Hialgan

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Hyalgan(Hyaluroprol)
10 mg/ml, solution for injection
Sodium hyaluronate
Hyalgan and Hyaluroprol are different trade names for the same drug.

You should read the leaflet carefully 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 you need to.
• 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 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 or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Hyalgan and what is it used for

Hyalgan contains the active substance - highly purified hyaluronic acid, i.e. a high molecular weight compound from the glycosaminoglycan group (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. The administration of Hyalgan in osteoarthritis 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 administration.
The indication for the use of Hyalgan is osteoarthritis of the knee joint with mild or moderate severity.

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 avian protein;
• if the patient has severe liver failure.

Warnings and precautions

• It is not recommended to use disinfectants containing quaternary ammonium salts, 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.
• The doctor will administer the medicine with particular caution to patients with localized infection in the area of the injection site, in order to avoid potential 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 advisability 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 Hyalgan

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as 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 think you may be pregnant or are planning to become pregnant, you should consult your 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 in cases where it is absolutely necessary. The doctor will decide on the basis of the risk-benefit assessment whether to use the medicine.

Driving and using machines

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

3. How to use Hyalgan

This medicine should always be used in accordance with the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.
Hyalgan 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
Syringe: remove the elastomer 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 product and its remains should be disposed of in accordance with applicable regulations.

Using a higher dose of Hyalgan 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 Hyalgan

In the event of a missed dose, 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, Hyalgan can cause side effects, although not everybody gets them.
The presented side effects come from controlled and open clinical trials as well as 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. any other complications after joint puncture.
Very rare side effects (occurring in less than 1 person out of 10,000) and unknown frequency (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, with concurrent 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 course.
Hypersensitivity reactions and anaphylactic reactions (known from spontaneous reports) resolved without permanent consequences.

Reporting side effects

If you experience any side effects, including those not listed in the 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
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 Hyalgan

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 given month.
Medicines should not be disposed of via wastewater or household waste. 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 pack and other information

What Hyalgan contains

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.
2 ml of the solution (1 syringe) contains 20 mg of sodium hyaluronate.
The medicine also contains: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

What Hyalgan looks like and what the pack contains

Hyalgan is a solution for injection and is available in a syringe with colorless glass type I in a blister pack, in a cardboard box.
To obtain 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 Kifissa, Attica, Greece

Manufacturer:

Ibsa Farmaceutici Italia S.R.L.
Via Emilia 99, 26900 Lodi, Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:27635/16/23-03-2017

Parallel import authorization number: 21/23 Date of approval of the leaflet: 14.02.2023

[Information about the trademark]