Mucosolvan

Leaflet attached to the packaging: patient information

Mucosolvan, 30 mg/5 ml, syrup

Ambroxol hydrochloride
[logo of the responsible entity]

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this 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. Contents of the pack 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 diseases of the lungs and bronchi with impaired mucus secretion and its transport.
If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

2. Important information before taking Mucosolvan

When not to take 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 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 contact their doctor immediately.

Mucosolvan and other medicines

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

Pregnancy and breastfeeding

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

Driving and operating machinery

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

3. How to take Mucosolvan

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, 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 in the initial period of treatment for chronic conditions, 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 medicine should not be taken before bedtime.

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

If the symptoms do not improve or worsen after 4 to 5 days of taking Mucosolvan, the patient should consult their doctor.

If the symptoms worsen or do not improve after 4 to 5 days, the patient should contact their doctor.

Taking a higher dose of Mucosolvan than recommended

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 side effects of the medicine 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 a missed dose. The next dose should be taken at the usual time.

Stopping treatment with Mucosolvan

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

4. Possible side effects

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

Common (may affect 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 (taste disorders)

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

• diarrhea
• indigestion
• abdominal pain (pain in the upper abdomen)
• dryness of the oral mucosa
• vomiting

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

• allergic reactions
• rash
• hives

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 polymorphic erythema, 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 consult their doctor immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Mucosolvan

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the month.
The shelf life after first opening the package is 12 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mucosolvan contains

• The active substance of Mucosolvan is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: sucralose, benzoic acid, hydroxyethylcellulose, strawberry flavor PHL-132200, vanilla flavor PHL-114481, purified water.

What Mucosolvan looks like and what the pack contains

Bottle made of orange glass type III with a PE cap with a guarantee ring and child-resistant closure, and a PP measuring cup with a scale for 1.25 ml, 2.5 ml, and 5 ml in a cardboard box.
1 bottle contains 100 ml or 200 ml of syrup.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
To obtain more detailed information about this medicine, the patient should contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00
Date of last revision of the leaflet:April 2024