Flegamina Babi

Package Leaflet: Information for the User

Flegamina Baby, 2 mg/ml, Oral Drops, Solution

Bromhexine Hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 to 5 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet

• 1. What is Flegamina Baby and what is it used for
• 2. Important information before using Flegamina Baby
• 3. How to use Flegamina Baby
• 4. Possible side effects
• 5. How to store Flegamina Baby
• 6. Contents of the pack and other information

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

Flegamina Baby contains the active substance bromhexine hydrochloride, which is an expectorant, making it easier to cough up mucus from the airways. The medicine facilitates coughing up and clearing the bronchi.
The indication for use of Flegamina Baby is acute and chronic respiratory diseases with impaired coughing up and removal of mucus.
Flegamina Baby is intended for use in children from 2 to 6 years old.

Flegamina Baby should not be used without medical supervision for more than 3 to 5 days.

2. Important information before using Flegamina Baby

When not to use Flegamina Baby:

• if the patient is allergic to bromhexine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• in children under 2 years of age.

Warnings and precautions

Before starting to use Flegamina Baby, discuss it with a doctor or pharmacist:

• if the patient has inflammatory diseases of the respiratory tract with accompanying bacterial infection, as Flegamina Baby should then be used simultaneously with antibiotics and bronchodilators prescribed by a doctor.
• if the patient has a fever, it is also important to ensure proper hydration of the patient. Adequate hydration of the body increases the thinning of bronchial secretions and facilitates coughing up.
• if the patient currently has or has had stomach or duodenal ulcers in the past, as the medicine may exacerbate its symptoms.
• if the patient has severe liver or kidney function disorders.

Severe skin reactions associated with the use of bromhexine hydrochloride have been reported.
If a rash appears (including changes in mucous membranes, e.g. mouth, throat, nose, eyes, genitals), discontinue use of Flegamina Baby and contact a doctor immediately.

Flegamina Baby and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Bromhexine should be used with caution with atropine and other anticholinergic medicines, as they cause dryness of the mucous membranes.
Bromhexine should not be used simultaneously with cough suppressants (e.g. containing codeine and its derivatives), as they may weaken the cough reflex and cause secretions to accumulate in the airways.
Bromhexine may enhance the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs on the mucous membrane of the gastrointestinal tract.
Concomitant use of Flegamina Baby with antibiotics (oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin) increases their concentration in lung tissue.

Flegamina Baby with food and drink

The medicine should be used after a meal.

Pregnancy and breastfeeding

This subsection does not apply to Flegamina Baby, as it is intended for use in children from 2 to 6 years old, but the following information is relevant to the active substance of the medicine, bromhexine hydrochloride.
If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor before using this medicine.
The medicine should not be used during the first three months of pregnancy.
In the remaining period of pregnancy, the medicine can be used only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
The medicine is not recommended during breastfeeding.

Driving and using machines

Caution should be exercised, as headaches, dizziness, or drowsiness may occur.
The medicine contains ethanol, which may impair the ability to drive vehicles and operate machinery.

Flegamina Baby contains ethanol 96% and methyl parahydroxybenzoate and propyl parahydroxybenzoate

1 ml of solution contains 40 mg of ethanol 96%.
This medicine contains 50 mg of alcohol (ethanol 96%) in the maximum single dose (25 drops). The amount of alcohol in the maximum single dose (25 drops) of this medicine is equivalent to 1.25 ml of 5% beer or 0.5 ml of 12.5% wine.
The small amount of alcohol in this medicine will not produce noticeable effects.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).

3. How to use Flegamina Baby

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
The medicine is for oral use.
Recommended dose:
children from 2 to 6 years old:
20 to 25 drops 3 times a day.

The maximum recommended duration of use of Flegamina Baby without medical supervision is 3 to 5 days.

Flegamina Baby should not be used in children under 2 years of age.
The medicine should be administered at equal intervals, after a meal.
Do not administer the medicine directly before bedtime.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Use of a higher than recommended dose of Flegamina Baby

In case of administration of a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
No symptoms of overdose of the medicine have been reported so far.
In case of overdose, activated charcoal should be administered. If necessary, the doctor will prescribe gastric lavage and symptomatic treatment.

Missed dose of Flegamina Baby

The medicine should be given to the child as soon as possible. When the time for the next dose is approaching, give the dose at the scheduled time. Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Flegamina Baby can cause side effects, although not everybody gets them.
Uncommon(may affect up to 1 in 100 people):

• upper abdominal pain, nausea, vomiting, diarrhea.

Rare(may affect up to 1 in 1,000 people):

• hypersensitivity reactions,
• rash, urticaria.

Frequency not known(frequency cannot be estimated from the available data):

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membrane, or submucosal tissue) and itching,
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis),
• headache, dizziness,
• bronchospasm,
• excessive sweating,
• indigestion,
• increased liver enzyme activity.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell 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:
Aleje Jerozolimskie 181C, 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 medicine.

5. How to store Flegamina Baby

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening: 28 days.
Do not use this medicine after the expiry date stated on the packaging. 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 pack and other information

What Flegamina Baby contains

• The active substance is bromhexine hydrochloride. 1 ml of solution (20 drops) contains 2 mg of bromhexine hydrochloride.
• The other ingredients are: propyl parahydroxybenzoate, methyl parahydroxybenzoate, ethanol 96%, hydrochloric acid 0.1 N, purified water.

What Flegamina Baby looks like and contents of the pack

Flegamina Baby is a clear, colorless, and odorless solution.
The packaging of the medicine is an orange or brown bottle containing 30 ml of solution, closed with a dropper for measuring and/or administering the dose, and a polypropylene or polyethylene cap.
The whole is placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Teva Czech Industries s.r.o.
Ostravská 305/29 Komárov
747 70 Opava
Czech Republic

Date of last revision of the leaflet: