Flegamina Classic Iunior o smaku truskavkovim

Leaflet attached to the packaging: information for the user

Flegamina Classic Junior strawberry flavor, 2 mg/5 ml, syrup

Bromhexine 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
the doctor, pharmacist, or nurse.

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

Table of contents of the leaflet

• 1. What is Flegamina Classic Junior strawberry flavor and what is it used for
• 2. Important information before taking Flegamina Classic Junior strawberry flavor
• 3. How to take Flegamina Classic Junior strawberry flavor
• 4. Possible side effects
• 5. How to store Flegamina Classic Junior strawberry flavor
• 6. Package contents and other information

1. What is Flegamina Classic Junior strawberry flavor and what is it used for

used for
Flegamina Classic Junior strawberry flavor syrup contains bromhexine hydrochloride as the active substance,
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 the use of Flegamina Classic Junior strawberry flavor is acute and chronic respiratory
tract diseases, accompanied by impaired coughing and mucus clearance.

2. Important information before taking Flegamina Classic Junior strawberry flavor

strawberry flavor

When not to take Flegamina Classic Junior strawberry flavor

• 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, due to the content of bromhexine.

Warnings and precautions

Before taking Flegamina Classic Junior strawberry flavor, the patient should discuss it with the doctor:

• if the patient has inflammatory respiratory tract diseases with accompanying bacterial infection. Flegamina Classic Junior strawberry flavor should be taken together with antibiotics and bronchodilators prescribed by the doctor. During treatment, the patient should drink plenty of fluids, especially if there is a fever. Proper hydration increases the thinning of bronchial secretions and facilitates coughing.
• if the patient has a history of stomach and duodenal ulcers or active stomach and duodenal ulcers, as the medicine may exacerbate their symptoms.
• if the patient has severe liver function disorders.
• if the patient has severe kidney function disorders.
• if the patient has intolerance to some sugars (see also "Flegamina Classic Junior strawberry flavor contains liquid maltitol").

Severe skin reactions associated with the use of bromhexine hydrochloride have been reported. If a rash occurs (including changes in the mucous membranes, e.g., mouth, throat, nose, eyes, genitals), the use of Flegamina Classic Junior strawberry flavor should be discontinued and the doctor should be consulted immediately.

Children

Due to the content of bromhexine, Flegamina Classic Junior strawberry flavor should not be used in children under 2 years of age.

Flegamina Classic Junior strawberry flavor and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken by the patient or recently taken, as well as any medicines planned to be taken, including those available without a prescription.
Flegamina Classic Junior strawberry flavor should not be used with:

• cough suppressants, e.g., containing codeine and its derivatives, as they may weaken the cough reflex and cause mucus to accumulate in the airways.

Flegamina Classic Junior strawberry flavor should be used with caution when taken with:

• atropine and other anticholinergic medicines, as they cause dryness of the mucous membranes.
• salicylates and other nonsteroidal anti-inflammatory drugs, as the medicine may enhance their irritating effect on the gastrointestinal mucosa.
• antibiotics, such as oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin, as concomitant use of the medicine with these antibiotics increases their concentration in lung tissue.

Taking Flegamina Classic Junior strawberry flavor with food and drink

The medicine should be taken after a meal.

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 the doctor or pharmacist before taking this medicine.
Pregnancy
The use of the medicine is not recommended 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.
Breastfeeding
The doctor should be consulted before taking the medicine.
The use of the medicine is not recommended during breastfeeding.

Driving and using machines

Care should be taken, as headaches, dizziness, or drowsiness may occur.

Flegamina Classic Junior strawberry flavor contains liquid maltitol (E 965)

5 ml of the syrup contains 1500 mg of liquid maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should consult the doctor before taking the medicine. In adults and children over 12 years of age, the medicine may have a mild laxative effect at doses above 10 g of liquid maltitol. The caloric value is 2.3 kcal/g of maltitol.

Flegamina Classic Junior strawberry flavor contains benzoic acid (E 210)

The medicine contains 1.5 mg of benzoic acid in 5 ml of the syrup.

3. How to take Flegamina Classic Junior strawberry flavor

This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.
The medicine is for oral use.
The recommended dose is:

Using the enclosed measuring spoon or measuring cup, the volume of the syrup should be measured according to the patient's age.
Flegamina Classic Junior strawberry flavor syrup, due to the content of bromhexine, should not be given to children under 2 years of age.
The medicine should be taken at equal intervals, after a meal.
The medicine should not be taken directly before bedtime.
Flegamina Classic Junior strawberry flavor syrup does not contain alcohol.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult the doctor.

Taking a higher dose of Flegamina Classic Junior strawberry flavor than recommended

No symptoms of bromhexine overdose 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.
In case of taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of Flegamina Classic Junior strawberry flavor

If a dose of the medicine is missed, it should be taken as soon as possible. When the time for the next dose is approaching, it should be taken at the scheduled time.
A double dose should not be taken to make up for the missed dose.
If there are any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Flegamina Classic Junior strawberry flavor, the following side effects may occur:
Uncommon(may affect up to 1 in 100 people):

• upper abdominal pain, nausea, vomiting, diarrhea

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

• hypersensitivity reactions, rash, urticaria

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

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

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed.
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 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Flegamina Classic Junior strawberry flavor

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Shelf life after first opening the bottle: 28 days.
The medicine should not be used after the expiry date stated on the carton and bottle after "EXP:" or "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Flegamina Classic Junior strawberry flavor contains:

• The active substance of the medicine is bromhexine hydrochloride. 5 ml of the syrup contains 2 mg of bromhexine hydrochloride.
• The other ingredients are: citric acid monohydrate (E 330), sucralose (E 955), liquid maltitol (E 965), hydroxyethylcellulose, benzoic acid (E 210), strawberry flavor (contains, among others, propylene glycol (E 1520)), purified water.

What Flegamina Classic Junior strawberry flavor looks like and what the package contains

Flegamina Classic Junior strawberry flavor is a clear syrup with a strawberry flavor in an orange glass bottle containing 120 ml or 200 ml of the syrup. The bottle is closed with a polypropylene cap with a foam LDPE/HDPE seal and a guarantee ring made of LDPE in a cardboard box. A measuring spoon with a scale of 1 ml; 1.25 ml; 2 ml; 2.5 ml; 3 ml; 4 ml; 5 ml or a polypropylene measuring cup with a scale of 1.25 ml; 2.5 ml; 5 ml; 7.5 ml; 10 ml is attached to the package.

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 Krakow
Teva Czech Industries s.r.o., Ostravská 305/29, Komárov, 747 70 Opava, Czech Republic

Date of last revision of the leaflet: