Flavamed

Package Leaflet: Information for the User

Warning! The leaflet must be kept. Information on the immediate packaging in a foreign language.

Flavamed (Flavamed for children)

15 mg/5 ml, syrup

Ambroxol hydrochloride
Flavamed and Flavamed for children are different trade names for the same medicine.

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The 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 any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Flavamed and what is it used for
• 2. Important information before taking Flavamed
• 3. How to take Flavamed
• 4. Possible side effects
• 5. How to store Flavamed
• 6. Package contents and other information

1. What is Flavamed and what is it used for

Flavamed is a mucolytic agent used in acute and chronic lung and bronchial diseases with impaired mucus production and transport.
Thanks to the use of Flavamed, thick mucus becomes more watery and can be coughed up more easily.
Flavamed is indicated for children over 1 year of age, adolescents, and adults.
If after 4 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Flavamed

When not to take Flavamed

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Flavamed, the patient should discuss it with their doctor or pharmacist.

• if the patient has a history of severe skin hypersensitivity reactions (Stevens-Johnson syndrome, Lyell's syndrome).
• 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 is also known as toxic epidermal necrolysis. Its symptoms include severe skin changes in the form of blisters, similar to burns. Page 1 5

Severe skin reactions associated with the use of ambroxol have been reported. If a rash occurs (including changes on the mucous membranes, e.g., in the mouth, throat, nose, eyes, genitals), the patient should stop taking Flavamed and immediately consult their doctor.

• if the patient has kidney function disorders or severe liver disease, Flavamed can be used only after consulting a doctor. In severe kidney function disorders, the degradation products of the active substance of Flavamed may accumulate.
• if the patient has a rare bronchial disease with increased mucus production (e.g., primary ciliary dyskinesia). In this case, it is not possible to remove mucus from the lungs. Flavamed should be used under medical supervision.
• if the patient has a history of stomach or duodenal ulcers, they should consult their doctor about taking Flavamed, as mucolytic agents may damage the stomach mucosa. The patient should consult their doctor before taking Flavamed.

Children

Flavamed can be used in children from 1 to 2 years of age only under medical supervision.
For more information, see section 3.

Flavamed and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Cough suppressants (antitussives)
While taking Flavamed, the patient should not use any medicines that suppress the cough reflex (so-called antitussives). The cough reflex is important for coughing up liquefied mucus and thus removing it from the lungs.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, Flavamed can be used only if clearly prescribed by a doctor! It is not recommended to use Flavamed, especially during the first trimester of pregnancy.
The active substance of Flavamed passes into breast milk.
It is not recommended to use Flavamed during breastfeeding.
Animal studies have not shown any harmful effects of ambroxol on fertility.
There is insufficient data on the effects of ambroxol on human fertility.

Driving and using machines

There is no data on the effects of Flavamed on the ability to drive and use machines.
No studies have been conducted on the effects of Flavamed on the ability to drive and use machines.

Flavamed contains sorbitol and benzoic acid (E 210)

This medicine contains 1.75 g of sorbitol in 5 ml of syrup.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains 5.75 mg of benzoic acid in 5 ml of syrup.
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3. How to take Flavamed

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The following information applies if the doctor has not prescribed a different dosage of Flavamed.
The patient should follow the instructions for taking the medicine, as otherwise, Flavamed will not work properly!

Recommended dose:

Children from 1 to 2 years of age:
Only under medical supervision!
½ measuring spoon, i.e., 2.5 ml of syrup, 2 times a day (which corresponds to 15 mg of ambroxol hydrochloride per day).
Children from 2 to 5 years of age:
½ measuring spoon, i.e., 2.5 ml of syrup, 3 times a day (which corresponds to 22.5 mg of ambroxol hydrochloride per day).
Children from 6 to 12 years of age:
1 measuring spoon, i.e., 5 ml of syrup, 2 to 3 times a day (which corresponds to 30 to 45 mg of ambroxol hydrochloride per day).
Adolescents from 12 years of age and adults:
2 measuring spoons, 5 ml of syrup each (i.e., 10 ml), 2 to 3 times a day (which corresponds to 60 to 90 mg of ambroxol hydrochloride per day) for the first 2 to 3 days of treatment, and then 2 measuring spoons, 5 ml of syrup each (i.e., 10 ml), 2 times a day (which corresponds to 60 mg of ambroxol hydrochloride per day).
Note:
In adults, the dose can be increased to 4 measuring spoons, 5 ml of syrup each (i.e., 20 ml), 2 times a day (which corresponds to 120 mg of ambroxol hydrochloride per day).

Method of administration

For oral use. Flavamed should be taken after meals using the enclosed measuring spoon.
Flavamed should not be taken directly before bedtime.

Duration of treatment

Flavamed should not be taken for more than 4-5 days without consulting a doctor.
If after 4-5 days the symptoms do not decrease or worsen, the patient should immediately consult their doctor!
If the patient feels that the effect of Flavamed is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Flavamed

Based on cases of accidental overdose and/or reports of improper use, symptoms corresponding to the known side effects of Flavamed at recommended doses have been observed.
In case of overdose, the patient should consult their doctor, who will provide appropriate treatment depending on the symptoms of overdose.

Missed dose of Flavamed

In case of a missed dose or taking a smaller dose, the patient should take the next prescribed dose at the usual time.
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A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Flavamed can cause side effects, although not everybody gets them.

Side effects

Common (may affect up to 1 in 10 people):

• nausea
• taste disorders
• feeling of numbness in the mouth and throat (hypoesthesia)

Uncommon (may affect up to 1 in 100 people):

• fever
• dryness of the mucous membranes in the mouth
• diarrhea
• gastrointestinal disorders (dyspepsia)
• abdominal pain
• vomiting
• facial swelling
• respiratory disorders

Rare (may affect up to 1 in 1000 people):

• hypersensitivity reactions
• rash
• urticaria

Frequency not known (frequency cannot be estimated from the available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue edema), and pruritus
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis; see section 2)
• 2)
• dryness in the throat

If any of the above side effects occur, the patient should stop taking Flavamed and immediately consult their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Flavamed

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The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special precautions for storage.

Shelf life after first opening

Shelf life after first opening of the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Flavamed contains

• The active substance of Flavamed is ambroxol hydrochloride. 5 ml (one measuring spoon) contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: liquid sorbitol, non-crystallizing, benzoic acid (E 210), glycerol 85%, hydroxyethylcellulose, raspberry flavor, purified water.

What Flavamed looks like and what the package contains

Flavamed is a clear, colorless to light brown solution with a raspberry flavor.
Packaging: a brown glass bottle with a screw cap and a measuring spoon made of polypropylene with a scale: 1.25 ml, 2.5 ml, and 5 ml, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany

Manufacturer:

Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 13-0158

Parallel import authorization number: 188/24

Date of leaflet approval: 07.05.2024

[Information about the trademark]
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