Nitisinone MDK 2 mg hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Nitisinone MDK 2 mg hard capsules

Nitisinone MDK 5 mg hard capsules

Nitisinone MDK 10 mg hard capsules

nitisinone

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Nitisinone MDK is and what it is used for

2. What you need to know before taking Nitisinone MDK

3. How to take Nitisinone MDK

4. Possible side effects

5. How to store Nitisinone MDK

6. Contents of the pack and other information

1. What Nitisinone MDK is and what it is used for

The active substance of Nitisinone MDK is nitisinone. This medicine is used for the treatment of a rare disease called hereditary tyrosinaemia type 1 in adults, adolescents, and children (of any age group).

In this disease, your body cannot fully break down the amino acid tyrosine (amino acids are the building blocks of proteins), leading to the formation of toxic substances. These substances accumulate in your body. Nitisinone MDK blocks the breakdown of tyrosine, thereby preventing the formation of toxic substances.

You must follow a special diet while taking this medicine, because tyrosine will still remain in your body. This diet is low in tyrosine and phenylalanine (another amino acid).

2. What you need to know before starting to take Nitisinone MDK

Do not take Nitisinone MDK

• if you are allergic to nitisinone or to any of the other ingredients of this medicine (listed in section 6).

Do not breast-feed while taking this medicine (see section “Pregnancy and breast-feeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Nitisinone MDK,

• An ophthalmologist will examine your eyes before starting treatment and regularly during treatment with nitisinone. If you notice redness of the eyes or any other eye-related symptoms, contact your doctor immediately for an ophthalmological examination. Eye problems (see section 4) may indicate inadequate dietary control.

During treatment, blood samples will be taken to monitor whether the treatment is appropriate and to ensure that there are no side effects causing blood abnormalities.

You will undergo periodic liver function checks because the disease affects the liver.

Your doctor should monitor you every 6 months. If you experience any adverse reactions, shorter monitoring intervals are recommended.

Other medicines and Nitisinone MDK

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Nitisinone MDK may interfere with the effect of other medicines, such as:

• Medicines for epilepsy (such as phenytoin)
• Medicines to prevent blood clots (such as warfarin)

Use of Nitisinone MDK with food and drink

If you start treatment taking it with food and drink, it is recommended to continue this regimen throughout the entire treatment.

Pregnancy and breast-feeding

The safety of this medicine in pregnant and breast-feeding women has not been studied.

Consult your doctor if you are planning to become pregnant. If you become pregnant, you must consult your doctor immediately.

Do not breast-feed while taking this medicine (see section “Do not take Nitisinone MDK”).

Driving and use of machines

The effect of this medicine on the ability to drive and operate machinery is minor. However, if you experience adverse effects affecting vision, you should not drive or operate machinery until your vision returns to normal (see section 4 “Possible side effects”).

3. How to take Nitisinone MDK

Follow exactly the instructions for use of the medicine provided by your doctor. If in doubt, consult your doctor or pharmacist.

Treatment with this medicine should be initiated and supervised by a physician experienced in the management of the disease (hereditary tyrosinemia type 1).

The recommended daily dose is 1 mg/kg body weight administered orally. Your doctor will adjust the dose individually. It is recommended to administer the dose once daily.

However, because data are limited in patients with body weight < 20 kg, in this patient population it is recommended to divide the total daily dose into two doses per day.

If you have difficulty swallowing the capsules, you may open the capsules and mix the powder with a small amount of water or dietary supplement before taking it.

If you take more Nitisinone MDK than you should

If you have taken more of this medicine than you should, inform your doctor or pharmacist immediately.

If you forget to take Nitisinone MDK

Do not take a double dose to make up for missed doses. If you have forgotten to take a dose, inform your doctor or pharmacist.

If you stop taking Nitisinone MDK

If you feel that the effect of the medicine is not adequate, inform your doctor. Do not change the dose or stop treatment without first talking to your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any eye-related adverse effects, inform your doctor immediately so that an ophthalmological examination can be performed. Treatment with nitisinone increases blood levels of tyrosine, which may cause eye-related symptoms. Frequent eye-related adverse effects (may affect more than 1 in 10 people) due to elevated tyrosine levels include ocular inflammation (conjunctivitis), corneal opacity and inflammation (keratitis), light sensitivity (photophobia), and eye pain. Inflammation of the eyelids (blepharitis) is an uncommon adverse effect (may affect up to 1 in 100 people).

Other frequent adverse effects

• Decrease in platelet count (thrombocytopenia) and white blood cells (leukopenia), reduction in certain types of white blood cells (granulocytopenia).

Other uncommon adverse effects

• Increase in white blood cell count (leukocytosis),
• Itching (pruritus), skin inflammation (exfoliative dermatitis), rash.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nitisinone MDK

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C). Keep in the original bottle to protect from light. The medicine may be stored for a period of 2 months, after first opening the bottle, at a temperature not exceeding 25 °C, after which it must be discarded.

Remember to note on the bottle the date when it was removed from the refrigerator.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nitisinone MDK

• The active substance is nitisinone.

Nitisinone MDK 2 mg: each capsule contains 2 mg of nitisinone.

Nitisinone MDK 5 mg: each capsule contains 5 mg of nitisinone.

Nitisinone MDK 10 mg: each capsule contains 10 mg of nitisinone.

• The other components (excipients) are:

Capsule contents: pregelatinized maize starch

Capsule shell: Gelatin, titanium dioxide (E 171)

Printing ink: iron oxide black (E 172), shellac

Nature and contents of the container

Nitisinone MDK capsules are white, opaque, hard gelatin capsules, 15.7 mm in length, printed with “Nitisinona” and the dose “2 mg”, “5 mg” or “10 mg” in black. The capsules contain a white or almost white powder.

The capsules are packed in plastic bottles. Each bottle contains 60 capsules. Each carton pack contains one bottle.

Marketing Authorization Holder

MendeliKABS Europe Limited
The Light Box
111 Power Rd, Unit G.07, Chiswick
London, W4 5PY, United Kingdom

Manufacturer

Elara Pharmaservices Limited
Iron Farm
7 Grimes Gate, Diseworth
Leicestershire, DE74 2QD
United Kingdom

Date of the latest revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.