Ambroksol Hasco Iunior

Package Leaflet: Information for the Patient

Ambroksol Hasco Junior

15 mg/5 ml, syrup

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 the package leaflet or as directed by a doctor, pharmacist, or nurse.

• 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 any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Ambroksol Hasco Junior and what is it used for

Ambroksol, the active substance of Ambroksol Hasco Junior, increases the secretion of mucus in the respiratory tract, making it easier to cough up and relieving cough.

Indications for Use

Acute and chronic lung and bronchial diseases with impaired mucus secretion and its transport.

2. Important information before taking Ambroksol Hasco Junior

When not to take Ambroksol Hasco Junior

If the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
if the patient has hereditary fructose intolerance (see section "Ambroksol Hasco Junior contains sorbitol").

Warnings and Precautions

Before taking Ambroksol Hasco Junior, the patient should discuss it with their doctor, pharmacist, or nurse.
If the patient has severe kidney or liver impairment, they should consult their doctor before taking Ambroksol Hasco Junior.
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in the mucous membranes, e.g., mouth, throat, nose, eyes, genitals), the patient should stop taking Ambroksol Hasco Junior and contact their doctor immediately.

Ambroksol Hasco Junior 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.
No significant clinically relevant adverse interactions with other medicines have been observed.
Ambroksol Hasco Junior should not be taken at the same time as cough suppressants, as this may lead to a dangerous accumulation of bronchial secretions due to weakened cough reflex.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Ambroksol Hasco Junior is not recommended during pregnancy, especially during the first three months.
Ambroksol Hasco Junior is not recommended for breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and using machines

There is no evidence of the medicine's effect on 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.

Ambroksol Hasco Junior contains sorbitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
5 ml of syrup contains 1.75 g of sorbitol, which corresponds to 14 g of sorbitol in the maximum recommended daily dose of the medicine (40 ml). Patients with fructose intolerance should not take this medicine.
The medicine may also have a mild laxative effect. The energy value is 2.6 kcal/g sorbitol.

3. How to take Ambroksol Hasco Junior

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.
The medicine is taken orally.
The recommended dose is:
Adults and children over 12 years: 20 ml of syrup 2 times a day.
The recommended dose for acute respiratory infections and in the initial period of treatment for chronic conditions, for the first 14 days of treatment.

The above dosage is recommended for the initial treatment period.
The dosage can be reduced by half after 14 days of treatment.
The medicine should not be taken by children without consulting a doctor.
The medicine should be measured using the enclosed measuring cup or measuring spoon.
Ambroksol Hasco Junior syrup can be taken with or without food.

If the symptoms do not improve or worsen during the use of Ambroksol Hasco Junior for acute respiratory diseases, the patient should consult their doctor.

If the symptoms worsen or do not improve after 4 to 5 days, the patient should contact their doctor.

Taking a higher dose of Ambroksol Hasco Junior than recommended

In case of taking a higher dose of Ambroksol Hasco Junior than recommended, the patient should consult their 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 adverse effects of the medicine at recommended doses have been observed, which may require symptomatic treatment.

Missing a dose of Ambroksol Hasco Junior

If a dose is missed, it should be taken as soon as possible.
A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.
If there are any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ambroksol Hasco Junior can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should stop taking Ambroksol Hasco Junior and consult their doctor immediately:

• allergic reaction with swelling localized to the face, lips, mouth, tongue, and/or throat (angioedema) - may cause a feeling of constriction in the throat, difficulty swallowing, and breathing, sudden onset of allergic reactions affecting the whole body (anaphylactic reactions, including anaphylactic shock).

The following side effects have been reported:
Common(in 1 to 10 patients out of 100):
taste disturbances (e.g., altered taste),
feeling of numbness in the mouth, tongue, and throat,
nausea.
Uncommon(in 1 to 10 patients out of 1,000):
diarrhea,
vomiting,
indigestion,
dryness of the oral mucosa,
abdominal pain.
Rare(in 1 to 10 patients out of 10,000):
hypersensitivity reactions,
rash,
urticaria.
Frequency not known(frequency 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 of the throat.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.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 Ambroksol Hasco Junior

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Shelf life after first opening: 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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. Contents of the pack and other information

What Ambroksol Hasco Junior contains

The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: liquid non-crystallizing sorbitol (E 420), glycerol, benzoic acid (E 210), propylene glycol, peach flavor AR0059, sodium saccharin (E 954), purified water.

What Ambroksol Hasco Junior looks like and contents of the pack

Ambroksol Hasco Junior is a colorless, clear syrup with a peach flavor and sweet taste.
One pack of the medicine (a brown glass bottle with an aluminum cap with a PE sealing ring and a guarantee ring or an HDPE cap with a PE sealing ring and a guarantee ring) contains 150 ml of syrup.
The bottle is placed in a cardboard box. A measuring cup or measuring spoon made of PP is attached to the packaging.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel. +48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: