2 mg, 5 mg, 10 mg Hard capsules
nitisinone<\/p>\n\n\n\n
The active substance in Nitisinone MDK is nitisinone.\u00a0This medicine is used to treat a rare disease called\u00a0hereditary\u00a0tyrosinemia type 1 in adults, adolescents, and children (in all ages).<\/p>\n\n\n\n
In this disease, your body can not break down the amino acid tyrosine completely ( amino acids are the building blocks of our proteins), which causes harmful substances to be formed. These substances accumulate in your body.<\/p>\n\n\n\n
Nitisinone MDK blocks the breakdown of tyrosine and therefore the harmful substances are not formed.<\/p>\n\n\n\n
You must follow a special diet when taking this medicine as tyrosine will remain in your body. This particular diet has low levels of tyrosine and phenylalanine (another amino acid ).<\/p>\n\n\n\n
– if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n
Do not breastfeed while taking this medicine, see section “Pregnancy and breast-feeding”.<\/p>\n\n\n\n
Talk to your doctor or pharmacist before taking Nitisinone MDK<\/p>\n\n\n\n
– Your eyes are checked before and regularly during treatment with nitisinone. If your eyes turn red or show other signs of exposure. In this case, contact your doctor immediately to have your eyes examined. Eye problems may be a sign of inadequate dietary control, see section 4.<\/p>\n\n\n\n
During the treatment, blood tests will be taken so that your doctor can check that the treatment is adequate and to ensure that it does not have side effects that cause blood disorders.<\/p>\n\n\n\n
Your liver is checked regularly because the disease affects the liver.<\/p>\n\n\n\n
A follow-up examination should be done every 6 months by your doctor.\u00a0If you experience\u00a0side effects, shorter intervals between examinations are recommended.<\/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
Nitisinone MDK may affect the effectiveness of other medicines, for example:<\/p>\n\n\n\n
medicines for epilepsy (eg phenytoin )<\/p>\n\n\n\n
medicines for blood clots (eg warfarin ).<\/p>\n\n\n\n
If you start treatment with Nitisinone MDK with food, you should continue with it throughout the treatment.<\/p>\n\n\n\n
The safety of this medicine has not been studied in pregnant and lactating women.<\/p>\n\n\n\n
Contact your doctor if you are planning to become pregnant. If you become pregnant, you should contact your doctor immediately.<\/p>\n\n\n\n
Do not breastfeed while taking this medicine, see section \u201cDo not take Nitisinone MDK\u201d.<\/p>\n\n\n\n
This medicine has less effect on the ability to drive and use machines. However, if you experience side effects that affect your vision, do not drive or use machines until your vision is normal again (see section 4 \u201cPossible side effects\u201d).<\/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
Treatment with this drug should be initiated and supervised by a physician experienced in the management of the disease ( hereditary tyrosinemia type 1).<\/p>\n\n\n\n
The recommended total daily dose is 1 mg\/kg body weight given orally.\u00a0Your doctor will adjust the\u00a0dose\u00a0individually.\u00a0Dosage\u00a0once daily is recommended.\u00a0However, due to limited data in patients with body weight <20 kg, it is recommended that the total daily dose be divided into two daily doses for these patients.<\/p>\n\n\n\n
If you have problems swallowing capsules, you can open them and mix the powder in a small amount of water or diet product in liquid form just before taking the medicine.<\/p>\n\n\n\n
If you have taken more medicine than you should, contact your doctor or pharmacist as soon as possible.<\/p>\n\n\n\n
Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0If you forget to take a\u00a0dose, contact your doctor or pharmacist.<\/p>\n\n\n\n
Contact your doctor if you feel that the effect of the medicine is too strong or weak. Do not change the dose or stop the treatment 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
If you notice any\u00a0side effects\u00a0that affect your eyes, you should consult your doctor immediately to have your eyes examined.\u00a0Treatment with nitisinone leads to higher tyrosine levels in the blood which can cause eye-related symptoms.\u00a0Common eye-related\u00a0side effects\u00a0(may affect more than 1 in 10 patients) caused by higher tyrosine levels are\u00a0inflammation\u00a0of the eye (\u00a0conjunctivitis\u00a0), cloudiness, inflammation\u00a0of the cornea (\u00a0keratitis\u00a0), photosensitivity (\u00a0photophobia\u00a0), and eye pain.\u00a0Inflammation\u00a0of the eyelid (\u00a0blepharitis\u00a0) is a less common\u00a0side effect\u00a0(may affect up to 1 in 100 patients).<\/p>\n\n\n\n
Other common side effects <\/em><\/strong><\/p>\n\n\n\n Decreased platelet count ( thrombocytopenia ) and white blood cells (leukocytopenia), deficiency of certain white blood cells ( granulocytopenia ).<\/p>\n\n\n\n Other less common side effects <\/em><\/strong><\/p>\n\n\n\n -Increased white blood cell count ( leukocytosis ),<\/p>\n\n\n\n itching ( pruritus ), dermatitis (exfoliative dermatitis ), skin rash.<\/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 and jar after \u201cEXP\u201d. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Store in the original package. Sensitive to light.<\/p>\n\n\n\n The product can be stored at temperatures up to 25 \u00b0 C for 2 months, after the first opening of the bottle, after which the product must be discarded.<\/p>\n\n\n\n Do not forget to write down the date on the jar when you take it out of the fridge.<\/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 Nitisinone MDK 2 mg<\/em>: Each capsule contains 2 mg nitisinone.<\/p>\n\n\n\n Nitisinone MDK 5 mg<\/em>: Each capsule contains 5 mg nitisinone.<\/p>\n\n\n\n Nitisinone MDK 10 mg<\/em>: Each capsule contains 10 mg nitisinone.<\/p>\n\n\n\n Capsule contents: pregelatinized maize starch<\/p>\n\n\n\n Capsule shell: gelatin, titanium dioxide (E 171)<\/p>\n\n\n\n Printing ink: black iron oxide (E 172), shellac cover<\/p>\n\n\n\n The capsules are 15.7 mm long, white, opaque, and made of hard gelatin.\u00a0They are marked with “Nitisinone” and the strength “2 mg”, “5 mg” or “10 mg” in black.\u00a0The capsules contain a white to off-white powder.<\/p>\n\n\n\n The capsules are packed in plastic jars. Each jar contains 60 capsules and each carton contains one jar.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n MendeliKABS Europe Limited<\/p>\n\n\n\n 3D Unit, North Point House<\/p>\n\n\n\n North Point Business Park<\/p>\n\n\n\n New Mallow Road<\/p>\n\n\n\n Cork, T23 AT2P, Ireland<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Elara Pharmaservices Limited<\/p>\n\n\n\n Iron Farm<\/p>\n\n\n\n 7 Grimes Gate, Diseworth<\/p>\n\n\n\n Leicestershire, DE74 2QD<\/p>\n\n\n\n UK<\/p>\n","protected":false},"excerpt":{"rendered":" The active substance in Nitisinone MDK is nitisinone. This medicine is used to treat a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in all ages).<\/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":[2200,15581],"tags":[18952,18948,18951,18949,18950],"class_list":["post-19053","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-nitisinone","tag-nitisinone","tag-nitisinone-side-effects","tag-what-is-nitisinone","tag-what-nitisinone-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19053","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=19053"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19053\/revisions"}],"predecessor-version":[{"id":19088,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19053\/revisions\/19088"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19053"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19053"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19053"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}How to store Nitisinone MDK<\/h2>\n\n\n\n
Contents of the package 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 Authorization Holder and Manufacturer<\/h2>\n\n\n\n