{"id":22392,"date":"2022-06-27T08:10:19","date_gmt":"2022-06-27T08:10:19","guid":{"rendered":"https:\/\/zeepedia.com\/?p=22392"},"modified":"2022-06-27T10:19:29","modified_gmt":"2022-06-27T10:19:29","slug":"roflumilast-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/roflumilast-accord\/","title":{"rendered":"Roflumilast Accord &#8211; Roflumilast uses, dose and side effects"},"content":{"rendered":"\n<p>500 micrograms&nbsp;film-coated tablets<br>roflumilast<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Roflumilast Accord is and what it is used for<\/h2>\n\n\n\n<p>Roflumilast Accord contains the active substance roflumilast which is an anti-inflammatory agent called&nbsp;phosphodiesterase&nbsp;\u20114 \u2011 inhibitor.&nbsp;Roflumilast reduces the activity of&nbsp;phosphodiesterase&nbsp;\u20114, a&nbsp;protein&nbsp;that occurs naturally in the body&#8217;s cells.&nbsp;When the activity of this protein is reduced,&nbsp;inflammation&nbsp;in the lungs decreases.&nbsp;This helps to stop the narrowing of the airways that occurs in chronic&nbsp;obstructive pulmonary disease&nbsp;(COPD).&nbsp;Roflumilast Accord thus relieves breathing problems.<\/p>\n\n\n\n<p>Roflumilast Accord is used for maintenance treatment of severe COPD in adults whose COPD symptoms have often worsened in the past (so-called\u00a0exacerbations\u00a0) and who have\u00a0chronic\u00a0bronchitis.\u00a0COPD is a\u00a0chronic\u00a0disease of the lungs that leads to the airways becoming narrower (\u00a0obstruction\u00a0) and to the walls of the small airways becoming swollen and irritated (\u00a0inflammation\u00a0).\u00a0This causes symptoms such as coughing, wheezing and voice, chest tightness, and difficulty breathing.\u00a0Roflumilast Accord should be used as an adjunct to bronchodilators.<\/p>\n\n\n\n<p>Roflumilast contained in Roflumilast Accord may also be approved for the treatment of other diseases not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before taking Roflumilast Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Roflumilast Accord<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you have moderate or severe liver problems.<\/li><\/ul>\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 Roflumilast Accord.<\/p>\n\n\n\n<p><strong>Sudden attacks of shortness of breath<\/strong><\/p>\n\n\n\n<p>Roflumilast Accord should not be used to relieve sudden attacks of shortness of breath (acute\u00a0bronchospasm\u00a0).\u00a0To relieve a sudden attack of shortness of breath, your doctor must prescribe another medicine that is designed for this and that you can always carry with you.\u00a0Roflumilast Accord does not help in such situations.<\/p>\n\n\n\n<p><strong>Body weight<\/strong><\/p>\n\n\n\n<p>You should weigh yourself regularly.&nbsp;Talk to your doctor if you inadvertently lose weight while taking this medicine (a weight loss that is not linked to any particular diet or exercise program).<\/p>\n\n\n\n<p>Other diseases<\/p>\n\n\n\n<p>Roflumilast Accord is not recommended if you have any of the following diseases:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>severe immunological diseases e.g.\u00a0HIV\u00a0infection,\u00a0multiple sclerosis\u00a0(MS),\u00a0lupus erythematosus (LE), or\u00a0progressive\u00a0multifocal\u00a0leukoencephalopathy (PML)<\/li><li>severe acute infectious diseases e.g.\u00a0acute hepatitis<\/li><li>cancer (in addition to basal cell carcinoma, a slowly growing type of skin cancer)<\/li><li>or severe disorders of heart function.<\/li><\/ul>\n\n\n\n<p>This is due to the lack of experience with the use of the Roflumilast Accord in these conditions.\u00a0Tell your doctor if you have such a disease.<\/p>\n\n\n\n<p>Experience is also limited in the treatment of patients who have previously had\u00a0tuberculosis, hepatitis caused by a viral infection, herpes infection, or\u00a0shingles.\u00a0Talk to your doctor if you have any of these conditions.<\/p>\n\n\n\n<p><strong>Symptoms you should be aware of<\/strong><\/p>\n\n\n\n<p>During the first weeks of treatment with Roflumilast Accord, you may experience diarrhea, nausea, abdominal pain, or headache.\u00a0Talk to your doctor if these\u00a0side effects\u00a0do not go away after the first few weeks of treatment.<\/p>\n\n\n\n<p>Roflumilast Accord is not recommended for patients who have a history of depression associated with suicidal ideation or behavior.\u00a0You may also experience insomnia, anxiety, nervousness, or depression.\u00a0Before starting treatment with Roflumilast Accord, tell your doctor if you are suffering from or taking any of these conditions.\u00a0Such drugs may increase the risk of getting any of these\u00a0side effects.\u00a0You or your healthcare provider should immediately tell your doctor if your behavior or mood has changed and if you have any suicidal thoughts.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>This medicine should not be given to children and adolescents under 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Roflumilast Accord<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, especially the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a medicine containing theophylline (a medicine for respiratory diseases) or<\/li><li>a drug for any immunological disease, e.g.\u00a0methotrexate, azathioprine, infliximab, etanercept, or oral\u00a0corticosteroids\u00a0to be taken for a long time<\/li><li>medicines containing fluvoxamine (a medicine for anxiety and depression), enoxacin (a medicine for bacterial infections), or cimetidine (a medicine for\u00a0stomach ulcers\u00a0and acid reflux).<\/li><\/ul>\n\n\n\n<p>The effect of the Roflumilast Accord may be reduced if it is taken with rifampicin (an\u00a0antibiotic\u00a0) or with phenobarbital, carbamazepine, or\u00a0phenytoin\u00a0(medicines commonly used for\u00a0epilepsy\u00a0).\u00a0Consult a doctor.<\/p>\n\n\n\n<p>Roflumilast Accord can be taken with other medicines used to treat COPD, e.g.&nbsp;inhaled or oral&nbsp;corticosteroids&nbsp;or bronchodilators.&nbsp;Do not stop using these medicines or do not reduce the&nbsp;dose&nbsp;of one of them unless your doctor has given you the go-ahead.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.\u00a0You must not become pregnant during treatment with this medicine and you must use an effective method of contraception during treatment as Roflumilast Accord may be harmful to the unborn baby.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Roflumilast does not affect the ability to drive or use machines.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Roflumilast Accord contains lactose<\/h2>\n\n\n\n<p>If 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<h2 class=\"wp-block-heading\">How to take Roflumilast Accord<\/h2>\n\n\n\n<p>Always take this medicine exactly as your doctor has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>For the first 28 days<\/strong>\u00a0&#8211; the recommended starting dose is one 250 microgram tablet once a day.<\/li><li>The starting dose is a low\u00a0dose\u00a0to help your body get used to the medicine before you start taking the full\u00a0dose.\u00a0At this low\u00a0dose,\u00a0you will not get the full effect of the medicine &#8211; therefore you must switch to the full\u00a0dose\u00a0(maintenance dose) after 28 days.<\/li><\/ul>\n\n\n\n<p>This&nbsp;dosage&nbsp;is not possible with Roflumilast Accord.&nbsp;Other&nbsp;preparations&nbsp;are available.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>After 28 days &#8211;<\/strong>&nbsp;the recommended maintenance dose is one 500 microgram tablet once a day.<\/li><\/ul>\n\n\n\n<p>Swallow the tablet with a little water.&nbsp;You can take this medicine with or without food.&nbsp;Take the tablet at the same time each day.<\/p>\n\n\n\n<p>You may need to take Roflumilast Accord for several weeks before the intended effect is achieved.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Roflumilast Accord than you should<\/h2>\n\n\n\n<p>If you take more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhea, dizziness, palpitations, fainting, cold sweats, and low\u00a0blood pressure.\u00a0Contact a doctor or pharmacist as soon as possible.\u00a0If possible, take the remaining tablets and this leaflet with you.<\/p>\n\n\n\n<p>If you have ingested too much medicine or if e.g.\u00a0a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Roflumilast Accord<\/h2>\n\n\n\n<p>If you forget to take a tablet at the usual time, take it as soon as you remember on the same day.\u00a0If you forget to take your Roflumilast tablet one day, take the next tablet, as usual, the next day.\u00a0Continue to take the medicine at the usual times.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop taking Roflumilast Accord<\/h2>\n\n\n\n<p>For the best possible lung function, you must continue to take Roflumilast Accord for as long as your doctor prescribes it, even if you have no symptoms.<\/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>You may experience diarrhea, nausea, abdominal pain, or headache during the first weeks of treatment with Roflumilast Accord.\u00a0Talk to your doctor if these\u00a0side effects\u00a0do not subside during the first weeks of treatment.<\/p>\n\n\n\n<p>Some\u00a0side effects\u00a0can be serious.\u00a0In\u00a0clinical trials\u00a0and after market introduction, rare cases of suicidal ideation and suicidal behavior (including suicide) have been reported.\u00a0Tell your doctor immediately if you have any suicidal thoughts.\u00a0You may also experience\u00a0side effects\u00a0such as insomnia (common), anxiety (uncommon), nervousness (rare), panic attack (rare), or depression (rare).<\/p>\n\n\n\n<p>In less common cases, allergic reactions occur.\u00a0Allergic reactions can affect the skin and in rare cases cause swelling of the eyelids, face, lips, and tongue, which can cause difficulty breathing and\/or a drop in blood pressure and increased\u00a0heart rate.\u00a0If you experience an\u00a0allergic reaction, stop taking Roflumilast Accord immediately and contact a doctor or go to the emergency department of the nearest hospital.\u00a0Bring the remaining tablets and this leaflet and provide full details of your current treatments.<\/p>\n\n\n\n<p><strong><em>Other side effects:<\/em><\/strong><\/p>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>diarrhea, nausea, abdominal pain<\/li><li>weight loss decreased appetite<\/li><li>headache.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>tremors, feeling of tingling in the head (dizziness), dizziness<\/li><li>the feeling of irregular heartbeat or increased number of heartbeats (palpitations)<\/li><li>gastritis, vomiting<\/li><li>leakage of stomach acid to the esophagus (acid reflux), indigestion<\/li><li>rash<\/li><li>muscle pain, muscle weakness, or cramps<\/li><li>back pain<\/li><li>feeling weak or tired, feeling sick.<\/li><\/ul>\n\n\n\n<p><strong>Rare&nbsp;side effects&nbsp;(may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>enlarged breasts in men<\/li><li>impaired sense of taste<\/li><li>respiratory tract infections (other than pneumonia)<\/li><li>blood in the stool, constipation<\/li><li>elevated liver or muscle enzymes (examined using blood tests)<\/li><li>raised, itchy rash on the skin (&nbsp;hives&nbsp;).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Roflumilast Accord<\/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 EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>No special storage instructions.<\/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 packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<p>The active substance is roflumilast.<\/p>\n\n\n\n<p>One film-coated tablet contains 500 micrograms of roflumilast.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Other ingredients are:<\/li><li>Core:\u00a0lactose monohydrate\u00a0(see section 2 under \u201cRoflumilast Accord contains lactose\u201d), pregelatinized maize starch, magnesium stearate.<\/li><li>Coating: hypromellose, titanium dioxide (E171), Macrogol 400, yellow iron oxide (E172), indigo carmine aluminum lacquer (E132), and red iron oxide (E172).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Roflumilast Accord 500 micrograms film-coated tablets are yellowish, round film-coated tablets with a diameter of 9 mm.<\/p>\n\n\n\n<p>One pack contains 30 or 90 film-coated 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 Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200,<\/p>\n\n\n\n<p>3526 VK Utrecht<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>J. Uriach y Compa\u00f1ia SA<\/p>\n\n\n\n<p>Poligon Industrial Riera De Caldes,<\/p>\n\n\n\n<p>Avinguda Cami Reial 51-57,<\/p>\n\n\n\n<p>08184 Palau-Solita I Plegamans, Barcelona,<\/p>\n\n\n\n<p>Spain<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Roflumilast Accord contains the active substance roflumilast which is an anti-inflammatory agent called phosphodiesterase \u20114 \u2011 inhibitor. Roflumilast reduces the activity of phosphodiesterase \u20114, a protein that occurs naturally in the body&#8217;s cells. When the activity of this protein is reduced, inflammation in the lungs decreases. This helps to stop the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Roflumilast Accord thus relieves breathing problems.<\/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":[2200,18529],"tags":[6041,23356,23360,23359,6043,6045,6042,23357,23358,23355],"class_list":["post-22392","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-roflumilast","tag-roflumilast-accord","tag-roflumilast-accord-side-effects","tag-roflumilast-accord-tablet","tag-roflumilast-side-effects","tag-roflumilast-tablet","tag-what-is-roflumilast","tag-what-is-roflumilast-accord","tag-what-roflumilast-accord-is-used-for","tag-what-roflumilast-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22392","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=22392"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22392\/revisions"}],"predecessor-version":[{"id":22429,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22392\/revisions\/22429"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22392"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22392"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}