ATERINA 60 mg/2 mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

ATERINA 60 mg/ 2ml injectable solution

Sulodexide

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

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

Contents of the Package Leaflet

1. What ATERINA injectable solution is and what it is used for
2. What you need to know before using ATERINA injectable solution
3. How to use ATERINA injectable solution
4. Possible side effects
5. Storage of ATERINA injectable solution
6. Package Contents and Additional Information

1. What ATERINA injectable solution is and what it is used for

ATERINA injectable solution contains sulodexide, which belongs to the group of medications called antithrombotics, fibrinolytics, and antiviscous agents, used to prevent and treat injuries to the walls of blood vessels, both arterial and venous.

ATERINA injectable solution is indicated in adults for:

• Treatment of symptoms of intermittent claudication in peripheral arterial occlusive disease (stage II).
• Treatment of chronic venous ulcers.

2. What you need to know before using ATERINA injectable solution

Do not use ATERINA injectable solution:

• if you are allergic to the active substance (sulodexide) or any of the other components of this medication (listed in section 6), to heparin or heparinoids (medications that decrease blood coagulation),
• if you have a risk of bleeding or suffer from hemorrhagic diseases.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use ATERINA injectable solution.

Children and Adolescents

The safety and efficacy of ATERINA injectable solution have not been established in children and adolescents under 18 years of age. No data are available.

Use of ATERINA injectable solution with other medications

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

ATERINA injectable solution may cause chemical reactions if administered with other medications. The incompatible substances commonly used in intravenous therapy are

• vitamins (vitamin K, B-complex vitamins),
• cortisone preparations (hydrocortisone),
• hyaluronidase (a substance used in medicine to facilitate the injection of drugs),
• calcium gluconate (used in case of calcium deficiency in the blood),
• disinfectants (quaternary ammonium salts),
• certain types of antibiotics (chloramphenicol, tetracycline, and streptomycin).

ATERINA injectable solution may increase the anticoagulant effect of heparin-based medications and other oral anticoagulants if used simultaneously (see Warnings and Precautions section).

Use of ATERINA injectable solution with food and beverages

No information is available on interactions with food or beverages.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

As a precaution, it is preferable to avoid using ATERINA injectable solution during pregnancy.

Breastfeeding

ATERINA injectable solution should not be used during breastfeeding.

Fertility

Studies in animals do not indicate direct or indirect harmful effects on the fertility of males and females.

Driving and Using Machines

This medication does not affect or affects insignificantly the ability to drive and use machines.

ATERINA injectable solution contains sodium chloride.

This medication contains less than 1 mmol (23 mg) of sodium per ampoule, so it is considered essentially "sodium-free".

3. How to use ATERINA injectable solution

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 ampoule (60 mg) per day by intravenous or intramuscular route.

Peripheral Arterial Disease: it is recommended to start treatment with 60 mg per day by parenteral route for 15-20 days and continue with the oral formulation for 6 months.

Chronic Venous Ulcer: it is recommended to start treatment with 60 mg per day by parenteral route for 15-20 days and continue with the oral formulation for 2-3 months.

Use in Children and Adolescents

The safety and efficacy of ATERINA injectable solution have not been established in children and adolescents due to the lack of data.

Patient with Hepatic Impairment

The use of ATERINA injectable solution is not recommended in patients with hepatic disorders since there are no data on the safety and efficacy of the medication in these patients.

If you use more ATERINA injectable solution than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you use more ATERINA injectable solution than recommended, you may increase the risk of bleeding. If bleeding occurs, go to the nearest emergency service.

If you forget to use ATERINA injectable solution

Do not use a double dose to make up for forgotten doses.

If you interrupt treatment with ATERINA injectable solution

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

ATERINA injectable solution is usually well tolerated. The following side effects have been observed:

Common Side Effects(may affect up to 1 in 10 people):

• dizziness (feeling of spinning),
• diarrhea,
• upper abdominal pain,
• skin rash.

Uncommon Side Effects(may affect up to 1 in 100 people):

• loss of consciousness,
• headache,
• stomach bleeding,
• pruritic rash,
• itching, redness, and dryness of the skin,
• swelling, especially of ankles and feet,
• bleeding at the injection site.

Side Effects of Unknown Frequency(cannot be estimated from available data):

• anemia,
• disorder of blood protein metabolism,
• perception disorders,
• seizures,
• tremors,
• visual impairment,
• palpitations,
• hot flashes,
• nosebleeds,
• coughing up blood (hemoptysis),
• asthma,
• black stools due to gastrointestinal bleeding,
• vomiting,
• gas,
• indigestion,
• nausea,
• abdominal discomfort,
• potentially life-threatening reaction with symptoms similar to those of the flu and painful rash affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• rapid swelling under the skin,
• redness of the skin,
• purple spots with hematomas (purpura),
• blood extravasation under the skin (ecchymosis),
• itching,
• papule,
• difficulty emptying the bladder,
• pain when urinating,
• loss of bladder control,
• more frequent menstrual periods,
• swelling of the genitals,
• redness of the skin around the genitals,
• chest pain,
• pain,
• pain at the injection site,
• fever.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ATERINA injectable solution

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

6. Package Contents and Additional Information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other components (excipients) are: sorbitol (E420), potassium acesulfame (E950), magnesium stearate, and mint flavor

Appearance of the Product and Package Contents

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one face.

They come in packages containing 15 and 30 sucking tablets.

Other Presentations

Angileptol Mint-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing Authorization Holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the Last Revision of this Package Leaflet:September 2021

Other Sources of Information

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