natgillin/translations-raw huggingface dataset:
Diagnozo je potrebno postaviti skladno z veljavnimi smernicami.
Diagnosis should be made according to current guidelines.
DATUM ZADNJE REVIZIJE BESEDILA
DATE OF REVISION OF THE TEXT
To velja tudi za zdravila, pridobljena brez recepta.
This includes medicines obtained without a prescription.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
OTHER SPECIAL WARNING(S), IF NECESSARY
6.2 Inkompatibilnosti
6.2 Incompatibilities
Vaš zdravnik vam bo povedal, če zaradi vaše bolezni lahko varno vozite in varno upravljate stroje.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Datum zadnjega podaljšanja:
Date of latest renewal:
Biotransformacija
Biotransformation
EL-69300 Rodopi
EL-69300 Rodopi Greece
Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Izguba spomina pri Alzheimerjevi bolezni nastane zaradi motenj v prenosu signalov v možganih.
Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Učinki barbituratov in nevroleptikov so lahko zmanjšani.
The effects of barbiturates and neuroleptics may be reduced.
Klinična pomembnost teh pojavov ni poznana.
The clinical relevance of these findings is unknown.
Tableta se lahko deli na enake odmerke.
The tablet can be divided into equal doses.
Glede na farmakološke učinke in mehanizem delovanja memantina se lahko pojavijo naslednje interakcije:
Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur:
4.6 Plodnost, nosečnost in dojenje
4.6 Fertility, pregnancy and lactation
ZA PROMET Datum prve odobritve: 22. april 2013
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Do not throw away any medicines via wastewater or household waste.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Da bi vam zdravilo koristilo, ga morate jemati redno vsak dan ob istem času.
To benefit from your medicine you should take it regularly every day at the same time of the day.
Pri znakih in simptomih splošne prekomerne stimulacije centralnega živčnega sistema (CŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
trajnih posledic. V nekem drugem primeru velikega prevelikega odmerka je bolnik prav tako preživel in okreval.
In another case of a large overdose, the patient also survived and recovered.
Zdravljenje naj prične in nadzoruje zdravnik, ki ima izkušnje z diagnozo in zdravljenjem Alzheimerjeve demence.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Opozorila in previdnostni ukrepi
Warnings and precautions
Memantin ima absolutno biološko uporabnost okoli 100 %.
Memantine has an absolute bioavailability of approximately 100%.
Alzheimerjeva bolezen je povezana z depresijo, samomorilnimi mislimi in samomorom.
Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Trajanje zdravljenja
Duration of treatment
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
2Posamezni primeri, o katerih so poročali v okviru izkušenj v obdobju trženja.
2Isolated cases reported in post-marketing experience.
Okoli 45 % memantina se veže na plazemske beljakovine.
About 45% of memantine is bound to plasma-proteins.
Ta učinek so opazili le pri visokih odmerkih pri glodalcih.
This effect was only observed at high doses in rodents.
Podobno velja za ketamin in dekstrometorfan (glejte tudi poglavje 4.4).
The same may be true for ketamine and dextromethorphan (see also section 4.4).
tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
4.3 Kontraindikacije
4.3 Contraindications
Pediatrična populacija
Paediatric population
Povzetek varnostnega profila zdravila
Summary of the safety profile
Verovškova 57, 1526 Ljubljana Slovenija
Verovškova 57, 1526 Ljubljana Slovenia
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
For the full list of excipients, see section 6.1.
Tablete pogoltnite z manjšo količino vode.
The tablets should be swallowed with some water.
- če ste alergični na memantinijev klorid ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
• if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
O prekinitvi zdravljenja z memantinom je treba razmisliti, ko ni več dokazov o zdravilnem učinku ali če bolnik zdravljenja ne prenaša.
Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
Pomožne snovi so:
• The other ingredients are:
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Vse več je dokazov, da motnje v delovanju glutamatnega živčnega prenosa, še posebej preko receptorjev NMDA, prispevajo tako k izraženosti simptomov kot k napredovanju nevrodegenerativne demence.
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Modulira učinke patološko zvišanih toničnih vrednosti glutamata, ki lahko vodijo v nevronsko disfunkcijo.
It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bolnika so zdravili simptomatsko in tudi s plazmaferezo.
The patient received symptomatic treatment and plasmapheresis.
4.7 Vpliv na sposobnost vožnje in upravljanja s strojev
4.7 Effects on ability to drive and use machines
- Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
- Do not take a double dose to make up for a forgotten dose.
Kot kaže, hrana ne vpliva na absorpcijo memantina.
There is no indication that food influences the absorption of memantine.
Zaradi nekaterih dejavnikov, ki lahko zvišajo pH urina (glejte poglavje 5.2 »Izločanje«) je potreben
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Ker ti učinki niso bili opaženi v dolgotrajnih študijah pri glodalcih ali drugih živalih, je klinična pomembnost teh pojavov neznana.
As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
PRILOGA II
ANNEX II
Farmakoterapevtska skupina: psihoanaleptiki; druga zdravila za zdravljenje demence, oznaka ATC: N06DX01.
Pharmacotherapeutic group: Psychoanaleptics; Other Anti-dementia drugs, ATC code: N06DX01.
Priporočeni začetni odmerek je 5 mg na dan, ki se postopoma zvišuje v prvih 4 tednih zdravljenja in doseže priporočeni vzdrževalni odmerek, kot sledi:
The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Če imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša na do 20 mg dnevno, po standardni titracijski shemi.
If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.
Na voljo je tudi objavljen klinični primer o morebitnem tveganju pri sočasni uporabi memantina in fenitoina.
There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Simptomi
Symptoms
Klinične študije
Clinical studies
Neznana psihotične reakcije2
Psychotic reactions2
Na splošno so opaženi neželeni učinki blagi do zmerni.
In general, the observed side effects are mild to moderate.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
V najhujšem primeru prevelikega odmerjanja je bolnik preživel peroralni vnos 2000 mg memantina z učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Industrial Park Sapes Rodopi Prefecture Block No 5
Pharmathen International S.A. Industrial Park Sapes Rodopi Prefecture Block No 5
Študije na zdravih prostovoljcih so pokazale, da ima memantin linearno farmakokinetiko v razponu odmerkov od 10 do 40 mg.
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Zdravila Mamantin LEK ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Razdelilna zareza ni namenjena delitvi tablete.
The score line is not intended for breaking the tablet.
ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IFAPPROPRIATE
Odrasli
Adults
Ime in naslov izdelovalcev, odgovornih za sproščanje serij
Name and address of the manufacturers responsible for batch release
Absorpcija
Absorption
Memantin se ne smet uporabljati med nosečnostjo, razen če je nujno potrebno.
Memantine should not be used during pregnancy unless clearly necessary.
Pri bolnikih z blago ali zmerno jetrno okvaro (Child-Pugh A in Child-Pugh B) prilagoditev odmerka ni potrebna.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
• Ostale učinkovine, kot so cimetidin, ranitidin, prokainamid, kinidin, kinin in nikotin, ki uporabljajo isti ledvični kationski transportni sistem kot amantadin, prav tako lahko medsebojno reagirajo z memantinom, kar vodi do povišanih vrednosti v plazmi.
• Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
Farmakokinetično/farmakodinamično razmerje
Pharmacokinetic/pharmacodynamic relationship
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Za shranjevanje zdravila niso potrebna posebna navodila.
This medicine does not require any special storage conditions.
Prav tako se lahko zviša pH urina v primeru ledvične tubularne acidoze (RTA) ali pri hudi okužbi mehurja, ki ga povzročajo bakterije vrste Proteus.
Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Vaš zdravnik naj redno preverja učinek zdravljenja.
Your doctor should assess your treatment on a regular basis.
Memantin in vitro ni zaviral CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monooksigenaze, ki vsebuje flavin, epoksidne hidroksilaze ali sulfatacije.
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Na trgu morda ni vseh navedenih pakiranj.
Not all pack sizes may be marketed.
Posledično je za bolnike z omenjenimi obolenji na voljo le omejeno število podatkov, zato je priporočljiv skrben nadzor
As a consequence, only limited data are available and patients with these conditions should be closely supervised.
- Če ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Memantin LEK, počakajte in vzemite naslednji odmerek ob običajnem času.
If you forget to take Memantine LEK - If you find you have forgotten to take your dose of Memantine LEK, wait and take your next dose at the usual time.
FARMACEVTSKA OBLIKA IN VSEBINA
PHARMACEUTICAL FORM AND CONTENTS
Neželeni učinki so razporejeni glede na organske sisteme ob uporabi naslednjih navedb: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
(≥1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Linearnost
Linearity
- če ste v preteklosti imeli epileptične napade, - če ste pred kratkim preboleli srčni infarkt (srčno kap), imate kongestivno srčno popuščanje ali neurejeno hipertenzijo (visok krvni tlak).
• if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Zdravljenje naj se začne le v primeru, če je na voljo ustrezna oseba, ki za bolnika skrbi in ki lahko nadzoruje bolnikovo redno jemanje zdravila.
Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.
Od četrtega tedna naprej je običajen odmerek 2 tableti enkrat dnevno (1 x 20 mg).
From the fourth week on, the usual dose is 2 tablets once a day (1 x 20 mg).
Sočasni uporabi memantina in amantadina se je potrebno izogniti, ker lahko pride do pojava farmakotoksične psihoze.
• Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
kot pri skupini, ki je prejemala placebo, so bili omotica (6,3 % proti 5,6 %), glavobol (5,2 % proti 3,9 %), zaprtje (4,6 % proti 2,6 %), zaspanost (3,4 % proti 2,2 %)
The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
V primeru, da ste sprejeti v bolnišnico, obvestite zdravnika, da jemljete zdravilo Memantin LEK.
If you go into hospital, let your doctor know that you are taking Memantine LEK.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pri človeku so naqjpomembnejši presnovki N-3,5-dimetil-gludantan, izomerna mešanica 4- in 6-hidroksi-memantina in 1-nitrozo-3,5-dimetil-adamantana.
Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
Pri alkalnem urinu lahko pride do za 7- do 9-krat zmanjšane hitrosti izločanja memantina (glejte poglavje 4.4).
The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Podrobni podatki o tem izdelku so na voljo na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Uporaba memantina pri nosečnicah ni priporočljiva.
The use of memantine in pregnant women is not recommended.
Previdnost se priporoča pri bolnikih z epilepsijo, s krči v anamnezi ali pri bolnikih z nagnjenostijo k epilepsiji.
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Vzdrževalni odmerek
Maintenance dose
Za kaj uporabljamo zdravilo Memantin LEK Zdravilo Memantin LEK uporabljamo za zdravljenje odraslih bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
What is Memantine LEK used for Memantine LEK is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Zdravljenje Pri prevelikem odmerjanju je potrebno simptomatsko zdravljenje.
In the event of overdose, treatment should be symptomatic.
• V okviru izkušenj iz obdobja trženja so poročali o posameznih primerih povečanja mednarodnega umerjenega razmerja (INR) pri bolnikih, ki so bili sočasno zdravljeni z varfarinom.
• In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Če imate ledvično okvaro, vam bo zdravnik prilagodil odmerek v skladu z vašim stanjem.
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte
Ask your pharmacist how to throw away medicines you no longer use.
V klinični raziskavi pri mladih zdravih osebah niso opazili pomembnega vpliva memantina na farmakokinetiko galantamina.
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ)
MARKETING AUTHORISATION NUMBER(S)
Prav tako ima zdravilo Memantin LEK blag do zmeren vpliv na sposobnost vožnje in upravljanja strojev, zato je potrebno bolnike opozoriti na posebno previdnost.
Furthermore, Memantine LEK has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Peroralno je dobil 400 mg memantina.
The patient had received 400 mg memantine orally.
V teh primerih bo zdravnik nadzoroval ledvično delovanje v določenih časovnih presledkih.
In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Izogibati se je treba sočasni uporabi zdravil, kot so amantadin (za zdravljenje Parkinsonove bolezni), ketamin (običajno se uporablja kot anestetik), dekstrometorfan (običajno se uporablja za zdravljenje kašlja) in ostali zaviralci receptorjev NMDA.
The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
V ledvicah poteka tudi tubularna reabsorpcija, verjetno preko beljakovinskega kationskega transporta.
Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins.
s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
1Halucinacije so bile večinoma opažene pri bolnikih
1Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Zdravilo Memantin LEK sodi v skupino zdravil, znanih kot zdravila za zdravljenje demence.
Memantine LEK belongs to a group of medicines known as anti-dementia medicines.
Obe učinkovini sta kemijsko sorodna antagonista NMDA.
Both active substances are chemically related NMDA-antagonists.
Ob dnevnih odmerkih 20 mg so v stanju dinamičnega ravnovesja dosežene plazemske koncentracije memantina od 70 do 150 ng/ml (0,5 - 1 µmol), z veliko variabilnostjo med posamezniki.
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/mL (0.5 - 1 μmol) with large interindividual variations.
Sočasno dajanje memantina in spazmolitikov, dantrolena ali baklofena lahko spremeni njihove učinke, zato bo morda potrebno prilagoditi odmerke.
Concomitant administration of memantine with the antispasmodic medicinal products, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
s hrano in pijačo
Memantine LEK with food and drink
FARMACEVTSKA OBLIKA filmsko obložena tableta
PHARMACEUTICAL FORM Film-coated tablet.
Druga zdravila in zdravilo Memantin LEK
Other medicines and Memantine LEK
NAVODILA ZA UPORABO
INSTRUCTIONS ON USE
vzdrževalnim zdravljenjem lahko nadaljujemo, dokler obstaja korist za bolnika in dokler bolnik zdravljenje prenaša.
Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine.
Kaj je zdravilo Memantin LEK in za kaj ga uporabljamo
What Memantine LEK is and what it is used for
teden (15.-21. dan):
From Week 4 on (day 22-28):
V študijah na živalih so ugotovili, da memantin lahko zavira intrauterino rast pri izpostavljenosti, ki je enaka ali le malo višja od izpostavljenosti pri ljudeh (glejte poglavje 5.3).
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
OZNAČEVANJE
A. LABELLING
Zdravilo Memantin LEK spada v skupino zdravil, ki se imenujejo antagonisti receptorjev NMDA.
Memantine LEK belongs to a group of medicines called NMDA-receptor antagonists.
Pri podganah so ugotovili zmanjšano rast ploda v odmerkih, ki so bili primerljivi ali malo višji kot pri ljudeh.
In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure.
Občasni venska tromboza/tromboembolija
Venous thrombosis/thromboembolism
Poročanje o domnevnih neželenih učinkih
Reporting of suspected adverse reactions
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
s centralnim živčnim sistemom, kot so nemir, psihoza, vidne halucinacije, nagnjenost h konvulzijam, zaspanost, stupor in nezavest.
The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost za zdravilo
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Občasni halucinacije1
Somnolence Confusion Hallucinations1