Mucosolvan mini

Package leaflet: Information for the user

Mucosolvan Mini, 15 mg/5 ml, syrup
Ambroxoli hydrochloridum
[logo of the marketing authorisation holder]
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• 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 not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 4 to 5 days, you should contact your doctor.

Contents of the leaflet:

1. What Mucosolvan Mini is and what it is used for
2. Important information before taking Mucosolvan Mini
3. How to take Mucosolvan Mini
4. Possible side effects
5. How to store Mucosolvan Mini
6. Contents of the pack and other information

1. What Mucosolvan Mini is and what it is used for

Ambroxol hydrochloride, the active substance in Mucosolvan Mini, increases mucus secretion in the
respiratory tract, thereby 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.
If there is no improvement or if your condition worsens after 4 to 5 days, you should contact your doctor.

2. Information before using Mucosolvan Mini

When not to use Mucosolvan Mini

• If the patient is allergic to ambroxol hydrochloride or to 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 Mini.
• Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, or genital organs), treatment with Mucosolvan Mini must be discontinued immediately and the patient should contact a doctor without delay.

Mucosolvan Mini and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum.
Mucosolvan Mini should not be administered concomitantly with antitussive agents (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.
Clinically significant adverse interactions with other medicines have not been reported.

Pregnancy and breastfeeding
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 Mini during pregnancy is not recommended, especially during the first trimester of pregnancy.
The use of Mucosolvan Mini in breastfeeding women is not recommended, as ambroxol hydrochloride passes into breast milk.

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 influence of the medicine on the ability to drive and operate machinery have not been conducted.

3. How to use Mucosolvan Mini

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 your doctor or pharmacist.
Recommended dose:
Adults and children over 12 years of age: 20 ml of syrup twice daily.
The recommended dose for acute respiratory tract infections and during initial treatment of chronic conditions, during the first 14 days of treatment.
Children from 1 to 12 years of age:

The above dosage is recommended during the initial treatment period; the dosage may be
reduced by half after 14 days of treatment.
Do not use the medicine before going to sleep.
The medicine should be measured using the provided measuring device.
If there is no improvement in symptoms during treatment with Mucosolvan Mini in acute respiratory tract diseases,
consult a doctor. If symptoms worsen or do not improve after 4 to 5 days, contact a doctor.
Mucosolvan Mini syrup can be taken with or without food.
Use of a higher than recommended dose of Mucosolvan Mini
In case of ingestion of a higher than recommended dose of Mucosolvan Mini, seek advice from a
doctor or pharmacist.
Specific symptoms of overdose have not been observed in humans so far. Based on cases of accidental overdose and (or) reports of improper use, symptoms corresponding to known adverse effects of the medicine used at recommended doses have been observed, which may require symptomatic treatment.
Missed dose of Mucosolvan Mini
If a dose has been missed, 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.
Discontinuation of Mucosolvan Mini
Mucosolvan Mini should be taken only when necessary, and treatment should be discontinued after symptoms have resolved.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Common (may occur in up to 1 in 10 people):

• nausea
• sensation of numbness in the oral cavity, tongue and throat (reduced sensation in the mouth and throat)
• altered taste perception (taste disturbances)

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

• diarrhoea
• indigestion
• abdominal pain (epigastric pain)
• dryness of the oral mucosa
• vomiting

Rare (may occur in up to 1 in 1000 people):

• hypersensitivity reactions
• rash
• urticaria

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

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

If any of the above adverse effects occur, discontinue use of
Mucosolvan Mini and seek immediate medical advice.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects
can be reported directly to the Department of Monitoring of 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. Adverse effects can also be reported to the marketing authorisation holder. By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Mucosolvan Mini

Keep this medicine out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the stated month.
The shelf life after first opening the container is 6 months.
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 pack and other information

What Mucosolvan Mini contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
• Other ingredients are: sucralose, hydroxyethylcellulose, benzoic acid, forest fruit flavour PHL-132195, vanilla flavour PHL-114481, purified water.

What Mucosolvan Mini looks like and contents of the pack
Mucosolvan Mini syrup is clear to almost clear and colourless to almost colourless, slightly viscous, with a forest fruit flavour.
The pack consists of an amber glass (Type III) bottle with a PE screw cap equipped with a tamper-evident seal and child-resistant closure, and a PP measuring cup with graduations at 1.25 ml, 2.5 ml and 5 ml, contained in a cardboard box.
1 bottle contains 100 ml or 200 ml of syrup.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Poland

Manufacturers:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France

Opella Healthcare Italy S.r.l.
viale Europa 11
21040 Origgio
Italy

A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne
Germany

For further information about this medicinal product, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Poland
Tel.: +48 22 280 00 00