Package leaflet: Information for the patient

Ambroksol Hasco
30 mg, tablets
Ambroxol hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4-5 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet

What is Ambroksol Hasco and what is it used for
Important information before taking Ambroksol Hasco
How to take Ambroksol Hasco
Possible side effects
How to store Ambroksol Hasco
Contents of the pack and other information

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

Ambroxol, the active substance in Ambroksol Hasco, increases mucus secretion in the
respiratory tract, thereby facilitating expectoration and relieving cough.
Indications
Acute and chronic diseases of the lungs and bronchi associated with impaired mucus secretion and difficulty in mucus transport.

2. Information before using Ambroksol Hasco

When not to use Ambroksol Hasco
if the patient is allergic to ambroxol hydrochloride or to any of the other
components of this medicine (listed in section 6);
if the patient has hereditary lactose intolerance (see section "Ambroksol Hasco
contains lactose").

Warnings and precautions
Before starting to use Ambroksol Hasco, discuss it with your doctor or pharmacist.
If the patient has severe renal function disorders or severe liver insufficiency, medical advice should be sought before using Ambroksol Hasco.
Severe skin reactions associated with ambroxol use have been reported. If a rash occurs (including lesions on mucous membranes, e.g. in the mouth, throat, nose, eyes, or genital organs), treatment with Ambroksol Hasco must be discontinued immediately and the patient should contact a doctor without delay.
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Ambroksol Hasco and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to use.
Clinically significant adverse interactions with other medicines have not been reported.
Ambroksol Hasco should not be administered concurrently with antitussive (cough suppressant) medicines, as this may lead to a dangerous accumulation of bronchial secretions due to suppression of the cough reflex.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The use of Ambroksol Hasco during pregnancy is not recommended, especially during the first trimester.
The use of Ambroksol Hasco is not recommended for breastfeeding women, as ambroxol hydrochloride is excreted in breast milk.

Driving and operating machinery
There is no evidence of the medicine's effect on the ability to drive or operate machinery.
No studies have been conducted on the influence of the medicine on the ability to drive and operate machinery.

Ambroksol Hasco contains lactose
One tablet contains 168 mg of lactose, corresponding 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 certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Ambroksol Hasco

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
Tablets should be taken with liquid. Tablets may be taken with or without food.
Recommended dose:
Adults and adolescents over 12 years of age:
1 tablet 3 times daily.
The effect of the medicine may be enhanced by taking 2 tablets 2 times daily.
This medicine in tablet form should not be used in children under 12 years of age. For children aged 2 to 12 years, a syrup containing the same active substance is available.
If symptoms do not improve during treatment with Ambroksol Hasco for acute respiratory tract diseases, medical advice should be sought.
If symptoms worsen or do not improve after 4-5 days, consult a doctor.
Taking more than the recommended dose of Ambroksol Hasco
If more than the recommended dose of Ambroksol Hasco has been taken, consult a doctor or pharmacist.
Specific symptoms of overdose have not been observed in humans so far. Based on cases of accidental overdose and/or reports of misuse, symptoms corresponding to the known adverse effects of the medicine when used at recommended doses have been observed, which may require symptomatic treatment.
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Missing a dose of Ambroksol Hasco
If a dose has been missed, take it as soon as possible.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse symptoms occur, discontinue use of the medicine
Ambroksol Hasco and immediately consult a doctor:
allergic reaction with swelling localized in the face, lips, mouth, tongue, and (or)
throat (angioedema) – this may cause a sensation of tightness in the throat, difficulty
swallowing and breathing,
sudden onset systemic allergic reactions (anaphylactic reactions, including anaphylactic
shock).
The frequency of these adverse reactions is unknown.

Additionally, the following adverse reactions have 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,
dyspepsia,
abdominal pain.

Rare (may occur in less than 1 in 1,000 people):
rash,
urticaria,
hypersensitivity reactions.

Frequency unknown (frequency cannot be estimated from available data):
itching,
anaphylactic reactions, including anaphylactic shock,
angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissues),
severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 4921301, fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
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Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Ambroksol Hasco

No special temperature storage requirements for this medicine. Store in the original packaging to protect from light.
Keep the medicine 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 stated month.
Medicines must 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 packaging and other information

What Ambroksol Hasco contains
The active substance is ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: monohydrate lactose, pregelatinized corn starch,
magnesium stearate, anhydrous colloidal silicon dioxide.
What Ambroksol Hasco looks like and contents of the pack
White, round, biconvex, smooth tablets.
One pack contains 15 or 30 tablets.
Marketing authorisation holder and manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product information
tel.: (22) 742 00 22
e-mail: [email protected]
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