Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Hyaluroprol
10 mg/ml, solution for injection
Natrii hyaluronas
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms are the same.
If any of the adverse effects worsen or if any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Hyaluroprol is and what it is used for
Important information before using Hyaluroprol
How to use Hyaluroprol
Possible side effects
How to store Hyaluroprol
Contents of the packaging and other information

1. What Hyaluroprol is and what it is used for

Hyaluroprol 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 naturally occurs in high concentrations, among others, in cartilage and synovial fluid. Exogenous administration of Hyaluroprol in joint degenerative disease leads to normalization of synovial fluid properties such as viscosity and elasticity, and stimulates 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 the use of Hyaluroprol is mild to moderate knee osteoarthritis.

2. Important information before using Hyaluroprol

When not to use Hyaluroprol

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

Warnings and precautions

Do not use disinfectants containing quaternary ammonium salts, as they may cause precipitation of hyaluronic acid.
Intra-articular injection of the medicine should be performed by a properly trained physician, using appropriate technique and under aseptic conditions required for this route of administration.

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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.
Before performing intra-articular injection, the physician must thoroughly examine the patient to rule out acute joint inflammation. If such a diagnosis is made, the physician should consider whether administration of the medicine is justified.
If joint effusion is present, the physician will perform joint puncture 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 overloading the joint for several hours after administration of the medicine.

Other medicines and Hyaluroprol
Inform your doctor about all medicines currently used, recently used, or planned to be used.
Hyaluronic acid, when used concomitantly with certain locally acting anesthetics, prolongs the duration of anesthesia.
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, Hyaluroprol should be used only if absolutely necessary. The physician will decide on the necessity of treatment based on a risk-benefit assessment.

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

3. How to use Hyaluroprol

This medicine should always be used exactly as prescribed by the physician. In case of doubt, consult
your doctor or pharmacist.
Hyaluroprol 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 preparing the medicine for administration and disposal of unused product and waste
Remove the cap and carefully screw the needle onto the syringe, taking care not to press the plunger.
Check that the needle is securely attached to the threaded connector.
Do not overtighten the needle, as this may cause damage to the connector.
Any unused medicine and waste material must be disposed of in accordance with applicable regulations.
Use of a higher than recommended dose of Hyaluroprol
Due to the specific mode of administration (intra-articular injections performed exclusively by a physician),
overdose by the patient is not possible.
Missed dose of Hyaluroprol
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If a dose has been 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 everybody gets them.
The adverse reactions listed below originate from controlled and open clinical trials as well as from spontaneous post-marketing reports.
Uncommon adverse reactions (occur in 1 to 10 people in 10,000):
pain, effusion, swelling, increased local warmth, redness, joint inflammation, post-local application conditions, i.e. any other complications following joint puncture.
Very rare adverse reactions (occur in less than 1 person in 10,000) and frequency not known (cannot be estimated from the available data):
synovitis, septic arthritis, hypersensitivity reactions, anaphylaxis, rash, urticaria, pruritus.
Reactions 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 adverse reactions very rarely had a more severe course and persisted longer.
Injecting hyaluronic acid when symptoms indicating exacerbation of a chronic inflammatory process are present rarely led to worsening of the disease.
Hypersensitivity and anaphylactic reactions (known from spontaneous reports) resolved without permanent consequences.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Hyaluroprol

Keep this medicine out of 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 the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

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

What Hyaluroprol looks like and contents of the pack
Hyaluroprol is a solution for injection, available in a type I ampoule-syringe, packed in a blister within a cardboard carton.
The ampoule-syringe contains 2 ml of solution.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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., Italy
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Greece, country of export: 17939/10-03-2011
27635/16/23-03-2017
Parallel Import Authorisation Number: 173/20
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