INDICATION AND CLINICAL USE
Nitisinone Tablets are indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Treatment with Nitisinone Tablets should be initiated and supervised by a physician experienced in the treatment of HT-1.
IMPORTANT INFORMATION ABOUT NITISINONE TABLETS
How do NITISINONE TABLETS work? NITISINONE TABLETS stop the build-up of toxic substances which cause the severe liver and kidney problems in patients with HT-1. By doing that, they also prevent the porphyric crises associated with HT-1.
What are the ingredients in NITISINONE TABLETS?
- Medicinal ingredients: Nitisinone
- Non-medicinal ingredients: glyceryl dibehenate, lactose monohydrate.
Do not use NITISINONE TABLETS if you:
- Are allergic (hypersensitive) to nitisinone or any of the other ingredients in NITISINONE TABLETS.
- Are breast-feeding. Do not breast feed while taking NITISINONE TABLETS.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NITISINONE TABLETS. Talk about any health conditions or problems you may have, including if you:
- Are pregnant or planning to become pregnant.
How to take NITISINONE TABLETS:
- NITISINONE TABLETS are usually taken twice a day.
- Swallow the tablets whole with a drink of water. NITISINONE TABLETS can be taken with or without food.
- For more information on infant administration refer to the product monograph.
Overdose: If you think you have taken too many NITISINONE TABLETS, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. If you go to a healthcare professional or to the hospital, take the NITISINONE TABLETS container with you.
Missed Dose: If you forget a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, contact your healthcare professional or pharmacist.
Keep out of reach and sight of children. Store your tablets at room temperature (15 – 30°C), in a dry place. Keep the container tightly closed. There is an expiry date on the label. Do not use the medicine after this date.