Fluimucil Muko Iunior

Package Leaflet: Information for the User

Fluimucil Muko Junior

100 mg, Granules for Oral Solution

Acetylcysteine

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 the Package Leaflet or as Directed by the Doctor or Pharmacist.

• Keep this Package 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 the Package Leaflet, Inform Your Doctor or Pharmacist. See Section 4.
• If After 5 Days There is no Improvement or the Patient Feels Worse, Consult a Doctor.

Package Leaflet Contents:

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

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

Acetylcysteine, the Active Substance of Fluimucil Muko Junior, Thins Mucus and Muco-Purulent Secretions by Breaking Disulfide Bonds in Mucoproteins in the Airways.
Fluimucil Muko Junior is Used for a Short Period as a Mucolytic Agent to Thin Secretions in the Airways and Facilitate their Expectoration in Patients with Symptoms of Upper Respiratory Tract Infections.
If After 5 Days There is no Improvement or the Patient Feels Worse, Consult a Doctor.

2. Important Information Before Using Fluimucil Muko Junior

When Not to Use Fluimucil Muko Junior

• If the Patient is Hypersensitive to Acetylcysteine or any of the Other Ingredients of this Medicinal Product (Listed in Section 6);
• In Asthmatic Status;
• If the Patient has Phenylketonuria;
• In Children Under 2 Years of Age, as the Active Substance: Acetylcysteine may Cause Airway Obstruction in Children Under 2 Years of Age (See also Section 3. How to Use Fluimucil Muko Junior).

Warnings and Precautions

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

• Caution is Advised When Using Fluimucil Muko Junior if the Patient has or has had in the Past a Gastric or Duodenal Ulcer, Especially if they are Also Taking Other Medicinal Products 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 Medicinal Product Should be Discontinued Immediately.
• In the Event of Thinning of Large Amounts of Secretions, Especially in Small Children and Severely Ill Immobilized Patients, it is Necessary to Ensure their Aspiration.
• Acetylcysteine Should Not be Administered to Patients with Reduced Ability to Expectorate, Unless they are Undergoing Respiratory Physiotherapy During Treatment.
• Caution Should be Exercised if the Medicinal Product is Used for a Long Period in Patients with Histamine Intolerance, as they may Experience Symptoms such as Headache, Vasomotor Rhinitis, Pruritus.

Children and Adolescents

Mucolytic Agents may Cause Airway Obstruction in Children Under 2 Years of Age.
Due to the Physiological Characteristics of the Airways in this Age Group, the Ability to Expectorate 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 Junior Should Not be Used in Children Under 3 Years of Age.

Fluimucil Muko Junior and Other Medicinal Products

Inform Your Doctor or Pharmacist About all Medicinal Products You are Currently Taking or Have Recently Taken, as well as any Medicinal Products You Plan to Take.
Fluimucil Muko Junior Should Not be Used at the Same Time as Cough Suppressants, as this may Lead to Secretion Retention Due to Reduced Cough Reflex.
Activated Charcoal may Reduce the Effectiveness of Fluimucil Muko Junior.
If it is Necessary to Take Other Medicinal Products, Including Antibiotics, it is Recommended to Maintain a 2-Hour Interval Between the Administration of these Medicinal Products and Fluimucil Muko Junior. This Does Not Apply to Loracarbef (a Medicinal Product Used in Infections).
Concomitant Use of Fluimucil Muko Junior and Nitroglycerin (a Medicinal Product Used in Coronary Heart Disease) may Cause Significant Hypotension. Headache may Also Occur. If You are Taking Nitroglycerin, You Should Consult Your Doctor Before Taking Fluimucil Muko Junior.
Concomitant Use of Fluimucil Muko Junior and Carbamazepine (a Medicinal Product Used in the Treatment of Epilepsy) may Decrease the Plasma Concentration of Carbamazepine and Reduce its Effectiveness.
Fluimucil Muko Junior may Affect the Results of Certain Laboratory Tests (Salicylate Determination by Colorimetry and Ketone Determination in Urine).
It is Recommended Not to Mix Other Medicinal Products with the Solution of Fluimucil Muko Junior.

Pregnancy, Breast-Feeding, and Fertility

If You are Pregnant or Breast-Feeding, Think You may be Pregnant or are Planning to Have a Child, Consult Your Doctor or Pharmacist Before Using this Medicinal Product.
Pregnancy
It is Recommended to Avoid Using Fluimucil Muko Junior During Pregnancy. During Pregnancy, Fluimucil Muko Junior Should Only be Used in Cases where it is Absolutely Necessary and Under Close Medical Supervision.
Breast-Feeding
It is Not Known if Fluimucil Muko Junior Passes into Breast Milk. A Risk to the Breast-Fed Child Cannot be Excluded. You Should Not Use Fluimucil Muko Junior if You are Breast-Feeding.
Fertility
There are no Data on the Effects of Fluimucil Muko Junior on Fertility in Humans. Animal Studies do not Indicate any Harmful Effects of Acetylcysteine on Human Fertility at the Recommended Dose.

Driving and Using Machines

The Effects of Fluimucil Muko Junior on the Ability to Drive and Use Machines are Not Known.

What Fluimucil Muko Junior 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, You Should Consult Your Doctor Before Taking the Medicinal Product.
• Less than 1 mmol (23 mg) of Sodiumper Sachet (β-Carotene Component), i.e., the Medicinal Product is Considered “Sodium-Free”.
• Glucose and Lactose (Orange Flavor Components). If You have been Diagnosed with Intolerance to some Sugars, You Should Consult Your Doctor Before Taking the Medicinal Product.
• 762.7 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 been Diagnosed with Hereditary Fructose Intolerance, a Rare Genetic Disorder in which the Body does not Break Down Fructose, You Should Consult Your Doctor Before Taking the Medicinal Product or Giving it to Your Child.

3. How to Use Fluimucil Muko Junior

This Medicinal Product Should Always be Used Exactly as Described in the Package Leaflet or as Directed by the Doctor or Pharmacist.
In Case of Doubt, Consult Your Doctor or Pharmacist.
Do Not Use Fluimucil Muko Junior for More than 5 Days Without Consulting a Doctor.
Recommended Dose

Children from 3 to 6 Years of Age

1 Sachet of Fluimucil Muko Junior (1 x 100 mg) 2 to 3 Times a Day.

Children from 7 to 14 Years of Age

2 Sachets of Fluimucil Muko Junior (2 x 100 mg) 2 Times a Day or 1 Sachet of Fluimucil Muko Junior (1 x 100 mg) 4 Times a Day.

Adults and Children Over 14 Years of Age

2 Sachets of Fluimucil Muko Junior (2 x 100 mg) 2 to 3 Times a Day.
Method of Administration:
Dissolve the Contents of the Sachet in Half a Glass of Water, if Necessary, Stir with a Spoon.
The Obtained Solution is Ready for Consumption. The Solution Should be Consumed Immediately After Preparation.
During Treatment, an Increased Amount of Fluid Should be Consumed.
Note:
The Last Dose of Fluimucil Muko Junior Should be Taken no Later than 4 Hours Before Bedtime.
If You Feel that the Effect of Fluimucil Muko Junior is too Strong or too Weak, Consult Your Doctor.

Overdose of Fluimucil Muko Junior

In Case of Overdose of Fluimucil Muko Junior, Gastrointestinal Symptoms such as Nausea, Vomiting, and Diarrhea may Occur.
There is no Known Antidote Specific to Acetylcysteine. Symptomatic Treatment is Used.
In Case of Overdose, Consult Your Doctor or Pharmacist Immediately.

Missed Dose of Fluimucil Muko Junior

Do Not Take a Double Dose to Make up for a Missed Dose.
In Case of any Further Doubts About the Use of this Medicinal Product, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicinal Products, Fluimucil Muko Junior 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 During Treatment with Fluimucil Muko Junior:
Uncommon (Less than 1 in 100 Patients):

• Hypersensitivity,
• 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,
• Hypotension.

Rare (Less than 1 in 1000 Patients):

• Bronchospasm, Dyspnea,
• Gastrointestinal Disorders.

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

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

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 After the Use of Fluimucil Muko Junior.
In Most Cases, at Least one Other Medicinal Product was Probably Involved in the Onset of Skin and Mucous Membrane Changes.
In Case of Side Effects, Discontinue the Medicinal Product and Consult Your Doctor.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in the Package Leaflet, Inform Your Doctor or Pharmacist. Side Effects can be Reported Directly to:
Department for Monitoring 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: ndl@urpl.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather more Information on the Safety of the Medicinal Product.

5. How to Store Fluimucil Muko Junior

Store the Medicinal Product in a Place that is Inaccessible to Children.
Do Not Use this Medicinal Product After the Expiration Date Stated on the Packaging.
The Expiration Date is the Last Day of the Specified Month.
Fluimucil Muko Junior Should be Stored at a Temperature Below 30°C.
Note:
The Possible Presence of a Sulfur Smell is Typical for the Active Substance Contained in the Medicinal Product.
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. Contents of the Package and Other Information

What Fluimucil Muko Junior Contains

• The Active Substance of Fluimucil Muko Junior is Acetylcysteine. One Sachet (1 g of Granules) Contains 100 mg of Acetylcysteine.
• The 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 Junior Looks Like and What the Package Contains

Fluimucil Muko Junior is a Yellow Granule with an Orange Odor and a Possible Sulfur Smell, which is Typical for the Active Substance Contained in the Medicinal Product.
Packaging:
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: info@komtur.com
A Package 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 Package Leaflet: