Flegamina Fast Iunior

Package Leaflet: Information for the Patient

Flegamina Fast Junior, 4 mg, Oral Disintegrating Tablets

Bromhexine Hydrochloride

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

This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Advised by a 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 this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If After 5 Days of Use in Adults or After 3 Days of Use in Adolescents and Children Over 2 Years, There is no Improvement or the Patient Feels Worse, Consult a Doctor.

Table of Contents of the Package Leaflet:

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

1. What is Flegamina Fast Junior and What is it Used for

Flegamina Fast Junior Contains the Active Substance Bromhexine Hydrochloride, which Acts as an Expectorant, Thinning the Secretion from the Airways. This Facilitates the Transport of Bronchial Secretion by the Cilia (Small Hairs Lining the Airways) and its Removal from the Lungs. Bromhexine Facilitates Coughing Up and Relieves Coughing. The Medication is Used in Acute and Chronic Respiratory Tract Diseases Characterized by Impaired Coughing Up and Removal of Mucus in Adults, Adolescents, and Children Over 2 Years. If After 5 Days of Use in Adults or After 3 Days of Use in Adolescents and Children Over 2 Years, There is no Improvement or the Patient Feels Worse, Consult a Doctor.

2. Important Information Before Taking Flegamina Fast Junior

When Not to Use Flegamina Fast Junior

• If the Patient is Hypersensitive (Allergic) to Bromhexine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6).
• In Children Under 2 Years of Age.

Warnings and Precautions

Before Starting Flegamina Fast Junior, Discuss with Your Doctor or Pharmacist if:

• The Patient has Inflammatory Diseases of the Respiratory Tract with Bacterial Infection. Flegamina Fast Junior Should be Taken Together with Antibiotics and Bronchodilators Prescribed by the Doctor. During Treatment, Drink Plenty of Fluids, Especially if You Have a Fever. Proper Hydration Helps to Thin Out Bronchial Secretions and Facilitates Coughing Up.
• The Patient has a History of Gastric or Duodenal Ulcer, as well as Active Gastric or Duodenal Ulcer, as Bromhexine May Worsen its Symptoms.
• The Patient has Asthma.
• The Patient has Impaired Motor Function of the Bronchi, e.g., a Disease Called Ciliary Dyskinesia.
• The Patient has Impaired Liver or Kidney Function.
• The Patient has Difficulty Coughing Up.
• Severe Skin Reactions Associated with Bromhexine Use have been Reported. If a Rash Occurs (Including Blisters or Changes in the Mucous Membranes, e.g., in the Mouth, Throat, Nose, Eyes, Genital Area), Discontinue Flegamina Fast Junior and Consult a Doctor Immediately (See Section 4).

Children

Do not Use in Children Under 2 Years of Age. Before Starting Flegamina Fast Junior in Children, Consult a Doctor or Pharmacist.

Flegamina Fast Junior and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking, Have Recently Taken, or Plan to Take. Flegamina Fast Junior Should be Used with Caution with Atropine and Other Anticholinergic Medications, as they Cause Dryness of the Mucous Membranes. Do not Take Flegamina Fast Junior with Cough Suppressants, e.g., Containing Codeine or its Derivatives, as this May Lead to Dangerous Accumulation of Bronchial Secretion Due to Weakened Cough Reflex. Bromhexine May Enhance the Irritant Effect of Salicylates and Other Non-Steroidal Anti-Inflammatory Drugs on the Gastrointestinal Tract Mucosa. Concurrent Use of Bromhexine and Antibiotics (Medications Used to Treat Infections: Erythromycin, Doxycycline, Amoxicillin, Cefuroxime) May Increase the Concentration of the Antibiotic in the Lungs.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult a Doctor or Pharmacist Before Taking this Medication. Flegamina Fast Junior is not Recommended During the First Trimester of Pregnancy. In the Remaining Period of Pregnancy, the Medication May be Used Only if, in the Doctor's Opinion, the Benefit to the Mother Outweighs the Potential Risk to the Fetus. If You are Breastfeeding, Consult a Doctor Before Taking this Medication. Bromhexine Passes into Breast Milk. There is Insufficient Information on the Effect of Bromhexine on Newborns and Children. Flegamina Fast Junior is not Recommended During Breastfeeding. There are no Data on the Effect of Bromhexine on Human Fertility.

Driving and Operating Machinery

No Studies have been Conducted on the Effect of Bromhexine on the Ability to Drive and Operate Machinery. Be Cautious, as Headaches, Dizziness, or Drowsiness May Occur.

Flegamina Fast Junior Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, i.e., it is Considered "Sodium-Free".

3. How to Take Flegamina Fast Junior

This Medication Should Always be Used Exactly as Described in this Package Leaflet or as Advised by a Doctor or Pharmacist. If You are Uncertain, Consult a Doctor or Pharmacist.

Adults, Including the Elderly

2 Tablets 3 Times a Day. At the Beginning of Treatment, it May be Necessary to Increase the Dose to 48 mg (Maximum Dose) (4 Tablets 3 Times a Day, Equivalent to 48 mg of Bromhexine).

Children and Adolescents

Adolescents Over 12 Years of Age: 2 Tablets 3 Times a Day, up to a Maximum of 12 Tablets a Day (Equivalent to 48 mg of Bromhexine). Children Between 6 and 12 Years of Age: 1 Tablet 3 Times a Day, up to a Maximum of 4 Tablets a Day (Equivalent to 16 mg of Bromhexine). Children Between 2 and 6 Years of Age: Half a Tablet 3 Times a Day, up to a Maximum of 2 Tablets a Day (Equivalent to 8 mg of Bromhexine).

Method of Administration

Oral Use. Flegamina Fast Junior Tablets Should not be Handled with Wet Hands, as they May Disintegrate. Place the Flegamina Fast Junior Oral Disintegrating Tablet in the Mouth, where it Will Dissolve in Saliva Within About 30 Seconds and Can be Easily Swallowed. Be Cautious When Administering the Medication to Small Children Due to the Risk of Choking. Immediately Before Administration, the Tablet Can be Dissolved on a Spoon in a Small Amount of Drinking Water. The Dose Should be Taken Immediately After Opening the Blister. The Tablet Can be Divided into Equal Doses. The Remaining Half of the Tablet Should be Placed in the Open Blister and Used no Later than the Next Day. The Medication Should not be Used for More than 7 Days Without Consulting a Doctor. If Symptoms Worsen or do not Improve After 5 Days of Use in Adults or After 3 Days of Use in Adolescents and Children Over 2 Years, Consult a Doctor. The Medication Should be Taken at Equal Intervals, After Meals. The Medication Should not be Taken Immediately Before Bedtime.

Use in Patients with Liver or Kidney Impairment

There are no Data on the Use of Bromhexine Hydrochloride in Patients with Liver or Kidney Impairment. The Elimination of Bromhexine or its Metabolites is Reduced in these Patients. Before Taking the Medication, the Patient Should Consult a Doctor.

Overdose of Flegamina Fast Junior

In Case of Overdose, Consult a Doctor Immediately. The Symptoms Observed in Case of Accidental Overdose are Similar to the Adverse Reactions of Bromhexine for Recommended Doses and Require Symptomatic Treatment. Excessive Increase in Secretion May Occur. In Case of Overdose, the Doctor Will Perform Gastric Lavage, Administer Activated Charcoal, and Provide Symptomatic Treatment.

Missed Dose of Flegamina Fast Junior

If You Miss a Dose, Take it as Soon as Possible, Unless it is Almost Time for the Next Dose. In this Case, Skip the Missed Dose and Continue with the Recommended Schedule. Do not Take a Double Dose to Make up for the Missed Dose. If You have any Further Questions About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Flegamina Fast Junior Can Cause Side Effects, Although not Everybody Gets them.

Immediately Inform Your Doctor or Go to the Nearest Hospital if You Experience:

• Severe Skin Reactions (Including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalized Exanthematous Pustulosis)
• Allergic Reactions (Including Rash, Face, Lip, Tongue, and/or Throat Swelling, which May Cause Difficulty Breathing or Swallowing). The Following Side Effects May Occur.

Uncommon(May Affect up to 1 in 100 People):
Upper Abdominal Pain, Nausea, Vomiting, Diarrhea
Rare(May Affect up to 1 in 1,000 People):
Skin Rash, Urticaria, Hypersensitivity Reactions.
Frequency Not Known (Cannot be Estimated from the Available Data):
Indigestion, Excessive Sweating, Severe Skin Reactions (Including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalized Exanthematous Pustulosis), Anaphylactic Reactions, Including Anaphylactic Shock, Angioedema, Itching, Decreased Blood Pressure, Increased Liver Enzyme Activity, Headache, Dizziness, Drowsiness, Bronchospasm.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Inform Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Medicinal Product Monitoring, 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, Website: https://smz.ezdrowie.gov.pl . 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 Flegamina Fast Junior

Keep the Medication Out of Sight and Reach of Children. There are no Special Recommendations for the Storage Temperature of the Medication. Store in the Original Packaging to Protect from Light and Moisture. Do not Use this Medication After the Expiration Date Stated on the Carton or Blister After "Expiration Date" or "EXP". The Expiration Date is the Last Day of the Specified Month. 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 Package and Other Information

What Flegamina Fast Junior Contains

The Active Substance is Bromhexine Hydrochloride. One Oral Disintegrating Tablet Contains 4 mg of Bromhexine Hydrochloride. The Other Ingredients are: Mannitol, Crospovidone (Type B), Sucralose, Colloidal Anhydrous Silica, Magnesium Stearate, Strawberry Flavor PHS-455920 of Composition: Natural Flavoring Substances, Flavoring Preparations, Corn Maltodextrin, Sodium Octenyl Succinate Starch (E 1450).

What Flegamina Fast Junior Looks Like and Contents of the Package

Flegamina Fast Junior Oral Disintegrating Tablets are White, Round with a Score Line, Flat on Both Sides, with a Beveled Edge, 7 mm in Diameter. The Tablet Can be Divided into Equal Doses. The Package Contains 10, 20, or 40 Oral Disintegrating Tablets.

Marketing Authorization Holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer

Mako Pharma Sp. z o.o., ul. Władysława Reymonta 2, 05-092 Dziekanów Leśny

Date of Last Revision of the Package Leaflet: March 2025