Patient Information Leaflet

Deflegmin Baby
7.5 mg/ml, oral drops, solution
Ambroxoli hydrochloridum
Please read this leaflet carefully before using the 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, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 to 5 days, or if your condition worsens, contact your doctor.

Leaflet Contents:

What Deflegmin Baby is and what it is used for
Important information before using Deflegmin Baby
How to use Deflegmin Baby
Possible side effects
How to store Deflegmin Baby
Contents of the pack and other information

1. What Deflegmin Baby is and what it is used for

Deflegmin Baby oral drops is a mucolytic medicine containing ambroxol hydrochloride. It increases mucus secretion in the respiratory tract and improves its transport, thereby facilitating expectoration and relieving cough.
Deflegmin Baby is used in acute and chronic lung and bronchial diseases associated with difficulty in expectorating viscous secretions from the respiratory tract.
If there is no improvement after 4 to 5 days, or if the patient feels worse, contact a doctor.

2. Important information before using Deflegmin Baby

When not to use Deflegmin Baby

if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).

This medicine should not be taken immediately before going to sleep.
Warnings and precautions
Before starting treatment with Deflegmin Baby, consult a doctor or pharmacist:

if the patient has peptic ulcer disease of the stomach or duodenum;
if the patient has impaired liver or kidney function;
if the patient has a weakened cough reflex or impaired ciliary clearance of the bronchi (in such cases there is a risk of mucus accumulation in the respiratory tract);
if the patient suffers from bronchial asthma (Deflegmin Baby may initially worsen coughing).

Severe skin reactions associated with ambroxol hydrochloride have been reported.
If a rash occurs (including mucosal lesions, e.g. in the mouth, throat, nose, eyes, genital organs), treatment with Deflegmin Baby must be discontinued immediately and the patient should contact a doctor without delay.
Deflegmin Baby with other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take.

Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
Antitussive medicines (e.g. codeine) suppress the cough reflex and make it difficult to expel liquefied mucus; therefore, ambroxol should not be used simultaneously with antitussive agents.
No significant interactions of ambroxol with other medicines have been demonstrated.

Deflegmin Baby with food and drink
Deflegmin Baby oral drops should be taken after meals, diluted with tea, fruit juice, milk or water.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

The use of Deflegmin Baby during pregnancy is not recommended, especially during the first trimester of pregnancy.
Ambroxol passes into breast milk. The use of Deflegmin Baby is not recommended during breastfeeding.
The effect of the medicine on human fertility has not been studied.
Animal studies have not shown any harmful effect of ambroxol on fertility.
Driving and operating machinery
There is no evidence of an effect of the medicine on the ability to drive or operate machinery.
No studies have been conducted on the effect of Deflegmin Baby on the ability to drive or operate machinery.
Deflegmin Baby contains benzalkonium chloride
The medicine contains 0.25 mg of benzalkonium chloride per 1 ml of solution (25 drops), equivalent to 1 mg of benzalkonium chloride per 4 ml of solution (100 drops).
Benzalkonium chloride may cause local irritation.
Deflegmin Baby contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution (25 drops), meaning the medicine is considered "sodium-free".
Deflegmin Baby does not contain sugar.

3. How to use Deflegmin Baby

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Typical dosage of Deflegmin Baby oral drops:
For adults and children over 12 years of age:
Initially, for 2 to 3 days, 4 ml (100 drops) 3 times daily; thereafter, the dose should be reduced
to 4 ml twice daily;
For children aged 6 to 12 years:
2 ml (50 drops) 2 to 3 times daily;
For children aged 2 to 6 years:
1 ml (25 drops) 3 times daily;
For children aged 1 to 2 years:
1 ml (25 drops) twice daily.
If there is no improvement after 4 to 5 days, or if the patient feels worse, consult a doctor.
Method of administration:
Deflegmin Baby oral drops should be taken orally, after meals, diluted with tea, fruit juice, milk, or water.
This medicine should not be taken immediately before going to sleep.
Taking a larger than recommended dose of Deflegmin Baby
Specific symptoms of overdose have not been described in humans.
After ingesting a larger than recommended dose of Deflegmin Baby, symptoms listed in section 4
"Possible side effects" may occur. If such symptoms occur, consult a doctor.
Missing a dose of Deflegmin Baby
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next
dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.
Stopping treatment with Deflegmin Baby
Discontinuing treatment with Deflegmin Baby does not cause adverse effects, except for the possible
worsening of disease symptoms for which the medicine was being used.
If there are any further doubts regarding 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 the patient experiences any of the following adverse reactions, stop using
Deflegmin Baby immediately and contact a doctor without delay:

anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching,
severe skin-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis).

The frequency of occurrence of the above-mentioned adverse reactions is unknown (cannot be
estimated based on available data).
Additionally, the following adverse reactions may occur:
Common adverse reactions (may occur in up to 1 in 10 people):

nausea,
numbness in the mouth and throat,
taste disturbances (e.g. altered taste).

Uncommon adverse reactions (may occur in up to 1 in 100 people):

vomiting, diarrhoea, indigestion, and abdominal pain,
dryness of the oral mucosa.

Rare adverse reactions (may occur in up to 1 in 1000 people):

hypersensitivity reactions,
rash, urticaria,
heartburn, constipation.

Adverse reactions with unknown frequency (frequency cannot be estimated based on
available data):

itching, other allergic reactions not listed above,
dry throat.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a 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:
Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Deflegmin Baby

Store below 25°C. Keep 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 a pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Deflegmin Baby contains

The active substance is ambroxol hydrochloride. 1 ml of solution (25 drops) contains 7.5 mg of ambroxol hydrochloride.
The other ingredients are: citric acid monohydrate, disodium phosphate dodecahydrate, sodium chloride, benzalkonium chloride, purified water.

What Deflegmin Baby looks like and contents of the pack
Deflegmin Baby is a colourless, clear solution.
Deflegmin Baby oral drops are supplied as a solution in a 50 ml amber glass bottle equipped with a dropper cap and a graduated measuring cup, packed in a cardboard box.
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland
For further information, please contact the marketing authorisation holder.