INSTRUCTION SHEET on medical application of preparation

noatac decaeaac dem no of preparation
Trade name: SOKA-e oandam oa
International nonproprietary name: vinpocetine
Dosage form: dnodaomuemaa nua o nc noacncnm noc
Composition for 1ml:
Active substance: - 5.0mg;
tloameumeu daed ca5.0atloacnc nta a100.0a–tloacnut mncatcnut magaa10.0a–tloataoa caecdn ncaa0.5a– dd a aomcoaecdnut daed ca
tloatemaua nua oeadm noca1.0a–ac cnc maatcnc ntatamet cnc mag .naamna1atca–
Description:a. accnt c amueocaeuaomacncnm no-luaao c anualuaao-dncnucaccoa accnta
Pharmacotherapeutic group: a.cunlam ema tauneacadauatuecatcnnca cnt
ATC code: 80XB61N
Pharmacological features
ma tauneacatametnc ctan am aatue ooa oduaecacadnocntam noan alcndncaaeocand laoat atue oam ccnac.a
ma tauneacauac cmeodaan aoanunocamna and etaauntnmacamueoct cc noan alcndncaamnam aatue oam unnl a
m a atemnaodaa ec da teuu auta mueoc auca m aa aundacca n a cacmundm noa n a lcndncaa mna ea tnuaa adnont da
caaaoceoma a nca nc acmauecaoa oduaecaca dnodaomuem noca n a-eaunt da te ta tcndeca cacadm eac a decd nt
oaa tnona nca emaa oa m aaecaonc oaa tnona nca emaoa d dc da lneonc oaa tnona nca emaa eoca ecaonc
tue o.aaaa ma omaoc acaadd eolaan aonuecuaoec oaaeocacaunmno oa oam aatue oaeoca ma ecaeoaeom nd ceoma
edm no.aao aaauaaeuem noacaduaecacaellualem noan am unttnd macaeocauacndaca l ae cdnc m an atcnncta
deaet c m a n a au m und maca eoca tcndeca nm c aem noa n a ecaonc oaa t a a ma oduaecaca m aa ca nut ol
au m und macta maeccna acaca oduaecaand laoannmanmat aau m und mac.a ma tauneacadauatuecatcnnca cntoa
ecad udncem no.acaduaecacauac cmeodaan atue oaeaccaccat m nnmac lo deomad eolacan am aa edmnucan alaoau
eoca ma oduaecacatcnncacnaac aau teu c a oam aaa”a uem ol“o aaauaaeuem noacnacaonma eeaam aaa adman a
aaaaaa. cd at dac macan am aatue o.a maaaoamuemacam aaacedaomecateuu au
By parenteral administration the therapeutic concentration of the preparation in plasma isa
olwtcoa m aa c cmu tnm noa encntaa ca 5.tcwel.a Bnoc ola t m a acectea aunma oca ca XXioa dcaeueodaa20-10
aau nca-cw aaddaaccaacecteaencntaan am aac eauoat d amacm acamnaadmueuaoecatametnc aa ec XX.7
ec c a aaoamuemaca cmn atemnlaonnca teuu auca t odcnc ol nnuc.a ma a5- ca i atemnaodaa ec da teuu augoa
atuaecmat ce(about 0.25 % for one hour). It is excreted by kidneys and intestines as 3:2.
Therapeutic indications
- a n a oanuncnl da eoca ac d da c tamntca t a c auaoma nutca n a dauatuneecdnceua cnta a omaoc m
ocn d aod acat odcnc ola cd at dacmuneaoauaaeuem eaacmelaan eanacadm dac ndeoadnocacnaodacan am aa
ocn d aod oaa auae nnca cmuneaoa mueoc mnu a cd at da emmedeoa eecdnceua cataom eoa eaumatuntec ceu
ttmuentem daeoca aaumaoc eaaaodaa ecnaem -em auncdcaunc can atue oaeaccaccoaancm
- chronic diseases of choroid and retinal vessels (including occlusion of the central artery or retina
hearing decrement of perceptive type, Meniere's disease, idiopathic buzzing in ears.
- acute form of apoplectic shock, severe ischemic heart disease, severe heart rhythm disturbances,
hypersensitivity to any component of the preparation;
pregnancy (placental bleedings and spontaneous abortions are possible, probably, due to the increase
of placental blood supply);
- breast-feeding periodt
young age (children younger than 18y.o.).
.Ba nuaa nnaect o cmauam aaauaaeuem nooaacaecaoataacnuaamnadnocncma nnuacndmnu
With special care
em aomcat m aeanacadm dac ndeadeoaect o cmauam aaauaaeuem noanoc ae mauam aaednmaac tamntcacntc caa
.tce ca7-laoauecc ae maua5g
Administration during pregnancy and breast-feeding
o a of the preparation during pregnancy and breast-feeding is counter-indicative. Breast-feeding
should be terminated.
Administration and dosages
cunaa o nc nocta mac nnccataa omuncndacaemaea-t -o aaauaaeuem noa canoc a omaocaca nua omueeaonncacuna
ocncnm noa cntauemaatm aa o nc noauemaac nnccaonmaaddaacaN0acunacwt og.aonateeaam aa o nc no 0.9 ai
acnc ntad cnu caacncnm noadeoataancacanuam aacncnm nocam emadnome aa o m ecace c acncelaa c
20mg in 500ml of 0.9% sodium chloride solution or solutions that contain dextrose. When the
preparation is well tolerated for two or three days, the dosage can be raised to the maximum –
1mg/kg/a day. The average duration of therapy is 10-14 days. For patients with renal or hepatic
disorders no dosage correction is required.
Side effects
From cardiovascular system: changes on the electrocardiogram: (depression of ST segment,
lengthening of Q-T interval); tachycardia, extrasystole, changes of arterial pressure (often its
From the central nervous system: sleep disorders (insomnia or high drowsiness), dizziness,
headaches, and general weakness.
From digestive system: dry mouth, nausea, heartburn.
Other side effects: severe allergic reactions, bronchospasm, excessive sweating, skin hyperemia,
If any of the specified symptoms worsen or if you develop some other side effects, please, inform
your doctor.
Symptoms: intensification of dose-dependent side effects.
Treatment: symptomatic therapy.
Interaction with other pharmaceuticals
Combination administration of vinpocetine and methyldopa sometimes caused some intensification
of hypotensive effect, so such therapy requires regular control of arterial blood pressure.
Despite absence of the data confirming possibility of interaction of the preparations of central,
antiarrhythmic and anticoagulant actions, special care should be taken when combination therapy
with these preparations is taken.
Vinpocetine and heparin are chemically incompatible, so they should not be introduced in the same
infusion mixture; however, combination therapy with anticoagulants and vinpocetine is possible.
Vinpocetine is incompatible with the solutions that contain amino acids, so they cannot be used for
its dilution.
Special warnings
By initial lengthening of Q-T interval, or by simultaneous administration of vinpocetine with the
preparations that lengthen .oa omaueecoaaau nc da E adnomunca cauacn uac-Q
o aaauaaeuem noadnome ocacnut mncoacna nuaaem aomcat m ac etamacaaau nc damacm olan alcndncaadnodaomuem noa oatcnnca ca
aa.uacn uac
Patients should be especially careful when operating machines or engaging in the activities requiring
prompt psychomotor response.
Dosage form
Concentrate for infusion solutions, 5mg/ml; 5ml of the preparation in ampoules of dimming glass; ten
ampoules are placed into a carton box.
Five or ten ampoules are placed into a strip cellular pack of polyvinylchloride film and aluminum
printed lacquered foil or with no foil. One strip cellular pack with ten ampoules or one-two strip
cellular packs with five ampoules are placed into a carton box. Every pack or box has an instruction
sheet and a scarificator for ampoules. If ampoules have fracture rings or grooves with fracture points,
ampoule scarificators are not attached.
Store in a shadowed place, at 15°‫ ر‬- 25°‫ر‬. Keep out of reach of children.
Shelf life
3 years. Do not use after expiration date indicated on the pack.
Dispensing from pharmacies
Prescription medicine.
Manufacturer/organization that accepts claims:
Open Joint Stock “Kurgan Joint Stock Company of Medical Preparations and Articles “Sintez”
(Sintez Joint Stock Company);
#7, Prospect Konstitutsii, city of Kurgan, Russian Federation, 640008;
Tel. /fax: (3522)481689