Solfran 30 mg (20 tablets)
- $2.80
The instruction for medical use
of Solfran® medicine
the Trade name
of Solfran®
the International unlicensed
name Ambroxol Dosage Form
of the Tablet of 30 mg
Structure
1 tablet contains
active agent – Ambroxol a hydrochloride of 30 mg,
excipients: lactoses monohydrate, cellulose microcrystalline, magnesium or calcium stearate, silicon dioxide colloidal anhydrous.
The description
of the Tablet of white color, round, with a flat surface, with a facet on both parties and an engraving of G on one party.
Pharmacotherapeutic group
Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol.
ATX R05CB06 code
Pharmacological
Pharmacokinetics Absorption properties. Absorption high and almost full, with linear dependence on a therapeutic dose. The maximum plasma concentration is reached within 1 - 2.5 hours. The absolute bioavailability is 79%.
Distribution. Distribution fast and extensive, with the highest concentration in tissue of lungs. The volume of distribution is about 552 l. Communication with proteins of blood plasma makes about 90%.
Metabolism and removal. About 30% of the dose accepted inside are exposed to effect of the first passing through a liver.
CYP3A4 – the main enzyme responsible for metabolism of Ambroxol under the influence of which, mainly in a liver, conjugates are formed.
Elimination half-life makes 10 hours. General clearance: within 660 ml/min., the renal clearance is 83% of the general clearance. It is removed by kidneys: 26% in the form of conjugates, 6% - in a free look.
Removal decreases in abnormal liver functions that leads to increase in level in blood plasma by 1.3-2 times, but does not demand dose adjustment.
Gender and age have no clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment.
Meal does not influence bioavailability of Ambroxol of a hydrochloride.
The pharmacodynamics
of Solfran® possesses sekretolitichesky and expectorant action, stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the content of mucous secretion and discharge of surfactant in alveoluses and bronchial tubes, normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of cilia of a ciliary epithelium, increases mukotsiliarny transport of a phlegm. Increase in secretion and mukotsiliarny clearance improves department of a phlegm and facilitates cough.
It is proved that mestnoanesteziruyushchy effect of Ambroxol is caused by dose-dependent blockade of natrium channels of neurons. Under the influence of Ambroxol the release of cytokines from blood and also from fabric mononuklear and polimorfonuklearny cells considerably decreases.
Indications
- sekretolitichesky therapy of the acute and chronic bronchopulmonary diseases which are characterized by disturbance of secretion and the complicated phlegm otkhozhdeniye
the Route of administration and doses
Inside after a meal, swallowing entirely, not chewing, washing down with a large amount of liquid.
Adults and children are more senior than 12 years: in the first 2–3 days of treatment — 1 tablet (30 mg) 3 times a day. If necessary for strengthening of therapeutic
effect the daily dose at adults can be increased up to 120 mg a day: on 2 tablets (60 mg) 2 times a day. In the next days it is necessary to accept on 1 tablet 30 mg 2 times a day.
Duration of treatment is defined by the attending physician.
Side effects
Often (≥ 1/100 - & lt, 1/10):
- nausea, change of taste, decrease in sensitivity in an oral cavity and a throat (oral and pharyngeal giposteziya)
Infrequently (≥ 1/1.000 - & lt, 1/100):
- vomiting, diarrhea dyspepsia, an abdominal pain, dryness in a mouth
it is rare (≥ 1/10.000 - & lt, 1/1.000):
- dryness in a throat
- rash, urticaria
it is not known:
- anaphylactic reactions, including an acute anaphylaxis
- an itching and other reactions of hypersensitivity, a Quincke's disease
of the Contraindication
- hypersensitivity to Ambroxol to a hydrochloride or other components of drug
- children's age up to 12 years
- rare hereditary intolerance of a galactose, deficiency of fructose
- pregnancy and the period of a lactation
With care:
- renal failure.
Medicinal interactions
it was not reported about clinically significant adverse interactions with other drugs.
Combined use with antibechic drugs leads to difficulty of an otkhozhdeniye of a phlegm against the background of suppression of cough.
Increases penetration and concentration in a bronchial secret of amoxicillin, a tsefuroksim and erythromycin.
Special instructions
the Mucolytic effect of drug is shown at reception of a large amount of liquid. Therefore during treatment plentiful drink is recommended.
Very exceptional cases of severe damages of skin such as Stephens-Johnson's syndrome and toxic epidermal necrolysis are registered, at hydrochloride Ambroxol use. Mainly they are caused by weight of a basic disease and the accompanying treatment. Besides at
an early stage of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis at patients signs of the beginning of a nonspecific disease, with the following symptoms can be shown: fervescence, all body pain, rhinitis, cough and sore throat. Emergence of these signs can lead to unnecessary symptomatic treatment by anti-cold drugs. In case of skin defeats – the patient immediately looks round the doctor, intake of Ambroxol of a hydrochloride stops.
Use of Solfrana® is shown to patients with a dekompensirovanny renal failure only after consultation with the doctor.
The fertility, pregnancy and the period of a lactation
of Ambroxol a hydrochloride gets through a placental barrier. Preclinical trials did not show direct or indirect negative impact on pregnancy, fetation, childbirth and post-natal development.
It is not recommended to apply Solfran® in the period of the I trimester of pregnancy. With care to apply in the II-III trimesters of pregnancy and a lactation.
Солфран® gets into breast milk, however, the drug appointed in therapeutic doses does not make negative impact on the child.
Preclinical trials did not show direct or indirect negative impact on fertility.
There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms messages about cases of influence of drug on ability to drive the car or mechanisms during the post-marketing period. Researches were not conducted.
Overdose
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: symptomatic therapy.
The form of release and packing
On 10 tablets place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
Storage conditions
In the dry, protected from light place at a temperature not above 25 °C.
To store out of children's reach!
Period of storage
of 5 years.
Not to use drug after the expiry date specified on packing.
Prescription status
Without
ProizvoditelTOO's prescription Abdi Ibrahim Global Pharm, Kazakhstan, Almaty, Dzhandosov St. 184 of , ph. +7 727 309 74 07, fax +7 727 309 74 14. E-mail address: info@aigp.kz
the Owner of the registration certificate of Abdi Ibrahim Global Pharm LLP
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Abdi Ibrahim Global Pharm LLP, Kazakhstan, Almaty, Dzhandosov St. 184 of , ph. +7 727 309 74 07, fax +7 727 309 74 14. E-mail address: info@aigp.kz
of Solfran® medicine
the Trade name
of Solfran®
the International unlicensed
name Ambroxol Dosage Form
of the Tablet of 30 mg
Structure
1 tablet contains
active agent – Ambroxol a hydrochloride of 30 mg,
excipients: lactoses monohydrate, cellulose microcrystalline, magnesium or calcium stearate, silicon dioxide colloidal anhydrous.
The description
of the Tablet of white color, round, with a flat surface, with a facet on both parties and an engraving of G on one party.
Pharmacotherapeutic group
Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol.
ATX R05CB06 code
Pharmacological
Pharmacokinetics Absorption properties. Absorption high and almost full, with linear dependence on a therapeutic dose. The maximum plasma concentration is reached within 1 - 2.5 hours. The absolute bioavailability is 79%.
Distribution. Distribution fast and extensive, with the highest concentration in tissue of lungs. The volume of distribution is about 552 l. Communication with proteins of blood plasma makes about 90%.
Metabolism and removal. About 30% of the dose accepted inside are exposed to effect of the first passing through a liver.
CYP3A4 – the main enzyme responsible for metabolism of Ambroxol under the influence of which, mainly in a liver, conjugates are formed.
Elimination half-life makes 10 hours. General clearance: within 660 ml/min., the renal clearance is 83% of the general clearance. It is removed by kidneys: 26% in the form of conjugates, 6% - in a free look.
Removal decreases in abnormal liver functions that leads to increase in level in blood plasma by 1.3-2 times, but does not demand dose adjustment.
Gender and age have no clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment.
Meal does not influence bioavailability of Ambroxol of a hydrochloride.
The pharmacodynamics
of Solfran® possesses sekretolitichesky and expectorant action, stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the content of mucous secretion and discharge of surfactant in alveoluses and bronchial tubes, normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of cilia of a ciliary epithelium, increases mukotsiliarny transport of a phlegm. Increase in secretion and mukotsiliarny clearance improves department of a phlegm and facilitates cough.
It is proved that mestnoanesteziruyushchy effect of Ambroxol is caused by dose-dependent blockade of natrium channels of neurons. Under the influence of Ambroxol the release of cytokines from blood and also from fabric mononuklear and polimorfonuklearny cells considerably decreases.
Indications
- sekretolitichesky therapy of the acute and chronic bronchopulmonary diseases which are characterized by disturbance of secretion and the complicated phlegm otkhozhdeniye
the Route of administration and doses
Inside after a meal, swallowing entirely, not chewing, washing down with a large amount of liquid.
Adults and children are more senior than 12 years: in the first 2–3 days of treatment — 1 tablet (30 mg) 3 times a day. If necessary for strengthening of therapeutic
effect the daily dose at adults can be increased up to 120 mg a day: on 2 tablets (60 mg) 2 times a day. In the next days it is necessary to accept on 1 tablet 30 mg 2 times a day.
Duration of treatment is defined by the attending physician.
Side effects
Often (≥ 1/100 - & lt, 1/10):
- nausea, change of taste, decrease in sensitivity in an oral cavity and a throat (oral and pharyngeal giposteziya)
Infrequently (≥ 1/1.000 - & lt, 1/100):
- vomiting, diarrhea dyspepsia, an abdominal pain, dryness in a mouth
it is rare (≥ 1/10.000 - & lt, 1/1.000):
- dryness in a throat
- rash, urticaria
it is not known:
- anaphylactic reactions, including an acute anaphylaxis
- an itching and other reactions of hypersensitivity, a Quincke's disease
of the Contraindication
- hypersensitivity to Ambroxol to a hydrochloride or other components of drug
- children's age up to 12 years
- rare hereditary intolerance of a galactose, deficiency of fructose
- pregnancy and the period of a lactation
With care:
- renal failure.
Medicinal interactions
it was not reported about clinically significant adverse interactions with other drugs.
Combined use with antibechic drugs leads to difficulty of an otkhozhdeniye of a phlegm against the background of suppression of cough.
Increases penetration and concentration in a bronchial secret of amoxicillin, a tsefuroksim and erythromycin.
Special instructions
the Mucolytic effect of drug is shown at reception of a large amount of liquid. Therefore during treatment plentiful drink is recommended.
Very exceptional cases of severe damages of skin such as Stephens-Johnson's syndrome and toxic epidermal necrolysis are registered, at hydrochloride Ambroxol use. Mainly they are caused by weight of a basic disease and the accompanying treatment. Besides at
an early stage of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis at patients signs of the beginning of a nonspecific disease, with the following symptoms can be shown: fervescence, all body pain, rhinitis, cough and sore throat. Emergence of these signs can lead to unnecessary symptomatic treatment by anti-cold drugs. In case of skin defeats – the patient immediately looks round the doctor, intake of Ambroxol of a hydrochloride stops.
Use of Solfrana® is shown to patients with a dekompensirovanny renal failure only after consultation with the doctor.
The fertility, pregnancy and the period of a lactation
of Ambroxol a hydrochloride gets through a placental barrier. Preclinical trials did not show direct or indirect negative impact on pregnancy, fetation, childbirth and post-natal development.
It is not recommended to apply Solfran® in the period of the I trimester of pregnancy. With care to apply in the II-III trimesters of pregnancy and a lactation.
Солфран® gets into breast milk, however, the drug appointed in therapeutic doses does not make negative impact on the child.
Preclinical trials did not show direct or indirect negative impact on fertility.
There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms messages about cases of influence of drug on ability to drive the car or mechanisms during the post-marketing period. Researches were not conducted.
Overdose
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: symptomatic therapy.
The form of release and packing
On 10 tablets place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
Storage conditions
In the dry, protected from light place at a temperature not above 25 °C.
To store out of children's reach!
Period of storage
of 5 years.
Not to use drug after the expiry date specified on packing.
Prescription status
Without
ProizvoditelTOO's prescription Abdi Ibrahim Global Pharm, Kazakhstan, Almaty, Dzhandosov St. 184 of , ph. +7 727 309 74 07, fax +7 727 309 74 14. E-mail address: info@aigp.kz
the Owner of the registration certificate of Abdi Ibrahim Global Pharm LLP
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Abdi Ibrahim Global Pharm LLP, Kazakhstan, Almaty, Dzhandosov St. 184 of , ph. +7 727 309 74 07, fax +7 727 309 74 14. E-mail address: info@aigp.kz
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