Fluimucil Muko

Package Leaflet: Information for the User

Fluimucil Muko

200 mg, Granules for Oral Solution

Acetylcysteine

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

This Medication Should Always be Taken Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse after 5 Days, Consult a Doctor.

Table of Contents of the Leaflet:

• 1. What is Fluimucil Muko and What is it Used for
• 2. Important Information Before Taking Fluimucil Muko
• 3. How to Take Fluimucil Muko
• 4. Possible Side Effects
• 5. How to Store Fluimucil Muko
• 6. Contents of the Pack and Other Information

1. What is Fluimucil Muko and What is it Used for

Acetylcysteine, the Active Substance of Fluimucil Muko, Thins Mucus and Muco-Purulent Secretions by Breaking Disulfide Bonds in Mucoproteins in the Respiratory Tract. Fluimucil Muko is Used as a Short-Term Mucolytic Agent to Facilitate Expectoration in Patients with Symptoms of Upper Respiratory Tract Infections. If There is no Improvement or You Feel Worse after 5 Days, Consult a Doctor.

2. Important Information Before Taking Fluimucil Muko

When Not to Take Fluimucil Muko

• If You are Allergic to Acetylcysteine or any of the Other Ingredients of this Medication (Listed in Section 6);
• In Asthmatic Status;
• If You Have Phenylketonuria;
• In Children Under 2 Years of Age, as the Active Substance: Acetylcysteine May Cause Respiratory Obstruction in Children Under 2 Years of Age (Also See Section 3. How to Take Fluimucil Muko).

Warnings and Precautions

Before Starting Treatment with Fluimucil Muko, Discuss it with Your Doctor or Pharmacist.

• Caution is Advised when Taking Fluimucil Muko if You Have or Have Had a Stomach or Duodenal Ulcer, Especially if You are Also Taking Other Medications Known to Irritate the Gastric Mucosa.
• Treatment of Patients with Bronchial Asthma Should be Carried out Under Close Medical Supervision Due to the Possibility of Bronchospasm. If this Symptom Occurs, the Medication Should be Discontinued Immediately.
• In Case of Thinning of Large Amounts of Secretion, Especially in Small Children and Severely Ill Immobilized Patients, it is Necessary to Ensure its Aspiration.
• Acetylcysteine Should Not be Administered to Patients with Reduced Ability to Cough, Unless the Patient is Provided with Respiratory Physiotherapy During Treatment.
• Caution Should be Exercised if the Medication is Used Long-Term in Patients with Histamine Intolerance, as Symptoms such as Headache, Vasomotor Rhinitis, and Skin Pruritus May Occur.

Children and Adolescents

Mucolytic Agents May Cause Respiratory Obstruction in Children Under 2 Years of Age. Due to the Physiological Characteristics of the Respiratory Tract in this Age Group, the Ability to Cough may be Limited, Therefore, Mucolytic Agents Should Not be Used in Children Under 2 Years of Age. Due to the Amount of Active Substance, Fluimucil Muko Should Not be Used in Children Under 7 Years of Age.

Fluimucil Muko and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking, Have Recently Taken, or Plan to Take. Do Not Take Fluimucil Muko at the Same Time as Cough Suppressants, as this May Lead to Secretion Accumulation Due to Reduced Cough Reflex. Activated Charcoal May Weaken the Effect of Fluimucil Muko. If it is Necessary to Take Other Medications, Including Antibiotics, a 2-Hour Interval Should be Maintained Between the Administration of these Medications and Fluimucil Muko. This Does Not Apply to Loracarbef (Used in Infections). Concurrent Use of Fluimucil Muko and Nitroglycerin (Used in Coronary Artery Disease) May Cause Significant Hypotension. Headache May Also Occur. If You are Taking Nitroglycerin, Consult Your Doctor Before Taking Fluimucil Muko. Concurrent Use of Fluimucil Muko and Carbamazepine (Used in Epilepsy) May Decrease Carbamazepine Levels in the Blood and Reduce its Effectiveness. Fluimucil Muko May Affect the Results of Certain Laboratory Tests (Salicylate Determination by Colorimetry and Ketone Determination in Urine). Do Not Mix Other Medications with the Fluimucil Muko Solution.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication. Pregnancy: Fluimucil Muko Should be Avoided During Pregnancy. Fluimucil Muko May Only be Administered During Pregnancy if Absolutely Necessary and Under Close Medical Supervision. Breastfeeding: It is Not Known if Fluimucil Muko Passes into Breast Milk. A Risk to the Breastfed Child Cannot be Excluded. Do Not Take Fluimucil Muko if You are Breastfeeding. Fertility: There are no Data on the Effect of Fluimucil Muko on Human Fertility. Animal Studies Do Not Indicate any Harmful Effects of Acetylcysteine on Human Fertility at the Recommended Doses.

Driving and Using Machines

The Effect of the Medication on the Ability to Drive and Use Machines is Not Known.

What Fluimucil Muko Contains

• 25 mg of Aspartameper Sachet (1 g of Granules). Aspartame is a Source of Phenylalanine. It May be Harmful to Patients with Phenylketonuria. This is a Rare Genetic Disorder in which Phenylalanine Accumulates in the Body Due to its Impaired Elimination.
• Sucrose (β-Carotene Component). If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking the Medication.
• Less than 1 mmol (23 mg) of Sodiumper Sachet (β-Carotene Component), i.e., the Medication is Considered “Sodium-Free”.
• Glucose and Lactose (Orange Flavor Components). If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking the Medication.
• 662.7 mg of Sorbitolper Sachet (1 g of Granules). Sorbitol is a Source of Fructose. If You or Your Child Have Been Diagnosed with Intolerance to Some Sugars or Have a Rare Genetic Disorder, Hereditary Fructose Intolerance, in which the Body Does Not Break Down Fructose, Consult Your Doctor Before Taking the Medication or Giving it to Your Child.

3. How to Take Fluimucil Muko

This Medication Should Always be Taken Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist. If You are in Doubt, Consult a Doctor or Pharmacist. Do Not Take Fluimucil Muko for More than 5 Days Without Consulting a Doctor. Recommended Dose:

Children from 7 to 14 Years of Age

1 Sachet of Fluimucil Muko (200 mg) 2 Times a Day.

Adults and Children Over 14 Years of Age

1 Sachet of Fluimucil Muko (200 mg) 2 to 3 Times a Day. Method of Use: Dissolve the Contents of the Sachet in Half a Glass of Cold Water, if Necessary, Stir with a Spoon. The Resulting Solution is Ready to Drink. The Solution Should be Drunk Immediately After Preparation. During Treatment, an Increased Amount of Fluid Should be Consumed. Note: The Last Dose of Fluimucil Muko Should be Taken no Later than 4 Hours Before Bedtime. If You Feel that the Effect of Fluimucil Muko is too Strong or too Weak, Consult a Doctor.

Taking a Higher Dose of Fluimucil Muko than Recommended

If You Take a Higher Dose of Fluimucil Muko than Recommended, Gastrointestinal Symptoms such as Nausea, Vomiting, and Diarrhea May Occur. There is no Known Antidote Specific to Acetylcysteine. Symptomatic Treatment is Used. If You Take a Higher Dose of the Medication than Recommended, Consult a Doctor or Pharmacist Immediately.

Missing a Dose of Fluimucil Muko

Do Not Take a Double Dose to Make Up for a Missed Dose. If You Have any Further Doubts About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Fluimucil Muko can Cause Side Effects, Although not Everybody Gets Them. In Clinical Trials, the Most Commonly Reported Side Effects were Related to the Stomach and Intestines, and Less Frequently, Allergic Reactions. Side Effects that May Occur when Taking Fluimucil Muko: Uncommon (Less than 1 in 100 Patients):

• Allergic Reactions,
• Headache,
• Tinnitus,
• Tachycardia (Increased Heart Rate),
• Vomiting, Diarrhea, Stomatitis, Abdominal Pain, Nausea,
• Urticaria, Rash, Angioedema (Swelling of the Skin and Mucous Membranes, which Most Often Affects the Face, Throat, Larynx, Genital Organs, and Intestines), Pruritus,
• Fever,
• Decreased Blood Pressure.

Rare (Less than 1 in 1000 Patients):

• Bronchospasm, Dyspnea,
• Indigestion.

Very Rare (Less than 1 in 10,000 Patients):

• Severe Allergic Reactions (Anaphylactic Shock, Anaphylactic Reaction, Anaphylactoid Reaction),
• Bleeding.

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

• Facial Edema.

Very Rarely, Severe Skin Reactions (Stevens-Johnson Syndrome, Lyell Syndrome) and Mucous Membrane Changes have been Reported with Fluimucil Muko. In Most Cases, at Least one Other Medication was Probably Involved in Causing these Skin and Mucous Membrane Changes. If You Experience any Side Effects, Stop Taking the Medication and Consult a Doctor.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to: Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Fluimucil Muko

Keep the Medication out of the Sight and Reach of Children. Do Not Use this Medication after the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month. Store Fluimucil Muko Below 30°C. Note: The Possible Presence of a Sulfur Smell is Typical for the Active Substance Contained in the Medication. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Fluimucil Muko Contains

• The Active Substance of Fluimucil Muko is Acetylcysteine. One Sachet (1 g of Granules) Contains 200 mg of Acetylcysteine.
• Other Ingredients are: Aspartame, β-Carotene (Contains Sucrose and Less than 1 mmol (23 mg) of Sodium), Orange Flavor (Contains Glucose and Lactose), Sorbitol.

What Fluimucil Muko Looks Like and What the Pack Contains

Fluimucil Muko is a Yellow Granule with an Orange Smell and a Possible Sulfur Smell, which is Typical for the Active Substance Contained in the Medication. Available Packs: 20 Sachets of 1 g of Granules, in a Cardboard Box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

ZAMBON S.p.A., Via Lillo del Duca, 10, 20091 Bresso (MI), Italy

Manufacturer:

ZAMBON S.p.A., Via Della Chimica, 9, 36100 Vicenza, Italy

Representative of the Marketing Authorization Holder:

Komtur Polska Sp. z o.o.

Plac Farmacji 1, 02-699 Warsaw, Tel. (22) 566 26 00, e-mail: [email protected]. The Leaflet in a Format Suitable for the Blind or Visually Impaired is Available at the Representative's Office of the Marketing Authorization Holder.

Date of the Last Update of the Leaflet: