Ketosteril

Package leaflet: Information for the user

Ketosteril film-coated tablets

Calcium salts of keto analogues of amino acids and amino acids
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Ketosteril is and what it is used for
2. What you need to know 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 Ketosteril is and what it is used for

Ketosteril is a medicinal product for nutritional therapy in patients with impaired renal function (renal insufficiency).
Ketosteril is used for the prevention and treatment of complications caused by altered or deficient protein metabolism in adults with chronic kidney disease. It is used in conjunction with a dietary protein intake limited to 40 g/day or less. This applies to patients whose glomerular filtration rate (GFR) (volume of blood filtered by the kidney each 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 ingredients of this medicine (listed in section 6).
• if you have too much calcium in your blood (hypercalcemia)
• if you suffer from amino acid metabolism disorders

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketosteril if you have phenylketonuria, an inherited metabolic disorder. In this case, you must pay attention to the fact that Ketosteril contains phenylalanine.
The level of calcium in your blood should be monitored regularly.
If you are also taking aluminium hydroxide, your serum phosphate levels should be monitored (see "Other medicines and Ketosteril").
Ensure an adequate caloric intake.

Children and adolescents
To date, there is insufficient experience regarding the administration of Ketosteril in pediatric patients, including children and adolescents.

Other medicines and Ketosteril
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.

• Taking Ketosteril together with medicines containing calcium may cause or increase high levels of calcium in the blood.
• Do not take this medicine at the same time as medicines that form poorly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin, and medicines containing iron, fluoride, or estramustine). These may alter the absorption of the active substances. Wait at least two hours after taking Ketosteril before taking any of these medicines.
• The levels of calcium in the blood may increase during treatment with Ketosteril. This may enhance the effect of some heart medicines (such as cardioactive glycosides), thereby increasing the risk of arrhythmias.
• Taking Ketosteril improves uremic symptoms (excess urea (a waste product) in the blood due to renal failure). Therefore, if you are using aluminium hydroxide, the dose of this medicine may need to be reduced. Serum phosphate levels should be monitored for any decrease.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
There is no experience with the use of Ketosteril during pregnancy and breastfeeding.

Driving and using machines
No special precautions are required.

3. How to take Ketosteril

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose is
Adults (70 kg body weight)
Take 4 to 8 tablets, 3 times a day during meals.
Method of administration:

• For oral use.
• Swallow the tablets with a sufficient amount of liquid.
• Do not chew the tablets due to the unpleasant odor of the contents.

Duration of treatment:
Ketosteril is administered as long as the glomerular filtration rate (GFR) (volume of blood
filtered by the kidney each minute) is less than 25 ml/min and, at the same time, dietary protein
intake is limited to 40 g/day or less (in adults).
If you feel that the effect of Ketosteril is too strong or too weak, talk to your doctor or
pharmacist.
If you forget to take Ketosteril
Do not take a double dose to make up for the forgotten dose.
If you stop taking Ketosteril
Do not stop taking Ketosteril without first consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Metabolism and nutrition disorders
Very rare (may affect up to 1 in 10,000 people):

• Hypercalcaemia (excess calcium in the blood)

Note:
In case of hypercalcaemia, reduce vitamin D intake. In case of persistent hypercalcaemia, your doctor will reduce the dose of Ketosteril and you will need to reduce intake from any other calcium sources.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketosteril

Keep this medicine out of sight and reach of children.
After opening the outer pouch, keep the blisters in the pouch to protect them from moisture.
Do not use this medicine after the expiry date stated on the carton and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ketosteril contains

• Each film-coated tablet contains the following active substances:
  D,L-Alpha-Ketoisoleucine, calcium salt 67 mg
  Alpha-Keto-leucine, calcium salt 101 mg
  Alpha-Keto-phenylalanine, calcium salt 68 mg
  Alpha-Keto-valine, calcium salt 86 mg
  D,L-Alpha-Hydroxymethionine, calcium salt 59 mg
  L-lysine acetate 105 mg (equivalent to 75 mg 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 components are: maize starch, crospovidone, talc, anhydrous colloidal silica, magnesium stearate E470b, macrogol, quinoline yellow E104, basic butylated methacrylate copolymer, triacetin, titanium dioxide E171, povidone.

Description of the appearance of Ketosteril and package contents
Ketosteril tablets are yellow, film-coated, oblong tablets with approximate dimensions of 17.2 x 6.6 mm (length x width).

Ketosteril is available in the following pack sizes:
Box containing 100 or 300 film-coated tablets in blisters, packed in an outer pouch.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Manufacturer:
Labesfal - Laboratórios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros, Portugal

Marketing Authorization Holder:
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala – Verona, Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal, Croatia: Ketarenil
Belgium, Denmark, Finland, Italy, Netherlands, Norway, Slovenia, Spain, Sweden: Ketosteril