Leaflet: information for the user

ATERINA 60 mg/ 2ml injectable solution

Sulodexida

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

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

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

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

3. How to use ATERINA injectable solution

4. Possible side effects

5. Storage of ATERINA injectable solution

6. Contents of the pack and additional information

ATERINA injectable solution contains sulodexide, which belongs to a group of medicines called antithrombotics, fibrinolytics and antiviscotics, which are used to prevent and treat injuries to the walls of blood vessels, both arterial and venous.

ATERINA injectable solution is indicated in adults for:

• The treatment of symptoms of intermittent claudication in peripheral arterial occlusive disease (stage II).
• The treatment of chronic venous ulcer.

Do not use ATERINA injectable solution:

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

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

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

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

• vitamins (vitamin K, B complex vitamins),
• preparations of cortisone (hydrocortisone),
• hyaluronidase (a substance used in medicine to facilitate the injection of medications),
• calcium gluconate (used in case of blood calcium deficiency),
• 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

As a precaution, it is recommended to avoid the use of ATERINA injectable solution during pregnancy.

Breastfeeding

ATERINA injectable solution should not be used during breastfeeding.

Fertility

Animal studies do not indicate direct or indirect harmful effects on male and female fertility.

Driving and operating machinery

This medication does not affect or insignificantly affects the ability to drive and operate machinery.

ATERINA injectable solution contains sodium chloride.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.This includes consulting with your doctor or pharmacist again if you are unsure.

The recommended dose is 1 ampoule (60 mg) per day administered intravenously or intramuscularly.

Peripheral arterial disease: it is recommended to start treatment with 60 mg per day administered parenterally 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 administered parenterally 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.

Patients with liver problems

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

Using more ATERINA injectable solution than prescribed

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

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

Missing a dose of ATERINA injectable solution

Do not use a double dose to compensate for missed doses.

Stopping treatment with ATERINA injectable solution

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

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

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

Frequent side effects(may affect up to 1 in 10 people):

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

Less frequent side effects(may affect up to 1 in 100 people):

• loss of consciousness,
• headache,
• gastric hemorrhage,
• pruritic rash,
• itching, redness, and dryness of the skin,
• swelling, especially of ankles and feet,
• bleedingat the injection site.

Side effects of unknown frequency(cannot be estimated from available data):

• anemia,
• disorder of blood protein metabolism,
• perceptual alterations,
• seizures,
• tremor,
• visual deterioration,
• palpitations,
• syncope,
• nasal bleeding,
• hemoptysis (coughing up blood),
• asthma,
• stool black as a result of gastrointestinal hemorrhage,
• vomiting,
• gas,
• indigestion,
• nausea,
• abdominal discomfort,
• potentially fatal reaction with symptoms similar to the flu and painful rash affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• rapid swelling under the skin,
• skin redness,
• purple spots with hematomas (purpura),
• subcutaneous bleeding (ecchymosis),
• itching,
• papule,
• difficulty urinating,
• painful urination,
• loss of bladder control,
• more frequent menstrual periods,
• genital swelling,
• redness of the skin around the genitals,
• chest pain,
• pain,
• pain at the injection site,
• fever.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainerafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of ATERINA injectable solution

• The active ingredient is sulodexide. Each ampoule contains 60 mg of sulodexide, equivalent in activityin vitroto:
• 1. -600 units of lipase activity (ULS)
  2. -5,400 units of international anti-factor Xa activity (UI anti Xa)
• The other components(excipients)are: sodium chloride, water for injection.

Appearance of the product and contents of the packaging

ATERINA injectable solution is presented in the form of an injectable solution contained in glass ampoules of 2 ml.

ATERINA injectable solution is available in packaging containing 6 ampoules.

Other presentations of ATERINA

ATERINA 15 mg soft capsules, 60 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona. SPAIN

Responsible for manufacturing:

Alfasigma S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara. ITALY

Date of the last review of thisleaflet: June 2023

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