Mucosolvan inhalacie

Package Leaflet: Information for the Patient

Mucosolvan Inhalations, 15 mg/2 ml, Solution for Nebulisation

Ambroxol Hydrochloride
(Responsible Entity Logo)

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

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicinal Product has been Prescribed for You. Do not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as Yours.
• If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents:

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

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

Ambroxol Hydrochloride, the Active Substance of Mucosolvan Inhalations, 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 Characterized by Impaired Mucus Secretion and its Transport.

2. Important Information Before Using Mucosolvan Inhalations

When Not to Use Mucosolvan Inhalations

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

Warnings and Precautions

• If You Have Renal Impairment or Severe Hepatic Impairment, Mucosolvan Inhalations Should be Used Only After Consulting a Doctor. As with Other Medicinal Products Metabolized in the Liver and Excreted by the Kidneys, in the Case of Severe Renal Impairment, Accumulation of Ambroxol Metabolites in the Body can be Expected.
• 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), Discontinue Use of Mucosolvan Inhalations and Consult a Doctor Immediately.

Mucosolvan Inhalations and Other Medicinal Products

Tell Your Doctor About all Medicinal Products You are Currently Taking or Have Recently Taken, as well as any Medicinal Products You Plan to Take.
No Clinically Significant Adverse Interactions with Other Medicinal Products have been Observed.
Ambroxol Increases the Concentration of Antibiotics (Amoxicillin, Cefuroxime, Erythromycin) in Bronchopulmonary Secretions and Sputum.
Mucosolvan Inhalations Should not be Administered Simultaneously with Cough Suppressants (e.g., Codeine), as this may Lead to Dangerous Accumulation of Bronchial Secretions due to Weakened Cough Reflex. Cough Suppressants, by Inhibiting the Cough Reflex, Make it Difficult to Cough Up the Thinned Mucus.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to Have a Child, Consult Your Doctor or Pharmacist Before Using this Medicinal Product.
The Use of Mucosolvan Inhalations is not Recommended During Pregnancy, Especially During the First Trimester.
The Use of Mucosolvan Inhalations 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 on Fertility. There are no Clinical Studies on the Effects on Fertility.

Driving and Using Machines

There is no Evidence that the Medicinal Product Affects the Ability to Drive and Use Machines.
No Studies have been Conducted on the Effects of the Medicinal Product on the Ability to Drive and Use Machines.

Mucosolvan Inhalations Contains a Preservative: Benzalkonium Chloride

The Medicinal Product Contains 0.45 mg of Benzalkonium Chloride per 2 ml of Solution.
Benzalkonium Chloride may Cause Wheezing (Whistling Breathing) or Respiratory Disturbances (Bronchospasm), Especially in Patients with Asthma.

Mucosolvan Inhalations Contains Sodium Chloride and Sodium Phosphate

The Medicinal Product Contains Less than 1 mmol (23 mg) of Sodium per 3 ml of Solution, i.e., the Medicinal Product is Considered "Sodium-Free".

3. How to Use Mucosolvan Inhalations

This Medicinal Product Should Always be Used in Accordance with the Doctor's Recommendations. In Case of Doubts, Consult a Doctor or Pharmacist.
Recommended Dose:
Adults, Children Over 6 Years of Age:
1 to 2 Inhalations of 2 to 3 ml of Solution per Day.
Children Under 6 Years of Age:
1 to 2 Inhalations of 2 ml of Solution per Day.
It is Recommended to Warm the Nebuliser Solution to Body Temperature Before Starting Inhalation.
Patients with Asthma may Take the Inhalation Solution After Taking their Usual Bronchodilators.
To Ensure Proper Functioning of the Dropper, Turn the Bottle Upside Down and Gently Tap it.

Mucosolvan Inhalations can be Administered Using any Modern Inhaler (Except Steam). The Nebuliser Solution can be Mixed with Physiological Saline (0.9% Sodium Chloride Solution) in a 1:1 Ratio to Optimize Air Humidification, Especially When Using a Respirator. Mucosolvan Inhalations Should not be Mixed with Cromoglycic Acid. The Medicinal Product Should also not be Mixed with Other Solutions that Result in a Solution with a pH Higher than 6.3, e.g., Alkaline Salt Water for Inhalation (Soll's Salt). Due to the Increased pH, a Precipitate of Free Ambroxol Hydrochloride or Clouding of the Solution may Occur.
The Patient Should Breathe Normally During Inhalation, as the Inhalation of the Solution itself may Cause a Cough Reflex.
Do not Use the Medicinal Product Before Going to Bed.

Using a Higher Dose of Mucosolvan Inhalations than Recommended

In Case of Using a Higher Dose of Mucosolvan Inhalations than Recommended, Consult a Doctor or Pharmacist.
No Specific Symptoms of Overdose of the Medicinal Product have been Observed in Humans. Based on Cases of Accidental Overdose and/or Reports of Incorrect Use, Symptoms Corresponding to the Known Adverse Reactions of the Medicinal Product at Recommended Doses have been Observed. Symptomatic Treatment may be Necessary.

Missing a Dose of Mucosolvan Inhalations

If a Dose is Missed, Take it as Soon as Possible.
Do not Take a Double Dose to Make up for the Missed Dose. The Next Dose Should be Taken at the Usual Time.

Stopping the Use of Mucosolvan Inhalations

Mucosolvan Inhalations Should be Used Only When Necessary, and its Use Should be Stopped After the Symptoms Have Disappeared.
In Case of any Further Doubts Regarding the Use of this Medicinal Product, Consult a Doctor or Pharmacist.

4. Possible Side Effects

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

If You Experience any of the Following Side Effects, Stop Using Mucosolvan Inhalations and Consult a Doctor Immediately:

Allergic Reaction with Angioedema (Rapidly Progressing Swelling of the Skin, Subcutaneous Tissue, Mucous Membranes, or Submucosal Tissue). This can Cause a Feeling of Tightness in the Throat, Difficulty Swallowing, and Breathing. Sudden Onset of Whole-Body Allergic Reactions (Anaphylactic Reactions, Including Anaphylactic Shock). The Frequency of these Adverse Reactions is Unknown.

• allergic reaction with angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissue). This can cause a feeling of tightness in the throat, difficulty swallowing, and breathing. Sudden onset of whole-body allergic reactions (anaphylactic reactions, including anaphylactic shock). The frequency of these adverse reactions is unknown.

The Following Adverse Reactions have been Reported:

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

• Taste Disorders (e.g., Altered Taste),
• Feeling of Numbness in the Mouth and Throat,
• Nausea.

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

• Diarrhoea,
• Vomiting,
• Indigestion,
• Dryness of the Mucous Membranes of the Mouth,
• Abdominal Pain.

Rare (May Occur in Less than 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 Swelling of the Skin, Subcutaneous Tissue, Mucous Membranes, or Submucosal Tissue), and Itching,
• Severe Skin Reactions (Including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalized Exanthematous Pustulosis),
• Dryness of the Throat.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. 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 Authorisation Holder. By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medicinal Product.

5. How to Store Mucosolvan Inhalations

There are no Special Precautions for Storage.
Keep this Medicinal Product out of the Sight and Reach of Children.
Do not Use this Medicinal Product After the Expiry Date Stated on the Bottle and Carton. The Expiry Date Refers to the Last Day of the Month Stated.
The Shelf Life After First Opening the Bottle is 12 Months.
Medicinal Products Should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist 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 Inhalations Contains

• The Active Substance is Ambroxol Hydrochloride. 2 ml of Nebuliser Solution Contains 15 mg of Ambroxol Hydrochloride.
• The Other Ingredients are: Citric Acid Monohydrate, Sodium Phosphate, Sodium Chloride, Benzalkonium Chloride, Purified Water.

What Mucosolvan Inhalations Looks Like and What the Package Contains

The Package Consists of 1 Bottle Containing 100 ml of Nebuliser Solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Istituto de Angeli S.r.l.
Loc. Prulli, 103/C
50066 Reggello (FI)
Italy
For Further Information on this Medicinal Product, Please 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