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NITISINONE MDK 2 mg HARD CAPSULES

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About the medicine

How to use NITISINONE MDK 2 mg HARD CAPSULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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 should 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).

Doctor consultation

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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 treatment with 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 on 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 to prevent blood clots (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 started 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 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.

Medicine questions

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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. Inflammation of the eyelids (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 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 took the bottle out of 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 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

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 packed 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 web site: http://www.ema.europa.eu/.

Online doctors for NITISINONE MDK 2 mg HARD CAPSULES

Discuss questions about NITISINONE MDK 2 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

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Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

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Frequently Asked Questions

Is a prescription required for NITISINONE MDK 2 mg HARD CAPSULES?
NITISINONE MDK 2 mg HARD CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in NITISINONE MDK 2 mg HARD CAPSULES?
The active ingredient in NITISINONE MDK 2 mg HARD CAPSULES is nitisinone. This information helps identify medicines with the same composition but different brand names.
Who manufactures NITISINONE MDK 2 mg HARD CAPSULES?
NITISINONE MDK 2 mg HARD CAPSULES is manufactured by Mendelikabs Europe Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of NITISINONE MDK 2 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether NITISINONE MDK 2 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to NITISINONE MDK 2 mg HARD CAPSULES?
Other medicines with the same active substance (nitisinone) include NITISINONA DIPHARMA 10 mg HARD CAPSULES, NITISINONA DIPHARMA 2 mg HARD CAPSULES, NITISINONA DIPHARMA 20 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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