Package leaflet: Information for the patient

Flegafortan, 1.6 mg/ml, syrup
Bromhexini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because 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 doctor, pharmacist, or nurse.

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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 5 days in adults or after 3 days in children aged 6 years and older, or if symptoms worsen, consult your doctor.

Table of contents

What Flegafortan is and what it is used for
What you need to know before taking Flegafortan
How to take Flegafortan
Possible side effects
How to store Flegafortan
Contents of the pack and other information

1. What Flegafortan is and what it is used for

Flegafortan is a syrup containing the active substance bromhexine hydrochloride, which has an expectorant effect and helps to liquefy respiratory tract secretions.
Flegafortan facilitates expectoration and bronchial clearance.
Flegafortan is indicated:

in acute and chronic respiratory tract diseases associated with difficulty in expectorating thick bronchial secretions.

If there is no improvement after 5 days (in adults) or 3 days (in children aged 6 years and older), or if the patient feels worse, consult a doctor.

2. Important information before taking Flegafortan

When not to take Flegafortan:

if the patient is allergic to bromhexine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
if the patient has active peptic ulcer disease of the stomach or duodenum, as the medicine may irritate the gastric or duodenal mucosa and worsen symptoms of the disease;
in children under 6 years of age.

Warnings and precautions
Before starting to take Flegafortan, discuss this with your doctor or pharmacist:

if the patient is taking other medicines. Flegafortan must not be used concomitantly with antitussive medicines or drugs that reduce bronchial secretions;
if the patient has a history of peptic ulcer disease of the stomach or duodenum;
if the patient suffers from bronchial asthma;
if the patient has impaired liver function or renal insufficiency, as elimination of bromhexine and its metabolites is reduced in these patients. During treatment, a significant increase in bronchial secretion may occur. If symptoms persist, contact your doctor.

Severe skin reactions associated with bromhexine hydrochloride have been reported.
If a rash appears (including lesions on mucous membranes, e.g. oral cavity, throat,
nose, eyes, genital organs), discontinue use of Flegafortan immediately and contact
your doctor without delay.
Children
Flegafortan must not be used in children under 6 years of age.
Flegafortan and other medicines
Tell your 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.
Flegafortan must not be used with antitussive medicines, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex.
Flegafortan should be used with caution with:

atropine and other anticholinergic medicines, as they cause dryness of mucous membranes;
salicylates and other non-steroidal anti-inflammatory drugs, as the medicine may enhance the irritating effect on the gastrointestinal mucosa. Concomitant use of bromhexine with antibiotics such as oxytetracycline, erythromycin, ampicillin, doxycycline, and amoxicillin increases their concentration in lung tissue.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
As a precautionary measure, it is recommended to avoid using Flegafortan during pregnancy.
Breastfeeding
Use of the medicine during breastfeeding is not recommended, as it passes into breast milk.
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.
Flegafortan contains non-crystallizing liquid sorbitol, propylene glycol, methyl and propyl
parahydroxybenzoate, benzyl alcohol, sodium and benzoic acid
Non-crystallizing liquid sorbitol
The medicine contains 760 mg of sorbitol in each ml of syrup. Calorific value: 2.6 kcal/g of sorbitol.
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 break down 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.
Propylene glycol
The medicine contains 40.3 mg of propylene glycol in each ml of syrup.
Methyl and propyl parahydroxybenzoate
The medicine contains methyl and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
Benzyl alcohol
The medicine contains 0.06 mg of benzyl alcohol in each ml of syrup.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Sodium
The medicine contains 0.011 mg of sodium in each ml of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium per ml of syrup, meaning the medicine is considered "sodium-free".
Benzoic acid
The medicine contains 0.000012 mg of benzoic acid in each ml of syrup.

3. How to take Flegafortan

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral administration.
Recommended dose:
Adults and adolescents over 12 years of age: 5 ml of syrup (1 measuring spoon) three times daily.
Children aged 6 to 12 years: 2.5 ml of syrup (half a measuring spoon) three times daily.
Flegafortan should not be taken before going to sleep.
Without consulting a doctor, Flegafortan should not be used for longer than 5 days in adults and longer than 3 days in children aged 6 years and older.
Flegafortan must not be used in children under 6 years of age.
Taking more Flegafortan than recommended
If more medicine is taken than recommended, contact your doctor.
An unintended increase in bronchial secretion volume may occur.
If you miss a dose of Flegafortan
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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.
You should immediately inform your doctor or go to the nearest hospital if any of the following occur:

Angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues). Swelling in the head and neck area may cause difficulty in swallowing and breathing;
Anaphylactic shock (skin rash, itching of hands and feet spreading throughout the body, swelling of the face, lips or throat causing breathing difficulties, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, cold extremities, loss of consciousness, cardiac arrest).

The following adverse reactions may occur:
Uncommon (may occur in fewer than 1 in 100 people):

Nausea, vomiting, diarrhoea, abdominal pain.

Rare (may occur in fewer than 1 in 1,000 people):

Hypersensitivity reactions;
Skin rash, urticaria.

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

Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching;
Headache, dizziness, drowsiness;
Low blood pressure;
Bronchospasm;
Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
Increased liver enzyme activity.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flegafortan

Keep the medicine out of the sight and reach of children.
There are no special requirements regarding storage temperature.
Store in the original packaging to protect from light.
Do not use the syrup if it is cloudy.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the stated month.
The shelf-life after first opening the bottle is 3 months.
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 Flegafortan contains

The active substance is bromhexine hydrochloride. 1 ml of syrup contains 1.6 mg of bromhexine hydrochloride. 5 ml of syrup (1 measuring spoon) contains 8 mg of bromhexine hydrochloride.
Other ingredients are: sorbitol liquid, non-crystallizing (E 420), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin (E 954), cherry flavour (propylene glycol, benzyl alcohol, triethyl citrate, DL-lactic acid, 4-methoxyacetophenone, 3-hydroxy-2-methyl-4-pyrone (maltol), anisaldehyde, benzoic acid), purified water.

What Flegafortan looks like and contents of the pack
Flegafortan is a clear, colourless syrup with a characteristic cherry odour.
The medicine is packed in an amber glass type III bottle with a polyethylene (PE) closure and a tamper-evident seal, placed in a cardboard box. A polypropylene (PP) measuring spoon is included with the bottle.
Pack sizes: 125 ml, 200 ml syrup.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 15 e 16
Mortágua, 3450-232
Portugal