NITISINONE MDK 5 mg HARD CAPSULES

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 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.

Contents of the pack

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

1. What you need to know before you take Nitisinone MDK
2. How to take Nitisinone MDK
3. Possible side effects

1. Storage of Nitisinone MDK
2. Contents of the pack and other information

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

The active substance of Nitisinone MDK is nitisinone. This medicine is used to treat a rare disease called hereditary tyrosinemia 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), forming toxic substances. These substances accumulate in your body. Nitisinone MDK blocks the breakdown of tyrosine, and the toxic substances are not formed.

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

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

Do not take Nitisinone MDK

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

Do not breastfeed while taking this medicine (see section “Pregnancy and breastfeeding”).

Warnings and precautions

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

• An ophthalmologist will examine your eyes before treatment and regularly during treatment with nitisinone. If you notice redness of the eyes or any other effect on the eyes, contact your doctor immediately for an ophthalmological examination. Eye problems (see section 4) may be a sign of inadequate diet control.

During treatment, blood samples will be taken to check if the treatment is adequate and to ensure that there are no side effects causing blood alterations.

Regular liver checks will be performed because the disease affects the liver.

Your doctor should check you every 6 months. If you experience any side effects, it is recommended to use shorter time intervals.

Other medicines and Nitisinone MDK

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

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

• Medicines for epilepsy (such as phenytoin)
• Medicines against blood clot formation (such as warfarin)

Using Nitisinone MDK with food and drinks

If you start treatment taking it with food and drinks, it is recommended to follow this regimen throughout the treatment.

Pregnancy and breastfeeding

The safety of this medicine in pregnant women and breastfeeding women has not been studied.

Consult your doctor if you plan to become pregnant. If you become pregnant, you should consult your doctor immediately.

Do not breastfeed while taking this medicine (see section “Do not take Nitisinone MDK”). Driving and using machines

The influence of this medicine on the ability to drive and use machines is small. However, if you experience side effects that affect your vision, do not drive or use machines until your vision has returned to normal (see section 4 “Possible side effects”).

3. How to take Nitisinone MDK

Follow exactly the administration instructions of the medicine indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Treatment with this medicine should be initiated and supervised by a doctor with experience in the treatment 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 a day.

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

If you have problems swallowing the capsules, you can 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, tell your doctor or pharmacist immediately.

If you forget to take Nitisinone MDK

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

If you stop taking Nitisinone MDK

If you think the action of the medicine is not adequate, tell your doctor. Do not change the dose or stop treatment without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any side effect related to the eyes, tell your doctor immediately for an ophthalmological examination. Treatment with nitisinone increases tyrosine levels in the blood, which can cause eye-related symptoms. Common eye side effects (may affect more than 1 in 10 people) due to higher tyrosine levels are eye inflammation (conjunctivitis), corneal opacity and inflammation (keratitis), sensitivity to light (photophobia), and eye pain. Eyelid inflammation (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).

Other common side effects

• Decrease in the number of platelets (thrombocytopenia) and white blood cells (leucopenia), reduction of certain types of white blood cells (granulocytopenia).

Other uncommon side effects

• Increase in the number of white blood cells (leucocytosis),
• Itching (pruritus), skin inflammation (exfoliative dermatitis), rash.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 which is stated on the carton and the bottle after “EXP”. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Keep the bottle in the outer carton in order to protect from light. The medicine can be stored for a period of 2 months after the first opening of the bottle, at a temperature not above 25°C, after which it should be discarded.

Do not forget to write the date you removed the bottle from the refrigerator on the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to 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 ingredients (excipients) are:

Capsule content: pregelatinized maize starch

Capsule shell: gelatin, titanium dioxide (E 171)

Printing: iron oxide black (E 172), shellac

Appearance and pack contents

The Nitisinone MDK capsules are white, opaque, hard, made of gelatin, 15.7 mm long, and have “Nitisinone” and the dose “2 mg”, “5 mg”, or “10 mg” printed in black. The capsules contain a white or off-white powder.

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

Marketing authorisation 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 last revision of this leaflet:

Other sources of information

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