Ambroxol apteo med

Package leaflet: Information for the patient

Ambroksol APTEO MED, 30 mg/5 mL, syrup
Ambroxol hydrochloride
Please read all of this leaflet carefully before taking the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet so that you can read it again if needed.
• If you need advice or further information, please 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 4 to 5 days, or if you feel worse, consult your doctor.

Table of contents

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

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

Ambroksol APTEO MED syrup contains the active substance ambroxol hydrochloride, which
thins thick mucus in the bronchi produced during various respiratory tract diseases.
Ambroksol APTEO MED syrup is used in adults and adolescents above 12 years of age to facilitate
expectoration and relieve cough in acute and chronic bronchial and lung diseases associated with
the production of thick mucus in the respiratory tract.
If there is no improvement after 4 to 5 days, or if you feel worse, consult your doctor.

2. Important information before taking Ambroksol APTEO MED

When not to use 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, consult a doctor or
pharmacist:

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

Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including lesions on mucous membranes, e.g. in the mouth, throat, nose, eyes, genital organs), treatment with Ambroksol APTEO MED must be discontinued and immediate medical advice must be sought.
Ambroksol APTEO MED and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.
Concomitant administration of ambroxol hydrochloride and antitussive (cough suppressant) medicines is not recommended.
No clinically significant adverse interactions have been reported with concomitant use of other medicines.
Pregnancy and breastfeeding
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.
Pregnancy
Use of Ambroksol APTEO MED is not recommended during pregnancy, especially during the first trimester.
Breastfeeding
Use of Ambroksol APTEO MED is not recommended in breastfeeding women, as ambroxol hydrochloride passes into breast milk.
Driving and operating machinery
Data obtained from post-marketing surveillance do not indicate any influence on the ability to drive or operate machinery.
No studies on the effect of the medicine on the ability to drive or operate machinery have been conducted.
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 sorbitol in 5 mL of syrup, equivalent to 350 mg/mL. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.
The excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed-type reactions).
The medicine contains 100 mg of propylene glycol in 5 mL of syrup, equivalent to 20 mg/mL.
This medicine contains less than 1 mmol (23 mg) of sodium per 5 mL of syrup, meaning the medicine is considered "sodium-free".

3. How to use Ambroksol APTEO MED

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dosage:
Adults and adolescents over 12 years of age:
5 mL of syrup three times daily (corresponding to 90 mg of ambroxol hydrochloride per day) for the first 2 to 3 days, followed by 5 mL of syrup twice daily (corresponding to 60 mg of ambroxol hydrochloride per day).
If necessary, in adults the dose of ambroxol hydrochloride may be increased to 60 mg twice daily (corresponding to 120 mg of ambroxol hydrochloride per day).
This dosing regimen is appropriate for the treatment of acute respiratory tract disorders and for initial treatment of chronic diseases.
If symptoms do not improve within 4–5 days during treatment of acute respiratory conditions, medical advice should be sought.
Elderly patients
Dosage in elderly patients does not differ from that in adults.
Patients with hepatic or renal impairment
Consult a doctor before using this medicine in patients with impaired liver or kidney function.
Ambroksol APTEO MED may be taken during meals or independently of meals.
Taking more Ambroksol APTEO MED than recommended
If more Ambroksol APTEO MED than recommended has been taken, consult a doctor or pharmacist. Symptoms of overdose have not been described in humans. Symptoms observed after accidental overdose or misuse are consistent with the known adverse effects following administration of recommended doses of Ambroksol APTEO MED and may require symptomatic treatment.
Missing a dose of Ambroksol APTEO MED
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose. Continue taking the medicine according to the recommended schedule.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Common (may affect less than 1 in 10 people):

• taste disturbances, nausea, reduced sensation in the oral cavity, tongue and throat.

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

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

Rare (may affect 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 developing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching;
• severe skin-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis);
• dry throat.

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

5. How to store Ambroksol APTEO MED

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation:
"EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect from light.
Shelf-life after first opening of 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Ambroksol APTEO MED contains

• The active substance 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 flavour (flavouring component: orange oil, ethyl butyrate, isoamyl acetate, isoamyl butyrate, vanillin; all-rac-α-tocopherol), purified water.

What Ambroksol APTEO MED looks like and contents of the pack
Ambroksol APTEO MED syrup is a clear, colourless syrup with a characteristic odour, pH 2.20–3.20.
The 120 mL syrup is available in a 125 mL amber glass bottle (type III) with an LDPE adapter and a child-resistant PP closure.
or
The 200 mL syrup is available in a 200 mL amber glass bottle (type III) with an LDPE adapter and a child-resistant PP closure.
One (1) bottle together with a PP measuring cup graduated at 2.5 mL, 3 mL, 5 mL, 7.5 mL, 10 mL, 12.5 mL, 15 mL and 20 mL, and the package leaflet are packed in a cardboard box.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland
Tel. 22 321 62 40

Manufacturer
SOPHARMA AD
Iliensko Shosse Str.16, 1220 Sofia, Bulgaria

This medicinal product is authorised in the European Economic Area countries 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