Ambroksol Hasco

Package Leaflet: Information for the Patient

Ambroksol Hasco

30 mg, tablets

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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package 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 not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4-5 days, they should contact their doctor.

Table of Contents of the Package 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

Ambroxol, the active substance of Ambroksol Hasco, increases the production 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 production 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 lactose intolerance (see section "Ambroksol Hasco contains lactose").

Warnings and precautions

Before taking Ambroksol Hasco, the patient should discuss it with their doctor or pharmacist.
If the patient has severe kidney or liver impairment, they should consult their doctor before taking Ambroksol Hasco.
Severe skin reactions associated with ambroxol have been reported. If a rash occurs (including changes in mucous membranes, e.g., mouth, throat, nose, eyes, genitals), the patient should stop taking Ambroksol Hasco and contact their doctor immediately.
1/4

Ambroksol Hasco 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 found.
Ambroksol Hasco should not be taken with cough suppressants, as this may lead to a dangerous accumulation of bronchial secretions due to a weakened cough reflex.

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.
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 lactose

One tablet contains 168 mg of lactose, which corresponds to 672 mg of lactose in the maximum recommended daily dose (120 mg, i.e., 4 tablets). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Ambroksol Hasco

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
The tablets should be swallowed with a liquid. The tablets can be taken with or without food.
The recommended dose is:
Adults and adolescents over 12 years old:
1 tablet 3 times a day.
The effect of the medicine can be increased by taking 2 tablets 2 times a day.
The medicine in the form of tablets should not be taken by children under 12 years old. For children between 2 and 12 years old, a syrup containing the same active substance is available.

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

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

Taking more than the recommended dose of Ambroksol Hasco

In case of taking more than the recommended dose of Ambroksol Hasco, 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 adverse effects of the medicine at recommended doses have been observed, which may require symptomatic treatment.
2/4

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 a missed dose. The next dose should be taken at the usual time.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

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:

allergic reaction with localized swelling of 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 whole-body allergic reactions (anaphylactic reactions, including anaphylactic shock).
The frequency of these side effects is unknown.
The following side effects have also been reported:
Common(may occur in less than 1 in 10 people):
nausea.
Uncommon(may occur in less than 1 in 100 people):
diarrhea,
vomiting,
indigestion,
abdominal pain.
Rare(may occur in less than 1 in 1000 people):
rash,
urticaria,
hypersensitivity reactions.
Frequency not known(frequency cannot be estimated from the available data):
itching,
anaphylactic reactions, including anaphylactic shock,
angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissue),
severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the patient 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
Aleje 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.
3/4
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ambroksol Hasco

There are no special precautions for storage temperature. Store in the original packaging to protect from light.
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. The expiry date refers to the last day of the specified 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. One tablet contains 30 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silica.

What Ambroksol Hasco looks like and contents of the package

White, round, biconvex, smooth tablets.
One package of the medicine contains 15 or 30 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the package leaflet:

4/4