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PATIENT MEDICATION INFORMATION

PrMDK-NitisinoneMC

Nitisinone capsules

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

Read this carefully before you start taking MDK- Nitisinone and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about MDK-Nitisinone.

WHAT IS MDK-NITISINONE USED FOR?
MDK-Nitisinone is used for the treatment of hereditary tyrosinemia type 1 (HT-1), in addition to limiting the amount of tyrosine and phenylalanine in the diet.

HOW DOES MDK-NITISINONE WORK?
MDK-Nitisinone stops the build-up of toxic substances which cause the severe liver and kidney problems in patients with HT-1. By doing that, it also prevents the porphyric crises associated with HT-1.

 WHAT ARE THE INGREDIENTS IN MDK-NITISINONE?

Medicinal ingredient: nitisinone
Non-medicinal ingredients: corn starch, gelatin, iron oxide, shellac glaze, titanium dioxide.

MDK-NITISINONE COMES IN THE FOLLOWING DOSAGE FORMS:

Capsules: 2 mg, 5 mg or 10 mg

 

DO NOT USE MDK-NITISINONE IF YOU:         

  • are allergic (hypersensitive) to nitisinone or any of the other ingredients in MDK-Nitisinone.
  • are breast-feeding. Do not breast feed while taking MDK-Nitisinone.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MDK-Nitisinone. Talk about any health conditions or problems you may have, including if you:

  • are pregnant or planning to become

 

OTHER WARNINGS YOU SHOULD KNOW ABOUT:   

Dietary Changes
Taking MDK-Nitisinone can cause high levels of tyrosine in your blood which can be toxic. As a result, while you are taking MDK-Nitisinone you must limit the amount of tyrosine and phenylalanine in your diet. Talk to your healthcare professional about which foods are safe to eat and which foods should be avoided.

Eye Problems
Your healthcare professional will check your eyes before starting treatment with MDK-Nitisinone. If you develop eye problems while taking MDK- Nitisinone, including sensitivity to light, eye pain, redness, swelling or burning, talk to your healthcare professional immediately.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take MDK-Nitisinone:

  • MDK-Nitisinone is usually taken twice a day
  • MDK-Nitisinone can be taken with or without food however, it should always be taken the same Therefore, if you start taking MDK-Nitisinone with food, you should always take it with food.
  • For young children, MDK-Nitisinone capsules can be opened and the contents sprinkled into a small amount of water or formula immediately before use

Usual dose:
Your healthcare professional will tell you how much MDK-Nitisinone to take and when to take it.

Overdose:
If you think you have taken too much MDK-Nitisinone, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:
If you miss a dose by less than 12 hours, take it as soon as you remember.

What are possible side effects from using MDK- Nitisinone?
These are not all the possible side effect you may feel when taking MDK-Nitisinone. If you experience any side effects not listed here, contact your healthcare professional.

MDK-Nitisinone can cause abnormal blood test results. While you are taking MDK-Nitisinone your healthcare professional will decide when to perform blood tests and will interpret the results.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Symptom / effect Talk to your healthcare professional Stop taking drug and get immediate medical help
COMMON
Low Platelets:

easy or unusual bruising.

Bleeding into the skin causing a rash of pinpoint-sized reddish-purple spots, usually in the lower legs, prolonged bleeding from cuts, bleeding from your gums or nose, blood in urine or stools.

Low White Blood Cells: infections, fatigue, weakness, fever, aches and pains, flu-like symptoms.
Eye Problems: redness, eye discharge, itchy eyes, burning eyes, blurred vision, sensitivity to light, milky or cloudy area on the eye, eye pain, a feeling that there is something in your eye
RARE
Skin Problems: dry/ cracked/scaly skin, rashes, small flat red bumps, itching that can be severe, blisters, draining fluid and crusting, swelling, burning, tenderness, loss of hair in patches.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect (www.healthcanada.gc.ca/medeffect);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program, Health Canada, Postal Locator 0701E Ottawa, ON, K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

STORAGE:
Store refrigerated between 2-8°C.
Keep out of reach and sight of children.

IF YOU WANT MORE INFORMATION ABOUT MDK-NITISINONE:

  • Talk to your healthcare
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.healthcanada.gc.ca); the manufacturer’s website www.mendelikabs.com, by calling 1-888-959-9987 or by sending an email to: contact@mendelikabs.com