500 mg capsule, hard
hydroxycarbamide<\/p>\n\n\n\n
Oribamide contains the active substance hydroxycarbamide, which belongs to a group of medicines used in certain blood diseases and prevents the growth of cancer cells.<\/p>\n\n\n\n
This medicine has been prescribed by your doctor for the treatment of blood diseases (\u00a0tumors\u00a0in the bone marrow:\u00a0chronic myeloid leukemia,\u00a0essential\u00a0thrombocythemia,\u00a0and\u00a0polycythemia vera\u00a0).<\/p>\n\n\n\n
Hydroxycarbamide contained in Oribamide may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before taking Oribamide.
Treatment with hydroxycarbamide requires extensive monitoring.\u00a0Before and during treatment with this medicine, your blood levels will be tested to check that you have enough\u00a0blood cells, as well as tests of kidney and liver function to check that they are adequate.\u00a0The tests of the blood values \u200b\u200bare normally done once a week.<\/p>\n\n\n\n
If you have a decrease in the number of\u00a0red blood cells,\u00a0anemia\u00a0(\u00a0anemia\u00a0), before or develop it during treatment,\u00a0red blood cells\u00a0can be added if necessary.<\/p>\n\n\n\n
If\u00a0hemolytic anemia\u00a0(a disease in which\u00a0red blood cells\u00a0are destroyed faster than they are created) is detected after your blood tests have been checked, your doctor will stop treatment with Oribamide.<\/p>\n\n\n\n
You should drink plenty of fluids during the treatment.<\/p>\n\n\n\n
If you have kidney or liver problems, tell your doctor before starting treatment with this medicine.<\/p>\n\n\n\n
If you receive long-term treatment with hydroxycarbamide, secondary leukemia may develop. To what extent this is due to the underlying disease or due to the treatment with hydroxycarbamide is currently unknown.<\/p>\n\n\n\n
Skin cancer has been reported in patients receiving long-term treatment with hydroxycarbamide. You must protect your skin from sunlight and examine your skin regularly during and after treatment with hydroxycarbamide. Your doctor will also examine your skin in connection with recurring follow-up visits.<\/p>\n\n\n\n
You can get leg ulcers. If so, your doctor will decide if you should continue to take this medicine. Leg ulcers usually heal slowly after a few weeks if you stop taking this medicine.<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
If you have previously received or are still receiving similar medications or radiation therapy,\u00a0side effects\u00a0may occur more often and be more severe.\u00a0Such\u00a0side effects\u00a0mainly include a decrease in the number of\u00a0blood cells\u00a0(suppressed bone marrow function),\u00a0inflammation of the\u00a0lining\u00a0of the stomach,\u00a0and\u00a0inflammation\u00a0of the skin.<\/p>\n\n\n\n
Previous or concurrent radiation therapy may cause redness and irritation of the skin.<\/p>\n\n\n\n
Hydroxycarbamide may increase the activity of NRTIs (nucleoside reverse transcriptase inhibitors), which are medicines used to treat HIV (eg didanosine, stavudine). Hydroxycarbamide in combination with NRTIs may increase the risk of side effects of NRTIs.<\/p>\n\n\n\n
If you have recently been vaccinated or are planning a vaccination, tell your doctor.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
There is a risk of harmful effects on the fetus. Therefore, do not take this medicine during pregnancy except on the prescription of a doctor.<\/p>\n\n\n\n Oribamide must not be used during breastfeeding.\u00a0Therefore, you must stop breastfeeding before taking this medicine for the first time.<\/p>\n\n\n\n Men should use effective contraception during treatment and for at least 3 months after stopping treatment. Ask your doctor about the possibility of sperm preservation before starting treatment.<\/p>\n\n\n\n Reactivity may be impaired during treatment with Oribamide. This should be remembered when sharper attention is needed, e.g. when driving and using machines.<\/p>\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 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 In\u00a0chronic myeloid leukemia, the usual starting\u00a0dose\u00a0is 40 mg per kg body weight daily.\u00a0Dose\u00a0one is then adjusted individually depending on the number of\u00a0white blood cells\u00a0in the blood.<\/p>\n\n\n\n Elderly patients may be more sensitive to hydroxycarbamide and may need a lower\u00a0dose.<\/p>\n\n\n\n The capsules should be swallowed whole and must not be dissolved in the mouth. The capsules should be handled with care. You should use gloves or wash your hands thoroughly after handling them. Although the risk to the fetus is minimal, pregnant women should avoid handling the capsules.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.\u00a0You may have symptoms related to the mucous membranes and skin.<\/p>\n\n\n\n It is important to complete the medication exactly as your doctor has prescribed it.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0If you miss a single\u00a0dose, continue treatment as\u00a0prescribed.\u00a0If you miss several\u00a0doses, continue treatment as prescribed, but contact your doctor for further advice.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children. Hard gelatin capsules with an opaque pink capsule body and an opaque light green top containing a white to off-white, homogeneous powder. The capsule size is 7.6 x 21.7 mm.<\/p>\n\n\n\n Orifarm Generics A \/ S<\/p>\n\n\n\n Energizer 15<\/p>\n\n\n\n 5260 Odense S<\/p>\n\n\n\n Denmark<\/p>\n\n\n\n Orifarm Generics AB,<\/p>\n\n\n\n Box 56048<\/p>\n\n\n\n 102 17 Stockholm <\/p>\n\n\n\n info@orifarm.com<\/p>\n\n\n\n Denmark, Finland, Norway, Sweden: Oribamide<\/p>\n","protected":false},"excerpt":{"rendered":" Oribamide contains the active substance hydroxycarbamide, which belongs to a group of medicines used in certain blood diseases and prevents the growth of cancer cells.<\/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":[13516,20242,13512,13517,20238,20241,13514,13513,20239,20240],"class_list":["post-19936","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-hydroxycarbamide","tag-benefits-of-oribamide","tag-hydroxycarbamide","tag-hydroxycarbamide-side-effects","tag-oribamide","tag-oribamide-side-effects","tag-what-hydroxycarbamide-is-used-for","tag-what-is-hydroxycarbamide","tag-what-is-oribamide","tag-what-oribamide-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19936","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=19936"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19936\/revisions"}],"predecessor-version":[{"id":19975,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19936\/revisions\/19975"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19936"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19936"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19936"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Pregnancy<\/em><\/p>\n\n\n\n
You must use effective contraception before and during treatment with this medicine. If you become pregnant while taking or after taking this medicine, you should contact your doctor.<\/p>\n\n\n\n
Breast-feeding<\/em><\/p>\n\n\n\n
Fertility<\/em><\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
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\nOribamide contains lactose<\/h2>\n\n\n\n
How to take Oribamide<\/h2>\n\n\n\n
Adults<\/em><\/p>\n\n\n\n
In\u00a0polycythemia vera, the usual initial\u00a0dose\u00a0is 15-20 mg per kg body weight daily.\u00a0Dose\u00a0one is then adjusted individually to 1-2 capsules (500-1,000 mg) depending on the blood value.<\/p>\n\n\n\n
In\u00a0essential\u00a0thrombocythemia, the usual initial\u00a0dose\u00a0is 15 mg per kg body weight daily with individual\u00a0dose\u00a0adjustment depending on the blood value.<\/p>\n\n\n\n
Elderly patients<\/em><\/p>\n\n\n\n
Careful handling<\/em><\/p>\n\n\n\nIf you take more Oribamide than you should<\/h2>\n\n\n\n
If you forget to take Oribamide<\/h2>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\nPossible side effects<\/h2>\n\n\n\n
Contact a doctor immediately if you get symptoms such as:<\/strong><\/p>\n\n\n\n
Very common<\/strong> (may affect more than 1 user in 10):<\/p>\n\n\n\n
Common<\/strong> (may affect up to 1 in 10 people):<\/p>\n\n\n\n
Uncommon<\/strong> (may affect up to 1 in 100 people):<\/p>\n\n\n\n
Rare<\/strong> (may affect up to 1 in 1,000 people):<\/p>\n\n\n\n
Very rare<\/strong> (may affect up to 1 in 10,000 people):<\/p>\n\n\n\n
Has been reported<\/strong> (occurs in an unknown number of users):<\/p>\n\n\n\n
Cases of low levels of\u00a0sodium\u00a0which can cause fatigue and confusion, muscle twitching, seizures, or\u00a0coma\u00a0have been observed after the market introduction.<\/p>\n\n\n\n
High doses can cause moderate drowsiness.<\/p>\n\n\n\n
If you receive long-term treatment with hydroxycarbamide, secondary leukemia (blood cancer) may develop. To what extent this is due to the underlying disease or due to the treatment with hydroxycarbamide is currently unknown.<\/p>\n\n\n\nHow to store Oribamide<\/h2>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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\nContents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Blister pack (PVC \/ ACLAR \/ Alu): 100 capsules.<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Local representative:<\/strong><\/p>\n\n\n\n
This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\n