Flegamina classic junior with strawberry flavor

Package leaflet: Information for the user

Flegamina Classic Junior o smaku truskawkowym, 2 mg/5 ml, syrup
Bromhexini 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 information leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or if you feel worse, contact your doctor.

Table of contents

1. What Flegamina Classic Junior o smaku truskawkowym is and what it is used for
2. What you need to know before taking Flegamina Classic Junior o smaku truskawkowym
3. How to take Flegamina Classic Junior o smaku truskawkowym
4. Possible side effects
5. How to store Flegamina Classic Junior o smaku truskawkowym
6. Contents of the pack and other information

1. What Flegamina Classic Junior o smaku truskawkowym is and what it is used for

Flegamina Classic Junior o smaku truskawkowym syrup contains bromhexine hydrochloride as the active substance, which is an expectorant and mucolytic agent that helps liquefy respiratory secretions. The medicine facilitates expectoration and clearance of the bronchi.
Flegamina Classic Junior o smaku truskawkowym is indicated for the treatment of acute and chronic respiratory tract diseases associated with impaired mucus clearance and expectoration.

2. Important information before using Flegamina Classic Junior strawberry-flavoured

When not to use Flegamina Classic Junior strawberry-flavoured

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

Warnings and precautions
Before starting to take Flegamina Classic Junior strawberry-flavoured, discuss with your doctor:

• if the patient has inflammatory respiratory conditions accompanied by bacterial infection. Flegamina Classic Junior strawberry-flavoured should be taken simultaneously with antibiotics and bronchodilators prescribed by the doctor. During treatment, it is important to drink plenty of fluids, especially if fever occurs. Adequate hydration enhances the liquefaction of bronchial secretions and facilitates expectoration.
• if the patient has a history of peptic ulcer disease of the stomach and duodenum or active peptic ulcer disease, as the medicine may exacerbate its symptoms.
• if the patient has severe liver function disorders.
• if the patient has severe kidney function disorders.
• if the patient has intolerance to certain sugars (see also "Flegamina Classic Junior strawberry-flavoured contains liquid maltitol").

Serious skin reactions associated with the use of bromhexine hydrochloride have been reported. If a rash occurs (including lesions on mucous membranes, e.g. oral cavity, throat, nose, eyes, genital organs), discontinue use of Flegamina Classic Junior strawberry-flavoured and contact a doctor immediately.

Children
Due to the presence of bromhexine, Flegamina Classic Junior strawberry-flavoured should not be used in children under 2 years of age.

Flegamina Classic Junior strawberry-flavoured and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Do not use Flegamina Classic Junior strawberry-flavoured with:

• antitussive medicines, e.g. those containing codeine and its derivatives, as they may suppress the cough reflex and lead to accumulation of secretions in the respiratory tract.

Use Flegamina Classic Junior strawberry-flavoured with caution when used concomitantly with:

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

Taking Flegamina Classic Junior strawberry-flavoured with food and drink
The medicine 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of the medicine is not recommended during the first three months of pregnancy.
During the remainder of pregnancy, the medicine should be used only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding
Consult a doctor before using the medicine.
Use of the medicine during breastfeeding is not recommended.

Driving and operating machinery
Exercise caution, as headache, dizziness or drowsiness may occur.

Flegamina Classic Junior strawberry-flavoured contains liquid maltitol (E 965)
5 ml of syrup contains 1500 mg of liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. In adults and children over 12 years of age, the medicine may have a mild laxative effect at doses exceeding 10 g of liquid maltitol. Calorific value: 2.3 kcal/g of maltitol.

Flegamina Classic Junior strawberry-flavoured contains benzoic acid (E 210)
The medicine contains 1.5 mg of benzoic acid in 5 ml of syrup.

3. How to take Flegamina Classic Junior o smaku truskawkowym

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

Using the provided measuring spoon or measuring device, measure the volume of syrup appropriate for the patient's age.
Due to its bromhexine content, Flegamina Classic Junior strawberry-flavoured syrup must not be administered to children under 2 years of age.
The medicine should be taken at regular intervals, after meals.
Do not take the medicine immediately before going to sleep.
Flegamina Classic Junior strawberry-flavoured syrup does not contain alcohol.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Taking a larger than recommended dose of Flegamina Classic Junior strawberry-flavoured syrup
Symptoms of bromhexine overdose have not been described so far.
In case of overdose, activated charcoal should be administered. If necessary, the doctor may recommend gastric lavage and symptomatic treatment.
If a larger than recommended dose of the medicine has been taken, seek immediate advice from a doctor or pharmacist.

Missing a dose of Flegamina Classic Junior strawberry-flavoured syrup
If a dose has been missed, take it as soon as possible. If it is almost time for the next dose, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
When using Flegamina Classic Junior strawberry-flavoured medicine, the following may occur:
Not common (may affect up to 1 in 100 people):

• pain in the upper part of the stomach, nausea, vomiting, diarrhoea

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

• hypersensitivity reactions, rash, urticaria

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

• headache, dizziness, somnolence,
• bronchospasm,
• dyspepsia,
• excessive sweating,
• increased liver enzyme activity,
• hypotension,
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues) and itching,
• serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Flegamina Classic Junior strawberry-flavoured medicine

Keep this medicine out of the sight and reach of children.
Store below 25°C. Protect from light.
Period of use after first opening the bottle: 28 days.
Do not use this medicine after the expiry date stated on the outer carton
and bottle following the words "Expiry date (EXP):" or "EXP:". The expiry date refers to the last
day of the stated month. The batch number on the packaging follows the abbreviation "Lot:".
Medicines must 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 Classic Junior strawberry-flavoured contains:

• The active substance is bromhexine hydrochloride. 5 ml of 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 flavour (containing, among others, propylene glycol (E 1520)), purified water.

What Flegamina Classic Junior strawberry-flavoured looks like and contents of the pack
Flegamina Classic Junior strawberry-flavoured is a clear, strawberry-flavoured syrup in an amber glass bottle containing 120 ml or 200 ml of syrup. The bottle is closed with a polypropylene screw cap with an LDPE/HDPE foam seal and an LDPE tamper-evident ring, packed in a cardboard box. An oral dosing spoon with graduations at 1 ml; 1.25 ml; 2 ml; 2.5 ml; 3 ml; 4 ml; 5 ml or a polypropylene dosing cup with graduations at 1.25 ml; 2.5 ml; 5 ml; 7.5 ml; 10 ml is provided in the package.

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

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