Bromhexine 8 Berlin-Chemie - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 34.400 mg, starch corn - 14,600 mg, gelatin - 1,800 mg, silicon dioxide colloid - 0,600 mg, magnesium stearate - 0.600 mg;

Sheath:

sucrose - 27,704 mg, calcium carbonate - 4,326 mg, magnesium carbonate - 1,507 mg, talc - 1,507 mg, macrogol 6000 - 1,750 mg, glucose syrup - 1,639 mg, titanium dioxide (E171) -1.166 mg, povidone K25 - 0,243 mg, carnauba wax - 0,012 mg, quinoline yellow (E 104) - 0,146 mg.

Description:

Dragee from yellow to greenvapo-yellow slightly biconcavewith an almost white core.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B Mucolytics

R.05.C.B.02 Bromhexine

Pharmacodynamics:

Bromhexine has mucolytic (secretolitic) and expectorant (secretory) action.

Reduces the viscosity of phlegm, activates the ciliated epithelium, increases the amount of sputum and improves its separation. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells in the process of breathing. The effect is manifested after 2-5 days from the beginning of treatment.

Pharmacokinetics:

Ingestion bromohexine practicecompletely (99%) is absorbed from of the gastrointestinal tract (GIT) in for 30 minutes, the connection with plasma proteins of the blood - 99%. Penetrates through placentatare and blood-brain barrier. Penetrates into breast milk. In nesubject to demethylation and oxidation, is metabolized to amBroxol. In severe diseases a decrease in clearance is noted bromohexine. Half-life is 15 hours (due to the slowdiffusion from tissues). Displayed kidneys in the form of metabolites. With chronorenal failure (CRF) is disrupted metabolismComrade. With multiple applications can cumulate.

Indications:

Disturbance of secretion and transport of phlegm in acute and chronic bronchial tubespulmonary diseases (for example, traherohnhitis, acute and chronic bronchitis, emphysema).

Contraindications:

hypersensitivity to brominehexyne and other components of the preparationta;
deficiency of lactase, intolerance to halactose or fructose, glucose syndromezo-galactose malabsorption; SaharaZo-isomaltase insufficiency;
Stomach ulcer and twelveof the colon (in the stage of exacerbationtion);
pregnancy (I trimester);
children's age till 6 years.

Carefully:

renal and / or liver failure;
when the bronchial motility is disturbed, accompanied by excessive accumulation of secretions;
with a tendency to gastric bleeding in the anamnesis.

Pregnancy and lactation:

The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the possible risk to the fetus. The use of the drug during lactation is contraindicated.

Dosing and Administration:

The drug is prescribed inside, after eating, without chewing, squeezed enough amount of liquid.

For adults and adolescents over 14 years of age: 3 times a day for 1-2 drops (24-48 mg / day).

Children from 6 to 14 years, as well as patients with a body weight of less than 50 kg: take 3 times a day for 1 dragee (24 mg / day).

If the kidney and / or liver function is impaired, you should increase the intervals between doses, or reduce the dose. On this issue you should consult your doctor.

The duration of application is determined individually and depends on the indications and course of the disease. If you need more than 4-5 days, you need a doctor's consultation.

Side effects:

Typically, the drug Bromhexin 8 Berlin-Hemi is well tolerated.

Possible side effects arelower in the descending frequencynone: Often (≥ 1/10), often (≥1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥1/10000, < 1/1000), very rarely, including individual(<1/10000), it is not knownto be assessed on the basis ofdata)

From the immune system

Infrequently: reactions are hypersensitive(skin rash, Quincke's edema, it is difficultRespiration, skin itching, hivests).

Rarely: anaphylactic reactions, up to anaphylactic shock.

From the skin and subcutaneous tissues

Rarely: severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome (see section "Special instructions").

Common violations

Infrequently: fever.

From the gastrointestinal tract

Infrequently: nausea, abdominal pain, vomiting, diarrhea.

For all forms of allergic reactions, it is necessary to stop taking this medication and inform the doctor about it.

Overdose:

The life-threatening consequences of an overdose, when applied to Bromhexine 8 Berlin-Chemie, are unknown.

The following are possible symptoms: nausea, vomiting, diarrhea, dyspeptic disorders.

Treatment: artificial vomiting, gastric lavage in the first 1 -2 hours after taking the drug.

Due to the high degree of binding to proteins and high volume of distribution, the elimination of bromhexine in hemodialysis or forced diuresis does not occur.

Interaction:

Bromhexine do not assign at the same time with antitussive agents (including number of codeine), t. this is fordifficult evacuation of liquefied wetcompanies.

Bromhexine promotes penetrationantibiotics (erythromycin, cephaliclexin, oxytetracycline, ampicillin, amoxicillin) into the bronchial secret in the first 4-5 days of antimicrobialRapi.

Special instructions:

In cases of violations of bronchial motility or with a significant amount of excretamy phlegm, the use of the drug Bromhexine 8 Berlin-Chemie requires an osin connection with the risk of delay separated in the respiratory tract.

In the course of treatment it is recommended consume enough fluid, which increases secretionbromhexine.

In severe renal failure must take into account the possibilitymulation of the meta-bolits. With prolonged treatment of rekoMenden monitoring of kidney function.

There is evidence of an occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, Lyell syndrome) when applied bromohexine. When an allergy occursreactions immediately discontinue use andgo to the doctor.

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

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Dragee 8 mg.

Packaging:

For 25 dragees in a contour mesh package (PVC blister / aluminum foil).

1 blister with instructions for use in a cardboard box.

Storage conditions:

The drug should be stored at a temperature not exceeding 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

5 years.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:Without recipe

Registration number:P N 015546/01

Date of registration:08.05.2009 / 25.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:Berlin-Chemie, AGBerlin-Chemie, AG Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Information update date: & nbsp25.02.2017

Illustrated instructions

Instructions

Bromhexine 8 Berlin-Chemie (Bromhexine 8 Berlin-Chemie)