Ambroxol Dr.max

Leaflet attached to the packaging: patient information

Ambroxol Dr. Max, 30 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 those 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 pack and other information

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

This medicine is used for acute and chronic respiratory tract diseases. Such as: acute 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 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, and hoarseness in the larynx. In the next stage, a sticky 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 it easier to expectorate and relieving cough.
Ambroxol Dr. Max is used to treat adults, but it can also be used by adolescents and children over 1 year of age. Ambroxol Dr. Max may be given to children under 12 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 patient has kidney function disorders or severe liver disease,
• if the patient has stomach or duodenal ulcer disease,
• if the patient has a rare bronchial disease with increased mucus production (e.g., primary ciliary dyskinesia).

Severe skin reactions associated with the use of ambroxol hydrochloride have been reported.
If a rash occurs (including changes in mucous membranes, e.g., mouth, throat, nose, eyes, genitals), 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 lung tissue, which may be a desirable effect.
Taking Ambroxol Dr. Max with cough medicines (e.g., codeine) is not recommended, as these medicines weaken the expectoration of thinned mucus.
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 should not be used during pregnancy, especially during the first 3 months of pregnancy.
Ambroxol Dr. Max should not be used during breastfeeding, as ambroxol hydrochloride passes into breast milk.

Driving and using machines

Based on the data obtained after the introduction of Ambroxol Dr. Max, there is no evidence of an impact on the ability to drive vehicles and operate machinery. No studies have been conducted to assess the impact on the ability to drive vehicles and operate machinery.

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 (20 ml) contains 7 g of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been found to have intolerance to some sugars or has been found to have hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient 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.

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).

• 4. week 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. If in doubt, the patient should consult their doctor or pharmacist.
Unless otherwise prescribed by a doctor, the recommended dose is:

• Adults and adolescents over 12 years of age: 5 ml 3 times a day. Efficacy can be increased by administering 10 ml of syrup 2 times a day.

Ambroxol Dr. Max (30 mg/5 ml) can be given to children under 12 years of age only on the advice of a doctor. In such cases, the following dosing schedule is recommended:

• Children 6-12 years of age: 2.5 ml 2-3 times a day
• Children 2-5 years of age: 1.25 ml 3 times a day
• Children 1-2 years of age: 1.25 ml 2 times a day

In chronic diseases, the dose is determined by the doctor based on the severity of the disease.
To measure the correct amount of the medicinal product, the measuring cup attached to the packaging should be used.

Method of administration:

1.

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

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

• 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 upright and pull the measuring cup out.

It is also allowed to use a different available strength (15 mg/5 ml) of Ambroxol Dr. Max syrup by adults or children.
Ambroxol Dr. Max syrup should be taken orally with a sufficient amount of liquid. It can be taken regardless of meals.
Adequate fluid intake during treatment supports the mucolytic effect of ambroxol hydrochloride (thinning of mucus and facilitating its expectoration).
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.

Using a higher dose of Ambroxol Dr. Max than recommended

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 so far in humans. Based on cases of accidental overdose and/or reports of improper use, symptoms corresponding to the known side effects of Ambroxol Dr. Max taken in recommended doses have been observed, which may require symptomatic treatment.

Missing a dose of Ambroxol Dr. Max

If a dose is missed, the patient should take it as soon as possible unless it is almost time for the next dose.
If this happens, the missed dose should be skipped and the next dose taken at the usual time. 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, this medicine 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 membrane of the mouth
• abdominal pain.

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

• allergic reactions
• rash
• hives.

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

• anaphylactic reactions, including anaphylactic shock (a life-threatening allergic reaction), angioedema (a rapidly spreading skin, subcutaneous tissue, mucous membrane, or submucosal tissue swelling), and pruritus (itching of the skin)
• 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 side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this 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. 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 pack and other information

What Ambroxol Dr. Max contains

• The active substance of the medicine is ambroxol hydrochloride: 6 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 contents of the pack

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 closure, 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 30 mg/5 ml
Poland
Ambroxol Dr.Max
Slovakia
Ambroxol Dr.Max 30 mg/5 ml syrup

Date of last revision of the leaflet: 04/2025