Hialuroprol

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Hyaluroprol

10 mg/ml, solution for injection

Sodium hyaluronate

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

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their illness symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Hyaluroprol and what is it used for

Hyaluroprol contains the active substance - highly purified hyaluronic acid, i.e. a high molecular weight compound from the group of glycosaminoglycans (polysaccharide acids), which is an important component of all extracellular structures. This compound occurs physiologically in high concentrations, among others, in cartilage and synovial fluid. Intra-articular administration of Hyaluroprol in degenerative joint disease leads to the normalization of such properties of synovial fluid as viscosity and elasticity, as well as the activation of cartilage repair processes. Studies have shown that hyaluronic acid has anti-inflammatory and analgesic effects, leading to improved joint mobility. Intra-articular use. The indication for the use of Hyaluroprol is degenerative disease of the knee joints of mild or moderate severity.

2. Important information before using Hyaluroprol

When not to use Hyaluroprol

Warnings and precautions

• Disinfectants containing quaternary ammonium salts should not be used, as they may cause hyaluronic acid to precipitate.
• Intra-articular injection of the medicine should be performed by a properly trained doctor, in accordance with the appropriate technique and under aseptic conditions required for this route of administration.

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• The doctor will administer the medicine to patients with localized infection in the area of the injection site with particular caution, in order to avoid potential development of bacterial arthritis.
• Before performing the intra-articular injection, the doctor will carefully examine the patient to rule out acute arthritis. If such a diagnosis is made, the doctor should consider the appropriateness of administering the medicine.
• In the event of joint effusion, the doctor will perform joint puncture before injecting the medicine.
• Before injecting the medicine, the doctor will make sure that the needle has not been inserted into a vessel (do not aspirate into the syringe with the medicine).
• It is recommended not to overload the joint for several hours after administering the medicine.

Other medicines and Hyaluroprol

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Hyaluronic acid used simultaneously with some locally acting anesthetics prolongs the anesthesia period. Disinfectants containing quaternary ammonium salts may cause hyaluronic acid to precipitate. No physico-chemical incompatibilities have been observed with medicines such as corticosteroids administered in intra-articular injections.

Pregnancy and breastfeeding

In pregnancy and breastfeeding or if you suspect you are pregnant, or if you plan to become pregnant, you should consult your doctor or pharmacist before using this medicine. Animal studies have not shown embryotoxic and teratogenic effects of hyaluronic acid; however, in pregnant and breastfeeding women, Hyaluroprol should be used only in absolutely necessary cases. The doctor will decide based on the assessment of the risk-to-benefit ratio whether to use the medicine.

Driving and using machines

Hyaluroprol does not affect the ability to drive and use machines.

3. How to use Hyaluroprol

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist. Hyaluroprol is administered in the form of intra-articular injections once a week in a dose of 20 mg (2 ml) for 5 weeks, under aseptic conditions. Instructions for preparing the medicine for use and disposing of its remains Remove the cap and carefully screw the needle onto the syringe so as not to press the plunger. Check that the needle is properly seated in the threaded connector. Do not screw the needle on too tightly, as this may cause the connector to twist. Unused medicine and its remains should be disposed of in accordance with applicable regulations.

Using a higher dose of Hyaluroprol than recommended

Due to the specific dosing (intra-articular injections are performed exclusively by a doctor), it is not possible for the patient to overdose on the medicine.

Missing a dose of Hyaluroprol

Page 2 of 4 If you miss a dose of the medicine, you should contact your doctor to determine the date of the next injection. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The presented side effects come from controlled and open clinical trials as well as from spontaneous reports after the medicine was placed on the market. Rare side effects (occurring in 1 to 10 people out of 10,000): pain, effusion, swelling, increased local warming, redness, arthritis, conditions after local use, i.e. all other complications after joint puncture. Very rare side effects (occurring in less than 1 person out of 10,000) and frequency not known (cannot be determined based on available data): synovitis, infectious arthritis, hypersensitivity reactions, anaphylaxis, rash, urticaria, itching. Discomfort at the injection site was transient and resolved on its own within a few days, along with the simultaneous use of ice packs and unloading of the joint (recommended rest). The above side effects only very rarely had a more severe course and lasted longer. The use of hyaluronic acid injections in the presence of symptoms indicating exacerbation of chronic inflammatory process rarely resulted in worsening of the disease. Hypersensitivity reactions and anaphylactic reactions (known from spontaneous reports) resolved without lasting consequences.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, 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 By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Hyaluroprol

The medicine should be stored out of sight and reach of children. Store at a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hyaluroprol contains

Page 3 of 4 The active substance of the medicine is sodium hyaluronate. 1 ml of the solution for injection contains the active substance: 10 mg of sodium hyaluronate. The medicine also contains: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

What Hyaluroprol looks like and what the packaging contains

Hyaluroprol is a solution for injection and is available in a type I glass pre-filled syringe in a cardboard box. The pre-filled syringe contains 2 ml of the solution. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Faran A.B.E.E., Achaias 5 & Troizinias, 145 64 Nea Kifissia, Attica, Greece

Manufacturer:

IBSA FARMACEUTICI ITALIA S.R.L., Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Number of the permit in Greece, the country of export: 17939/10-03-2011 27635/16/23-03-2017

Number of the permit for parallel import: 173/20

Date of approval of the leaflet: 18.06.2025

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