n<p>Experience with Opsumit treatment in patients older than 75 years is limited.&nbsp;Opsumite should be used with caution in this age group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Opsumit<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0Opsumite can affect other medicines.<\/p>\n\n\n\n<p>If you are taking Opsumit with other medicines, including those mentioned below, the effect of Opsumit or other medicines may change.&nbsp;Tell your doctor or pharmacist if you are taking any of the following medicines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>rifampicin, clarithromycin, telithromycin,&nbsp;ciprofloxacin&nbsp;, erythromycin (&nbsp;antibiotics&nbsp;used to treat&nbsp;infections&nbsp;)<\/li><li>phenytoin&nbsp;(a medicine used to treat seizures)<\/li><li>carbamazepine (used to treat depression and&nbsp;epilepsy&nbsp;)<\/li><li>St. John&#8217;s wort&nbsp;(a traditional herbal medicine used to treat depression)<\/li><li>ritonavir, saquvinavir (used to&nbsp;treat&nbsp;HIV&nbsp;infections&nbsp;)<\/li><li>nefazodone (used to treat depression)<\/li><li>ketoconazole&nbsp;(excluding&nbsp;shampoos&nbsp;),&nbsp;fluconazole&nbsp;, itraconazole,&nbsp;miconazole&nbsp;, voriconazole (medicines used to treat fungal infections)<\/li><li>amiodarone&nbsp;(to control heart rhythm)<\/li><li>cyclosporine (used to prevent organ rejection after a transplant)<\/li><li>diltiazem&nbsp;, verapamil (to treat high&nbsp;blood pressure&nbsp;or specific heart problems).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Summarize with food<\/h2>\n\n\n\n<p>Taking piperine as a dietary supplement may change the way your body responds to certain medicines, including Opsumit.&nbsp;Talk to your doctor or pharmacist if this applies to you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.<\/p>\n\n\n\n<p>Opsumit can harm the fetus if you become pregnant before, during, or shortly after treatment.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you can get pregnant, use a reliable contraceptive while you are taking Opsumit.&nbsp;Talk to your doctor about this.<\/li><li>Do not take Opsumit if you are pregnant or planning to become pregnant.<\/li><li>If you become pregnant or think you may be pregnant while you are taking Opsumit, or shortly after you stop taking Opsumit (up to one month), contact your doctor immediately.<\/li><\/ul>\n\n\n\n<p>If you are a woman and could become pregnant, your doctor will want to do a pregnancy test before you start taking Opsumit and at regular intervals (once a month) while you are taking Opsumit.<\/p>\n\n\n\n<p>It is unknown whether Opsumit is excreted in human milk.&nbsp;You should not breast-feed while taking Opsumit.&nbsp;Talk to your doctor about this.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Opsumite can cause&nbsp;side effects&nbsp;such as headaches and low&nbsp;blood pressure&nbsp;(see section 4) and the symptoms of your condition may also make you less fit to drive.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Opsumite contains lactose, soy lecithin and sodium<\/h2>\n\n\n\n<p>Opsumite contains the sugar\u00a0lactose.\u00a0If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<\/p>\n\n\n\n<p>Opsumite contains lecithin from soy.&nbsp;Do not take this medicine if you are allergic to soy, (see section 2, \u201cDo not take Opsumit\u201d).<\/p>\n\n\n\n<p>This medicine contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per tablet, ie essentially &#8216;sodium-free&#8217;.\u00a0is almost &#8220;sodium-free&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Opsumit<\/h2>\n\n\n\n<p>Opsumit should only be prescribed by doctors who have experience in the treatment of\u00a0pulmonary\u00a0arterial\u00a0hypertension.<\/p>\n\n\n\n<p>Always take this medicine exactly as your doctor has told you.&nbsp;Consult a doctor if you are unsure.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Opsumit is one 10 mg tablet once a day.&nbsp;Swallow the tablet whole with a glass of water.&nbsp;The tablet must not be chewed or shared.&nbsp;You can take Opsumit with or without food.&nbsp;It is best if you take the tablet at the same time each day.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Opsumit than you should<\/h2>\n\n\n\n<p>If you take more tablets than you should, you may experience headaches, nausea, or vomiting.\u00a0Consult your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Opsumit<\/h2>\n\n\n\n<p>If you forget to take Opsumit, take your&nbsp;dose&nbsp;as soon as you remember.&nbsp;Then continue to take the tablets at the usual time.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten tablet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Opsumit<\/h2>\n\n\n\n<p>Opsumit is a treatment that you need to take all the time to keep your PAH under control.&nbsp;Do not stop taking Opsumit unless you have agreed to do so with your doctor.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reactions (swelling around the eyes, face, lips, tongue or throat,&nbsp;itching&nbsp;and \/ or rash)<\/li><\/ul>\n\n\n\n<p>If you notice any of these signs, tell your doctor immediately.<\/p>\n\n\n\n<p><strong>Very common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect more than 1 user in 10)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Anemia&nbsp;(low&nbsp;red blood cell count&nbsp;) or decreased hemoglobin value<\/li><li>Headache<\/li><li>Bronchitis&nbsp;(&nbsp;inflammation&nbsp;of the trachea)<\/li><li>Nasopharyngitis&nbsp;(&nbsp;inflammation&nbsp;of the nose and throat)<\/li><li>Edema&nbsp;(swelling), especially in the ankles and feet<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pharyngitis&nbsp;(&nbsp;inflammation&nbsp;of the pharynx)<\/li><li>Influenza<\/li><li>Urinary tract infection<\/li><li>Hypotension&nbsp;(low&nbsp;blood pressure&nbsp;)<\/li><li>Nasal congestion<\/li><li>Elevated liver values<\/li><li>Leukopenia&nbsp;(decreased&nbsp;white blood cell count&nbsp;)<\/li><li>Thrombocytopenia&nbsp;(decreased platelet count)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Opsumit<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and blister after \u201cEXP\u201d.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Do not store above 30 \u00b0 C.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the pack and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is macitentan.&nbsp;Each tablet contains 10 mg of macitentan.<\/li><li>The other ingredients are&nbsp;lactose monohydrate&nbsp;(see section 2 &#8220;Opsumit contains&nbsp;lactose&nbsp;, soy lecithin and sodium&#8221;), microcrystalline cellulose (E460i), povidone, sodium starch glycolate type A (see section 2 &#8220;Opsumit contains&nbsp;lactose&nbsp;, soy lecithin and sodium (E5), magnesium5&#8221;, E72). polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soy lecithin (E322) (see section 2 \u201cOpsumite contains&nbsp;lactose&nbsp;, soy lecithin and sodium\u201d) and xanthan gum (E415).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Opsumit 10 mg tablets are white to off-white, biconvex, round, film-coated tablets debossed with \u201c10\u201d on both sides.<\/p>\n\n\n\n<p>Opsumite is supplied as 10 mg film-coated tablets, packaged in blister cards of 15 or 30 tablets.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Janssen-Cilag International NV<\/p>\n\n\n\n<p>Turnhoutseweg 30<\/p>\n\n\n\n<p>B-2340 Beerse<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Janssen Pharmaceutica NV<\/p>\n\n\n\n<p>Turnhoutseweg 30<\/p>\n\n\n\n<p>B-2340 Beerse<\/p>\n\n\n\n<p>Belgium<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Opsumite contains the active substance macitentan and belongs to a group of medicines called &#8220;endothelin receptor antagonists&#8221;.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18526],"tags":[20145,20151,20140,20144,20143,20146,20150,20149,20141,20147,20142,20148],"class_list":["post-19868","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-macitentan","tag-benefits-of-opsumit","tag-macitentan","tag-macitentan-side-effects","tag-macitentan-tablet","tag-opsumit","tag-opsumit-side-effects","tag-opsumit-tabelt","tag-what-is-macitentan","tag-what-is-opsumit","tag-what-macitentan-is-used-for","tag-what-opsumit-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19868","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=19868"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19868\/revisions"}],"predecessor-version":[{"id":19911,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19868\/revisions\/19911"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19868"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19868"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19868"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}