MUCOSOLVAN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Mucosolvan
30 mg, tablets
Ambroxol hydrochloride
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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, you should contact your doctor.

Contents of the leaflet:

1. What Mucosolvan is and what it is used for
2. What you need to know 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 lung and bronchial diseases associated with impaired mucus secretion and
difficulties in 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 renal function disorders 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 lesions of mucous membranes, e.g. in the oral cavity, throat, nose, eyes, genital organs), treatment with Mucosolvan must be discontinued immediately and the patient should contact a doctor without delay.

Mucosolvan and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretion 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 suppressed cough reflex. Antitussive agents impair the expectoration of liquefied mucus by suppressing the cough reflex.
No clinically significant adverse interactions with other medicines have 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 is not recommended, 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 operating machinery
There is no evidence of an effect of the medicine on 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.

Mucosolvan contains lactose monohydrate
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 lactose monohydrate, corresponding to 684 mg of lactose in the maximum recommended daily dose of 4 tablets. Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take this medicine.

3. How to take Mucosolvan

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your 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, consult your doctor.
If symptoms worsen or do not improve after 4 to 5 days, contact your doctor.

Taking more Mucosolvan than recommended
If you take more Mucosolvan than recommended, consult your doctor or pharmacist immediately.
Specific symptoms of overdose have not been observed in humans so far. Based on cases of accidental overdose and (or) reports of inappropriate use, symptoms observed were consistent with the known adverse effects of the medicine when used at recommended doses, which may require symptomatic treatment.

If you forget to take Mucosolvan
If you miss a dose, take it as soon as possible.
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping Mucosolvan
Mucosolvan should only be taken when necessary and treatment should be discontinued once symptoms have resolved.
If you have any further questions about 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 experiences them.
Common (may affect fewer than 1 in 10 people):

• nausea

Uncommon (may affect fewer than 1 in 100 people):

• diarrhoea
• vomiting
• indigestion
• abdominal pain

Rare (may affect fewer 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 developing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching
• 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 the medicine.

5. How to store Mucosolvan

Store below 25°C in the original packaging.
Keep the medicine out of the 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Mucosolvan contains

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

What Mucosolvan looks like and contents of the pack
Mucosolvan is available as oral tablets.
The tablets are packed in PVC blisters, which are placed in a cardboard box.
Pack size: 20 tablets
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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
Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warszawa
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1
02-202 Warszawa
Number of Marketing Authorisation in the Czech Republic, the country of export: 52/122/81-C
Number of parallel import authorisation: 233/20