Mucosolvan

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Mucosolvan

30 mg, tablets

Ambroxol hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, 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 using Mucosolvan
• 3. How to use Mucosolvan
• 4. Possible side effects
• 5. How to store Mucosolvan
• 6. Contents of the packaging 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.

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 kidney function disorders or severe liver failure, they should consult their doctor before using Mucosolvan.
• There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. If a rash occurs (including changes in mucous membranes, such as the mouth, throat, nose, eyes, genitals), the use of Mucosolvan should be discontinued and medical advice should be sought 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 administered 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 liquefied mucus.
No significant clinically relevant adverse interactions with other medicines have been observed.

Pregnancy, breastfeeding, and fertility

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 using this medicine.
The use of Mucosolvan is not recommended during pregnancy, especially during the first three months of pregnancy.
The use of Mucosolvan is not recommended in breastfeeding women, as ambroxol hydrochloride passes into breast milk.
Non-clinical studies have not shown a direct or indirect harmful effect of the medicine on fertility. There are no clinical studies on the effect of the medicine on fertility.

Driving and using machines

There is no evidence that the medicine affects the ability to drive or use machines. Studies on the effect of the medicine on the ability to drive or use machines have not been conducted.

Mucosolvan contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
One tablet contains 171 mg of lactose monohydrate, which corresponds to 684 mg of lactose in the maximum recommended daily dose of the medicine, i.e., 4 tablets. Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicine.

3. How to use Mucosolvan

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults
3 times a day, 1 tablet.
The effect of the medicine can be increased by taking 2 times a day, 2 tablets.
The tablets should be taken with a liquid.
Mucosolvan tablets can be taken with or without food.
The medicine should not be taken before bedtime.

If during the use of Mucosolvan in acute respiratory diseases, there is no alleviation of symptoms, 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.

Using 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 so far in humans. Based on cases of unintentional overdose and/or reports of improper use, symptoms corresponding to the known adverse effects of the medicine used in 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 the use of Mucosolvan

Mucosolvan should only be taken when necessary, and its use should be discontinued 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

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

• diarrhea
• vomiting
• indigestion
• abdominal pain

Rare (may affect up to 1 in 1,000 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 edema) and itching
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

If any of the above side effects occur, the use of Mucosolvan should be discontinued and medical advice should be sought immediately.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Mucosolvan

Store in a temperature below 25°C, in the original packaging.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Mucosolvan contains

• The active substance of Mucosolvan is ambroxol hydrochloride. 1 tablet contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate.

What Mucosolvan looks like and contents of the pack

Mucosolvan is in the form of oral tablets.
The tablets are placed in PVC blisters, which are then placed in a cardboard box.
Pack sizes: 20 tablets
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Opella Healthcare Czech s.r.o.
Evropská 846/176a
160 00 Praha 6
Czech Republic

Manufacturer:

Delpharm Reims
10 rue Colonel Charbonneaux
Reims, France

Parallel importer:

Pharmapoint SA
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
Marketing authorization number in the Czech Republic, the country of export: 52/122/81-C
Parallel import authorization number: 233/20
Date of leaflet approval: 18.05.2022
[Information about the trademark]