Erdosol

Package leaflet: Information for the patient

ERDOSOL, 35 mg/mL, powder for the preparation of
oral suspension
Erdosteine
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

1. What ERDOSOL is and what it is used for
2. Important information before taking ERDOSOL
3. How to take ERDOSOL
4. Possible side effects
5. How to store ERDOSOL
6. Contents of the pack and other information

1. What ERDOSOL is and what it is used for

ERDOSOL contains the active substance erdosteine, which belongs to a group of medicines
known as mucolytics, reducing the viscosity of bronchial secretions and facilitating expectoration.
ERDOSOL 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 the prophylactic treatment of seasonal exacerbations of chronic bronchitis.

2. Important information before using ERDOSOL

When not to use ERDOSOL:

• if the patient is allergic to erdosteine or to any of the other ingredients of this medicine (listed in section 6); to any excipient or to substances containing free SH groups (e.g. acetylcysteine);
• if the patient has liver function disorders (e.g. increased serum alkaline phosphatase activity and/or increased serum aminotransferase activity);
• if the patient has renal failure (creatinine clearance <25 mL/min);
• if the patient has homocystinuria, i.e. a metabolic disorder involving impaired metabolism of the amino acid methionine (especially in patients on a methionine-free diet);
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with ERDOSOL, consult a doctor or pharmacist. 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 increased risk of accumulation of large amounts of mucus).
The risk of adverse reactions can be reduced by using the lowest effective doses for the shortest possible duration.
If no improvement occurs, the patient should consult a doctor, who will consider discontinuing treatment.

Use of ERDOSOL in patients with renal impairment
ERDOSOL should not be used in patients with renal failure.
In patients with severe renal impairment, metabolites of erdosteine formed in the liver may accumulate.

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

Use of ERDOSOL with food and drink
Food and drink do not affect absorption of the medicine.

ERDOSOL and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions have been observed with other medicines used in the treatment of respiratory tract infections and chronic obstructive pulmonary disease (COPD), such as: theophylline, bronchodilators (corticosteroids), erythromycin, amoxicillin or cotrimoxazole.
After administration of erdosteine, increased concentrations of amoxicillin (antibiotic) in the respiratory tract have been demonstrated.
Concomitant treatment with cough suppressants (antitussives) may lead to accumulation of large amounts of bronchial secretions, which may worsen the patient's condition, e.g. due to deterioration of respiratory function.
To avoid complications, concomitant use of antitussive and secretolytic (mucus-increasing) medicines should be avoided, especially before bedtime.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The decision to use the medicine will be made by a doctor.
ERDOSOL is intended for use in children aged 2 years and older.

Driving and operating machinery
ERDOSOL has no influence on the ability to drive vehicles or operate machinery.

ERDOSOL contains isomalt (E 953)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

ERDOSOL contains sodium benzoate (E 211)
The medicine contains 2 mg of sodium benzoate in each 1 mL of oral suspension.

3. How to use the medicine ERDOSOL

This medicine should always be used exactly as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The recommended dose for children who have completed their 2nd year of life is:
10 mg/kg body weight per day, divided into two doses.
Administer orally.
Do not administer the medicine before sleep.
This medicine should not be used in children who have not completed their 2nd year of life.

Suspension preparation:
To prepare the suspension, first gently tap the closed bottle several times to loosen the powder.
Then add approximately 65–70 mL of boiled water cooled to room temperature up to the indentation marked on the bottle. Shake well for at least 30 seconds until a thin, cloudy suspension is obtained. If necessary, add boiled water up to the marked indentation on the bottle and shake again. This results in 100 mL of ready-to-use, white or slightly white, homogeneous suspension.
After each use, the dosing spoon should be washed and dried.
Always shake the prepared suspension well before use. If the suspension is not administered within 5 minutes, shake the medicine again.
Administer orally, immediately after preparation, according to the dosing schedule indicated above.

Taking a higher than recommended dose of ERDOSOL
No cases of overdose have been reported.
In case a higher than recommended dose is taken, seek immediate medical advice from a doctor.

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

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

4. Possible adverse reactions

Like all medicines, ERDOSOL may cause adverse reactions, although they do not occur in
everyone.
Common (occurring in fewer than 1 in 10 patients): stomach complaints (epigastric pain), nausea, headache.
Uncommon (occurring in fewer than 1 in 100 patients): heartburn, constipation, diarrhoea,
dry mouth, dizziness, general malaise.
Rare (occurring in fewer than 1 in 1,000 patients): loss of taste sensation or taste disturbances, allergic reactions: rash, urticaria, fever.

In some individuals, other adverse reactions may occur during treatment with ERDOSOL.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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,
tel. + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store ERDOSOL

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for the powder for oral suspension.
Store the prepared suspension in a refrigerator (2°C to 8°C) and do not keep it for longer than 15 days.
The shelf-life after reconstitution is 15 days.
Do not use this medicine after the expiry date stated on the cardboard package and on the bottle. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What ERDOSOL contains

• The active substance is erdosteine. One mL of oral suspension contains 35 mg of erdosteine.
• Other ingredients are: isomalt (E 953), sodium carboxymethyl starch (type A), sucralose, citric acid, sodium benzoate (E 211), raspberry flavour 052383 AP0551 [corn maltodextrin, triacetin, flavouring substances].

What ERDOSOL looks like and contents of the pack
An orange type III glass bottle containing 50 g of white powder for the preparation of 100 mL of raspberry-flavoured oral suspension, closed with a PE cap with tamper-evident HDPE ring, packed in a cardboard box.
A dosing syringe made of PP (graduated at 2.5 mL, 3 mL, 5 mL, 7.5 mL, 10 mL, 15 mL, 18.5 mL) is included in the pack.
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
Tel.: +48 81 463 48 82
{logo of the marketing authorisation holder}
Manufacturer:
Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom