Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Mucosolvan, 30 mg, tablets
Ambroxoli hydrochloridum
Please read carefully the entire 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 a doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, 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 symptoms do not improve or worsen after 4 to 5 days, consult your doctor.

Leaflet 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 liver impairment, medical advice should be sought before using Mucosolvan.
Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including lesions on mucous membranes, e.g. oral cavity, throat, nose, eyes, genital organs), treatment with Mucosolvan must be discontinued and immediate medical advice sought.

Mucosolvan and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
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 suppressed cough reflex. Antitussive medicines impair the expectoration of liquefied mucus by suppressing the cough reflex.
No clinically significant adverse interactions with other medicines have been reported.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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 three months of pregnancy, 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. No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery.

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 lactose, corresponding 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 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.
The recommended dose is:
Adults
1 tablet three times daily.
The effect of the medicine may be enhanced by taking 2 tablets twice daily.
Tablets should be taken with liquid.
Mucosolvan tablets can be taken with or without food.
This medicine should not be taken immediately before going to bed.
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 your doctor.
Taking more Mucosolvan than recommended
If you have taken 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.
Missing a dose of Mucosolvan
If you have missed 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 be taken only 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 everybody will experience them.

Common (may affect less than 1 in 10 people):

nausea

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

diarrhoea
vomiting
dyspepsia
abdominal pain

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

hypersensitivity reactions
rash
urticaria

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

anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or submucosal tissue), and pruritus
severe skin-related adverse 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Reporting adverse reactions helps 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 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 required. Such measures help protect the environment.

6. Contents of the pack and other information

What Mucosolvan contains

The active substance is ambroxol hydrochloride. Each 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 available as oral tablets.
The tablets are packed in blisters, which are placed in a cardboard box.
Pack sizes:
20 tablets
50 tablets

For more detailed information, please contact the Marketing Authorisation Holder or the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 52/122/81-C
Parallel Import Licence Number: 49/19