HYALGAN 20 mg INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Hyalgan 20 mg Solution for Injection in Pre-filled Syringe

Sodium Hyaluronate

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Hyalgan and what is it used for
2. What you need to know before you use Hyalgan
3. How to use Hyalgan
4. Possible side effects
5. Storage of Hyalgan
6. Contents of the pack and further information

1. What is Hyalgan and what is it used for

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

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

2. What you need to know before you use Hyalgan

Do not use Hyalgan

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

Warnings and precautions

Talk to your doctor or pharmacist before you start using Hyalgan.

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

Children

This medicine is not recommended for use in children due to the lack of data on safety and efficacy.

Using Hyalgan with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not use with quaternary ammonium salts, as they may cause precipitation of hyaluronic acid.

It is not recommended to mix or administer simultaneously with other intra-articular drugs.

The use of local anesthetics such as lidocaine, bupivacaine, may cause an increase in anesthesia time.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There is not enough data on the use of this medicine in pregnant or breast-feeding women.

This medicine should not be used during pregnancy or breast-feeding unless strictly necessary.

Driving and using machines

No effects on the ability to drive or use machines have been reported.

Hyalgan contains sodium;this medicine contains less than 1 mmol of sodium (23 mg) per 2 ml pre-filled syringe; this is essentially "sodium-free".

3. How to use Hyalgan

This medicine will only be administered by a medical professional with experience, in their office.

This medicine will be administered by intra-articular injection.

Your doctor will tell you how long your treatment will last, although the normal recommended dose is one intra-articular injection once a week for 5 consecutive weeks, following the injection technique described below.

No dose adjustment is necessary in elderly patients.

The injection area must be carefully cleaned with antiseptic to ensure its sterility. Remove any air bubbles from the syringe before administering Hyalgan.

The injection should be performed exactly in the intra-articular space of the affected knee. The administration will be performed through 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 medicine, it will be drained by arthrocentesis (removal of synovial fluid) with a 20G needle until no synovial fluid is obtained, without compromising the accuracy of the subsequent intra-articular injection of the medicine. The extracted fluid will be examined and the presence of bacterial infection will be ruled out before injection.

The injection of the medicine 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 slowly injecting the medicine; if the patient experiences pain during the injection, the doctor will stop the application and assess the continuation of the treatment.

Once the administration is complete, it is recommended to perform passive flexion-extension movements for better intra-articular distribution of the medicine.

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 medicine will only be administered by a medical professional with experience, in their office, so it is unlikely that you will receive more than the recommended dose.

However, if you think you have been given more medicine than you should, inform your doctor immediately.

If you miss a dose of Hyalgan

This medicine will only be administered by a medical professional with experience, in their office, so it is unlikely that you will miss a dose. However, if you think you have missed a dose, inform your doctor immediately.

If you stop using Hyalgan

The symptoms may reappear and you may not obtain the desired effects.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Local reactions such as pain, swelling, and heat or redness at the injection site have been reported, generally they are of short duration and resolve spontaneously within a few days, keeping the joint at rest and applying ice to the area. Only occasionally have these reactions been of greater intensity and duration.

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

In the presence of clear signs of inflammation, the intra-articular administration of hyaluronic acid may occasionally worsen them.

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

Rarely, systemic allergic reactions (skin rash, hives, and itching) have been reported.

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

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

Reactions at the injection site such as: pain, swelling, effusion, irritation, affectation of the movement of the affected joint, inflammation, redness, rash, discomfort, warming, 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;

Hemorrhage;

Numbness, tingling;

Blisters;

Feeling of heat;

Fever;

Synovitis (inflammation of the membrane that covers the joints);

Joint stiffness;

Inflammation of the joints due to 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), swelling of the face, swelling of the epiglottis, swelling of the larynx, swelling of the lip, swelling of the eyelids,

Generalized rash,

Generalized itching,

Eczema,

Generalized redness of the skin,

Dermatitis

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hyalgan

Keep the product in the original packaging, protected from light, at a temperature below 25°C. Do not freeze.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice that the solution is not clear, has a coloration, or particles in suspension.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Hyalgan

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

Appearance of the product and pack contents

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Avda. de Europa 24 - Edificio Torona.

Parque Empresarial "La Moraleja" Edificio A - Oficina 1ºB, 28108

Alcobendas (Madrid)

Spain

Manufacturer:

Fidia Farmaceutici S.p.A.

Via Ponte della Fabbrica 3/A

35031 Abano Terme (Italy)

Date of last revision of this package leaflet:October 2018.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/