Flegtac Oro

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Flegtac ORO, 8 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 a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 adolescents over 12 years of age, consult a doctor. This medicine should not be used for more than 7 days without consulting a 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 package and other information

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

Flegtac ORO contains the active substance bromhexine hydrochloride, which has an expectorant effect, thinning the secretion of the respiratory tract. Bromhexine facilitates expectoration and alleviates cough.

The medicine 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 treatment in adults or after 3 days in adolescents over 12 years of age, consult a 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 the patient is hypersensitive (allergic) to bromhexine or any of the other ingredients of the medicine (listed in section 6),
• in children under 12 years of age.

Warnings and precautions

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

• the patient has inflammatory respiratory diseases with accompanying bacterial infection, Flegtac ORO should be taken simultaneously with antibiotics and bronchodilators prescribed by a doctor. During treatment, drink plenty of fluids, especially when there is a fever. Proper hydration helps to thin the bronchial secretion and facilitates expectoration.
• the patient is at risk of stomach and duodenal ulcers, has a history of stomach and duodenal ulcers, or has active stomach and duodenal ulcers.
• the patient has asthma.
• the patient has impaired motor function of the bronchi, such as a disease called ciliary dyskinesia.
• the patient has liver or kidney function disorders.
• the patient has difficulty expectorating.
• there have been reports of severe skin reactions associated with the use of bromhexine. If a rash occurs (including blisters or changes in the mucous membranes, such as the mouth, throat, nose, eyes, genitals), discontinue use of Flegtac ORO and consult a doctor immediately.

Children

Do not use the medicine in children under 12 years of age.

Before starting treatment with Flegtac ORO, consult a doctor or pharmacist.

For children between 2 and 12 years of age, it is recommended to use Flegtac ORO 4 mg.

Flegtac ORO and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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, such as those containing codeine or its derivatives, as this may lead to dangerous accumulation of bronchial secretion 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 (such as amoxicillin, cefuroxime, erythromycin, doxycycline) may lead to increased antibiotic concentration in the lungs.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

The use of 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 the patient is breastfeeding, they should consult a doctor before taking this medicine.

Bromhexine passes into human milk. The use of the medicine is not recommended during breastfeeding.

There is 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. Caution should be exercised, 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 a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults, including the elderly

1 tablet 3 times a day.

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

Children and adolescents

Adolescents over 12 years of age: 1 tablet 3 times a day, up to a maximum of 6 tablets per day (equivalent to 48 mg of bromhexine).

For children between 2 and 12 years of age, it is recommended to use Flegtac ORO 4 mg.

Method of administration

Oral use.

Flegtac ORO tablets should not be touched with wet hands, as they may disintegrate.

The Flegtac ORO orally disintegrating tablet should be placed in the mouth, where it will quickly dissolve in saliva and can be easily swallowed. Alternatively, the tablet can be dissolved in a small amount of drinking water on a spoon immediately before administration. The dose should be taken immediately after opening the blister.

The medicine should be taken at equal intervals, after a meal.

The medicine should not be taken 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 treatment in adults or after 3 days in adolescents over 12 years of age, consult a doctor.

In case of taking a higher dose of Flegtac ORO than recommended, consult a doctor immediately.

Symptoms observed in case of accidental overdose are similar to the side effects of bromhexine at recommended doses and require symptomatic treatment. Excessive increase in bronchial secretion 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 the patient forgets to take a dose, they should take it as soon as possible, 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 the patient has any further doubts about the use of this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Flegtac ORO can cause side effects, although not everybody gets them.

Consult a doctor or go to the nearest hospital immediately if the following occur:

• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis),
• allergic reactions (including rash, facial, 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, itching, decreased blood pressure, increased liver enzyme activity, headache, dizziness, drowsiness, bronchospasm.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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:

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 side effects will help gather more information on the safety of the medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Flegtac ORO

Keep out of sight and reach of children.

There are no special storage temperature recommendations 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 package 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. Consult a pharmacist on how to dispose of unused medicines. This will help protect the environment.

6. Contents of the package and other information

What Flegtac ORO contains

• The active substance of the medicine is bromhexine hydrochloride. One orally disintegrating tablet contains 8 mg of bromhexine hydrochloride.
• The other ingredients are: mannitol, crospovidone (type B), sucralose, colloidal anhydrous silica, magnesium stearate, strawberry flavor containing: natural flavoring substances, flavoring preparations, corn maltodextrin, modified corn starch.

What Flegtac ORO looks like and contents of the package

Flegtac ORO: white, round, flat, beveled-edge orally disintegrating tablets with a diameter of 9 mm.

The package 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