Flegamax Forte

Package Leaflet: Information for the Patient

Flegamax Forte, 2700 mg/sachet, Granules for Oral Solution, in a Sachet

Carbocisteinum lysinum

Read the Package Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Flegamax Forte and What is it Used For
• 2. Important Information Before Using Flegamax Forte
• 3. How to Use Flegamax Forte
• 4. Possible Side Effects
• 5. How to Store Flegamax Forte
• 6. Contents of the Pack and Other Information

1. What is Flegamax Forte 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, and their excess blocks the airways, causing cough and breathing problems. This secretion can accumulate in different places, including the nose, sinuses, and bronchi.
Flegamax Forte contains carbocisteine as the active substance, which affects the composition of bronchial secretions. Carbocisteine makes the secretions more fluid. This facilitates the transport of bronchial secretions by cilia (small hairs lining the airways) and their removal from the airways during coughing.
This medication is used for the symptomatic treatment of respiratory diseases (rhinitis, pharyngitis, sinusitis, laryngitis, bronchitis, pneumonia) characterized by excessive production of thick and sticky secretions.
To facilitate the expectoration of accumulated secretions, in addition to using a medication that thins secretions, it is also recommended to drink plenty of fluids (at least 2-3 liters per day).
If there is no improvement or the patient feels worse after 4 to 5 days of using the medication, they should consult their doctor.

2. Important Information Before Using Flegamax Forte

When Not to Use Flegamax Forte

• if the patient is allergic to carbocisteine or any of the other ingredients of this medication (listed in section 6),
• in asthma attacks,
• if the patient has active gastric or duodenal ulcer disease,
• in children under 12 years of age.

Warnings and Precautions

Before starting to use Flegamax Forte, the patient should discuss it with their doctor or pharmacist:

• if the patient has 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 medications.

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 medication should be stopped immediately.

Flegamax Forte and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
During treatment with Flegamax Forte, the patient should not use cough suppressants or medications that reduce bronchial secretion.

Pregnancy, Breastfeeding, and Fertility

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 medication.
There are no data on the use of carbocisteine in pregnant women.
The use of this medication is not recommended in pregnant women.
It is not known whether carbocisteine passes into breast milk. The medication should not be used during breastfeeding.
There are no data on the effect of carbocisteine on fertility.

Driving and Using Machines

No studies have been conducted on the effect of carbocisteine on the ability to drive and use machines.

Flegamax Forte Contains Aspartame (E 951)

The medication contains 30 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.

3. How to Use Flegamax Forte

This medication should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medication is for oral use.
Recommended dose
Adults and adolescents over 12 years of age:
1 sachet once a day (2700 mg of carbocisteine with lysine).
Method of administration
The contents of one sachet should be dissolved in half a glass of water, mixed until completely dissolved, and then drunk. After dissolving the granules, a white-yellowish solution with an orange odor is formed.
The prepared solution should be taken immediately after preparation.
Without a doctor's recommendation, the medication should not be used for more than 4 to 5 days.
During treatment, the patient should drink plenty of fluids.
The medication should not be taken before bedtime. The dose of Flegamax Forte should be taken no later than 4 hours before bedtime.
Flegamax Forte is not intended for use in children under 12 years of age.

Using a Higher Than Recommended Dose of Flegamax Forte

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 medication than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a Dose of Flegamax Forte

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about using this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

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

If the Patient Experiences Any of the Following Symptoms (Frequency Not Known), They Should Stop Using Flegamax Forte 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).

Other 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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, Tel.: +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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Flegamax Forte

The medication should be stored out of sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from light.
The prepared solution should be taken immediately after preparation.
Do not use this medication after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What Flegamax Forte Contains

• The active substance of the medication is carbocisteine with lysine. Each sachet contains 2700 mg of carbocisteine with lysine, equivalent to 1500 mg of carbocisteine.
• Other ingredients are: aspartame (E 951), mannitol, anhydrous citric acid, povidence K30, orange flavor (corn maltodextrin, gum arabic, ascorbic acid, butylhydroxyanisole (E 320)).

What Flegamax Forte Looks Like and What the Pack Contains

Yellowish granules with an orange odor.
After dissolving the granules, a white-yellowish solution with an orange odor is formed.
Sachet Paper/Aluminum/LDPE, in a cardboard box.
6, 8, or 10 sachets.

Marketing Authorization 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, Alcalá de Henares, Madrid 28802, Spain

Date of Last Revision of the Leaflet: