Mucosolvan

Package Leaflet: Information for the Patient

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

Mucosolvan (Mucosolvan Kindersaft), 30 mg/5 ml, Syrup

Ambroxol Hydrochloride
Mucosolvan and Mucosolvan Kindersaft are different trade names for the same drug.

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

This medication should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Mucosolvan and What is it Used For

Ambroxol hydrochloride, the active substance of Mucosolvan, increases the secretion of mucus in the respiratory tract, making it easier to cough up and relieving cough.
Indications for Use
Acute and chronic lung and bronchial diseases with impaired mucus secretion and its transport.

2. Important Information Before Taking Mucosolvan

When Not to Take Mucosolvan

• If the patient is allergic to ambroxol hydrochloride or any other component of this medication (listed in section 6).

Warnings and Precautions

• If the patient has kidney function disorders or severe liver failure, they should consult their doctor before taking Mucosolvan.
• Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in the mucous membranes, such as the mouth, throat, nose, eyes, genitals), the patient should stop taking Mucosolvan and immediately consult their doctor.

Mucosolvan and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchial and pulmonary secretions and sputum.
Mucosolvan should not be taken simultaneously with cough suppressants (e.g., codeine), as this may lead to a dangerous accumulation of bronchial secretions due to a weakened cough reflex. Cough suppressants, by inhibiting the cough reflex, make it difficult to cough up the thinned mucus.
No significant clinically relevant adverse interactions with other medications have been found.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. The use of Mucosolvan is not recommended during pregnancy, especially during the first three months.
The use of Mucosolvan is not recommended for breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and Operating Machines

There is no evidence that the medication affects the ability to drive or operate machines. No studies have been conducted on the effect of the medication on the ability to drive or operate machines.

3. How to Take Mucosolvan

This medication should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.
In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults and children over 12 years old:
2 times a day, 10 ml of syrup
The recommended dose for acute respiratory infections and the initial period of chronic disease treatment, for the first 14 days of treatment.
Children from 1 to 12 years old:
The above dosage is recommended for the initial treatment period; the dosage can be reduced by half after 14 days of treatment.
Mucosolvan syrup can be taken with or without food.
The medication should not be taken before bedtime.

The medication should be measured using the enclosed measuring cup.
The medication should not be given to children without consulting a doctor.

If the Patient's Symptoms Do Not Improve While Taking Mucosolvan for Acute Respiratory Diseases, They Should Consult Their Doctor.

If the Symptoms Worsen or Do Not Improve After 4 to 5 Days, the Patient Should Contact Their Doctor.

Overdose of Mucosolvan

In case of taking a higher dose of Mucosolvan than recommended, the patient should consult their doctor or pharmacist.
No specific symptoms of overdose have been observed in humans to date. Based on cases of accidental overdose and/or reports of improper use, symptoms corresponding to the known adverse effects of the medication at recommended doses have been observed, which may require symptomatic treatment.

Missing a Dose of Mucosolvan

If a dose is missed, it should be taken as soon as possible.
A double dose should not be taken to make up for the missed dose. The next dose should be taken at the usual time.

Stopping Mucosolvan Treatment

Mucosolvan should only be taken when necessary, and its use should be stopped after the symptoms have subsided.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

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

Frequent (May Occur in Up to 1 in 10 People):

• Nausea
• Feeling of numbness in the mouth, tongue, and throat (reduced sensation in the mouth and throat)
• Change in taste perception (taste disorders)

Uncommon (May Occur in Up to 1 in 100 People):

• Diarrhea
• Indigestion
• Abdominal pain (pain in the upper abdomen)
• Dryness of the oral mucosa
• Vomiting

Rare (May Occur in Up to 1 in 1000 People):

• Hypersensitivity reactions
• Rash
• Urticaria

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue swelling), and itching
• Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)
• Dryness in the throat

If Any of the Above Side Effects Occur, the Patient Should Stop Taking Mucosolvan and Immediately Consult Their Doctor.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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; phone: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medication.

5. How to Store Mucosolvan

There are no special storage instructions.
The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The shelf life after opening the package is 6 months.
Medications should not be disposed of in wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Mucosolvan Contains

• The active substance of Mucosolvan is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• Other ingredients are: benzoic acid, liquid sorbitol, non-crystallizing, hydroxyethyl cellulose, glycerol 85%, acesulfame potassium, vanilla flavor 201629, wild strawberry flavor PHL 132195, purified water.

What Mucosolvan Looks Like and What the Package Contains

An orange glass bottle with a child-resistant cap and a measuring cup with graduations in a cardboard box.
1 bottle contains 100 ml of syrup.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Germany, the Country of Export:

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main, Germany

Manufacturer:

Sanofi S.r.l.
Viale Europa 11, 21040 Origgio (Va), Italy

Parallel Importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Cesky Tesin
Czech Republic

Repackaged by:

Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Krakow
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
German Marketing Authorization Number: 25684.00.00

Parallel Import Authorization Number: 63/22 Date of Leaflet Approval: 02.02.2022

[Information about the Registered Trademark]