Deflegmin Kids

Leaflet attached to the packaging: information for the user

Deflegmin KIDS

15 mg/5 ml, syrup

Ambroxol hydrochloride

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Deflegmin KIDS syrup and what is it 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. Package contents and other information

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

Deflegmin KIDS syrup is a mucolytic medicine containing ambroxol hydrochloride. It increases the secretion of mucus in the airways and improves its transport, making it easier to cough up and relieving cough.
Deflegmin KIDS is used in acute and chronic lung and bronchial diseases with difficulty in coughing up viscous secretions from the airways.

2. Important information before taking Deflegmin KIDS syrup

When not to take Deflegmin KIDS syrup

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

Warnings and precautions

Before starting to take Deflegmin KIDS, the patient should discuss it with their doctor or pharmacist:

• if the patient has stomach or duodenal ulcers;
• if the patient has liver or kidney function disorders;
• if the cough reflex is weakened or there are disorders of ciliary clearance of the bronchi (there is a risk of secretions accumulating in the airways);
• if the patient has bronchial asthma (Deflegmin KIDS may initially worsen cough).

Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in mucous membranes, such as the mouth, throat, nose, eyes, genitals), the patient should stop taking Deflegmin KIDS and contact their doctor immediately.

Deflegmin KIDS syrup and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Cough suppressants (e.g., codeine) weaken the effect of ambroxol by inhibiting the cough reflex and making it difficult to cough up liquefied mucus.
• No interaction between ambroxol and other medicines has 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Ambroxol hydrochloride is not recommended during pregnancy, especially in the first trimester.
Ambroxol passes into breast milk. Deflegmin KIDS syrup is not recommended during breastfeeding.
The effect of the medicine on human fertility has not been studied.
Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and using machines

There is no evidence that the medicine affects the ability to drive or use machines.
No studies have been conducted on the effect of Deflegmin KIDS syrup on the ability to drive or use machines.

Deflegmin KIDS syrup contains sorbitol

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

Deflegmin KIDS syrup contains propylene glycol

The medicine contains 42.4 mg of propylene glycol per 2.5 ml of syrup, which corresponds to 169.6 mg/10 ml of syrup.

Deflegmin KIDS syrup contains sodium benzoate

The medicine contains 5 mg of sodium benzoate per 2.5 ml of syrup, which corresponds to 20 mg/10 ml of syrup.

Deflegmin KIDS syrup contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml of syrup, which means the medicine is considered "sodium-free".
Deflegmin KIDS syrup does not contain sugar.

3. How to take Deflegmin KIDS syrup

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The usual 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 a day, then the dose should be reduced to 10 ml of syrup 2 times a day;
for children from 6 to 12 years of age:
5 ml of syrup 2 to 3 times a day;
for children from 2 to 6 years of age:
2.5 ml of syrup 3 times a day;
for children from 1 to 2 years of age:
2.5 ml of syrup 2 times a day.
If there is no improvement or the patient feels worse after 4 to 5 days of taking the medicine, they should contact their doctor.

Taking a higher dose of Deflegmin KIDS syrup than recommended

No cases of overdose have been reported. However, if symptoms such as nausea, excessive fatigue, or excessive mucus production occur, the patient should contact their doctor immediately.

Missing a dose of Deflegmin KIDS syrup

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. A double dose should not be taken to make up for a missed dose.

Stopping Deflegmin KIDS syrup

Stopping Deflegmin KIDS syrup does not cause any adverse effects, except for the possibility of worsening symptoms of the disease for which it is being taken.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Deflegmin KIDS syrup can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should stop taking the medicine and contact their doctor immediately:

• anaphylactic reactions, including anaphylactic shock, angioedema, and itching,
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

The frequency of the above side effects is unknown (cannot be estimated from the available data).
In addition, the following side effects may occur:
Common side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

• vomiting, diarrhea, indigestion, and abdominal pain,
• dryness of the mucous membranes in the mouth.

Rare side effects(may affect up to 1 in 1000 people):

• hypersensitivity reactions,
• rash, urticaria.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• itching, other allergic reactions not listed above,
• dryness in the throat.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych:
Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Deflegmin KIDS syrup

Store in a temperature below 25°C. Store in the original packaging. Protect from light.
The medicine should be kept 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Deflegmin KIDS syrup contains

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

What Deflegmin KIDS syrup looks like and what the package contains

A brown glass bottle containing 120 ml or 150 ml of syrup, closed with a child-resistant PP cap and a tamper-evident seal. A polypropylene measuring cup is attached to the bottle. The outer packaging is a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: