Flegamina Classic Mint Syrup

Flegamina Classic Syrup with a mint flavor acts as an expectorant, liquefying secretions from the respiratory tract. It facilitates expectoration and bronchial cleansing. Flegamina Classic Syrup with mint flavor is indicated in acute and chronic respiratory diseases with disorders of expectoration and mucus removal.

Intended Use

Acute and chronic respiratory diseases with disorders of expectoration and mucus removal.

Active substance: Bromhexini hydrochloridum

Composition

5 ml of syrup contains:	4 mg of bromhexine hydrochloride
	glucose monohydrate, propyl parahydroxybenzoate (E 216), ethanol 96%, levomenthol, substance improving the taste and aroma of eucalyptus-mint liquid, patent blue (E 131), turmeric, hydrochloric acid, purified water.

Dosage

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
The drug should be taken orally.
If the doctor does not prescribe a specific dosage, the drug is most often used:

• children from 7 to 10 years: 5 ml of syrup (1 teaspoon) 3 times a day.
• adults and children over 10 years of age: 10 ml of syrup (2 teaspoons) 3 times a day.

The drug should be taken at regular intervals, every 8 hours, after a meal.
Do not take the drug immediately before going to bed.
If you have the impression that the effect of the drug is too strong or too weak, consult your doctor.

Use of the drug in children and adolescents
Due to the alcohol content, Flegamina Classic should not be used in children under 7 years of age.

Contradictions

Do not use the medicinal product:

• in hypersensitivity to bromhexine or any of the excipients;
• in children under 7 years of age as it contains alcohol.

Application Notes:

Flegamina Classic with mint flavor contains 96% ethanol.
1 teaspoon (5 ml) of the syrup contains 0.17 g of 96% ethanol.
Due to its alcohol content, the drug may have adverse effects in patients with liver failure, alcoholism, epilepsy, brain damage, mental illness, as well as in pregnant women and children.

Flegamina Classic with mint flavor contains propyl parahydroxybenzoate.
Due to the content of propyl parahydroxybenzoate, the drug may cause allergic reactions (possible late-type reactions) and, exceptionally, bronchospasm.

Flegamina Classic with mint flavor contains glucose.
1 teaspoon (5 ml) of the syrup contains 1.75 g of glucose.
Due to the content of glucose, if the patient has been diagnosed with an intolerance to some sugars, the patient should consult a doctor before taking the drug. The drug contains 1.75 g of glucose per 5 ml. This should be taken into account in diabetic patients. Glucose in the drug may be harmful to the teeth.

The drug Flegamina Classic with mint flavor contains patent blue (E 131).
Due to the content of patent blue (E 131), the drug may cause allergic reactions.

Contents

Brown glass bottle containing 120 ml of the syrup, in a cardboard box

Storage Method

15°C-25°C

Manufacturer

TEVA

Warnings

In inflammation of the respiratory tract accompanied by a bacterial infection, bromhexine should be administered simultaneously with antibiotics and drugs expanding the respiratory tract.
You should drink a lot during treatment. Adequate hydration of the body helps to dilute bronchial secretions and facilitate expectoration.
The drug should be used with caution in patients with a history of gastric and duodenal ulcer disease, as well as with active gastric and duodenal ulcer disease, as it may aggravate its symptoms.
Caution should also be exercised in the event of severe hepatic or renal impairment.
If new pathological changes appear on the skin or mucous membranes, medical advice should be sought immediately and treatment with bromhexine should be discontinued.

Pregnancy and lacttion
Ask your doctor for advice before using the drug.
It is not recommended to use the drug in the first trimester 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.

Breast-feeding:
Consult a physician before using the drug.

Interactions with other drugs
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Caution should be exercised when using Flegamina with atropine and other cholinolytic drugs, as they cause dryness of the mucous membranes.
Do not use the drug simultaneously with antitussive drugs containing codeine or its derivatives, as they may reduce the cough reflex and cause secretion in the respiratory tract.
The drug may increase the irritating effect on the gastrointestinal mucosa of salicylates and other non-steroidal anti-inflammatory drugs.
The simultaneous use of the drug with antibiotics (oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime and amoxicillin) increases their concentration in the lung parenchyma.

Side Effects

Like all medicines, Flegamina Classic with mint flavor can cause side effects, although not everybody gets them.

During treatment, especially long-term use, 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;
• Not known (frequency cannot be estimated from the available data): anaphylactic reactions, anaphylactic shock, headache, dizziness, somnolence, drop in blood pressure, bronchospasm, indigestion, angioedema, urticaria, itching, sweating, increased activity liver enzymes.