Mucosolvan

Package Leaflet: Information for the Patient

Mucosolvan, 30 mg, Tablets

Ambroxol Hydrochloride
[Responsible Entity Logo]

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor, Pharmacist, or Nurse.

• This 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 Leaflet, they Should Inform their Doctor, Pharmacist, or Nurse. See Section 4.
• If After 4 to 5 Days there is no Improvement or the Patient Feels Worse, 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. Package Contents and Other Information

1. What is Mucosolvan and What is it Used For

Ambroxol Hydrochloride, the Active Substance of Mucosolvan, Increases Mucus Secretion in the Respiratory Tract, Making it Easier to Cough Up and Relieving Cough.
Indications for Use
Acute and Chronic Lung and Bronchial Diseases Characterized by Mucus Secretion Disorders and its Transportation Difficulties.
If After 4 to 5 Days there is no Improvement or the Patient Feels Worse, they Should Contact their Doctor.

2. Important Information Before Taking Mucosolvan

When Not to Take Mucosolvan

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

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 Appears (Including Changes in Mucous Membranes, e.g., Mouth, Throat, Nose, Eyes, Genital Organs), the Use of Mucosolvan Should be Stopped and a Doctor Consulted Immediately.

Mucosolvan and Other Medications

The Doctor or Pharmacist Should be Informed About all Medications Currently or Recently Taken by the Patient, as well as any Planned Medications.
Ambroxol Increases the Concentration of Antibiotics (Amoxicillin, Cefuroxime, Erythromycin) in Bronchial and Pulmonary Secretions and Sputum.
Mucosolvan Should not be Taken Simultaneously with Cough Medications (e.g., Codeine), as it may Lead to a Dangerous Accumulation of Bronchial Secretion due to a Weakened Cough Reflex. Cough Medications, by Inhibiting the Cough Reflex, Make it Difficult to Cough Up the Thinned Mucus.
No Clinically Significant Adverse Interactions with Other Medications have been Found.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, Breastfeeding, or Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
The Use of Mucosolvan is not Recommended During Pregnancy, Especially in the First Three Months of Pregnancy.
The Use of 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 Medication on Fertility. There are no Clinical Studies on the Effects of the Medication on Fertility.

Driving and Operating Machinery

There is no Evidence of the Medication's Influence on the Ability to Drive and Operate Machinery.
No Studies have been Conducted on the Influence of the Medication on the Ability to Drive and Operate Machinery.

Mucosolvan Contains Lactose

If the Patient has been Diagnosed with an Intolerance to some Sugars, they Should Consult a Doctor Before Taking the Medication.
One Tablet Contains 171 mg of Lactose, which Corresponds to 684 mg of Lactose in the Maximum Recommended Daily Dose of the Medication, i.e., 4 Tablets. Patients with Galactose Intolerance, Lactase Deficiency, or Glucose-Galactose Malabsorption Syndrome Should not Take this Medication.

3. How to Take Mucosolvan

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, a Doctor or Pharmacist Should be Consulted.
The Recommended Dose is:
Adults: 1 Tablet 3 Times a Day.
The Medication's Effect can be Increased by Taking 2 Tablets 2 Times a Day.
Tablets Should be Taken with a Liquid.
Mucosolvan Tablets can be Taken with or Without Food.
The Medication Should not be Taken Before Bedtime.

If the Symptoms do not Improve or Worsen After 4 to 5 Days of Taking Mucosolvan, a Doctor Should be Consulted.

If the Symptoms Worsen or do not Improve After 4 to 5 Days, a Doctor Should be Consulted.

Overdose of Mucosolvan

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

Missed Dose of Mucosolvan

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 Mucosolvan

Mucosolvan Should be Taken 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 Medication, a Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medications, Mucosolvan can Cause Side Effects, although not Everybody gets them.

Frequent (May Occur in Less than 1 in 10 People):

• Nausea

Uncommon (May Occur in Less than 1 in 100 People):

• Diarrhea
• Vomiting
• Indigestion
• Abdominal Pain

Rare (May Occur in Less than 1 in 1000 People):

• Hypersensitivity Reactions
• Rash
• Urticaria

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

• Anaphylactic Reactions, Including Anaphylactic Shock, Angioedema (Rapidly Progressive 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 Use of Mucosolvan Should be Stopped and a Doctor Consulted Immediately.

Reporting Side Effects

If any Side Effects Occur, Including those not Listed in this Leaflet, the Doctor, Pharmacist, or Nurse Should be Informed. 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.
Side Effects can also be Reported to the Responsible Entity. By Reporting Side Effects, more Information can be Gathered on the Safety of the Medication.

5. How to Store Mucosolvan

There are no Special Precautions for Storing the Medication.
The Medication Should be Stored Out of Sight and Reach of Children.
The Medication Should not be Used After the Expiration Date Stated on the Blister and Carton. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in the Drain or Household Waste. A Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Mucosolvan Contains

• The Active Substance of the Medication is Ambroxol Hydrochloride. 1 Tablet Contains 30 mg of Ambroxol Hydrochloride.
• Other Ingredients are: Lactose Monohydrate, Corn Starch, Colloidal Silica, Magnesium Stearate.

What Mucosolvan Looks Like and What the Package Contains

Mucosolvan is in the Form of Oral Tablets.
Tablets are Packaged in Blisters, which are then Packaged in a Cardboard Box.
Package Sizes:
20 Tablets
50 Tablets
Not all Package Sizes may be Marketed.

Responsible Entity and Manufacturer

Responsible Entity:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52, 35-233 Rzeszów
To Obtain more Detailed Information About this Medication, Contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of Last Update of the Leaflet:April 2024