Ambrosan

Package Leaflet: Information for the User

AMBROSAN

30 mg, tablets

ambroxol hydrochloride

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Ambrosan and what is it used for

Ambroxol hydrochloride, the active substance of Ambrosan, increases the secretion of mucus in the respiratory tract. It also stimulates the production of pulmonary surfactant (a substance that facilitates lung expansion) and the function of the cilia of the respiratory tract epithelium. This results in increased mucus transport, which facilitates expectoration and alleviates cough.
Indications for use
The medicine is used in patients with acute and chronic lung and bronchial diseases, characterized by impaired mucus secretion and its transport.

2. Important information before taking Ambrosan

When not to take Ambrosan:

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

Warnings and precautions

Before taking Ambrosan, discuss it with your doctor or pharmacist:

• If you have stomach or duodenal ulcers.
• If you have kidney function disorders or severe liver failure, you should consult a doctor before taking Ambrosan.
• Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including changes in mucous membranes, e.g., mouth, throat, nose, eyes, genitals), you should stop taking Ambrosan and contact your doctor immediately.

Ambrosan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretion and sputum.
Ambrosan should not be taken simultaneously with cough suppressants (e.g., codeine), as this may lead to dangerous accumulation of bronchial secretions due to weakened cough reflex. Cough suppressants, by inhibiting the cough reflex, make it difficult to expectorate liquefied mucus.
No significant clinically relevant adverse interactions with other medicines have been found.

Ambrosan with food and drink

Tablets can be taken with or without food, with a large amount of liquid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Ambrosan is not recommended during pregnancy, especially during the first three months of pregnancy.
Ambrosan is not recommended for breastfeeding women, as ambroxol hydrochloride passes into breast milk.
Non-clinical studies have not shown any direct or indirect harmful effects of the medicine on fertility. There are no clinical studies on the effects of the medicine on fertility.

Driving and using machines

There is no evidence that the medicine affects the ability to drive or operate machines.
No studies have been conducted on the effects of the medicine on the ability to drive or operate machines.

Ambrosan contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
One tablet contains 125 mg of lactose monohydrate, which corresponds to 500 mg of lactose monohydrate in the maximum recommended daily dose of the medicine, i.e., 4 tablets. Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicine.

3. How to take Ambrosan

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years: 1 tablet three times a day.
The effect of the medicine may be increased after taking 2 tablets of Ambrosan twice a day.
Use in children
Children from 6 to 12 years: half a tablet two or three times a day.
The tablet can be divided into equal doses.
Tablets can be taken with or without food, with a large amount of liquid.
The medicine should not be taken before bedtime.

If during the use of Ambrosan in acute respiratory diseases there is no alleviation of symptoms, you should consult your doctor.

If after 4 to 5 days there is no improvement or you feel worse, you should contact your doctor.

Overdose of Ambrosan

In case of overdose, consult your doctor or pharmacist.
No specific symptoms of overdose have been observed in humans to date. Based on cases of unintentional overdose and/or reports of improper use, symptoms corresponding to the known side effects of the medicine at recommended doses have been observed, which may require symptomatic treatment.

Missed dose of Ambrosan

If you miss a dose, take it as soon as possible.
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping Ambrosan

Ambrosan should be taken only when necessary, and its use should be stopped after the symptoms have subsided.
If you have any further doubts 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 gets them.

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

• nausea

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

• diarrhea
• vomiting
• indigestion
• abdominal pain

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 edema) and itching
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

If you experience any of the above side effects, you should stop taking Ambrosan and seek medical attention immediately.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 the medicine.

5. How to store Ambrosan

Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
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 Ambrosan contains

• The active substance is ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, magnesium stearate, copovidone, microcrystalline cellulose.

What Ambrosan looks like and contents of the pack

Ambrosan is available in the form of almost white, smooth, flat tablets with a dividing line on one side and beveled edges. The tablet can be divided into equal doses.
PVC/Al blisters containing 10 tablets, in a cardboard box.
Pack sizes:

• 20 tablets (2 blisters of 10 tablets) in a cardboard box,
• 30 tablets (3 blisters of 10 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s.
Telčská 377/1, Michle
140 00 Prague 4
Czech Republic
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
PRO.MED.PL Sp. z o.o.
e-mail: [email protected]

Date of last revision of the package leaflet: