Deflegmin Babi

Package Leaflet: Information for the User

Deflegmin Baby

7.5 mg/ml, Oral Drops, Solution

Ambroxol Hydrochloride

Read the Package Leaflet Carefully Before Using the Medicinal Product

This medicinal product must be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet:

• 1. What is Deflegmin Baby and What is it Used For
• 2. Important Information Before Using Deflegmin Baby
• 3. How to Use Deflegmin Baby
• 4. Possible Side Effects
• 5. How to Store Deflegmin Baby
• 6. Contents of the Package and Other Information

1. What is Deflegmin Baby and What is it Used For

Deflegmin Baby in the form of oral drops is a mucolytic medicinal product containing ambroxol hydrochloride. It increases the production of mucus in the respiratory tract and improves its transport, making it easier to cough up and relieving cough. Deflegmin Baby is used in acute and chronic lung and bronchial diseases with difficulty in coughing up viscous secretions from the respiratory tract. If after 4 to 5 days there is no improvement or you feel worse, you should contact your doctor.

2. Important Information Before Using Deflegmin Baby

When Not to Use Deflegmin Baby

This medicinal product should not be used immediately before bedtime.

Warnings and Precautions

Before starting to use Deflegmin Baby, you should discuss it with your doctor or pharmacist:

Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including changes in mucous membranes, e.g. mouth, throat, nose, eyes, genitals), you should stop using Deflegmin Baby and contact your doctor immediately.

Deflegmin Baby and Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, as well as those you plan to take.

• Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Cough suppressants (e.g. codeine) suppress the cough reflex and make it difficult to cough up liquefied mucus, so you should not use ambroxol at the same time as cough suppressants.
• No significant interaction between ambroxol and other medicinal products has been found.

Deflegmin Baby with Food and Drink

Deflegmin Baby in the form of oral drops should be taken after meals, diluted with tea, fruit juice, milk, or water.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product. The use of Deflegmin Baby is not recommended during pregnancy, especially during the first trimester. Ambroxol passes into breast milk. The use of Deflegmin Baby is not recommended during breast-feeding. The effect of the medicinal product 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 medicinal product affects the ability to drive and use machines. No studies have been conducted on the effect of Deflegmin Baby on the ability to drive and use machines.

Deflegmin Baby Contains Benzalkonium Chloride

The medicinal product contains 0.25 mg of benzalkonium chloride in each 1 ml of solution (25 drops), which corresponds to 1 mg of benzalkonium chloride/4 ml of solution (100 drops). Benzalkonium chloride may cause local irritation.

Deflegmin Baby Contains Sodium

The medicinal product contains less than 1 mmol (23 mg) of sodium in 1 ml of solution (25 drops), which means that the medicinal product is considered "sodium-free". Deflegmin Baby does not contain sugar.

3. How to Use Deflegmin Baby

This medicinal product should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The usual dose of Deflegmin Baby in the form of oral drops:for adults and children over 12 years of age:initially, for 2 to 3 days, 4 ml (100 drops) 3 times a day, then the dose should be reduced to 4 ml 2 times a day; for children from 6 to 12 years of age:2 ml (50 drops) 2 to 3 times a day; for children from 2 to 6 years of age:1 ml (25 drops) 3 times a day; for children from 1 to 2 years of age:1 ml (25 drops) 2 times a day.

If after 4 to 5 days there is no improvement or you feel worse, you should contact your doctor.

Method of administration: Deflegmin Baby in the form of oral drops should be taken orally, after meals, diluted with tea, fruit juice, milk, or water. The medicinal product should not be used immediately before bedtime.

Overdose of Deflegmin Baby

No specific symptoms of overdose have been reported in humans. After taking a higher dose of Deflegmin Baby than recommended, the side effects listed in section 4 "Possible Side Effects" may occur. If these symptoms occur, you should contact your doctor.

Missed Dose of Deflegmin Baby

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Use of Deflegmin Baby

Stopping the use of Deflegmin Baby does not cause any adverse effects, except for the possibility of worsening symptoms of the disease for which it is used. If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Deflegmin Baby can cause side effects, although not everybody gets them.

If You Experience Any of the Following Side Effects, Stop Using Deflegmin Baby and Contact Your 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 these side effects is unknown (cannot be estimated from the available data). Additionally, the following side effects may occur: Very Common Side Effects(may affect up to 1 in 10 people):

• nausea;
• reduced sensation in the mouth and throat;
• taste disorders (e.g. altered taste).

Common Side Effects(may affect up to 1 in 100 people):

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

Uncommon Side Effects(may affect up to 1 in 1,000 people):

• hypersensitivity reactions;
• rash, urticaria;
• heartburn, constipation.

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 you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: 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. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Deflegmin Baby

Store in a temperature below 25°C. Store in the original package to protect from light. Keep this medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date stated on the package. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package 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 Package

Deflegmin Baby is a colorless, clear solution. Deflegmin Baby in the form of oral drops is a solution in a brown glass bottle containing 50 ml of solution, with a dropper and a graduated measuring cup, in 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, Poland. For more detailed information, please contact the marketing authorization holder.

Date of Last Revision of the Package Leaflet: