Deflegmin kids

Package leaflet: Information for the user

Deflegmin KIDS
15 mg/5 ml, syrup
Ambroxoli hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor 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 adverse reactions 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, consult your doctor.

Contents of the leaflet:

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

1. What Deflegmin KIDS syrup is and what it is used for

Deflegmin KIDS syrup 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 KIDS is used in acute and chronic lung and bronchial diseases associated with difficulty in expectorating thick mucus from the respiratory tract.

2. Important information before using Deflegmin KIDS syrup

When not to use Deflegmin KIDS syrup

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• immediately before going to sleep.

Warnings and precautions
Before starting treatment with Deflegmin KIDS, discuss this with your doctor or pharmacist:

• if the patient has a peptic ulcer of the stomach or duodenum;
• if the patient has impaired liver or kidney function;
• if the cough reflex is weakened or if there are disturbances in ciliary clearance of the bronchi (in such cases there is a risk of mucus accumulation in the airways);
• in case of bronchial asthma (Deflegmin KIDS may initially increase 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), stop using Deflegmin KIDS and contact your doctor immediately.

Deflegmin KIDS syrup 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 intends to take.

• Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Antitussive medicines (e.g. codeine) reduce the effect of ambroxol by suppressing the cough reflex and making it harder to expel liquefied mucus.
• No interactions of ambroxol with other medicines have been demonstrated.

Deflegmin KIDS syrup with food and drink
Deflegmin KIDS syrup should be taken after meals.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

The use of Deflegmin KIDS is not recommended during pregnancy, especially during the first trimester.

Ambroxol passes into breast milk. The use of Deflegmin KIDS is not recommended during breastfeeding.

The effect of this medicine on human fertility has not been studied.
Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and operating machinery
There is no evidence of an effect of this medicine on the ability to drive or operate machinery.
No studies have been conducted on the effect of Deflegmin KIDS on the ability to drive or operate machinery.

Deflegmin KIDS contains sorbitol in the form of sorbitol solution
This medicine contains 1250 mg of sorbitol in the form of sorbitol solution in 2.5 ml of syrup, equivalent to 2500 mg sorbitol/5 ml syrup or 5000 mg sorbitol/10 ml syrup.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking this medicine or giving it to the child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Deflegmin KIDS contains propylene glycol
This medicine contains 42.4 mg of propylene glycol in 2.5 ml of syrup, equivalent to 169.6 mg/10 ml syrup.

Deflegmin KIDS contains sodium benzoate
This medicine contains 5 mg of sodium benzoate in 2.5 ml of syrup, equivalent to 20 mg/10 ml syrup.

Deflegmin KIDS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup, meaning the medicine is considered "sodium-free".

Deflegmin KIDS does not contain sugar.

3. How to use Deflegmin KIDS syrup

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Typically used dose of Deflegmin KIDS syrup:
For adults and children over 12 years of age:
Initially, for 2 to 3 days, 10 ml of syrup 3 times daily; thereafter, the dose should be reduced to 10 ml of syrup 2 times daily;
For children aged 6 to 12 years:
5 ml of syrup 2 to 3 times daily;
For children aged 2 to 6 years:
2.5 ml of syrup 3 times daily;
For children aged 1 to 2 years:
2.5 ml of syrup 2 times daily.
If there is no improvement or if the patient feels worse after 4 to 5 days of treatment, consult a doctor.
Use of a higher than recommended dose of Deflegmin KIDS syrup
No cases of overdose have been reported. However, if symptoms such as nausea, excessive fatigue, or excessive mucus secretion occur, consult a doctor immediately.
Missed dose of Deflegmin KIDS syrup
If a dose is missed, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for the missed one.
Discontinuation of Deflegmin KIDS syrup
Stopping treatment with Deflegmin KIDS does not cause adverse effects, except for the possible worsening of symptoms of the condition for which the medicine is being used.
If you have any further questions about the use of this medicine, consult your 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, discontinue use of the medicine 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 generalized exanthematous pustulosis).

The frequency of occurrence of the above-mentioned adverse reactions is unknown (cannot be determined from 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.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

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

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 at 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Deflegmin KIDS syrup

Store below 25°C. Keep in the original packaging. Protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". 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 required. These measures help protect the environment.

6. Contents of the package and other information

What Deflegmin KIDS syrup contains

• The active substance is ambroxol hydrochloride. 5 ml of syrup contains 15 mg of ambroxol hydrochloride.
• Other ingredients are: sorbitol solution, glycerol, propylene glycol (E 1520), sodium benzoate, purified water, flavouring agent 11031-33 (containing, among others, propylene glycol (E 1520) and anise alcohol), hydrochloric acid 10% (for pH adjustment).

What Deflegmin KIDS syrup looks like and contents of the pack
An amber glass bottle containing 120 ml or 150 ml of syrup, closed with a PP screw cap with a child-resistant closure and a tamper-evident seal. A polypropylene measuring cup is attached to the bottle. The outer packaging is 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