Mucosolvan mini

Package Leaflet: Information for the User

Mucosolvan Mini, 15 mg/5 ml, Syrup

Ambroxol Hydrochloride
[Logo of the Marketing Authorization Holder]

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

This Medicinal Product Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Directed by the Doctor or Pharmacist.

• This Package Leaflet Should be Kept in Case it Needs to be Consulted Again.
• If Advice or Further Information is Needed, the Pharmacist Should be Contacted.
• If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If After 4 to 5 Days there is no Improvement or the Patient Feels Worse, the Doctor Should be Contacted.

Package Leaflet Contents:

• 1. What is Mucosolvan Mini and What is it Used for
• 2. Important Information Before Using Mucosolvan Mini
• 3. How to Use Mucosolvan Mini
• 4. Possible Side Effects
• 5. How to Store Mucosolvan Mini
• 6. Package Contents and Other Information

1. What is Mucosolvan Mini and What is it Used for

Ambroxol Hydrochloride, the Active Substance of Mucosolvan Mini, Increases the Secretion of Mucus in the Airways, Making it Easier to Cough Up and Relieving Cough.
Indications for Use
Acute and Chronic Lung and Bronchial Diseases with Impaired Mucus Secretion and its Transport.
If After 4 to 5 Days there is no Improvement or the Patient Feels Worse, the Doctor Should be Contacted.

2. Important Information Before Using Mucosolvan Mini

When Not to Use Mucosolvan Mini

• If the Patient is Allergic to Ambroxol Hydrochloride or any of the Other Ingredients of this Medicinal Product (Listed in Section 6).

Warnings and Precautions

• If the Patient has Kidney Function Disorders or Severe Liver Failure, they Should Consult a Doctor Before Using Mucosolvan Mini.
• Severe Skin Reactions Associated with the Use of Ambroxol Hydrochloride have been Reported. If a Rash Appears (Including Changes in the Mucous Membranes, e.g., Mouth, Throat, Nose, Eyes, Genital Organs), the Use of Mucosolvan Mini Should be Stopped and a Doctor Consulted Immediately.

Mucosolvan Mini and Other Medicinal Products

The Doctor or Pharmacist Should be Informed of all Medicinal Products Currently Being Taken or Recently Taken by the Patient, as well as any Medicinal Products the Patient Plans to Take.
Ambroxol Increases the Concentration of Antibiotics (Amoxicillin, Cefuroxime, Erythromycin) in Bronchopulmonary Secretions and Sputum.
Mucosolvan Mini Should not be Used at the Same Time as Cough Suppressants (e.g., Codeine), as this may Lead to a Dangerous Accumulation of Bronchial Secretion due to a Reduced Cough Reflex. Cough Suppressants can Make it Difficult to Cough Up the Thinned Mucus by Inhibiting the Cough Reflex.
No Clinically Significant Adverse Interactions with Other Medicinal Products have been Found.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or are Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Using this Medicinal Product.
The Use of Mucosolvan Mini is not Recommended During Pregnancy, Especially in the First Three Months of Pregnancy.
The Use of Mucosolvan Mini is not Recommended in Breastfeeding Women, as Ambroxol Hydrochloride Passes into Breast Milk.

Driving and Using Machines

There is no Evidence of the Medicinal Product's Influence on the Ability to Drive and Use Machines.
No Studies have been Conducted on the Influence of the Medicinal Product on the Ability to Drive and Use Machines.

3. How to Use Mucosolvan Mini

This Medicinal Product Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Directed by the Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
The Recommended Dose is:
Adults and Children Over 12 Years: 2 Times a Day, 20 ml of Syrup
The Recommended Dose for Acute Respiratory Tract Infections and in the Initial Period of Treatment of Chronic Conditions, for the First 14 Days of Treatment.
Children from 1 to 12 Years:
The Above Dosing is Recommended for the Initial Treatment Period; the Dose can be Reduced by Half After 14 Days of Treatment.
The Medicinal Product Should not be Used Before Bedtime.
The Medicinal Product Should be Measured Using the Enclosed Measuring Cup.

If the Symptoms do not Improve After Using Mucosolvan Mini for Acute Respiratory Tract Infections, the Doctor Should be Consulted. If the Symptoms Worsen or do not Improve After 4 to 5 Days, the Doctor Should be Contacted.

Mucosolvan Mini Syrup can be Taken with or Without Food.

Use of a Higher than Recommended Dose of Mucosolvan Mini

In Case of an Overdose of Mucosolvan Mini, the Doctor or Pharmacist Should be Consulted.
No Specific Symptoms of Overdose have been Observed to Date in Humans. Based on Cases of Accidental Overdose and/or Reports of Incorrect Use, Symptoms Corresponding to the Known Side Effects of the Medicinal Product at Recommended Doses have been Observed, which may Require Symptomatic Treatment.

Missed Dose of Mucosolvan Mini

If a Dose is Missed, it Should be Taken 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 the Use of Mucosolvan Mini

Mucosolvan Mini Should be Used Only When Necessary, and its Use Should be Stopped After the Symptoms have Disappeared.
In Case of any Further Doubts About the Use of this Medicinal Product, the Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medicinal Products, this Medicinal Product can Cause Side Effects, although not Everybody gets them.

Common (May Affect up to 1 in 10 People):

• Nausea
• Feeling of Numbness in the Mouth, Tongue, and Throat (Decreased Sensation in the Mouth and Throat)
• Change in Taste (Taste Disorders)

Uncommon (May Affect up to 1 in 100 People):

• Diarrhea
• Indigestion
• Abdominal Pain (Pain in the Upper Abdomen)
• Dryness of the Mouth
• Vomiting

Rare (May Affect up to 1 in 1,000 People):

• Hypersensitivity Reactions
• Rash
• Urticaria

Frequency Not Known (Cannot be Estimated from the Available Data):

• Anaphylactic Reactions, Including Anaphylactic Shock, Angioedema (Rapidly Progressing Swelling of the Skin, Subcutaneous Tissue, Mucous Membranes, or Submucosal Tissues) and Pruritus
• Severe Skin Reactions (Including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalized Exanthematous Pustulosis)
• Dryness in the Throat

If any of the Above Side Effects Occur, the Use of Mucosolvan Mini Should be Stopped and a Doctor Consulted Immediately.

Reporting Side Effects

If any Side Effects Occur, Including those not Listed in this Package Leaflet, the Doctor, Pharmacist, or Nurse Should be Informed. Side Effects can be Reported Directly to the Department for 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 Medicinal Product.

5. How to Store Mucosolvan Mini

The Medicinal Product Should be Stored Out of Sight and Reach of Children.
No Special Precautions.
The Medicinal Product Should not be Used After the Expiry Date Stated on the Bottle and Carton. The Expiry Date Refers to the Last Day of the Specified Month.
The Shelf Life After First Opening the Package is 6 Months.
Medicinal Products Should not be Disposed of via Wastewater or Household Waste. The Pharmacist Should be Asked how to Dispose of Medicinal Products that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Mucosolvan Mini Contains

• The Active Substance is Ambroxol Hydrochloride. 5 ml of Syrup Contains 15 mg of Ambroxol Hydrochloride.
• The Other Ingredients are: Sucralose, Hydroxyethylcellulose, Benzonic Acid, Forest Fruit Flavor PHL-132195, Vanilla Flavor PHL-114481, Purified Water.

What Mucosolvan Mini Looks Like and What the Package Contains

Mucosolvan Mini Syrup is a Clear to Almost Clear, Colorless to Almost Colorless, Slightly Viscous Liquid with a Forest Fruit Flavor.
The Package Contains a Brown Glass Bottle (Type III) with a PE Cap and a Child-Resistant Closure, and a PP Measuring Cup with a Gradation of 1.25 ml, 2.5 ml, and 5 ml, in a Cardboard Box.
1 Bottle Contains 100 ml or 200 ml of Syrup.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Boehringer Ingelheim España S.A.
Prat de la Riba 50
08174 Sant Cugat del Vallès (Barcelona)
Spain
To Obtain More Detailed Information on this Medicinal Product, Contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00
Date of Last Revision of the Package Leaflet:April 2024