Use effective contraception<\/strong> when taking Odefsey.<\/li><\/ul>\n\n\n\nIf you are pregnant, ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n
If you have taken Odefsey during pregnancy, your doctor may ask for regular blood tests and other diagnostic tests to monitor your baby’s development.\u00a0In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of\u00a0HIV\u00a0protection outweighed the risk of\u00a0side effects.<\/p>\n\n\n\n
Do not breast-feed during treatment with Odefsey. <\/strong>The reason is some of the active substances in this drug pass into breast milk. To avoid transmitting HIV to your baby through breast milk, you should not breast-feed your baby.<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Do not drive or use machines if you feel tired, drowsy or dizzy after taking this medicine.<\/p>\n\n\n\n
Odefsey contains lactose and sodium<\/h2>\n\n\n\n
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
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.<\/p>\n\n\n\n
\u2192 If any of these apply to you, talk to your doctor before taking Odefsey.<\/strong><\/p>\n\n\n\nHow to take Odefsey<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
The recommended dose is:<\/strong><\/p>\n\n\n\nAdults:<\/strong> one tablet a day with food<\/p>\n\n\n\nAdolescents <\/strong>12 years and older, weighing at least 35 kg:<\/strong> one tablet a day with food.<\/p>\n\n\n\nIt is important to take Odefsey with food to get the right levels of active substance in the body. A nutritional drink alone does not replace a meal.<\/p>\n\n\n\n
It is recommended not to chew, crush or split the tablet due to the bitter taste.<\/p>\n\n\n\n
If you are taking antacids,<\/strong>\u00a0e.g.\u00a0aluminum\/magnesium hydroxide or\u00a0calcium carbonate, you should take it at least 2 hours before or at least 4 hours after Odefsey.<\/p>\n\n\n\nIf you are taking an H2\u00a0antagonist,<\/strong>\u00a0e.g.\u00a0famotidine, cimetidine, nizatidine or ranitidine, you should take it at least 12 hours before or at least 4 hours after Odefsey.\u00a0H\u00a02<\/sub>\u00a0antagonist\u00a0can\u00a0only be taken once daily if you are taking Odefsey.\u00a0H\u00a02<\/sub>\u00a0– your\u00a0antagonist\u00a0should not be taken twice a day.\u00a0Talk to your doctor about an alternative treatment.<\/p>\n\n\n\nIf you are on\u00a0dialysis<\/strong>, take your daily\u00a0dose\u00a0of Odefsey after completing\u00a0dialysis.<\/p>\n\n\n\nIf you take more Odefsey than you should<\/h2>\n\n\n\n
If you accidentally take more than the prescribed\u00a0dose\u00a0of Odefsey, the risk of\u00a0side effects\u00a0with this medicine may increase (see section 4,\u00a0Possible\u00a0side effects\u00a0)<\/em>.<\/p>\n\n\n\nContact your doctor or nearest emergency department immediately for advice. Save or take the jar with you so that you can easily describe what you have taken.<\/p>\n\n\n\n
If you forget to take Odefsey<\/h2>\n\n\n\n
You mustn’t miss a\u00a0dose\u00a0of Odefsey.<\/p>\n\n\n\n
If you miss a dose:<\/p>\n\n\n\n
- If you notice it within 12 hours<\/strong> of the time you usually take Odefsey, you must take the tablet as soon as possible. The tablet must always be taken with food. Then take the next dose as usual.<\/li>
- If you notice it 12 hours or more<\/strong> after the time you usually take Odefsey, do not take the missed dose . Wait and take the next dose of food at the usual time.<\/li><\/ul>\n\n\n\n
If you vomit within less than 4 hours after a\u00a0dose\u00a0of Odefsey,<\/strong>\u00a0take a new tablet of food.\u00a0If you vomit more than 4 hours after taking Odefsey<\/strong>, you do not need to take a new tablet until the next normally scheduled tablet.<\/p>\n\n\n\nDo not stop taking Odefsey<\/h2>\n\n\n\n
Do not stop taking Odefsey without talking to your doctor. <\/strong>If you stop taking Odefsey, it could seriously affect the outcome of your future treatment. If for any reason you stop taking Odefsey, talk to your doctor before taking Odefsey tablets again.<\/p>\n\n\n\nWhen your Odefsey supply starts to run out,<\/strong> get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop taking the medicine for a short time. The disease can then become more difficult to treat.<\/p>\n\n\n\nIf you have both\u00a0HIV\u00a0infection\u00a0and\u00a0hepatitis\u00a0B<\/strong>,\u00a0you mustn’t stop taking Odefsey without first talking to your doctor.\u00a0You may need to submit blood samples for several months after stopping treatment.\u00a0In some patients with advanced liver disease or\u00a0cirrhosis, discontinuation of treatment is not recommended, as this may lead to worsening of\u00a0hepatitis\u00a0A, which may be life-threatening.<\/p>\n\n\n\n\u2192\u00a0<\/strong>\u00a0Tell your doctor immediately<\/strong>\u00a0about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your\u00a0hepatitis\u00a0B\u00a0infection.<\/p>\n\n\n\nIf you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
Possible side effects: Contact a doctor immediately<\/strong><\/p>\n\n\n\n- Signs of inflammation or infection . <\/strong>In some patients with advanced HIV infection ( AIDS ) who have previously had opportunistic infections ( infections that occur in people with weakened immune systems), signs and symptoms of inflammation from previous infections may appear shortly after starting HIV treatment. . It is believed that these symptoms are due to the fact that the body’s immune system has been strengthened so that the body can fight infections that may have been present without giving any clear symptoms.<\/li>
- Autoimmune diseases,<\/strong> when the immune system attacks healthy body tissue, can also occur after you start taking medicines for HIV infection . Autoimmune diseases can occur many months after starting treatment. Be observant of symptoms of infection or other symptoms such as:- muscle weaknessweakness that begins in the hands and feet and moves towards the torsopalpitations, tremors or hyperactivity.<\/li><\/ul>\n\n\n\n
\u2192 If you notice these or other symptoms of\u00a0inflammation\u00a0or\u00a0infection, tell your doctor immediately.<\/strong><\/p>\n\n\n\nVery common side effects are<\/strong><\/p>\n\n\n\n(may occur in more than 1 in 10 people)<\/em><\/p>\n\n\n\n- insomnia _<\/em> _<\/li>
- headache<\/li>
- dizziness<\/li>
- nausea<\/li><\/ul>\n\n\n\n
Tests can also show:<\/em><\/p>\n\n\n\n- increased levels of cholesterol and \/ or pancreatic amylase (a digestive enzyme) in the blood<\/li>
- increased levels of liver enzymes in the blood<\/li><\/ul>\n\n\n\n
Common side effects are<\/strong><\/p>\n\n\n\n(can occur in up to 1 in 10 people)<\/em><\/p>\n\n\n\n- decreased appetite<\/li>
- Depression<\/li>
- abnormal dreams<\/li>
- sleep disorders<\/li>
- Depression<\/li>
- somnolence<\/li>
- fatigue<\/li>
- abdominal pain or discomfort<\/li>
- nausea ( vomiting<\/em> )<\/li>
- bloated feeling<\/li>
- dry mouth<\/li>
- flatulence<\/em> _ _<\/em><\/em><\/li>
- diarrhea<\/li>
- rash<\/li><\/ul>\n\n\n\n
Tests can also show:<\/em><\/p>\n\n\n\n- low white blood cell count (a decrease in white blood cell count may make you more prone to infection )<\/li>
- low platelet count (a type of blood cell involved in the coagulation of blood)<\/li>
- decreased hemoglobin in the blood<\/li>
- increased fatty acids ( triglycerides<\/em> ), bilirubin <\/em>or lipase in the blood<\/li><\/ul>\n\n\n\n
Uncommon side effects are<\/strong><\/p>\n\n\n\n(can occur in up to 1 in 100 people)<\/em><\/p>\n\n\n\n- signs or symptoms of inflammation or infection<\/li>
- low red blood cell count ( anemia<\/em> )<\/li>
- severe skin reactions including rash along with fever, swelling and liver problems<\/li>
- indigestion which results in discomfort after meals ( dyspepsia )<\/li>
- swelling of the face, lips, tongue or throat ( angioedema<\/em> )<\/li>
- pruritus _ _<\/em> _<\/li>
- hives ( urticaria<\/em> )<\/li>
- joint pain ( arthralgia<\/em> )<\/li><\/ul>\n\n\n\n
\u2192 If any side effects get worse, talk to your doctor.<\/strong><\/p>\n\n\n\nOther side effects that may occur during HIV treatment<\/strong><\/p>\n\n\n\nThe frequency of the following side effects is not known (frequency can not be calculated from the available data).<\/p>\n\n\n\n
- Skeletal problem. <\/strong>Some patients taking combination antiretroviral medicines such as Odefsey may develop a skeletal disease called osteonecrosis<\/em> (bone tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing this disease are long-term use of this type of drug, treatment with corticosteroids , alcohol consumption, a very weak immune system and obesity. Signs of osteonecrosis are:joint stiffness- joint pain and pain (especially in the hips, knees and shoulders)- mobility difficulties<\/li><\/ul>\n\n\n\n
\u2192 Tell your doctor if you notice any of these symptoms.<\/strong><\/p>\n\n\n\nDuring HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. Your doctor will perform tests to find such changes.<\/p>\n\n\n\n
How to store Odefsey<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton and can after {EXP}. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Store in the original package. Moisture sensitive. Close the jar tightly.<\/p>\n\n\n\n
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n
The active substances are<\/strong> emtricitabine, rilpivirine and tenofoviralafenamide. One Odefsey tablet contains 200 mg emtricitabine, rilpivirine hydrochloride equivalent to 25 mg rilpivirine and tenofoviralafenamide fumarate equivalent to 25 mg tenofoviralafenamide.<\/p>\n\n\n\nThe other ingredients are<\/strong><\/p>\n\n\n\nTablet core:<\/em><\/p>\n\n\n\nCroscarmellose sodium, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.<\/p>\n\n\n\n
Film coating:<\/em><\/p>\n\n\n\nMacrogol, polyvinyl alcohol, talc, titanium dioxide (E171), black iron oxide (E172).<\/p>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Odefsey is a gray, capsule-shaped, film-coated tablet debossed with \u201cGSI\u201d on one side and \u201c255\u201d on the other side.\u00a0Odefsey is delivered in cans of 30 tablets and packs of 3 cans, each with 30 tablets.\u00a0Each jar contains a desiccant in the form of silica gel which must be stored in the jar to protect the tablets.\u00a0The desiccant (silica gel) is in a separate\u00a0sachet\u00a0or container and should not be swallowed.<\/p>\n\n\n\n
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Marketing Authorisation Holder:<\/strong><\/p>\n\n\n\nGilead Sciences Ireland UC<\/p>\n\n\n\n
Carrigtohill<\/p>\n\n\n\n
County Cork, T45 DP77<\/p>\n\n\n\n
Ireland<\/p>\n\n\n\n
Manufacturer<\/strong><\/p>\n\n\n\nGilead Sciences Ireland UC<\/p>\n\n\n\n
IDA Business and Technology Park<\/p>\n\n\n\n
Carrigtohill<\/p>\n\n\n\n
County Cork<\/p>\n\n\n\n
Ireland<\/p>\n","protected":false},"excerpt":{"rendered":"
Odefsey is an antiviral medicine used to treat human immunodeficiency virus ( HIV ) infection . It is a single tablet containing a combination of three active substances: emtricitabine, rilpivirine and tenofoviralafenamide. Each of these active substances works by acting on an enzyme called “reverse transcriptase”, which is necessary for the HIV -1 virus to multiply.<\/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":[3398,4328,19597,19600,3394,4738,5872,5877,8832,4318,19598,4737,5873,19599,14838,8833],"class_list":["post-19488","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-emtricitabine","tag-emtricitabine-tablet","tag-odefsey","tag-odefsey-tablet","tag-rilpivirine","tag-rilpivirine-tablet","tag-tenofoviralafenamide","tag-tenofoviralafenamide-tablet","tag-what-emtricitabine-is-used-for","tag-what-is-emtricitabine","tag-what-is-odefsey","tag-what-is-rilpivirine","tag-what-is-tenofoviralafenamide","tag-what-odefsey-is-used-for","tag-what-rilpivirine-is-used-for","tag-what-tenofoviralafenamide-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19488","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=19488"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19488\/revisions"}],"predecessor-version":[{"id":19522,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19488\/revisions\/19522"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19488"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19488"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19488"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}