Ambroxoli hidrohloridum Fontane

Leaflet attached to the packaging: patient information

Ambroxol hydrochloride Fontane, 15 mg/5 ml, oral solution

For children from 2 years of age, adolescents and adults
Ambroxol hydrochloride

Read the leaflet carefully before taking the medicine, 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 Ambroxol hydrochloride Fontane and what is it used for
• 2. Important information before taking Ambroxol hydrochloride Fontane
• 3. How to take Ambroxol hydrochloride Fontane
• 4. Possible side effects
• 5. How to store Ambroxol hydrochloride Fontane
• 6. Contents of the pack and other information

1. What is Ambroxol hydrochloride Fontane and what is it used for

Ambroxol hydrochloride Fontane 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 acute or chronic lung and bronchial diseases. Ambroxol hydrochloride Fontane is indicated for children from 2 years of age, adolescents and adults.
Thanks to the use of Ambroxol hydrochloride Fontane, thick mucus becomes more fluid and can be coughed up more easily.
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 Ambroxol hydrochloride Fontane

When not to take Ambroxol hydrochloride Fontane

Warnings and precautions

Before starting to take Ambroxol hydrochloride Fontane, consult a doctor or pharmacist:

• Stevens-Johnson syndrome is a disease characterized by high fever and rash with blisters on the skin and mucous membranes.
• Life-threatening Lyell's syndrome is also known as toxic epidermal necrolysis. The symptoms of this syndrome are severe skin changes in the form of blisters, similar to those that occur in burns.

There have been reports of severe skin reactions associated with the use of ambroxol. If a rash occurs (including changes in mucous membranes, e.g. mouth, throat, nose, eyes, genitals), the use of Ambroxol hydrochloride Fontane should be discontinued and a doctor consulted immediately.

Children

In the case of persistent or recurrent cough in children aged 2 to 4 years, a doctor should be consulted before starting treatment.

Ambroxol hydrochloride Fontane and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Cough suppressants (antitussives)
When taking Ambroxol hydrochloride Fontane, do not use any medicines that suppress the cough reflex (so-called antitussives). The cough reflex is important as it allows you to cough up the thinned mucus and thus remove it from the lungs.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, Ambroxol hydrochloride Fontane should only be used if your doctor considers it necessary! It is not recommended to use Ambroxol hydrochloride Fontane, especially during the first trimester of pregnancy.
It has been observed that the active substance contained in Ambroxol hydrochloride Fontane passes into breast milk. It is not recommended to use Ambroxol hydrochloride Fontane during breastfeeding.
Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and using machines

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

Ambroxol hydrochloride Fontane contains sorbitol and benzoic acid

This medicine contains 1.75 g of sorbitol in each 5 ml measuring spoon of oral solution.
Sorbitol is a source of fructose. If the doctor has informed the patient (or child) of an intolerance to some sugars or if hereditary fructose intolerance (HFI) has been diagnosed, a rare genetic disorder in which the body cannot break down fructose, consult a doctor before taking the medicine.
Sorbitol may cause gastrointestinal disorders and may have a mild laxative effect.
This medicine contains 5.75 mg of benzoic acid in each 5 ml measuring spoon of oral solution.

3. How to take Ambroxol hydrochloride Fontane

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The following information applies if the doctor has not recommended a different use of Ambroxol hydrochloride Fontane. Follow the instructions for use of the medicine, as otherwise Ambroxol hydrochloride Fontane will not work properly!

Recommended dose:

Children aged 2 to 5 years:
½ measuring spoon, i.e. 2.5 ml of oral solution 3 times a day (which corresponds to 22.5 mg of ambroxol hydrochloride per day in three doses of 7.5 mg).
Children aged 6 to 12 years:
1 measuring spoon, i.e. 5 ml of oral solution 2 to 3 times a day (which corresponds to 30 to 45 mg of ambroxol hydrochloride per day in two to three doses of 15 mg).
Adolescents over 12 years of age and adults:
2 measuring spoons, each 5 ml of oral solution 3 times a day for the first 2 to 3 days (which corresponds to 90 mg of ambroxol hydrochloride per day in three doses of 30 mg), and then 2 measuring spoons, each 5 ml of oral solution 2 times a day (which corresponds to 60 mg of ambroxol hydrochloride per day in two doses of 30 mg).
Note:
In adults, the dose can be increased to 4 measuring spoons, each 5 ml of oral solution 2 times a day (which corresponds to 120 mg of ambroxol hydrochloride per day in two doses of 60 mg).

Method of administration

For oral use. Ambroxol hydrochloride Fontane should be taken after meals, using the enclosed measuring spoon.

Duration of use

Without consulting a doctor, Ambroxol hydrochloride Fontane 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 Ambroxol hydrochloride Fontane is too strong or too weak, consult a doctor or pharmacist.

Taking a higher dose of Ambroxol hydrochloride Fontane than recommended

Based on cases of accidental overdose and/or reports of improper use, symptoms corresponding to the known side effects of Ambroxol hydrochloride Fontane used in 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 Ambroxol hydrochloride Fontane

In case of a missed dose or use of a smaller dose of the medicine, take the next prescribed 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 medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Side effects

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

• Nausea
• Altered taste
• Feeling of numbness in the mouth and throat (hypoesthesia)

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

• Vomiting
• Dryness of the mucous membrane of the mouth
• Diarrhea
• Indigestion
• Abdominal pain
• Fever

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):

• Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane or submucosal tissue swelling) and itching
• Severe skin reactions (including polymorphic erythema, 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 any possible side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices and Biocidal 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
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 medicine.

5. How to store Ambroxol hydrochloride Fontane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage precautions.

Shelf life after first opening the bottle

Shelf life after first opening the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ambroxol hydrochloride Fontane contains

The active substance is ambroxol hydrochloride. 1 ml of oral solution contains 3 mg of ambroxol hydrochloride.
Each measuring spoon, i.e. 5 ml of oral solution, contains 15 mg of ambroxol hydrochloride.
The other excipients are: liquid sorbitol, non-crystallizing (E 420), benzoic acid (E 210), glycerol (85%), hydroxyethylcellulose, raspberry flavor, purified water (see section 2).

What Ambroxol hydrochloride Fontane looks like and contents of the pack

Clear, colorless to light brown oral solution with a raspberry flavor.
Ambroxol hydrochloride Fontane is available in a pack containing 100 ml of oral solution.
Not all pack sizes may be marketed.
The pack includes a polypropylene measuring spoon with a scale of 1.25 ml, 2.5 ml and 5 ml.

Marketing authorization holder

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
To obtain more detailed information, contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
Flavamed Hustensaft 15 mg/5 ml Lösung zum Einnehmen
Bulgaria
Флавамед за деца
Czech Republic
Flavamed 15 mg/5 ml perorální roztok
Estonia
Flavamed vaarikas
Finland
Flavamed 3 mg/ml oraaliliuos
Hungary
Flavamed 15 mg/5 ml belsőleges oldat
Latvia
Flavamed bērniem 15 mg/5 ml šķīdums iekšķīgai lietošanai
Lithuania
Flavamed 15 mg/5 ml geriamasis tirpalas
Poland
Ambroxol hydrochloride Fontane
Romania
Flavamed 15 mg/5 ml soluţie orală
Slovakia
Flavamed 15 mg/5 ml perorálny roztok
Slovenia
Flavamed 3 mg/ml peroralna raztopina
Date of last revision of the leaflet: 03/2023