NITISINONA 2 mg Hard Capsules

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Doctor
5.0(36)

Andrei Popov

General medicinePain medicine7 years of experience

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.

Book a video appointment
€86
This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use NITISINONA DIPHARMA 2 mg HARD CAPSULES

Contents of the leaflet

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

Introduction

Package Leaflet:information for the user

Nitisinona Dipharma 2 mg hard capsules EFG

Nitisinona Dipharma 20 mg hard capsules EFG

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 experience 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 Nitisinona Dipharma is and what it is 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

  1. Contents of the pack and other information

1. What Nitisinona Dipharma is and what it is 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 elements 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

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 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 taking, have recently taken, or might take 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 initiated and supervised by a doctor with experience in the treatment of 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 the 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.

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 further questions on 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 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, the 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 cell count (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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (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 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. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Nitisinona 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:

Contents of the hard capsule:

Pregelatinized starch (from corn)

Stearic acid

Capsule shell:

Gelatin

Titanium dioxide (E171)

Printing ink:

Lacquer (Shellac)

Propylene glycol

Aluminum lake indigo carmine (E132)

Appearance and pack contents

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 a child-resistant closure of 60 capsules and OPA/Alu/PVC-Alu blister packs 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 Quinto dé Stampi - Rozzano (MI), Italy

You can request more information about this medicine from 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/).

Online doctors for NITISINONA DIPHARMA 2 mg HARD CAPSULES

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

Doctor
5.0(36)

Andrei Popov

General medicinePain medicine7 years of experience

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.

Book a video appointment
€86
Doctor
5.0(19)

Nuno Tavares Lopes

Family medicineGeneral medicine18 years of experience

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.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
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.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

Book a video appointment
€70
Doctor
0.0(0)

Hocine Lokchiri

General medicine21 years of experience

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.
Book a video appointment
€64
Doctor
0.0(0)

Muhammad Tayyab Altaf

General medicine3 years of experience

Dr. Muhammad Tayyab Altaf is a primary care physician with extensive international experience, offering online consultations for adults and children. His background includes clinical practice in Policlinico San Matteo Hospital Pavia in Italy, Mount Sinai Hospital in New York, United States and other healthcare settings, allowing him to manage a wide range of acute and chronic medical conditions with confidence and clarity.

His clinical expertise spans multi-system conditions, preventive care and long-term management of chronic diseases. Dr. Altaf combines hands-on experience with a strong research background in both medical and surgical fields, enabling him to provide accurate assessments and structured, evidence-based treatment plans. Patients value his ability to explain diagnoses clearly, outline next steps and support them in making informed healthcare decisions.

Online consultations with Dr. Altaf are suitable for many everyday and acute situations where a timely medical opinion can help determine the safest next steps. He evaluates and treats conditions affecting the cardiovascular, respiratory, gastrointestinal, neurological, haematological and endocrine systems. Common examples include:

  • hypertension and other blood pressure issues
  • ischaemic heart disease and angina
  • asthma, COPD and emphysema
  • pneumonia and lung fibrosis
  • gastroenteritis and digestive infections
  • liver conditions, including alcohol-related disease
  • epilepsy, seizures and post-stroke symptoms
  • dementia and cognitive decline
  • anaemia and other haematological changes
  • diabetes, thyroid disorders and pituitary disease
Many patients reach out when they experience new or worsening symptoms, fluctuations in blood pressure, non-severe chest discomfort, breathing symptoms, digestive issues, suspected infections, chronic fatigue or concerns that affect daily life. He also helps patients understand test results, adjust existing treatment plans and navigate long-term health strategies safely and effectively.

When clinically appropriate, Dr. Altaf can also provide health and fitness certificates, including documentation required for physical activity, sports participation or gym use, based on the patient’s health status and medical indications.

Some conditions are not suitable for online care. Severe chest pain, loss of consciousness, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack require immediate attention from local emergency services. Dr. Altaf prioritises patient safety and will guide you accordingly if your situation needs urgent in-person care.

In all consultations, Dr. Muhammad Tayyab Altaf focuses on clear communication, accurate diagnosis and patient-centred decision-making. His approach ensures that individuals and families feel informed, supported and confident in their next steps, no matter where they are.

Book a video appointment
€71

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Frequently Asked Questions

Is a prescription required for NITISINONA DIPHARMA 2 mg HARD CAPSULES?

NITISINONA DIPHARMA 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 NITISINONA DIPHARMA 2 mg HARD CAPSULES?

The active ingredient in NITISINONA DIPHARMA 2 mg HARD CAPSULES is nitisinone. This information helps identify medicines with the same composition but different brand names.

Who manufactures NITISINONA DIPHARMA 2 mg HARD CAPSULES?

NITISINONA DIPHARMA 2 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 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 NITISINONA DIPHARMA 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.

How to buy NITISINONA DIPHARMA 2 mg HARD CAPSULES in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy NITISINONA DIPHARMA 2 mg HARD CAPSULES in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to NITISINONA DIPHARMA 2 mg HARD CAPSULES?

Other medicines with the same active substance (nitisinone) include NITISINONA DIPHARMA 10 mg HARD CAPSULES, NITISINONA DIPHARMA 20 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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