Aterina 60 mg/2 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ATERINA 60 mg/2ml injection solution

Sulodexide

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What ATERINA injection solution is and what it is used for
2. What you need to know before using ATERINA injection solution
3. How to use ATERINA injection solution
4. Possible adverse effects
5. How to store ATERINA injection solution
6. Contents of the pack and other information

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

ATERINA injectable solution contains sulodexide, which belongs to a group of medicines called antithrombotics, fibrinolytics, and anti-viscous 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 occlusive peripheral arterial disease (stage II).
• Treatment of chronic venous ulcer.

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 to any of the other ingredients of this medicine (listed in section 6), to heparin or heparinoids (medicines that reduce blood clotting),
• if you are at 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 in children and adolescents under 18 years of age has not been established. Data are lacking.

Use of ATERINA injectable solution with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

ATERINA injectable solution may cause chemical reactions if administered together with other medicines. Substances commonly used in intravenous therapy that are incompatible include:

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

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

Use of ATERINA injectable solution with food and drinks

There is no information available on interactions with food or drinks.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Breastfeeding

ATERINA injectable solution must not be used during breastfeeding.

Fertility

Animal studies have not shown any direct or indirect harmful effects on fertility in males or females.

Driving and using machines

This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

ATERINA injectable solution contains sodium chloride.

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule and is therefore considered essentially “sodium-free”.

3. How to use ATERINA injectable solution

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Peripheral arterial disease: treatment should be initiated with 60 mg daily by parenteral route for 15–20 days, followed by oral formulation for 6 months.

Chronic venous ulcer: treatment should be initiated with 60 mg daily by parenteral route for 15–20 days, followed by oral formulation for 2–3 months.

Use in children and adolescents

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

Patients with hepatic impairment

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

If you use more ATERINA injectable solution than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount administered.

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

If you forget to use ATERINA injectable solution

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

If you stop treatment with ATERINA injectable solution

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

4. Possible adverse effects

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

Injectable ATERINA solution is usually well tolerated. The adverse effects observed are listed below:

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

• dizziness (sensation of spinning),
• diarrhoea,
• abdominal pain in the upper part of the abdomen,
• skin rash.

Uncommon adverse effects (may affect up to 1 in 100 people):

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

Adverse effects with unknown frequency (cannot be estimated from the available data):

• anaemia,
• disorder of blood protein metabolism,
• disturbances in perception,
• seizures,
• tremor,
• visual impairment,
• palpitations,
• hot flushes,
• nosebleeds,
• coughing up blood (haemoptysis),
• asthma,
• black stools due to gastrointestinal bleeding,
• vomiting,
• flatulence,
• indigestion,
• nausea,
• abdominal discomfort,
• potentially life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome),
• rapid swelling under the skin,
• skin redness,
• purple spots like bruises (purpura),
• blood leakage 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 of adverse effects

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

5. Storage of ATERINA injectable solution

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of ATERINA injectable solution

• The active substance is sulodexide. Each ampoule contains 60 mg of sulodexide, equivalent in in vitro activity to:
  1. • 600 lipasemic units (LU)
  2. • 5,400 international anti-activated factor X units (IU anti Xa)
• The other components (excipients) are: sodium chloride, water for injectable preparations.

Appearance of the product and contents of the pack

ATERINA injectable solution is presented as an injectable solution contained in 2 ml glass ampoules.

ATERINA injectable solution is available in packs containing 6 ampoules.

Other presentations of ATERINA

ATERINA 15 mg soft capsules, 60 capsules.

Marketing Authorization Holder and Manufacturer

Holder:

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Manufacturer:

Alfasigma S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara. ITALY

Date of the latest review of this product information: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/