Ernodasa hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ernodasa hard capsules
Streptokinase and Streptodornase
Read all of 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, 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 effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ernodasa is and what it is used for
- What you need to know before taking Ernodasa
- How to take Ernodasa
- Possible side effects
- How to store Ernodasa
- Contents of the pack and other information
1. What Ernodasa is and what it is used for
Ernodasa belongs to a group of medicines called antithrombotics.
Ernodasa is indicated in adults for the treatment of acute or chronic inflammatory processes, whether of infectious or traumatic origin (with edema and/or hematoma).
2. What you need to know before starting Ernodasa
Do not take Ernodasa
- If you are allergic to streptokinase, streptodornase, or any of the other ingredients of this medicine (listed in section 6).
- If you have blood clotting disorders (known hemorrhagic diathesis).
- If you have uncontrolled severe hypertension.
- If you have low levels of fibrinogen (a protein involved in blood clotting).
- If you have low platelet levels in the blood (thrombocytopenia).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Ernodasa.
If an allergic reaction occurs, including anaphylactic shock, dyspnea (difficulty breathing), or urticaria, treatment with Ernodasa must be discontinued.
Take special care with Ernodasa in the following situations:
- Recent severe gastrointestinal bleeding.
- Recent major surgery (6th to 10th postoperative day, depending on the severity of the surgery).
- Recent trauma and cardiopulmonary resuscitation.
- Recent organ biopsy, punctures in non-compressible vessels, intramuscular injections, or intubation.
- Recent childbirth or abortion.
- Patients receiving oral anticoagulants (medications that prevent blood clotting).
- Severe liver or kidney impairment.
- Lesions in organs prone to bleeding (e.g., active peptic ulcer).
- Inflammation of the heart (acute pericarditis and/or subacute bacterial endocarditis).
- Active, existing, or recent internal bleeding.
- Recent stroke; intracranial or intraspinal surgery.
- Brain tumor (intracranial neoplasm).
- Recent head injury (cranioencephalic trauma).
- Known tumor with risk of bleeding.
- Inflammation of the pancreas (acute pancreatitis).
- Retinal abnormalities (hypertensive retinopathy grades III/IV).
Ernodasa should be used with caution in patients with a history of impaired liver function.
Children and adolescents
The use of Ernodasa is not recommended in patients under 18 years of age, as its safety and efficacy have not been established in these patients.
Other medicines and Ernodasa
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Prior or concomitant treatment with Ernodasa and anticoagulants or substances affecting platelet formation or function may increase the risk of bleeding:
- oral anticoagulants.
- platelet aggregation inhibitors.
- non-steroidal anti-inflammatory analgesics, especially acetylsalicylic acid, indomethacin, phenylbutazone, and other platelet aggregation inhibitors, especially sulfinpyrazone.
- volume-expanding solutions with antihemostatic effects (dextran).
- antifibrinolytics such as aminocaproic acid, aprotinin, and tranexamic acid.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The safety and efficacy of Ernodasa during pregnancy, breastfeeding, or fertility have not been demonstrated; therefore, its use is not recommended in these situations.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Ernodasa contains lactose and cochineal (E-122)
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains cochineal. It may cause allergic-type reactions.
3. How to take Ernodasa
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the dose and duration of your treatment with Ernodasa. Do not stop treatment prematurely, as it may not produce the desired effect.
Ernodasa capsules are for oral administration. The capsules must be swallowed whole, without chewing, with a little liquid.
The recommended dose is one capsule four times a day for 4\–6 days.
In acute episodes, higher doses may be used as an initial therapeutic measure, consisting of two capsules three times a day; if necessary, the dose may be increased up to two capsules four times a day.
If you take more Ernodasa than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Ernodasa
If you forget a dose of the medicine, take the next dose at the scheduled time. Do not take a double dose to make up for missed doses.
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 produce adverse effects, although not everyone will experience them.
The following adverse effects have been reported, categorized by the frequencies indicated below:
Frequent (at least 1 in 100 patients):
- Development of antibodies against streptokinase.
Uncommon (at least 1 in 1,000 patients):
- Hypersensitivity and allergic reactions (including anaphylactic shock), dyspnea (difficulty breathing), and urticaria.
- Nausea, diarrhea, epigastric pain, vomiting.
- Transient increase in liver enzymes (transaminases) and bilirubin.
- Headache (cephalalgia), back pain (dorsalgia), muscle pain (myalgia), chills and/or increased body temperature, feeling of weakness (asthenia), general malaise.
Very rare (less than 1 in 10,000 patients):
- Red inflammatory skin lesion (erythematous exanthema), dermatitis, itching.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ernodasa
Keep this medicine out of sight and reach of children.
Store in the original packaging to protect it from light and moisture.
Store at room temperature.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ernodasa
- The active substances are streptokinase and streptodornase. Each capsule contains 10,000 International Units of streptokinase and 2,500 International Units of streptodornase.
- The other components are lactose, magnesium stearate and talc. The gelatin capsule consists of: gelatin, titanium dioxide (E-171), indigo carmine (E-132) and cochineal red A (E-122).
Appearance of the medicine and contents of the pack
Ernodasa is a medicine presented in hard capsules, granate red and white in colour. The packs contain 20, 40 or 500 capsules, depending on the pack size. Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Laboratorios ERN, S.A.
C/Perú, 228
08020 Barcelona, Spain
Manufacturer
Laboratorios ERN, S.A.
C/Gorchs Lladó, 188
Pol. Ind. Can Salvatella
08210 Barberá del Vallés (Barcelona), Spain
Date of the most recent revision of the package leaflet: March 2025.
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/