The instruction for medical use
of Ambroxol a hydrochloride
the Trade name
of Ambroxol a hydrochloride
the International unlicensed
name Ambroxol Dosage Form
of the Tablet of 30 mg
One tablet contains
active agent – Ambroxol a hydrochloride – 30 mg,
excipients: lactoses monohydrate, starch corn, magnesium stearate, aerosil, cellulose microcrystalline.
of the Tablet, round shape, with a biconvex surface of color, white or white with a yellowish shade.
Drugs for elimination of symptoms of cough and cold. Expectorant drugs. Mucolytics. Ambroxol
the ATX R05C B06 Code
Pharmacokinetics Absorption properties high, Tmax – 2 h, communication with proteins of plasma – 80%. Gets through a blood-brain barrier, a placental barrier, it is allocated with breast milk. After intake the action comes in 30 min. and continues during 6-12 h.
Metabolism – in a liver, forms dibromantranilovy acid and glucuronic conjugates. T½ – 7-12 h. It is removed by kidneys: 90% in the form of water-soluble metabolites, in not changed look – 5%. T½ increases in heavy chronic kidney disease, does not change in an abnormal liver function.
Mucolytic means, possesses sekretomotorny, sekretolitichesky and expectorant action, stimulates formation of surfactant, normalizes the changed bronchopulmonary secretion, improves rheological indicators of a phlegm, reduces its viscosity and adhesive properties, increases mukotsiliarny transport, facilitates removal of a phlegm from bronchial tubes. Increases physical activity of a ciliary epithelium, increases mukotsiliarny transport.
as a part of complex therapy
– acute and chronic bronchitis
– bronchial asthma with difficulty of an otkhozhdeniye of a phlegm
– a bronchoectatic disease
the Route of administration and doses
Inside, during meal, with a small amount of liquid. To adults and children 12 years are more senior appoint on 1 tablet (30 mg) 3 times a day, children are 6-12 years old – 1/2 tablets (15 mg) 2-3 times a day.
It is not recommended to apply without observation of the doctor of more than 4-5 days.
– nausea, vomiting, diarrhea, a gastralgia, discomfort in epigastric area,
– allergic reactions: skin rash, an itching, a small tortoiseshell
– contact dermatitis, a Quincke’s edema, an acute anaphylaxis
it was Very seldom reported about damages of skin (Stephens-Johnson’s syndrome and a Lyell’s disease)
others: weakness, headache, dysuria, rhinorrhea.
– hypersensitivity to Ambroxol to a hydrochloride and/or to other components of drug
– a peptic ulcer of a stomach and duodenum
– pregnancy (I trimester) and the lactation period
– children’s age up to 6 years
the Combined use with antibechic medicines leads Medicinal interactions to difficulty of an otkhozhdeniye of a phlegm against the background of reduction of cough.
Facilitates penetration into a bronchial secret of antibiotics.
Use of Ambroxol together with cardiac glycosides, diuretics is possible.
should not be combined with the antibechic medicines complicating removal of a phlegm. It is necessary to observe extra care when using Ambroxol at patients with a renal/liver failure. It is recommended to reduce a drug dose twice in comparison with usual or to increase an interval between introductions at clearance of creatinine less than 30 ml/min.
Pregnancy and the period of a lactation
Use of drug in II and III trimesters of pregnancy perhaps after the careful analysis of a ratio advantage/risk the attending physician.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: artificial vomiting, gastric lavage in the first 1-2 h after administration of drug, reception of fat-containing products.
A form of release and packing
On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the place protected from light at a temperature not above 25 °C.
To store out of children’s reach!
Not to use a period of storage of 5 years after expiry date.
Ukraine JSC Lekkhim-Kharkiv Producer, 61115 Kharkiv, 17th Partsjezda St., 36
the Owner of the registration certificate
of JSC Lekkhim-Kharkiv, Ukraine
the Name and the country
of the JSC Lekkhim-Kharkiv organization packer, Ukraine
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Medicus Centre LLP
050000, Almaty, Mussorgsky St., 2A
ph. +007 (7272) 71-48-12, 71 48 13