Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Mucosolvan, 30 mg, tablets
Ambroxoli hydrochloridum
Please read this leaflet carefully 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
the doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 4 to 5 days, please consult your doctor.

Table of Contents:

What Mucosolvan is and what it is used for
Important information before taking Mucosolvan
How to take Mucosolvan
Possible side effects
How to store Mucosolvan
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, 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 renal function disorders or severe hepatic insufficiency, medical advice should be sought before using Mucosolvan.
Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including lesions of mucous membranes, e.g. in the oral cavity, throat, nose, eyes, genital organs), treatment with Mucosolvan must be discontinued and immediate medical advice sought.

Mucosolvan and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum.
Mucosolvan should not be administered simultaneously with antitussive medicines (e.g. codeine), as this may lead to dangerous accumulation of bronchial secretions due to suppression of the cough reflex. Antitussive medicines impair the expectoration of liquefied mucus by suppressing the cough reflex.
Clinically significant adverse interactions with other medicines have not been demonstrated.

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

Mucosolvan contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
One tablet contains 171 mg of monohydrate lactose, corresponding to 684 mg of monohydrate 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 information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults
1 tablet three times daily.
The effect of the medicine may be increased by taking 2 tablets twice daily.
Tablets should be taken with liquid.
Mucosolvan tablets may be taken with or without food.
This medicine should not be taken immediately before going to sleep.
If there is no improvement in symptoms during treatment with Mucosolvan for acute respiratory tract diseases, medical advice should be sought.
If symptoms worsen or do not improve after 4 to 5 days, consult a doctor.
Taking more Mucosolvan than recommended
If more Mucosolvan has been taken than recommended, consult a doctor or pharmacist.
Specific symptoms of overdose have not been observed in humans. Based on cases of accidental overdose and (or) reports of misuse, symptoms observed were consistent with the known adverse effects of the medicine when used at recommended doses, 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 only be taken when necessary, and treatment should be discontinued once symptoms have resolved.
If there are any further doubts regarding the use of this medicine, consult a 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 less than 1 in 10 people):

nausea

Uncommon (may occur in less than 1 in 100 people):

diarrhoea
vomiting
indigestion
abdominal pain

Rare (may occur in less than 1 in 1000 people):

hypersensitivity reactions
rash
urticaria

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

anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and pruritus
severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis).

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, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring 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 this medicine.

5. How to store Mucosolvan

Store below 25°C, in the original packaging.
Keep the medicine 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.
Medicines must not be disposed of via wastewater or household waste. Ask your 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 is ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride.
Other ingredients are: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate.

What Mucosolvan looks like and contents of the pack
Mucosolvan is an oral tablet.
The tablets are contained in blisters, which are placed in a cardboard box.
Pack sizes:
20 tablets
50 tablets
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Opella Healthcare Czech s.r.o., Evropská 846/176a, 160 00 Prague 6, Czech Republic
Manufacturer:
Delpharm Reims, 10 rue Colonel Charbonneaux, Reims, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Czech Republic, country of export: 52/122/81-C
Parallel import authorisation number: 23/21