Flegamina Classic is a drug that facilitates expectoration and bronchial cleansing, used in acute and chronic respiratory diseases associated with expectoration and mucus removal disorders (wet cough).Bromhexine, the active substance of the tablets, has a mucolytic effect, cleansing the bronchial tree of thick mucus secretions accompanying many respiratory diseases. After administration of the drug, the volume of the mucus secretion increases and its viscosity decreases, and the dense secretion is easier to strain.

Composition

The active substance is: bromhexine hydrochloride. One tablet contains 8 mg of bromhexine hydrochloride.

The other ingredients are: lactose monohydrate, sodium carboxymethyl starch, magnesium stearate.

Dosage

The recommended dose is:

• Adults and children over 12 years of age: 1 tablet 3 times a day.
• Children from 6 to 12 years of age: half a tablet 3 times a day.
• Children from 3 to 6 years of age: half a tablet 2 times a day.

It is not advisable to use Flegamina in children aged 3 to 6 years who are unable to swallow a tablet; in these patients it is recommended to use the drug in the form of Flegamina Classic Junior syrup with strawberry flavor.

How to use Flegamina?

• The drug is administered orally.
• The tablets should be taken at regular intervals after a meal.
• Do not use the drug immediately before going to bed.
• Usually the drug is used for 7 to 10 days.

Use of the drug in children and adolescents

The drug should not be used in children 3 to 6 years of age who are unable to swallow a tablet. In these patients, it is recommended to use bromhexine in the form of Flegamina Classic Junior syrup with strawberry flavor. Due to the bromhexine content, Flegamina Classic should not be administered to children under 2 years of age.

Contraindications

• allergy (hypersensitivity) to bromhexine or any of the excipients of the drug.
• children 3 to 6 years of age who are unable to swallow a tablet; in these patients it is recommended to use bromhexine in the form of Flegamina strawberry syrup. Flegamina syrup with strawberry flavor and Flegamina Classic tablets, due to the content of bromhexine, should not be given to children under 2 years of age.

Contents

The package contains 40 tablets. The package includes a patient information leaflet.

Storage method

15°C-25°C

Manufacturer

TEVA

Warnings

Talk to your doctor before taking Flegamina:

• if you suffer from inflammation of the airways accompanied by bacterial infection. Flegamina tablets should be taken simultaneously with antibiotics and medications expanding the respiratory tract prescribed by a doctor. You should drink a lot during treatment, especially if you have a fever. Adequate hydration of the body increases the dilution of bronchial secretions and facilitates expectoration.
• if you have a history of gastric ulcer and duodenal ulcer, or an active duodenal ulcer, as this medicine may make symptoms worse.
• if you have severe liver problems.
• if you have severe kidney problems.
• if you are intolerant to some sugars

There have been reports of severe skin reactions associated with the administration of bromhexine hydrochloride. If you develop a rash (including lesions on the mucous membranes, e.g. mouth, throat, nose, eyes, genitals), stop taking Flegamina and contact your doctor immediately.

Pregnancy and breastfeeding
The drug should not be used in the first three months of pregnancy. During the remainder of pregnancy, the drug should only be used when, in the doctor’s opinion, the benefit to the mother outweighs the potential risk to the fetus.

It is not recommended to use Flegamina Classic during breastfeeding.

Conflicts with other drugs
Flegamina should not be used with:

• cough suppressants, such as codeine and its derivatives, as they may suppress the cough reflex and cause secretions in the respiratory tract.

Flegamina should be used with caution in the case of simultaneous use:

• atropine and other cholinolytic drugs as they make the mucous membranes dry.
• salicylates and other non-steroidal anti-inflammatory drugs, as the drug may increase the irritating effect on the gastrointestinal mucosa.
• antibiotics such as: oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin, as the simultaneous use of the drug with these antibiotics increases their concentration in the lung parenchyma.

Side effects

During the use of Flegamina Classic, the following may occur:

Uncommon (may affect up to 1 in 100 people):

• upper abdominal pain, nausea, vomiting, diarrhea

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions, rash, hives

Not known (frequency cannot be estimated from the available data):

• headache, dizziness, sleepiness
• bronchospasm
• indigestion,
• excessive sweating
• increased liver enzymes
• lowering blood pressure,
• anaphylactic reactions including anaphylactic shock, angioedema (rapidly progressive
  swelling of the skin, subcutaneous tissue, mucosa or submucosa) and itching;
• severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis).