Erdomed

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Erdomed

300 mg, Hard Capsules

Erdostein

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any further doubts.
• This medication has been prescribed for a specific person. Do not pass it on to others.
• The medication can harm another person, even if their illness symptoms are the same.
• If any of the side effects worsen or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Erdomed and What is it Used For
• 2. Important Information Before Taking Erdomed
• 3. How to Take Erdomed
• 4. Possible Side Effects
• 5. How to Store Erdomed
• 6. Package Contents and Other Information

1. What is Erdomed and What is it Used For

Erdomed contains the active substance erdosteine, which belongs to the group of mucolytic agents - reducing the viscosity of bronchial secretions and facilitating expectoration. Erdomed is recommended for the treatment of secretory conditions in acute and chronic upper respiratory tract diseases, bronchi, and lungs with accompanying abnormal secretion and transport of mucus. It is also used for preventive treatment of seasonal exacerbations of chronic bronchitis.

2. Important Information Before Taking Erdomed

When Not to Take Erdomed:

Warnings and Precautions

In case of typical hypersensitivity symptoms (rash, urticaria), treatment should be stopped immediately. Use with caution in patients with weakened cough reflex or disorders of ciliary clearance (due to the risk of accumulation of large amounts of mucus). The risk of side effects can be reduced by using the smallest effective doses for the shortest possible period. If there is no improvement, the doctor will consider discontinuing treatment. No dose adjustment is required in adults with chronic obstructive pulmonary disease (COPD).

Children

The medication should not be given to children under 12 years of age.

Taking Erdomed with Food and Drink

Food and drink do not affect the absorption of the medication.

Taking Erdomed in Patients with Renal Impairment

In patients with severe renal impairment, erdosteine metabolites produced in the liver may accumulate.

Taking Erdomed in Elderly Patients

No dose adjustment is necessary in patients over 65 years of age.

Other Medications and Erdomed

No interactions have been observed with other medications used to treat respiratory infections and chronic obstructive pulmonary disease, such as theophylline, smooth muscle relaxants (corticosteroids), erythromycin, amoxicillin, or cotrimoxazole. After administration of erdosteine, an increase in amoxicillin concentration in the respiratory tract has been demonstrated. Combined treatment with antitussive medications may cause accumulation of large amounts of bronchial secretions, which can worsen the patient's condition. To avoid complications, antitussive and secretolytic medications should not be routinely combined, especially before bedtime.

Pregnancy, Breastfeeding, and Fertility

Consult a doctor before taking the medication. The decision to use the medication is made by the doctor.

Driving and Operating Machines

Erdomed does not affect the ability to drive and operate machines.

Erdomed Contains the Following Excipients:

povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).

3. How to Take Erdomed

This medication should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist. The recommended dose for adults is: 1 capsule of 300 mg twice a day. The medication should not be taken before bedtime.

Overdose of Erdomed

No cases of overdose have been reported. If a higher dose than recommended is taken, consult a doctor immediately.

Missed Dose of Erdomed

Take the prescribed dose as soon as possible, and then continue with the usual dosing schedule. If it is time for the next dose, take only one dose, and then continue with the recommended dosing schedule. Do not take a double dose to make up for the missed dose. If you have any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Erdomed can cause side effects, although not everybody gets them.

• Common (in 1 to 10 out of 100 patients): stomach discomfort, nausea, headache
• Uncommon (in 1 to 10 out of 1000 patients): heartburn
• Rare (in 1 to 10 out of 10,000 patients): loss of taste or taste disorders, constipation, dry mouth, dizziness, general malaise, diarrhea, allergic reactions: rash, urticaria, fever.

In some individuals, other side effects may occur during treatment with Erdomed.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to Store Erdomed

Store the medication out of sight and reach of children. Store at a temperature below 25°C. Do not take Erdomed after the expiration date stated on the packaging. Medications should not be disposed of in wastewater or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Erdomed Contains

The active substance of Erdomed is erdosteine. One capsule contains 300 mg of erdosteine. Other ingredients are: povidone, microcrystalline cellulose, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).

What Erdomed Looks Like and What the Package Contains

The package contains 10, 20, or 60 capsules in Al/PVC/PVDC blisters in a cardboard box. For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in the Czech Republic, the Country of Export:

Angelini Pharma Česká republika s.r.o. Palachovo náměstí 799/5, 625 00 Brno, Czech Republic

Manufacturer:

Aziende Chimiche Riunite Angelini Francesco, ACRAF S.p.A. Via vecchia del Pinocchio, 22 - 60100 Ancona, Italy Astrea Fontaine S.A.S. Rue des Prés Potets, 21121 Fontaine-les-Dijon, France

Parallel Importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249, 04-458 Warsaw Marketing Authorization Number in the Czech Republic, the Country of Export:52/045/96-C

Parallel Import Authorization Number: 79/25

Date of Leaflet Approval: 28.02.2025

[Information about the Trademark]