Abrol solution for inhalation and oral administration 15 mg/2 ml bottle 100 ml with 5 ml dosing syringe

• 2 ml of solution for inhalation and oral administration contain 15 mg of ambroxol hydrochloride;
• Excipients: citric acid, monohydrate; sodium chloride; benzalkonium chloride solution; sodium hydrogen phosphate, dihydrate; purified water.

Abrol®, a solution for inhalation and oral administration, should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.

Inhalation solution

Adults and children over 6 years of age: 1–2 inhalations of 2–3 ml of solution per day.

Children under 6 years of age: 1–2 inhalations of 2 ml of solution per day.

Solution for oral use.

Adults and children over 12 years of age: 4 ml 3 times a day for the first 2-3 days, which is 90 mg of ambroxol per day, then 2 ml 3 times a day, which is 45 mg of ambroxol per day. The dosage of 4 ml 3 times a day may be continued after consultation with a doctor.

Patients with impaired renal function or severe hepatic insufficiency should take Abrol® only after consulting a doctor. In patients with severe renal insufficiency, when using ambroxol, as with any active substance that is metabolized in the liver and then excreted by the kidneys, accumulation of metabolites formed in the liver is possible.

Pregnant women

As a result of clinical studies of the use of the drug after the 28th week of pregnancy, no harmful effects on the fetus and the course of pregnancy were detected.

However, the usual precautions regarding the use of medications during pregnancy should be observed. Abrol® is not recommended, especially in the first trimester of pregnancy.

Children

The drug can be used in pediatric practice. Children under 2 years of age should only be used as directed by a doctor.

Drivers

There is no data on the effect on the reaction speed when driving vehicles or working with other mechanisms.

Symptoms known from isolated reports of overdose and/or cases of medication errors correspond to known adverse reactions when using ambroxol hydrochloride at recommended doses and require symptomatic treatment.

Immune system disorders: hypersensitivity reactions, anaphylactic reactions including anaphylactic shock, angioedema and pruritus.

Skin and subcutaneous tissue disorders: rash, urticaria, serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).

Nervous system: dysgeusia (changes in taste).

Gastrointestinal: nausea, decreased sensitivity in the oral cavity, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth, dry throat, drooling.

Store at a temperature not exceeding 25°C.

Keep out of reach of children.