Erdosol

Package Leaflet: Information for the Patient

ERDOSOL, 35 mg/mL, Powder for Oral Suspension

Oral Suspension
Erdostein

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

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Another Person, Even if Their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet:

• 1. What is ERDOSOL and What is it Used for
• 2. Important Information Before Taking ERDOSOL
• 3. How to Take ERDOSOL
• 4. Possible Adverse Reactions
• 5. How to Store ERDOSOL
• 6. Contents of the Package and Other Information

1. What is ERDOSOL and What is it Used for

ERDOSOL Contains the Active Substance Erdosteine, which Belongs to the Group of Mucolytic Agents, Reducing the Viscosity of Bronchial Secretions and Facilitating Expectoration.
ERDOSOL is Recommended for the Treatment of Secretolytic Therapy 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 ERDOSOL

When Not to Take ERDOSOL:

• If the Patient is Allergic to Erdosteine or any of the Other Ingredients of this Medication (Listed in Section 6); or to any Auxiliary Substance or to Substances Containing Free SH Groups (e.g., Acetylcysteine)
• If the Patient has Liver Function Disorders (e.g., Increased Alkaline Phosphatase Activity in Blood Serum and/or Increased Aminotransferase Activity in Blood Serum);
• If the Patient has Renal Insufficiency (Creatinine Clearance <25 ml min);< li>
• If the Patient has Homocystinuria, i.e., a Metabolic Disease Involving Abnormal Metabolism of the Amino Acid Methionine (Especially in Patients on a Methionine-Excluding Diet)
• In Children who have not Reached the Age of 2 Years.

Warnings and Precautions

Before Starting ERDOSOL, Discuss it with a Doctor or Pharmacist.
In Case of Typical Hypersensitivity Symptoms (Rash, Urticaria), Discontinue Treatment Immediately.
Use with Caution in Patients with Impaired Cough Reflex or Disorders of Mucociliary Clearance (Due to Increased Risk of Accumulation of Large Amounts of Mucus).
The Risk of Adverse Reactions can be Minimized by Using the Smallest Effective Doses for the Shortest Possible Period.
If No Improvement Occurs, the Patient Should Consult a Doctor, who will Consider Discontinuing Treatment.

Using ERDOSOL in Patients with Renal Impairment

ERDOSOL Should Not be Used in Patients with Renal Insufficiency.
In Patients with Severe Renal Insufficiency, Metabolites of Erdosteine Produced in the Liver may Accumulate.

Children

ERDOSOL Should Not be Administered to Children who have not Reached the Age of 2 Years.

Using ERDOSOL with Food and Drink

Food and Drink do not Affect the Absorption of the Medication.

ERDOSOL and Other Medications

Inform a Doctor or Pharmacist about all Medications Currently or Recently Taken by the Patient, as well as any Medications Planned to be Taken.
No Interactions have been Observed with Other Medications Used to Treat Respiratory Tract Infections and Chronic Obstructive Pulmonary Disease, such as: Theophylline, Medications Causing Smooth Muscle Relaxation of the Bronchi (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-Reducing Medications (Antitussives) may Cause Accumulation of Large Amounts of Bronchial Secretion, Leading to Worsening of the Patient's Condition in the Course of the Disease, e.g., Due to Decreased Respiratory Function.
To Avoid Complications, do not Use Cough-Reducing and Secretolytic Medications (Increasing Secretion) at the Same Time, Especially Before Bedtime.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
The Doctor will Decide on the Use of the Medication.
ERDOSOL is Intended for Use in Children who have Reached the Age of 2 Years.

Driving and Operating Machines

ERDOSOL does not Affect the Ability to Drive and Operate Machines.

ERDOSOL Contains Isomalt (E 953)

If the Patient has Previously been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking the Medication.

ERDOSOL Contains Sodium Benzoate (E 211)

The Medication Contains 2 mg of Sodium Benzoate in each 1 mL of Oral Suspension.

3. How to Take ERDOSOL

This Medication Should Always be Taken According to the Doctor's Recommendations. In Case of Doubts, Consult a Doctor or Pharmacist.
The Recommended Dose for Children who have Reached the Age of 2 Years is:
10 mg/kg Body Weight per Day in Two Divided Doses.
Take Orally.
Do not Take the Medication Before Bedtime.
Do not Administer the Medication to Children who have not Reached the Age of 2 Years.

Preparing the Suspension:

To Prepare the Suspension, Gently Tap the Closed Bottle Several Times to Disperse the Powder.
Then Add Approximately 65-70 mL of Boiled and Cooled Water to the Marked Indentation on the Bottle. Shake Well for at Least 30 Seconds, Until a Rare, Turbid Suspension is Obtained. If Necessary, Add Boiled Water to the Marked Indentation on the Bottle and Shake Again. This will Result in 100 mL of Ready-to-Use, White or Off-White Homogeneous Suspension.
After Each Use, Wash and Dry the Measuring Cup.
Always Shake the Prepared Suspension Before Use. If the Suspension is not Administered Within 5 Minutes, Shake the Medication Again.
Take Orally, Immediately After Preparation, According to the Dosing Schedule Above.

Taking a Higher than Recommended Dose of ERDOSOL

No Cases of Overdose have been Reported.
In Case of Taking a Higher Dose than Recommended, Consult a Doctor Immediately.

Missing a Dose of ERDOSOL

Take the Missed Dose as Soon as Possible, and then Continue with the Previous Dosing Schedule. If it is Almost 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.
In Case of Further Doubts About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, ERDOSOL can Cause Adverse Reactions, although not Everybody gets them.
Frequently(Occurring in Less than 1 in 10 Patients): Stomach Disorders (Abdominal Pain), Nausea, Headache.
Less Frequently(Occurring in Less than 1 in 100 Patients): Heartburn, Constipation, Diarrhea, Dryness in the Mouth, Dizziness, General Malaise.
Rarely(Occurring in Less than 1 in 1000 Patients): Loss of Taste or Taste Disorders, Allergic Symptoms: Rash, Urticaria, Fever.
In Some Individuals, Other Adverse Reactions may Occur During ERDOSOL Treatment.

Reporting Adverse Reactions

If any Adverse Reactions Occur, Including those not Listed in the Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of 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
Adverse Reactions can also be Reported to the Marketing Authorization Holder.
Reporting Adverse Reactions will Help to Gather More Information on the Safety of the Medication.

5. How to Store ERDOSOL

Store the Medication in a Place Inaccessible to Children.
No Special Recommendations for Storing the Medication in the Form of Powder for Oral Suspension.
Store the Prepared Suspension in the Refrigerator (2°C to 8°C) for no Longer than 15 Days.
Shelf Life After Dilution – 15 Days.
Do not Use the Medication After the Expiration Date Stated on the Carton and Bottle. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in the Drain or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What ERDOSOL Contains

• The Active Substance of the Medication is Erdosteine. One mL of Oral Suspension Contains 35 mg of Erdosteine.
• Other Ingredients are: Isomalt (E 953), Carboxymethylcellulose Sodium (Type A), Sucralose, Citric Acid, Sodium Benzoate (E 211), Raspberry Flavor 052383 AP0551 [Corn Starch, Triacetin, Flavoring Substances].

What ERDOSOL Looks Like and What the Package Contains

A Bottle Made of Orange-Colored Glass Type III, Containing 50 g of White Powder for Preparing 100 mL of Oral Suspension with a Raspberry Scent, Closed with a PE Cap with an HDPE Ring, in a Cardboard Box.
A Measuring Cup Made of PP (with a Scale of 2.5 mL, 3 mL, 5 mL, 7.5 mL, 10 mL, 15 mL, 18.5 mL) is Included in the Package.

Marketing Authorization Holder:

Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
tel.: +48 81 463 48 82
{logo of the Marketing Authorization Holder}

Manufacturer:

Mako Pharma Sp. z o.o.
ul. Kolejowa 231A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of the Last Update of the Package Leaflet: