Ambrolitin max

Leaflet attached to the packaging: patient information

Ambrolytin max, 30 mg, tablets

Ambroxol hydrochloride

Please read the contents of 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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ambrolytin max and what is it used for
• 2. Important information before taking Ambrolytin max
• 3. How to take Ambrolytin max
• 4. Possible side effects
• 5. How to store Ambrolytin max
• 6. Package contents and other information

1. What is Ambrolytin max and what is it used for

Ambrolytin max tablets contain the active substance ambroxol hydrochloride, which thins the thick secretions in the bronchi, formed in various respiratory diseases. Ambrolytin max tablets are used in children over 6 years of age, adolescents, and adults to facilitate expectoration and alleviate cough in acute and chronic bronchial and pulmonary diseases, in which thick secretions are formed in the airways. If after 4 to 5 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Ambrolytin max

When not to take Ambrolytin max

• in children under 6 years of age.

Warnings and precautions

Before taking Ambrolytin max, the patient should discuss it with their doctor or pharmacist:

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 Ambrolytin max and immediately consult their doctor.

Ambrolytin max and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Concurrent use of Ambrolytin max and cough suppressants is not recommended. No clinically significant interactions have been reported during concurrent use of other medicines.

Pregnancy and breastfeeding

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. Pregnancy: Ambrolytin max is not recommended during pregnancy, especially during the first three months. Breastfeeding: Ambrolytin max is not recommended for breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and using machines

Data obtained after the marketing authorization of the medicine do not indicate that it affects the ability to drive or operate machinery. No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery.

Ambrolytin max contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Ambrolytin 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: Adults1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then 1 tablet (30 mg ambroxol) 2 times a day. The daily dose can be increased to 2 tablets (60 mg ambroxol) 2 times a day. Adolescents over 12 years of age1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then 1 tablet (30 mg ambroxol) 2 times a day. Children from 6 to 12 years of agehalf a tablet (15 mg ambroxol) 2-3 times a day. This regimen is suitable for the treatment of acute respiratory disorders and initial treatment of chronic diseases for up to 14 days. The duration of treatment without consulting a doctor should not exceed 4-5 days. Ambrolytin max should be taken after meals, with a sufficient amount of liquid (e.g., water, tea, or fruit juice).

Taking a higher dose of Ambrolytin max than recommended

In case of taking a higher dose of Ambrolytin max than recommended, the patient should consult their doctor or pharmacist. No symptoms of overdose have been described in humans to date. The symptoms observed after accidental overdose or misuse are consistent with the known side effects of the recommended doses of Ambrolytin max and may require symptomatic treatment.

Missing a dose of Ambrolytin max

In case of missing a dose, the patient should take it as soon as possible. They should not take a double dose to make up for the missed dose. The patient should continue taking the medicine according to the recommended regimen. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ambrolytin max can cause side effects, although not everybody gets them. Frequent (may occur in less than 1 in 10 people):

• nausea

Uncommon (may occur in less than 1 in 100 people):

• vomiting, diarrhea, indigestion, abdominal pain.

Rare (may occur in less than 1 in 1,000 people):

• hypersensitivity reactions;
• rash, urticaria.

Unknown frequency (cannot be estimated from the available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membranes, or submucosal tissue swelling) and itching;
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ambrolytin max

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the packaging after the term "EXP". The expiry date refers to the last day of the month stated. The medicine should not be stored at temperatures above 25°C. 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. Package contents and other information

What Ambrolytin max contains

The active substance of the medicine is ambroxol hydrochloride. Each tablet contains 30 mg of ambroxol hydrochloride. The other ingredients are: lactose monohydrate; maize starch; colloidal anhydrous silica; magnesium stearate.

What Ambrolytin max looks like and what the package contains

Ambrolytin max is a white or almost white, round, flat tablet with a diameter of 9 mm, with a scored line on both sides. The tablet can be divided into equal doses. 10 (ten) tablets are packaged in PVC/Aluminum or PVC/PVdC/Aluminum blisters. One folding box contains 2 (two), 3 (three), or 5 (five) blisters and a patient leaflet. Not all pack sizes may be marketed.

Marketing authorization holder

Sopharma Warszawa Sp. z o. o. Al. Jerozolimskie 136, 02-305 Warsaw

Manufacturer

SOPHARMA AD 16, Iliensko Shosse str., 1220 Sofia, Bulgaria

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

Bulgaria: Амбролитин 30 mg таблетки Estonia: Ambrolytin Latvia: Ambrolytin 30 mg tabletes Poland: Ambrolytin max

Date of the last revision of the leaflet: