PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Flegtac ORO, 4 mg, orodispersible tablets
Bromhexini hydrochloridum
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms worsen or do not improve after 5 days of treatment in adults or after 3 days in children over 2 years of age, consult your doctor.

Table of contents

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

1. What Flegtac ORO is and what it is used for

Flegtac ORO contains as the active substance bromhexine hydrochloride, which acts as an expectorant by liquefying mucus secretions from the respiratory tract. Bromhexine facilitates expectoration and relieves cough.
This medicine is indicated in acute and chronic respiratory conditions associated with impaired expectoration and mucus clearance.
If symptoms worsen or do not improve after 5 days of treatment in adults or after 3 days in children over 2 years of age, consult your doctor. This medicine should not be used for longer than 7 days without consulting a doctor.

2. Information before taking Flegtac ORO

When not to use Flegtac ORO

if the patient is allergic (hypersensitive) to bromhexine or any of the other ingredients of the medicine (listed in section 6),
in children under 2 years of age.

Warnings and precautions
Before starting treatment with Flegtac ORO, consult a doctor or pharmacist if:

the patient has inflammatory respiratory conditions associated with bacterial infection; Flegtac ORO should be taken simultaneously with antibiotics and bronchodilators as prescribed by the doctor. During treatment, it is important to drink plenty of fluids, especially when fever is present. Adequate hydration helps to liquefy bronchial secretions and facilitates expectoration.
the patient has a risk of developing gastric or duodenal ulcer, a history of gastric or duodenal ulcer, or active gastric or duodenal ulcer disease.
the patient has asthma.
the patient has impaired bronchial motility, e.g. a condition called ciliary dyskinesia.
the patient has impaired liver or kidney function.
the patient has difficulty expectorating.
severe skin reactions associated with bromhexine use have been reported. If a rash occurs (including blisters or mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, or genital organs), discontinue use of Flegtac ORO immediately and contact a doctor without delay.

Children
Do not use in children under 2 years of age.
Before starting treatment with Flegtac ORO, consult a doctor or pharmacist.

Flegtac ORO and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Flegtac ORO should be used with caution together with atropine and other anticholinergic drugs, as they may cause dryness of mucous membranes.
Flegtac ORO should not be administered simultaneously with antitussive medicines, e.g. those containing codeine or its derivatives, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex.
Bromhexine may enhance the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs) on the gastrointestinal mucosa.
Concomitant use of bromhexine and antibiotics (medicines used to treat infections: amoxicillin, cefuroxime, erythromycin, doxycycline) may increase antibiotic concentrations in the lungs.

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.
Use of Flegtac ORO 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.
If the patient is breastfeeding, she should consult a doctor before using this medicine.
Bromhexine passes into human milk.
Use of the medicine is not recommended during breastfeeding.
There is no data available on the effect of bromhexine on fertility in humans.

Driving and using machines
Studies on the effect of bromhexine on the ability to drive vehicles and operate machinery have not been conducted. Caution is advised, as headache, dizziness or drowsiness may occur.

3. How to take Flegtac ORO

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults, including elderly people
2 tablets three times daily.
At the beginning of treatment, the dose may need to be increased to 48 mg (maximum dose) (4 tablets three times daily, corresponding to 48 mg of bromhexine).

Children and adolescents
Adolescents over 12 years of age: 2 tablets three times daily, up to a maximum of 12 tablets per day (corresponding to 48 mg of bromhexine).
Children aged 6 to 12 years: 1 tablet three times daily, up to a maximum of 4 tablets per day (corresponding to 16 mg of bromhexine).
Children aged 2 to 6 years: half a tablet three times daily, up to a maximum of 2 tablets per day (corresponding to 8 mg of bromhexine).

Method of administration
For oral use.
Do not handle Flegtac ORO tablets with wet hands, as they may disintegrate.
The Flegtac ORO tablet, which disperses in the mouth, should be placed in the oral cavity, where it will rapidly disperse in saliva and can be easily swallowed. Alternatively, immediately before administration, the tablet may be dissolved on a spoon in a small amount of drinking water. The dose should be taken immediately after opening the blister.
The tablet may be divided into equal doses.
The remaining half tablet should be stored in the open blister and used no later than the following day.
Exercise caution when administering the medicine to young children due to the risk of choking.
The medicine should be taken at regular intervals, after meals.
The medicine should not be administered immediately before bedtime.
Do not use for longer than 7 days without consulting a doctor. If symptoms worsen or do not improve after 5 days of treatment in adults or after 3 days in children aged 2 years and older, consult a doctor.

Taking more Flegtac ORO than recommended
In case of accidental overdose, seek medical advice immediately.
Symptoms observed in cases of accidental overdose are similar to the adverse effects of bromhexine at recommended doses and require symptomatic treatment. Excessive increase in secretion may occur.
In case of overdose, the doctor may perform gastric lavage, administer activated charcoal, and provide symptomatic treatment.

If a dose of Flegtac ORO is missed
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. In that case, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Flegtac ORO can cause adverse reactions, although they do not occur in everyone.
Immediately notify a doctor or go to the nearest hospital if any of the following occur:

severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis),
allergic reactions (including rash, swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing).

The following adverse reactions may also occur:
Uncommon (occur less frequently than in 1 out of 100 patients):
upper abdominal pain, nausea, vomiting, diarrhoea.
Rare (occur less frequently than in 1 out of 1,000 patients):
hypersensitivity reactions, skin rash, urticaria.
Frequency not known (frequency cannot be estimated from available data):
dyspepsia, severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis), anaphylactic reactions including anaphylactic shock, angioedema, pruritus, hypotension, increased liver enzyme activity, headache, dizziness, somnolence, bronchospasm.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Flegtac ORO

Keep this medicine out of sight and reach of children.
There are no special requirements regarding storage temperature. Store in the original packaging
to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)" or "EXP".
The expiry date refers to the last day of the stated month.
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 Flegtac ORO contains

The active substance is bromhexine hydrochloride. One orodispersible tablet contains 4 mg of bromhexine hydrochloride.
Other ingredients are: mannitol, crospovidone (type B), sucralose, colloidal anhydrous silica, magnesium stearate, strawberry flavour with composition: natural flavouring substances, flavouring preparations, corn maltodextrin, modified corn wax starch.

What Flegtac ORO looks like and contents of the pack
Flegtac ORO: white, round orodispersible tablets with a dividing line, biconvex, flat on both sides with a bevelled edge, 7 mm in diameter.
The tablet can be divided into equal doses.
The pack contains 20 or 40 orodispersible tablets.
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Królowej Jadwigi Street 148a/1a
30-212 Kraków
tel.: +48 889 388 538
{logo of the Marketing Authorisation Holder}
Manufacturer
Mako Pharma Sp. z o.o.
Władysława Reymonta Street 2
05-092 Dziekanów Leśny