Ambroksol Hasco

Leaflet included in the packaging: patient information

Ambroksol Hasco

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 the patient leaflet or as advised by
the doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, you should consult a pharmacist.
• 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 after 4 to 5 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Ambroksol, the active substance of Ambroksol Hasco, 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

When not to take Ambroksol Hasco

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 the section "Ambroksol Hasco contains sorbitol").

Warnings and precautions

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

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Ambroksol Hasco is not recommended during pregnancy, especially in the first three months of pregnancy.
Ambroksol Hasco is not recommended for 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 use machines.
No studies have been conducted on the effect of the medicine on the ability to drive or use machines.

Ambroksol Hasco 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 7.0 g of sorbitol in the maximum recommended daily dose of the medicine (20 ml). Patients with fructose intolerance should not take this medicine.
The medicine may also have a mild laxative effect. Energy value: 2.6 kcal/g sorbitol.

3. How to take Ambroksol Hasco

This medicine should always be taken exactly as described in the patient leaflet or as advised by the doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
The medicine is taken orally.
The recommended dose is:
Adults and children over 12 years: 10 ml of syrup 2 times a day.
Recommended dose in case of acute respiratory tract infections and in the initial period of treatment of 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 attached measuring cup or measuring spoon.
Ambroksol Hasco syrup can be taken with or without food.

If the symptoms do not improve after taking Ambroksol Hasco during acute respiratory tract infections, 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 than recommended

In case of taking a higher dose of Ambroksol Hasco 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 accidental overdose and/or reports of improper use, symptoms corresponding to the known side effects of the medicine taken in recommended doses have been observed, which may require symptomatic treatment.

Missing a dose of Ambroksol Hasco

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

4. Possible side effects

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

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

Ambroksol Hasco and seek medical attention:

• allergic reaction with swelling in 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 disorders (e.g. altered taste),
feeling of dryness in the mouth, throat, and pharynx,
nausea.
Uncommon(in 1 to 10 patients out of 1,000):
diarrhea,
vomiting,
indigestion,
dryness of the mucous membrane of the mouth,
abdominal pain.
Rare(in 1 to 10 patients out of 10,000):
allergic reactions,
rash,
urticaria.
Frequency not known(frequency cannot be estimated from the available data):
anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue edema) and swelling,
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 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:
Al. Jerozolimskie 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 helps to gather more information on the safety of the medicine.

5. How to store Ambroksol Hasco

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 take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
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 Hasco contains

The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 30 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 looks like and what the package contains

Ambroksol Hasco is a colorless, clear syrup with a peach flavor and sweet taste.
One package of the medicine (a 160 ml brown glass bottle with an aluminum cap with a PE sealing plug and a guarantee ring or an HDPE cap with a PE sealing plug and a guarantee ring) contains 150 ml of syrup. The bottle is placed in a cardboard box. A measuring cup made of PP or a 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 the last update of the leaflet: