ATERINA 25 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Aterina 25 mg Soft Capsules

Sulodexide

Read the entire package leaflet carefully before starting to take 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 Capsules are and what they are used for
2. What you need to know before taking Aterina Capsules
3. How to take Aterina Capsules
4. Possible side effects
5. Storage of Aterina Capsules
6. Package Contents and Additional Information

1. What Aterina Capsules are and what they are used for

Aterina Capsules contain sulodexide, which belongs to the group of medications called antithrombotics, used to prevent and treat blood clots (thrombi) that can form in blood vessels.

Aterina Capsules are indicated in adults for:

• Treatment of chronic venous insufficiency (when veins weaken and blood pooling occurs, associated with swelling, heaviness, and pain in the legs).

Due to its antithrombotic effect, Aterina Capsules improve blood circulation and alleviate symptoms associated with chronic venous insufficiency.

• Treatment of chronic venous ulcers

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

2. What you need to know before taking Aterina Capsules

Do not take Aterina Capsules

• if you are allergic to the active substance (sulodexide) or to 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 take Aterina Capsules.

Children and Adolescents

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

Other Medications and Aterina

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

Aterina Capsules may increase the anticoagulant effect of heparin-based medications and other oral anticoagulants if taken simultaneously (see Warnings and Precautions section).

Taking Aterina Capsules with Food and Drinks

No information is available on interactions with food or drinks.

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 recommended to avoid using Aterina Capsules during pregnancy.

Breastfeeding

Aterina Capsules should not be taken during breastfeeding.

Fertility

Studies in animals do not indicate direct or indirect harmful effects on male and female fertility.

Driving and Using Machines

This medication does not affect or has negligible effects on the ability to drive and use machines.

Aterina Capsules contain sodium ethyl para-hydroxybenzoate (E 215), sodium propyl para-hydroxybenzoate, and sodium.

Aterina Capsules may cause allergic reactions (possibly delayed) because they contain sodium ethyl para-hydroxybenzoate (E 215) and sodium propyl para-hydroxybenzoate.

This medication contains less than 1 mmol (23 mg) of sodium per capsule; it is essentially "sodium-free".

3. How to Take Aterina Capsules

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment of chronic venous insufficiency:

The recommended dose is one 25 mg capsule twice a day (2 capsules a day) for 3 months and medical reevaluation.

Chronic venous ulcers:

Treatment is recommended to start with 60 mg per day by parenteral route (ampoules) for 15-20 days and continue with the oral formulation taking 1 capsule of 25 mg twice a day (2 capsules a day), which may be increased up to a maximum of 2 capsules of 25 mg twice a day (4 capsules a day). The recommended treatment duration is 2-3 months and medical reevaluation.

Symptomatic treatment of intermittent claudication in occlusive peripheral arterial disease (stage II):

Treatment is recommended to start with 60 mg per day by parenteral route (ampoules) for 15-20 days and continue with the oral formulation taking 1 capsule of 25 mg twice a day (2 capsules a day), which may be increased up to a maximum of 2 capsules of 25 mg twice a day (4 capsules a day). The recommended treatment duration is 6 months and medical reevaluation.

Aterina Capsules should be taken orally with liquid and separated from meals.

Use in Children and Adolescents

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

Patients with Hepatic Problems

The use of Aterina Capsules 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 Take More Aterina Capsules 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 taken.

If you take more Aterina Capsules than recommended, you may increase the risk of bleeding. If bleeding occurs, go to the nearest emergency service.

If You Forget to Take Aterina Capsules

In case of a missed dose, take another as soon as possible, then follow the usual schedule. However, if it is close to the time for the next dose, do not take the missed dose and wait until the next one.

Do not take a double dose to make up for missed doses.

If You Interrupt Treatment with Aterina Capsules

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 will experience them.

Aterina Capsules are 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.

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-colored stools due to gastrointestinal bleeding,
• vomiting,
• gas,
• indigestion,
• nausea,
• abdominal discomfort,
• potentially life-threatening reaction with symptoms similar to 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 bruising (purpura),
• blood extravasation under the skin (ecchymosis),
• papule,
• itching,
• difficulty emptying the bladder,
• pain while urinating,
• loss of bladder control,
• more frequent menstrual periods,
• swelling of the genitals,
• redness of the skin around the genitals,
• chest pain,
• pain,
• 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 Medication Surveillance System for Human Use: 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 Capsules

Keep this medication out of 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 ºC.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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), acesulfame potassium (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 España S.L.

C/ Aribau 195, 4º

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