Libexin Muko - instructions for use, dose, side effects, contraindications

Excipients: sucrose 40,000 g, methyl parahydroxybenzoate 0.150 g, caramel dye (E 150) 0,0344 g, aromatic elixir * 2.00 ml, cinnamon oil 0.002 g, sodium hydroxide to pH 6.10-6.30, water purified to 100 ml.

* aromatic elixir (55.3% ethanol, 42.7% rum, 2.0% aroma additive "rum").

One measuring cup (15 ml) of the syrup contains 750 mg of carbocysteine, 6 g of sucrose, 0.2 g of ethanol and 97 mg of sodium.

Ethanol content (v / v): 1.64%.

Description:

Syrup-like liquid from brownish-yellow to light-brown color.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B.03 Carbocysteine

Pharmacodynamics:

Carbocysteine, being a mucolytic, exerts an effect on the gel phase of endobronchial secretion, rupturing the disulfide bridges of glycoproteins and, thus, reducing viscosity and increasing the elasticity of secretions. Carbocysteine activates sialic transferase - the enzyme of goblet cells of the bronchial mucosa, normalizes the quantitative ratio of acidic and neutral sialomucins, promotes regeneration of the mucosa, normalizes its structure, activates the activity of the ciliary epithelium, restores the secretion of the immunologically active IgA (specific protection), improves mucociliary clearance.

Pharmacokinetics:

Carbocysteine is rapidly absorbed after oral administration, reaching a maximum serum concentration after 2 hours. Bioavailability is low (less than 10% of the accepted dose) as a result of possible rapid passage through the liver. The elimination half-life is about 2 hours. It is excreted mainly by the kidneys together with metabolites.

Indications:

Acute and chronic bronchopulmonary diseases and ENT diseases, accompanied by the formation of viscous, hard to separate sputum (tracheitis, bronchitis, tracheobronchitis,bronchial asthma, bronchiectatic disease) and mucus (inflammatory diseases of the middle ear, nose and adnexal sinuses - rhinitis, otitis media, sinusitis).

Preparation of the patient for bronchoscopy or bronchography.

Contraindications:

- Hypersensitivity to carbocysteine or other components of the drug;

- IStomach ulcer and duodenal ulcer in the stage of exacerbation;

- chronic glomerulonephritis (in the phase of exacerbation), cystitis;

- bVariability;

- dUp to 15 years of age.

Carefully:

Peptic ulcer of the stomach and duodenum in the anamnesis (see section "Special instructions").
Breastfeeding period.
Patients of advanced age (see section "Special instructions").
Simultaneous reception of drugs that increase the risk of gastrointestinal bleeding (see section "Special instructions").

Pregnancy and lactation:

Pregnancy

Due to insufficient clinical data, the use of Libexin Muco® in pregnant women is not recommended (see "Contraindications").

Breastfeeding period

It is not known whether carbocysteine with breast milk. In the period of breastfeeding, the drug Libexin Muko® should be applied from caution (cm. see "With caution").

Dosing and Administration:

Inside.

One measuring cup of syrup (15 ml) contains 750 mg of carbocysteine.

Take 3 times a day for one measuring cup (15 ml), preferably separately from food intake.

The duration of treatment should not exceed 8 days.

Side effects:

Disorders from the gastrointestinal tract: tnausea, diarrhea, epigastric pain. gastrointestinal bleeding, vomiting.

Immune system disorders: alaryngic skin rash and anaphylactic reactions, including hives, angioedema; itching, exanthema, fixed drug rash.

Disturbances from the skin and subcutaneous tissues: aboutSpecial cases of bullous Dermatitis, such as Stevens-Johnson syndrome and erythema multiforme.

General disorders: gotovruzhenie, weakness, malaise.

Overdose:

Symptoms: gastralgia, nausea, diarrhea.

Treatment: symptomatic.

Interaction:

Carbocysteine increases the effectiveness of glucocorticosteroid and antibacterial therapy for inflammatory diseases of the upper and lower respiratory tract.

Potentsiruet broncholytic effect of theophylline.

Action of carbocisteine relieves antitussive and atropine-like remedies.

Due to the ethanol content, the preparation of Libexin Muco® is prescribed with caution:

- with drugs that cause disulfiram-like reactions ("tides" of blood to the skin, redness of the skin, vomiting, tachycardia) with simultaneous reception with alcoholic (ethanol-containing) beverages: disulfiram; cefamandol, cefoperazone, latamoxef (cephalosporin antibiotics); chloramphenicol; chlorpropamide, glibenclamide, glipizide, tolbutamide (hypoglycemic agents, sulfonylureas derivatives); griseofulvin (antifungal agent); derivatives of 5-nitroimidazole (metronidazole, ornidazole, secnidazole, tinidazole), ketoconazole; procarbazine (cytostatic);

- with drugs that depress the central nervous system.

Special instructions:

Caution should be exercised when using Libexin Muco ® in elderly patients with peptic ulcer and duodenal ulcer, while taking drugs that increase the risk of developing gastrointestinal bleeding (see the section "With caution").With the development of gastrointestinal bleeding should stop taking the drug.

The ethanol content in the preparation is 1.64%, that is, 0.2 g of ethanol per measuring cup, which should be taken into account when using Libexin Muco ® for liver diseases, alcoholism, epilepsy, injuries or brain diseases.

When prescribing Libexin Muco® to patients with diabetes mellitus or patients who observe a low-carb diet, it should be taken into account that 1 measuring cup of syrup (15 ml) contains 6 g of sucrose.

When patients comply with a salt-free or low-salt diet, one should take into account that 1 measuring cup of syrup (15 ml) contains 97 mg of sodium.

Since the preparation Libexin Muco® contains sucrose, its use is not recommended in patients with sugarase / isomaltase deficiency, fructose intolerance, glucose malabsorption / galactose syndrome.

Effect on the ability to drive transp. cf. and fur:

Violation of the speed of psychomotor reactions, associated with the presence of ethanol in the formulation, can be dangerous when driving vehicles and engaging in other potentially hazardous activities.

Form release / dosage:

Syrup, 50 mg / ml.

Packaging:

For 125 ml, 200 ml or 300 ml in a vial of colorless glass (type III), closed with a screwed aluminum cover with the control of the first opening.

One bottle together with a measuring cup and instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013994 / 01

Date of registration:25.04.2008 / 08.02.2017

Expiration Date:Unlimited

The owner of the registration certificate:Sanofi-Aventis FranceSanofi-Aventis France France

Manufacturer: & nbsp

UNITHER LIQUID MANUFACTURING France

A.NATTERMANN and Cie., GmbH Germany

Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia

Information update date: & nbsp04.03.2018

Illustrated instructions

Instructions

Libexin Muco® (Libexin Muco®)