Flegamina Classic

Package Leaflet: Information for the User

Flegamina Classic, 8 mg, 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 Taken Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or 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 the Leaflet, the Doctor or Pharmacist or Nurse Should be Informed. See Section 4.
• If there is no Improvement or the Patient Feels Worse, a Doctor Should be Consulted.

Table of Contents of the Leaflet

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

1. What is Flegamina Classic and What is it Used for

Flegamina Classic Contains the Active Substance Bromhexine Hydrochloride, which is an Expectorant, Making it Easier to Cough Up Mucus from the Airways. The Medication Facilitates Coughing Up and Cleansing the Bronchi.

The Indication for the Use of Flegamina Classic is Acute and Chronic Respiratory Diseases with Impaired Coughing Up and Mucus Clearance.

2. Important Information Before Taking Flegamina Classic

When Not to Take Flegamina Classic

• If the Patient is Allergic to Bromhexine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6).
• In Children Aged 3 to 6 Years who are Unable to Swallow Tablets.
• In Children Under 2 Years of Age Due to the Content of Bromhexine.

Warnings and Precautions

Before Starting to Take Flegamina Classic, the Patient Should Discuss it with a Doctor:

• If the Patient has Inflammatory Diseases of the Airways with Bacterial Infection. Flegamina Classic Tablets Should be Taken Together with Antibiotics and Bronchodilators Prescribed by the Doctor. During Treatment, the Patient Should Drink Plenty of Fluids, Especially if they have a Fever. Proper Hydration of the Body Increases the Thinning of Bronchial Secretion and Facilitates Coughing Up.
• If the Patient has a History of Gastric and Duodenal Ulcer or Active Gastric and Duodenal Ulcer, as the Medication may Exacerbate its Symptoms.
• If the Patient has Severe Liver Function Disorders.
• If the Patient has Severe Kidney Function Disorders.
• If the Patient has Intolerance to Some Sugars (See also "Flegamina Classic Contains Lactose").

Severe Skin Reactions Associated with the Use of Bromhexine Hydrochloride have been Reported. If a Rash Appears (Including Changes in the Mucous Membranes, e.g., Mouth, Throat, Nose, Eyes, Genital Organs), the Use of Flegamina Classic Should be Stopped and a Doctor Consulted Immediately.

Children

Flegamina Classic in the Form of Tablets Should not be Used in Children Aged 3 to 6 Years who are Unable to Swallow Tablets. In these Patients, the Use of Bromhexine in the Form of Flegamina Classic Junior Syrup with a Strawberry Flavor is Recommended.

Flegamina Classic Tablets, Due to the Content of Bromhexine, Should not be Given to Children Under 2 Years of Age.

Flegamina Classic and Other Medications

The Patient Should Inform the Doctor or Pharmacist about all Medications Currently Being Taken or Recently Taken, as well as those Planned to be Taken, Including those Available Without a Prescription.

Flegamina Classic Tablets Should not be Used with:

• Cough Suppressants, e.g., Containing Codeine and its Derivatives, as they may Weaken the Cough Reflex and Cause Mucus to Accumulate in the Airways.

Flegamina Classic Tablets Should be Used with Caution when Taken Together with:

• Atropine and Other Anticholinergic Medications, as they Cause Dryness of the Mucous Membranes.
• Salicylates and Other Non-Steroidal Anti-Inflammatory Medications, as the Medication may Enhance the Irritant Effect on the Gastrointestinal Tract Mucosa.
• Antibiotics such as Oxytetracycline, Erythromycin, Ampicillin, Doxycycline, Cefuroxime, Amoxicillin, as the Concurrent Use of the Medication with these Antibiotics Increases their Concentration in the Lung Tissue.

Using Flegamina Classic with Food and Drink

The Medication Should be Taken After a Meal.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or is Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.

Pregnancy

The Medication Should not be Used in the First Three Months of Pregnancy.

In the Remaining Period of Pregnancy, the Medication can be Used Only if, in the Doctor's Opinion, the Benefit to the Mother Outweighs the Potential Risk to the Fetus.

Breastfeeding

The Use of the Medication is not Recommended During Breastfeeding.

Driving and Operating Machinery

Care Should be Taken, as Pains and Dizziness or Drowsiness may Occur.

Flegamina Classic Contains Lactose

If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, they Should Consult a Doctor Before Taking the Medication.

Flegamina Classic Contains Sodium

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

3. How to Take Flegamina Classic

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

In Case of Doubt, a Doctor or Pharmacist Should be Consulted.

The Medication is for Oral Use.

The Recommended Dose is:

Adults and Children Over 12 Years of Age: 1 Tablet 3 Times a Day.

Children Aged 6 to 12 Years: Half a Tablet 3 Times a Day.

Children Aged 3 to 6 Years: Half a Tablet 2 Times a Day.

It is not Recommended to Use Flegamina Classic in the Form of Tablets in Children Aged 3 to 6 Years who are Unable to Swallow Tablets; in these Patients, the Use of Bromhexine in the Form of Flegamina Classic Junior Syrup with a Strawberry Flavor is Recommended.

The Medication Should be Taken at Equal Intervals, After a Meal.

The Medication Should not be Taken Directly Before Bedtime.

The Medication is Usually Taken for 7 to 10 Days.

If Symptoms Worsen or do not Improve, a Doctor Should be Consulted.

In Case of Feeling that the Medication's Effect is too Strong or too Weak, a Doctor Should be Consulted.

Using a Higher Than Recommended Dose of Flegamina Classic

No Symptoms of Bromhexine Overdose have been Described so far. In Case of Overdose, Activated Charcoal Should be Administered. If Necessary, the Doctor will Prescribe Gastric Lavage and Symptomatic Treatment.

In Case of Taking a Higher Dose of the Medication than Recommended, a Doctor or Pharmacist Should be Consulted Immediately.

Missing a Dose of Flegamina Classic

The Medication Should be Taken as Soon as Possible. When the Time for the Next Dose is Approaching, it Should be Taken at the Designated Time.

A Double Dose Should not be Taken to Make Up for a Missed Dose.

In Case of any Further Doubts Regarding the Use of this Medication, a Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

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

During Treatment with Flegamina Classic, 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):

• Hypersensitivity Reactions, Rash, Urticaria

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

• Headache, Dizziness, Drowsiness,
• Bronchospasm,
• Indigestion,
• Excessive Sweating,
• Increased Activity of Liver Enzymes,
• Decreased Blood Pressure ,
• -Anaphylactic Reactions, including Anaphylactic Shock, Angioedema (Rapidly Progressing Swelling of the Skin, Subcutaneous Tissue, Mucous Membranes or Submucosal Tissue) and Pruritus;
• Severe Skin Reactions (including Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Acute Generalized Exanthematous Pustulosis).

Reporting Side Effects

If any Side Effects Occur, including those not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed.

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 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.

Reporting Side Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Flegamina Classic

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.

Store in a Temperature Below 25°C, in a Dry Place.

Do not Use this Medication After the Expiry Date Stated on the Label after "Expiry Date:" or "EXP". The Expiry Date Refers to the Last Day of the Specified Month.

Medications Should not be Disposed of via Wastewater or Household Waste Containers. A Pharmacist Should be Asked how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

The Batch Number on the Packaging is Located after the Abbreviation "Lot".

6. Contents of the Pack and Other Information

What Flegamina Classic Contains

• The Active Substance of the Medication is: Bromhexine Hydrochloride. One Tablet Contains 8 mg of Bromhexine Hydrochloride.
• The Other Ingredients are: Lactose Monohydrate, Sodium Carboxymethylcellulose (See Section 2 "Flegamina Classic Contains Sodium"), Magnesium Stearate.

What Flegamina Classic Looks Like and What the Pack Contains

Flegamina Classic Tablets are Round, Flat on Both Sides with a Score Line on one Side. The Packaging Contains 20, 40 or 60 Tablets.

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53, 00-113 Warsaw, Tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Krakow

Date of the Last Update of the Leaflet: