Flegamina classic with mint flavor sugar-free

Package leaflet: Information for the user

Flegamina Classic o smaku miętowym bez cukru, 4 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 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, please contact your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If your symptoms do not improve or if you feel worse, contact your doctor.

Table of contents:

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

1. What Flegamina Classic o smaku miętowym bez cukru is and what it is used for

Flegamina Classic o smaku miętowym bez cukru syrup contains bromhexine hydrochloride as the active substance, which acts as an expectorant and helps liquefy respiratory tract secretions.
The medicine facilitates expectoration and clearance of the bronchi. This medicine does not contain sugar.
Flegamina Classic o smaku miętowym bez cukru is indicated in acute and chronic respiratory diseases associated with impaired expectoration and mucus clearance.

2. What you need to know before taking Flegamina Classic o smaku miętowym bez cukru

Do not take Flegamina Classic o smaku miętowym bez cukru:

• if you are allergic to bromhexine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• in children under 7 years of age, because the medicine contains alcohol.

Warnings and precautions

Before taking Flegamina Classic o smaku miętowym bez cukru, consult your doctor:

• if you have inflammatory respiratory conditions accompanied by bacterial infection. Flegamina Classic o smaku miętowym bez cukru should be taken simultaneously with antibiotics and bronchodilators prescribed by your doctor. During treatment, drink plenty of fluids, especially if you have a fever. Adequate hydration enhances bronchial secretion thinning and facilitates expectoration.
• if you have a history of peptic ulcer disease or active peptic ulcer of the stomach or duodenum, as the medicine may worsen its symptoms.
• if you have severe liver function disorders.
• if you have severe kidney function disorders.

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• if you have intolerance to certain sugars (see also "Flegamina Classic o smaku miętowym bez cukru contains sorbitol").

Severe skin reactions have been reported with the use of bromhexine hydrochloride. If a rash occurs (including lesions of mucous membranes, e.g. in the mouth, throat, nose, eyes, or genital organs), discontinue use of Flegamina Classic o smaku miętowym bez cukru and contact your doctor immediately.

Children

Due to its alcohol content, Flegamina Classic o smaku miętowym bez cukru should not be used in children under 7 years of age.

Flegamina Classic o smaku miętowym bez cukru and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.

Do not take Flegamina Classic o smaku miętowym bez cukru with:

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

Use Flegamina Classic o smaku miętowym bez cukru with caution when taking simultaneously:

• atropine and other anticholinergic medicines, as they cause dryness of mucous membranes.
• salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs), as the medicine may intensify 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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

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

Breastfeeding:
Do not use this medicine during breastfeeding.

Driving and operating machinery

Exercise caution, as the medicine may cause headache, dizziness, or drowsiness. The medicine contains ethanol and may therefore impair the ability to drive or operate machinery.

Flegamina Classic o smaku miętowym bez cukru contains ethanol

The medicine contains 200 mg of alcohol (ethanol) in 5 ml of syrup. The amount of alcohol in 5 ml of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Flegamina Classic o smaku miętowym bez cukru contains propyl parahydroxybenzoate (E 216)

The medicine contains propyl parahydroxybenzoate and may cause allergic reactions (including delayed-type reactions).

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Flegamina Classic o smaku miętowym bez cukru contains sorbitol

The medicine contains sorbitol (5 ml of syrup contains 2.1 g of sorbitol). Sorbitol is a source of fructose. If you (or your child) have previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolize fructose, consult your doctor before taking this medicine or giving it to a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. The caloric value is 2.6 kcal/g of sorbitol.

Flegamina Classic o smaku miętowym bez cukru contains patent blue (E 131)

The medicine may cause allergic reactions.

Flegamina Classic o smaku miętowym bez cukru contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, meaning it is considered "sodium-free".

3. How to use Flegamina Classic o smaku miętowym bez cukru

This medicine should always be used as recommended by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This is an oral medicine.
Using the provided measuring spoon or measuring device, measure the volume of syrup appropriate
for the patient's age.
If the doctor has not specified a different dosage, the medicine is usually administered as follows:
Children aged 7 to 12 years: 5 ml of syrup – 3 times daily.
Adults and children over 12 years of age: 10 ml of syrup – 3 times daily.
Do not take the medicine immediately before going to sleep.
Use of a higher than recommended dose of Flegamina Classic o smaku miętowym bez cukru
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 higher than recommended dose of the medicine has been taken, consult a doctor or
pharmacist immediately.
Missed dose of Flegamina Classic o smaku miętowym bez cukru
If a dose is 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 regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When using Flegamina Classic o smaku miętowym bez cukru, the following may occur:
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Not common (may affect up to 1 in 100 people):

• abdominal pain, 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, drowsiness,
• bronchospasm,
• dyspepsia,
• excessive sweating,
• increased liver enzyme activity,
• hypotension,
• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue), and itching,
• severe 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flegamina Classic sugar-free mint-flavoured medicine

Keep out of sight and reach of children.
Store in the original packaging to protect from light.
Keep the bottle tightly closed.
Shelf life after first opening the bottle: 28 days.
Do not use this medicine after the expiry date stated on the cardboard box and on the bottle after "Expiry date (EXP):" or "EXP:". The expiry date refers to the last day of the stated month.
The batch number on the packaging is indicated after 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Flegamina Classic sugar-free mint-flavoured medicine contains

• The active substance is bromhexine hydrochloride. 5 ml of syrup contains 4 mg of bromhexine hydrochloride.
• Other ingredients are: sorbitol liquid, non-crystallizing, glycerol, ethanol 96%, propyl parahydroxybenzoate (E 216), levomenthol, eucalyptus-menthol flavour (containing, among others, ethanol), concentrated hydrochloric acid, patent blue (E 131), turmeric (turmeric (E 100), polysorbate 80 (E 433), propylene glycol (E 1520)), purified water.

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What Flegamina Classic sugar-free mint-flavoured medicine looks like and contents of the pack
Flegamina Classic sugar-free mint-flavoured medicine is a clear, light green syrup with a minty odour and taste, contained in an amber glass bottle with a capacity of 120 ml or 200 ml of syrup, packed in a cardboard box. The bottle is closed with a polypropylene screw cap with an LDPE/HDPE foam seal and an LDPE tamper-evident ring. A polystyrene measuring spoon graduated at 1 ml; 1.25 ml; 2 ml; 2.5 ml; 3 ml; 4 ml; 5 ml, or a polypropylene dosing cup graduated at 1.25 ml; 2.5 ml; 5 ml; 7.5 ml; 10 ml is included in the pack.

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

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

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