Ambroxol-Hemofarm - instructions for use, dose, side effects, contraindications

Excipients: sodium hydrocitrate - 850.00 mg, sodium hydrogen carbonate - 510.00 mg, povidone K25 - 32.00 mg, sodium saccharate - 2.00 mg, aspartame - 20.00 mg, sodium sulfate - 400.00 mg, sodium cyclamate - 20.00 mg, lemon acid - 700.00 mg, lactose monohydrate 226.00 mg, flavoring lemon 502,336 - 50.00 mg, lemon flavor lemon 987323) - 20.00 mg, mannitol - 200.00 mg, macrogol 6000 - 60.00 mg.

Description:Round tablets of flat-cylindrical shape with a facet on both sides, with a risk on one side, from white to white with a yellowish tint of color, with a faint smell of lemon.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its disintegration). Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clark cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours.

Pharmacokinetics:

Absorption is high (for any route of administration), the maximum concentration in the blood plasma (T_C_max) - after 2 hours, the connection with plasma proteins - 80%. Penetrates through the blood-brain barrier (GEB), the placental barrier, excreted in breast milk.

Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. Half-life (T_1/2) - 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%.

The elimination half-life increases with severe chronic renal failure, but does not change if the liver function is impaired.

Indications:

Diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty of sputum discharge, bronchiectatic disease.

Contraindications:

Hypersensitivity to all components of the drug; rare hereditary diseases, such as: galactose intolerance, lactase deficiency or glucose-galactose malabsorption, pregnancy (I trimester), phenylketonuria; children under 12 years.

Carefully:

Hepatic failure, renal failure, peptic ulcer of stomach and duodenum, pregnancy (II-III trimester), the period of lactation.

Pregnancy and lactation:

Application in pregnancy (I trimester) - is contraindicated.

Pregnancy (II-III trimester) and during lactation - use with caution.

Dosing and Administration:

Effervescent tablets inside after eating.

Effervescent tablets.

1 or ½ tablets of effervescent are dissolved in a glass of water (200 ml). Tablets should not be swallowed, chewed and sucked in the mouth.

Adults and children over 12 years of age: in the first 2-3 days for ½ tablets effervescent (30 mg) 3 times a day or 1 tablet 60 mg in the morning and ½ tablets (30 mg) in the evening; in the following days, ½ tablets of effervescent (30 mg) 2 times a day.

If necessary, to increase the therapeutic effect in the first 2-3 days, you can appoint 60 mg (1 tablet effervescent) 2 times / day.

It is not recommended to use the drug for more than 4-5 days without prescribing a doctor.

Side effects:

Allergic reactions: skin rash, hives, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock.

Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With prolonged use in high doses - gastralgia, nausea, vomiting.

Overdose:

Symptoms: nausea, vomiting, diarrhea, and other gastrointestinal disorders.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products.

Interaction:

Joint use with antitussive drugs leads to difficulty in getting away from sputum while reducing the cough.

Increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

Form release / dosage:

The effervescent tablets are 60 mg.

Packaging:

For 10 or 20 tablets of effervescent in a plastic tube, ukuporennuyu plastic cover with silica gel and control the first opening. For 1 or 2 tubes together with instructions for use in a pack of cardboard.

Storage conditions:Store in a dry, dark place at a temperature of 15 to 25 ° C.

Shelf life:3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N 015470/01

Date of registration:04.06.2009

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Information update date: & nbsp02.08.2017

Illustrated instructions

Instructions

Ambroxol-Hemofarm (Ambroxol-Hemofarm)