Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Nitisinone
Dipharma Arzneimittel GmbH
A16AX04
Nitisinone
Capsule, hard
nitisinone
2020-05-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NITISINONE DIPHARMA 2 MG HARD CAPSULES NITISINONE DIPHARMA 20 MG HARD CAPSULES Nitisinone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nitisinone Dipharma is and what it is used for 2. What you need to know before you take Nitisinone Dipharma 3. How to take Nitisinone Dipharma 4. Possible side effects 5. How to store Nitisinone Dipharma 6. Contents of the pack and other information 1. WHAT NITISINONE DIPHARMA IS AND WHAT IT IS USED FOR Nitisinone Dipharma contains the active substance nitisinone. Nitisinone Dipharma is used to treat - a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range) - a rare disease called alkaptonuria (AKU) in adults. In these diseases your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances. These substances are accumulated in your body. Nitisinone Dipharma blocks the breakdown of tyrosine and the harmful substances are not formed. For the treatment of hereditary tyrosinemia type 1, you must follow a special diet while you are taking this medicine, because tyrosine will remain in your body. This special diet is based on low tyrosine and phenylalanine (another amino acid) content. For the treatment of AKU, your doctor may advice you to follow a special diet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITISINONE DIPHARMA DO NOT TAKE NITISINONE DIPHARMA - if you are allergic t Soma hati kamili
Health Products Regulatory Authority 02 December 2022 CRN00D83F Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nitisinone Dipharma 2 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 2 mg nitisinone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. White, opaque capsules (shell size 3, length 15.9 mm) imprinted "company logo" on the cap and "2" on the body of the capsule in dark blue ink The capsules contain a white to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hereditary tyrosinemia type 1 (HT-1) Nitisinone Dipharma is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Alkaptonuria (AKU) Nitisinone Dipharma is indicated for the treatment of adult patients with alkaptonuria (AKU). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HT-1: Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients. Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease. Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8). _Starting dose HT-1_ The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally. The dose of nitisinone should be adjusted individually. It is recommended to administer the dose once daily. However, due to the limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population. _Dose adjustment HT-1_ During regular monitoring, it is appropriate to follow urine su Soma hati kamili