Ketosteril

Package Leaflet: Information for the User

KETOSTERIL, coated tablets

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Important information for the patient.

• Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is KETOSTERIL and what is it used for
• 2. Important information before taking KETOSTERIL
• 3. How to take KETOSTERIL
• 4. Possible side effects
• 5. How to store KETOSTERIL
• 6. Contents of the pack and other information

1. What is KETOSTERIL and what is it used for

KETOSTERIL is a medicinal product used in nutritional therapy for patients with kidney function disorders (renal insufficiency).

Indications for use:

KETOSTERIL is indicated for the prevention and treatment of the consequences of abnormal or inadequate protein metabolism in adult patients with chronic kidney disease, in combination with limited protein intake in the diet of 40 g/day or less. It is usually used in patients with a glomerular filtration rate (first stage of urine formation) of less than 25 ml/min.

2. Important information before taking KETOSTERIL

When not to take KETOSTERIL

Do not take the medicine:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have elevated blood calcium levels (hypercalcemia);
• if you have amino acid metabolism disorders (disorders of protein metabolism in the body).

Warnings and precautions

Caution should be exercised when taking the medicine in patients with phenylketonuria (see section: KETOSTERIL contains phenylalanine). During treatment with KETOSTERIL, your doctor may order regular monitoring of blood calcium levels. When taking KETOSTERIL with aluminum hydroxide, monitor phosphate levels (see section: KETOSTERIL and other medicines). During treatment, you should consume sufficient calories, which is necessary to maintain good health.

Children

There is no sufficient data on the use of KETOSTERIL in children.

KETOSTERIL and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. To avoid absorption disorders, keep at least 2 hoursintervalbetween taking KETOSTERIL and any of the following medicines that form poorly soluble compounds with calcium:

• antibiotics (used to treat infections, such as tetracyclines, quinolones, such as ciprofloxacin and norfloxacin);
• medicines containing iron, fluorine;
• estramustine (a medicine used to treat prostate cancer). Be cautious when taking KETOSTERIL with:
• medicines containing calcium - which may cause or exacerbate elevated blood calcium levels.
• cardiac glycosides (medicines used to treat heart failure and arrhythmias) - KETOSTERIL may cause elevated blood calcium levels, which increases the sensitivity to cardiac glycosides. Therefore, they should be used with caution due to the risk of heart rhythm disorders.
• aluminum hydroxide - during treatment with KETOSTERIL, the symptoms of uremia decrease, so when taking aluminum hydroxide, your doctor may reduce the dose of KETOSTERIL and order phosphate level monitoring.

KETOSTERIL with food and drink

The medicine should be taken during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The decision to use KETOSTERIL in pregnant and breastfeeding women will be made by your doctor.

Driving and using machines

KETOSTERIL has no effect on the ability to drive and use machines.

KETOSTERIL contains phenylalanine

The medicine may be harmful to patients with phenylketonuria (a hereditary disorder of metabolism).

3. How to take KETOSTERIL

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Oral administration.

Recommended dosage (adults with a body weight of 70 kg)

Unless otherwise prescribed by your doctor, the recommended dose is 4 to 8 tablets 3 times a day. The medicine should be taken during meals. Swallow the tablets whole with a sufficient amount of liquid.

Duration of treatment

The duration of treatment will be decided by your doctor.

Taking more than the recommended dose of KETOSTERIL

If you have taken more than the recommended dose of the medicine, contact your doctor. So far, no cases of taking more than the recommended dose have been reported.

Missing a dose of KETOSTERIL

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with KETOSTERIL

Do not stop taking this medicine without first consulting your doctor. If you have any further questions about 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 frequency of side effects is defined as follows: very common: more than 1 in 10 patients, common: between 1 in 10 and 1 in 100 patients, uncommon: between 1 in 100 and 1 in 1000 patients, rare: between 1 in 1000 and 1 in 10,000 patients, very rare: less than 1 in 10,000 patients, not known: cannot be estimated from the available data.

Very rare side effects:

• hypercalcemia (elevated blood calcium levels). If hypercalcemia occurs, your doctor will recommend reducing the dose of vitamin D. If hypercalcemia persists, your doctor will reduce the dose of KETOSTERIL and all other sources of calcium.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KETOSTERIL

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package. Store blisters tightly closed to protect from moisture. Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month stated. 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 protect the environment.

6. Contents of the pack and other information

What KETOSTERIL contains

• The active substances of the medicine are (content in 1 tablet): Calcium (R,S)-3-methyl-2-oxovalerianate (α-ketoanalog of DL-isoleucine) 67 mg, Calcium 4-methyl-2-oxovalerianate (α-ketoanalog of leucine) 101 mg, Calcium 2-oxo-3-phenylpropionate (α-ketoanalog of phenylalanine) 68 mg, Calcium 3-methyl-2-oxoisocaproate (α-ketoanalog of valine) 86 mg, Calcium (R,S)-2-hydroxy-4-methylthiobutyrate (α-hydroxyanalog of DL-methionine) 59 mg, L-lysine acetate (corresponding to 75 mg L-lysine) 105 mg, L-threonine 53 mg, L-tryptophan 23 mg, L-histidine 38 mg, L-tyrosine 30 mg. Total nitrogen content in the tablet 36 mg. Calcium content in the tablet 1.25 mmol = 50 mg.
• Other ingredients are: maize starch, crospovidone, talc, colloidal anhydrous silica, magnesium stearate, macrogol 6000, quinoline yellow (E 104), methacrylic acid - ethyl acrylate copolymer (1:1), triacetin, titanium dioxide (E 171), povidone K 29-32.

What KETOSTERIL looks like and contents of the pack

The medicine is in the form of yellow, prolonged-release tablets. The tablets are packaged in aluminum/PVC/PVDC blisters in an outer aluminum foil bag, placed in a cardboard box. The pack contains 100 prolonged-release tablets (5 blisters of 20 tablets each) or 300 prolonged-release tablets (15 blisters of 20 tablets each).

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH, 61346 Bad Homburg v.d.H., Germany

Manufacturer

Labesfal, Laboratórios Almiro S.A., Zona Industrial do Lagedo, 3465-157 Santiago de Besteiros, Portugal. For more detailed information, please contact the representative of the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89. Date of last revision of the package leaflet:23.12.2021