Ambroxol Reneval, tablets 30 mg 20 pcs

Ambroxol is an active N-demethylated metabolite of bromhexine.

It has secretomotor, secretolytic and expectorant action.

It stimulates bronchial glands activity, increases motor activity of the syncytial epithelium by means of influence on type 2 pneumocytes in alveoli and Clara cells in bronchioles, increases formation of endogenous surfactant – a surfactant providing bronchial secretion gliding in the airway lumen.

Ambroxol increases the proportion of the serous component in bronchial secretion, improving its structure and contributing to a decrease in viscosity and liquefaction of sputum; as a result, mucociliary transport is improved and the removal of sputum from the bronchial tree is facilitated.

On average when taken orally the action of the drug comes within 30 minutes, duration of action – 6-12 hours, depending on the dose taken.

Indications

Impaired secretion and transport of sputum in acute and chronic respiratory diseases: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis.

Pharmacological effect

Ambroxol is an active N-demethylated metabolite of bromhexine.

It has secretomotor, secretolytic and expectorant effects.

Stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by affecting type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant – a surfactant that ensures the sliding of bronchial secretions in the lumen of the respiratory tract.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and helping to reduce viscosity and thin the sputum; as a result, mucociliary transport improves and the removal of sputum from the bronchial tree is facilitated.

On average, when taken orally, the effect of the drug occurs within 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.

Special instructions

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Active ingredient

Ambroxol

Composition

Active ingredient:
Ambroxol hydrochloride – 30.0 mg
Excipients:
lactose monohydrate – 171.0 mg
corn starch – 36.0 mg
colloidal silicon dioxide (aerosil) – 1.8 mg
magnesium stearate – 1.2 mg

Pregnancy

The drug is not recommended for use during the first trimester of pregnancy.

Contraindications

Hypersensitivity to the components of the drug, hereditary galactose intolerance, lactase deficiency or glucose and galactose malabsorption syndrome, first trimester of pregnancy and breastfeeding, children under 6 years of age.

With caution:

Impaired bronchial motility and increased mucus secretion (for example, in the rare syndrome of primary ciliary dyskinesia); renal failure and/or severe liver failure); peptic ulcer of the stomach and duodenum, including a history; II-III trimesters of pregnancy.

Side Effects

Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO):

very often > 1/10; often from > 1/100 to 1/1000 to 1/10000 to < 1/1000; very rarely <1/10000, including isolated reports; frequency unknown - based on available data, it is not possible to determine the frequency of occurrence.

Allergic reactions:

frequency unknown – hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), angioedema.

From the digestive system:

often – nausea, decreased sensitivity in the mouth or pharynx; uncommon – dyspepsia, vomiting, diarrhea, abdominal pain; rarely – heartburn, dryness of the mucous membrane of the mouth and pharynx, constipation.

From the respiratory system:

rarely – dryness of the mucous membrane of the respiratory tract, rhinorrhea (discharge of mucus from the nose).

From the skin:

rarely – skin rash, urticaria; frequency unknown – pruritus, Stevens-Johnson syndrome (erythema multiforme exudative), Lyell’s syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis.

From the senses:

infrequently – dysgeusia (disturbances in the sense of taste).

Others:

rarely – weakness, headache, dysuria (impaired urination), hyperthermia, fever.

Interaction

When used with antitussive drugs, it may be difficult to discharge sputum as a result of suppression of the cough reflex.

Overdose

Symptoms: nausea, vomiting, gastralgia, diarrhea, dyspepsia.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Manufacturer

Update of PFC JSC, Russia