FLEGMAX FORTE

Patient Information Leaflet

Flegmax Forte, 2700 mg/sachet, granules for oral solution in sachet
Carbocisteinum lysinum
Please read all of this leaflet carefully before taking this medicine, because 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 doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• 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 doctor or pharmacist. See section 4.
• If there is no improvement after 4 to 5 days of treatment, or if you feel worse, contact your doctor.

Table of Contents

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

1. What Flegmax Forte is and what it is used for

The respiratory system includes the nasal cavity, pharynx, larynx, trachea, bronchi, forming an elaborate network – the bronchial tree, and the lungs. As a result of various respiratory diseases, secretion begins to accumulate, 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.
Flegmax Forte contains carbocysteine as the active substance, which affects the composition of bronchial secretions. Carbocysteine makes the mucus more fluid. This facilitates the movement of mucus by cilia (tiny hair-like structures lining the respiratory tract) and its removal from the airways during coughing.
This medicine is indicated for symptomatic treatment of respiratory tract diseases (nasopharyngitis, sinusitis, laryngitis, bronchitis, pneumonia) associated with excessive production of thick and sticky mucus.
To facilitate expectoration of retained secretions, in addition to using a mucolytic agent, it is also recommended to drink large amounts of fluids (at least 2–3 litres per day).
If there is no improvement after 4 to 5 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Flegmax Forte

When not to use Flegmax Forte

• 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 the patient has active gastric or duodenal ulcer,
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Flegmax Forte, 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 disease, 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 carried out under strict medical supervision due to the possibility of bronchospasm. If this symptom occurs, administration of the medicine must be stopped immediately.

Flegmax Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

During treatment with Flegmax Forte, cough suppressants or drugs reducing bronchial mucus secretion should not be used.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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 unknown whether carbocysteine passes into human 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.

Flegmax Forte contains aspartame (E 951)
The medicine contains 30 mg of aspartame per 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 impaired excretion.

3. How to use Flegmax Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
Recommended dose
Adults and adolescents over 12 years of age:
1 sachet once daily (2700 mg of carbocysteine with lysine).
Method of administration
Dissolve the contents of one sachet in half a glass of water, mix thoroughly until completely dissolved, and then drink. After dissolving the granules, a white-yellowish solution with an orange odour is obtained.
The prepared solution should be taken immediately after preparation.
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 immediately before going to bed. The dose of Flegmax Forte should be taken no later than 4 hours before bedtime.
Flegmax Forte is not intended for use in children under 12 years of age.
Use of a higher than recommended dose of Flegmax Forte
There are no known cases of poisoning in case of overdose. The most likely symptoms of overdose may be gastrointestinal disturbances. An antidote is not known.
If a higher than recommended dose has been taken, seek immediate advice from a doctor or pharmacist.
Missed dose of Flegmax Forte
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.
If the patient experiences any of the symptoms listed below (frequency unknown), discontinue use of
Flegmax Forte immediately and seek medical help immediately:

• Angioedema (severe allergic reaction) with skin swelling and (or) mucosal membranes, e.g. in the face, limbs, joints;
• Stevens-Johnson syndrome (blisters progressing to erosions on mucous membranes of the oral cavity, conjunctiva, genital organs).

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

• Headache;
• Abdominal pain, diarrhea, 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 a 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 helps to provide more information on the safety of the medicine.

5. How to store Flegmax Forte

Keep this medicine 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 medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Flegmax Forte contains

• The active substance is carbocysteine lysine salt. Each sachet contains 2700 mg of carbocysteine lysine salt, equivalent to 1500 mg of carbocysteine.
• Other ingredients are: aspartame (E 951), mannitol, anhydrous citric acid, povidone K30, orange flavour (corn maltodextrin, gum arabic, ascorbic acid, butylated hydroxyanisole (E 320)).

What Flegmax Forte looks like and contents of the pack
Yellowish granules with an orange odour.
After dissolving the granules, a white-yellowish solution with an orange odour is obtained.
Sachet made of Paper/Aluminium/LDPE, packed in a cardboard box.
6, 8 or 10 sachets.
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, Alcalá de Henares, Madrid 28802, Spain