The instruction for medical use
of NO-ShPAÒ medicine,
Trade name
of No-shpaÒ,
the International unlicensed
name Drotaverinum Dosage Form
of the Tablet, 40 mg
One tablet contains Structure:
active agent - Drotaverinum a hydrochloride of 40.0 mg
excipients: lactoses monohydrate, starch corn, povidone, magnesium stearate, talc.
The description
of the Tablet of round shape, with a biconvex surface, yellow color with a greenish or orange shade, spa engraving on one party.
Pharmacotherapeutic group
Drugs for treatment of functional disorders of intestines. Papaverine and its derivatives. Drotaverinum.
The ATX A03AD02 code
the Pharmacological
Pharmacokinetics Drotaverinum properties is quickly soaked up both after peroral, and after parenteral administration. It highly contacts plasma albumine (for 95-98%), alpha and beta globulins. The maximum concentration in blood serum is reached in 45-60 minutes after oral administration.
After primary metabolism 65% of the accepted Drotaverinum dose come to a system blood stream in not changed form.
Drotaverinum is metabolized in a liver. Its biological elimination half-life makes 8-10 hours. In 72 hours, drug is almost completely removed from an organism, at the same time about 50% are removed with urine, and about 30% with a stake. Drotaverinum is removed generally in the form of metabolites, not changed drug form in urine is not found.
The pharmacodynamics
Nospanum represents derivative isoquinoline which has spasmolytic effect directly on smooth muscles.
The inhibition of enzyme of phosphodiesterase and the subsequent increase in the tsAMF level are determinal factors of the mechanism of effect of drug and lead to relaxation of smooth muscles by means of an inactivation of the easy chain of a kinase of myosin (ECKM).
Nospanum inhibits enzyme IV in vitro phosphodiesterase (FDE) without inhibition of isoenzymes of FDE III and FDE V. FDE IV plays an important role in decrease in sokratitelny ability of unstriated muscles, in this regard, the FDE IV selection inhibitors can be useful at treatment of the hyperkinetic disturbances and various diseases which are followed by spastic conditions of smooth muscles of digestive tract. The isoenzyme of FDE III hydrolyzes tsAMF in cells of smooth muscles of a myocardium and vessels.
Irrespective of type of a vegetative innervation, Drotaverinum equally affects smooth muscles of digestive tract, biliary tract, an urinogenital system and vessels. Due to the vasodilating action of No-shpaÒ, improves blood supply of fabrics.
Indications
- spasms of smooth muscles in diseases of biliary tract: a cholecystolithiasis, a cholangiolithiasis, cholecystitis, a pericholecystitis, a cholangitis, a papillitis
- spasms of smooth muscles of mochevyvovdyashchy ways: a nephrolithiasis, an ureterolithiasis, a pyelitis, cystitis, bladder tenesmus
as auxiliary therapy:
- at spasms of smooth muscles of digestive tract: a peptic ulcer of a stomach and duodenum, gastritis, spasms of the cardia and the gatekeeper, enteritis, colitis, a spastic colitis with a constipation and a meteorism at a syndrome of the angry intestines
- in tension headaches
- in gynecologic diseases: dysmenorrhea (painful periods)
Route of administration and doses
Adult: the usual dose makes 120-240 mg a day (divided into 2-3 receptions). Clinical trials of use of Drotaverinum for children were not conducted if prescribing of Drotaverinum is necessary:
- to children aged from 6 up to 12 years the maximum daily dose makes 80 mg in two steps,
- to children 12 years the maximum daily dose are more senior makes 160 mg in 2-4 receptions.
Duration of treatment depends on the applied indications. At administration of drug the recommended duration of administration of drug usually is 1-2 days. In cases when Drotaverinum is applied as auxiliary therapy, duration of treatment can be more (2-3 days). If the pain syndrome remains, the patient should see a doctor.
Use of the dosing plastic container: before use to remove a protective strip from an upper part of a bottle and a sticker from a bottle bottom.
Then to press on bottle top therefore one tablet will drop out of the dosing opening on a bottom.
Side effects
Seldom (& ge, 1/10,000, & lt, 1/1000)
- a headache, dizziness, insomnia
- nausea, a constipation
- a cardiopalmus, hypotension
- allergic reactions (Quincke's disease, a small tortoiseshell, rash, an itching)
of the Contraindication
- hypersensitivity to active agent or to any of drug excipients
- a heavy liver or renal failure
- heart failure (syndrome of low warm emission)
- patients with diseases of hereditary intolerance of a galactose, deficiency of Lappa lactase or disturbance of absorption of glucose galactose
- children's age up to 6 years
Medicinal interactions
phosphodiesterase Inhibitors, such as papaverine, reduce protivoparkinsonichesky effect of a levodopa. At their simultaneous use with a levodopa the protivoparkinsonichesky effect of the last decreases, i.e. strengthening of a tremor and rigidity is possible, it is necessary to be careful.
With other antispasmodics, including m-holinoblokatory: mutual strengthening of spasmolytic action.
Special instructions
At the lowered arterial blood pressure the use of drug demands the increased care.
The tablet of Nospanum of 40 mg contains 52 mg of lactose. Patients with seldom found diseases of hereditary intolerance of a galactose, deficiency of Lappa lactase or disturbance of absorption of glucose galactose should not take this drug.
Children
Clinical trials with participation of children were not conducted therefore it is recommended to apply with care.
Pregnancy
Preclinical trials did not show any signs of direct or indirect negative impact on a pregnancy course, embryonic development, childbirth or a course of a puerperal period.
Nevertheless, pregnant women can appoint drug only after careful weighing of a ratio of advantage and risk.
The lactation period
Owing to lack of these clinical trials is not recommended to appoint drug during breastfeeding.
Reproductive function
Data on influence on reproductive function are absent.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Patients should warn that if after administration of drug they feel dizzy, to them should avoid potentially dangerous activity, such as driving or other mechanisms.
Overdose
Symptoms: the excess dose of Drotaverinum can lead to cardiac conduction abnormalities and a warm rhythm, including interventricular blockade and cardiac arrest that can lead to death.
Treatment: in case of overdose of the patient has to be under careful observation and receive the symptomatic and supporting treatment, including induction of vomiting and/or gastric lavage.
The form of release and packing
On 24 tablets place in blister strip packaging from a polyvinylchloride film and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
On 60 tablets place in the dosing plastic containers or on 100 tablets place in the bottles from polypropylene corked by polyethylene traffic jams.
On a container and a bottle paste labels from self-adhesive paper.
The container or bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not higher than 25 wasps in original packing.
To store out of children's reach!
Period of storage
3 years.
Not to apply after an expiration date.
Prescription status
Without prescription
HINOIN Producer the plant of Pharmaceutical and Chemical Products of closed joint stock company,
Hungary
the location Address: Levai u. 5, 2112 Veresegyhaz, Hungary
the Owner of the registration certificate
Sanofi-aventis of closed joint stock company, Budapest, Hungary
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013 Almaty, N. Nazarbayev Ave., 187B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail: quality.info@sanofi.com
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013, Almaty, N. Nazarbayev Ave., 187 B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail:
To Develop Kazakhstan.Pharmacovigilance@sanofi.com
of NO-ShPAÒ medicine,
Trade name
of No-shpaÒ,
the International unlicensed
name Drotaverinum Dosage Form
of the Tablet, 40 mg
One tablet contains Structure:
active agent - Drotaverinum a hydrochloride of 40.0 mg
excipients: lactoses monohydrate, starch corn, povidone, magnesium stearate, talc.
The description
of the Tablet of round shape, with a biconvex surface, yellow color with a greenish or orange shade, spa engraving on one party.
Pharmacotherapeutic group
Drugs for treatment of functional disorders of intestines. Papaverine and its derivatives. Drotaverinum.
The ATX A03AD02 code
the Pharmacological
Pharmacokinetics Drotaverinum properties is quickly soaked up both after peroral, and after parenteral administration. It highly contacts plasma albumine (for 95-98%), alpha and beta globulins. The maximum concentration in blood serum is reached in 45-60 minutes after oral administration.
After primary metabolism 65% of the accepted Drotaverinum dose come to a system blood stream in not changed form.
Drotaverinum is metabolized in a liver. Its biological elimination half-life makes 8-10 hours. In 72 hours, drug is almost completely removed from an organism, at the same time about 50% are removed with urine, and about 30% with a stake. Drotaverinum is removed generally in the form of metabolites, not changed drug form in urine is not found.
The pharmacodynamics
Nospanum represents derivative isoquinoline which has spasmolytic effect directly on smooth muscles.
The inhibition of enzyme of phosphodiesterase and the subsequent increase in the tsAMF level are determinal factors of the mechanism of effect of drug and lead to relaxation of smooth muscles by means of an inactivation of the easy chain of a kinase of myosin (ECKM).
Nospanum inhibits enzyme IV in vitro phosphodiesterase (FDE) without inhibition of isoenzymes of FDE III and FDE V. FDE IV plays an important role in decrease in sokratitelny ability of unstriated muscles, in this regard, the FDE IV selection inhibitors can be useful at treatment of the hyperkinetic disturbances and various diseases which are followed by spastic conditions of smooth muscles of digestive tract. The isoenzyme of FDE III hydrolyzes tsAMF in cells of smooth muscles of a myocardium and vessels.
Irrespective of type of a vegetative innervation, Drotaverinum equally affects smooth muscles of digestive tract, biliary tract, an urinogenital system and vessels. Due to the vasodilating action of No-shpaÒ, improves blood supply of fabrics.
Indications
- spasms of smooth muscles in diseases of biliary tract: a cholecystolithiasis, a cholangiolithiasis, cholecystitis, a pericholecystitis, a cholangitis, a papillitis
- spasms of smooth muscles of mochevyvovdyashchy ways: a nephrolithiasis, an ureterolithiasis, a pyelitis, cystitis, bladder tenesmus
as auxiliary therapy:
- at spasms of smooth muscles of digestive tract: a peptic ulcer of a stomach and duodenum, gastritis, spasms of the cardia and the gatekeeper, enteritis, colitis, a spastic colitis with a constipation and a meteorism at a syndrome of the angry intestines
- in tension headaches
- in gynecologic diseases: dysmenorrhea (painful periods)
Route of administration and doses
Adult: the usual dose makes 120-240 mg a day (divided into 2-3 receptions). Clinical trials of use of Drotaverinum for children were not conducted if prescribing of Drotaverinum is necessary:
- to children aged from 6 up to 12 years the maximum daily dose makes 80 mg in two steps,
- to children 12 years the maximum daily dose are more senior makes 160 mg in 2-4 receptions.
Duration of treatment depends on the applied indications. At administration of drug the recommended duration of administration of drug usually is 1-2 days. In cases when Drotaverinum is applied as auxiliary therapy, duration of treatment can be more (2-3 days). If the pain syndrome remains, the patient should see a doctor.
Use of the dosing plastic container: before use to remove a protective strip from an upper part of a bottle and a sticker from a bottle bottom.
Then to press on bottle top therefore one tablet will drop out of the dosing opening on a bottom.
Side effects
Seldom (& ge, 1/10,000, & lt, 1/1000)
- a headache, dizziness, insomnia
- nausea, a constipation
- a cardiopalmus, hypotension
- allergic reactions (Quincke's disease, a small tortoiseshell, rash, an itching)
of the Contraindication
- hypersensitivity to active agent or to any of drug excipients
- a heavy liver or renal failure
- heart failure (syndrome of low warm emission)
- patients with diseases of hereditary intolerance of a galactose, deficiency of Lappa lactase or disturbance of absorption of glucose galactose
- children's age up to 6 years
Medicinal interactions
phosphodiesterase Inhibitors, such as papaverine, reduce protivoparkinsonichesky effect of a levodopa. At their simultaneous use with a levodopa the protivoparkinsonichesky effect of the last decreases, i.e. strengthening of a tremor and rigidity is possible, it is necessary to be careful.
With other antispasmodics, including m-holinoblokatory: mutual strengthening of spasmolytic action.
Special instructions
At the lowered arterial blood pressure the use of drug demands the increased care.
The tablet of Nospanum of 40 mg contains 52 mg of lactose. Patients with seldom found diseases of hereditary intolerance of a galactose, deficiency of Lappa lactase or disturbance of absorption of glucose galactose should not take this drug.
Children
Clinical trials with participation of children were not conducted therefore it is recommended to apply with care.
Pregnancy
Preclinical trials did not show any signs of direct or indirect negative impact on a pregnancy course, embryonic development, childbirth or a course of a puerperal period.
Nevertheless, pregnant women can appoint drug only after careful weighing of a ratio of advantage and risk.
The lactation period
Owing to lack of these clinical trials is not recommended to appoint drug during breastfeeding.
Reproductive function
Data on influence on reproductive function are absent.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Patients should warn that if after administration of drug they feel dizzy, to them should avoid potentially dangerous activity, such as driving or other mechanisms.
Overdose
Symptoms: the excess dose of Drotaverinum can lead to cardiac conduction abnormalities and a warm rhythm, including interventricular blockade and cardiac arrest that can lead to death.
Treatment: in case of overdose of the patient has to be under careful observation and receive the symptomatic and supporting treatment, including induction of vomiting and/or gastric lavage.
The form of release and packing
On 24 tablets place in blister strip packaging from a polyvinylchloride film and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
On 60 tablets place in the dosing plastic containers or on 100 tablets place in the bottles from polypropylene corked by polyethylene traffic jams.
On a container and a bottle paste labels from self-adhesive paper.
The container or bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not higher than 25 wasps in original packing.
To store out of children's reach!
Period of storage
3 years.
Not to apply after an expiration date.
Prescription status
Without prescription
HINOIN Producer the plant of Pharmaceutical and Chemical Products of closed joint stock company,
Hungary
the location Address: Levai u. 5, 2112 Veresegyhaz, Hungary
the Owner of the registration certificate
Sanofi-aventis of closed joint stock company, Budapest, Hungary
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013 Almaty, N. Nazarbayev Ave., 187B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail: quality.info@sanofi.com
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013, Almaty, N. Nazarbayev Ave., 187 B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail:
To Develop Kazakhstan.Pharmacovigilance@sanofi.com
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