Patient Information Leaflet

MUCOSOLVAN MAX, 75 mg, prolonged-release hard capsules
Ambroxoli hydrochloridum
Please read all of this leaflet carefully before 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 side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 4 to 5 days, or if you feel worse, you should contact your doctor.

Contents of this leaflet:

What Mucosolvan Max is and what it is used for
Important information before taking Mucosolvan Max
How to take Mucosolvan Max
Possible side effects
How to store Mucosolvan Max
Contents of the pack and other information

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

Ambroxol, the active substance in Mucosolvan Max, increases mucus secretion in the respiratory tract, facilitates expectoration, and relieves cough.
Indications
Acute and chronic diseases of the lungs and bronchi associated with impaired mucus secretion and difficulty in mucus clearance.

2. Important information before using Mucosolvan Max

When not to use Mucosolvan Max

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 severe renal function disorders or severe hepatic insufficiency, medical advice should be sought before using Mucosolvan Max.
Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash appears (including lesions of mucous membranes, e.g. in the oral cavity, throat, nose, eyes, genital organs), treatment with Mucosolvan Max must be discontinued immediately and the patient should contact a physician without delay.

Children and adolescents
Mucosolvan Max is not intended for use in children and adolescents.
Mucosolvan Max 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 intends to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum.
Mucosolvan Max should not be administered concurrently with antitussive medicines (e.g. codeine), as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex. Antitussive medicines reduce the effect of ambroxol by suppressing the cough reflex and impairing the expectoration of liquefied mucus.
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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Mucosolvan Max is not recommended during pregnancy, especially during the first trimester.
The use of Mucosolvan Max is not recommended in 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 effect of the medicine on fertility.

Driving and operating machinery

Since the medicine was placed on the market, there has been 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.

3. How to use Mucosolvan Max

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 prolonged-release capsule once daily, preferably in the morning or before noon.
This medicine should not be taken before going to sleep.
Do not open or chew the capsule; swallow it whole with an adequate amount of liquid.
The so-called "carrier granules", which may sometimes be visible in the stool, release the active substance during passage through the gastrointestinal tract and have no therapeutic significance themselves.
If symptoms do not improve during treatment with Mucosolvan Max for acute respiratory tract diseases, consult your doctor. If symptoms worsen or do not resolve after 4–5 days, contact your doctor.
Mucosolvan Max capsules may be taken with or without food.
Taking more Mucosolvan Max than recommended
If you have taken more than the recommended dose of Mucosolvan Max, 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 misuse, symptoms observed were consistent with the known adverse effects of the medicine when used at recommended doses, which may require symptomatic treatment.
Missed dose of Mucosolvan Max
If you have missed a dose, 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 Mucosolvan Max
This medicine should not be taken longer than necessary. Discontinue use 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 occur in fewer than 1 in 10 people):

nausea

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

diarrhoea
vomiting
indigestion
abdominal pain

Rare (may occur in fewer than 1 in 1,000 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, stop using
Mucosolvan Max 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 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 reactions can also be reported to the marketing authorisation holder. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Mucosolvan Max

Do not store above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" or "EXP". 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 pack and other information

What Mucosolvan Max contains

The active substance is ambroxol hydrochloride. One capsule contains 75 mg of ambroxol hydrochloride.
Other ingredients are:
Capsule contents: crospovidone, carnauba wax, stearyl alcohol, magnesium stearate.
Capsule shell: gelatin, purified water, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).
White print: shellac, titanium dioxide (E171), propylene glycol.

What Mucosolvan Max looks like and contents of the pack
Blister pack made of PVC/PVDC/Aluminium, in a cardboard box.
Pack contains: 10 or 20 prolonged-release capsules.
Elongated gelatin capsules with a red opaque cap and an orange opaque body.
White imprint "MUC 01" on the cap.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland

Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51 100 Reims, France

For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel.: +48 22 280 00 00