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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

Translated with AI

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

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (5)
Doctor

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. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80
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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50
5.0 (41)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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€60

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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