Erdomed

Package Leaflet: Information for the Patient

ERDOMED

35 mg/ml, powder for oral suspension

Erdostein

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please 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. Contents of the pack and other information

1. What is Erdomed and what is it used for

Erdomed contains the active substance erdosteine, which belongs to a group of mucolytic medicines, 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 the 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 discontinued immediately. Use with caution in patients with weakened cough reflex or impaired mucociliary 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, consideration should be given to discontinuing treatment.

Taking Erdomed in patients with kidney function disorders

In patients with severe kidney failure, 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.

Children

The medicine should not be given to children who have not reached the age of 2.

Erdomed with food and drink

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

Other medicines and Erdomed

No interactions have been observed with other medicines used to treat respiratory infections and chronic obstructive pulmonary disease, such as theophylline, bronchodilators (corticosteroids), erythromycin, amoxicillin, or cotrimoxazole. After administration of erdosteine, an increase in amoxicillin concentration (antibiotic) in the respiratory tract has been demonstrated. Combination therapy with cough suppressants (antitussives) may cause accumulation of large amounts of bronchial secretions, which can worsen the patient's condition during the disease, e.g., due to decreased respiratory function. To avoid complications, do not take cough suppressants and secretolytics (expectorants) at the same time, especially before bedtime.

Pregnancy, breastfeeding, and fertility

Before taking the medicine, consult your doctor. The decision to use the medicine is made by the doctor. Erdomed is intended for use in children who have reached the age of 2.

Driving and using machines:

Erdomed has no effect on the ability to drive and use machines. Erdomed is intended for use in children who have reached the age of 2.

Important information about some ingredients of Erdomed:

The medicine contains:

• sucrose; if you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. 2.5 ml of the medicine contains 1 g of sucrose. 5 ml of the medicine contains 2 g of sucrose. 7.5 ml of the medicine contains 3 g of sucrose. This should be taken into account in patients with diabetes.
• 10 mg of sodium benzoate in 5 ml of suspension.
• less than 1 mmol (23 mg) of sodium in 5 ml of suspension, which means the medicine is considered sodium-free.

3. How to take Erdomed

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. The recommended dose for children who have reached the age of 2 is: 10 mg/kg body weight per day in two divided doses. Take orally. Do not take the medicine before bedtime. The medicine should not be given to children who have not reached the age of 2.

Preparing the suspension:

To prepare the suspension, add water at room temperature to the marked indentation on the bottle. Shake well until a thin, cloudy suspension is obtained, and if necessary, add water to the marked indentation on the bottle and shake again. This will give 100 ml of ready-to-use suspension. The prepared suspension should be stored in the refrigerator, i.e., at a temperature between 2°C and 8°C, for no longer than 15 days. Always shake before use, as the suspension may separate during storage in the refrigerator.

Taking a higher dose of Erdomed than recommended

No cases of overdose have been reported. If you have taken more than the recommended dose, consult your doctor immediately.

Missing a dose of Erdomed

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

4. Possible side effects

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

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

In some people, 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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. Side effects can also be reported to the marketing authorization holder.

Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Erdomed

Keep the medicine out of the reach and sight of children. Store at a temperature below 25°C. The prepared suspension should be stored in the refrigerator, i.e., at a temperature between 2°C and 8°C, for no longer than 15 days. Always shake before use, as the suspension may separate during storage in the refrigerator. Do not use Erdomed after the expiry date stated on the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Erdomed contains

The active substance of the medicine is erdosteine. One ml of oral suspension contains 35 mg of erdosteine. The other ingredients are sucrose, sodium benzoate, sodium carboxymethylcellulose, anhydrous citric acid, sucralose, Mask CLD nat. pwd flavor [containing: vanillin, natural flavoring substances, sodium starch octenylsuccinate, vegetable oil (coconut), silicon dioxide, alpha-tocopherol], blood orange pwd flavor [containing: orange oil, corn maltodextrin, gum arabic, butylated hydroxyanisole (BHA), flavoring substances, natural flavoring substances].

What Erdomed looks like and contents of the pack

The pack contains 50 g of powder for oral suspension (100 ml) in a 125 ml bottle, in a cardboard box. A 10 ml polpropylene measuring cup (with 2.5 ml, 5 ml, 10 ml graduations) is attached to the packaging.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel. (22) 70 28 200
email: angelini@angelini.pl
Manufacturer:
ZETA FARMACEUTICI S.P.A.
Via Galvani 10
36066 Sandrigo (VI), Italy

Date of approval of the leaflet: 01.07.2021