Spazmeks 30s 15 mg film-coated tablets
- $39.20
The instruction for medical use
of medicine
Спазмекс®
the Trade name
of Spazmeks®
the International
name Trospiya chloride
the Dosage form
of the Tablet of 5 mg
of the Tablet, film coated 15 mg
Structure
One tablet of 5 mg contains
active agent – a trospiya chloride of 5 mg
excipients: lactoses monohydrate, cellulose microcrystalline, sodium of starch glikolit (type A), starch corn, stearic acid, povidone (To 25), silicon dioxide colloidal anhydrous.
One tablet of coated 15 mg contains
active agent – a trospiya chloride of 15 mg
excipients: lactoses monohydrate, cellulose microcrystalline, sodium of starch glikolit (type A), starch corn, stearic acid, povidone (To 25), silicon dioxide colloidal anhydrous
structure of a cover: Сепифильм® low-molecular polymer 770 white (a giproksipropilmetiltsellyuloza, the titan dioxide, cellulose microcrystalline, stearic acid)
the Description
of the Tablet of almost white color, round shape, with a biconvex surface, flavourless, with a diameter about 9 mm (for a dosage of 5 mg).
Tablets, film coated, almost white color, round shape, with a biconvex surface, flavourless, with risky on one party, with a diameter about 9 mm (for a dosage of 15 mg).
Pharmacotherapeutic group
Drugs for treatment of urological diseases. Spasmolysants.
The code of automatic telephone exchange G04BD09
the Pharmacological
Pharmacokinetics Maximum Concentration properties in blood is reached in 4 – 6 hours after oral administration of tablets a chloride trospiya. Elimination half-life strongly varies and at oral administration averages 5 – 18 hours. It does not kumulirutsya. Linking with proteins of blood plasma makes 50% – 80%. At single dose of drug in a dose of 20 mg – 60 mg concentration in blood plasma is proportional to the accepted dose. The prevailing amount of the chloride which is systematically accepted a trospiya is removed without changes, a smaller part (about 10%) is removed with urine – in the form of spiroalcohol – the metabolite which is formed at hydrolysis of radio bonds.
Trospiya's pharmacodynamics chloride – the quarternary ammonium basis of a nortropanol – belongs to group parasympatolytic or anticholinergics. Active agent is a competitive antagonist of acetylcholine on receptors of postsynaptic membranes of smooth muscles. Trospiya chloride has high affinity to M1- and M3 receptors and rather smaller affinity to M2 receptors, in very insignificant degree contacts nicotinic receptors.
The trospiya of chloride is the most significant anticholinergic effect the weakening action on smooth muscle bodies implemented through muskarinovy receptors.
Trospiya chloride reduces a tone of smooth muscles of digestive tract and urinary tract. Reduces discharge of bronchial slime, salivary and sweating. Impact of drug on the central nervous system was not observed.
Indications
- idiopathic or neurogenetic hyperactivity of a detruzor (with a pollakiuria, imperative desires on urination and urine incontinence)
the Route of administration and doses:
A pill is taken inside to food, without chewing and washing down with enough water.
To adults and children of 12 years a trospiya chloride is appointed individually, depending on a clinical picture and disease severity.
At idiopathic hyperactivity of a detruzor a trospiya chloride is appointed inside on 10 mg 3 times a day (30 mg/days) or on 15 mg by 2-3 times a day (30-45 mg/days). At a daily dose of 45 mg about 30 mg and 15 mg are also admissible to accept in the morning in the evening.
At neurogenetic hyperactivity of a detruzor a trospiya chloride is appointed on 20 mg by 2 times a day in the morning and in the evening (40 mg/days). The maximum daily dose - 135 mg. On average, duration of treatment is 2-3 months.
After disappearance of symptomatology performing antirecurrent treatment within 2-4 weeks is recommended. In need of longer therapy, the question of continuation of treatment is reconsidered by the doctor each 3 months.
At patients with a renal failure (clearance of creatinine of 10-30 ml/min. / 1.73 sq.m) a daily dose the trospiya of chloride should not exceed 20 mg.
Side effects
Often (≥ 1% to
- dryness in a mouth, dyspepsia, a constipation, an abdominal pain, nausea
Infrequently (≥ 0.1% to
- tachycardia
- accommodation paresis
- short wind
- diarrhea, an abdominal distension
- disturbance of bladder emptying
- skin rash
- weakness, pain behind a breast
Seldom (≥ 0.01% to
- small or moderate increase in activity of transaminases
- an ischuria
- a Quincke's disease, anaphylactic reaction
of the Contraindication
- hypersensitivity to active agent (a trospiya to chloride) or to other components of drug
- a mechanical stenosis of digestive tract
- chronic inflammatory bowel diseases (ulcer colitis, Crohn's disease
- toxic megacolon
- an ischuria, owing to a benign hyperplasia of a prostate or a stenosis of an urethra
- closed-angle glaucoma
- arrhythmia, a tachyarrhythmia
- a myasthenia
- the renal failure demanding dialysis (clearance of creatinine
- pregnancy and the period of a lactation
- children's age up to 12 years
Medicinal interactions
At simultaneous use the trospiya chloride with amantadiny, quinidine tricyclic antidepressants, blockers of histamine H1 receptors, Disopyramidum amplifies anticholinergic effect. At combined use with beta-adrenergic agonists strengthening of tachycardia is noted. At combined use with Metoclopramidum the weakening of therapeutic action of the last is noted.
Special instructions
Prior to therapy by the drug Spazmeks® need to be excluded the organic reasons of a pollakiuria and incontinence of urine, such as heart or renal failure, polydipsia, tumors of urinary tract.
At dysfunction of a sphincter of an urethra or a detruzor the liberation of a bladder by catheterization has to be provided. It is necessary to use with care drug in a renal/liver failure, a thyrotoxicosis, coronary heart disease, chronic heart failure, arrhythmia, arterial hypertension, a prostate hyperplasia, hernia of an esophageal opening of a diaphragm, a pyloric stenosis, the diarrhea accompanying incomplete intestinal obstruction (especially at patients with ileo- or kolostomy), at elderly people.
Lactose is a part of excipients of drug. Patients with rare hereditary intolerance of a galactose, a lactose intolerance of Lapp or a sprue of glucose galactose should not take the drug.
Use in pediatrics
Considering insufficiency of data on safety and efficiency of drug in pediatric practice it is recommended to refrain from its appointment at children's age up to 12 years.
Influence on ability of control of vehicles and potentially dangerous mechanisms
During treatment it is necessary to abstain from driving of transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
The overdose
Trospium chloride is well transferred. Symptoms of overdose were not observed.
Symptoms: in poisoning the expressiveness of symptoms of anticholinergic intoxication can be shown (accommodation disturbance, tachycardia, dryness in a mouth, erubescence).
Treatment: symptoms of overdose can be facilitated by use of a neostigmin. To patients with glaucoma pilocarpine can be entered locally.
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 3 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard box.
Storage conditions
In the dry place protected from light at a temperature of 15 - 25 0C.
To store out of children's reach!
Not to apply a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription
the Producer
Other R. Pfleger, Chemical factory GmbH
D-96045, Bamberg, Germany
the Exclusive distributor
of the Prague PRO.MED.TsS and. the lake
of Telchsk 1, 140 00 Prague 4
Czech Republic
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of goods
PROM.MEDIC.KAZ. LLP
Almaty, Dostyk Ave. 132, office 9, ph. 8 (727) 260-89-36, fax 8 (727) 260-89-36
Email:
To develop sekretar@prommedic.kz
of medicine
Спазмекс®
the Trade name
of Spazmeks®
the International
name Trospiya chloride
the Dosage form
of the Tablet of 5 mg
of the Tablet, film coated 15 mg
Structure
One tablet of 5 mg contains
active agent – a trospiya chloride of 5 mg
excipients: lactoses monohydrate, cellulose microcrystalline, sodium of starch glikolit (type A), starch corn, stearic acid, povidone (To 25), silicon dioxide colloidal anhydrous.
One tablet of coated 15 mg contains
active agent – a trospiya chloride of 15 mg
excipients: lactoses monohydrate, cellulose microcrystalline, sodium of starch glikolit (type A), starch corn, stearic acid, povidone (To 25), silicon dioxide colloidal anhydrous
structure of a cover: Сепифильм® low-molecular polymer 770 white (a giproksipropilmetiltsellyuloza, the titan dioxide, cellulose microcrystalline, stearic acid)
the Description
of the Tablet of almost white color, round shape, with a biconvex surface, flavourless, with a diameter about 9 mm (for a dosage of 5 mg).
Tablets, film coated, almost white color, round shape, with a biconvex surface, flavourless, with risky on one party, with a diameter about 9 mm (for a dosage of 15 mg).
Pharmacotherapeutic group
Drugs for treatment of urological diseases. Spasmolysants.
The code of automatic telephone exchange G04BD09
the Pharmacological
Pharmacokinetics Maximum Concentration properties in blood is reached in 4 – 6 hours after oral administration of tablets a chloride trospiya. Elimination half-life strongly varies and at oral administration averages 5 – 18 hours. It does not kumulirutsya. Linking with proteins of blood plasma makes 50% – 80%. At single dose of drug in a dose of 20 mg – 60 mg concentration in blood plasma is proportional to the accepted dose. The prevailing amount of the chloride which is systematically accepted a trospiya is removed without changes, a smaller part (about 10%) is removed with urine – in the form of spiroalcohol – the metabolite which is formed at hydrolysis of radio bonds.
Trospiya's pharmacodynamics chloride – the quarternary ammonium basis of a nortropanol – belongs to group parasympatolytic or anticholinergics. Active agent is a competitive antagonist of acetylcholine on receptors of postsynaptic membranes of smooth muscles. Trospiya chloride has high affinity to M1- and M3 receptors and rather smaller affinity to M2 receptors, in very insignificant degree contacts nicotinic receptors.
The trospiya of chloride is the most significant anticholinergic effect the weakening action on smooth muscle bodies implemented through muskarinovy receptors.
Trospiya chloride reduces a tone of smooth muscles of digestive tract and urinary tract. Reduces discharge of bronchial slime, salivary and sweating. Impact of drug on the central nervous system was not observed.
Indications
- idiopathic or neurogenetic hyperactivity of a detruzor (with a pollakiuria, imperative desires on urination and urine incontinence)
the Route of administration and doses:
A pill is taken inside to food, without chewing and washing down with enough water.
To adults and children of 12 years a trospiya chloride is appointed individually, depending on a clinical picture and disease severity.
At idiopathic hyperactivity of a detruzor a trospiya chloride is appointed inside on 10 mg 3 times a day (30 mg/days) or on 15 mg by 2-3 times a day (30-45 mg/days). At a daily dose of 45 mg about 30 mg and 15 mg are also admissible to accept in the morning in the evening.
At neurogenetic hyperactivity of a detruzor a trospiya chloride is appointed on 20 mg by 2 times a day in the morning and in the evening (40 mg/days). The maximum daily dose - 135 mg. On average, duration of treatment is 2-3 months.
After disappearance of symptomatology performing antirecurrent treatment within 2-4 weeks is recommended. In need of longer therapy, the question of continuation of treatment is reconsidered by the doctor each 3 months.
At patients with a renal failure (clearance of creatinine of 10-30 ml/min. / 1.73 sq.m) a daily dose the trospiya of chloride should not exceed 20 mg.
Side effects
Often (≥ 1% to
- dryness in a mouth, dyspepsia, a constipation, an abdominal pain, nausea
Infrequently (≥ 0.1% to
- tachycardia
- accommodation paresis
- short wind
- diarrhea, an abdominal distension
- disturbance of bladder emptying
- skin rash
- weakness, pain behind a breast
Seldom (≥ 0.01% to
- small or moderate increase in activity of transaminases
- an ischuria
- a Quincke's disease, anaphylactic reaction
of the Contraindication
- hypersensitivity to active agent (a trospiya to chloride) or to other components of drug
- a mechanical stenosis of digestive tract
- chronic inflammatory bowel diseases (ulcer colitis, Crohn's disease
- toxic megacolon
- an ischuria, owing to a benign hyperplasia of a prostate or a stenosis of an urethra
- closed-angle glaucoma
- arrhythmia, a tachyarrhythmia
- a myasthenia
- the renal failure demanding dialysis (clearance of creatinine
- pregnancy and the period of a lactation
- children's age up to 12 years
Medicinal interactions
At simultaneous use the trospiya chloride with amantadiny, quinidine tricyclic antidepressants, blockers of histamine H1 receptors, Disopyramidum amplifies anticholinergic effect. At combined use with beta-adrenergic agonists strengthening of tachycardia is noted. At combined use with Metoclopramidum the weakening of therapeutic action of the last is noted.
Special instructions
Prior to therapy by the drug Spazmeks® need to be excluded the organic reasons of a pollakiuria and incontinence of urine, such as heart or renal failure, polydipsia, tumors of urinary tract.
At dysfunction of a sphincter of an urethra or a detruzor the liberation of a bladder by catheterization has to be provided. It is necessary to use with care drug in a renal/liver failure, a thyrotoxicosis, coronary heart disease, chronic heart failure, arrhythmia, arterial hypertension, a prostate hyperplasia, hernia of an esophageal opening of a diaphragm, a pyloric stenosis, the diarrhea accompanying incomplete intestinal obstruction (especially at patients with ileo- or kolostomy), at elderly people.
Lactose is a part of excipients of drug. Patients with rare hereditary intolerance of a galactose, a lactose intolerance of Lapp or a sprue of glucose galactose should not take the drug.
Use in pediatrics
Considering insufficiency of data on safety and efficiency of drug in pediatric practice it is recommended to refrain from its appointment at children's age up to 12 years.
Influence on ability of control of vehicles and potentially dangerous mechanisms
During treatment it is necessary to abstain from driving of transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
The overdose
Trospium chloride is well transferred. Symptoms of overdose were not observed.
Symptoms: in poisoning the expressiveness of symptoms of anticholinergic intoxication can be shown (accommodation disturbance, tachycardia, dryness in a mouth, erubescence).
Treatment: symptoms of overdose can be facilitated by use of a neostigmin. To patients with glaucoma pilocarpine can be entered locally.
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 3 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard box.
Storage conditions
In the dry place protected from light at a temperature of 15 - 25 0C.
To store out of children's reach!
Not to apply a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription
the Producer
Other R. Pfleger, Chemical factory GmbH
D-96045, Bamberg, Germany
the Exclusive distributor
of the Prague PRO.MED.TsS and. the lake
of Telchsk 1, 140 00 Prague 4
Czech Republic
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of goods
PROM.MEDIC.KAZ. LLP
Almaty, Dostyk Ave. 132, office 9, ph. 8 (727) 260-89-36, fax 8 (727) 260-89-36
Email:
To develop sekretar@prommedic.kz
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