KETOSTERIL FILM-COATED TABLETS

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.

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.

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)