Package Insert: Information for the Patient

Hyalgan 20 mg Injectable Solution in Preloaded Syringe

Sodium Hyaluronate

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Hyalgan belongs to a group of medicines called other medicines for musculoskeletal system disorders.

This medicine is used in the symptomatic treatment of knee arthritis.

Do not use Hyalgan

• If you are allergic to hyaluronic acid or any of the other components of this medication included in section 6.
• If you are allergic (hypersensitive) to proteins from birds, feathers, and egg-derived products.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hyalgan.

• If joint effusion (inflammation of the knee) is observed, your doctor must drain it before injecting this medication.
• If possible signs of acute inflammation are determined.
• In patients with infection or skin alterations in the areas near the injection site.
• This medication should not be used with disinfectants containing quaternary ammonium salts.
• Avoid overloading the treated joint immediately after treatment.
• The injection technique will be performed in aseptic conditions to avoid possible infections at the administration site.

Children

Use is not recommended in children due to the absence of data on safety and efficacy.

Use of Hyalgan with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use with quaternary ammonium salts, precipitations of hyaluronic acid may occur.

Do not mix or administer simultaneously with other intra-articular drugs.

Use with local anesthetics of the type lidocaine, bupivacaine, may cause an increase in anesthesia time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is insufficient data on its use in pregnant women or breastfeeding women.

It should not be used during pregnancy or breastfeeding unless strictly necessary.

Driving and operating machines

No effects have been described on the ability to drive vehicles and use machines.

Hyalgan contains sodium;This medication contains less than 1 mmol of sodium (23 mg) per preloaded syringe of 2 ml; it is essentially "sodium-free".

This medication will only be administered to you by an experienced medical professional in your consultation center.

This medication will be administered via intraarticular injection.

Your doctor will inform you of the duration of your treatment, although the standard recommended dose is typically one intraarticular injection per week for 5 consecutive weeks, following the injection technique described below.

No dose adjustment is necessary for elderly patients.

The injection site must be thoroughly cleaned with antiseptic to ensure sterility. Remove any bubbles from the syringe before administering Hyalgan.

The injection must be administered exactly in the intraarticular space of the affected knee. The administration will be performed at the easiest injection point. Generally, a lateral area will be chosen, but in some cases, an anterior area may be preferred.

If fluid retention is observed before injecting the medication, it will be drained by arthrocentesis (extraction of synovial fluid) with a 20G needle until no synovial fluid is obtained, but without compromising the accuracy of the subsequent intraarticular injection of the medication. The extracted fluid will be examined and any bacterial infection will be ruled out before the injection.

The medication injection can be performed with the same needle used for arthrocentesis, removing the aspiration syringe and attaching the one containing the hyaluronic acid solution.

To verify that the needle is correctly attached, a small amount of synovial fluid will be aspirated before injecting the medication slowly; if the patient experiences pain during the injection, their doctor will stop the application and evaluate the continuation of treatment.

Once the administration is complete, it is recommended to perform passive flexoextension movements to ensure better intraarticular distribution of the medication.

Keep the treated knee at rest for the first 48 hours after treatment, avoiding any strenuous or prolonged activity. In the following days, you can gradually return to normal activity.

If you receive more Hyalgan than you should

This medication will only be administered to you by an experienced medical professional in your consultation center, so it is unlikely that you will receive more doses than you should.

However, if you believe you have been administered more medication than you should have, inform your doctor immediately.

If you do not receive any dose of Hyalgan

This medication will only be administered to you by an experienced medical professional in your consultation center, so it is unlikely that you will not receive the dose you should have. However, if you believe that a dose has been forgotten, inform your doctor immediately.

If you interrupt treatment with Hyalgan

Symptoms may recur, and you may not achieve the desired effects.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Local reactions such as pain, swelling, and heat or redness at the injection site have been reported, which are usually of short duration and resolve spontaneously in a few days by keeping the joint at rest and applying ice to the area. These reactions have only sporadically been of greater intensity and duration.

Somewhat cases of fever have also been reported, in some cases associated with the local reactions mentioned earlier.

In the presence of evident signs of inflammation, intra-articular administration of hyaluronic acid may occasionally exacerbate them in rare cases.

Some very rare cases of intra-articular infection (see “How to use Hyalgan”) have been reported.

In rare cases, systemic allergic reactions (skin rash, hives, and itching) have been reported.

The side effects listed below have been observed in patients who received this medicine, both in clinical trials and with regular use.

Rare side effects (occur in up to 1 in 1,000 patients):

Reactions at the injection site such as: pain, swelling, effusion, irritation, joint movement impairment, inflammation, redness, rash, discomfort, warmth, itching, hypersensitivity, hives.

Very rare side effects (occur in up to 1 in 10,000 patients):

Other reactions at the injection site such as:

Nodules;

Bleeding;

Numbness, tingling;

Blisters;

Warmth sensation;

Fever;

Septic arthritis (infection of the joint membrane);

Joint stiffness;

Infection of the joint due to an infection (septic arthritis or reactive arthritis);

Hypersensitivity;

Urticaria (hives);

Allergic reactions, which in some cases can be severe;

Serum sickness, similar to an allergic reaction caused by medicines containing proteins.

Other signs and symptoms of allergic reactions such as:

Angioedema (swelling under the skin), facial swelling, epiglottis swelling, laryngeal swelling, lip swelling, eyelid swelling,

Generalized rash,

Generalized itching,

Eczema,

Generalized skin redness,

Dermatitis

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store the product in the original packaging protected from light below 25°C. Do not freeze.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is not transparent, presents coloration or particles in suspension.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hyalgan

• The active ingredient is sodium hyaluronate. Each pre-filled syringe contains 20 mg of sodium hyaluronate.
• The other components are sodium chloride, sodium phosphate dodecahydrate, dihydrogen phosphate dihydrate, and water for injections.

Appearance of the product and contents of the packaging

This medicine is presented in pre-filled syringes, packaged in cardboard boxes with 1 or 5 pre-filled syringes containing a viscous, transparent, particle-free, sterile, and apyrogenic injectable solution.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Avda. de Europa 24 - Torona Building.

Parque Empresarial "La Moraleja" Building A - Office 1st B, 28108

Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Fidia Farmaceutici S.p.A.

Vía Ponte della Fabbrica 3/A

35031 Abano Terme (Italy)

Last review date of this leaflet:October 2018.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:/www.aemps.gob.es/