Ambroksol Apteo Med

Leaflet attached to the packaging: patient information

Ambroksol APTEO MED, 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 advised 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 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 Ambroksol APTEO MED and what is it used for
• 2. Important information before taking Ambroksol APTEO MED
• 3. How to take Ambroksol APTEO MED
• 4. Possible side effects
• 5. How to store Ambroksol APTEO MED
• 6. Package contents and other information

1. What is Ambroksol APTEO MED and what is it used for

Ambroksol APTEO MED syrup contains the active substance ambroxol hydrochloride, which thins the thick mucus in the bronchi, produced in various respiratory diseases. Ambroksol APTEO MED syrup is used in adults and adolescents over 12 years of age to facilitate expectoration and alleviate cough in acute and chronic bronchial and pulmonary diseases, in which thick mucus is produced in the airways. If after 4 to 5 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Ambroksol APTEO MED

When not to take Ambroksol APTEO MED

• 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 taking Ambroksol APTEO MED, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or severe liver function disorders.

There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. If a rash occurs (including changes in the mucous membranes, such as the mouth, throat, nose, eyes, genitals), the patient should stop taking Ambroksol APTEO MED and immediately consult a doctor.

Ambroksol APTEO MED 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. It is not recommended to take ambroxol hydrochloride and cough medicines at the same time. No clinically significant interactions have been reported during the 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: Ambroksol APTEO MED should not be taken during pregnancy, especially during the first three months of pregnancy. Breastfeeding: Ambroksol APTEO MED should not be taken by breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and using machines

Data obtained after the registration of the medicine do not indicate that it affects the ability to drive and use machines. No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Ambroksol APTEO MED contains sorbitol (E420), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), propylene glycol (E1520) and sodium

This medicine contains 1.75 g of sorbitolin 5 mL of syrup, which corresponds to 350 mg/mL. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine. The excipients methyl parahydroxybenzoate and propyl parahydroxybenzoatemay cause allergic reactions (possible late reactions). The medicine contains 100 mg of propylene glycolin 5 mL of syrup, which corresponds to 20 mg/mL. This medicine contains less than 1 mmol (23 mg) of sodium per 5 mL of syrup, which means the medicine is considered "sodium-free".

3. How to take Ambroksol APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose is: Adults and adolescents over 12 years of age:5 mL of syrup three times a day (which corresponds to 90 mg of ambroxol hydrochloride per day) for the first 2 to 3 days, and then 5 mL of syrup twice a day (which corresponds to 60 mg of ambroxol hydrochloride per day). If necessary, in adults, the dose of ambroxol hydrochloride can be increased to 60 mg twice a day (which corresponds to 120 mg of ambroxol hydrochloride per day). This regimen is suitable for the treatment of acute respiratory disorders and initial treatment of chronic diseases. If symptoms do not improve within 4-5 days of treatment for acute respiratory diseases, the patient should consult a doctor. Elderly patientsThe dosage in elderly patients does not differ from that in adults. Patients with liver or kidney function disordersBefore taking this medicine in patients with liver or kidney function disorders, they should consult their doctor. Ambroksol APTEO MED can be taken during or outside of meals.

Taking a higher dose of Ambroksol APTEO MED than recommended

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

Missing a dose of Ambroksol APTEO MED

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 schedule. If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ambroksol APTEO MED can cause side effects, although not everybody gets them. Common (may occur in less than 1 in 10 people):

• taste disorders, nausea, weakness of sensation in the mouth, tongue, and throat.

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

• dry mouth, vomiting, diarrhea, indigestion, abdominal pain.

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

• hypersensitivity reactions;
• rash, urticaria.

Frequency not known (cannot be estimated from the available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissue) and itching;
• 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 those not listed in the 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 collected on the safety of the medicine.

5. How to store Ambroksol APTEO MED

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the specified month. This medicine does not require special precautions for storage temperature. Store in the original packaging to protect from light. 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. Package contents and other information

What Ambroksol APTEO MED contains

• The active substance of the medicine is ambroxol hydrochloride. 1 mL contains 6 mg of ambroxol hydrochloride. 5 mL of syrup contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol, propylene glycol, sodium saccharin, citric acid monohydrate, Tutti Frutti flavor (flavoring part: orange oil, ethyl butyrate, isoamyl acetate, isoamyl propionate, vanillin; all-rac-α-tocopherol), purified water.

What Ambroksol APTEO MED looks like and what the package contains

Ambroksol APTEO MED syrup is a clear, colorless syrup with a specific odor, pH 2.20-3.20. The syrup is available in 120 mL in a brown glass bottle (type III) with a capacity of 125 mL with an LDPE connector and a PP closure that is child-resistant. orThe syrup is available in 200 mL in a brown glass bottle (type III) with a capacity of 200 mL with an LDPE connector and a PP closure that is child-resistant. 1 (one) bottle with a PP measuring cup with a scale of 2.5 mL, 3 mL, 5 mL, 7.5 mL, 10 mL, 12.5 mL, 15 mL, and 20 mL, and a leaflet are placed in a cardboard box.

Marketing authorization holder

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw

Manufacturer

SOPHARMA AD Iliensko Shosse Str.16, 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/5ml сироп Estonia: Ambrolytin Latvia: Ambrolytin 30 mg/5 ml sīrups Poland: Ambroksol APTEO MED Lithuania: Amrex 30mg/5ml sirupas

Date of last revision of the leaflet: February 2024