Ambroksol Hasco Max

Leaflet attached to the packaging: patient information

Ambroksol Hasco Max

60 mg, coated tablets

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 this patient leaflet or as directed by a doctor or pharmacist.

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

Table of contents of the leaflet

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

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

Ambroxol, the active substance of Ambroksol Hasco Max, 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 Max

When not to take Ambroksol Hasco Max

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 Max contains lactose").

Warnings and precautions

Before taking Ambroksol Hasco Max, the patient should discuss it with their doctor or pharmacist.
If the patient has severe kidney dysfunction or severe liver failure, they should consult their doctor before taking Ambroksol Hasco Max.
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 Max and contact their doctor immediately.
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Ambroksol Hasco Max 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 found.
Ambroksol Hasco Max 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 Max is not recommended during pregnancy, especially during the first three months of pregnancy.
Ambroksol Hasco Max is not recommended for breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and operating machinery

There is no evidence that the medicine affects 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 Max contains lactose

One tablet contains 336 mg of lactose, which corresponds to 672 mg of lactose in the maximum recommended daily dose (120 mg, i.e. 2 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 Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in 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.
A tablet can be divided into equal doses.
The recommended dose is:
Adults and adolescents over 12 years old:
1 tablet 2 times a day or half a tablet 3 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 Max 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 a higher dose of Ambroksol Hasco Max than recommended

In case of taking a higher dose of Ambroksol Hasco Max 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 adverse effects of the medicine at recommended doses have been observed, which may require symptomatic treatment.
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Missing a dose of Ambroksol Hasco Max

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 the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If one of the following side effects occurs, the patient should stop taking Ambroksol Hasco Max and consult their doctor immediately:

Ambroksol Hasco Max

allergic reaction with localized swelling of the face, lips, mouth, tongue, and/or throat (angioedema) - this 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 side effects not listed in this 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.
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Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Ambroksol Hasco Max

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
The medicine should not be used 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 Max contains

The active substance of the medicine is ambroxol hydrochloride. One coated tablet contains 60 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: lactose monohydrate, cornstarch, magnesium stearate, colloidal silica, Opadry 200 200F280000 White (polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, methacrylic acid copolymer, sodium hydrocarbonate).

What Ambroksol Hasco Max looks like and what the package contains

White, oval, biconvex, smooth tablets with a dividing line.
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

Information about the medicine

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

Date of last revision of the leaflet:

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