AMBROXOL HASCO

Package leaflet: Information for the patient

Ambroksol Hasco
30 mg/5 ml, syrup
Ambroxoli hydrochloridum
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, pharmacist, or nurse.

• 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 possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 4 to 5 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

Ambroksol, 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. Important information before using Ambroksol Hasco

When not to use 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 section "Ambroksol Hasco contains sorbitol").

Warnings and precautions
Before starting to use Ambroksol Hasco, discuss it with your doctor, pharmacist, or
nurse.
If the patient has severe renal function disorders or severe hepatic insufficiency, they should
consult a doctor before using Ambroksol Hasco.
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported.
If a rash occurs (including lesions of mucous membranes, e.g. in the mouth, throat,
nose, eyes, genital organs), stop using Ambroksol Hasco and
contact a doctor immediately.

Ambroksol Hasco and other medicines
Tell 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 take.
Clinically significant adverse interactions with other medicines have not been demonstrated.
Ambroksol Hasco should not be administered simultaneously with antitussive medicines, because
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.
The use of Ambroksol Hasco is not recommended during pregnancy, especially during the first
three months of pregnancy.
The use of Ambroksol Hasco is not recommended in breastfeeding women, because
ambroxol hydrochloride passes into breast milk.

Driving and operating machinery
There is no evidence of the effect of this medicine on 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 contains sorbitol
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
5 ml of syrup contains 1.75 g of sorbitol, equivalent 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. The caloric value is 2.6 kcal/g of sorbitol.

3. How to use Ambroksol Hasco

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is taken orally.
Recommended dose:
Adults and children over 12 years of age: 10 ml of syrup twice daily.
This dose is recommended for acute respiratory tract infections and at the beginning of treatment for chronic conditions, during the first 14 days of treatment.

The above dosage is recommended during the initial treatment period.
The dosage may be reduced by half after 14 days of treatment.
Do not use in children without consulting a doctor.
The medicine should be measured using the provided measuring cup or measuring spoon.
Ambroksol Hasco syrup can be taken with or without food.
If there is no improvement in symptoms during treatment with Ambroksol Hasco syrup in acute respiratory tract diseases,
medical advice should be sought.
If symptoms worsen or do not improve after 4 to 5 days, consult a doctor.
Use of a higher than recommended dose of Ambroksol Hasco
If a higher than 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 improper use, symptoms corresponding to the known adverse effects of the medicine used
at recommended doses have been observed, which may require symptomatic treatment.
Missed 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 the missed dose. Take the next dose at the usual time.
If you have any further doubts concerning the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur, stop using the medicine
Ambroksol Hasco 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 following adverse reactions have been reported:
Common (in 1 to 10 patients out of 100):
taste disturbances (e.g. altered taste),
numbness sensation in the oral cavity, tongue and throat,
nausea.
Uncommon (in 1 to 10 patients out of 1,000):
diarrhea,
vomiting,
dyspepsia,
dryness of the oral mucosa,
abdominal pain.
Rare (in 1 to 10 patients out of 10,000):
hypersensitivity reactions,
rash,
urticaria.
Frequency not known (frequency cannot be estimated from available data):
anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of skin, subcutaneous tissue, mucous membrane or submucosal tissue), and itching,
severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis),
dryness of the throat.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ambroksol Hasco

Keep the medicine 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 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. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: non-crystallizing sorbitol liquid (E 420), glycerol, benzoic acid (E 210), propylene glycol, apricot flavor AR0059, sodium saccharin (E 954), purified water.
What Ambroksol Hasco looks like and contents of the pack
Ambroksol Hasco is a colourless, clear syrup with an apricot odour and sweet taste.
One pack of the medicine (a brown glass bottle with a capacity of 160 ml, closed with an aluminium cap with a PE sealing insert and a tamper-evident ring, or with an HDPE cap with a PE sealing insert and a tamper-evident ring) contains 150 ml or 135 ml of syrup.
The bottle is placed in a cardboard box. The pack includes a measuring cup made of PP or a measuring spoon made of PP.
Marketing authorisation holder and manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. + 48 (22) 742 00 22
e-mail: [email protected]