Flegafortan

Patient Information Leaflet

Flegafortan, 0.8 mg/ml, syrup
Bromhexini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as 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 physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days in adults or after 3 days in children aged 2 years and older, or if symptoms worsen, consult your physician.

Table of Contents

1. What Flegafortan is and what it is 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 Flegafortan is and what it is used for

Flegafortan is an oral syrup. It contains the active substance bromhexine hydrochloride, which has an expectorant and mucolytic effect, helping to liquefy respiratory tract secretions.
Flegafortan facilitates expectoration and clears the bronchi from thick mucus.
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 2 years and older), or if symptoms worsen, consult your physician.

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 2 years of age.

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

• if the patient is taking other medicines. Do not use Flegafortan together with antitussive medicines or drugs that reduce bronchial secretion;
• 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 liver function disorders or renal insufficiency, as in these patients the elimination of bromhexine and its metabolites is reduced. During treatment, a significant increase in bronchial secretion may occur. If symptoms persist, contact your doctor.

Severe skin reactions associated with the use of bromhexine hydrochloride have been reported. If a rash occurs (including lesions of mucous membranes, e.g. oral cavity, throat, nose, eyes, genital organs), discontinue use of Flegafortan and contact your doctor immediately.

Children
Flegafortan must not be used in children under 2 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.

Do not use Flegafortan with antitussive medicines, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex.

Use Flegafortan with caution when taking:

• atropine and other anticholinergic drugs, as they cause dryness of mucous membranes;
• salicylates and other non-steroidal anti-inflammatory drugs, as the medicine may enhance their 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 and breastfeeding
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
Flegafortan is not recommended during breastfeeding, as it passes into breast milk. The doctor will decide whether the patient should discontinue breastfeeding or discontinue use of Flegafortan.

Driving and operating machinery
No studies have been conducted on the effects of bromhexine on the ability to drive vehicles or operate machinery. Exercise caution, as headache, dizziness, or drowsiness may occur.

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

Liquid, non-crystallizing 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 the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot metabolize fructose, 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 women, 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 information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral use.
Recommended dose:
Adults and adolescents over 12 years of age: 10 ml of syrup (2 measuring spoons) three times daily.
Children from 6 to 12 years of age: 5 ml of syrup (1 measuring spoon) three times daily.
Children from 2 to 6 years of age: 2.5 ml of syrup (half a measuring spoon) three times daily.
Flegafortan should not be used before going to sleep.
The medicine should be taken only during the presence of symptoms. Without consulting a doctor, Flegafortan should not be used for longer than 5 days in adults and longer than 3 days in children aged 2 years and above.
Flegafortan must not be used in children under 2 years of age.
Taking more Flegafortan than recommended
If more medicine has been taken than recommended, contact your doctor.
An unintended increase in bronchial secretion volume may occur.
If you forget to take Flegafortan
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 a doctor or go to the nearest hospital if 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:
Not common (may occur in fewer than 1 in 100 people):

• nausea, vomiting, diarrhoea, abdominal pain.

Rare (may occur in fewer than 1 in 1000 people):

• hypersensitivity reactions;
• skin rash, urticaria.

Frequency unknown (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, somnolence;
• hypotension;
• bronchospasm;
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised 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 a 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Flegafortan

Keep the medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicine.
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. Such measures help protect the environment.

6. Contents of the packaging 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: 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 smell.
The medicine is packed in an amber glass type III bottle with a polyethylene (PE) cap with a tamper-evident seal, placed in a cardboard box. A measuring spoon made of polypropylene (PP) is attached to the bottle.
The pack contains 125 ml of 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 8, 15 e 16
Mortágua, 3450-232
Portugal