Deflegmin extended-release capsules 0.075g 10 pieces

Deflegmin 75 mg 10 capsules

Name: Deflegmin
Form: prolonged-release capsules
Dose: 0.075 g
Package: 10 capsules (blister)

Deflegmin Description and indications

Acute and chronic diseases of the lungs and bronchi proceeding with obstruction of expectoration of viscous secretions from the respiratory tract.

Action

Ambroxol is a metabolite of bromohexine, exhibiting mucolytic activity. It increases the secretion of mucus in the respiratory tract, stimulates the production of pulmonary surfactant and the function of respiratory epithelial cilia. As a result, it increases the amount of mucus in the airways and improves its transport (mucociliary clearance). By increasing fluid secretion into the bronchial tree and improving mucociliary clearance, it facilitates expectoration and relieves coughing.

Composition - what ingredients the drug Deflegmin contains

One Deflegmin extended-release capsule contains 75 mg of ambroxol hydrochloride.

The other ingredients of Deflegmin are: grain sucrose, corn starch, shellac, povidone, talc; the composition of the gelatin capsule: erythrosine (E 127), titanium dioxide (E 171), indigotine (E 132), gelatin.

Dosage - how to use the drug Deflegmin

Adults: 1 capsule/day in the morning or evening after eating, drinking a small amount of liquid.

Children and adolescents: the product in the form of extended-release capsules should not be used in children (oral drops or syrup can be used).

Elderly: there is no need to modify the dosage. The patient should not use the product for more than 4 to 5 days without consulting a doctor.

Duration of treatment. The patient should not use the product for more than 4 to 5 days without consulting a doctor.

Notes

The product should not be used immediately before bedtime.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Notes and warnings about the drug Deflegmin

This is a medication. For safety, use it according to the package insert. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Special warnings / Precautions

Use with caution in patients with gastric or duodenal ulcer disease and renal or hepatic insufficiency. The preparation should be used with caution in patients with impaired cough reflex or impaired bronchial ciliary clearance due to the possibility of retention of secretions in the airways. In patients with bronchial asthma, ambroxol may aggravate cough at the beginning of treatment. The preparation should not be used immediately before bedtime. The medicinal product 30 mg tabl. contains lactose. It should not be used in patients with rare hereditary intolerance of galactose, Lapp lactase deficiency or glucose-galactose malabsorption syndrome. The preparation does not affect the ability to drive or operate machinery.

Interactions

Concomitant use of ambroxol with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases the concentration of antibiotics in the lung parenchyma. Ambroxol should not be used concomitantly with antitussives (e.g. codeine), as they may inhibit the cough reflex and impede expectoration of liquefied mucus from the bronchial tree. No clinically significant adverse interactions of ambroxol with other drugs have been demonstrated.

Pregnancy and lactation

Ambroxol hydrochloride crosses the placental barrier. Animal studies have shown no direct or indirect adverse effects on pregnancy, embryonic and/or fetal development, the course of labor or postnatal development. Based on extensive clinical experience in pregnant women after the 28th week of pregnancy, no harmful effects of ambroxol on the fetus have been demonstrated. Nevertheless, the usual precautions should be taken when using the drug product during pregnancy. Especially in the first trimester of pregnancy, the use of the product is not recommended. Ambroxol hydrochloride passes into breast milk. Although adverse effects on a breastfed child are not expected, the product is not recommended for use in breastfeeding women.

Adverse effects

Immune system disorders (unknown): Anaphylactic reactions, including anaphylactic shock, angioedema,pruritus and other hypersensitivity reactions. Gastrointestinal disorders (common): nausea; (uncommon): vomiting, diarrhea, indigestion and abdominal pain. Skin and subcutaneous tissue disorders (rare): rash, urticaria; (very rare): severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, having a temporary association with the use of mucolytic drugs.

Overdose

No specific symptoms of ambroxol overdose in humans have been described so far. Symptoms reported after accidental overdose and/or misuse of ambroxol corresponded to adverse reactions occurring after administration of the product at recommended doses. Symptomatic treatment may be required.

Responsible Entity
Bausch Health