Ambroksol Apteo Med

Leaflet attached to the packaging: patient information

Ambroksol APTEO MED, 15 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 the patient leaflet or as directed by the doctor.

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

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. Contents of the packaging and other information

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

Ambroxol hydrochloride, the active substance of Ambroksol APTEO MED, increases the secretion of mucus in the respiratory tract, making it easier to cough up and relieving cough. Ambroksol APTEO MED syrup is indicated for use in acute and chronic respiratory diseases characterized by the accumulation of thick, mucous secretions and difficulty in coughing them up.

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 starting treatment with Ambroksol APTEO MED, the doctor should be consulted.

• If the patient has kidney or liver disease, they should not take Ambroksol APTEO MED without consulting a doctor.
• If after 4 to 5 days of taking the medicine, there is no reduction in cough severity and improvement in the patient's condition, the doctor should be consulted.
• If the patient has ciliary transport disorders in the bronchi and a large amount of secretions (e.g., in the rare primary ciliary dyskinesia syndrome) due to the possibility of bronchial secretion accumulation, the doctor should be consulted.
• If the patient has a history of stomach or duodenal ulcer, they should consult a doctor before taking Ambroksol APTEO MED, as mucolytic agents may damage the gastric mucosa.

Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in the mucous membranes, such as the mouth, throat, nose, eyes, genitals), the use of Ambroksol APTEO MED should be discontinued and the doctor should be consulted immediately.

Ambroksol APTEO MED and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Concomitant administration of ambroxol and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) leads to an increase in the concentration of the antibiotic in the lung tissue.
• Concomitant administration of ambroxol and cough suppressants (e.g., codeine) is not recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine. The use of Ambroksol APTEO MED is not recommended during pregnancy, especially during the first three months of pregnancy. The use of Ambroksol APTEO MED is not recommended in breastfeeding women, as ambroxol hydrochloride passes into breast milk.

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 effect of the medicine on the ability to drive or operate machines.

Ambroksol APTEO MED contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol

• 5 ml of Ambroksol APTEO MED syrup contains 1.75 g of sorbitol. The caloric value of sorbitol is 2.6 kcal/g. If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine. The medicine may have a mild laxative effect.
• Ambroksol APTEO MED contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late reactions).
• Ambroksol APTEO MED syrup also contains propylene glycol, which may cause symptoms similar to those after alcohol consumption.

3. How to take Ambroksol APTEO MED

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. The syrup should be taken orally, during meals. Without consulting a doctor, the medicine should not be taken for more than 4 to 5 days.

Use in adults and children over 12 years of age

Treatment of acute diseases or initial treatment of chronic diseases should be started with a dose of 60 mg (20 ml of syrup) 2 times a day for the first 2 to 3 days, and then the dose can be reduced by half to 30 mg (10 ml) 2 times a day.

Use in children

• from 6 to 12 years of age - 5 ml 2 to 3 times a day;
• from 2 to 6 years of age - 2.5 ml 3 times a day;
• from 1 to 2 years of age - 2.5 ml 2 times a day;
• in the first year of life - the medicine is not recommended; the medicine should not be used in children without consulting a doctor.

Use of a higher dose of Ambroksol APTEO MED than recommended

In case of taking a higher dose of Ambroksol APTEO MED than recommended, the doctor should be consulted.

Missing a dose of Ambroksol APTEO MED

In case of missing a dose, it should be taken as soon as possible. If it is close to the time of taking the next dose, it should be skipped and the next dose taken at the usual time. A double dose should not be taken to make up for the missed dose. The medicine should be continued according to the prescribed schedule. In case of any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Ambroksol APTEO MED can cause side effects, although not everybody gets them. During treatment with Ambroksol APTEO MED, the following side effects may occur:
Frequent (may occur in up to 1 in 10 people):

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

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

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

Rare (may occur in up to 1 in 1,000 people):

• allergic reactions,
• rash, urticaria.

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

• dryness in the throat,
• anaphylactic reactions, including anaphylactic shock (an allergic reaction that can cause, among other things, swelling of the face, lips, mouth, and/or throat, which can cause difficulty breathing and swallowing), angioedema (a rapidly progressing swelling of the skin, subcutaneous tissue, mucous membrane, or submucosal tissue) and itching,
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

If any of the side effects worsen or any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor should be informed. 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

This medicine does not require special precautions for storage temperature. It should be stored in the original packaging to protect it from light. The medicine should be kept out of sight and reach of children. The medicine should not be used after the expiry date stated on the label after EXP. The expiry date refers to the last day of the specified month. The shelf life after opening the bottle is 6 months. Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Ambroksol APTEO MED contains

• The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: sorbitol (E 420), citric acid monohydrate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), glycerol, propylene glycol, sodium saccharin (E 954), raspberry flavor*, purified water. *flavor composition: lactic acid, triacetin, vanillin, p-hydroxybenzyl acetone, rose oil.

What Ambroksol APTEO MED looks like and what the packaging contains

Ambroksol APTEO MED syrup is a clear, pale yellow liquid with a slight brown tint and a raspberry flavor. The packaging consists of a brown glass bottle with a polyethylene or aluminum cap with a guarantee seal, or a brown PET bottle with a polyethylene cap with a guarantee seal, placed in a cardboard box with a measuring cup made of PP. The bottle contains 100 ml of syrup.

Marketing authorization holder

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

Manufacturer

SOPHARMA AD
16, Iliensko Shosse Str.
1220 Sofia, Bulgaria
To obtain more detailed information, the marketing authorization holder should be contacted.
Date of last revision of the leaflet: