100 mg hard capsules
miglustat<\/p>\n\n\n\n
In this leaflet you will find information about:
1. What Miglustat Gen.Orph is and what it is used for
2. What you need to know before you use Miglustat Gen.Orph
3. How to take Miglustat Gen.Orph
4. Possible side effects
5. How Miglustat Gen.Orph should be kept
6. Contents of the package and other information<\/p>\n\n\n\n
Miglustat Gen.Orph contains the active substance miglustat, which belongs to a group of medicines that affect\u00a0metabolism.\u00a0It is used to treat two diseases:<\/p>\n\n\n\n
For\u00a0Gaucher\u00a0type 1 disease, a substance called glucosylceramide is not removed from your body.\u00a0It begins to be stored in certain cells that belong to the body’s immune system.\u00a0This can lead to liver and spleen enlargement, changes in the blood, and skeletal disease.<\/p>\n\n\n\n
Gaucher’s type 1 disease is normally treated with enzyme replacement therapy. Miglustat Gen.Orph is used only if the patient is not considered suitable for treatment with enzyme replacement therapy.<\/p>\n\n\n\n
If you have Niemann-Pick C disease, fats, such as glycosphingolipids, are stored in your brain cells.\u00a0This can lead to disturbances in neurological functions such as slow eye movements, balance, swallowing ability, memory, and to seizures.<\/p>\n\n\n\n
Miglustat Gen.Orph works by inhibiting an enzyme called “glucosylceramide synthetase”, which is responsible for the first step in the production of most glycosphingolipids.<\/p>\n\n\n\n
Talk to your doctor or pharmacist before taking Miglustat Gen.Orph<\/p>\n\n\n\n
Your doctor will perform the following checks before and during treatment with Miglustat Gen.Orph:<\/p>\n\n\n\n
The reason for these controls is that some patients have had tingling or numbness in their hands and feet or lost weight during treatment with Miglustat Gen.Orph. The checks make it easier for the doctor to determine if these problems are due to your illness or something you have had in the past, or if they are due to side effects of Miglustat Gen.Orph (for other information see section 4).<\/p>\n\n\n\n
If you get diarrhea, your doctor may ask you to change your diet so that you reduce your intake of milk sugar, and carbohydrates such as sucrose (regular sugar).\u00a0Your doctor may also ask you not to take Miglustat Gen.Orph with food.\u00a0In some cases, your doctor may temporarily lower your\u00a0dose\u00a0or prescribe a medicine for diarrhea (such as loperamide).\u00a0If your diarrhea does not respond to these measures, or if you have any other stomach problems, consult your doctor.\u00a0In this case, your doctor may decide on further investigations.<\/p>\n\n\n\n
Male patients should use reliable contraception during treatment with Miglustat Gen.Orph and for 3 months after stopping treatment.<\/p>\n\n\n\n
Do not give this medicine to children and adolescents (under 18 years of age) with Gaucher type 1 disease because it is not known if it works against that disease.<\/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
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Gen.Orph. They can lower the amount of Miglustat Gen.Orph in your body.<\/p>\n\n\n\n
You should not take Miglustat Gen.Orph if you are pregnant or planning to become pregnant.\u00a0Your doctor can give you more information.\u00a0You must use safe contraception when taking Miglustat Gen.Orph.\u00a0Do not breastfeed while taking Miglustat Gen.Orph.<\/p>\n\n\n\n
Male patients should use reliable contraception during treatment with Miglustat Gen.Orph and 3 months after stopping treatment.<\/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
Miglustat Gen.Orph may make you feel dizzy. Do not drive or use any tools or machines if you feel dizzy.<\/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
For children under the age of 12<\/strong> who have Niemann-Pick type C disease, your doctor will adjust the dose one.<\/p>\n\n\n\n If you have kidney problems, you may receive a lower starting dose.\u00a0Your doctor may reduce your\u00a0dose\u00a0e.g.\u00a0to one capsule (100 mg) once or twice a day if you suffer from diarrhea during treatment with Miglustat Gen.Orph (see section 4).\u00a0Your doctor will tell you how long you will be treated.<\/p>\n\n\n\n Miglustat Gen.Orph can be taken with or without food. You should swallow the whole capsule with a glass of water.<\/p>\n\n\n\n Talk to your doctor immediately if you have taken more capsules than you should.\u00a0Miglustat Gen.Orph has been used in\u00a0clinical trials\u00a0at\u00a0doses\u00a0ten times higher than the recommended\u00a0dose: this caused a decrease in the number of\u00a0white blood cells\u00a0and other\u00a0side effects\u00a0similar to those described in section 4.<\/p>\n\n\n\n Take the next capsule at the usual time.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n Do not stop taking Miglustat Gen.Orph without talking to your doctor.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Most serious side effects:<\/p>\n\n\n\n Some patients have experienced tingling or numbness in the hands and feet (common). <\/strong>This may be a sign of peripheral neuropathy due to side effects of Miglustat Gen.Orph or due to pre-existing conditions. Your doctor will perform some checks before and during treatment with Miglustat Gen.Orph to evaluate this (see section 2).<\/p>\n\n\n\n If you experience any of these symptoms, consult your doctor as soon as possible.<\/strong><\/p>\n\n\n\n If you experience mild tremors<\/strong>, usually in\u00a0your hands,\u00a0\u00a0consult your doctor\u00a0as soon as possible.\u00a0These tremors usually disappear without the need to interrupt treatment.\u00a0Sometimes your doctor will need to reduce the\u00a0dose\u00a0one or discontinue treatment with Miglustat Gen.Orph, to get rid of the tremors.<\/p>\n\n\n\n Very common <\/strong> –<\/em> may affect more than 1 in 10 people<\/p>\n\n\n\n The most common\u00a0side effects\u00a0are diarrhea, gas, abdominal pain, weight loss, and decreased appetite.<\/p>\n\n\n\n Do not worry if you lose any weight<\/strong> when you start treatment with Miglustat Gen.Orph. You usually stop losing weight when the treatment continues.<\/p>\n\n\n\n Common <\/strong>–<\/em> can affect up to 1 in 10 people<\/p>\n\n\n\n Common\u00a0side effects\u00a0of the treatment include headache, dizziness, paracentesis (tingling or numbness), abnormal coordination,\u00a0hypoesthesia\u00a0(decreased sensation), acid regurgitation (heartburn), nausea, constipation and vomiting, swelling or discomfort from the abdomen (stomach), and\u00a0thrombocytopenia\u00a0(decreased\u00a0platelet\u00a0level\u00a0).\u00a0The neurological symptoms and thrombocytopenia may be caused by the underlying disease.<\/p>\n\n\n\n Other possible\u00a0side effects\u00a0are muscle<\/strong>\u00a0spasms or weakness, fatigue, chills and general malaise, depression, difficulty sleeping, forgetfulness, and decreased\u00a0libido.<\/p>\n\n\n\n Most patients experience one or more of these\u00a0side effects, usually at the beginning of treatment or periodically during treatment.\u00a0In most cases, the\u00a0side effects\u00a0are mild and disappear fairly quickly.\u00a0If any of these\u00a0side effects\u00a0occur, consult your doctor.\u00a0He or she can then reduce the\u00a0dose\u00a0of one of Miglustat Gen.Orph or suggest other medications that can help reduce the\u00a0side effects.<\/p>\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 after \u201cEXP\u201d. The expiration date is the last day of the specified month.<\/p>\n\n\n\n This medicine does not require any special storage instructions.<\/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 Miglustat Gen.Orph 100 mg hard capsules are white opaque end and side, hard gelatin capsules, size 4, 14.0 mm long.<\/p>\n\n\n\n Pack size of 84 capsules in non-perforated blister packs and 84×1 capsules in perforated unit dose blister packs.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Gen.Orph<\/p>\n\n\n\n 185 Bureaux de la Colline<\/p>\n\n\n\n 92213 Saint Cloud Cedex<\/p>\n\n\n\n France<\/p>\n\n\n\n Manufacturer:<\/strong><\/p>\n\n\n\n Delpharm Reims<\/p>\n\n\n\n 10 rue Colonel Charbonneaux<\/p>\n\n\n\n 51100 Reims<\/p>\n\n\n\n France<\/p>\n\n\n\n or<\/p>\n\n\n\n Center Lab<\/p>\n\n\n\n ZA Granderaie<\/p>\n\n\n\n 23000 Gu\u00e9ret<\/p>\n\n\n\n France<\/p>\n\n\n\n Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n Miglustat Gen.Orph contains the active substance miglustat, which belongs to a group of medicines that affect metabolism . It is used to treat two diseases:<\/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":[2200,15580],"tags":[17547,17552,17542,17545,17548,17551,17546,17543,17549,17550,17544],"class_list":["post-17966","post","type-post","status-publish","format-standard","hentry","category-medicines","category-m","tag-benefits-of-miglustat","tag-benefits-of-miglustat-gen-orph","tag-miglustat","tag-miglustat-capsule","tag-miglustat-gen-orph","tag-miglustat-gen-orph-side-effects","tag-miglustat-side-effects","tag-what-is-miglustat","tag-what-is-miglustat-gen-orph","tag-what-miglustat-gen-orph-is-used-for","tag-what-miglustat-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17966","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=17966"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17966\/revisions"}],"predecessor-version":[{"id":17984,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17966\/revisions\/17984"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=17966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=17966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=17966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}If you take more Miglustat Gen.Orph than you should<\/h2>\n\n\n\n
If you forget to take Miglustat Gen.Orph<\/h2>\n\n\n\n
If you stop taking Miglustat Gen.Orph<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Miglustat Gen.Orph<\/h2>\n\n\n\n
Contents 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
Marketing Authorisation Holder:<\/h2>\n\n\n\n
Belgium \/ Belgique \/ Belgien<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Lithuania<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Bulgaria<\/strong> Diakomers LODTel .: +359 2 807 50 00Email: diacommerce@diacommerce.bg<\/td> Luxembourg \/ Luxemburg<\/strong>Gene. OrphTel \/ Tel .: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Czech Republic<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Hungary<\/strong>Gen.OrphTel .: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Denmark<\/strong>Gen.OrphTel: +46 (0) 8 21 54 45email: pharmacovigilance.SE@propharmagroup.com<\/td> Malta<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Germany<\/strong>Gen.OrphTel: +49 30 8560687897email: ph armacovigilance.DE@propharmagroup.com<\/td> The Netherlands<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Eesti<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Norway<\/strong>Gen.OrphTel: +46 (0) 8 21 54 45email: pharmacovigilance.SE@propharmagroup.com<\/td><\/tr> Greece<\/strong> Gen.Orph:\u0397\u03bb: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Austria<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Spain<\/strong>Pharma International SATel: +34 915 635 856e-mail:farmacovigilancia@pharmaintl.net<\/td> Poland<\/strong>Gen.OrphTel .: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> France<\/strong>Gen.OrphTel .: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Portugal<\/strong>PharSolution Pharmaceutical Consulting, Lda.Tel: +351 21 464 32 25email: pharmacovigilance@pharsolution.com<\/td><\/tr> Croatia<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Romania<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Ireland<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Slovenia<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Iceland<\/strong>Gen.OrphPhone: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Slovak Republic<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr> Italy<\/strong>Biovalley Investments Partner SrlTel: +39 040 899 2219e.mail: info@biovalleyinvestmentspartner.it<\/td> Finland \/ Finland<\/strong>Gen.OrphPuh \/ Tel: +46 (0) 8 21 54 45email: pharmacovigilance.SE@propharmagroup.com<\/td><\/tr> .\u03a0\u03c1\u03bf\u03c2<\/strong> Gen.Orph:\u0397\u03bb: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> Sweden<\/strong>Gen.OrphTel: +46 (0) 8 21 54 45email: pharmacovigilance.SE@propharmagroup.com<\/td><\/tr> Latvia<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td> United Kingdom<\/strong>Gen.OrphTel: +33 (0) 1 47 71 04 50email: contact@gen-orph.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"