ERNODASA HARD CAPSULES

2. What you need to know before you take Ernodasa

Do not take Ernodasa

• If you are allergic to streptokinase, streptodornase, or any of the other components of this medicine (listed in section 6).
• If you have bleeding disorders (known hemorrhagic diathesis).
• If you have uncontrolled severe hypertension.
• If you have low levels of fibrinogen (a protein involved in blood coagulation).
• If you have low platelet counts in the blood (thrombocytopenia).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Ernodasa.

In the event of an allergic reaction, including anaphylactic shock, dyspnea (difficulty breathing), and urticaria, treatment with Ernodasa should be discontinued.

Be particularly careful 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 biopsy of any organ, punctures in non-compressible vessels, intramuscular injections, or intubation.
• Recent childbirth, abortion.
• Patient undergoing treatment with oral anticoagulants (medicines that prevent blood coagulation).
• Severe liver or kidney damage.
• Lesions in organs that are prone to bleeding (e.g., active peptic ulcer).
• Inflammations of the heart (acute pericarditis and/or subacute bacterial endocarditis).
• Active internal bleeding, existing or recent.
• Recent stroke; intracranial or intraspinal surgery.
• Brain tumor (intracranial neoplasia).
• Recent head trauma (cranioencephalic trauma).
• Known tumor with a risk of bleeding.
• Inflammation of the pancreas (acute pancreatitis).
• Retinal disorders (hypertensive retinopathy grades III/IV).

Ernodasa should be used with caution in patients with a history of decreased 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 using, have recently used, or might use any other medicines.

Prior or simultaneous treatment with Ernodasa and anticoagulants or substances that act on 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.
• expansive solutions with antihemostatic effect (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 plan 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, so its use is not recommended in these situations.

Driving and using machines

No effects on the ability to drive or use machinery have been described.

Ernodasa contains lactose and azorubine (E-122)

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains azorubine. It may cause allergic reactions.

3. How to take Ernodasa

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

Your doctor will indicate the dose and duration of your treatment with Ernodasa. Do not stop treatment before, as it may not have the desired effect.

Ernodasa capsules are for oral administration. The capsules should 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 conditions, higher doses may be used as a therapeutic attack measure, consisting of two capsules three times a day, and if necessary, the dose may be increased 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, phone 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 when it is due. Do not take a double dose to make up for forgotten doses.

If you have any other questions about 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.

The following side effects have been described, according to the frequency categories 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.

Rare(less than 1 in 10,000 patients):

• Inflammatory red skin lesions (erythematous exanthema), dermatitis, itching.

If you think any of the side effects are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ernodasa

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

Store in the original packaging to protect from light and moisture.

Store at room temperature.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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 is composed of: gelatin, titanium dioxide (E-171), carmine indigo (E-132), and azorubine (E-122).

Appearance of the product and pack contents

Ernodasa is a medicine that comes in the form of hard capsules, purple and white in color. The packs contain 20, 40, or 500 capsules, depending on the format. Not all pack sizes may be marketed.

Marketing authorization 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 last revision of this leaflet: March 2025

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/