Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Hyalgan (Hyaluroprol)
10 mg/ml, solution for injection
Natrii hyaluronas
Hyalgan and Hyaluroprol are different trade names for the same medicinal product.
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

Keep this leaflet, as you may need to read it again.
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.
The medicine may harm another person, even if their symptoms are the same.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist. See section 4.

Table of contents:

What Hyalgan is and what it is used for
What you need to know before using Hyalgan
How to use Hyalgan
Possible side effects
How to store Hyalgan
Contents of the pack and other information

1. What Hyalgan is and what it is used for

Hyalgan contains as its active substance highly purified hyaluronic acid, 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 Hyalgan in joint degenerative disease leads to normalization of synovial fluid properties such as viscosity and elasticity, and stimulates reparative processes in articular cartilage. Studies have shown that hyaluronic acid exerts anti-inflammatory and analgesic effects, resulting in improved joint mobility.
For intra-articular use.
The indication for use of Hyalgan is mild to moderate osteoarthritis of the knee joints.

2. Important information before using Hyalgan

When not to use Hyalgan

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 poultry 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, using appropriate technique and under aseptic conditions required for this route of administration.
The physician will administer the medicine with particular caution in patients with an infection localized in the area of the injection site to avoid possible development of bacterial arthritis.
Before performing intra-articular injection, the physician will thoroughly examine the patient to rule out acute joint inflammation. If such a diagnosis is established, 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 Hyalgan
Inform your doctor about all medicines currently used, recently used, or which the patient plans to use.
Hyaluronic acid, when used simultaneously 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 drugs such as corticosteroids administered via intra-articular injections.

Pregnancy and breastfeeding
During pregnancy and breastfeeding, or if pregnancy is suspected or planned, 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, Hyalgan should be used only when absolutely necessary. The physician will decide on the necessity of using the medicine based on an assessment of the risk-benefit ratio.

Driving and using machines
Hyalgan has no influence on the ability to drive or operate machinery.

3. How to use Hyalgan

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult
your doctor or pharmacist.
Hyalgan 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 and disposing of any residue
Pre-filled syringe: remove the elastomeric 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 product and waste material should be disposed of in accordance with local regulations.
Use of a higher than recommended dose of Hyalgan
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 Hyalgan
If a dose has been missed, contact your doctor to schedule the next injection. Do not administer
a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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 in 10,000):
pain, effusion, swelling, increased local warmth, redness, arthritis, post-procedural complications following intra-articular injection such as any other complications related to 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.

Local reactions at the injection site were transient and resolved spontaneously within a few days, especially with concomitant use of cold compresses and joint rest (recommended rest).

The above adverse reactions very rarely had a severe course or persisted for a prolonged period.

Administration of hyaluronic acid injections in the presence of signs indicating an exacerbation of chronic inflammatory process rarely led to worsening of the disease.

Hypersensitivity and anaphylactic reactions (reported in spontaneous reports) resolved without permanent consequences.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 this medicine.

5. How to store Hyalgan

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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Hyalgan contains
The active substance of the medicine is sodium hyaluronate.
1 ml of injection solution contains the active substance: 10 mg of sodium hyaluronate.
2 ml of solution (1 pre-filled syringe) contains 20 mg of sodium hyaluronate.
The other ingredients are: sodium chloride, disodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

What Hyalgan looks like and contents of the pack
Hyalgan is a solution for injection, available in a pre-filled syringe made of colourless type I glass, packed in a blister within a cardboard box.
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.
Via Emilia 99, 26900 Lodi, Italy

Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in Greece, country of export: 27635/16/23-03-2017
Parallel import authorisation number: 21/23