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KETOSTERIL FILM-COATED TABLETS

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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 KETOSTERIL FILM-COATED 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 Patient

Ketosteril Film-Coated Tablets EFG

Calcium salts of keto-analogues of amino acids and amino acids

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Ketosteril and what is it used for
  2. What you need to know before taking Ketosteril
  3. How to take Ketosteril
  4. Possible side effects
    1. Storage of Ketosteril
  1. Package Contents and Additional Information

1. What is Ketosteril and what is it used for

Ketosteril is a medication for nutritional treatment in patients with impaired renal function (renal insufficiency).

This medication is used for the prevention and treatment of damage caused by incorrect or deficient protein metabolism in adults with chronic renal insufficiency. It is used in conjunction with a limited intake of dietary proteins of 40 g/day or less. This is the case in patients whose glomerular filtration rate (GFR) (volume of blood filtered by the kidney per minute) is less than 25 ml/min.

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 taking Ketosteril

Do not take Ketosteril

  • if you are allergic to the active substances or to any of the other components of this medication (listed in section 6),
- if you have too much calcium in the blood (hypercalcemia),
- if you have disorders of amino acid metabolism.

Warnings and Precautions

Consult your doctor or pharmacist before taking Ketosteril if you have phenylketonuria, a hereditary disorder of metabolism. In this case, you should be aware that this medication contains phenylalanine.

Calcium levels in the blood should be periodically monitored.

If you are also taking aluminum hydroxide, serum phosphate concentrations should be monitored (see "Other Medications and Ketosteril").

Adequate caloric intake should be ensured.

Children and Adolescents

There is not enough experience to date on the administration of this medication to pediatric patients, including children and adolescents.

Other Medications and Ketosteril

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including medications obtained without a prescription.

  • Taking this medication at the same time as medications containing calciummay cause high levels of calcium in the blood or increase those levels.
  • Do not take this medication at the same time as medications that form poorly soluble compounds with calcium (such as tetracyclines, quinolones like ciprofloxacin and norfloxacin, as well as medications containing iron, fluorine, or estramustine). It may alter the absorption of the active substances. Wait at least two hours after taking this medication before taking any of these medications.
  • The levels of calcium in your blood may increase when taking this medication. This can enhance the effect of certain heart medications(such as cardioactive glycosides) and, therefore, increase the risk of arrhythmias.
  • Taking this medication improves uremic symptoms (excess urea - a waste product - in the blood due to renal insufficiency). Therefore, if you are taking aluminum hydroxide, you should reduce the dose of this medication if necessary. You should monitor for possible decreased serum phosphate concentrations.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

There is no experience with the use of this medication during pregnancy and breastfeeding.

Driving and Using Machines

No special precautions are required.

3. How to Take Ketosteril

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

If your doctor has not prescribed a different dose, the recommended dose is

Adults (70 kg body weight)

Take 4 to 8 tablets 3 times a day during meals.

Method of administration:

  • Oral route.
  • Swallow the tablets with a sufficient amount of liquid.
  • Do not chew the tablets; their contents have a bad smell.

Duration of treatment:

This medication is administered while the glomerular filtration rate (GFR) (volume of blood filtered by the kidney per minute) is less than 25 ml/min and, at the same time, the intake of proteins in the diet is restricted to 40 g/day or less (adults).

If you feel that the effect of this medication is too strong or too weak, talk to your doctor or pharmacist.

If you forgot to take Ketosteril

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

If you stop taking Ketosteril

Do not stop taking this medication without consulting your doctor first.

If you have any other questions about the use of this medication, 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 medications, this medication can cause side effects, although not everyone experiences them.

Metabolic and nutritional disorders

Very rare (may affect up to 1 in 10,000 people):

  • Hypercalcemia (too much calcium in the blood)

Note:

If hypercalcemia occurs, reduce the intake of vitamin D. In case of persistent hypercalcemia, your doctor will reduce the dose of this medication, and you should decrease your consumption of other calcium sources.

Reporting Side Effects

If you experience any side effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ketosteril

Keep this medication out of the sight and reach of children.

Once the outer bag is opened, keep the blisters in the bag to protect them from moisture.

Do not use this medication after the expiration date stated on the box and blister after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ketosteril

  • Each film-coated tablet contains the active substances:

α-keto-analogue of D,L-isoleucine, calcium salt 67 mg

α-keto-analogue of leucine, calcium salt 101 mg

α-keto-analogue of phenylalanine, calcium salt 68 mg

α-keto-analogue of valine, calcium salt 86 mg

α-hydroxy-analogue of D,L-methionine, calcium salt 59 mg

L-lysine acetate 105 mg

(corresponding to 75 mg of L-lysine)

L-threonine 53 mg

L-tryptophan 23 mg

L-histidine 38 mg

L-tyrosine 30 mg

Total nitrogen content per tablet 36 mg

Total calcium content per tablet 1.25 mmol = 50 mg

  • The other components are: cornstarch, crospovidone, talc, silica, anhydrous colloidal, magnesium stearate E470b, macrogol, quinoline yellow E104, basic butylated methacrylate copolymer, triacetin, titanium dioxide E171, povidone.

Appearance and Package Contents

Ketosteril tablets are film-coated, oblong, and yellow, with an approximate size of 17.2 × 6.6 mm (length × width).

Ketosteril is available in the following package sizes:

Box containing 100 or 300 film-coated tablets in blisters packaged in an outer bag.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U

Torre Mapfre-Vila Olímpica

Marina 16-18

08005 Barcelona

Spain

Manufacturer:

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros, Portugal

This medication is authorized in the EEA Member States under the following names:

Portugal, Croatia: Ketaneril

Belgium, Denmark, Finland, Italy, Netherlands, Norway, Slovenia, Spain, Sweden: Ketosteril

Date of the last revision of this package leaflet: December 2020

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

  • Country of registration
  • Dosage form
    TABLET, Not applicable as several active substances
  • ATC code
    V06DD90
  • Active substance
  • Prescription required
    Yes
  • Manufacturer

Online doctors for KETOSTERIL FILM-COATED TABLETS

Discuss questions about KETOSTERIL FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

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

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

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

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

Dr. Lokchiri’s professional training includes:

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

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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

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

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€80
5.0 (1056)
Doctor

Andrei Popov

General medicine 7 years exp.

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

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

Pain: how he can help

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

General medicine

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

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

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€80
0.0 (0)
Doctor

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.

Camera Book a video appointment
€55

Frequently Asked Questions

Is a prescription required for KETOSTERIL FILM-COATED TABLETS?
KETOSTERIL FILM-COATED 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 KETOSTERIL FILM-COATED TABLETS?
The active ingredient in KETOSTERIL FILM-COATED TABLETS is Amino acids, incl. combinations with polypeptides. This information helps identify medicines with the same composition but different brand names.
Who manufactures KETOSTERIL FILM-COATED TABLETS?
KETOSTERIL FILM-COATED TABLETS is manufactured by Fresenius Kabi España, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of KETOSTERIL FILM-COATED 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 KETOSTERIL FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
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