Flegamina Classic o smaku malinovim

Leaflet attached to the packaging: information for the user

Flegamina Classic with raspberry flavor, 4 mg/5 ml, syrup

Bromhexine hydrochloride

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

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

• The 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, they should inform the doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact the doctor.

Table of contents of the leaflet:

• 1. What is Flegamina Classic with raspberry flavor and what is it used for
• 2. Important information before using Flegamina Classic with raspberry flavor
• 3. How to use Flegamina Classic with raspberry flavor
• 4. Possible side effects
• 5. How to store Flegamina Classic with raspberry flavor
• 6. Package contents and other information

1. What is Flegamina Classic with raspberry flavor and what is it used for

Flegamina Classic with raspberry flavor syrup contains bromhexine hydrochloride as the active substance, which acts as an expectorant, thinning the secretions from the respiratory tract. The medicine facilitates coughing up and cleaning of the bronchi.
Flegamina Classic with raspberry flavor is indicated in acute and chronic respiratory diseases, characterized by disorders of coughing up and removing mucus.

2. Important information before using Flegamina Classic with raspberry flavor

When not to use Flegamina Classic with raspberry 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 7 years of age.

Warnings and precautions

Before starting to use Flegamina Classic with raspberry flavor, the patient should discuss it with their doctor:

• -if the patient has inflammatory diseases of the respiratory tract with accompanying bacterial infection. Flegamina Classic with raspberry flavor should be taken simultaneously with antibiotics and bronchodilators prescribed by the doctor. During treatment, the patient should drink plenty of fluids, especially if they have a fever. Proper hydration of the body increases the thinning of bronchial secretions and facilitates coughing up.
• 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 the section "Flegamina Classic with raspberry flavor contains liquid maltitol (E965)").

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 with raspberry flavor should be discontinued and the doctor should be consulted immediately.

Children

Flegamina Classic with raspberry flavor should not be used in children under 7 years of age.

Flegamina Classic with raspberry flavor and other medicines

The patient should inform the doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Flegamina Classic with raspberry flavor should not be used with:

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

Flegamina Classic with raspberry flavor should be used with caution when taken simultaneously with:

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

Using Flegamina Classic with raspberry flavor with food and drink

The medicine should be taken after a meal.

Pregnancy and breastfeeding

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 using 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 may be used only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding:
The medicine should not be used during breastfeeding.

Driving and operating machinery

Care should be taken, as the medicine may cause headaches, dizziness, or drowsiness.

Flegamina Classic with raspberry flavor contains benzoic acid (E 210)

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

Flegamina Classic with raspberry flavor contains benzyl alcohol

The medicine contains 0.875 micrograms of benzyl alcohol in 5 ml of syrup. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (metabolic acidosis). Patients with liver or kidney diseases should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (metabolic acidosis).

Flegamina Classic with raspberry flavor contains liquid maltitol (E965)

5 ml of syrup contains 1500 mg of liquid maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Flegamina Classic with raspberry flavor

This medicine should always be used 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:
Children from 7 to 12 years of age:5 ml 3 times a day.
Adults and adolescents over 12 years of age:10 ml 3 times a day.
The medicine should not be taken directly before bedtime.

Using a higher dose of Flegamina Classic with raspberry flavor than recommended

No symptoms of bromhexine overdose have been reported.
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 with raspberry flavor

If a dose is missed, it should be taken as soon as possible. If 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 a missed dose.
If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Flegamina Classic with raspberry flavor can cause side effects, although not everybody gets them.
During the use of Flegamina Classic with raspberry flavor, the following side effects may occur:
Uncommon(may occur in up to 1 in 100 people):

• upper abdominal pain, nausea, vomiting, diarrhea

Rare(may occur in 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 membrane, 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 side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of 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 allow for the collection of more information on the safety of the medicine.

5. How to store Flegamina Classic with raspberry flavor

Store in a place out of sight and reach of children.
Store at a temperature below 30°C.
Shelf life after first opening the bottle: 28 days.
Do not use this medicine after the expiry date stated on the carton and bottle after the statement "Expiry date (EXP):" or "EXP:". The expiry date stated is the last day of the specified month. The batch number on the packaging is located after the abbreviation "Lot".
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 used. This will help protect the environment.

6. Package contents and other information

What Flegamina Classic with raspberry flavor contains

• The active substance is bromhexine hydrochloride. 5 ml of syrup contains 4 mg of bromhexine hydrochloride.
• The other ingredients are: citric acid monohydrate, hydroxyethylcellulose (E 1525), liquid maltitol (E 965), sucralose (E 955), benzoic acid (E 210), raspberry flavor liquid (contains, among others, propylene glycol (E 1520) and benzyl alcohol), purified water.

What Flegamina Classic with raspberry flavor looks like and what the package contains

Flegamina Classic with raspberry flavor is a clear syrup with a raspberry smell and taste in a brown glass or colored glass bottle with an aluminum or polypropylene cap with a polyethylene (LDPE or HDPE) foam seal and a polyethylene LDPE ring, along with a measuring cup made of polystyrene or polypropylene, in a cardboard box.

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: