PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Flegtac ORO, 8 mg, orodispersible tablets
Bromhexini hydrochloridum
Please read this 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 leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects 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 adolescents over 12 years of age, consult a doctor. This medicine should not be used for longer than 7 days without consulting a 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 bromhexine hydrochloride as the active substance, which acts as an expectorant by liquefying mucus secretions from the respiratory tract. Bromhexine facilitates expectoration and relieves cough.
This medicine is used in acute and chronic respiratory conditions associated with impaired mucus expectoration and 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 longer than 7 days without consulting a doctor.

2. Information before taking Flegtac ORO

When not to take 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 12 years of age.

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

the patient has inflammatory respiratory conditions accompanied by bacterial infection; Flegtac ORO should be taken simultaneously with antibiotics and bronchodilators prescribed by a doctor. During treatment, it is important to drink plenty of fluids, especially when fever is present. Adequate hydration supports the liquefaction of bronchial secretions and facilitates expectoration.
the patient is at risk of gastric or duodenal ulcer disease, has a history of gastric or duodenal ulcer, or has active gastric or duodenal ulcer.
the patient has asthma.
the patient has impaired bronchial motility, e.g. a condition known as 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 lesions on mucous membranes, e.g. in the mouth, 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 12 years of age.
Before starting treatment with Flegtac ORO, consult a doctor or pharmacist.
For children aged 2 to 12 years, Flegtac ORO 4 mg is recommended.

Flegtac ORO and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Flegtac ORO should be used with caution with atropine and other anticholinergic drugs, as they may cause dryness of mucous membranes.
Flegtac ORO should not be taken 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 later stages 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 during breastfeeding is not recommended.
There are no data on the effect of bromhexine on human fertility.

Driving and operating machinery
No studies have been conducted on the effects of bromhexine on the ability to drive or operate machinery. 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults, including elderly people
1 tablet 3 times daily.
At the beginning of treatment, the dose may need to be increased to 48 mg (maximum dose) (2 tablets 3 times daily, corresponding to 48 mg of bromhexine).

Children and adolescents
Adolescents over 12 years of age: 1 tablet 3 times daily, up to a maximum of 6 tablets per day (corresponding to 48 mg of bromhexine).
For children aged 2 to 12 years, Flegtac ORO 4 mg formulation is recommended.

Method of administration
Oral administration.
Do not handle Flegtac ORO tablets with wet hands, as they may disintegrate.
The Flegtac ORO tablet that 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 pack.
The medicine should be taken at regular intervals, after meals.
Do not administer the medicine immediately before going to sleep.
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 adolescents over 12 years of age, consult a doctor.

Taking more Flegtac ORO than recommended
If more medicine has been taken than recommended, seek medical advice immediately.
Symptoms observed in 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.

Missing a dose of Flegtac ORO
If a dose has been missed, take it as soon as remembered, 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 not everyone experiences them.
Immediately inform 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, facial swelling, swelling of the lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing).

The following adverse reactions may also occur:
Uncommon (occur in less than 1 in 100 patients):
upper abdominal pain, nausea, vomiting, diarrhoea.
Rare (occur in less than 1 in 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 effects occur, including any not listed in this leaflet, inform a 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Flegtac ORO

Keep out of the sight and reach of children.
No special storage temperature requirements apply. 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 specified month.
Medicines must not be disposed of via wastewater or 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 Flegtac ORO contains

The active substance is bromhexine hydrochloride. One orodispersible tablet contains 8 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, biconvex orodispersible tablets with bevelled edges, 9 mm in diameter.
Pack contains 20 or 40 orodispersible tablets.
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Królowej Jadwigi 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 2
05-092 Dziekanów Leśny