Flegamax

Leaflet attached to the packaging: information for the user

Flegamax, 50 mg/ml, oral solution

Carbocisteine

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If after 4 to 5 days of use there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

• 1. What is Flegamax and what is it used for
• 2. Important information before using Flegamax
• 3. How to use Flegamax
• 4. Possible side effects
• 5. How to store Flegamax
• 6. Contents of the packaging and other information

1. What is Flegamax and what is it used for

The respiratory system consists of the nasal cavity, throat, larynx, trachea, bronchi, forming a
complex system - the bronchial tree, and lungs. Due to various respiratory diseases, secretions
begin to accumulate, the excess of which blocks the airways, causing cough and breathing problems.
This secretion can accumulate in different places, including the nose, sinuses, and bronchi.
Flegamax contains carbocisteine as the active substance, which affects the composition of bronchial
secretions. Carbocisteine makes the secretions less viscous and more fluid, making them easier to
expel from the airways during coughing (mucolytic action).
This medicine is used for symptomatic treatment of respiratory diseases characterized by excessive
production of thick and viscous secretions.
To facilitate the expectoration of accumulated secretions, in addition to using a medicine that thins
secretions, it is also recommended to consume a large amount of fluids (at least 2-3 liters per day).
If after 4 to 5 days of use there is no improvement or the patient feels worse, the doctor should be
contacted.

2. Important information before using Flegamax

When not to use Flegamax

• if the patient is allergic to carbocisteine or any of the other ingredients of this medicine (listed in section 6),
• in asthmatic status,
• if there is an active gastric or duodenal ulcer disease,
• in children under 6 years of age.

Warnings and precautions

Before starting to use Flegamax, the doctor or pharmacist should be consulted:

• if the patient has had a history of ulcer disease.

In case of abundant purulent secretions and fever, as well as in case of chronic bronchitis or lung disease and in patients with reduced ability to expectorate, a doctor's visit is necessary, who may prescribe other medicines.
Treatment of patients with bronchial asthma should be carried out under close medical supervision due to the possibility of bronchospasm. If this symptom occurs, the administration of the medicine should be stopped immediately.

Children

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

Flegamax and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to take.
During the use of Flegamax, cough suppressants or medicines that reduce bronchial secretion should not be used.

Pregnancy and breastfeeding

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

Driving and operating machinery

No studies have been conducted on the effect of carbocisteine on the ability to drive and operate machinery.

Flegamax contains carmoisine (E 124), methyl parahydroxybenzoate, sodium

The medicine may cause allergic reactions (possible late reactions).
The medicine contains from 7.6 to 8.1 mg of sodium (the main component of table salt) in each ml.
This corresponds to 0.38 to 0.41% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Flegamax

This medicine should always be used exactly as described in the patient leaflet or as directed by
the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The medicine is for oral use.
15 ml of the medicine contains 750 mg of carbocisteine.
A measuring cup is attached to the packaging, which allows the correct volume of the medicine to be measured.
Recommended dose
Adults and adolescents over 12 years of age:
Initially, a dose of 15 ml of the medicine should be used 3 times a day, and then after the mucolytic effect (thinning of secretions) occurs, the dose should be reduced to 10 ml of the medicine 3 times a day.
Childrenfrom 6 to 12 years of age:
5 ml of the medicine 3 times a day.
In children and adolescents, the daily dose of carbocisteine should not exceed 30 mg/kg body weight.
It is recommended that the child drink water after taking the dose of the medicine.
Without the doctor's recommendation, the medicine should not be used for more than 4 to 5 days.
During treatment, an increased amount of fluids should be consumed.
The medicine should not be used before bedtime. 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.

Use of a higher than recommended dose of Flegamax

No cases of poisoning have been reported in case of overdose. The most likely symptoms of overdose may be gastrointestinal disorders. There is no antidote.
In case of taking a higher dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.

Missed dose of Flegamax

A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should stop using Flegamax and seek medical help immediately:

• angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g. in the face, limbs, joints;
• Stevens-Johnson syndrome (blisters turning into ulcers, on the mucous membranes of the mouth, eyes, genitals).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• headache;
• abdominal pain, diarrhea, gastrointestinal bleeding, nausea, and vomiting;
• allergic skin reactions, including rash, itching, urticaria, drug rash.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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: +48 22 49 21 301
Fax: +48 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, more information can be collected on the safety of the use of the medicine.

5. How to store Flegamax

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
After opening the bottle, the medicine should be used within 24 months.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Flegamax contains

• The active substance of the medicine is carbocisteine. Each ml of the solution contains 50 mg of carbocisteine.
• The other ingredients are: sodium saccharin, methyl parahydroxybenzoate, raspberry flavor (composition: maltodextrin (from corn), modified starch (E 1450), flavoring substances identical to natural ones, flavoring preparation), carmoisine (E 124), sodium hydroxide, carboxymethylcellulose, purified water, sodium hydroxide, 1N aqueous solution (to adjust pH).

What Flegamax looks like and what the packaging contains

Flegamax is a red, transparent solution.
A PET bottle closed with an aluminum cap, with a measuring cup made of PP with a capacity of 15 ml, in a cardboard box.
The packaging contains 120 ml or 200 ml of oral solution.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański

Manufacturer

Laboratorios Alcalá Farma, S.L.
Avenida de Madrid 82
28802 Alcalá de Henares (Madrid)
Spain
To obtain more detailed information, the local representative of the marketing authorization holder should be contacted:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6, 00-728 Warsaw
phone 22 364 61 01

Date of last update of the leaflet: