ATERINA 15 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

ATERINA 15 mg Soft Capsules

Sulodexide

Read this package leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible 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 you take ATERINA capsules
3. How to take ATERINA capsules
4. Possible side effects
5. Storage of ATERINA capsules
6. Package contents and further information

1. What ATERINA capsules are and what they are used for

ATERINA capsules contain sulodexide, which belongs to a group of medicines 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 become weak and blood pools, 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

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

2. What you need to know before you take ATERINA capsules

Do not take ATERINA capsules

• if you are allergic to the active substance (sulodexide) or any of the other ingredients of this medicine (listed in section 6), to heparin or heparinoids (medicines that decrease blood coagulation),
• if you have a risk of bleeding or suffer from bleeding disorders.

Warnings and precautions

Consult your doctor or pharmacist before taking 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.

Taking ATERINA capsules with other medicines

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

ATERINA capsules may increase the anticoagulant effect of heparin-based medicines 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

As a precautionary measure, it is preferable to avoid the use of ATERINA capsules during pregnancy.

Breastfeeding

ATERINA capsules should not be taken during breastfeeding

Fertility

Studies in animals have not shown any direct or indirect harmful effects on the fertility of males and females.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

ATERINA capsules contain Yellow-Orange S (E 110), Cochineal Red A (E 124), Sodium Ethyl Para-Hydroxybenzoate (E 215), and Sodium Propyl Para-Hydroxybenzoate.

This medicine may cause allergic reactions because it contains Yellow-Orange S (E 110) and Cochineal Red A (E 124). They can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine may cause allergic reactions (possibly delayed) because it contains Sodium Ethyl Para-Hydroxybenzoate (E 215) and Sodium Propyl Para-Hydroxybenzoate.

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

3. How to take ATERINA capsules

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

Treatment of chronic venous insufficiency:

The recommended dose is two 15 mg capsules twice a day (4 capsules per day in total) for 3 months.

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 2 capsules of 15 mg twice a day (4 capsules per day), which can be increased up to a maximum of 3 capsules of 15 mg twice a day (6 capsules per day). The recommended duration of treatment is 2-3 months.

Symptomatic treatment of intermittent claudication in peripheral arterial occlusive 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 2 capsules of 15 mg twice a day (4 capsules per day), which can be increased up to a maximum of 3 capsules of 15 mg twice a day (6 capsules per day). The recommended duration of treatment is 6 months.

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.

Patient 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 medicine 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medicine 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 forgetting a 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 forgotten doses.

If you stop taking ATERINA capsules

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.

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 the available data):

• anemia,
• disorder of blood protein metabolism,
• perception disorders,
• seizures,
• tremor,
• visual impairment,
• palpitations,
• hot flushes,
• nosebleeds,
• hemoptysis (coughing up blood),
• asthma,
• black 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ATERINA capsules

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 store above 30°C.

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. Package contents and further information

Composition of Angileptol mint flavor

Each tablet contains:

• The active substances:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (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 are available in packs of 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, 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 on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es