natgillin/translations-raw huggingface dataset:
RISPERDAL orodispersible tablets and oral solution are bio-equivalent to RISPERDAL film-coated tablets.
RISPERDAL orodisperzibilne tablete in peroralna raztopina sta bioekvivalentna zdravilu RISPERDAL filmsko obložene tablete.
Risperidone is metabolised to 9-hydroxy-risperidone, which has a similar pharmacological activity to risperidone (see Biotransformation and Elimination).
Risperidon se presnavlja v 9- hidroksi- risperidon, ki ima podobne farmakološke lastnosti kot risperidon (glejte Biotrasformacija in eliminacija).
67 Absorption
Absorpcija
Risperidone is completely absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours.
Risperidon se po peroralni uporabi popolnoma absorbira in doseže največje koncentracije v plazmi v 1 do 2 urah.
The absolute oral bioavailability of risperidone is 70% (CV=25%).
Absolutna biološka uporabnost risperidona po peroralni aplikaciji je 70% (CV=25%).
The relative oral bioavailability of risperidone from a tablet is 94% (CV=10%) compared with a solution.
Relativna biološka uporabnost risperidona po peroralni aplikaciji tablet je 94% (CV=10%) v primerjavi z raztopino.
Steady-state of risperidone is reached within 1 day in most patients.
Hrana ne vpliva na absorpcijo, zato se risperidon lahko jemlje ne glede na obroke.
Steady-state of 9-hydroxy-risperidone is reached within 4-5 days of dosing.
Pri številnih bolnikih je stanje dinamičnega ravnovesja risperidona doseženo v enem dnevu, 9- hidroksi- risperidona pa v 4 do 5 dneh.
In plasma, risperidone is bound to albumin and alpha1-acid glycoprotein.
V plazmi se risperidon veže na albumin in α1- kisli glikoprotein.
The plasma protein binding of risperidone is 90%, that of 9-hydroxy- risperidone is 77%.
Na plazemske beljakovine se veže 90% risperidona in 77% 9- hidroksi- risperidona.
Biotransformation and elimination
68 Biotrasformacija in eliminacija
Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Citokrom CYP 2D6 presnovi risperidon v 9- hidroksi- risperidon, ki ima podobno farmakološko delovanje kot risperidon.
Another metabolic pathway of risperidone is N-dealkylation.
Risperidon se presnavlja tudi z N- dealkilacijo.
In vitro studies in human liver microsomes showed that risperidone at clinically relevant concentration does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5.
Študije in vitro na mikrosomih človeških jeter pa so pokazale, da risperidon, v terapevtskih koncentracijah bistveno ne zavira presnove zdravil, ki se presnavljajo z izoencimi citokroma P450, vključno s CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4 in CYP 3A5.
One week after administration, 70% of the dose is excreted in the urine and 14% in the faeces.
En teden po peroralni aplikaciji risperidona, se 70% odmerka izloči z urinom, 14% pa z blatom.
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the dose.
Risperidon in 9- hidroksi- risperidon predstavljata 35- 45% peroralnega odmerka v urinu.
After oral administration to psychotic patients, risperidone is eliminated with a half-life of about 3 hours.
Po peroralni uporabi pri psihotičnih bolnikih se risperidon izloča z razpolovnim časom okoli 3 ure.
The elimination half-life of 9-hydroxy-risperidone and of the active antipsychotic fraction is 24 hours.
Razpolovni čas izločanja 9- hidroksi- risperidona in aktivne antipsihotične frakcije je 24 ur.
Risperidone plasma concentrations are dose-proportional within the therapeutic dose-range.
Plazemske koncentracije risperidona so odvisne od odmerka v razponu terapevtskih odmerkov.
Elderly, hepatic and renal impairment
Starejši, bolniki z jetrno in ledvično okvaro
A single-dose study showed on average a 43% higher active antipsychotic fraction plasma concentrations, a 38% longer half-life and a reduced clearance of the active antipsychotic fraction by 30% in the elderly. Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Pri bolnikih z ledvično insuficienco so v povprečju opazili 60% višje plazemske koncentracije aktivne antipsihotične frakcije in 60% zmanjšanje očistka aktivne antipsihotične frakcije.
Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Pri bolnikih z jetrno insuficienco so bile plazemske koncentracije normalne, srednje plazemske koncentracije prostega risperidona pa so bile zvišane za 35%.
The pharmacokinetics of risperidone, 9-hydroxy-risperidone and the active antipsychotic fraction in children are similar to those in adults.
Farmakokinetika risperidona, 9- hidroksi- risperidona in aktivne antipsihotične frakcije je podobna pri otrocih in odraslih.
68 Gender, race and smoking habits
Spol, rasa, kajenje
In (sub)chronic toxicity studies, in which dosing was started in sexually immature rats and dogs, dose- dependant effects were present in male and female genital tract and mammary gland.
V študijah (sub) kronične toksičnosti, na spolno nezrelih podganah in psih je bil prisoten od odmerka odvisen vpliv na spolovila in na mlečne žleze samcev in samic.
These effects were related to the increased serum prolactin levels, resulting from the dopamine D2-receptor blocking activity of risperidone.
Ti učinki so bili povezani s zvišanimi serumskimi vrednostmi prolaktina, ki so posledica antagonističnega delovanja risperidona na dopaminske receptorje D2.
In addition, tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Poleg tega so študije na tkivnih kulturah pokazale, da prolaktin lahko spodbudi rast rakavih celic pri raku dojke.
In rat reproduction studies with risperidone, adverse effects were seen on mating behaviour of the parents, and on the birth weight and survival of the offspring.
V študijah reprodukcije pri podganah z risperidonom so opazili neželene učinke na obnašanje med parjenjem pri starših in na porodno težo in stopnjo preživetja mladičev.
In rats, intrauterine exposure to risperidone was associated with cognitive deficits in adulthood.
Pri podganah je bila intrauterina izpostavljenost risperidonu povezana s kognitivnim primanjkljajem v odrasli dobi.
Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
69 živalim povzročili negativne učinke na učenje in motorični razvoj pri mladičih.
Risperidone was not genotoxic in a battery of tests.
V številnih različnih testih risperidon ni bil genotoksičen.
These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Ti tumorji so lahko povezani z dolgotrajnejšim antagonističnim delovanjem na dopaminske receptorje D2 in s hiperprolaktinemijo.
[To be completed nationally.]
[Poglavje bo dopolnjeno nacionalno]
Oro-dispersible Tablets (see section 4.2)
Orodisperzibilne tablete (glejte poglavje 4. 2)
1:
70 Slika 1:
The bottle comes with a child- resistant cap, and should be opened as follows: – Push the plastic screw cap down while turning it counter clockwise. – Remove the unscrewed cap.
Steklenička ima za otroke varno zaporko in se odpira na naslednji način: – Plastično navojno zaporko potisnite navzdol in jo zavrtite v nasprotni smeri urinega kazalca. – Odstranite odvito zaporko.
2:
Slika 2:
Insert the pipette into the bottle.
Odmerno kapalko vstavite v stekleničko.
While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or milligrams you need to give.
Medtem ko držite spodnji obroč, potegnite zgornji obroč navzgor do oznake, ki ustreza številu mililitrov ali miligramov, ki jih želite odmeriti.
Fig.3:
Slika 3:
Holding the bottom ring, remove the entire pipette from the bottle.
Držite spodnji obroč in izvlecite celo odmerno kapalko iz stekleničke.
Empty the pipette into any non- alcoholic drink, except for tea, by sliding the upper ring down.
Izpraznite odmerno kapalko v katerokoli brezalkoholno pijačo, razen v čaj, tako da potisnete zgornji obroč navzdol.
Close the bottle.
Zaprite stekleničko.
Rinse the pipette with some water.
Pipeto sperite z vodo.
See Annex I - To be completed nationally
Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA DOVOLJENJ ZA PROMET
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 OZNAČEVANJE
Carton for PVC-PE-PVDC/ Al blister
Škatla za PVC- PE- PVDC/ Al pretisni omot
RISPERDAL and associated names (see Annex I) 0.25 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 25 mg filmsko obložene tablete
Film-coated tablet [To be completed nationally]
Filmsko obložene tablete [Poglavje bo dopolnjeno nacionalno]
72 {Name and Address}
{Ime in naslov}
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 PODATKI NA ZUNANJI OVOJNINI
RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablet
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 5 mg filmsko obložene tablete
74 {Name and Address}
{Ime in naslov}
75 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
76 PODATKI NA ZUNANJI OVOJNINI
76 {Name and Address}
{Ime in naslov}
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 PODATKI NA ZUNANJI OVOJNINI
[To be completed nationally].
[Poglavje bo dopolnjeno nacionalno]
78 {Name and Address}
{Ime in naslov}
80 {Name and Address}
{Ime in naslov}
82 {Name and Address}
{Ime in naslov}
Oral use Read the package leaflet before use.
za peroralno uporabo Pred uporabo preberite priloženo navodilo.
84 {Name and Address}
{Ime in naslov}
PVC-PE-PVDC/ Al blister
PVC- PE- PVDC/ Al pretisni omot
RISPERDAL and associated names (see Annex I) 0.25 mg film-coated tablets RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablets RISPERDAL and associated names (see Annex I) 1 mg film-coated tablets RISPERDAL and associated names (see Annex I) 2 mg film-coated tablets RISPERDAL and associated names (see Annex I) 3 mg film-coated tablets RISPERDAL and associated names (see Annex I) 4 mg film-coated tablets RISPERDAL and associated names (see Annex I) 6 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 25 mg filmsko obložene tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 5 mg filmsko obložene tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 1 mg filmsko obložene tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 2 mg filmsko obložene tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 3 mg filmsko obložene tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 4 mg filmsko obložene tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 6 mg filmsko obložene tablete
86 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
87 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PVC-PE-PVDC/ Al blister [6 mg calendar pack only]
PVC- PE- PVDC/ Al pretisni omot (za 6 mg koledarsko pakiranje)
[Abbreviation for 7 days of the week.]
[Kratice za 7 dni v tednu.]
87 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
88 PODATKI NA ZUNANJI OVOJNINI
Plastic bottle
Plastenka
RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablets
RISPERDAL in sorodna imena (glejte Dodatek 1) 0, 5 mg filmsko obložene tablete
Film-coated tablet [To be completed nationally.]
Filmsko obložene tablete [Poglavje bo dopolnjeno nacionalno]
88 [To be completed nationally.]
[Poglavje bo dopolnjeno nacionalno]
Not applicable
Podatek ni potreben
89 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
90 PODATKI NA ZUNANJI OVOJNINI
RISPERDAL and associated names (see Annex I) 1 mg film-coated tablets
RISPERDAL in sorodna imena (glejte Dodatek 1) 1 mg filmsko obložene tablete
Not applicable.
Podatek ni potreben
91 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
92 PODATKI NA ZUNANJI OVOJNINI
RISPERDAL and associated names (see Annex I) 2 mg film-coated tablets
RISPERDAL in sorodna imena (glejte Dodatek 1) 2 mg filmsko obložene tablete
11.
93 11.
92 [To completed nationally.]
[Poglavje bo dopolnjeno nacionalno]
Carton for Foil/ Foil blister (PVC-Al-Polyamide/ 4511 heat seal coating/ A1-polyester paper)
Škatla za pretisni omot folija/ folija (PVC- Al- Poliamid/ 4511 toplotno zavarjena obloga/ A1- poliester papir)
RISPERDAL and associated names (see Annex I) 0.5 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 1 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 2 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 3 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 4 mg orodispersible tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 5 mg orodisperzibilne tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 1 mg orodisperzibilne tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 2 mg orodisperzibilne tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 3 mg orodisperzibilne tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 4 mg orodisperzibilne tablete
Orodispersible tablet [To be completed nationally]
Orodisperzibilne tablete [Poglavje bo dopolnjeno nacionalno]
Peel open the blister and tip the tablet out Do not push the tablet through the foil Melts on the tongue.
S potegom odprite pretisni omot in stresite tableto ven Ne potiskajte tablete skozi folijo Raztopite jo na jeziku.
SPECIAL STORAGE CONDITIONS
POSEBNA NAVODILA ZA SHRANJEVANJE 95 [Poglavje bo dopolnjeno nacionalno]
Carton for Film/ Foil Blister (PVC-PE-PCTFE/ Al blister)
Škatla za pretisni omot film/ folija (PVC- PE- PCTFE/ A1 pretisni omot)
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
98 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Foil/ Foil blister (PVC-Al-Polyamide/ 4511 heat seal coating/ A1-polyester paper) Film/ Foil Blister (PVC-PE-PCTFE/ Al blister)
Pretisni omot folija/ folija pretisni omot (PVC- Al- Poliamid/ 4511 toplotno zavarjena obloga/ A1 - poliester papir) Pretisni omot film/ folija pretisni omot (PVC- PE- PCTFE/ Al pretisni omot)
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
99 PODATKI NA ZUNANJI OVOJNINI
Carton for amber glass bottle
Škatla za steklenico iz jantarjevega stekla
RISPERDAL and associated names (see Annex I) 1 mg/ ml oral solution
RISPERDAL® in sorodna imena (glejte Dodatek 1) 1 mg/ ml peroralna raztopina
[To be completed nationally]
peroralna raztopina [Poglavje bo dopolnjeno nacionalno]
To facilitate accurate measurement, use the enclosed calibrated pipette or a graduated measure.
Za lažje odmerjanje točnega odmerka uporabljajte priloženo umerjeno pipeto ali merico.
Use within 3 months of first opening.
Zdravilo porabite v treh mesecih po odprtju.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI 100 11.
100 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
101 PODATKI NA PRIMARNI OVOJNINI
amber glass bottle
Steklenica iz jantarjevega stekla
[To be completed nationally.]
peroralna raztopina [Poglavje bo dopolnjeno nacionalno]
Date opened……..
Zdravilo porabite v treh mesecih po odprtju.
102 PACKAGE LEAFLET
[Poglavje bo dopolnjeno nacionalno]
INFORMATION FOR THE USER
104 NAVODILO ZA UPORABO
0.5, 1, 2, 3 and 4 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 1 mg/ ml oral solution [See Annex I – To be completed nationally) Risperidone
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 25, 0, 5, 1, 2, 3, 4 in 6 mg filmsko obložene tablete RISPERDAL QUICKLET® in sorodna imena (glejte Dodatek 1) 0, 5, 1, 2, 3 in 4 mg orodisperzibilne tablete RISPERDAL® in sorodna imena (glejte Dodatek 1) 1 mg/ ml peroralna raztopina [Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno] Risperidon
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v
What RISPERDAL is and what it is used for 2.
Kaj je zdravilo RISPERDAL in za kaj ga uporabljamo 2.
Before you take RISPERDAL 3.
Kaj morate vedeti, preden boste vzeli zdravilo RISPERDAL 3.
How to take RISPERDAL 4.
Kako jemati zdravilo RISPERDAL 4.
How to store RISPERDAL 6.
Shranjevanje zdravila RISPERDAL 6.
WHAT RISPERDAL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO RISPERDAL IN ZAKAJ GA UPORABLJAMO
RISPERDAL belongs to a group of medicines called ‘ anti-psychotics’.
Zdravilo RISPERDAL uvrščamo v skupino zdravil imenovano antipsihotiki.
• Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused • Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive Mania occurs in an illness called “ bipolar disorder” • Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’ s dementia, who harm themselves or others.
Manija se pojavi pri bolezni imenovani bipolarna motnja. • kratkotrajno zdravljenje (do 6 tednov) dolgotrajne agresije pri bolnikih z Alzheimerjevo demenco, ki lahko poškodujejo sebe ali druge.
Alternative (non-drug) treatments should have been used previously • Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder.
Predhodno se je treba posvetovati o alternativnem nefarmakološkem zdravljenju. • kratkotrajno zdravljenje (do 6 tednov) dolgotrajne agresije pri otrocih (starih najmanj 5 let) z duševno manjrazvitostjo in mladostnikih z vedenjskimi motnjami.
BEFORE YOU TAKE RISPERDAL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO RISPERDAL
Do not take RISPERDAL if: • You are allergic (hypersensitive) to risperidone or any of the other ingredients of RISPERDAL (listed in Section 6 below).
Ne jemljite zdravila RISPERDAL, če: • ste alergični (preobčutljivi) na risperidon ali katerokoli sestavino zdravila RISPERDAL (navedeno v poglavju 6.).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using RISPERDAL.
Če niste prepričani ali se katero izmed naštetih stanj nanaša na vas, se pogovorite s svojim zdravnikom pred uporabo zdravila RISPERDAL.
Take special care with RISPERDAL Check with your doctor or pharmacist before taking RISPERDAL if:
105 Bodite posebno pozorni pri uporabi zdravila RISPERDAL Pred uporabo zdravila RISPERDAL se posvetujte z zdravnikom ali farmacevtom, če:
104 • You have a heart problem.
• imate težave s srcem.
Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure.
To lahko vključuje neredno bitje srca ali ste nagnjeni k nizkemu krvnemu tlaku ali jemljete zdravila za krvni tlak.
RISPERDAL may cause low blood pressure.
Zdravilo RISPERDAL lahko zniža krvni tlak.
Your dose may need to be adjusted • You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain • You have Parkinson’ s disease or dementia • You are diabetic • You have epilepsy • You are a man and you have ever had a prolonged or painful erection If you experience this while taking RISPERDAL, contact your doctor straight away • You have problems controlling your body temperature or overheating • You have kidney problems • You have liver problems • You have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.
Če se vam to zgodi med jemanjem zdravila RISPERDAL, se o tem takoj posvetujte z zdravnikom • imate težave z vzdrževanjem telesne temperature oz. se hitro pregrejete • imate težave z ledvicami • imate težave z jetri • imate nenormalno visoko koncentracijo hormona prolaktina v krvi ali imate tumor, ki je odvisen od prolaktina.
Tell your doctor immediately if you experience • involuntary rhythmic movements of the tongue, mouth and face.
Takoj obvestite zdravnika če se pri vas pojavijo: • nehoteni ritmični gibi jezika, ust ali obraza.
Withdrawal of risperidone may be needed • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “ neuroleptic malignant syndrome).
Morda bo potrebno prekiniti zdravljenje z risperidonom • zvišana telesna temperatura, okorelost mišic, potenje ali zmanjšana stopnja zavesti (stanje, ki se imenuje nevroleptični maligni sindrom).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL.
Če niste prepričani ali se katero izmed naštetih stanj nanaša na vas, se pogovorite s svojim zdravnikom pred uporabo zdravila RISPERDAL.
RISPERDAL may cause you to gain weight.
Med uporabo zdravila RISPERDAL se lahko zredite.
Elderly people with dementia In elderly patients with dementia, there is an increased risk of stroke.
Starejši ljudje z demenco Pri starejših ljudeh z demenco obstaja povečano tveganje za možgansko kap.
You should not take risperidone if you have dementia caused by stroke.
Če imate demenco, ki jo je povzročila možganska kap, ne smete uporabljati risperidona.
During treatment with risperidone you should frequently see your doctor.
Med zdravljenjem z risperidonom boste pogosto obiskali zdravnika.
Medical treatment should be sought straight away if you or your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
Če ste opazili oziroma je vaš skrbnik opazil nenadno spremembo v vašem duševnem stanju ali nenadno slabotnost ali otopelost obraza, rok ali nog, posebej na eni strani telesa, nejasen govor, tudi če samo za kratek čas, nemudoma poiščite zdravniško pomoč.
Children and adolescents Before treatment is started in conduct disorder, other causes of aggressive behaviour should have been ruled out.
Otroci in mladostniki Pred začetkom zdravljenja vedenjskih motenj je potrebno izključiti druge vzroke agresivnega vedenja.
If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Če se med zdravljenjem z risperidonom pojavi utrujenost, lahko težave s pozornostjo izboljšate s spremembo časa jemanja zdravila.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, vključno z zeliščnimi pripravki.
It is especially important to talk to your doctor or pharmacist if you are taking any of the following: • Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these • Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems • Medicines that cause a slow heart beat • Medicines that cause low blood potassium (e. g. certain diuretics) • Medicines to treat elevated blood pressure.
Posebej pomembno je, da se pogovorite z zdravnikom ali farmacevtom, če jemljete kaj od navedenega: • zdravila, ki delujejo na vaše možgane in vam pomagajo, da se pomirite (benzodiazepini), nekatera zdravila proti bolečinam (opioidi), zdravila proti alergijam (nekateri antihistaminiki), ker risperidon lahko poveča sedativni učinek teh zdravil