Package leaflet: Information for the user

KETOSTERIL, coated tablets
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What KETOSTERIL is and what it is used for
Important information before taking KETOSTERIL
How to take KETOSTERIL
Possible side effects
How to store KETOSTERIL
Contents of the pack and other information

1. What KETOSTERIL is and what it is used for

KETOSTERIL is a medicinal product used in nutritional therapy for patients with impaired kidney function (renal insufficiency).
Indications:
KETOSTERIL is indicated for the prevention and treatment of consequences of abnormal or inadequate protein metabolism in adult patients with chronic kidney disease, in combination with a low-protein diet containing 40 g of protein per day or less.
It is usually used in patients with a glomerular filtration rate (the first stage of urine formation) of less than 25 ml/min.

2. Important information before using KETOSTERIL

When not to use KETOSTERIL
Do not use this medicine:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the patient has high blood calcium levels (hypercalcaemia);
if the patient has amino acid metabolism disorders (protein metabolism disorders in the body).

Warnings and precautions
Exercise caution when administering this medicine to patients with phenylketonuria (see section: KETOSTERIL contains phenylalanine). During treatment with KETOSTERIL, the doctor may order regular monitoring of blood calcium levels. When KETOSTERIL is used concomitantly with aluminium hydroxide, phosphate levels should be monitored (see section: KETOSTERIL with other medicines).

During treatment, an adequate intake of calories should be maintained, which is essential for good health.

Children
There is insufficient data on the use of KETOSTERIL in children.

KETOSTERIL with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

To avoid impaired absorption of active substances, a minimum interval of 2 hours should be maintained between the administration of KETOSTERIL and any of the following medicines, which may form poorly soluble complexes with calcium:

antibiotics used to treat infections, such as tetracyclines and quinolones (e.g. ciprofloxacin and norfloxacin);
medicines containing iron or fluoride;
estramustine (a medicine used in the treatment of prostate cancer).

Exercise caution when using the following medicines concomitantly with KETOSTERIL:

calcium-containing medicines – may cause or worsen high blood calcium levels (hypercalcaemia);
cardiac glycosides (medicines used in the treatment of heart failure and cardiac arrhythmias) – KETOSTERIL may increase blood calcium levels, thereby increasing sensitivity to cardiac glycosides. Therefore, concomitant use requires caution due to the risk of cardiac disturbances;
aluminium hydroxide – during treatment with KETOSTERIL, uraemic symptoms may decrease; therefore, when aluminium hydroxide is used concomitantly, the doctor may reduce the dose of KETOSTERIL and order monitoring of blood phosphate levels.

KETOSTERIL with food and drink
This medicine should be taken during meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The decision to use KETOSTERIL in pregnant or breastfeeding women will be made by the doctor.

Driving and operating machinery
KETOSTERIL has no influence on the ability to drive or operate machinery.

KETOSTERIL contains phenylalanine
This medicine may be harmful to patients with phenylketonuria (an inherited metabolic disorder).

3. How to use KETOSTERIL

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
Oral administration.
Recommended dosage (adults weighing 70 kg)
Unless otherwise prescribed by the physician, the recommended dose is 4 to 8 tablets three times daily.
The medicine should be taken during meals.
Tablets should be swallowed whole, with an adequate amount of fluid.
Duration of treatment
The duration of treatment is determined by the physician.
Taking more than the recommended dose of KETOSTERIL
If more than the recommended dose is taken, contact your doctor immediately.
To date, no cases of overdose have been reported.
Missed dose of KETOSTERIL
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose.
Take the next dose at the regular scheduled time.
Do not take a double dose to make up for a missed tablet.
Stopping treatment with KETOSTERIL
Do not discontinue this medicine without prior consultation with your doctor.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions is defined as follows:
very common: more frequently than in 1 out of 10 patients
common: in 1 to 10 out of 100 patients
uncommon: in 1 to 10 out of 1,000 patients
rare: in 1 to 10 out of 10,000 patients
very rare: less frequently than in 1 out of 10,000 patients
frequency not known: cannot be estimated based on available data.
Very rare adverse reaction:

hypercalcemia (excessively high calcium levels in the blood). 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 of adverse reactions If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store KETOSTERIL

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging. Keep blister packs 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 stated month.
Medicines must 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 in the medicine are (amount per tablet):
Calcium (R,S)-3-methyl-2-oxovalerianate (α-keto analogue of DL-isoleucine) 67 mg
Calcium 4-methyl-2-oxovalerate (α-keto analogue of leucine) 101 mg
Calcium 2-oxo-3-phenylpropionate (α-keto analogue of phenylalanine) 68 mg
Calcium 3-methyl-2-oxobutyrate (α-keto analogue of valine) 86 mg
Calcium (R,S)-2-hydroxy-4-methylthiobutyrate (α-hydroxy analogue of DL-methionine) 59 mg
L-lysine acetate 105 mg (equivalent 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
Calcium content per tablet 1.25 mmol = 50 mg
Other ingredients are:
corn starch, crospovidone, talc, colloidal anhydrous silica, magnesium stearate, macrogol 6000, quinoline yellow (E 104), basic butyl methacrylate copolymer, 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, film-coated, elongated tablets.
Film-coated tablets are packed in blisters made of Aluminium/PVC/PVDC foil in an outer aluminium foil pouch (5 blisters per pouch), placed in a cardboard box.
The pack contains 100 film-coated tablets (5 blisters with 20 tablets each) or 300 film-coated tablets (15 blisters with 20 tablets each).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 further information, please contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89