Patient Information Leaflet

ATERINA 15 mg Soft Capsules

Sulodexide

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 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 capsules are and what they are used for

2. What you need to know before you start taking ATERINA capsules

3. How to take ATERINA capsules

4. Possible side effects

5. Storage of ATERINA capsules

6. Contents of the pack and additional information

ATERINA capsules contain sulodexide, which belongs to a group of medicines called antithrombotics, which are used to prevent and treat blood clots (thrombi) that may form in blood vessels.

ATERINA capsules is indicated in adults for:

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

Due to its antithrombotic effect, ATERINA capsules improves blood circulation and alleviates symptoms associated with chronic venous insufficiency.

-Treatment of chronic venous ulcer

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

Do not take ATERINA capsules

- 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 (blood-thinning medications),

- if you have a risk of bleeding or suffer from bleeding disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ATERINA capsules.

Children and adolescents

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

Taking ATERINA capsules with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

ATERINA capsules should not be taken during breastfeeding.

Fertility

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

Driving and operating machines

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

ATERINA capsules contain Yellow-orange S (E 110), Red Cochineal A (E 124), Sodium ethyl para-hydroxybenzoate (E 215), and Propyl para-hydroxybenzoate of sodium.

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

This medication may cause allergic reactions (possibly delayed) because it contains sodium ethyl para-hydroxybenzoate (E 215) and propyl para-hydroxybenzoate of sodium.

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

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

In case of doubt, consult your doctor or pharmacist again.

Chronic venous insufficiency treatment:

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

Chronic venous ulcer:

It is recommended to start treatment with 60 mg per day via 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 may be increased up to a maximum of 3 capsules of 15 mg twice a day (6 capsules per day). The recommended treatment duration is 2-3 months.

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

It is recommended to start treatment with 60 mg per day via 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 may be increased up to a maximum of 3 capsules of 15 mg twice a day (6 capsules per day). The recommended treatment duration 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 absence of data.

Patients with liver problems

The use of Aterina capsules is not recommended in patients with liver 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 forgot to take Aterina capsules

In case of forgotten dose, take another as soon as possible, then follow the usual schedule. However, if there are only a few hours left until the next dose, do not take the forgotten dose and wait until the next one.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Aterina capsules

If you have any other doubts 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.

This medicine 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 eruption
• 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,
• 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),
• papule,
• itching,
• difficulty urinating,
• painful urination,
• loss of bladder control,
• more frequent menstrual periods,
• genital swelling,
• skin redness around the genitals,
• chest pain,
• pain,
• 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 that does not appear in this prospectus. You can also report them directly tothrough 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.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ATERINA capsules

• The active principle is sulodexide. Each soft capsule contains 15 mg of sulodexide, equivalent in activityin vitroto:

- 150 lipase units (ULS)

- 1,350 international anti-factor Xa units (UI anti Xa)

• The other components (excipients) are: sodium laurilsarcosinate, anhydrous colloidal silica, triacetin, gelatin, glycerol (E 422), titanium dioxide (E 171), yellow-orange S (E 110), red cochineal A (E 124), sodium ethyl para-hydroxybenzoate (E 215), and propyl para-hydroxybenzoate.

Appearance of the product and contents of the packaging

ATERINA capsules are presented in the form of soft gelatin capsules, orange in color, containing a white paste.

ATERINA capsules are available in packaging containing 60 soft 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

Last review date of this leaflet: 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/