Neoton

PATIENT INFORMATION LEAFLET: USER INFORMATION

Neoton

1 g, powder for solution for infusion

Sodium phosphocreatine

You should read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS NEOTON AND WHAT IS IT USED FOR

Neoton is a medicine that provides muscles with energy reserves necessary during their contraction. Maintaining the proper concentration of such substances helps to limit damage to the heart muscle and is the basis for metabolic protection of the heart. The protective effect of phosphocreatine (the active substance of the medicine) on the heart muscle is related to the stabilization of the cell membrane of muscle fibers and the conservation of intracellular resources of molecules that function as universal energy carriers (adenine nucleotides), by inhibiting enzymes involved in their breakdown. Neoton is used as a medicine to protect the heart muscle in cardiac surgery, as an additive to cardioplegic solution.

2. IMPORTANT INFORMATION BEFORE USING NEOTON

When not to use Neoton:

Warnings and precautions:
Before starting to use Neoton, you should discuss it with your doctor.
If the medicine is administered quickly, as rapid (less than 30-40 minutes) intravenous administration of phosphocreatine in a dose exceeding 1 g may cause a decrease in blood pressure;
when high doses of phosphocreatine are administered (5-10 g/day), as this may cause an increase in phosphate levels in the blood and affect the metabolism and secretion of hormones that regulate calcium homeostasis in the body, kidney function, and purine metabolism (components of nucleic acids).

• if the medicine is administered quickly, because rapid (less than 30-40 minutes) intravenous administration of phosphocreatine in a dose exceeding 1 g may cause a decrease in blood pressure;
• when high doses of phosphocreatine are administered (5-10 g/day), because this may cause an increase in phosphate levels in the blood and affect the metabolism and secretion of hormones that regulate calcium homeostasis in the body, kidney function, and purine metabolism (components of nucleic acids).

Neoton and other medicines

No interactions have been found between phosphocreatine and other medicines, or between other medicines and phosphocreatine.
You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Neoton with food and drink

Neoton can be used independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
The medicine may be used during pregnancy and breastfeeding if your doctor decides so.

Driving and using machines

Neoton has no effect on the ability to drive vehicles or operate machines.

Neoton 1 g contains sodium.

The medicine contains 180 mg of sodium (the main component of table salt) per dose. This corresponds to 9% of the maximum recommended daily dose of sodium in the diet for adults.

3. HOW TO USE NEOTON

This medicine should always be used according to the doctor's recommendations. If you have any doubts, you should contact your doctor again.
The recommended dose of Neoton is:
In cardiac surgery, as an additive to cardioplegic solution
To protect the heart muscle during cardiac surgery, 10 mmol/l (which corresponds to 3 g/l of solution), as an additive to the usually used cardioplegic solutions.
This medicine should always be used according to the doctor's recommendations. If you have any doubts, you should consult your doctor.

Using a higher dose of Neoton than recommended

In preclinical studies, when doses much higher than therapeutic doses were administered, and in clinical studies in humans, when phosphocreatine was administered intravenously at a dose greater than 1 g, a slight decrease in blood pressure was observed.
If you think you have received a higher dose of Neoton than recommended, you should immediately consult your doctor, who will apply the appropriate treatment if necessary.

Missing a dose of Neoton

You should not take a double dose to make up for a missed dose.
If you have any doubts about using the medicine, you should consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Neoton can cause side effects, although they may not occur in everyone.
The frequency of side effects is defined as follows: very common (affects 1 or more patients in 10); common (affects 1 to 10 patients in 100); uncommon (affects 1 to 10 patients in 1,000); rare (affects 1 to 10 patients in 10,000); very rare (affects less than 1 patient in 10,000).
Frequency not known (frequency cannot be estimated from available data)
hypersensitivity reactions
If any of the side effects worsen or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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:
ul. Al. Jerozolimskie 181C, PL - 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE NEOTON

There are no special precautions for storage.
Store in a place inaccessible and invisible to children.
Do not use Neoton after the expiration date stated on the label.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Neoton contains

• The active substance of the medicine is sodium phosphocreatine.

What Neoton looks like and what the pack contains

The pack (cardboard box) contains: 1 vial with powder.

Marketing authorization holder

Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807 Warsaw
Tel. +48 22 824 03 64

Manufacturer

ALFASIGMA S.p.A.
Via Enrico Fermi 1,

• 65020 – Alanno (PE), Italy

Date of last update of the leaflet:

Information intended exclusively for medical professionals:

Before use, disinfect the surface of the rubber stopper of the vial.
Dissolve the contents of the vial in 50 ml of water for injections.