{"id":5894,"date":"2020-12-28T14:42:35","date_gmt":"2020-12-28T14:42:35","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5894"},"modified":"2021-07-08T08:57:06","modified_gmt":"2021-07-08T08:57:06","slug":"baraclude","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/baraclude\/","title":{"rendered":"Baraclude &#8211; Entecavir uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n0.5 mg&nbsp;film-coated tablets&nbsp;<br>Entecavir<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Baraclude is and what it is used for<\/h2>\n\n\n\n<p><strong>Baraclude tablet is anti-virus&nbsp;for the treatment of&nbsp;chronic&nbsp;(long-term)&nbsp;infection&nbsp;with&nbsp;hepatitis&nbsp;B&nbsp;virus&nbsp;(HBV) in adults.&nbsp;<\/strong>Baraclude can be used by people whose liver is damaged but still works properly (compensated liver disease) and by people whose liver is damaged and does not work properly (decompensated liver disease).<br><\/p>\n\n\n\n<p><strong>Baraclude tablets are also used to treat&nbsp;chronic&nbsp;(long-term) HBV&nbsp;infection&nbsp;in children and adolescents between 2 and younger than 18 years.&nbsp;<\/strong>Baraclude can be used by children whose liver is damaged but still functioning properly (compensated liver disease).<br><\/p>\n\n\n\n<p>Infection&nbsp;with the&nbsp;hepatitis&nbsp;B&nbsp;virus&nbsp;can lead to liver damage.&nbsp;Baraclude reduces the amount of&nbsp;virus&nbsp;in your body and improves the condition of the liver.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Baraclude<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Baraclude<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>if you are allergic (hypersensitive)<\/strong>&nbsp;to entecavir or any of the other ingredients of this medicine (listed in section 6).<\/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 Baraclude<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>If you have ever had kidney problems, tell your doctor.&nbsp;This is important because Baraclude is excreted from the body through the kidneys and your&nbsp;dose<\/strong> dosing schedule may need to be adjusted.<br><\/li><li><strong>Do not stop taking Baraclude without your doctor&#8217;s advice, as your&nbsp;hepatitis B&nbsp;infection&nbsp;may worsen after stopping treatment.&nbsp;When your treatment with Baraclude ends, your doctor will follow up with<\/strong> the treatment and take blood samples for several months.<br><\/li><li><strong>Discuss with your doctor <\/strong>if <strong>your liver is working properly,<\/strong>&nbsp;and if not, what effect this may have on your Baraclude treatment.<br><\/li><li><strong>if you also have&nbsp;HIV&nbsp;<\/strong>(human immunodeficiency virus) do not forget to tell your doctor.&nbsp;You should not take Baraclude to treat your&nbsp;hepatitis&nbsp;B&nbsp;infection&nbsp;unless you are taking&nbsp;HIV&nbsp;at the same time, as the effect of future&nbsp;HIV&nbsp;treatment may be reduced.&nbsp;Baraclude will not control your&nbsp;HIV&nbsp;&#8211;&nbsp;infection&nbsp;under control.<br><\/li><li><strong>Using Baraclude does not prevent you from infecting other people with the&nbsp;hepatitis&nbsp;B&nbsp;virus<\/strong>&nbsp;through sexual intercourse or body fluids (including blood transfusions).&nbsp;Thus, it is important to take precautions to prevent others from becoming infected with the&nbsp;hepatitis&nbsp;B&nbsp;virus.&nbsp;There are vaccines that protect people who are at risk of contracting the&nbsp;hepatitis&nbsp;B&nbsp;virus.<br><\/li><li><strong>Baraclude belongs to a group of medicines that can cause lactic acidosis (too much&nbsp;lactic acid&nbsp;in the blood)<\/strong>&nbsp;and liver enlargement.&nbsp;Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis.&nbsp;This rare but serious&nbsp;side effect&nbsp;has in some cases be fatal.&nbsp;Lactic acidosis is more common in women, especially if they are very overweight.&nbsp;Your doctor will perform regular check-ups when you take Baraclude.<br><\/li><li>Inform your doctor&nbsp;<strong>if you have previously been treated for&nbsp;chronic&nbsp;hepatitis B.<\/strong><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Baraclude should not be used by children under 2 years of age or weighing less than 10 kg.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Baraclude<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Baraclude with food and drink<\/h2>\n\n\n\n<p>In most cases, you can take Baraclude with or without food.&nbsp;However, if you have previously been treated with a medicine containing the active substance <a href=\"https:\/\/zeepedia.com\/medical\/medicines\/triumeq\/\">lamivudine<\/a>, you should consider the following.&nbsp;If you have switched to Baraclude treatment because lamivudine treatment has not had sufficient effect, Baraclude should be taken once daily on an empty stomach.&nbsp;If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach.&nbsp;Fasting means at least 2 hours after one meal and at least 2 hours before your next meal.<\/p>\n\n\n\n<p>Children and adolescents (from 2 to younger than 18 years) can take Baraclude with or without food.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>Tell your doctor if you are pregnant or planning to become pregnant.&nbsp;It has not been shown that it is safe to use Baraclude during pregnancy.&nbsp;Baraclude should not be used during pregnancy unless clearly instructed to do so by your doctor.&nbsp;It is important that women of&nbsp;childbearing potential&nbsp;receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.<br><\/p>\n\n\n\n<p>Breast-feeding mothers should not breast-feed during treatment with Baraclude.&nbsp;Tell your doctor if you are breast-feeding.&nbsp;It is unknown whether entecavir, the active substance in Baraclude, is excreted in human milk.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Dizziness, tiredness, and drowsiness are common&nbsp;side effects&nbsp;that can impair your ability to drive and use machines.&nbsp;If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Baraclude contains lactose<\/h2>\n\n\n\n<p>This medicine contains&nbsp;lactose.&nbsp;If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Baraclude<\/h2>\n\n\n\n<p><strong>Not all patients need to take the same&nbsp;dose&nbsp;of Baraclude.<\/strong><br><\/p>\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.<br><\/p>\n\n\n\n<p><strong>For adults<\/strong>, the recommended&nbsp;dose is&nbsp;either 0.5 mg or 1 mg once daily taken orally (by mouth).<br><\/p>\n\n\n\n<p><strong>Your&nbsp;dosage&nbsp;depends on:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have been treated for&nbsp;hepatitis&nbsp;B&nbsp;infection&nbsp;before and what medicine you were given.<\/li><li>if you have kidney problems.&nbsp;Your doctor may&nbsp;prescribe&nbsp;a lower&nbsp;dose&nbsp;or instruct you to take&nbsp;dose&nbsp;one less often than once a day.<\/li><li>the condition of your liver.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">For children and young people<\/h2>\n\n\n\n<p>(from 2 to younger than 18 years) the child&#8217;s doctor determines the correct&nbsp;dosages based on the child&#8217;s weight.&nbsp;Baraclude&nbsp;oral&nbsp;solution is recommended for patients weighing from 10 kg to 32.5 kg.&nbsp;Children weighing at least 32.6 kg can take the oral solution or 0.5 mg tablet.&nbsp;All&nbsp;doses&nbsp;are taken orally (orally) once daily.&nbsp;There are no recommendations for Baraclude for children under 2 years or weighing less than 10 kg.<br><\/p>\n\n\n\n<p>Your doctor will prescribe a&nbsp;dose&nbsp;that is right for you.&nbsp;In order for the medicine to have full effect and to reduce the risk of developing&nbsp;resistance&nbsp;to the treatment, you should always take the&nbsp;dose&nbsp;recommended by your doctor.&nbsp;Your doctor will tell you if and when to stop treatment.<br><\/p>\n\n\n\n<p>Some patients have to take Baraclude on an empty stomach (see&nbsp;<strong>Baraclude with food and drink<\/strong>&nbsp;in&nbsp;<strong>section 2<\/strong>&nbsp;).&nbsp;If your doctor instructs you to take Baraclude on an empty stomach, fasting means at least 2 hours after a meal and at least two hours before the next meal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Baraclude than you should<\/h2>\n\n\n\n<p>Contact your doctor immediately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Baraclude<\/h2>\n\n\n\n<p>It is important that you do not forget to take your medicine.&nbsp;If you forget to take a&nbsp;dose&nbsp;of Baraclude, take it as soon as you can, and then take the next&nbsp;dose&nbsp;as usual at the time you should take it.&nbsp;Do not take the missed&nbsp;dose&nbsp;if you have only a short time to take your next&nbsp;dose.&nbsp;Then wait and take the next&nbsp;dose&nbsp;as usual.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Do not stop taking Baraclude without your doctor&#8217;s instructions<\/h2>\n\n\n\n<p>Some people get very severe hepatitis symptoms when they stop taking Baraclude.&nbsp;Talk to your doctor immediately if you notice any changes in symptoms when you stop treatment.<br><\/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\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects,&nbsp;although not everybody gets them.<br><\/p>\n\n\n\n<p>Patients treated with Baraclude have reported the following side effects:<br><\/p>\n\n\n\n<p><strong>Adults<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea,&nbsp;dyspepsia&nbsp;(problems with digestion that cause discomfort in the stomach and intestines after meals), and elevated levels of liver enzymes in the blood.<\/li><li>uncommon (at least 1 in 1,000 patients): rash, hair loss.<\/li><li>rare (at least 1 in 10,000 patients): severe allergic reactions.<\/li><\/ul>\n\n\n\n<p><strong>Children and young people<\/strong><\/p>\n\n\n\n<p>The side effects&nbsp;experienced by children and adolescents are similar to those described above for adults with the following difference:<\/p>\n\n\n\n<p>Very common (at least 1 in 10 patients): low levels of&nbsp;neutrophils&nbsp;(a type of&nbsp;white blood cell&nbsp;that is important in defending against&nbsp;infections&nbsp;).<br><\/p>\n\n\n\n<p>If you get&nbsp;any side effects, talk to your doctor or pharmacist.&nbsp;This also applies to any&nbsp;side effects&nbsp;not mentioned in this information.<br><\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Baraclude<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the can, pressure pack, or carton after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Pressure packaging: do not store above 30 \u00b0 C.&nbsp;Store in the original package.<\/p>\n\n\n\n<p>Jar: Do not store above 25 \u00b0 C.&nbsp;Close the jar tightly.<br><\/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\">6. Contents of the packaging 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 entecavir.&nbsp;Each film-coated tablet contains 0.5 mg entecavir.<\/li><li>The other ingredients are:&nbsp;<br><em>Tablet core:<\/em>&nbsp;crospovidone,&nbsp;lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.&nbsp;<br><em>Film coatings:<\/em>&nbsp;hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).<\/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>The film-coated tablets (tablets) are white to off-white and triangular.&nbsp;They are marked with &#8220;BMS&#8221; on one side and &#8220;1611&#8221; on the other.&nbsp;Baraclude 0.5 mg film-coated tablets are sold in packs of 30 x 1 or 90 x 1 film-coated tablet (in single-dose blisters) and in cans of 30 film-coated tablets.<br><\/p>\n\n\n\n<p>Not all pack sizes may be marketed in your country.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Bristol-Myers Squibb Pharma EEIG&nbsp;<br>Plaza 254&nbsp;<br>Blanchardstown Corporate Park 2&nbsp;<br>Dublin 15, D15 T867&nbsp;<br>Ireland<br><\/p>\n\n\n\n<p>Manufacturer:<\/p>\n\n\n\n<p>CATALENT ANAGNI SRL&nbsp;<br>Loc.&nbsp;Fontana del Ceraso snc&nbsp;<br>Strada Provinciale 12 Casilina, 41<\/p>\n\n\n\n<p>03012 Anagni (FR)&nbsp;<br>Italy<br><\/p>\n\n\n\n<p>Swords Laboratories T \/ A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing<\/p>\n\n\n\n<p>Plaza 254<\/p>\n\n\n\n<p>Blanchardstown Corporate Park 2<\/p>\n\n\n\n<p>Dublin 15, D15 T867<\/p>\n\n\n\n<p>Ireland<br><\/p>\n\n\n\n<p>Further information on this medicine can be obtained from the representative of the marketing authorization holder:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgique \/ Belgi\u00eb \/ Belgien<\/strong>NV Bristol-Myers Squibb Belgium SATel: + 32 2 352 76 11<\/td><td><strong>Lithuania<\/strong>Bristol-Myers Squibb Kft.Tel: +370 52 369140<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>Bristol-Myers Squibb Kft.Tel: +359 2 4942 480<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>NV Bristol-Myers Squibb Belgium SATel: + 32 2 352 76 11<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Bristol-Myers Squibb spol.&nbsp;s roTel: + 420 221 016 111<\/td><td><strong>Hungary<\/strong>Bristol-Myers Squibb Kft.Tel .: + 36 1 9206 550<\/td><\/tr><tr><td><strong>Denmark<\/strong>Bristol-Myers SquibbTel: + 45 45 93 05 06<\/td><td><strong>Malta<\/strong>Bristol-Myers Squibb SrlTel: + 356 23976333<\/td><\/tr><tr><td><strong>Germany<\/strong>Bristol-Myers Squibb GmbH &amp; Co.&nbsp;KGaATel: 0800 0752002 (+49 (0) 89 121 42\u2011350)<\/td><td><strong>The Netherlands<\/strong>Bristol-Myers Squibb BVTel: + 31 (0) 30 300 2222<\/td><\/tr><tr><td><strong>Eesti<\/strong>Bristol-Myers Squibb Kft.Tel: +372 640 1030<\/td><td><strong>Norway<\/strong>Bristol-Myers Squibb Norway LtdTel: + 47 67 55 53 50<\/td><\/tr><tr><td><strong>Greece<\/strong>Bristol-Myers Squibb AE:\u0397\u03bb: + 30 210 6074300<\/td><td><strong>\u00d6&nbsp;<\/strong><strong>sterreich<\/strong>Bristol-Myers Squibb GesmbHTel: + 43 1 60 14 30<\/td><\/tr><tr><td><strong>Spain<\/strong>Bristol-Myers Squibb, SATel: + 34 91 456 53 00<\/td><td><strong>Poland<\/strong>Bristol-Myers Squibb Polska Sp.&nbsp;z ooTel .: + 48 22 2606400<\/td><\/tr><tr><td><strong>France<\/strong>Bristol-Myers Squibb SARLTel: +33 (0) 1 58 83 84 96<\/td><td><strong>Portugal<\/strong>Bristol-Myers Squibb Pharmac\u00eautica Portuguesa, SATel: + 351 21 440 70 00<\/td><\/tr><tr><td><strong>Croatia<\/strong>Bristol-Myers Squibb spol.&nbsp;s roTel: +385 1 2078 508<\/td><td><strong>Romania<\/strong>Bristol-Myers Squibb Kft.Tel: + 40 (0) 21 272 16 00<\/td><\/tr><tr><td><strong>Ireland<\/strong>Bristol-Myers Squibb Pharmaceuticals ucTel: + 353 (0) 1 483 3625<\/td><td><strong>Slovenia<\/strong>Bristol-Myers Squibb spol.&nbsp;s roTel: +386 1 2355 100<\/td><\/tr><tr><td><strong>Iceland<\/strong>Bristol-Myers Squibb AB at Vistor hf.Phone: + 354 535 7000<\/td><td><strong>Slovak Republic<\/strong>Bristol-Myers Squibb spol.&nbsp;s Rotel: +421 2 20833 600<\/td><\/tr><tr><td><strong>Italy<\/strong>Bristol-Myers Squibb SrlTel: + 39 06 50 39 61<\/td><td><strong>Finland \/ Finland<\/strong>Oy Bristol-Myers Squibb (Finland) AbPuh \/ Tel: + 358 9 251 21 230<\/td><\/tr><tr><td><strong>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>Bristol-Myers Squibb AE:\u0397\u03bb: + 357 800 92666<\/td><td><\/td><\/tr><tr><td><strong>Latvia<\/strong>Bristol-Myers Squibb Kft.Tel: +371 66164750<\/td><td><strong>United Kingdom<\/strong>Bristol-Myers Squibb Pharmaceuticals LtdTel: + 44 (0800) 731 1736<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Baraclude tablet is anti-virus for the treatment of chronic (long-term) infection with hepatitis B virus (HBV) in adults. Baraclude can be used by people whose liver is damaged but still works properly (compensated liver disease) and by people whose liver is damaged and does not work properly (decompensated liver disease).<\/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":[2202,2200],"tags":[9300,9304,9302,4140,9297,9299,9303,9298,9301,4141],"class_list":["post-5894","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-baraclude","tag-baraclude-side-effects","tag-baraclude-tablet","tag-entecavir","tag-entecavir-tablet","tag-side-effects-of-entecavir","tag-what-baraclude-is-used-for","tag-what-entecavir-is-used-for","tag-what-is-baraclude","tag-what-is-entecavir"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5894","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=5894"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5894\/revisions"}],"predecessor-version":[{"id":12188,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5894\/revisions\/12188"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5894"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5894"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5894"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}