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CARBAGLU 200 mg DISPERSIBLE TABLETS

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About the medicine

How to use CARBAGLU 200 mg DISPERSIBLE TABLETS

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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

Carbaglu 200 mg dispersible tablets

carglumic acid

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 or pharmacist.
  • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

  1. What is Carbaglu and what is it used for
  2. What you need to know before you take Carbaglu
  3. How to take Carbaglu
  4. Possible side effects

5 Storage of Carbaglu

  1. Contents of the pack and further information

1. What is Carbaglu and what is it used for

Carbaglu can help eliminate excessive plasma levels of ammonia (high blood ammonia levels). Ammonia is particularly toxic to the brain and can cause, in severe cases, a decrease in the level of consciousness and coma.

Hyperammonemia can be due to

  • the lack of a specific liver enzyme, N-acetylglutamate synthase. Patients with this rare disorder are unable to eliminate nitrogen waste, which increases after eating proteins.

This disorder persists throughout the patient's life, so this treatment is necessary for life.

  • isovaleric acidemia, methylmalonic acidemia, or propionic acidemia. Patients suffering from one of these disorders need treatment during the hyperammonemia crisis.
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 Carbaglu

DonottakeCarbaglu:

Do not take Carbaglu if you are allergic (hypersensitive) to carglumic acid or any of the other ingredients of Carbaglu (listed in section 6).

Do not take Carbaglu during breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carbaglu.

Treatment with Carbaglu should be initiated under the supervision of a doctor experienced in the treatment of metabolic disorders.

Your doctor will assess your individual response to carglumic acid before starting any long-term treatment.

The dose should be adjusted individually to maintain normal blood ammonia levels.

Your doctor may prescribe you arginine supplements or limit your protein intake.

In order to monitor your disease and treatment, your doctor may periodically examine your liver, kidneys, heart, and blood.

Other medicines andCarbaglu

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

Using Carbaglu with food and drinks

Carbaglu should be taken orally before main meals or food intake.

The tablets should be dispersed in a minimum of 5 to 10 ml of water and taken immediately. The suspension has a slightly acidic taste.

Pregnancyand breast-feeding

The effects of Carbaglu on pregnancy and the fetus are unknown.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The effects on the ability to drive and use machines are unknown.

3. How to take Carbaglu

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual dose:

The initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weigh 10 kg, you should take 1 g per day, or 5 tablets). For patients with N-acetylglutamate synthase deficiency, the long-term daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.

Your doctor will determine the suitable dose for you to maintain normal blood ammonia levels.

Carbaglu should be administered ONLYorally or through a nasogastric tube (using a syringe if necessary).

When the patient is in hyperammonemic coma, Carbaglu is administered by rapid push with a syringe through the tube used for feeding.

Tell your doctor if you have kidney impairment. Your daily dose should be reduced.

If you take more Carbaglu than you should

Consult your doctor or pharmacist.

If you forgetto take Carbaglu

Do not take a double dose to make up for forgotten doses.

If you stop taking Carbaglu:

Do not stop taking Carbaglu without informing your doctor.

If you have any further questions on the use of this product, 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.

The following side effects have been reported: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and not known (cannot be estimated from the available data).

  • Common:increased sweating
  • Uncommon:bradycardia (decreased heart rate), diarrhea, fever, increased aminotransferases, vomiting.
  • Not known:rash

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Carbaglu

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 after EXP.

The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

After first opening of the tablet container: do not refrigerate. Do not store above 30°C.

Keep the container tightly closed to protect from moisture.

Write the date of opening on the tablet container. Discard 3 months after first opening.

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 further information

Composition of Carbaglu

  • The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
  • The other ingredients are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.

Appearance and packaging

Carbaglu 200 mg tablets are bar-shaped tablets with 4 divisions on one side and 3 break marks. Carbaglu is available in plastic containers of 5, 15, and 60 tablets, closed with a child-resistant cap.

Marketing Authorisation Holder

Recordati Rare Diseases

Immeuble “Le Wilson”

70 avenue du Général de Gaulle

F-92800 Puteaux

France

Tel.: + 33 1 4773 6458

Fax: + 33 1 4900 1800

Manufacturer

Recordati Rare Diseases

Immeuble “Le Wilson”

70, Avenue du Général de Gaulle

F-92800 Puteaux

France

or

Recordati Rare Diseases

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

France

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder.

Belgium/België/Belgien

Recordati

Tel: +32 2 46101 36

Lithuania

Recordati AB.

Tel: + 46 8 545 80 230

Sweden

Greece

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Luxembourg/Luxemburg

Recordati

Tel: +32 2 46101 36

Belgium

Czech Republic

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Hungary

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Denmark

Recordati AB.

Tel: +46 8 545 80 230

Sweden

Malta

Recordati Rare Diseases

Tel: +33 1 47 73 64 58

France

Germany

Recordati Rare Diseases Germany GmbH

Tel: +49 731 140 554 0

Netherlands

Recordati

Tel: +32 2 46101 36

Belgium

Estonia

Recordati AB.

Tel: + 46 8 545 80 230

Sweden

Norway

Recordati AB.

Tel: +46 8 545 80 230

Sweden

Greece

Recordati Hellas

Tel: +30 210 6773822

Austria

Recordati Rare Diseases Germany GmbH

Tel: +49 731 140 554 0

Germany

Spain

Recordati Rare Diseases Spain S.L.U.

Tel: + 34 91 659 28 90

Poland

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

France

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

Portugal

Jaba Recordati S.A.

Tel: +351 21 432 95 00

Croatia

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Romania

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Ireland

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Slovenia

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Iceland

Recordati AB.

Tel: +46 8 545 80 230

Sweden

Slovakia

Recordati Rare Diseases

Tel: +33 (0)1 47 73 64 58

France

Italy

Recordati Rare Diseases Italy Srl

Tel: +39 02 487 87 173

Finland

Recordati AB.

Tel: +46 8 545 80 230

Sweden

Cyprus

Recordati Rare Diseases

Tel: +33 1 47 73 64 58

France

Sweden

Recordati AB.

Tel: +46 8 545 80 230

Latvia

Recordati AB.

Tel: + 46 8 545 80 230

Sweden

United Kingdom(Northern Ireland)

Recordati Rare Diseases UK Ltd.

Tel: +44 (0)1491 414333

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other web sites about rare diseases and treatments.

Online doctors for CARBAGLU 200 mg DISPERSIBLE TABLETS

Discuss questions about CARBAGLU 200 mg DISPERSIBLE TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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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:

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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
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  • 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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Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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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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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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Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Frequently Asked Questions

Is a prescription required for CARBAGLU 200 mg DISPERSIBLE TABLETS?
CARBAGLU 200 mg DISPERSIBLE TABLETS 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 CARBAGLU 200 mg DISPERSIBLE TABLETS?
The active ingredient in CARBAGLU 200 mg DISPERSIBLE TABLETS is carglumic acid. This information helps identify medicines with the same composition but different brand names.
Who manufactures CARBAGLU 200 mg DISPERSIBLE TABLETS?
CARBAGLU 200 mg DISPERSIBLE TABLETS is manufactured by Recordati Rare Diseases. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CARBAGLU 200 mg DISPERSIBLE TABLETS 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 CARBAGLU 200 mg DISPERSIBLE TABLETS 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 CARBAGLU 200 mg DISPERSIBLE TABLETS?
Other medicines with the same active substance (carglumic acid) include CARGLUMIC ACID TILLOMED 200 mg DISPERSIBLE TABLETS, CARGLUMIC ACID WAYMADE 200 mg DISPERSIBLE TABLETS, CARBAGLU 200 mg DISPERSIBLE TABLETS. 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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