Flegafortan

Package Leaflet: Information for the Patient

Flegafortan, 0.8 mg/ml, Syrup

Bromhexine Hydrochloride

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

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 5 days in adults and after 3 days in children aged 2 years and above, there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Flegafortan and what is it used for

Flegafortan is a syrup. It contains the active substance bromhexine hydrochloride, which has an expectorant and mucolytic effect on the respiratory tract.

Flegafortan facilitates the expectoration and clearance of mucus from the airways.

Flegafortan is indicated:

• in acute and chronic respiratory diseases with difficult expectoration of thick bronchial secretions.

If after 5 days (in adults) or 3 days (in children aged 2 years and above) there is no improvement or the patient feels worse, a doctor should be consulted.

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 an active stomach or duodenal ulcer, as the medicine may irritate the gastric mucosa and exacerbate the symptoms of the disease;
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Flegafortan, the patient should discuss it with their doctor or pharmacist:

• if the patient is taking other medicines. Flegafortan should not be taken at the same time as cough suppressants and medicines that reduce the amount of bronchial secretions;

if the patient has a history of stomach or duodenal ulcer;

• if the patient has asthma;
• if the patient has liver or kidney function disorders, as the elimination of bromhexine and its metabolites is reduced in these patients. During treatment, a significant increase in bronchial secretions may occur. If the symptoms persist, a doctor should be consulted.

There have been reports of severe skin reactions associated with the use of bromhexine hydrochloride. If a rash occurs (including changes in the mucous membranes, such as the mouth, throat, nose, eyes, genitals), the use of Flegafortan should be discontinued and a doctor consulted immediately.

Children

Flegafortan should not be used in children under 2 years of age.

Flegafortan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Flegafortan should not be taken with cough suppressants, as it may lead to a dangerous accumulation of bronchial secretions due to a weakened cough reflex.

Flegafortan should be used with caution with:

• atropine and other anticholinergic medicines, as they cause dryness of the mucous membranes;
• salicylates and other nonsteroidal anti-inflammatory medicines, as they may enhance the irritating effect on the gastrointestinal mucosa.

The simultaneous use of bromhexine with antibiotics such as oxytetracycline, erythromycin, ampicillin, doxycycline, and amoxicillin increases their concentration in lung tissue.

Pregnancy and breastfeeding

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

Pregnancy

As a precaution, it is recommended to avoid using Flegafortan during pregnancy.

Breastfeeding

Flegafortan should not be used during breastfeeding, as it passes into breast milk. The doctor will decide whether the patient should stop breastfeeding or stop using Flegafortan.

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, headache, or drowsiness may occur.

Flegafortan contains sorbitol, liquid, non-crystallizing, propylene glycol, methyl and propyl parahydroxybenzoate, benzyl alcohol, sodium, and benzoic acid

Liquid sorbitol, non-crystallizing

The medicine contains 760 mg of sorbitol in each ml of syrup. The energy value is 2.6 kcal/g of sorbitol.

Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

Sorbitol may cause gastrointestinal discomfort and 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 (possible late-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 their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (such as 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 in each ml of syrup, which means it 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 package leaflet for the patient, or as directed by a doctor or pharmacist.

In case of doubt, a doctor or pharmacist should be consulted.

Oral administration.

Recommended dose:

Adults and adolescents over 12 years: 10 ml of syrup (2 measuring spoons) 3 times a day.

Children aged 6 to 12 years: 5 ml of syrup (1 measuring spoon) 3 times a day.

Children aged 2 to 6 years: 2.5 ml of syrup (half a measuring spoon) 3 times a day.

Flegafortan should not be taken before bedtime.

The medicine should only be taken during the occurrence of symptoms. Without consulting a doctor, Flegafortan should not be taken for more than 5 days in adults and more than 3 days in children aged 2 years and above.

Flegafortan should not be used in children under 2 years of age.

Taking a higher dose of Flegafortan than recommended

In case of taking a higher dose of the medicine than recommended, a doctor should be consulted.

An unintended increase in the volume of bronchial secretions may occur.

Missing a dose of Flegafortan

A double dose should not be taken to make up for a missed dose.

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

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

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membrane, or submucosal tissue). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• anaphylactic shock (rash on the skin, itching of the hands and feet, swelling of the face, lips, or throat, making breathing difficult, wheezing, shortness of breath, unpalpable pulse, significantly lowered blood pressure, sweating, cold limbs, loss of consciousness, cardiac arrest).

The following side effects may occur:

Uncommon(may affect up to 1 in 100 people):

• nausea, vomiting, diarrhea, abdominal pain.

Rare(may affect up to 1 in 1,000 people):

• allergic reactions;
• skin rash, urticaria.

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membrane, or submucosal tissue), and itching;
• headache, dizziness, drowsiness;
• lowered 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 side effects

If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl

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

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Flegafortan

The medicine should be stored out of sight and reach of children.

There are no special precautions for storage temperature.

Store in the original packaging to protect from light.

The syrup should not be used if it is cloudy.

The medicine should not be used after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.

The shelf life after opening the bottle is 3 months.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked 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 Flegafortan contains

• The active substance is bromhexine hydrochloride. 1 ml of syrup contains 0.8 mg of bromhexine hydrochloride. 5 ml of syrup (1 measuring spoon) contains 4 mg of bromhexine hydrochloride.
• The other ingredients are: liquid sorbitol, non-crystallizing (E 420), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin (E 954), cherry flavor (propylene glycol, benzyl alcohol, triethyl citrate, DL-lactic acid, 4-methoxyacetophenone, 3-hydroxy-2-methyl-4-pyrone (maltol), anise aldehyde, benzoic acid), purified water.

What Flegafortan looks like and contents of the pack

Flegafortan is a clear, colorless syrup with a characteristic cherry odor.

The packaging is a brown glass bottle type III with a polyethylene (PE) cap and a tamper-evident seal, in a cardboard box.

A measuring spoon made of polypropylene (PP) is attached to the bottle.

The packaging contains 125 ml of syrup.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

phone: (42) 22-53-100

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

Mortágua, 3450-232

Portugal

Date of last revision of the package leaflet:28.03.2023