PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Natrii hyaluronas Medezin (Hyaluroprol)
10 mg/mL, solution for injection
Sodium hyaluronate
Natrii hyaluronas Medezin and Hyaluroprol are different trade names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Natrii hyaluronas Medezin is and what it is used for
Important information before using Natrii hyaluronas Medezin
How to use Natrii hyaluronas Medezin
Possible side effects
How to store Natrii hyaluronas Medezin
Contents of the pack and other information

1. What Natrii hyaluronas Medezin is and what it is used for

Natrii hyaluronas Medezin contains the active substance – highly purified hyaluronic acid, i.e. a high-molecular-weight compound belonging to the group of glycosaminoglycans (polysaccharide acids), which is an important component of all extracellular structures. This compound occurs physiologically in high concentrations, inter alia, in cartilage and synovial fluid. Intra-articular administration of Natrii hyaluronas Medezin in joint degenerative disease leads to normalization of synovial fluid properties such as viscosity and elasticity, and to activation of cartilage repair processes. Studies have shown that hyaluronic acid exerts anti-inflammatory and analgesic effects, resulting in improved joint mobility.
Intra-articular use.
The indication for Natrii hyaluronas Medezin is mild to moderate knee osteoarthritis.

2. Important information before using Natrii hyaluronas Medezin

When not to use Natrii hyaluronas Medezin

if the patient is allergic (hypersensitive) to hyaluronic acid or to any of the other ingredients of the medicine (listed in section 6);
if the patient has ever had an allergy to avian (bird) protein;
if the patient has severe liver insufficiency.

Warnings and precautions

Disinfectants containing quaternary ammonium salts are not recommended, as hyaluronic acid may precipitate in their presence.
Intra-articular injection of the medicine should be performed by a properly trained physician, following the appropriate technique and under aseptic conditions required for this route of administration.
The physician must be especially cautious when administering the medicine to patients with a localized infection at the injection site, to avoid potential development of bacterial arthritis.
Prior to intra-articular injection, the physician should thoroughly examine the patient to exclude acute joint inflammation. If such a diagnosis is established, the physician should consider whether administration of the medicine is justified.
If joint effusion is detected, the physician should perform joint aspiration before injecting the medicine.
Before injecting the medicine, the physician must ensure that the needle has not been inserted into a blood vessel (do not aspirate into the syringe containing the medicine).
It is recommended to avoid stressing the joint for several hours after administration of the medicine.

Other medicines and Natrii hyaluronas Medezin
Inform your doctor about all medicines currently used, recently used, or planned to be used.
Hyaluronic acid, when used concomitantly with certain local anaesthetic agents, may prolong the anaesthetic effect.
Disinfectants containing quaternary ammonium salts may cause precipitation of hyaluronic acid.
No physico-chemical incompatibilities have been observed with medicines such as corticosteroids administered via intra-articular injections.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Animal studies have not shown embryotoxic or teratogenic effects of hyaluronic acid; however, in pregnant and breastfeeding women, Natrii hyaluronas Medezin should be used only if absolutely necessary. The decision to use the medicine should be made by the physician based on an assessment of the benefit-risk ratio.

Driving and operating machinery
Natrii hyaluronas Medezin has no influence on the ability to drive or operate machinery.

3. How to use Natrii hyaluronas Medezin

This medicine should always be used exactly as recommended by the doctor. If in doubt, consult
your doctor or pharmacist.
Natrii hyaluronas Medezin is administered as intra-articular injections once a week at a dose of 20 mg (2 ml) for 5 weeks, under aseptic conditions.
Instructions for preparation of the medicine for administration and disposal of any residue
Remove the elastomeric stopper and carefully screw the needle onto the syringe without pressing the plunger.
Check that the needle is securely attached to the threaded connector.
Do not tighten the needle too firmly, as this may cause breakage of the connector.
Any unused product and waste material must be disposed of in accordance with applicable regulations.
Use of more than the recommended dose of Natrii hyaluronas Medezin
Due to the specific mode of administration (intra-articular injections are performed exclusively by a physician), overdose by the patient is not possible.
Missed dose of Natrii hyaluronas Medezin
If a dose is missed, contact your doctor to schedule the next injection. Do not administer a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below originate from controlled and open clinical trials as well as from spontaneous reports following marketing authorization.
Uncommon adverse reactions (occur in 1 to 10 people out of 10,000):
pain, effusion, swelling, increased local warmth, redness, arthritis, post-administration conditions at injection site, i.e. any other complications following joint puncture.
Very rare adverse reactions (occur in less than 1 person out of 10,000) and frequency not known (cannot be estimated from the available data):
synovitis, septic arthritis, hypersensitivity reactions, anaphylaxis, rash, urticaria, pruritus.
Symptoms at the injection site were transient and resolved spontaneously within a few days, especially with concomitant use of cold compresses and joint unloading (recommended rest).
The above-mentioned adverse reactions were only very rarely severe and persistent.
Administration of hyaluronic acid injections in cases of symptoms indicating an exacerbation of chronic inflammatory process rarely led to worsening of the disease course.
Hypersensitivity and anaphylactic reactions (known from spontaneous reports) resolved without permanent consequences.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Natrii hyaluronas Medezin.

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Natrii hyaluronas Medezin contains
The active substance is sodium hyaluronate.
1 ml of injection solution contains the active substance: 10 mg of sodium hyaluronate.
The other ingredients are: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

What Natrii hyaluronas Medezin looks like and contents of the pack
Natrii hyaluronas Medezin is a solution for injection, supplied in a pre-filled syringe made of colorless type I glass.
Each pre-filled syringe contains 2 ml of solution.

For further information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Greece, country of export:
Faran A.B.E.E.
Achaias 5 & Troizinias
145 64 Nea Kifissia
Attica
Greece

Manufacturer:
IBSA FARMACEUTICI ITALIA S.R.L.
Via Emilia 99
26900 Lodi
Italy

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Marketing Authorization Numbers in Greece, country of export:
27635/16/23-03-2017
17939/10-03-2011

Parallel Import Authorization Number: 326/22