Mucosolvan

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Mucosolvan, 30 mg, Tablets

Ambroxol Hydrochloride

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, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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.

2. Important information before taking Mucosolvan

When not to take Mucosolvan

Warnings and precautions

• If the patient has kidney function disorders or severe liver failure, they should consult a doctor before taking Mucosolvan.
• Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in mucous membranes, e.g., mouth, throat, nose, eyes, genitals), the patient should stop taking Mucosolvan and contact their doctor immediately.

Mucosolvan and other medicines

The patient should inform 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 simultaneously with cough suppressants (e.g., codeine), as this may lead to dangerous accumulation of bronchial secretions due to weakened cough reflex. Cough suppressants, by inhibiting the cough reflex, make it difficult to cough up liquefied mucus.
No significant clinically relevant adverse interactions with other medicines have been found.

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

Driving and using machines

There is no evidence that the medicine affects the ability to drive or operate machinery. No studies have been conducted on the effects 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 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 monohydrate 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 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 doubts, 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.
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 the patient's symptoms do not improve while taking Mucosolvan for acute respiratory diseases, they should consult their doctor.

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

Overdose of Mucosolvan

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 known adverse reactions of the medicine at recommended doses have been observed, which may require symptomatic treatment.

Missed dose of Mucosolvan

If a dose is missed, the patient should take it 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 Mucosolvan

Mucosolvan should be taken only 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

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 erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)

If any of the above side effects occur, the patient should stop taking Mucosolvan and seek medical advice immediately.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of 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; phone: +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 kept 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mucosolvan contains

• The active substance is ambroxol hydrochloride. One 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.
Tablets are placed in blisters, which are then placed in a cardboard box.
Pack sizes:
20 tablets
50 tablets
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 52/122/81-C

Parallel import authorization number: 23/21 Date of approval of the leaflet: 04.02.2022

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