Ambroxol hasco junior

Patient Information Leaflet

Ambroksol Hasco Junior
15 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 4 to 5 days, you should contact your doctor.

Contents of the leaflet

1. What Ambroksol Hasco Junior is and what it is used for
2. Important information before taking Ambroksol Hasco Junior
3. How to take Ambroksol Hasco Junior
4. Possible side effects
5. How to store Ambroksol Hasco Junior
6. Contents of the pack and other information

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

Ambroksol, the active substance in Ambroksol Hasco Junior, 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 clearance.

2. Important information before using Ambroksol Hasco Junior

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

Warnings and precautions
Before starting to use Ambroksol Hasco Junior, discuss it with your doctor,
pharmacist, or nurse.
If the patient has severe renal function impairment or severe hepatic insufficiency,
medical advice should be sought before using Ambroksol Hasco Junior.
Severe skin reactions associated with ambroxol hydrochloride have been reported.
If a rash occurs (including mucosal lesions, e.g., in the oral cavity, throat,
nose, eyes, genital organs), treatment with Ambroksol Hasco Junior must be discontinued immediately and the patient should contact a doctor without delay.

Ambroksol Hasco Junior 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 use.
No clinically significant adverse interactions with other medicines have been reported.
Ambroksol Hasco Junior should not be administered simultaneously 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 Junior during pregnancy is not recommended, especially during the first trimester of pregnancy.
Use of Ambroksol Hasco Junior 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 Junior 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 14 g of sorbitol in the maximum recommended daily dose (40 ml). Patients with fructose intolerance must not take this medicine.
The medicine may also have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal/g.

3. How to use Ambroksol Hasco Junior

This medicine should always be used 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.
The medicine is taken orally.
Recommended dose:
Adults and children over 12 years of age: 20 ml of syrup twice daily.
This recommended dose should be used for acute respiratory tract inflammations and during the initial phase of chronic conditions, during the first 14 days of treatment.

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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 physician.
The medicine should be measured using the provided measuring device or measuring spoon.
Ambroksol Hasco Junior syrup can be taken with or without food.
If during the use of Ambroksol Hasco Junior syrup in acute respiratory diseases symptoms do not improve, medical advice should be sought.
If symptoms worsen or do not improve after 4 to 5 days, consult a physician.
Use of a higher than recommended dose of Ambroksol Hasco Junior
If a higher than recommended dose of Ambroksol Hasco Junior has been taken, consult a physician 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 corresponded to the known adverse effects of the medicine administered at recommended doses, which may require symptomatic treatment.
Missed dose of Ambroksol Hasco Junior
If a dose has been missed, it should be taken 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 regarding the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse symptoms occur, discontinue use of the medicine
Ambroksol Hasco Junior immediately and seek immediate medical advice:

• Allergic reaction with swelling of the face, lips, mouth, tongue, and (or) throat (angioedema) – this may cause a sensation of tightness in the throat, difficulty swallowing and breathing, or 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,
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urticaria.
Frequency not known (frequency cannot be estimated from available data):
anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and pruritus,
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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 4921301, fax: +48 22 4921309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ambroksol Hasco Junior

Keep the medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Usable for 6 months after first opening.
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 should 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 Junior contains
The active substance is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
The other ingredients (excipients) are: non-crystallizing sorbitol solution (E 420), glycerol,
benzoic acid (E 210), propylene glycol, apricot flavour AR0059, sodium saccharin (E 954), purified water.

What Ambroksol Hasco Junior looks like and contents of the pack
Ambroksol Hasco Junior is a colourless, clear syrup with an apricot scent and sweet taste.
One pack (a brown glass bottle closed with an aluminium cap with a PE sealing insert and tamper-evident ring, or a cap made of HDPE with a PE sealing insert and tamper-evident ring) contains 150 ml of syrup.
The bottle is placed in a cardboard box. A measuring cup or measuring spoon made of PP is included in the pack.

Marketing Authorisation Holder and Manufacturer
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"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel. +48 (22) 742 00 22
e-mail: [email protected]
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