Ambroxol Dr.max

Leaflet attached to the packaging: patient information

Ambroxol Dr. Max, 15 mg/5 ml, syrup

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 this 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days (3 days in children) there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Ambroxol Dr. Max and what is it used for
• 2. Important information before taking Ambroxol Dr. Max
• 3. How to take Ambroxol Dr. Max
• 4. Possible side effects
• 5. How to store Ambroxol Dr. Max
• 6. Contents of the packaging and other information

1. What is Ambroxol Dr. Max and what is it used for

This medicine is used for acute and chronic respiratory diseases, such as: acute recurring bronchitis, laryngitis and tracheitis, and chronic diseases such as: chronic bronchitis and chronic obstructive pulmonary disease.
Patients with acute respiratory disease may take the medicine without consulting a doctor. Patients with chronic respiratory diseases may take this medicine for long-term treatment only after consulting a doctor.
Initially, acute diseases are usually accompanied by a dry, irritating cough, and even a burning sensation in the chest due to bronchitis, as well as hoarseness in the larynx. In the next stage, a wet mucus forms and its expectoration occurs. Both types of cough can occur in chronic diseases - dry, irritating cough and productive cough (with mucus expectoration).
Ambroxol, the active substance of Ambroxol Dr. Max, increases mucus secretion in the respiratory tract, causes the formation of pulmonary surfactant (a substance found on the inner wall of the alveoli) and stimulates the activity of cilia, ensuring mucus transport. These actions cause significant thinning, better transport, and secretion of mucus (mucociliary clearance), making expectoration easier and relieving cough.
Ambroxol Dr. Max is used to treat children under 12 years of age, but it can also be used by adults and adolescents. Ambroxol Dr. Max may be administered to children under 2 years of age only after a doctor's recommendation.
If after 5 days (3 days in children) there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Ambroxol Dr. Max

When not to take Ambroxol Dr. Max

• 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 Ambroxol Dr. Max, the patient should discuss it with their doctor or pharmacist:

• if the cough has lasted for a longer period,
• if the patient has asthma or is experiencing acute asthma attacks,
• if the patient has liver or kidney function disorders,
• if the patient has stomach or duodenal ulcers.

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

Ambroxol Dr. Max 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.
Taking Ambroxol Dr. Max with antibiotics (amoxicillin, cefuroxime, erythromycin) increases the concentration of antibiotics in the lung tissue, which may be a desirable effect.
Concomitant use of Ambroxol Dr. Max with cough suppressants (e.g., codeine) is not recommended, as these medicines weaken the expectoration of thinned mucus, which can lead to serious respiratory obstruction.
No significant clinically relevant adverse interactions with other medicines have been found.

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.
Ambroxol Dr. Max, syrup is not recommended during pregnancy, especially during the first 3 months of pregnancy.
Ambroxol Dr. Max is not recommended during breastfeeding, as ambroxol passes into breast milk.

Driving and using machines

Ambroxol Dr. Max has no influence or negligible influence on the ability to drive and use machines.

Ambroxol Dr. Max contains sorbitol

This medicine contains 3500 mg of sorbitol in every 10 ml of syrup, which corresponds to 350 mg/ml.
The maximum recommended daily dose (30 ml) contains 10.5 g of sorbitol. Sorbitol is a source of fructose.
If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease 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 have a mild laxative effect.

Ambroxol Dr. Max contains sodium benzoate

This medicine contains 15 mg of sodium benzoate in every 10 ml of syrup, which corresponds to 1.5 mg/ml.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

Ambroxol Dr. Max contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Ambroxol Dr. Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose:

• Adults and adolescents over 12 years: 10 ml 3 times a day
• Children 6-12 years: 5 ml 2-3 times a day
• Children 2-5 years: 2.5 ml 3 times a day
• Children under 2 years: 2.5 ml 2 times a day

To measure the correct amount of the medicinal product, the patient should use the measuring cup provided with the packaging.

Method of administration:

1.

• 1. Press the plastic child-resistant cap down (1) and unscrew it in the opposite direction of the clock hands (2).

• 2. Insert the measuring cup into the bottle neck.

• 3. Turn the bottle with the measuring cup upside down (180°). Then pull the plunger of the measuring cup down and draw the required volume according to the scale on the measuring cup (ml).

• 4. Turn the bottle back to its original position and pull the measuring cup out.

Ambroxol Dr. Max may be administered to children under 2 years of age only after a doctor's recommendation.
Ambroxol Dr. Max, syrup should be taken orally only.
Ambroxol Dr. Max, syrup can be taken regardless of meals. It is recommended to drink a glass of water after taking the medicine and to drink plenty of fluids throughout the day.
The duration of treatment with Ambroxol Dr. Max is determined individually depending on the indication and type of disease. However, if the symptoms of acute respiratory disease do not improve or worsen within 5 days (within 3 days in children), the patient should consult a doctor.
The medicine should not be taken without consulting a doctor for a period longer than 10 days.
Long-term use of Ambroxol Dr. Max in chronic respiratory diseases is possible only after consulting a doctor.

Overdose of Ambroxol Dr. Max

In case of taking a higher dose of Ambroxol Dr. Max than recommended, the patient should consult their doctor or pharmacist. No specific symptoms of overdose have been observed in humans to date. Based on cases of accidental overdose and/or reports of improper use, symptoms corresponding to the known adverse reactions of Ambroxol Dr. Max at recommended doses have been observed, which may require symptomatic treatment.

Missed dose of Ambroxol Dr. Max

If a dose of Ambroxol Dr. Max is missed, the patient should take it as soon as possible, unless it is almost time for the next dose.
If this happens, the patient should skip the missed dose and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ambroxol Dr. Max can cause side effects, although not everybody gets them.
Common side effects:may occur in less than 1 in 10 people

• taste disorders
• feeling of numbness in the throat
• nausea
• numbness of the mouth and tongue.

Uncommon side effects:may occur in less than 1 in 100 people

• diarrhea
• vomiting
• indigestion
• dryness of the mucous membranes of the mouth
• abdominal pain.

Rare side effects:may occur in less than 1 in 1,000 people

• hypersensitivity reactions
• rash
• hives.

Unknown frequency of adverse reactions: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 itching (skin pruritus)
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 medicine.

5. How to store Ambroxol Dr. Max

The medicine should be stored out of 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 stated.
There are no special precautions for storage.
Shelf life after first opening 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. Contents of the packaging and other information

What Ambroxol Dr. Max contains

• The active substance of Ambroxol Dr. Max is ambroxol hydrochloride: 3 mg in 1 ml of syrup.
• The other ingredients (excipients) are: sodium benzoate (E 211), sorbitol (E 420), sucralose, hydroxyethylcellulose, citric acid monohydrate (E 330), strawberry flavor 501 440 T (consisting of propylene glycol and flavoring substances) and purified water.

What Ambroxol Dr. Max looks like and what the pack contains

Ambroxol Dr. Max is a colorless or light yellow liquid with a strawberry flavor.
Ambroxol Dr. Max syrup is packaged in an orange glass bottle with a child-resistant cap, closed with a cap in a cardboard box. Each package contains a plastic oral measuring cup.
Bottle sizes: 100 ml, 200 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

Balkanpharma – Troyan AD
1 Krayrechna Str.
5600 Troyan
Bulgaria

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

Czech Republic
Ambroxol Dr.Max 15 mg/5 ml
Poland
Ambroxol Dr.Max
Slovakia
Ambroxol Dr.Max 15 mg/5 ml syrup

Date of last revision of the leaflet: 04/2025