No-spa 80mg tablets forte 24's
- $10.50
The instruction for medical use
of NO-ShPAÒ medicine, FORTE
Trade name
of No-shpaÒ, forte
the International unlicensed
name Drotaverinum Dosage Form
of the Tablet, 80 mg
Structure
One tablet contains
active agent - Drotaverinum a hydrochloride of 80.0 mg
excipients: lactoses monohydrate, starch corn, povidone, magnesium stearate, talc.
The description
of the Tablet of yellow color with a greenish or orange shade, oblong shape, with a biconvex surface, on one party with NOSPA engraving, on other party the line of a break, with a diameter about 13 mm, about 6 mm wide, about 3.8 mm high.
Pharmacotherapeutic group
Drugs for treatment of functional disorders of a GIT.
Drugs for treatment of functional disorders of intestines.
Papaverine and its derivatives. Drotaverinum.
The ATX A03AD02 code
the Pharmacological
Pharmacokinetics Drotaverinum Absorption properties a hydrochloride is quickly and fully soaked up, both after peroral, and after parenteral administration.
Drotaverinum distribution a hydrochloride highly contacts proteins of blood plasma (95-98%), especially albumine, gamma and beta globulins. The maximum concentration in blood plasma is reached in 45 - 60 minutes after intake.
Biotransformation
After primary metabolism of drug in a liver of 65% of a dose are in blood circulation in an invariable look. Drotaverinum the hydrochloride is metabolized in a liver.
Elimination
Biological elimination half-life is 8 10th hour. In 72 hours of Drotaverinum the hydrochloride is almost completely brought out of an organism, more than 50% are removed with urine and about 30% - with a stake. Drotaverinum the hydrochloride is removed mainly in the form of metabolites, initial connection in urine is not found.
The pharmacodynamics
Nospanum forte represents the action Mechanism derivative isoquinoline which shows spasmolytic action on smooth muscles by suppression of enzyme of phosphodiesterase IV (FDE IV). The inhibition of enzyme of phosphodiesterase IV results in the increased concentration of tsAMF (cyclic adenosinemonophosphate) that inactivates the easy chain of a kinase of myosin (ECKM) that, in turn, leads to relaxation of smooth muscles.
Nospanum forte inhibits enzyme (FDE) IV phosphodiesterase without inhibition of isoenzymes of FDE III and FDE V. Probably, FDE IV is functionally very important for decrease in sokratitelny ability of unstriated muscles that it suggests an idea that the FDE IV selection inhibitors can be useful at treatment of the hyperkinetic diseases and various diseases connected with spastic conditions of digestive tract.
The enzyme hydrolyzing tsAMF in cells of smooth muscles of a myocardium and vessels generally is FDE III isoenzyme, it explains that Drotaverinum is an effective spasmolytic agent without serious cardiovascular side effects and strong cardiovascular therapeutic activity.
Drug is effective at spasms of smooth muscles of both a nervous, and muscular etiology. Irrespective of type of a vegetetivny innervation, Drotaverinum affects the unstriated muscles which are in gastrointestinal, bilious, urogenital and vascular systems.
Thanks to the vasodilating action Nospanum forte strengthens fabric blood circulation.
Indications
the spasms of smooth muscles connected with diseases of a biliary path: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis,
spasms of smooth muscles of urinary tract: 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 syndrome of the angry intestines with a spastic constipation or the forms proceeding with a meteorism
in tension headaches,
in gynecologic diseases: dysmenorrhea.
Route of administration and doses
Adult: the usual average dose makes daily 120-240 mg (in 2-3 receptions). The maximum single dose makes 80 mg, the maximum daily dose of 240 mg.
Use of Nospanum forte at children was not exposed to assessment in clinical trials, the maximum daily dose for children over 12 years if necessary: makes 160 mg (in 2-4 receptions).
Treatment duration for adults and children is more senior than 12 years depends on the applied indications. In pains of spastic character, it agrees to the above-stated indications, it is necessary to apply drug 1-2 days, in other cases duration of treatment is defined by the doctor.
Side effects
Seldom
nausea, a constipation
a headache, dizziness, insomnia
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
heavy heart failure (syndrome of low warm emission)
patients with rare hereditary diseases of a lactose intolerance, deficiency of Lappa lactase or a syndrome of the broken absorption of a glucose/galactose
children's age to 12 years
Medicinal interactions
the phosphodiesterase Inhibitors similar to a papaverine reduce antiparkinsonny effect of a levodopa.
It is necessary to be careful at combined use of Nospanum
forte with a levodopa as the antiparkinsonny effect of the last decreases and observed strengthening of a tremor and rigidity.
Special instructions
At the lowered arterial blood pressure the use of drug demands the increased care.
Tablets of Nospanum forte contain 104 mg of lactose therefore drug should not be used to the persons having rare diseases of a hereditary lactose intolerance, deficiency of Lappa lactase or a syndrome of the broken absorption of a glucose/galactose.
Children
Clinical trials with participation of children were not conducted.
Pregnancy
In the conducted preclinical trials the direct or indirect harmful effects of drug on pregnancy, fetation, childbirth or post-natal development are not revealed. Drug can be appointed to pregnant women after weighing of potential risk and advantage.
The lactation
Due to the lack of necessary clinical data is not recommended to appoint.
Reproductive function
Data on influence on reproductive function are absent.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Patients should be instructed about that, in case of developing of dizziness the patients should avoid potentially dangerous activity, such as management, the car and 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 aluminum foil or from PVC and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at
a temperature not higher than 25 S. Hranit out of children's reach!
3 years
not to apply a period of storage after the expiration date specified on packing.
Prescription status
Without prescription
the Producer/packer
of HINOIN 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 closed joint stock company, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013, Almaty, Furmanov St. of 187 B
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, Furmanov St. of 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, FORTE
Trade name
of No-shpaÒ, forte
the International unlicensed
name Drotaverinum Dosage Form
of the Tablet, 80 mg
Structure
One tablet contains
active agent - Drotaverinum a hydrochloride of 80.0 mg
excipients: lactoses monohydrate, starch corn, povidone, magnesium stearate, talc.
The description
of the Tablet of yellow color with a greenish or orange shade, oblong shape, with a biconvex surface, on one party with NOSPA engraving, on other party the line of a break, with a diameter about 13 mm, about 6 mm wide, about 3.8 mm high.
Pharmacotherapeutic group
Drugs for treatment of functional disorders of a GIT.
Drugs for treatment of functional disorders of intestines.
Papaverine and its derivatives. Drotaverinum.
The ATX A03AD02 code
the Pharmacological
Pharmacokinetics Drotaverinum Absorption properties a hydrochloride is quickly and fully soaked up, both after peroral, and after parenteral administration.
Drotaverinum distribution a hydrochloride highly contacts proteins of blood plasma (95-98%), especially albumine, gamma and beta globulins. The maximum concentration in blood plasma is reached in 45 - 60 minutes after intake.
Biotransformation
After primary metabolism of drug in a liver of 65% of a dose are in blood circulation in an invariable look. Drotaverinum the hydrochloride is metabolized in a liver.
Elimination
Biological elimination half-life is 8 10th hour. In 72 hours of Drotaverinum the hydrochloride is almost completely brought out of an organism, more than 50% are removed with urine and about 30% - with a stake. Drotaverinum the hydrochloride is removed mainly in the form of metabolites, initial connection in urine is not found.
The pharmacodynamics
Nospanum forte represents the action Mechanism derivative isoquinoline which shows spasmolytic action on smooth muscles by suppression of enzyme of phosphodiesterase IV (FDE IV). The inhibition of enzyme of phosphodiesterase IV results in the increased concentration of tsAMF (cyclic adenosinemonophosphate) that inactivates the easy chain of a kinase of myosin (ECKM) that, in turn, leads to relaxation of smooth muscles.
Nospanum forte inhibits enzyme (FDE) IV phosphodiesterase without inhibition of isoenzymes of FDE III and FDE V. Probably, FDE IV is functionally very important for decrease in sokratitelny ability of unstriated muscles that it suggests an idea that the FDE IV selection inhibitors can be useful at treatment of the hyperkinetic diseases and various diseases connected with spastic conditions of digestive tract.
The enzyme hydrolyzing tsAMF in cells of smooth muscles of a myocardium and vessels generally is FDE III isoenzyme, it explains that Drotaverinum is an effective spasmolytic agent without serious cardiovascular side effects and strong cardiovascular therapeutic activity.
Drug is effective at spasms of smooth muscles of both a nervous, and muscular etiology. Irrespective of type of a vegetetivny innervation, Drotaverinum affects the unstriated muscles which are in gastrointestinal, bilious, urogenital and vascular systems.
Thanks to the vasodilating action Nospanum forte strengthens fabric blood circulation.
Indications
the spasms of smooth muscles connected with diseases of a biliary path: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis,
spasms of smooth muscles of urinary tract: 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 syndrome of the angry intestines with a spastic constipation or the forms proceeding with a meteorism
in tension headaches,
in gynecologic diseases: dysmenorrhea.
Route of administration and doses
Adult: the usual average dose makes daily 120-240 mg (in 2-3 receptions). The maximum single dose makes 80 mg, the maximum daily dose of 240 mg.
Use of Nospanum forte at children was not exposed to assessment in clinical trials, the maximum daily dose for children over 12 years if necessary: makes 160 mg (in 2-4 receptions).
Treatment duration for adults and children is more senior than 12 years depends on the applied indications. In pains of spastic character, it agrees to the above-stated indications, it is necessary to apply drug 1-2 days, in other cases duration of treatment is defined by the doctor.
Side effects
Seldom
nausea, a constipation
a headache, dizziness, insomnia
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
heavy heart failure (syndrome of low warm emission)
patients with rare hereditary diseases of a lactose intolerance, deficiency of Lappa lactase or a syndrome of the broken absorption of a glucose/galactose
children's age to 12 years
Medicinal interactions
the phosphodiesterase Inhibitors similar to a papaverine reduce antiparkinsonny effect of a levodopa.
It is necessary to be careful at combined use of Nospanum
forte with a levodopa as the antiparkinsonny effect of the last decreases and observed strengthening of a tremor and rigidity.
Special instructions
At the lowered arterial blood pressure the use of drug demands the increased care.
Tablets of Nospanum forte contain 104 mg of lactose therefore drug should not be used to the persons having rare diseases of a hereditary lactose intolerance, deficiency of Lappa lactase or a syndrome of the broken absorption of a glucose/galactose.
Children
Clinical trials with participation of children were not conducted.
Pregnancy
In the conducted preclinical trials the direct or indirect harmful effects of drug on pregnancy, fetation, childbirth or post-natal development are not revealed. Drug can be appointed to pregnant women after weighing of potential risk and advantage.
The lactation
Due to the lack of necessary clinical data is not recommended to appoint.
Reproductive function
Data on influence on reproductive function are absent.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Patients should be instructed about that, in case of developing of dizziness the patients should avoid potentially dangerous activity, such as management, the car and 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 aluminum foil or from PVC and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at
a temperature not higher than 25 S. Hranit out of children's reach!
3 years
not to apply a period of storage after the expiration date specified on packing.
Prescription status
Without prescription
the Producer/packer
of HINOIN 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 closed joint stock company, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013, Almaty, Furmanov St. of 187 B
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, Furmanov St. of 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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