Mucosolvan

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Mucosolvan (Mucosolvan Kindersaft), 30 mg/5 ml, syrup
Ambroxoli hydrochloridum
Mucosolvan and Mucosolvan Kindersaft are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 to 5 days, or if the patient feels worse, contact your doctor.

Table of contents of the leaflet:

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

1. What Mucosolvan is and what it is used for

Ambroxol hydrochloride, the active substance in Mucosolvan, increases mucus secretion in the
respiratory tract, thereby facilitating expectoration and relieving cough.
Indications
Acute and chronic diseases of the lungs and bronchi associated with impaired mucus secretion and
difficulty in mucus transport.

2. Important information before using Mucosolvan

When not to use Mucosolvan

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

Warnings and precautions

• If the patient has impaired kidney function or severe liver insufficiency, medical advice should be sought before using Mucosolvan.
• Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, or genital organs), treatment with Mucosolvan must be discontinued and immediate medical advice must be sought.

Mucosolvan and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or which the patient plans to use.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchial-pulmonary secretions and sputum.
Mucosolvan should not be administered simultaneously with antitussive drugs (e.g. codeine), as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex. Antitussive drugs impair the expectoration of liquefied mucus by suppressing the cough reflex.
Clinically significant negative interactions with other medicines have not been demonstrated.

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 use of Mucosolvan during pregnancy, especially during the first trimester, is not recommended.
The use of Mucosolvan in breastfeeding women is not recommended, as ambroxol hydrochloride passes into breast milk.

Driving and operating machinery
There is no evidence of an effect of the medicine on the ability to drive or operate machinery. Studies on the influence of the medicine on the ability to drive and operate machinery have not been conducted.

3. How to use Mucosolvan

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dosage:
Adults and children over 12 years of age:
10 ml of syrup twice daily.
Recommended dose for acute respiratory tract infections and during the initial phase of chronic conditions, for the first 14 days of treatment.
Children from 1 to 12 years of age:

The above dosage is recommended during the initial treatment period; the dosage may be
reduced by half after 14 days of treatment.
Mucosolvan syrup can be taken with or without food.
Do not use the medicine before going to sleep.
The medicine should be measured using the provided measuring device.
Do not use in children without consulting a doctor.
If there is no improvement in symptoms during treatment with Mucosolvan in acute respiratory
diseases, medical advice should be sought.
If symptoms worsen or do not improve after 4 to 5 days, contact a doctor.
Use of a higher than recommended dose of Mucosolvan
In case of ingestion of a higher than recommended dose of Mucosolvan, consult a doctor or
pharmacist immediately.
Specific symptoms of overdose have not been observed in humans so far. Based on cases of
unintentional overdose and (or) reports of improper use, symptoms corresponding to the known
adverse effects of the medicine administered at recommended doses have been observed, which
may require symptomatic treatment.
Missing a dose of Mucosolvan
If a dose has been missed, take it as soon as possible.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping treatment with Mucosolvan
Mucosolvan should be taken only when necessary and treatment should be discontinued once
symptoms have resolved.
If you have any further questions concerning the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (may occur in up to 1 in 10 people):

• nausea
• numbness of the mouth, tongue and throat (reduced sensation in the oral cavity and throat)
• taste disturbances (altered taste perception)

Uncommon (may occur in up to 1 in 100 people):

• diarrhoea
• indigestion
• abdominal pain (epigastric pain)
• dryness of the oral mucosa
• vomiting

Rare (may occur in up to 1 in 1,000 people):

• hypersensitivity reactions
• rash
• urticaria

Frequency not known (frequency cannot be estimated from available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue), and pruritus
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis)
• dry throat

If any of the above adverse reactions occur, discontinue use of
Mucosolvan and seek immediate medical advice.

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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al.
Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mucosolvan

No special storage instructions are required.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The shelf life after first opening the container is 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Mucosolvan contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: benzoic acid, liquid non-crystallizing sorbitol, hydroxyethylcellulose, glycerol 85%, potassium acesulfame, vanilla flavour 201629, wild berry flavour PHL 132195, purified water.

What Mucosolvan looks like and contents of the pack
An amber glass bottle with a child-resistant cap and a measuring cup with graduations,
packaged in a cardboard box.
1 bottle contains 100 ml of syrup.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 Czesky Tesin
Czech Republic
Repackaged in:
Euceryna Pharmaceutical Manufacturing Plant COEL S.J. E.Z.M. KONSTANTY
ul. Wl. Zelenskiego 45
31-353 Krakow
CEFEA Sp. z o.o. Sp. komandytowa
ul. Dzialkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellonska 76
03-301 Warsaw
Medezin Sp. z o.o.
ul. Zbaszynska 3
91-342 Lodz
Marketing authorisation number in Germany, the country of export: 25684.00.00
Parallel import authorisation number: 63/22
[Information about the registered trademark]