AMBROXOL HASCO MAX

Package leaflet: information for the patient

Ambroksol Hasco Max
60 mg, coated tablets
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
• If there is no improvement after 4–5 days, or if the patient feels worse, consult a physician.

Table of contents

1. What Ambroksol Hasco Max is and what it is 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. Contents of the pack and other information

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

Ambroxol, the active substance in Ambroksol Hasco Max, 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. Important information before using Ambroksol Hasco Max

When not to use 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 starting to use Ambroksol Hasco Max, discuss this with a doctor or
pharmacist.
If the patient has severe renal function disorders or severe hepatic insufficiency, medical advice should be sought before using Ambroksol Hasco Max.
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, genital organs), discontinue use of Ambroksol Hasco Max immediately and contact a doctor without delay.
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Ambroksol Hasco Max 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 plans to use.
No clinically significant adverse interactions with other medicines have been demonstrated.
Ambroksol Hasco Max should not be administered concomitantly with antitussive (cough suppressant) medicines, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Ambroksol Hasco Max during pregnancy is not recommended, especially during the first trimester of pregnancy.
Use of Ambroksol Hasco Max is not recommended in breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and operating machinery
There is no evidence of an effect of this medicine on the ability to drive or operate machinery.
Studies on the effect of the medicine on the ability to drive and operate machinery have not been conducted.

Ambroksol Hasco Max contains lactose
One tablet contains 336 mg of lactose, corresponding 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 certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Ambroksol Hasco Max

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.
The tablet may be divided into equal doses.
Recommended dose:
Adults and adolescents over 12 years of age:
1 tablet twice daily or half a tablet three 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 Max for acute respiratory tract diseases, consult a doctor.
If symptoms worsen or do not resolve after 4-5 days, contact a doctor.
Taking a higher than recommended dose of Ambroksol Hasco Max
If more than the recommended dose of Ambroksol Hasco Max has been taken, consult a doctor or pharmacist immediately.
Specific symptoms of overdose have not been observed in humans. Based on cases of accidental overdose and/or reports of inappropriate use, 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 Max
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 concerning 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 will experience them.
If any of the following adverse reactions occur, stop taking the medicine
Ambroksol Hasco Max and seek immediate medical advice:
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.

In addition, the following adverse reactions have been reported:

Common (may occur in fewer than 1 in 10 people):
nausea.

Uncommon (may occur in fewer than 1 in 100 people):
diarrhea,
vomiting,
dyspepsia,
abdominal pain.

Rare (may occur in fewer than 1 in 1000 people):
rash,
urticaria,
hypersensitivity reactions.

Frequency not known (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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 helps to provide more information on the safety of the medicine.

5. How to store Ambroksol Hasco Max

No special storage instructions are required for this medicine.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ambroksol Hasco Max contains
The active substance is ambroxol hydrochloride. One coated tablet contains 60 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: monohydrate lactose, pregelatinized corn starch, magnesium stearate, anhydrous colloidal silicon dioxide, Opadry 200 200F280000 White coating (polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, methacrylic acid copolymer, sodium hydrogen carbonate).

What Ambroksol Hasco Max looks like and contents of the pack
White, oval, biconvex, smooth coated tablets with a score line.
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

Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]
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