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KETOSTERIL FILM-COATED TABLETS

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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

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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.

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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.

5.0 (184)
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:

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  • 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.
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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).
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  • 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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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.
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  • 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.
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Gastroenterology – Digestive health:
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  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
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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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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:

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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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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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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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