Package leaflet: Information for the user

Flegamax, 50 mg/ml, oral solution
Carbocisteine
Please read the entire leaflet carefully before using 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
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens after 4 to 5 days of treatment, consult your doctor.

Table of contents

What Flegamax is and what it is used for
Important information before taking Flegamax
How to take Flegamax
Possible side effects
How to store Flegamax
Contents of the pack and other information

1. What Flegamax is and what it is used for

The respiratory system includes the nasal cavity, pharynx, larynx, trachea, bronchi forming an extensive network – the bronchial tree – and the lungs. In various respiratory diseases, secretion accumulates, and its excess may block the airways, causing cough and breathing difficulties. This secretion may accumulate in various locations, including the nose, sinuses, and bronchi.
Flegamax contains carbocisteine as the active substance, which affects the composition of bronchial secretions. Carbocisteine makes the secretion less viscous and more fluid, thus facilitating its removal from the airways during coughing (so-called mucolytic action).
This medicine is indicated for symptomatic treatment of respiratory tract diseases associated with excessive production of thick and sticky mucus.
To facilitate expectoration of retained secretions, in addition to using a mucus-thinning agent, it is also recommended to drink large amounts of fluids (at least 2–3 litres per day).
If there is no improvement or if your condition worsens after 4 to 5 days of treatment, consult your doctor.

2. Information before using Flegamax

When not to use Flegamax

if the patient is allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6),
in asthmatic conditions,
if there is active peptic ulcer of the stomach or duodenum,
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Flegamax, consult a doctor or pharmacist:

if the patient has previously suffered from peptic ulcer disease.

In case of abundant purulent sputum and fever, as well as in chronic bronchial or lung diseases and in patients with reduced ability to expectorate, a visit to a doctor is necessary, who may recommend other medications.
Treatment of patients with bronchial asthma should be conducted under strict medical supervision due to the risk of bronchospasm. If this symptom occurs, the administration of the medicine must be stopped immediately.

Children
Flegamax is not intended for use in children under 6 years of age.

Flegamax with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or which you plan to use.
During treatment with Flegamax, do not use antitussive medicines or drugs that reduce bronchial mucus secretion.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no data on the use of carbocysteine in pregnant women.
The use of this medicine is not recommended during pregnancy.
It is not known whether carbocysteine passes into breast milk. The medicine should not be used during breastfeeding.
There are no data on the effect of carbocysteine on fertility.

Driving and operating machinery
No studies have been conducted on the effect of carbocysteine on the ability to drive or operate machinery.

Flegamax contains carmine (E 124), methyl parahydroxybenzoate, and sodium
This medicine may cause allergic reactions (including delayed-type reactions).
The medicine contains 7.6 to 8.1 mg of sodium (main component of table salt) per ml.
This corresponds to 0.38% to 0.41% of the maximum recommended daily dietary intake of sodium for adults.

3. How to take Flegamax

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This is an oral medicine.
15 ml of the medicine contains 750 mg of carbocysteine.
A measuring device is provided with the packaging to allow accurate measurement of the appropriate volume of medicine.

Recommended dose
Adults and adolescents over 12 years of age:
Initially, the dose should be 15 ml of medicine three times a day. After the mucolytic (sputum-thinning) effect occurs, the dose should be reduced to 10 ml of medicine three times a day.
Children aged 6 to 12 years:
5 ml of medicine three times a day.
In children and adolescents, the daily dose of carbocysteine must not exceed 30 mg/kg body weight.
It is recommended that the child drinks water after taking the dose.

Do not use the medicine for longer than 4 to 5 days without medical advice.
During treatment, increased fluid intake is recommended.
Do not take the medicine before going to sleep. The last dose should be taken no later than 4 hours before bedtime.

Use in children
Flegamax is not intended for use in children under 6 years of age.

Taking more Flegamax than recommended
There are no known cases of poisoning due to overdose. The most likely symptoms of overdose may be gastrointestinal disturbances. An antidote is not known.
If more than the recommended dose has been taken, seek immediate advice from a doctor or pharmacist.

If you miss a dose of Flegamax
Do not take a double dose to make up for a missed dose.
If you have any further doubts about 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.
If the patient experiences any of the symptoms listed below, stop using the
Flegamax medicine immediately and seek medical help without delay:

angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g. in the face, limbs, joints;
Stevens-Johnson syndrome (blisters progressing to erosions) affecting mucous membranes of the mouth, conjunctiva, or genital organs.

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from
available data):

headache;
abdominal pain, diarrhoea, gastrointestinal bleeding, nausea and vomiting;
skin allergic reactions, including erythematous rash, pruritus, urticaria, drug eruption.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Flegamax

Keep this medicine out of sight and reach of children.
Store below 25ºC.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
After first opening the bottle, the medicine should be used within 24 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Flegamax contains

The active substance is carbocysteine. Each ml of solution contains 50 mg of carbocysteine.
Other ingredients are: sodium saccharin, methyl parahydroxybenzoate, raspberry flavour (composition: maltodextrin (from maize), modified starch (E 1450), flavouring substances identical to natural ones, flavouring preparation), cochineal red (E 124), sodium hydroxide, carboxymethylcellulose, purified water, sodium hydroxide, 1N aqueous solution (for pH adjustment).

What Flegamax looks like and contents of the pack
Flegamax is a red, clear solution.
PET bottle closed with a cap made of HDPE (with child-resistant closure) or aluminium,
with an attached PP measuring cup of 15 ml capacity, in a cardboard box.
The pack contains 120 ml or 200 ml of oral solution.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19; 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid 82
28802 Alcalá de Henares (Madrid)
Spain

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz