Aterina 15 mg soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
ATERINA 15 mg soft capsules
Sulodexide
Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What ATERINA soft capsules are and what they are used for
- What you need to know before taking ATERINA soft capsules
- How to take ATERINA soft capsules
- Possible side effects
- How to store ATERINA soft capsules
- Contents of the pack and other information
1. What ATERINA capsules is and what it is used for
ATERINA capsules contain sulodexide, which belongs to a group of medicines called antithrombotics, 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 become weakened and blood stagnates, leading to swelling, heaviness, and pain in the legs).
Due to its antithrombotic effect, ATERINA capsules improves blood circulation and relieves symptoms associated with chronic venous insufficiency.
-
Treatment of chronic venous ulcer
-
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 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 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.
Taking ATERINA capsules with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
ATERINA capsules may enhance the anticoagulant effect of heparin-containing medicines and other oral anticoagulants when taken simultaneously (see section Warnings and Precautions).
Taking ATERINA capsules with food and drinks
No information is available regarding interactions with food or beverages.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 capsules during pregnancy.
Breast-feeding
ATERINA capsules should not be taken during breast-feeding.
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 capsules contain Sunset Yellow FCF (E 110), Carmoisine (E 124), Sodium ethyl para-hydroxybenzoate (E 215) and Sodium propyl para-hydroxybenzoate.
This medicine may cause allergic reactions because it contains Sunset Yellow FCF (E 110) and Carmoisine (E 124). These may 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; i.e., essentially "sodium-free".
3. How to take ATERINA capsules
Follow exactly the instructions for use of this medicine provided by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Treatment of chronic venous insufficiency:
The recommended dose is two 15 mg capsules twice daily (4 capsules in total per day) for 3 months.
Chronic venous ulcer:
Treatment should be initiated with 60 mg daily administered parenterally (vials) for 15–20 days, followed by oral formulation with 2 capsules of 15 mg twice daily (4 capsules per day), with the dose possibly increased up to a maximum of 3 capsules of 15 mg twice daily (6 capsules per day). The recommended duration of treatment is 2–3 months.
Symptomatic treatment of intermittent claudication in occlusive peripheral arterial disease (stage II):
Treatment should be initiated with 60 mg daily administered parenterally (vials) for 15–20 days, followed by oral formulation with 2 capsules of 15 mg twice daily (4 capsules per day), with the dose possibly increased up to a maximum of 3 capsules of 15 mg twice daily (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 have not been established in children and adolescents due to lack of data.
Patients with hepatic impairment
The use of ATERINA capsules 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 take more ATERINA capsules than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you take more ATERINA capsules than recommended, the risk of bleeding may increase. If bleeding occurs, go to the nearest emergency department.
If you forget to take ATERINA capsules
If you miss a dose, take it as soon as possible, then continue with your regular schedule. However, if it is almost time for the next dose, do not take the missed dose and wait until the next scheduled dose.
Do not take a double dose to make up for a missed dose.
If you stop treatment with ATERINA capsules
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 may cause adverse effects, although not everyone will experience them.
ATERINA capsules are generally well tolerated. The following are the adverse effects observed:
Frequent adverse effects (may affect up to 1 in 10 people):
- dizziness (sensation of spinning),
- diarrhea,
- pain in the upper 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.
Adverse effects with unknown frequency (cannot be estimated from available data):
- anemia,
- 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 with bruising (purpura),
- blood leakage under the skin (ecchymosis),
- papule,
- pruritus,
- difficulty emptying the bladder,
- pain when urinating,
- loss of bladder control,
- more frequent menstrual periods,
- genital swelling,
- redness of the skin around the genitals,
- chest pain,
- pain,
- 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 via 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 capsules
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 refers to the last day of the month indicated.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of ATERINA capsules
-
The active substance is sulodexide. Each soft capsule contains 15 mg of sulodexide, equivalent in in vitro activity to:
-
150 lipase units (LU)
-
1,350 anti-activated factor X international units (IU anti-Xa)
- The other components (excipients) are: sodium lauryl sarcosinate, colloidal anhydrous silica, triacetin, gelatin, glycerol (E 422), titanium dioxide (E 171), orange-yellow S (E 110), carmine red A (E 124), sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate.
Appearance of the medicine and contents of the pack
ATERINA capsules are presented as soft gelatin capsules, orange in colour, containing a white paste.
ATERINA capsules are available in packs containing 60 soft capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma España, S.L.
C/ Aribau 195, 4th floor
08021 Barcelona, Spain
Manufacturer:
Alfasigma, S.p.A.
Via Enrico Fermi, 1
65020 Alanno, Pescara, ITALY
Date of the most recent revision of this package leaflet: June 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/