Flavamed max

Package Leaflet: Information for the Patient

Flavamed max, 30 mg/5 ml, Oral Solution

Ambroxol 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 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 the Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If After 4 to 5 Days There is no Improvement or You Feel Worse, Consult a Doctor.

Package Leaflet Contents

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

1. What is Flavamed max and What is it Used for

Flavamed max Contains the Active Substance Ambroxol Hydrochloride and Belongs to the Therapeutic Group of Cough and Cold Medicines, Mucolytics. Ambroxol Hydrochloride is Used to Treat Wet Cough Associated with Lung and Bronchial Diseases. Flavamed max is Indicated for Use in Children from 2 Years of Age, Adolescents, and Adults. Thanks to the Use of Flavamed max, Thick Mucus Becomes more Fluid and Easier to Cough Up. If After 4 to 5 Days There is no Improvement or You Feel Worse, Consult a Doctor.

2. Important Information Before Taking Flavamed max

When Not to Take Flavamed max

• If You are Allergic to Ambroxol Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6). Flavamed max Should not be Used in Children Under 2 Years of Age.

Warnings and Precautions

Before Taking Flavamed max, Consult a Doctor or Pharmacist:

• If You Have Had Severe Skin Allergic Reactions (Stevens-Johnson Syndrome, Lyell's Syndrome) in the Past.
• Stevens-Johnson Syndrome is a Disease Characterized by High Fever and a Rash with Blisters on the Skin and Mucous Membranes.
• Life-Threatening Lyell's Syndrome Also Occurs Under the Name of Toxic Epidermal Necrolysis. The Symptoms of this Syndrome are Severe Skin Changes in the Form of Blisters, Similar to those Occurring in Burns.

Severe Skin Reactions have been Reported with the Use of Ambroxol. If a Rash Occurs (Including Changes on the Mucous Membranes, e.g., Mouth, Throat, Nose, Eyes, Genital Organs), Discontinue Use of Flavamed max and Consult a Doctor Immediately.

• If You Have Kidney Function Disorders or Severe Liver Disease. In Such Cases, Particular Caution Should be Exercised When Using Flavamed max (i.e., Prolong the Intervals Between Doses of the Medication or Use a Lower Dose of the Medication - Consult a Doctor). In Severe Kidney Function Disorders, the Risk of Accumulation (Build-Up) of the Active Substance of Flavamed max May Increase.
• If You Have a Rare Disease of the Bronchial Tubes, Characterized by Increased Mucus Production (e.g., Primary Ciliary Dyskinesia). In this Case, there is no Possibility of Removing Mucus from the Lungs. Flavamed max Should be Used Under Medical Supervision Only.
• If You Have Had Stomach or Duodenal Ulcer in the Past, Consult a Doctor on How to Use Flavamed max, as Mucolytic Medications May Damage the Gastric Mucosa. Consult a Doctor Before Taking Flavamed max.

Flavamed max and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking, Have Recently Taken, or Plan to Take. Cough Suppressants (Antitussives)Should not be Used During Treatment with Flavamed max. The Cough Reflex is Important as it Allows the Coughing Up of Fluidized Mucus and its Removal from 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. During Pregnancy and Breastfeeding, Flavamed max Should be Used Only if Clearly Advised by a Doctor! Especially in the First Trimester of Pregnancy, the Use of Flavamed max is not Recommended. It has been Observed that the Active Substance of Flavamed max Passes into Breast Milk. The Use of Flavamed max is not Recommended During Breastfeeding. Animal Studies have not Shown any Harmful Effects of Ambroxol on Fertility.

Driving and Using Machines

There is no Evidence of the Medication's Influence on the Ability to Drive and Use Machines. No Studies have been Conducted on the Influence of the Medication on the Ability to Drive and Use Machines.

Flavamed max Contains Sorbitol and Benzonic Acid

The Medicinal Product Contains 1.75 g of Sorbitol in one 5 ml Measuring Spoon of Oral Solution. Sorbitol is a Source of Fructose. If You Have been Diagnosed with Intolerance to some Sugars or have been Diagnosed with a Rare Genetic Disease, Hereditary Fructose Intolerance, in which the Body does not Break Down Fructose, You Should Consult a Doctor Before Taking the Medication or Giving it to Your Child. Sorbitol may Cause Gastrointestinal Discomfort and has a Mild Laxative Effect. The Medication Contains 5.75 mg of Benzonic Acid in one 5 ml Measuring Spoon of Oral Solution.

3. How to Take Flavamed max

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, Consult a Doctor or Pharmacist. The Following Information Applies if a Doctor has not Advised Otherwise. Follow the Instructions for Use, as Otherwise, Flavamed max will not Work Properly!

Recommended Dose:

Children from 2 to 5 Years of Age: ¼ Measuring Spoon, i.e., 1.25 ml of Oral Solution 3 Times a Day (Corresponding to 22.5 mg of Ambroxol Hydrochloride per Day, Divided into 3 Doses of 7.5 mg). Children from 6 to 12 Years of Age: ½ Measuring Spoon, i.e., 2.5 ml of Oral Solution 2 to 3 Times a Day (Corresponding to 30-45 mg of Ambroxol Hydrochloride per Day, Divided into 2-3 Doses of 15 mg). Adolescents Over 12 Years of Age and Adults: 1 Measuring Spoon, i.e., 5 ml of Oral Solution 3 Times a Day for the First 2-3 Days (Corresponding to 90 mg of Ambroxol Hydrochloride per Day, Divided into 3 Doses of 30 mg), and then 1 Measuring Spoon, i.e., 5 ml of Oral Solution 2 Times a Day (Corresponding to 60 mg of Ambroxol Hydrochloride per Day, Divided into 2 Doses of 30 mg). Note: If Necessary, in Adults, the Dose can be Increased to 2 Measuring Spoons of 5 ml of Oral Solution 2 Times a Day to Achieve a Better Effect (Corresponding to 120 mg of Ambroxol Hydrochloride per Day, Divided into 2 Doses of 60 mg).

Method of Administration

For Oral Use. Flavamed max is Best Taken After Meals, Using a Measuring Spoon.

Duration of Use

Without Consulting a Doctor, Flavamed max Should not be Taken for More than 4 to 5 Days. If After 4 to 5 Days the Symptoms do not Decrease or Even Worsen, Consult a Doctor Immediately! If You Feel that the Effect of Flavamed max is too Strong or too Weak, Consult a Doctor or Pharmacist.

Use of a Higher than Recommended Dose of Flavamed max

Based on Cases of Accidental Overdose and/or Reports of Incorrect Use, Symptoms Corresponding to the Known Side Effects of Flavamed max at Recommended Doses have been Observed. In Case of Overdose, Consult a Doctor who will Provide Appropriate Treatment Depending on the Symptoms of Overdose.

Missing a Dose of Flavamed max

In Case of a Missed Dose or Use of a Lower Dose, Take the Next Scheduled Dose at the Usual Time. Do not Take a Double Dose to Make Up for the 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, Flavamed max can Cause Side Effects, although not Everybody gets them.

Side Effects

Frequent (May Affect up to 1 in 10 Patients):

• Nausea
• Altered Taste
• Feeling of Numbness in the Mouth and Throat (Hypoaesthesia)

Uncommon (May Affect up to 1 in 100 Patients):

• Vomiting
• Dryness of the Mouth
• Diarrhea
• Indigestion
• Abdominal Pain
• Fever

Rare (May Affect up to 1 in 1,000 Patients):

• Allergic Reactions
• Rash, Urticaria

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

• Anaphylactic Reactions, Including Anaphylactic Shock, Angioedema (Rapidly Progressing Skin Swelling, 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)
• Dryness in the Throat

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in the Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department for the Monitoring of Adverse Reactions to 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 Flavamed max

Store in a Place Inaccessible to Children. Do not Use this Medication After the Expiry Date Stated on the Label and Carton, Expressed as the Last Day of the Specified Month. There are no Special Precautions for Storage.

Shelf Life After First Opening of the Bottle

Shelf Life After First Opening of the Bottle: 6 Months. 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. Package Contents and Other Information

What Flavamed max Contains

The Active Substance is Ambroxol Hydrochloride. 1 ml of Oral Solution Contains 6 mg of Ambroxol Hydrochloride. Each Measuring Spoon, i.e., 5 ml of Oral Solution, Contains 30 mg of Ambroxol Hydrochloride. The Other Excipients are: Liquid Non-Crystallizing Sorbitol (E 420) (Ph.Eur), Benzonic Acid (E 210), Glycerol (85%) (E 422), Hydroxyethyl Cellulose, Raspberry Flavor (Containing Valerian Oil, Ethyl Acetate, Ethyl Butyrate, p-Hydroxyphenyl-Butanone, Alpha Ionone, Beta Ionone, Isoamyl Acetate, Isoamyl Butyrate, Rose Oil, and Propylene Glycol (E 1520)), Purified Water.

What Flavamed max Looks Like and What the Package Contains

Clear, Colorless to Light Yellow Oral Solution. Flavamed max is Available in a 100 ml Brown Glass Bottle with a PP Cap and a PP Measuring Spoon with Gradations (1.25 ml, 2.5 ml, 5 ml).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin
Germany
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
For More Detailed Information on this Medication, Please Contact the Local Representative of the Marketing Authorization Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00
Fax: +48 22 566 21 01

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria
Flavamed forte
Estonia
Flavamed forte
Finland
Flavamed 6 mg/ml Oral Solution
Germany
Flavamed Hustensaft 30 mg/5 ml Solution for Oral Use
Latvia
Flavamed 30 mg/5 ml Solution for Oral Use
Lithuania
Flavamed 30 mg/5 ml Oral Solution
Poland
Flavamed max
Slovak Republic
Flavamed forte Oral Solution
Slovenia
Ambroxol Hydrochloride Berlin-Chemie 6 mg/ml Oral Solution
Date of Last Revision of the Package Leaflet:02/2025