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NITISINONA DIPHARMA 20 mg HARD CAPSULES

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About the medicine

How to use NITISINONA DIPHARMA 20 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

Nitisinona Dipharma 2 mg hard capsules EFG

Nitisinona Dipharma 20 mg hard capsules EFG

nitisinona

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 Nitisinona Dipharma and what is it used for
  2. What you need to know before you take Nitisinona Dipharma
  3. How to take Nitisinona Dipharma
  4. Possible side effects
  5. Storage of Nitisinona Dipharma
  6. Contents of the pack and other information

1. What is Nitisinona Dipharma and what is it used for

Nitisinona Dipharma contains the active substance nitisinone. Nitisinone is used to treat:

  • a rare disease called hereditary tyrosinemia type 1 in adults, adolescents, and children (of any age range).
  • a rare disease called alkaptonuria (AKU) in adults.

In these diseases, your body cannot fully break down the amino acid tyrosine (amino acids are the basic building blocks of proteins), forming toxic substances. These substances accumulate in your body. Nitisinone blocks the breakdown of tyrosine, and the toxic substances are not formed.

For the treatment of hereditary tyrosinemia type I, 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).

For the treatment of AKU, your doctor may advise you to follow a special diet.

Doctor consultation

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2. What you need to know before you take Nitisinona Dipharma

Do not takeNitisinona Dipharma

  • 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

Talk to your doctor or pharmacist before starting to take Nitisinona Dipharma.

  • 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 dietary 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.

If you receive Nitisinona Dipharma for the treatment of hereditary tyrosinemia type I, you will have regular liver checks 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 medicinesand Nitisinona Dipharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Nitisinona Dipharma may interfere with the effect of other medicines, such as:

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

Taking Nitisinona Dipharmawith food

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

Pregnancy andbreastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not breastfeed while taking this medicine (see section “Do not take Nitisinona Dipharma”).

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 Nitisinona Dipharma

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

For hereditary tyrosinemia type I, treatment with this medicine must be started and supervised by a doctor with experience in treating the disease.

For hereditary tyrosinemia type I, 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>

For AKU, the recommended dose is 10 mg once a day.

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 Nitisinona Dipharma than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nitisinona Dipharma

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 Nitisinona Dipharma

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 other questions 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 effects 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. In patients with hereditary tyrosinemia type 1, frequently reported (may affect more than 1 in 100 people) eye-related side effects 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).

In patients with AKU, eye irritation (keratopathy) and eye pain are very frequently reported (may affect more than 1 in 10 people) side effects.

The following are other side effects reported in patients with hereditary tyrosinemia type 1:

Other frequent side effects

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

Other uncommon side effects

    • increase in white blood cells (leucocytosis),
    • itching (pruritus), skin inflammation (exfoliative dermatitis), rash.
  • The following are other side effects reported in patients with AKU:
  • Other frequent side effects
    • bronchitis,
    • pneumonia,
    • itching (pruritus), 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 Spanish Medicines Monitoring System (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nitisinona Dipharma

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 blister after “EXP” and on the bottle and carton after “CAD”. The expiry date is the last day of the month stated.

Store at a temperature below 30°C.

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 ofNitisinona Dipharma

  • The active substance is nitisinone.

Nitisinona Dipharma 2 mg:each hard capsule contains 2 mg of nitisinone.

Nitisinona Dipharma 20 mg:each hard capsule contains 20 mg of nitisinone.

  • The other ingredients (excipients) are:

Hard capsule content:

Pregelatinized starch (from corn)

Stearic acid

Capsule shell:

Gelatin

Titanium dioxide (E171)

Printing ink:

Shellac

Propylene glycol

Aluminum lacquer indigo carmine (E132)

Appearance of the product and contents of the pack

The capsules are hard, white, opaque, made of gelatin, and have the company logo and dose “2” or “20” printed in dark blue. The capsule contains a powder that may be white or off-white.

Nitisinona Dipharma is available in plastic bottles with tamper-evident closure of 60 capsules and OPA/Alu/PVC-Alu blister precut unit dose of 60 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Dipharma Arzneimittel GmbH

Offheimer Weg 33

65549 Limburg a.d. Lahn

Germany

Manufacturer

Doppel Farmaceutici S.r.l.

Via Volturno 48

20089 Quinti dé Stampi – Rozzano (MI) – Italy

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany Nitisinone Dipharma

Austria Nitisinon Dipharma

Belgium Nitisinone Dipharma

Denmark Nitisinone Dipharma

Spain Nitisinona Dipharma

France Nitisinone Dipharma

Ireland Nitisinone Dipharma

Italy Nitisinone Dipharma

Norway Nitisinone Dipharma

Netherlands Nitisinone Dipharma

Portugal Nitisinona Dipharma

United Kingdom Nitisinone Dipharma

Sweden Nitisinone Dipharma

Date of last revision of thisleaflet:February 2022.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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Discuss questions about NITISINONA DIPHARMA 20 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
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  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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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. 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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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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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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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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Frequently Asked Questions

Is a prescription required for NITISINONA DIPHARMA 20 mg HARD CAPSULES?
NITISINONA DIPHARMA 20 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 NITISINONA DIPHARMA 20 mg HARD CAPSULES?
The active ingredient in NITISINONA DIPHARMA 20 mg HARD CAPSULES is nitisinone. This information helps identify medicines with the same composition but different brand names.
Who manufactures NITISINONA DIPHARMA 20 mg HARD CAPSULES?
NITISINONA DIPHARMA 20 mg HARD CAPSULES is manufactured by Dipharma Arzneimittel Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of NITISINONA DIPHARMA 20 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 NITISINONA DIPHARMA 20 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 NITISINONA DIPHARMA 20 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 5 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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