Package leaflet: Information for the patient

Flegamina MAX, 8 mg/5 mL, syrup
Bromhexini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Table of contents

What Flegamina MAX is and what it is used for
Important information before taking Flegamina MAX
How to take Flegamina MAX
Possible side effects
How to store Flegamina MAX
Contents of the pack and other information

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

Flegamina MAX syrup contains bromhexine hydrochloride, which acts as an expectorant and liquefies respiratory secretions. The medicine facilitates the expectoration of thick mucus in productive cough and helps clear the bronchi.
Flegamina MAX is indicated in acute and chronic respiratory tract diseases associated with impaired mucus expectoration and clearance in adults, adolescents, and children aged 7 years and older.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

2. Important information before taking Flegamina MAX

When not to use Flegamina MAX:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
in patients with rare hereditary fructose intolerance.
in children under 7 years of age.

Warnings and precautions
Before starting treatment with Flegamina MAX, consult a doctor or pharmacist.

in patients with inflammatory respiratory conditions accompanied by bacterial infection. Flegamina MAX should be taken simultaneously with antibiotics and bronchodilators prescribed by the doctor. Adequate hydration of the patient is particularly important, especially when fever is present. Proper hydration increases the liquefaction of bronchial secretions and facilitates expectoration.
in patients with a history of peptic ulcer disease, as well as active gastric or duodenal ulcers, because the medicine may exacerbate symptoms.
in patients with severe liver function disorders.
in patients with severe kidney function disorders.
if the patient develops a rash (including mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, genital organs), discontinue use of Flegamina MAX immediately and contact a doctor without delay. Cases of severe skin reactions associated with bromhexine hydrochloride have been reported (see section 4). Children Flegamina MAX must not be used in children under 7 years of age.

Flegamina MAX and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, including those available without a prescription.
Do not take Flegamina MAX with:

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

Use Flegamina MAX with caution when used concomitantly with:

atropine and other anticholinergic drugs, as they cause drying 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 of the medicine with these antibiotics increases their concentration in lung tissue.

Taking Flegamina MAX with food and drink
The medicine should be taken after meals.
Pregnancy and breastfeeding
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 trimester 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:
Use of the medicine is not recommended 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 MAX contains 96% ethanol
This 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 per dose for adults and adolescents over 12 years of age. The small amount of alcohol in this medicine will not cause noticeable effects.
Flegamina MAX contains benzoic acid (E 210)
The medicine contains 0.55 mg of benzoic acid in 5 mL of syrup, corresponding to 0.11 mg/mL of syrup.
Flegamina MAX contains sorbitol
The medicine contains 1.47 g of sorbitol in 5 mL of syrup, corresponding to approximately 0.3 g/mL of syrup. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolize fructose—has been diagnosed, the patient should consult a doctor before taking the 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 MAX contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 5 mL of syrup, meaning the medicine is considered "sodium-free".

3. How to take Flegamina MAX

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This is an oral medicine.
The appropriate volume of syrup, adjusted according to the patient's age, should be measured using the provided measuring device.
The recommended dose is:

Children aged 7 to 12 years: 2.5 mL of syrup three times daily
Adults and adolescents over 12 years of age: 5 mL of syrup three times daily

Do not take the medicine immediately before going to sleep.
Take the medicine after meals.
Do not use Flegamina MAX for longer than 7 days without consulting a doctor.
Taking more Flegamina MAX than recommended
Symptoms of overdose have not been reported so far. If more than the recommended dose has been taken, consult a doctor or pharmacist immediately. In case of overdose, activated charcoal should be administered. If necessary, the doctor may recommend gastric lavage and symptomatic treatment.
Missed dose of Flegamina MAX
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.
Stopping Flegamina MAX
If you have any further questions about 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.
The following adverse reactions may occur during treatment with Flegamina MAX:
Not common (may affect fewer than 1 in 100 people): abdominal pain in the upper part of the abdomen,
nausea, vomiting, diarrhoea
Rare (may affect fewer than 1 in 1,000 people): hypersensitivity, rash
Frequency not known (frequency cannot be estimated from the available data): anaphylactic
reactions, anaphylactic shock, headache, dizziness, somnolence, bronchospasm,
dyspepsia, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), urticaria, pruritus, excessive sweating, severe skin reactions (cases of serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP) have been reported with hydrobromide bromhexine) , increased liver enzyme activity, hypotension.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Flegamina MAX

Keep the medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Shelf-life after first opening of the bottle: 6 months
Do not use this medicine after the expiry date stated on the carton and bottle after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Flegamina MAX contains

The active substance is bromhexine hydrochloride. 5 mL of syrup contains 8 mg of bromhexine hydrochloride.
The other ingredients are: sorbitol liquid, non-crystallizing (70%), glycerol, benzoic acid (E 210), levomenthol, ethanol 96%, eucalyptus-menthol flavour (containing ethanol), citric acid monohydrate, purified water.

What Flegamina MAX looks like and contents of the pack
Flegamina MAX is a clear, slightly opalescent, colourless syrup with an eucalyptus-menthol odour and taste, contained in a 120 mL or 200 mL amber glass type III bottle with a white polypropylene screw cap with polyethylene foam seal and polyethylene tamper-evident ring, packed in a cardboard box. The pack includes a polypropylene measuring cup with a capacity of 10 mL, marked with graduations at 1.25 mL, 2.5 mL, 5 mL, 7.5 mL, and 10 mL.
Marketing Authorisation Holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer
Teva Czech Industries s.r.o., Ostravská 305/29, Komárov, 747 70 Opava, Czech Republic
For further information, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland
Tel.: +48 22 345 93 00; Fax: +48 22 345 93 01; Email: [email protected]