Flegtac Oro

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Flegtac ORO, 4 mg, orally disintegrating tablets
Bromhexine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If symptoms worsen or do not improve after 5 days of use in adults or 3 days in children over 2 years, consult your doctor.

Table of contents of the leaflet

• 1. What is Flegtac ORO and what is it used for
• 2. Important information before taking Flegtac ORO
• 3. How to take Flegtac ORO
• 4. Possible side effects
• 5. How to store Flegtac ORO
• 6. Contents of the pack and other information

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

Flegtac ORO contains the active substance bromhexine hydrochloride, which acts as an expectorant, thinning the secretion of the respiratory tract. Bromhexine facilitates expectoration and soothes cough.
Flegtac ORO is used in acute and chronic respiratory diseases with impaired expectoration and sputum clearance.
If symptoms worsen or do not improve after 5 days of use in adults or 3 days in children over 2 years, consult your doctor. This medicine should not be used for more than 7 days without consulting a doctor.

2. Important information before taking Flegtac ORO

When not to use Flegtac ORO

• if you are 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, discuss it with your doctor or pharmacist if:

• you have inflammatory respiratory diseases with accompanying bacterial infection, Flegtac ORO should be taken simultaneously with antibiotics and bronchodilators prescribed by your doctor. During treatment, drink plenty of fluids, especially if you have a fever. Proper hydration helps to thin out bronchial secretions and facilitates expectoration.
• you are at risk of stomach or duodenal ulcers, have a history of stomach or duodenal ulcers, or have active stomach or duodenal ulcers.
• you have asthma.
• you have impaired motor function of the bronchi, e.g., a disease called ciliary dyskinesia

of the respiratory tract.

• you have impaired liver or kidney function.
• you have difficulty expectorating.
• severe skin reactions associated with bromhexine use have been reported. If a rash occurs (including blisters or changes in mucous membranes, e.g., mouth, throat, nose, eyes, genitals), discontinue Flegtac ORO and consult your doctor immediately.

Children

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

Flegtac ORO and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Flegtac ORO should be used with caution with atropine and other anticholinergic medicines, as they cause dryness of the mucous membranes.
Flegtac ORO should not be taken simultaneously with cough suppressants, e.g., those containing codeine or its derivatives, as this may lead to dangerous accumulation of bronchial secretions due to weakened cough reflex.
Bromhexine may enhance the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs on the gastrointestinal mucosa.
Concomitant use of bromhexine and antibiotics (medicines used to treat infections: amoxicillin, cefuroxime, erythromycin, doxycycline) may lead to increased antibiotic concentration in the lungs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Flegtac ORO is not recommended during the first trimester 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.
If you are breastfeeding, consult your doctor before using this medicine.
Bromhexine passes into breast milk.
Flegtac ORO is not recommended during breastfeeding.
There are no data on the effect of bromhexine on human fertility.

Driving and using machines

No studies have been conducted on the effect of bromhexine on the ability to drive and use machines. Be cautious, as dizziness or drowsiness may occur.

3. How to take Flegtac ORO

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults, including the elderly

2 tablets 3 times a day.
At the beginning of treatment, it may be necessary to increase the dose to 48 mg (maximum dose) (4 tablets 3 times a day, equivalent to 48 mg of bromhexine).

Children and adolescents

Adolescents over 12 years of age: 2 tablets 3 times a day, up to a maximum of 12 tablets per day (equivalent to 48 mg of bromhexine).
Children between 6 and 12 years of age: 1 tablet 3 times a day, up to a maximum of 4 tablets per day (equivalent to 16 mg of bromhexine).
Children between 2 and 6 years of age: half a tablet 3 times a day, up to a maximum of 2 tablets per day (equivalent to 8 mg of bromhexine).

Method of administration

Oral use.
Do not touch Flegtac ORO tablets with wet hands, as they may disintegrate.
Place the Flegtac ORO orally disintegrating tablet in the mouth, where it will quickly dissolve in saliva and can be easily swallowed. Alternatively, just before administration, the tablet can be dissolved in a small amount of drinking water on a spoon. The dose should be taken immediately after opening the blister pack.
The tablet can be divided into equal doses.
The remaining half of the tablet should be placed in the opened blister pack and used no later than the next day.
Caution should be exercised when administering the medicine to small children due to the risk of choking.
The medicine should be taken at equal intervals, after a meal.

Do not take the medicine directly before bedtime.

Do not use for more than 7 days without consulting a doctor. If symptoms worsen or do not improve after 5 days of use in adults or 3 days in children over 2 years, consult your doctor.
If you take more than the recommended dose of Flegtac ORO
In case of overdose, consult your doctor immediately.
Symptoms observed in case of accidental overdose are similar to the adverse effects of bromhexine at recommended doses and require symptomatic treatment. Excessive increase in secretions may occur.
In case of overdose, the doctor will perform gastric lavage, administer activated charcoal, and provide symptomatic treatment.

Missing a dose of Flegtac ORO

If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. In this case, skip the missed dose and continue with the recommended schedule. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flegtac ORO can cause side effects, although not everybody gets them.
Immediately inform your doctor or go to the nearest hospital if you experience:

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

The following side effects may occur.

Uncommon (occurring in less than 1 in 100 patients):

upper abdominal pain, nausea, vomiting, diarrhea.

Rare (occurring in less than 1 in 1000 patients):

hypersensitivity reactions, skin rash, urticaria.

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

indigestion, 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, drowsiness, bronchospasm.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Flegtac ORO

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicine. Store in the original package to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Flegtac ORO contains

• The active substance is bromhexine hydrochloride. One orally disintegrating tablet contains 4 mg of bromhexine hydrochloride.
• The other ingredients are: mannitol, crospovidone (type B), sucralose, colloidal anhydrous silica, magnesium stearate, strawberry flavor consisting of: natural flavoring substances, flavoring preparations, corn maltodextrin, modified corn starch.

What Flegtac ORO looks like and contents of the pack

Flegtac ORO: white, round, orally disintegrating tablets with a dividing line, flat on both sides with a beveled edge, 7 mm in diameter.
The tablet can be divided into equal doses.
The pack contains 20 or 40 orally disintegrating tablets.

Marketing authorization holder

TACTICA Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
tel.: +48 889 388 538
{logo of the marketing authorization holder}

Manufacturer

Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny
Date of last revision of the leaflet:01/2025