natgillin/translations-raw huggingface dataset:
The outside of the backing layer is beige and labelled with “ Exelon”, “ 9.5 mg/ 24 h” and “ BHDI”.
Zunanji del krovne plasti je rjavkasto bele (beige) barve z oznakami “ Exelon ”, “ 9. 5 mg/ 24 h ” in “ BHDI ”.
Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients 67 treated with Exelon capsules or oral solution can be switched to Exelon transdermal patches as follows: • A patient on a dose of 3 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a dose of 6 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a stable and well tolerated dose of 9 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
73 Prehod z zdravljenja s kapsulami ali peroralno raztopino na zdravljenje z obliži Glede na to, da je izpostavljenost rivastigminu primerljiva pri peroralni in transdermalni aplikaciji (glejte poglavje 5. 2), lahko bolniki, ki se zdravijo s kapsulami ali peroralno raztopino Exelon, preidejo na zdravljenje s transdermalnimi obliži Exelon na naslednji način: • Bolnik, ki jemlje rivastigmin peroralno v odmerku 3 mg/ dan, lahko preide na zdravljenje s transdermalnimi obliži 4, 6 mg/ 24 h. • Bolnik, ki jemlje rivastigmin peroralno v odmerku 6 mg/ dan, lahko preide na zdravljenje s transdermalnimi obliži 4, 6 mg/ 24 h. • Bolnik, ki dobro prenaša rivastigmin peroralno v odmerku 9 mg/ dan in odmerka ne spreminja, lahko preide na zdravljenje s transdermalnimi obliži 9, 5 mg/ 24 h.
68 Care must be taken when prescribing Exelon transdermal patches: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases. • to patients with a history of asthma or obstructive pulmonary disease.
Previdnost je potrebna pri predpisovanju transdermalnih obližev Exelon: • bolnikom s sindromom bolnega sinusnega vozla ali prevodnimi motnjami (sinuatrialni blok, atrioventrikularni blok) (glejte poglavje 4. 8); • bolnikom z aktivnimi razjedami želodca ali dvanajstnika ali bolnikom z nagnjenostjo k tem boleznim, ker rivastigmin lahko povzroči povečano izločanje želodčne kisline (glejte poglavje 4. 8); • bolnikom, ki so nagnjeni k zapori sečnih izvodil in k epileptičnim napadom, ker holinomimetiki lahko sprožijo te bolezni ali njihovo poslabšanje; • bolnikom z anamnezo astme ali obstruktivne pljučne bolezni.
In peri/ postnatal studies in rats, an increased gestation time was observed.
75 opazili podaljšano obdobje brejosti.
69 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Table 1
76 Preglednica 1
4.9 Overdose
77 4. 9 Preveliko odmerjanje
71 cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’ s disease.
Zato bi lahko rivastigmin izboljšal stanje holinergično posredovanega upada kognitivnih funkcij pri demenci, povezani z Alzheimerjevo boleznijo.
Exelon Exelon
78 Preglednica 2
5.2 Pharmacokinetic properties
79 5. 2 Farmakokinetične lastnosti
73 Exposure (AUC ∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
Izpostavljenost (AUC∞) rivastigminu (in presnovku NAP266- 90) je bila največja pri aplikaciji transdermalnega obliža na zgornji del hrbta, prsi ali nadlaket ter približno 20- 30% manjša pri aplikaciji na trebuh ali stegno.
Metabolism Rivastigmine is rapidly and extensively metabolised with an apparent elimination half-life in plasma of approximately 3.4 hours after removal of the transdermal patch.
80 Presnova Rivastigmin se hitro in obsežno presnavlja z navideznim razpolovnim časom izločanja iz plazme približno 3, 4 ure po odstranitvi transdermalnega obliža.
Elimination was absorption rate limited (flip-flop kinetics), which explains the longer t½ after transdermal patch (3.4 h) versus oral or intravenous administrations (1.4 to 1.7 h).
Izločanje je omejeno s hitrostjo absorpcije (flip - flop učinek), kar pojasnjuje daljši t½ pri uporabi transdermalnih obližev (3, 4 ure) v primerjavi s peroralnim ali intravenskim odmerjanjem (1, 4 do 1, 7 ure).
Metabolism is primarily via cholinesterase-mediated hydrolysis to the metabolite NAP226-90.
Presnova poteka predvsem s hidrolizo, ki jo katalizira holinesteraza, do presnovka NAP226- 90.
74 Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose exceeding 104 times the foreseen clinical exposure.
V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih aberacij v človeških perifernih levkocitih v odmerku, ki je 104- krat presegal dotedanjo klinično izpostavljenost.
Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
81 podganah in kuncih se niso pokazali nikakršni znaki teratogenega potenciala rivastigmina.
75 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
6.6 Special precautions for disposal
82 6. 6 Posebni varnostni ukrepi za odstranjevanje
76 ANNEX II
83 DODATEK II
Capsule, hard Novartis Farmacéutica, S. A.
Kapsula, trda Novartis Farmacéutica, S. A.
Planta de Producción Ronda de Santa Maria 158 E-08210 Barberà del Vallès, Barcelona Spain
Planta de Producción Ronda de Santa Maria 158 E- 08210 Barberà del Vallès, Barcelona Španija
Oral solution Novartis Pharma S. A. S.
Peroralna raztopina Novartis Pharma S. A. S.
26, rue de la Chapelle F-68333 Huningue France
26, rue de la Chapelle F- 68333 Huningue Francija
Transdermal patch Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Transdermalni obliž Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Nemčija
PSURs:
Periodično poročilo o varnosti zdravila (PSUR):
The Marketing Authorisation Holder will submit PSURs every six months for a period of two years after the Commission Decision on the extension of the indication to treat symptomatic mild to moderately severe dementia in patients with idiopathic Parkinson’ s disease, then yearly for two years and then every three years thereafter.
Imetnik dovoljenja za promet bo predložil PSUR vsakih šest mesecev v obdobju dveh let po odločbi Komisije o podaljšanju indikacije za zdravljenje simptomatske blage do zmerno težke demence pri bolnikih z idiopatsko Parkinsonovo boleznijo, nato dve leti enkrat letno in kasneje vsake tri leta.
Pharmacovigilance system:
Sistem farmakovigilance:
The Marketing Authorization Holder ensures that the system of pharmacovigilance, as described in version 2 dated 22 July 2008 presented in Module 1.8.1. of the Marketing Authorization, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora vzpostaviti in zagotoviti delovanje sistema farmakovigilance, kot je navedeno v 2. verziji dovoljenja za promet z zdravilom z dne 22. julija 2008 v modulu 1. 8. 1, preden je zdravilo dostopno na tržišču in dokler je trženo zdravilo v uporabi.
Risk Management Plan:
Načrt obvladovanja tveganja:
The Marketing Authorization Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorization Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil raziskave in dodatne dejavnosti v okviru farmakovigilance, opisane v načrtu farmakovigilance, sprejetem v različici 1. 1 Načrta obvladovanja tveganja (Risk Management Plan - RMP) v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih dopolnilih Načrta obvladovanja tveganja, ki jih sprejme Odbor za zdravila za uporabo v humani medicini (CHMP).
78 ANNEX III
85 DODATEK III
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 PODATKI NA ZUNANJI OVOJNINI
Exelon 1.5 mg hard capsules Rivastigmine
Exelon 1, 5 mg trde kapsule rivastigmin
1 capsule contains rivastigmine 1.5 mg present as rivastigmine hydrogen tartrate.
1 kapsula vsebuje 1, 5 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
90 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Exelon 1.5 mg [folding box only]
Exelon 1, 5 mg [samo na škatli]
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
92 PODATKI NA ZUNANJI OVOJNINI
Exelon 3.0 mg hard capsules Rivastigmine
Exelon 3, 0 mg trde kapsule rivastigmin
1 capsule contains rivastigmine 3.0 mg present as rivastigmine hydrogen tartrate.
1 kapsula vsebuje 3, 0 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
95 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Exelon 3.0 mg [folding box only]
Exelon 3, 0 mg [samo na škatli]
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
97 PODATKI NA ZUNANJI OVOJNINI
Exelon 4.5 mg hard capsules Rivastigmine
Exelon 4, 5 mg trde kapsule rivastigmin
1 capsule contains rivastigmine 4.5 mg present as rivastigmine hydrogen tartrate.
1 kapsula vsebuje 4, 5 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
100 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Exelon 4.5 mg [folding box only]
Exelon 4, 5 mg [samo na škatli]
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
102 PODATKI NA ZUNANJI OVOJNINI
Exelon 6.0 mg hard capsules Rivastigmine
Exelon 6, 0 mg trde kapsule rivastigmin
1 capsule contains rivastigmine 6.0 mg present as rivastigmine hydrogen tartrate.
1 kapsula vsebuje 6, 0 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
104 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
105 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Exelon 6.0 mg [folding box only]
Exelon 6, 0 mg [samo na škatli]
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
107 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Exelon 2 mg/ ml oral solution Rivastigmine
Exelon 2 mg/ ml peroralna raztopina rivastigmin
Each ml contains 2.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Vsak ml vsebuje 2, 0 mg rivastigmina v obliki rivastigminijevega hidrogentartrata.
Exelon 2 mg/ ml [folding box only]
Exelon 2 mg/ ml [samo na škatli]
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
109 PODATKI NA ZUNANJI OVOJNINI
Exelon 4.6 mg/ 24 h transdermal patch rivastigmine
Exelon 4, 6 mg/ 24 h transdermalni obliž rivastigmin
1 transdermal patch of 5 cm2 contains 9 mg rivastigmine and delivers 4.6 mg/ 24 h.
1 transdermalni obliž velikosti 5 cm2 vsebuje 9 mg rivastigmina in sprosti 4, 6 mg/ 24 h.
Also contains: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methyl-methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer- coated.
Med drugim vsebuje: lakiran polietilentereftalatni film, α- tokoferol, polimer (butil metakrilat, metil metakrilat), akrilni kopolimer, silikonsko olje, dimetikon, poliestrski film obložen s fluoro- polimerom.
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
111 PODATKI NA ZUNANJI OVOJNINI
CARTON FOR INTERMEDIATE PACK
ŠKATLICA ZA VMESNO PAKIRANJE
30 transdermal patches Component of a multipack comprising 2 cartons, each containing 30 sachets.
30 transdermalnih obližev Zloženi so v skupno pakiranje z dvema škatlicama, od katerih vsaka vsebuje 30 vrečk.
Component of a multipack comprising 3 cartons, each containing 30 sachets.
Zloženi so v skupno pakiranje s tremi škatlicami, od katerih vsaka vsebuje 30 vrečk.
60 transdermal patches 90 transdermal patches
60 transdermalnih obližev 90 transdermalnih obližev
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
ŠKATLICA ZA SKUPNO PAKIRANJE (VKLJUČNO Z "BLUE BOX" PODATKI)
Multipack comprising 2 cartons, each containing 30 sachets.
Skupno pakiranje z dvema škatlicama, od katerih vsaka vsebuje 30 vrečk.
Multipack comprising 3 cartons, each containing 30 sachets.
Skupno pakiranje s tremi škatlicami, od katerih vsaka vsebuje 30 vrečk.
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
115 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Transdermal use Read the package leaflet before use.
Transdermalna uporaba Pred uporabo preberite priloženo navodilo.
Exelon 9.5 mg/ 24 h transdermal patch rivastigmine
Exelon 9, 5 mg/ 24 h transdermalni obliž rivastigmin
1 transdermal patch of 10 cm2 contains 18 mg rivastigmine and delivers 9.5 mg/ 24 h.
1 transdermalni obliž velikosti 10 cm2 vsebuje 18 mg rivastigmina in sprosti 9, 5 mg/ 24 h.
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
118 PODATKI NA ZUNANJI OVOJNINI
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 PODATKI NA ZUNANJI OVOJNINI
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
122 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
INFORMATION FOR THE USER
124 NAVODILO ZA UPORABO
Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules Rivastigmine
Exelon 1, 5 mg trde kapsule Exelon 3, 0 mg trde kapsule Exelon 4, 5 mg trde kapsule Exelon 6, 0 mg trde kapsule rivastigmin
What Exelon is and what it is used for 2.
Kaj je zdravilo Exelon in za kaj ga uporabljamo 2.
Before you take Exelon 3.
Kaj morate vedeti, preden boste vzeli zdravilo Exelon 3.
How to take Exelon 4.
Kako jemati zdravilo Exelon 4.
How to store Exelon 6.
Shranjevanje zdravila Exelon 6.
WHAT EXELON IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EXELON IN ZA KAJ GA UPORABLJAMO
Exelon belongs to a class of substances called cholinesterase inhibitors.
Exelon pripada skupini snovi, ki se imenujejo zaviralci holinesteraze.
Exelon is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Exelon uporabljamo za zdravljenje motenj spomina pri bolnikih z Alzheimerjevo boleznijo.
Exelon is used for the treatment of dementia in patients with Parkinson’ s disease.
Exelon uporabljamo za zdravljenje demence pri bolnikih s Parkinsonovo boleznijo.
BEFORE YOU TAKE EXELON
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EXELON
Before taking Exelon it is important that you read the following section and discuss any questions you might have with your doctor.
Preden vzamete Exelon, je pomembno, da preberete naslednje poglavje in se o vseh morebitnih vprašanjih pogovorite s svojim zdravnikom.
Do not take Exelon
Ne jemljite zdravila Exelon
- if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Exelon.
- če ste alergični na (preobčutljivi za) rivastigmin ali katerokoli sestavino zdravila Exelon.
Take special care with Exelon
Bodite posebno pozorni pri uporabi zdravila Exelon
- if you have, or have ever had impaired kidney or liver function, irregular heartbeat, an active
- če imate ali če ste kdaj imeli zmanjšano delovanje ledvic ali okvarjeno delovanje jeter,
stomach ulcer, asthma or severe respiratory disease, difficulties in passing urine, or seizures (fits or convulsions).
nepravilen srčni utrip, aktivno želodčno razjedo, astmo ali hudo bolezen dihal, težave pri odvajanju vode ali epileptične napade (napade krčev),
- if you have not taken Exelon for several days, do not take the next dose until you have talked to
- če zdravila Exelon več dni niste jemali, ne vzemite naslednjega odmerka, dokler se ne
your doctor.
pogovorite s svojim zdravnikom,
- if you experience gastro-intestinal reactions such as nausea (feeling sick) and vomiting (being
- če imate prebavne motnje, kot sta navzea (slabost s siljenjem na bruhanje) in bruhanje,
- if you suffer from trembling.
- če imate težave s tresenjem.
118 The use of Exelon in children and adolescents (age below 18 years) is not recommended.
Pri otrocih in mladostnikih (starih manj kot 18 let) uporaba zdravila Exelon ni priporočena.
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.
125 Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If you have to undergo surgery whilst taking Exelon, you should inform the doctor before you are given any anaesthetics, because Exelon may exaggerate the effects of some muscle relaxants during anaesthesia.
Če morate v času jemanja zdravila Exelon na operacijo, morate obvestiti zdravnika, da jemljete Exelon, preden dobite kakršnokoli anestezijo, ker lahko Exelon med anestezijo poveča učinke nekaterih mišičnih relaksantov.
Exelon should not be given at the same time as other medicines with similar effects to Exelon.
Zdravila Exelon ne smete jemati sočasno z drugimi zdravili, ki imajo podobne učinke kot Exelon.
Exelon might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’ s disease or to prevent travel sickness).
Exelon bi lahko vplival na zdravljenje z antiholinergičnimi zdravili (zdravili, ki se uporabljajo za lajšanje želodčnih krčev ali spazmov, za zdravljenje Parkinsonove bolezni ali za preprečevanje slabosti na potovanju).
Pregnancy and breast-feeding It is preferable to avoid the use of Exelon during pregnancy, unless clearly necessary.
Nosečnost in dojenje Med nosečnostjo ne jemljite zdravila Exelon, razen če to ni nujno potrebno.
Women on Exelon should not breast-feed.
Ženske, ki jemljejo Exelon, ne smejo dojiti.
Driving and using machines Your illness may impair your ability to drive or operate machinery and you must not carry out these activities unless your doctor tells you that it is safe to do so.
Teh dejavnosti ne smete opravljati, razen če vam vaš zdravnik pove, da je to varno.
Exelon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Exelon lahko povzroči vrtoglavost in zaspanost, predvsem na začetku zdravljenja ali ob povečanju odmerka.
If you experience such effects, you should not drive or operate machinery.
Če opazite takšne učinke, ne smete upravljati motornih vozil ali uporabljati strojev.
HOW TO TAKE EXELON
KAKO JEMATI ZDRAVILO EXELON
Always take Exelon exactly as your doctor has told you.
Pri jemanju zdravila Exelon natančno upoštevajte zdravnikova navodila.
Swallow the capsules whole with a drink, without opening or crushing them.
Kapsule pogoltnite cele z nekaj tekočine, ne da bi jih prej odprli ali zdrobili.
You should take Exelon twice a day with food (in the morning and evening).
Exelon morate jemati s hrano dvakrat na dan, zjutraj in zvečer.
Your doctor will tell you what dosage of Exelon to take, starting with a low dose and gradually increasing, depending on how you respond to the treatment.
Zdravnik vam bo določil odmerek zdravila Exelon, ki bo v začetku majhen in se bo postopoma povečeval, odvisno od vašega odziva na zdravljenje.
The highest dose that should be taken is 6.0 mg twice a day.
Največji odmerek, ki ga smete vzeti, je 6, 0 mg dvakrat na dan.
If you have not taken Exelon for several days, do not take the next dose until you have talked to your doctor.
Če zdravila Exelon več dni niste jemali, ne vzemite naslednjega odmerka, dokler se ne pogovorite s svojim zdravnikom.
To benefit from your medicine you should take it every day.
Da vam bo zdravilo pomagalo, ga morate jemati vsak dan.
Tell your caregiver that you are taking Exelon.
Povejte svojemu negovalcu, da jemljete Exelon.
This medicine should only be prescribed by a specialist and your doctor should regularly review whether it is having the desired effect.
To zdravilo lahko predpiše samo zdravnik specialist in vaš zdravnik mora redno ocenjevati, ali zdravilo dosega želeni učinek.
Your doctor will monitor your weight whilst you are taking this medicine.
V času jemanja zdravila bo vaš zdravnik spremljal tudi vašo telesno maso.
If you take more Exelon than you should Tell your doctor if you find you have accidentally taken more Exelon than you are told to.
Če ste vzeli večji odmerek zdravila Exelon, kot bi smeli Če ugotovite, da ste pomotoma vzeli več zdravila Exelon, kot vam ga je zdravnik predpisal, ga o tem nemudoma obvestite.
Some people who have accidentally taken too much Exelon have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations.
Pri nekaterih ljudeh, ki so pomotoma vzeli preveč zdravila Exelon, so se pojavili navzea (slabost s siljenjem na bruhanje), bruhanje, driska, zvišan krvni tlak in halucinacije.
Slow heart beat and fainting may also occur.
Lahko se pojavita tudi upočasnjen srčni utrip in omedlevica.
If you forget to take Exelon If you find you have forgotten to take your dose of Exelon, wait and take the next dose at the usual time.
126 Če ste pozabili vzeti zdravilo Exelon Če ugotovite, da ste pozabili vzeti odmerek zdravila Exelon, počakajte in ob običajnem času vzemite naslednji odmerek.
Like all medicines, Exelon can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Exelon neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
You may tend to get side effects most frequently when you start taking your medicine or increase to a higher dose.
Največja verjetnost, da se bodo pojavili neželeni učinki, je na začetku jemanja zdravila in ob povečanju odmerka.
Side effects will gradually disappear most probably as your body becomes used to the medicine.
Neželeni učinki bodo postopoma izginili, najverjetneje zato, ker se telo zdravila navadi.
Very common side effects (affects more than 1 patient in 10) are dizziness, nausea (feeling sick), vomiting (being sick), diarrhoea, and loss of appetite.
Zelo pogosti neželeni učinki (prizadenejo več kot 1 bolnika od 10) so vrtoglavost, navzea (slabost s siljenjem na bruhanje), bruhanje, driska in izguba teka.
Common side effects (affects 1 to 10 patients in 100) are: heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, a general feeling of being unwell, weight loss and trembling.
Pogosti neželeni učinki (prizadenejo 1 do 10 bolnikov od 100) so: zgaga, bolečine v želodcu, glavobol, huda vznemirjenost, zmedenost, oslabelost, utrujenost, potenje, splošno slabo počutje, hujšanje in tresenje (tremor).
Uncommonly (affects 1 to 10 patients in 1,000), patients have complained of depression, difficulty in sleeping, changes in liver function, fainting or accidentally falling.
Občasno (prizadenejo 1 do 10 bolnikov na 1. 000) so bolniki tožili zaradi potrtosti (depresije), nespečnosti, sprememb delovanja jeter, omedlevice ali nezgodnih padcev.
Rarely (affects 1 to 10 patients in 10,000), patients have experienced chest pain, seizures (fits or convulsions), rashes, gastric and intestinal ulcers.
Redko (prizadenejo 1 do 10 bolnikov od 10. 000) so se pri bolnikih pojavili bolečina v prsih, epileptični napadi (napadi krčev ali konvulzije), izpuščaji, razjede želodca ali črevesja.