FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and intervention detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Ansvarlig(e) fremstiller(e) har pligt til at udføre de påkrævede lægemiddelovervågningsaktiviteter og -interventioner i henhold til den aftalte risikohåndteringsplan angivet i Modul 1.8.2. af markedsføringstilladelsen og eventuelt aftalte efterfølgende opdateringer af risikohåndteringsplanen.
English: Patients with dementia and Parkinson's disease
Danish: Patienter med demens og Parkinsons sygdom
English: However, due to increased exposure in these populations, dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
Danish: På grund af øget biotilgængelighed hos disse patienter bør anbefalingerne vedrørende titrering i henhold til individuel tolerance dog følges nøje, da patienter med klinisk signifikant nedsat nyre- eller leverfunktion kan opleve flere dosisafhængige bivirkninger.
English: HEXAL AG Industriestraße 25 83607 Holzkirchen Germany
Danish: HEXAL AG Industriestraße 25 83607 Holzkirchen Tyskland
English: To be swallowed whole without crushing or opening.
Danish: Må ikke knuses eller åbnes.
English: Novartis Farmacéutica, S.A. Planta de Producción Ronda de Santa Maria 158
Danish: Planta de Producción Ronda de Santa Maria 158
English: Dosing recommendations to titrate according to individual tolerability must be closely followed.
Danish: dosistitrering skal følges nøje i henhold den enkelte patients tolerabilitet.
English: The oral solution is packaged with an oral dosing syringe in a plastic tube container.
Danish: Den orale opløsning er pakket sammen med en oral doseringssprøjte i et plastikrør.
English: By blocking these enzymes, Rivastigmine HEXAL allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Danish: Ved at blokere disse enzymer, lader Rivastigmine HEXAL acetylkolinniveauerne stige i hjernen, og det hjælper til at reducere symptomerne af Alzheimers sygdom og demens, som skyldes Parkinsons sygdom.
English: HEXAL AG Industriestraße 25 D-83607 Holzkirchen Germany
Danish: HEXAL AG Industriestraße 25 D-83607 Holzkirchen Tyskland
English: - The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide red iron oxide, titanium dioxide, and shellac.
Danish: - Øvrige indholdsstoffer er hypromellose, magnesiumstearat, mikrokrystallinsk cellulose, kolloidt silica, gelatine, gul jernoxid, rød jernoxid, titandioxid og shellac.
English: • Take Rivastigmine HEXAL twice a day in the morning and evening with food.
Danish: • Tag Rivastigmine HEXAL to gange om dagen (morgen og aften) sammen med mad.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Rivastigmin hos alle undergrupper af den pædiatriske population ved behandling af Alzheimers demens og demens hos patienter med idiopatisk Parkinsons sygdom (se pkt.
English: Rivastigmine HEXAL might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Danish: Rivastigmine HEXAL kan påvirke antikolinerg medicin (medicin, der bruges mod mavekramper og Parkinsons sygdom eller til at forebygge transportsyge).
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30%.
Danish: Indgift af rivastigmin sammen med føde forsinker optagelsen (tmax) med 90 min, sænker Cmax og øger AUC med ca. 30 %.
English: Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Danish: Kolinesterasehæmmere bør udskrives med forsigtighed til patienter, som tidligere har haft astma eller kronisk obstruktiv lungesygdom.
English: CARTON FOR HDPE BOTTLE LABEL FOR HDPE BOTTLE
Danish: KARTON TIL HDPE-FLASKE ETIKET TIL HDPE-FLASKE
English: Rivastigmine Hexal should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Danish: Rivastigmine HEXAL må ikke indgives samtidig med metoclopramid (et lægemiddel, der bruges til at lindre eller forebygge kvalme og opkastning).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du får nogen bivirkninger så tal med din læge eller apotekspersonalet.
English: In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Danish: Rivastigmin og/eller metabolitter passerede placenta hos drægtige dyr.
English: The use of this medicinal product is contraindicated in patients with known hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Danish: Anvendelse af denne medicin er kontraindiceret til patienter med kendt overfølsomhed over for det aktive stof rivastigmin, over for andre carbamatderivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Rivastigmine HEXAL oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Danish: Rivastigmine HEXAL oral opløsning leveres som 50 ml eller 120 ml klar gul opløsning (2 mg/ml base) i en brun glasflaske med børnesikret låg med tætningsindsats, isat rør med holder, hvori doseringssprøjten fastgøres.
English: Caution when Rivastigmine HEXAL is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Danish: Udvis forsigtighed, når Rivastigmine 1 HEXAL tages sammen med betablokkere (lægemidler såsom atenolol anvendes til behandling af forhøjet blodtryk, angina og andre hjertelidelser).
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Danish: Der bør derfor udvises forsigtighed, når rivastigmin kombineres med betablokkere og med andre bradykardimidler (f.eks. antiarytmika af klasse III, calciumantagonister, digitalis glycosid, pilocarpin).
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Danish: Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24-ugers studie, der blev udført med rivastigmin hos patienter med demens, der er associeret med Parkinsons sygdom med prædefinerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
English: Abdominal pain and dyspepsia Salivary hypersecretion
Danish: Abdominale smerter og dyspepsi Hypersekretion af spyt
English: No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see section 5.3).
Danish: Der blev ikke observeret nogen bivirkninger på fertilitet eller forplantningsdygtighed hos rotter (se pkt.
English: Sodium benzoate Citric acid
Danish: - Natriumbenzoat - Citronsyre
English: Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary urination and/or defecation, lacrimation, hypotension and salivary hypersecretion.
Danish: Kolinerg toksicitet er blevet rapporteret med muskarine symptomer, som er observeret med moderate forgiftningssymptomer, såsom pupilforsnævring, blussen, fordøjelsesforstyrrelser, herunder mavesmerter, kvalme, opkastning og diarré, bradykardi, bronkospasme og forøget bronkial sekretion, hyperhidrose, ufrivillig vandladning og/eller afføring, tåresekretion, hypotension og forøget spytafsondring.
English: Reporting of side effects
Danish: Rapportering af bivirkninger
English: Initial dose 1.5 mg twice a day.
Danish: Initialdosis 1,5 mg to gange daglig.
English: Package leaflet: Information for the patient Rivastigmine HEXAL 2 mg/ml oral solution
Danish: Indlægsseddel: Information til patienten Rivastigmine HEXAL 2 mg/ml oral opløsning
English: The Cmax of rivastigmine was approximately 60% higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Danish: Cmax for rivastigmin var cirka 60 % højere, og AUC for rivastigmin var mere end dobbelt så høj hos personer med mild til moderat nedsat leverfunktion end hos raske personer.
English: Cardiac arrhythmia (e.g. bradycardia, atrioventricular block, atrial fibrillation and tachycardia)
Danish: Hjertearytmi (f.eks. bradykardi, atrioventrikulært blok, atrieflimren og takykardi)
English: If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Danish: Hvis der observeres bivirkninger (f.eks. kvalme, opkastning, mavesmerter, appetitløshed), vægttab eller forværring af ekstrapyramidale symptomer (f.eks. tremor) hos patienter med demens, der er associeret med Parkinsons sygdom, i løbet af behandlingen, vil disse muligvis kunne undgås ved udeladelse af en eller flere doser.
English: Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson's disease (see section 4.8).
Danish: Forværring (inklusive bradykinesi, dyskinesi, gangforstyrrelser) og forøget incidens eller intensitet af tremor er blevet observeret hos patienter med demens, der er associeret med Parkinsons sygdom (se pkt.
English: • The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles,
Danish: Symptomer på Parkinsons sygdom bliver værre, eller der optræder parkinsonlignende symptomer - såsom muskelstivhed og bevægelsesbesvær
English: • Push down and turn the child resistant cap to open bottle.
Danish: • Tryk det børnesikrede låg ned og drej for at åbne flasken.
English: What you need to know before you take Rivastigmine HEXAL Do not take Rivastigmine HEXAL
Danish: Det skal du vide, før du begynder at tage Rivastigmine HEXAL Tag ikke Rivastigmine HEXAL
English: Reporting of suspected adverse reactions
Danish: Rapportering af mistænkte bivirkninger
English: The starting dose is 1.5 mg twice a day.
Danish: Startdosis er 1,5 mg to gange daglig.
English: At least 4 points improvement on ADAS-Cog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Danish: CIBIC-Plus: forbedring PDS: mindst 10 % forbedring Mindst 4-pointsforbedring af ADAS-Cog med ingen forværring af CIBIC-Plus og PDS *p<0,05, **p<0,01, ***p<0,001
English: You should not breast-feed during treatment with Rivastigmine HEXAL.
Danish: Du må ikke amme, mens du er i behandling med Rivastigmine HEXAL.
English: The prescribed amount of solution should be withdrawn from the bottle using the oral dosing syringe supplied.
Danish: Den doserede mængde opløsning skal udtages fra flasken ved hjælp af den vedlagte orale doseringssprøjte.
English: Medicinal product on “restricted” medical prescription, reserved for use in certain specialised area (See Annex I: Summary of Product Characteristics, Section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en begrænset recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: 1020 WienTel: + 43 (0)1 486 96 22
Danish: Tel: + 43 (0)1 486 96 22
English: Bradycardia Arial fibrillation Atrioventricular block Sick sinus syndrome
Danish: Atrieflimren Atrioventrikulært blok Syg sinus-syndrom
English: If you get any of these side effects, contact your doctor as you may need medical assistance.
Danish: Kontakt din læge, hvis sådanne symptomer opstår, da du muligvis har brug for lægehjælp.
English: Detailed information of this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/
English: Rivastigmine oral solution should be administered twice a day, with morning and evening meals.
Danish: Rivastigmin oral opløsning skal indtages to gange daglig sammen med henholdsvis morgen- og aftensmåltid.
English: • Ulcers in your stomach or intestine
Danish: Mavesår eller sår på tarmen
English: Rivastigmine HEXAL may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Danish: Rivastigmine HEXAL kan give svimmelhed og døsighed, specielt i starten af behandlingen, eller når dosis øges.
English: Adjusted treatment difference p-value versus placebo n/a
Danish: Justeret behandlingsforskel p-værdi versus placebo ikke relevant
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Danish: Efter indgift af 14C-rivastigmin var renal udskillelse hurtig og nærmest fuldstændig
English: Rare Very rare
Danish: Sjælden Meget sjælden
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Rivastigmine HEXAL kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Danish: Bivirkningerne i tabel 1 er blevet akkumuleret hos patienter med Alzheimers demens, som har modtaget behandling med rivastigmin.
English: • Feeling agitated
Danish: Følelse af uro
English: HEXAL Pharma GmbH Stella-Klein-Löw-Weg 17
Danish: HEXAL Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Wien
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Danish: Nogle tilfælde af alvorlig opkastning blev associeret med esophagusruptur (se pkt.
English: Pruritus, allergic dermatitis (disseminated)
Danish: Kløe, allergisk kontakteksem (dissemineret)
English: - The active substance is rivastigmine hydrogen tartrate.
Danish: - Aktivt stof er rivastigminhydrogentartrat.
English: Very rare Very rare Not known
Danish: Meget sjælden Meget sjælden Ikke kendt
English: Patients with severe hepatic impairment have not been studied, however, rivastigmine oral solution may be used in this patient population provided close monitoring is exercised (see sections 4.4 and
Danish: Patienter med stærkt nedsat leverfunktion er ikke blevet undersøgt, men rivastigmin oral opløsning kan anvendes i denne patientpopulation under betingelse af, at den overvåges nøje (se pkt.
English: • Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
Danish: Leversygdomme (gulfarvet hud, gulfarvning af det hvide i øjnene, unormalt mørk urin eller uforklarlig kvalme, opkastning, træthed og appetitløshed) Aggressiv adfærd, rastløshed
English: Rivastigmine Hexal should not be given at the same time as other medicines with similar effects to Rivastigmine HEXAL.
Danish: Du må ikke tage Rivastigmine HEXAL samtidigt med andre lægemidler der har en virkning, der ligner Rivastigmine HEXALs.
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03 Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Danish: Rivastigmin er en acetyl- og butyrylkolinesterasehæmmer af carbamattypen, som menes at lette kolinerg neurotransmission ved at nedsætte nedbrydningen af acetylkolin, som er frigjort af funktionelt intakte kolinerge neuroner.
English: • Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
Danish: Maveproblemer, såsom kvalme eller opkastning, diarré
English: Rivastigmine HEXAL 2 mg/ml oral solution
Danish: Rivastigmine HEXAL 2 mg/ml oral opløsning
English: There is no relevant use of Rivastigmine HEXAL in the paediatric population in the treatment of Alzheimer's disease.
Danish: Der er ingen relevant brug af Rivastigmine HEXAL hos den pædiatriske population til behandling af Alzheimers sygdom.
English: The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Danish: Følgende bivirkninger er blevet observeret i forbindelse med rivastigmin-depotplaster: delirium, feber, nedsat appetit, urininkontinens (almindelig), psykomotorhyperaktivitet (ikke almindelig), erytem, urticaria, blærer, allergisk dermatitis (ikke kendt).
English: Π.T.Χατζηγeωργίου εταιρεία Ltd Γιλντίζ 31-3042 Λεμεσός Τηλέφωνο: 00357 25372425 Φαξ: 00357 25376400
Danish: Τηλέφωνο: 00357 25372425
English: There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
Danish: Der er ingen relevant brug af Rivastigmin i den pædiatriske population til behandling af Alzheimers sygdom.
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Danish: Rivastigmin skal indtages to gange daglig sammen med henholdsvis morgen- og aftensmåltid.
English: - Capsule fill: - Microcrystaline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
Danish: Kapselfyldning: - Mikrokrystallinsk cellulose - Magnesiumstearat - Hypromellose - Silica, kolloid vandfri
English: Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements
Danish: Sjælden (kan ramme op til 1 patient ud af 100) Uregelmæssig hjerterytme (puls), dårlig kontrol over bevægelser
English: Type III amber glass bottle with a child-resistant cap, dip tube and self aligning plug.
Danish: Type III brun glasflaske med børnesikret låg, isat rør med holder, hvori doseringssprøjten fastgøres.
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Danish: Anamnese med reaktioner på applikationsstedet, som tyder på allergisk kontakteksem forårsaget af rivastigminplasteret (se pkt.
English: Attaching the syringe to the bottle • Push the nozzle of the syringe into the hole in the white stopper.
Danish: • Sæt doseringssprøjtens spids ned i hullet i flaskens hvide gummilukke.
English: Quinoline yellow WS dye (E104) Purified water
Danish: - Natriumcitrat - Vandopløselig quinolingult farve (E 104) - Renset vand
English: OTHER CODDITIONS AND REQUIREMENT OF THE MARKETING AUTHORISATION
Danish: ANDRE BETINGELSER OG KRAV TIL MARKEDSFØRINGSTILLADELSEN
English: Hexal S.p.A. c/o Sandoz S.p.A. Largo Umberto Boccioni 1 I-21040 Origgio / VA Tel: + 39-02-96 541
Danish: Largo Umberto Boccioni 1 I-21040 Origgio / VA Tel: + 39-02-96 541
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan ramme flere end 1 patient ud af 10)
English: After using the syringe
Danish: Efter brug af doseringssprøjten
English: Rivastigmine HEXAL 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Danish: Rivastigmine HEXAL 2 mg/ml oral opløsning rivastigmin (som hydrogentartrat)
English: • Take the syringe out of its protective case.
Danish: • Tag doseringssprøjten ud af det beskyttende hylster.
English: Rivastigmine HEXAL 3 mg and 6 mg hard capsules:
Danish: Rivastigmine HEXAL 3 mg og 6 mg hårde kapsler:
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Danish: ADAS-Cog: mindst 4pointsforbedring
English: Parkinson's disease (worsening) Salivary hypersecretion Dyskinesia
Danish: Parkinsons sygdom (forværring) Øget spytsekretion
English: Very common Very common Very common Common Rare
Danish: Meget almindelig Meget almindelig Meget almindelig Almindelig Sjælden
English: Patients with severe hepatic impairment have not been studied, however, rivastigmine capsules may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Danish: Patienter med stærkt nedsat leverfunktion er ikke blevet undersøgt, men rivastigminkapsler kan anvendes i patientpopulationer under betingelse af, at den overvåges nøje (se pkt.
English: - Printing ink: - Shellac - Titanium dioxide (E171)
Danish: Trykfarve: - Shellac - Titandioxid (E171)
English: Preparing the bottle and syringe
Danish: Klargøring af flaske og doseringssprøjte
English: Only for carton box: Rivastigmine HEXAL 2 mg/ml
Danish: Kun for kartonæske: Rivastigmine HEXAL 2 mg/ml
English: If you are pregnant, the benefits of using Rivastigmine HEXAL must be assessed against the possible effects on your unborn child. Rivastigmine HEXAL should not be used during pregnancy unless clearly necessary
Danish: Hvis du er gravid, skal fordelen ved at tage Rivastigmine HEXAL bedømmes op mod de mulige indvirkninger på dit ufødte barn.
English: Teл.
Danish: Τηλ.
English: Each Rivastigmine HEXAL 6 mg capsule contains 6 mg of rivastigmine.
Danish: Hver Rivastigmine HEXAL 6 mg kapsel indeholder 6 mg rivastigmin.
English: Rivastigmine HEXAL 1.5 mg hard capsules:
Danish: Rivastigmine HEXAL 1,5 mg hårde kapsler:
English: Each Rivastigmine HEXAL 1.5 mg capsule contains 1.5 mg of rivastigmine.
Danish: Hver Rivastigmine HEXAL 1,5 mg kapsel indeholder 1,5 mg rivastigmin.
English: Each Rivastigmine HEXAL 3 mg capsule contains 3 mg of rivastigmine.
Danish: Hver Rivastigmine HEXAL 3 mg kapsel indeholder 3 mg rivastigmin.
English: Each Rivastigmine HEXAL 4.5 mg capsule contains 4.5 mg of rivastigmine.
Danish: Hver Rivastigmine HEXAL 4,5 mg kapsel indeholder 4,5 mg rivastigmin.
English: Very common Common Not known
Danish: Meget almindelig Almindelig Ikke kendt
English: • Trembling or feeling confused
Danish: Rysten eller følelse af forvirring Nedsat appetit
English: Only for carton box: Rivastigmine HEXAL 1.5 mg
Danish: Kun for kartonæske: Rivastigmine HEXAL 1,5 mg
English: Very common Very common Common
Danish: Meget almindelig Meget almindelig Almindelig
English: Only for carton box: Rivastigmine HEXAL 6 mg
Danish: Kun for kartonæske: Rivastigmine HEXAL 6 mg
English: Rivastigmine HEXAL 4.5 mg hard capsules:
Danish: Rivastigmine HEXAL 4,5 mg hårde kapsler:
English: • Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
Danish: Blødning i tarmen - blod i afføringen eller ved opkastning Betændelse i bugspytkirtlen - symptomerne omfatter alvorlige smerter øverst i maven, ofte med kvalme eller opkastning
English: Restlessness Hallucination, visual Depression Aggression
Danish: Visuelle hallucinationer Depression
English: See section 4
Danish: (Se punkt 4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om Rivastigmine HEXAL på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.