Ambroxol dr. max

Package leaflet: Information for the patient

Ambroxol Dr. Max, 30 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before using this 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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days (3 days in children), or if you feel worse, consult your doctor.

Contents of the leaflet:

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

This medicine is used in acute and chronic respiratory tract diseases, such as acute bronchitis, laryngitis and tracheitis, and chronic conditions such as chronic bronchitis and chronic obstructive pulmonary disease (COPD).
Patients with acute respiratory diseases may use this medicine without consulting a doctor. Patients with chronic respiratory diseases should use this medicine only after consultation with a doctor.
Acute respiratory conditions are initially characterized by a dry, irritating cough and even a burning sensation in the chest due to bronchial inflammation, as well as hoarseness due to laryngitis. In the following stage, sticky mucus forms and is expectorated. Both types of cough—dry, irritating cough and productive (wet) cough with mucus expectoration—may occur in chronic respiratory diseases.
Ambroxol, the active substance in Ambroxol Dr. Max, increases mucus secretion in the respiratory tract, promotes the formation of pulmonary surfactant (a substance present on the inner surface of lung alveoli), and stimulates ciliary activity, facilitating mucus transport. These effects result in significant liquefaction of mucus, improved mucus transport and clearance (mucociliary clearance), thereby facilitating expectoration and relieving cough.
Ambroxol Dr. Max is primarily used in adults, but may also be used by adolescents and children above 1 year of age. Ambroxol Dr. Max may be administered to children under 12 years of age only upon prior recommendation by a physician.
If there is no improvement after 5 days (3 days in children), or if you feel worse, consult your doctor.

2. Important information before using Ambroxol Dr. Max

When not to use Ambroxol Dr. Max

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

Warnings and precautions
Before starting treatment with Ambroxol Dr. Max, consult a doctor or pharmacist:

• if the patient has impaired kidney function or severe liver disease,
• if the patient has peptic ulcer disease of the stomach or duodenum,
• if the patient suffers from a rare bronchial disorder with increased mucus production (e.g. primary ciliary dyskinesia).

Severe skin reactions have been reported with the use of ambroxol hydrochloride.
If a rash occurs (including lesions of mucous membranes, e.g. in the mouth, throat, nose, eyes,
genital organs), discontinue use of Ambroxol Dr. Max immediately and contact a doctor
without delay.
Ambroxol Dr. Max and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
Concomitant use of Ambroxol Dr. Max with antibiotics (amoxicillin, cefuroxime,
erythromycin) increases antibiotic concentrations in lung tissue, which may be a beneficial effect.
Concomitant use of Ambroxol Dr. Max with antitussive agents (e.g. codeine) is not
recommended, as these drugs may impair the expectoration of liquefied mucus.
No clinically significant adverse interactions with other medicines have been demonstrated.
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.
Use of Ambroxol Dr. Max syrup is not recommended during pregnancy, especially during the first
three months of pregnancy.
Use of Ambroxol Dr. Max is not recommended during breastfeeding, as ambroxol hydrochloride is excreted into breast milk.
Driving and operating machinery
Based on post-marketing data, there is no evidence of an effect of Ambroxol Dr. Max on the ability to drive or operate machinery. No studies have been conducted to evaluate the effect on the ability to drive and operate machinery.
Ambroxol Dr. Max contains sorbitol
This medicine contains 3500 mg of sorbitol in each 10 ml of syrup, equivalent to 350 mg/ml.
The maximum recommended daily dose (20 ml) contains 7 g of sorbitol. Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to the 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 each 10 ml of syrup, equivalent 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, meaning 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 advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Unless otherwise directed by a physician, the recommended dose is:

• Adults and adolescents over 12 years of age: 5 ml three times daily. Efficacy may be enhanced by administering 10 ml of syrup twice daily.

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

• Children aged 6–12 years: 2.5 ml two to three times daily
• Children aged 2–5 years: 1.25 ml three times daily
• Children aged 1–2 years: 1.25 ml twice daily

In chronic conditions, the dose should be determined by the physician according to the severity of the disease.
To measure the correct amount of the medicinal product, use the oral syringe provided in the package.
Administration method:
1

1.

1. Press down the child-resistant safety cap (1) and unscrew it counterclockwise (2).

2. Insert the dosing syringe into the neck of the bottle.

3. Invert the bottle with the dosing syringe upside down (180°). Then pull the plunger of the dosing syringe downward to draw up the required volume according to the markings on the syringe (ml).

4. Return the bottle to an upright position and remove the dosing syringe.

The use of another available strength (15 mg/5 ml) of Ambroxol Dr.Max syrup by adults or children is also permitted.
Ambroxol Dr.Max syrup should be taken orally with an adequate amount of liquid. It may be taken independently of meals.
Adequate fluid intake during treatment supports the mucolytic action of ambroxol hydrochloride (dissolving 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 symptoms of acute respiratory tract disease do not improve or worsen within 5 days (within 3 days in children), medical advice must be sought.
Do not take the medicine for longer than 10 days without consulting a doctor.
Long-term use of Ambroxol Dr.Max in chronic respiratory diseases is possible only after consultation with a physician.

Use of a higher than recommended dose of Ambroxol Dr.Max
If a higher than recommended dose of Ambroxol Dr.Max has been taken, consult a doctor or pharmacist. Specific symptoms of overdose have not been observed in humans so far. Based on cases of accidental overdose and/or reports of improper use, symptoms corresponding to the known adverse effects of Ambroxol Dr.Max administered at recommended doses have been observed, which may require symptomatic treatment.

Missed dose of Ambroxol Dr.Max
If a dose has been missed, take it as soon as possible unless the time for the next dose is approaching.
If this is the case, skip the missed dose and take the next dose at the usual time. Do not use a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions: may occur in less than 1 in 10 people

• taste disturbances
• sensation of numbness in the throat
• nausea
• numbness of the lips and tongue.

Uncommon adverse reactions: may occur in less than 1 in 100 people

• diarrhoea
• vomiting
• indigestion
• dryness of the oral mucosa
• abdominal pain.

Rare adverse reactions: may occur in less than 1 in 1,000 people

• hypersensitivity reactions
• rash
• urticaria.

Adverse reactions with unknown frequency: frequency cannot be determined from available data

• anaphylactic reactions, including anaphylactic shock (a life-threatening allergic reaction), angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissue) and pruritus (itching of the skin)
• severe skin-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis)
• dry throat.

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

5. How to store Ambroxol Dr.Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
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 Dr. Max contains

• The active substance is ambroxol hydrochloride: 6 mg per 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 odor.
Ambroxol Dr. Max syrup is packed in an amber glass bottle with child-resistant closure, sealed with a screw cap, and placed in a cardboard box. Each package contains an oral plastic syringe.
Bottle sizes: 100 ml, 200 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in 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