Mucosolvan Max

Package Leaflet: Information for the User

MUCOSOLVAN MAX, 75 mg, prolonged-release hard capsules

Ambroxol hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package 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.

Package Leaflet Contents:

• 1. What is Mucosolvan Max and what is it used for
• 2. Important information before taking Mucosolvan Max
• 3. How to take Mucosolvan Max
• 4. Possible side effects
• 5. How to store Mucosolvan Max
• 6. Package contents and other information

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

Ambroxol, the active substance of Mucosolvan Max, increases the secretion of mucus in the respiratory tract, facilitates expectoration, and alleviates cough.
Indications for use
Acute and chronic lung and bronchial diseases with impaired mucus secretion and its transport.

2. Important information before taking Mucosolvan Max

When not to take 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 kidney function disorders or severe liver failure, they should consult their doctor before taking Mucosolvan Max.
• 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 use of Mucosolvan Max should be discontinued and medical advice should be sought immediately.

Children and adolescents

Mucosolvan Max is not intended for use in children and adolescents.

Mucosolvan Max 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 Max should not be administered simultaneously with cough suppressants (e.g., codeine), as this may lead to a dangerous accumulation of bronchial secretions due to weakened cough reflex. Cough suppressants weaken the effect of ambroxol by inhibiting the cough reflex and making it difficult to expectorate 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.
The use of Mucosolvan Max is not recommended during pregnancy, especially during the first three months of pregnancy.
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 effects of the medicine on fertility.

Driving and using machines

After the medicine has been on the market, no evidence of its impact on the ability to drive and use machines has been found.
No studies have been conducted on the effects of the medicine on the ability to drive and use machines.

3. How to take Mucosolvan Max

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults: 1 prolonged-release capsule once a day, preferably in the morning or before noon.
The medicine should not be taken before bedtime.
The capsules should not be opened or chewed but swallowed whole, with a sufficient amount of liquid.
The so-called "carrier granules" that are sometimes visible in the stool release the active substance during passage through the gastrointestinal tract and have no therapeutic significance themselves.
If the symptoms do not improve during the use of Mucosolvan Max for acute respiratory diseases, the patient should consult their doctor. If the symptoms worsen or do not disappear after 4-5 days, the patient should contact their doctor.
Mucosolvan Max capsules can be taken with or without food.

Overdose of Mucosolvan Max

In case of overdose of Mucosolvan Max, the patient should consult their doctor or pharmacist. No specific symptoms of overdose have been observed in humans to date.
Based on cases of unintentional overdose and/or reports of improper use, symptoms corresponding to the known adverse effects of the medicine at recommended doses have been observed, which may require symptomatic treatment.

Missed dose of Mucosolvan Max

If a dose is missed, it should be taken as soon as possible. A double dose should not be taken to make up for the missed dose. The next dose should be taken at the usual time.

Discontinuation of Mucosolvan Max

The medicine should not be taken without a need for it. After the symptoms have disappeared, its use should be stopped.
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, this medicine 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 swelling) and itching
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

If any of the above side effects occur, the use of Mucosolvan Max should be discontinued and medical advice should be sought immediately.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the patient 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; tel: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Mucosolvan Max

Do not store above 30°C.
The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Mucosolvan Max contains

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

What Mucosolvan Max looks like and contents of the pack

PVC/PVDC/Aluminum blister in a cardboard box.
The pack contains: 10 or 20 prolonged-release capsules.
White, prolonged-release, hard gelatin capsules with a red, opaque cap and an orange, opaque body. White imprint "MUC 01" on the cap.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw.
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51 100 Reims
France
For more detailed information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 280 00 00

Date of last revision of the package leaflet: