AMBROXOL HYDROCHLORIDE FONTANE

Package leaflet: Information for the patient

Ambroxoli hydrochloridum Fontane, 15 mg/5 ml, oral solution
For children from two years of age, adolescents and adults
Ambroxoli hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 4 to 5 days, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

1. What Ambroxoli hydrochloridum Fontane is and what it is used for
2. Important information before taking Ambroxoli hydrochloridum Fontane
3. How to take Ambroxoli hydrochloridum Fontane
4. Possible side effects
5. How to store Ambroxoli hydrochloridum Fontane
6. Contents of the pack and other information

1. What Ambroxoli hydrochloridum Fontane is and what it is used for

Ambroxoli hydrochloridum Fontane contains the active substance ambroxol hydrochloride and
belongs to the therapeutic group of cough and cold remedies, specifically mucolytic agents. Ambroxol
hydrochloride is used in the treatment of productive cough associated with acute or chronic
pulmonary and bronchial diseases. Ambroxoli hydrochloridum Fontane is indicated for children from
two years of age, adolescents and adults.
With the use of Ambroxoli hydrochloridum Fontane, thick mucus becomes more watery and easier to cough up.
If there is no improvement after 4 to 5 days, or if the patient feels worse, contact a doctor.

2. Important information before using Ambroxoli hydrochloridum Fontane

When not to use Ambroxoli hydrochloridum Fontane

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6). Ambroxoli hydrochloridum Fontane must not be used in children under 2 years of age.

Warnings and precautions
Before starting to take Ambroxoli hydrochloridum Fontane, consult a
doctor or pharmacist:

• if the patient has previously experienced very severe skin allergic reactions (Stevens-Johnson syndrome, Lyell's syndrome).
• Stevens-Johnson syndrome is a condition characterized by high fever and blistering rash on the skin and mucous membranes.
• Life-threatening Lyell's syndrome is also known as toxic epidermal necrolysis. Symptoms of this syndrome include severe skin lesions with blistering, similar to those seen in burns.

Severe skin reactions associated with ambroxol use have been reported. If a rash occurs (including lesions on mucous membranes, e.g. in the mouth, throat, nose, eyes, or genital organs), treatment with Ambroxoli hydrochloridum Fontane must be discontinued immediately and medical advice must be sought without delay.

• if the patient has impaired kidney function or severe liver disease. In such cases, special caution is required when using Ambroxoli hydrochloridum Fontane (i.e. extend the intervals between doses or use a lower dose – only after consultation with a doctor). In severe kidney impairment, accumulation (build-up) of metabolites of the active substance in Ambroxoli hydrochloridum Fontane may occur.
• if the patient has a rare bronchial disorder associated with increased mucus production (e.g. immotile cilia syndrome). In such cases, mucus cannot be effectively cleared from the lungs. Ambroxoli hydrochloridum Fontane should only be used under medical supervision in these patients.
• if the patient has histamine intolerance. Prolonged use should be avoided, as the active substance in Ambroxoli hydrochloridum Fontane affects histamine metabolism and may lead to symptoms of intolerance (e.g. headache, rhinitis, itching).
• if the patient has a history of gastric or duodenal ulcer disease, consult a doctor on how to use Ambroxoli hydrochloridum Fontane, as mucolytic agents may damage the gastric mucosa. Consult a doctor before using Ambroxoli hydrochloridum Fontane.

Children
In children aged 2 to 4 years with persistent or recurrent cough, consult a doctor before starting treatment.
Ambroxoli hydrochloridum Fontane and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Cough suppressants (antitussive medicines)
Do not use any medicines that suppress the cough reflex (so-called antitussives) while taking Ambroxoli hydrochloridum Fontane. The cough reflex is important because it enables expectoration of liquefied mucus and thus its removal from the lungs.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Ambroxoli hydrochloridum Fontane should only be used during pregnancy or breastfeeding if clearly prescribed by a doctor. Use of Ambroxoli hydrochloridum Fontane is not recommended, especially during the first trimester of pregnancy.
It has been observed that the active substance in Ambroxoli hydrochloridum Fontane passes into breast milk. Use of Ambroxoli hydrochloridum Fontane is not recommended during breastfeeding.
Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and operating machinery
There are no data available on the effects on the ability to drive or operate machinery.
No studies have been conducted on the effects on the ability to drive or operate machinery.

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

3. How to use Ambroxoli hydrochloridum Fontane

This medicine should always be used according to the instructions provided in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The following information applies if your doctor has not advised otherwise regarding the use of Ambroxoli hydrochloridum Fontane. Follow the instructions carefully, as failure to do so may result in Ambroxoli hydrochloridum Fontane not working properly!

Recommended dosage:
Children aged 2 to 5 years:
½ measuring spoon, i.e. 2.5 ml of oral solution, 3 times daily (corresponding to 22.5 mg of ambroxol hydrochloride per day administered in three doses of 7.5 mg each).

Children aged 6 to 12 years:
1 measuring spoon, i.e. 5 ml of oral solution, 2 to 3 times daily (corresponding to 30 to 45 mg of ambroxol hydrochloride per day administered in two to three doses of 15 mg each).

Adolescents over 12 years of age and adults:
2 measuring spoons, each 5 ml of oral solution, 3 times daily for the first 2 to 3 days (corresponding to 90 mg of ambroxol hydrochloride per day administered in three doses of 30 mg each),
then 2 measuring spoons, each 5 ml of oral solution, 2 times daily (corresponding to 60 mg of ambroxol hydrochloride per day administered in two doses of 30 mg each).

Note:
In adults, the dose may be increased to 4 measuring spoons, each 5 ml of oral solution, twice daily (corresponding to 120 mg of ambroxol hydrochloride per day administered in two doses of 60 mg each).

Method of administration
For oral use. Ambroxoli hydrochloridum Fontane should be taken after meals, using the provided measuring spoon.

Duration of treatment
Ambroxoli hydrochloridum Fontane should not be used for longer than 4 to 5 days without consulting a doctor.
If symptoms do not improve or worsen after 4 to 5 days, consult a doctor immediately!
If you feel that the effect of Ambroxoli hydrochloridum Fontane is too strong or too weak, consult your doctor or pharmacist.

Overdose of Ambroxoli hydrochloridum Fontane
Based on cases of accidental overdose and (or) reports of improper use, symptoms observed were consistent with the known adverse effects of Ambroxoli hydrochloridum Fontane when used at recommended doses.
In case of overdose, contact a doctor who will initiate appropriate treatment depending on the symptoms presented.

Missed dose of Ambroxoli hydrochloridum Fontane
If you miss a dose or take an insufficient dose, take the next prescribed dose at the usual time.
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Side effects
Common (may affect up to 1 in 10 people):

• Nausea
• Altered taste
• Numbness sensation in the oral cavity and throat (paraesthesia)

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

• Vomiting
• Dryness of the oral mucosa
• Diarrhoea
• Dyspepsia
• Abdominal pain
• Fever

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 (rapid swelling of the skin, subcutaneous tissue, mucous membrane or submucosal tissues), and pruritus
• Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis)
• Dry throat

Reporting of side effects
If any side effects occur, including any possible side effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ambroxoli hydrochloridum Fontane

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and cardboard packaging, following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Shelf-life after first opening of the bottle
Shelf-life after first opening the bottle: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

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

What Ambroxoli hydrochloridum Fontane looks like and contents of the pack
Clear, colourless to light brown solution with a raspberry odour.
Ambroxoli hydrochloridum Fontane is available in a pack containing 100 ml of oral solution.
Not all pack sizes may be marketed.
The pack contains a polypropylene measuring spoon graduated at 1.25 ml, 2.5 ml and 5 ml.

Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.

This medicinal product is authorised 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 Ambroxoli hydrochloridum Fontane
Romania Flavamed 15 mg/5 ml soluţie orală
Slovakia Flavamed 15 mg/5 ml perorálny roztok
Slovenia Flavamed 3 mg/ml peroralna raztopina