Package leaflet: Information for the patient

ERDOMED
35 mg/ml, powder for oral suspension
Erdosteinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm others, even if their symptoms are the same.
If any of the adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Erdomed is and what it is used for
Important information before taking Erdomed
How to take Erdomed
Possible side effects
How to store Erdomed
Contents of the pack and other information

1. What Erdomed is and what it is used for

Erdomed contains the active substance erdosteine, which belongs to a group of medicines called mucolytics that reduce the viscosity of bronchial secretions and facilitate expectoration.
Erdomed is indicated for secretolytic treatment in acute and chronic diseases of the upper respiratory tract, bronchi and lungs associated with abnormal mucus secretion and mucus transport. It is also used for prophylactic treatment of seasonal exacerbations of chronic bronchitis.

2. Important information before using Erdomed

When not to use Erdomed:

if the patient is allergic (hypersensitive) to the active substance, to any of the excipients, or to substances containing free SH groups
if the patient has liver function disorders
if the patient has renal failure
if the patient has homocystinuria (especially in patients on a methionine-free diet)
in children under 2 years of age.

Warnings and precautions
If typical symptoms of hypersensitivity occur (rash, urticaria), treatment must be discontinued immediately.
Use with caution in patients with weakened cough reflex or impaired ciliary clearance (due to the risk of accumulation of large amounts of mucus).
The risk of adverse effects can be reduced by using the lowest effective doses for the shortest possible duration. If no improvement occurs, treatment discontinuation should be considered.

Use of Erdomed in patients with kidney function disorders
In patients with severe renal failure, metabolites of erdosteine formed in the liver may accumulate.

Use of Erdomed in elderly patients
No dosage adjustment is necessary in patients over 65 years of age.

Children
Erdomed should not be administered to children under 2 years of age.

Erdomed with food and drink
Food and drink do not affect drug absorption.

Other medicines and Erdomed
No interactions have been observed with other drugs used in the treatment of respiratory tract infections and chronic obstructive pulmonary disease (COPD), such as: theophylline, bronchodilators (corticosteroids), erythromycin, amoxicillin, or co-trimoxazole.
After administration of erdosteine, increased concentrations of amoxicillin (an antibiotic) in the respiratory tract have been demonstrated.
Concomitant use with antitussive drugs (cough suppressants) may lead to accumulation of large amounts of bronchial secretions, which may worsen the patient's condition, e.g. due to impaired respiratory function.
To avoid complications, antitussive and secretolytic (mucus-increasing) drugs should not be used simultaneously, especially before going to sleep.

Pregnancy, breastfeeding and fertility
Consult a doctor before taking this medicine. The decision on using the medicine is made by a physician.
Erdomed is intended for use in children aged 2 years and older.

Driving and operating machinery:
Erdomed has no influence on the ability to drive or operate machinery.
Erdomed is intended for use in children aged 2 years and older.

Important information about certain ingredients of Erdomed:
The medicine contains:

sucrose; if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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, meaning the medicine is considered sodium-free.

3. How to use Erdomed

This medicine should always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
The recommended dose for children who have completed 2 years of age is:
10 mg/kg body weight per day, divided into two doses.
Administer orally.
This medicine should not be taken before going to sleep.
This medicine should not be used in children who have not completed 2 years of age.

Body weight in kg
from 15 to 20
from 21 to 30
above 30

Dosage
2.5 ml twice daily
5 ml twice daily
7.5 ml twice daily

Preparation of the suspension:
To prepare the suspension, add water at room temperature up to the mark indicated in the depression on the bottle. Shake well until a thin, cloudy suspension is obtained. If necessary, add more water up to the mark on the bottle and shake again. This will yield 100 mL of ready-to-use suspension. The prepared suspension should be stored in the refrigerator, i.e. at a temperature of 2°C to 8°C, for no longer than 15 days.
Always shake well before use, as the suspension may separate during storage in the refrigerator.

Taking a larger than recommended dose of Erdomed
No cases of overdose have been reported.
If a larger than recommended dose of the medicine is taken, seek medical advice immediately.

Missed dose of Erdomed
Take the missed dose as soon as possible, then continue according to the prescribed dosing schedule. If it is almost time for the next dose, take only one dose as scheduled and continue the prescribed dosing regimen.
Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Erdomed can cause adverse reactions, although not everyone experiences them.

Common (in 1 to 10 out of 100 patients): stomach discomfort (epigastric pain), nausea, headache
Uncommon (in 1 to 10 out of 1,000 patients): heartburn, constipation, diarrhoea, dry mouth, dizziness, general malaise
Rare (in 1 to 10 out of 10,000 patients): loss of taste sensation or taste disturbances, allergic reactions: rash, urticaria, fever

Other adverse reactions may occur in some individuals during treatment with Erdomed.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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 below 25°C.
The prepared suspension should be stored in the refrigerator, i.e. at a temperature of 2°C to 8°C, for no longer than 15 days.
Always shake well 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 must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Erdomed contains
The active substance is erdosteine. One ml of oral suspension contains 35 mg of erdosteine.
Other ingredients are sucrose, sodium benzoate, sodium carboxymethyl starch, anhydrous citric acid,
sucralose, Mask CLD nat. pwd flavor [composition: vanillin, natural flavouring substances, starch
octenyl succinate sodium, vegetable oil (coconut), silicon dioxide, alpha-tocopherol], blood orange
pwd flavor [composition: orange oil, maltodextrin (corn), gum arabic, butylated hydroxyanisole (BHA),
flavouring, natural flavouring 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, with a cardboard
box. An oral dosing spoon made of polypropylene with a capacity of 10 ml (graduated at 2.5 ml,
5 ml, and 10 ml) is included in the pack.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel. (22) 70 28 200
email: [email protected]

Manufacturer:
ZETA FARMACEUTICI S.P.A.
Via Galvani 10
36066 Sandrigo (VI), Italy