This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use AMMONAPS 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

AMMONAPS 500 mg tablets

Sodium phenylbutyrate

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:

What is AMMONAPS and what is it used for
What you need to know before you take AMMONAPS
How to take AMMONAPS

Possible side effects
Storing AMMONAPS

Contents of the pack and further information

1. What is AMMONAPS and what is it used for

AMMONAPS is prescribed to patients with urea cycle disorders. Patients with these rare disorders have a deficiency of certain liver enzymes, so they cannot eliminate nitrogen waste. Since nitrogen is a component of proteins, it accumulates in the body after protein consumption. Nitrogen waste, in the form of ammonia, is especially toxic to the brain and, in severe cases, can cause loss of consciousness and coma.

AMMONAPS helps the body eliminate excess nitrogen and reduces the amount of ammonia in the body.

2. What you need to know before you take AMMONAPS

Do not take AMMONAPS:

If you are pregnant.
If you are breast-feeding.
If you are allergic (hypersensitive) to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking AMMONAPS

If you have difficulty swallowing. AMMONAPS tablets may get stuck in the esophagus and cause ulcers. If you have difficulty swallowing them, it is recommended to use AMMONAPS granules as an alternative.
If you have heart failure, kidney failure, or other conditions that may worsen due to sodium retention caused by this medicine.
If you have liver or kidney failure, as AMMONAPS is eliminated from the body through the kidneys and liver.
When administering to small children, as they may be unable to swallow the tablets and choke. As an alternative, it is recommended to administer AMMONAPS granules.

AMMONAPS must be combined with a low-protein diet that your doctor or dietitian has specifically designed for your case. You must follow this diet carefully.

AMMONAPS does not completely prevent excess ammonia from occurring in the blood and is not suitable for treating this condition, which is considered a medical emergency.

If you need to have tests, it is important to remind your doctor that you are taking AMMONAPS, as sodium phenylbutyrate may alter the results of some tests.

Using AMMONAPS with other medicines

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

It is especially important to inform your doctor if you are taking medicines that contain:

valproic acid (an antiepileptic medicine)
haloperidol (used to treat certain psychotic disorders)
corticosteroids (medicines similar to cortisone used to relieve inflamed areas of the body)
probenecid (for the treatment of hyperuricemia associated with gout)

These medicines may modify the effect of AMMONAPS, and you may need to have blood tests more frequently. If you are not sure if the medicines you are using contain these active ingredients, consult your doctor or pharmacist.

Pregnancy and breast-feeding

Do not take AMMONAPS if you are pregnant, as this medicine may harm the fetus. If you could become pregnant, you must use an effective contraceptive method during treatment with AMMONAPS.

Do not use AMMONAPS if you are breast-feeding, as this medicine may pass into breast milk and harm your baby.

Driving and using machines

No studies have been performed on the effects on the ability to drive and use machines.

AMMONAPS contains sodium

Each AMMONAPS tablet contains 62 mg of sodium.

Consult your doctor or pharmacist if you need to take 6 or more tablets daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take AMMONAPS

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Dosage

The daily dose of AMMONAPS is calculated according to your tolerance to proteins, diet, and body weight or body surface area. You will need to have regular blood tests to adjust the correct daily dose. Your doctor will tell you how many tablets to take.

Method of administration

AMMONAPS should be taken orally in equal doses with each meal (e.g., three times a day). You should take AMMONAPS with plenty of water.

AMMONAPS should be taken while following a special low-protein diet.

AMMONAPS tablets should not be administered to children who are unable to swallow the tablets. As an alternative, it is recommended to administer AMMONAPS granules.

You will need to follow the diet and treatment for life, unless you undergo a successful liver transplant.

If you take more AMMONAPS than you should

Patient who have taken very high doses of AMMONAPS experience:

drowsiness, fatigue, dizziness, and, less frequently, confusion
headache
changes in taste (taste disorders)
decreased hearing
disorientation
memory problems
worsening of existing neurological conditions

If you experience any of these symptoms, you should contact your doctor or the emergency department of the nearest hospital immediately to receive symptomatic treatment.

If you forget to take AMMONAPS

You should take a dose as soon as possible with the next meal. Make sure that at least 3 hours pass between two doses. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequencies are used to describe the occurrence of side effects:

Very common: affects more than 1 in 10 people

Common: affects 1 to 10 in 100 people

Uncommon: affects 1 to 10 in 1,000 people

Rare: affects 1 to 10 in 10,000 people

Very rare: affects less than 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Very common side effects: irregular menstrual periods and cessation of menstruation.

It is possible that the absence of menstruation in sexually active women is not caused by the use of AMMONAPS. If this occurs, consult your doctor, as you may be pregnant (see "Pregnancy and breast-feeding" in the previous section).

Common side effects: changes in blood cell count (red blood cells, white blood cells, and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disorders), abdominal pain, vomiting, nausea, constipation, body odor, rash, abnormal kidney function, weight gain, alteration of test results.

Uncommon side effects: low red blood cell count (anemia) due to bone marrow depression, bruising, irregular heartbeat, rectal bleeding, stomach irritation, gastroduodenal ulcer, pancreatitis.

If you have persistent vomiting, you should consult your doctor immediately.

Reporting of side effects

If you experience 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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing AMMONAPS

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 packaging and the label on the bottle after "EXP". The expiry date is the last day of the month stated.

Do not store above 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 further information

Composition of AMMONAPS

The active substance is sodium phenylbutyrate

Each AMMONAPS tablet contains 500 mg of sodium phenylbutyrate.

The other ingredients are microcrystalline cellulose, magnesium stearate, and anhydrous colloidal silica.

Appearance and packaging

AMMONAPS tablets are white, oval, and engraved with "UCY 500".

The tablets are packaged in plastic bottles with child-resistant caps. Each bottle contains 250 or 500 tablets.

Marketing authorisation holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Manufacturer

PATHEON France – BOURGOIN JALLIEU

40 boulevard de Champaret

BOURGOIN JALLIEU

38300

France

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/

Country of registration
Spain
Active substance
sodium phenylbutyrate
Prescription required
Yes
Manufacturer
Immedica Pharma Ab
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
Alternatives to AMMONAPS 500 mg TABLETS
AMMONAPS 940 mg/g GRANULES
Dosage form: ORAL SOLUTION/SUSPENSION, Unknown
Active substance: sodium phenylbutyrate
Manufacturer: Immedica Pharma Ab
Prescription required
PHEBURANE 350 MG/ML ORAL SOLUTION
Dosage form: ORAL SOLUTION/SUSPENSION, 350 mg/ml
Active substance: sodium phenylbutyrate
Manufacturer: Eurocept International B.V.
Prescription required
PHEBURANE 483 mg/g GRANULES
Dosage form: ORAL SOLUTION/SUSPENSION, 483 mg/g
Active substance: sodium phenylbutyrate
Manufacturer: Eurocept International B.V.
Prescription required

Alternatives to AMMONAPS 500 mg TABLETS in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to AMMONAPS 500 mg TABLETS in Ukraine

ROMASKI KVITKI

Dosage form: flowers, 50 g in a pack

Manufacturer: TOV "Ternofarm

Prescription not required

ROMASKI KVITKI

Dosage form: flowers, 40 g or 50 g

Manufacturer: AT "Lubnifarm

Prescription not required

ROMASKI KVITKI

Dosage form: flowers, 40 g or 50 g

Manufacturer: PrAT Farmacevticna fabrika "Viola

Prescription not required

ROMASKI KVITKI

Dosage form: flowers, 30 g or 40 g, or 50 g, or 75 g

Manufacturer: PrAT "Liktravi

Prescription not required

OBLIPIHOVI SUPOZITORII

Dosage form: suppositories, 0.3 g in 5 suppositories per strip

Manufacturer: PAT "Monfarm

Prescription not required

OBLIPIHOVA OLIA

Dosage form: suppositories, 0.35 g

Manufacturer: Privatne akcionerne tovaristvo "Lekhim - Harkiv

Prescription not required

Online doctors for AMMONAPS 500 mg TABLETS

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for AMMONAPS 500 mg TABLETS – subject to medical assessment and local rules.

5.0(39)

Yevgen Yakovenko

General surgery11 years of experience

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.

Book a video appointment

Hocine Lokchiri

General medicine20 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

Karim BenHarbi

General medicine8 years of experience

Dr. Karim Ben Harbi is a licensed general practitioner based in Italy. He provides online consultations for adults and children, combining international clinical experience with evidence-based medicine. His care approach is focused on accurate diagnosis, preventive care, and personalised health guidance.

Dr. Ben Harbi received his medical degree from Sapienza University in Rome. His training included hands-on experience in diverse settings — tropical medicine, rural healthcare, and urban outpatient practice. He also conducted clinical research in microbiology, exploring the role of the gut microbiome in chronic gastrointestinal issues.

You can consult Dr. Ben Harbi for:

General health concerns, prevention, and primary care.
Hypertension, type 1 and type 2 diabetes, metabolic issues.
Cold, cough, flu, respiratory infections, sore throat, fever.
Chronic digestive issues: bloating, gastritis, IBS, microbiome imbalance.
Skin rashes, mild allergic reactions, basic dermatological complaints.
Medication guidance, treatment adjustments, prescription review.
Paediatric concerns — fever, infections, general well-being.
Lifestyle optimisation: stress, sleep, weight, and diet counselling.

Dr. Ben Harbi offers reliable, accessible medical support through online consultations, helping patients make informed decisions about their health with a clear, structured, and compassionate approach.

Book a video appointment

Tetiana Fedoryshyn

General medicine29 years of experience

Dr Tetiana Fedoryshyn is a senior general practitioner, certified nutritionist, and psychologist with over 29 years of clinical experience. She combines classical internal medicine with modern approaches in lifestyle medicine, functional nutrition, and emotional health support.

Her focus is on helping patients regain health through deep understanding of symptoms, personalised nutrition plans, and evidence-based correction of deficiencies, stress-related conditions, and metabolic imbalances. Dr Fedoryshyn works with adults experiencing chronic conditions, fatigue, hormonal disruption, and post-stress exhaustion.

She integrates medical analysis, psychological insight, and real-life behaviour change tools to offer treatment plans tailored to each patient’s biochemistry, mental state, and lifestyle.

Main areas of practice:

Chronic condition management and medical counselling
Weight loss programmes based on metabolic profiling
Diagnosis and treatment of micronutrient deficiencies
Recovery from stress, burnout, and hormonal imbalances
Emotional support and psychosomatic symptom care

Her approach is never one-size-fits-all – each consultation begins with a deep dive into your unique health history, test results, and emotional landscape. Consultations are available in Ukrainian, Polish, and Russian.

Book a video appointment

Anna Biriukova

General medicine5 years of experience

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.
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Holistic approach – symptom relief, complication prevention, and quality of life improvement.

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Book a video appointment

Svetlana Kolomeeva

Cardiology17 years of experience

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

High blood pressure, headaches, dizziness, swelling, palpitations.
Diagnosis and management of hypertension, arrhythmias, and tachycardia.
Metabolic syndrome, excess weight, high cholesterol.
Chronic fatigue, insomnia, poor concentration, anxiety.
Respiratory symptoms: colds, flu, sore throat, cough, fever.
Digestive issues: heartburn, bloating, constipation, IBS symptoms.
Chronic conditions: diabetes, thyroid disorders.
Interpretation of lab tests and medical reports, therapy adjustment.
Second opinion and decision-making support.
Cardiovascular disease prevention and metabolic risk reduction.
Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Roman Raevskii

General medicine6 years of experience

Dr. Roman Raevskii is a licensed general practitioner in Spain, offering online medical consultations with a strong focus on prevention, early diagnosis, and personalized care. He combines evidence-based clinical expertise with a patient-centered approach to deliver comprehensive support.

Dr. Raevskii provides medical care in the following areas:

Diagnosis and management of common conditions: hypertension, diabetes, respiratory and digestive disorders.
Oncological consultations: early cancer detection, risk evaluation, and treatment navigation.
Supportive care for oncology patients – pain control, symptom relief, and side effect management.
Preventive medicine and health screenings.
Development of tailored treatment plans based on clinical guidelines.

With a patient-centred approach, Dr. Raevskii helps individuals manage both chronic illnesses and complex oncological cases. His consultations are guided by current medical standards and adapted to each patient’s needs.

Book a video appointment

Mar Tabeshadze

Endocrinology10 years of experience

Dr. Mar Tabeshadze is a licensed endocrinologist and general practitioner in Spain. She provides online consultations for adults, offering medical support for a wide range of endocrine conditions and related health concerns.

Diagnostic consultations for suspected endocrine disorders
Management of thyroid conditions, including in pregnant women
Early detection and treatment of type 1 and type 2 diabetes, with personalised therapy plans
Obesity treatment: identifying underlying causes of weight gain, combining medication and non-pharmacological strategies, and long-term support
Diagnosis and treatment of endocrine-related skin, hair, and nail issues
Ongoing care for patients with osteoporosis, pituitary, and adrenal gland disorders

Dr. Tabeshadze takes a patient-centred approach based on evidence-based medicine. Her goal is to help patients achieve hormonal balance, manage chronic conditions effectively, and improve overall well-being through targeted, personalised care.

Book a video appointment

Maryna Kuznetsova

Cardiology16 years of experience

Dr Marina Kuznetsova is an internal medicine doctor and cardiologist with a PhD in medicine. She provides online consultations for adults with chronic and acute conditions, with a strong focus on cardiovascular health. Her approach is based on current clinical guidelines and evidence-based treatment strategies.

Areas of expertise:

dyslipidaemia and lipid metabolism disorders
prevention and management of atherosclerosis
blood pressure monitoring and antihypertensive therapy
arrhythmias: diagnosis, follow-up, and treatment adjustment
cardiovascular care and recovery support after Covid-19

Dr Kuznetsova helps patients manage cardiovascular risk factors, optimise long-term treatment, and gain clarity in complex health situations – all through accessible and structured online care.

Book a video appointment

Antonio Cayatte

General medicine43 years of experience

Dr Antonio Cayatte is a physician in General and Acute Medicine with over 30 years of experience across clinical care, medical research, and education. He offers online consultations for adults with a wide range of symptoms, both acute and chronic.

His clinical background includes: