natgillin/translations-raw huggingface dataset:
Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC) Blister (polyamide/ aluminium/ PVC)
blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC)
30 tabletter 100 tabletter 30 tabletter 100 tabletter 30 tabletter 100 tabletter 30 tabletter 100 tabletter 30 tabletter 100 tabletter
30 100 30 100 30 100 30 100 30 100
Sifrol 0, 088 mg tabletter
SIFROL 0.088 mg tablets
Sifrol 0, 088 mg tabletter indeholder 0, 088 mg pramipexolbase (som 0, 125 mg pramipexol dihydrochloridmonohydrat).
SIFROL 0.088 mg tablets contain 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Sifrol kan gives, som monoterapi eller i kombination med levodopa i hele sygdomsforløbet herunder i de sene stadier, når effekten af levodopa klinger af eller bliver ustabil, og svingninger i den terapeutiske effekt opstår.
SIFROL is indicated for treatment of the signs and symptoms of idiopathic Parkinson’ s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “ on off” fluctuations).
4. 2).
SIFROL is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2.).
2 Skema for øgning af dosis for Sifrol
Ascending – Dose Schedule of SIFROL
Det kan anbefales, at levodopadosis reduceres både under dosisstigning og vedligeholdelsesbehandling med Sifrol, afhængigt af den enkelte patients reaktioner.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with SIFROL, depending on reactions in individual patients.
• Ved kreatininclearance mellem 20 og 50 ml/ min. bør initialdosis af Sifrol fordeles på 2 daglige doser begyndende med 0, 088 mg base (0, 125 mg salt) to gange dagligt svarende til 0, 176 mg base (0, 25 mg salt) per døgn.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of SIFROL should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
• Ved kreatininclearance mindre end 20 ml/ min. bør initialdosis af Sifrol gives som en enkeltdosis begyndende med 0, 088 mg base (0, 125 mg salt) per døgn.
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Dvs. hvis f. eks. kreatininclearance reduceres med 30%, så reduceres den daglige dosis tilsvarende med 30%.
If renal function declines during maintenance therapy, reduce SIFROL daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the SIFROL daily dose by 30%.
Den anbefalede startdosis for Sifrol er 0, 088 mg base (0, 125 mg salt), som tages 1 gang dagligt 2- 3 timer før sengetid.
The recommended starting dose of SIFROL is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Behandlingens effekt hos RLS- patienten og den forsatte behandling bør evalueres efter 3 måneders brug, eftersom langtidsvirkningen af Sifrol ikke er tilstrækkelig kendt.
As long-term efficacy of SIFROL in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Behandlingsophør Sifrol kan ved behandling af Restless Legs Syndrome seponeres uden aftrapning, idet dosis ikke vil overstige 0, 54 mg base (0, 75 mg salt).
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) SIFROL can be discontinued without tapering off.
Brugen af Sifrol har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion.
The use of SIFROL has not been studied in hemodialysis patients, or in patients with severe renal impairment.
Børn og unge Sifrol bør ikke anvendes til børn og unge under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Dosing in children and adolescents SIFROL is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
-4- 4.4 Special warnings and precautions for use
4. 2.
When prescribing SIFROL in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Dyskinesi Ved fremskreden Parkinsons sygdom kan dyskinesi forekomme i optitreringsfasen med Sifrol, når det gives i kombination med levodopa.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
4 Pludselig opståede søvnanfald og somnolens Sifrol er blevet forbundet med somnolens og episoder med pludselig opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Sudden onset of sleep and somnolence SIFROL has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Manglende impulskontrol og tvangshandlinger Ludomani, forøget libido og hyperseksualitet er set hos patienter, som blev behandlet med dopaminagonister for Parkinsons sygdom herunder Sifrol.
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL.
Generelt har de kontrollerede kliniske forsøg med Sifrol hos patienter med Restless Legs Syndrome ikke været af tilstrækkelig varighed til at vurdere forekomsten af augmentation.
The frequency of
Hyppigheden af augmentation efter længerevarende brug af Sifrol og korrekt håndtering af disse tilfælde er derfor ikke evalueret.
-5- augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Det bør overvejes at reducere pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Sifrol.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.
Kombination med levodopa Når Sifrol gives i kombination med levodopa, anbefales det at reducere levodopa- dosis og at holde dosis af andre antiparkinson- lægemidler konstant, mens dosis af Sifrol øges.
Combination with levodopa When SIFROL is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.
Sifrol bør ikke bruges under graviditet, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret.
SIFROL should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Da Sifrol hæmmer sekretionen af prolaktin hos mennesker, forventes amningen også at blive hæmmet.
As SIFROL treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Udskillelsen af Sifrol i modermælk er ikke kendt.
The excretion of SIFROL into breast milk has not been studied in women.
Der er ikke erfaring med Sifrols udskillelse i modermælk.
In the absence of human data, SIFROL should not be used during breast-feeding.
Sifrol kan have stor virkning på evnen til at føre motorkøretøj eller betjene maskiner.
SIFROL can have a major influence on the ability to drive and use machines.
4. 4, 4. 5 og 4. 8).
Patients being treated with SIFROL and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Unormale drømme, hukommelsestab, usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger såsom uhæmmet madindtagelse, tvangshandling, der fører til overdrevent indkøbsmønster, hyperseksualitet og ludomani; konfusion, forstoppelse, vrangforestillinger, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hyperfagi, hypotension, søvnløshed, libido forstyrrelser, kvalme, paranoia, perifert ødem, kløe, udslæt og anden overfølsomhed, rastløshed, somnolens, pludselig opstået søvn, synkope, synsforstyrrelse, sløret syn og nedsat synsskarphed, opkastning, vægttab, vægtøgning.
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
En analyse af poolede placebo- kontrollerede kliniske forsøg, omfattende 1923 patienter i behandling med Sifrol og 1354 patienter i placebo behandling viste, at rapportering af bivirkninger var hyppigt forekommende i begge grupper.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
63% af patienterne i Sifrol- behandling og 52% af patienterne i placebobehandling rapporterede mindst én bivirkning.
63% of patients on SIFROL and 52% of patients on placebo reported at least one adverse drug reaction.
Desuden er klinisk relevante bivirkninger også anført.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with SIFROL and were reported significantly more often in patients taking SIFROL than placebo, or where the event was considered clinically relevant.
Mest almindelige bivirkninger ved Parkinsons sygdom De mest almindeligt (≥ 5%) rapportede bivirkninger hos patienter med Parkinsons sygdom, som oftere ses efter behandling med Sifrol end efter behandling med placebo er kvalme, dyskinesi, hypotension, svimmelhed, somnolens, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
Parkinson’ s disease, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with SIFROL treatment than with Placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Dyskinesi ses hyppigere i kombination med levodopa.
More frequent adverse drug reactions in combination with levodopa were dyskinesia,.
Hypotension kan forekomme i begyndelsen af behandlingen, specielt hvis Sifrol justeres for hurtigt.
Hypotension may occur at the beginning of treatment, especially if SIFROL is titrated too fast.
Mest almindlige bivirkninger ved Restless Legs Syndrom De mest almindelige (≥ 5%) rapporterede bivirkninger hos patienter med Restless Legs Syndrom, er kvalme, hovedpine, svimmelhed og træthed.
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med Sifrol (henholdsvis 20, 8% og 10, 5%) sammenlignet med mandlige patienter (henholdsvis 6, 7% og 7, 3%).
Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Somnolens Sifrol er forbundet med somnolens (8, 6%), og er blevet forbundet med overdreven somnolens i dagtimerne og pludseligt opstået søvnepisoder (0, 1%).
Somnolence SIFROL is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Ændring af libido Ændringer i libido er set (øget libido (0, 1%) eller nedsat libido (0, 4%)).
Libido disorders SIFROL may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Disse tilstande er sædvanligvis reversible ved dosisreduktion eller seponering.
Impulse control disorders and compulsive behaviours Patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
4. 9 Overdosering
-9- 4.9 Overdose
Hos patienter reducerer Sifrol tegn og symptomer på idiopatisk Parkinsons sygdom.
In patients SIFROL alleviates signs and symptoms of idiopathic Parkinson’ s disease.
6 måneder.
In early and advanced Parkinson’ s disease, efficacy of SIFROL in the controlled clinical trials was maintained for approximately six months.
Effekten af Sifrol er blevet evalueret i fire placebo kontrollerede kliniske forsøg hos cirka 1000 patienter med moderat til meget svær idiopatisk Restless Legs Syndrom.
The efficacy of SIFROL was evaluated in four placebo-controlled clinical trials in approximately 1000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
Den justerede gennemsnitsforskel var - 4, 3 point (CI 95% - 6, 4; - 2, 1 procent, p- værdi < 0, 0001).
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value < 0.0001).
9 I et placebo- kontrolleret polysomnografi- studie over 3 uger reducerede Sifrol signifikant antallet af periodiske benbevægelser mens forsøgspersonerne var sengeliggende.
In a placebo-controlled polysomnography study over 3 weeks SIFROL significantly reduced the number of periodic limb movements during time in bed.
14. oktober 1997 Dato for fornyelse af tilladelsen:
14 October 1997 Date of Renewal of the authorisation:
14. oktober 2007
14 October 2007
Sifrol 0, 18 mg tabletter
SIFROL 0.18 mg tablets
Sifrol 0, 18 mg tabletter indeholder 0, 18 mg pramipexolbase (som 0, 25 mg pramipexoldihydrochloridmonohydrat).
SIFROL 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
4. 2).
SIFROL is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
12 Skema for øgning af dosis for Sifrol
Ascending – Dose Schedule of SIFROL
4. 2.
When prescribing SIFROL tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
14 Pludselig opståede søvnanfald og somnolens Sifrol er blevet forbundet med somnolens og episoder med pludselig opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Sudden onset of sleep and somnolence SIFROL has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Generelt har de kontrollerede kliniske forsøg med Sifrol hos patienter med Restless Legs Syndrome ikke været af tilstrækkelig varighed til at vurdere forekomsten af augmentation.
The controlled trials of SIFROL in patients with Restless Legs Syndrome were generally not of sufficient duration to adequately capture augmentation phenomena.
Hyppigheden af augmentation efter længerevarende brug af Sifrol og korrekt håndtering af disse tilfælde er derfor ikke evalueret.
The frequency of augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Patienter, som bliver behandlet med Sifrol, og som har oplevet somnolens og/ eller episoder af pludselig opstået søvn, bør informeres om, at de skal afstå fra at køre bil eller deltage i aktiviteter, hvor nedsat årvågenhed kan udsætte dem eller andre for alvorlig fare eller død (f. eks. betjening af maskiner) indtil sådanne tilbagevendende episoder og somnolens er ophørt (se også pkt.
Patients being treated with SIFROL and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
4. 8 Bivirkninger
- 17 -
Unormale drømme, hukommelsestab, usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger såsom uhæmmet madindtagelse, tvangshandling, der fører til overdrevent indkøbsmønster, hyperskesualitet og ludomani; konfusion, forstoppelse, vrangforestillinger, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hyperfagi, hypotension, søvnløshed, libido forstyrrelser, kvalme, paranoia, perifert ødem, kløe, udslæt og anden overfølsomhed, rastløshed, somnolens, pludselig opstået søvn, synkope, synsforstyrrelse, sløret syn og nedsat synsskarphed, opkastning, vægttab, vægtøgning.
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase, pruritus.
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt (kan ikke estimeres ud fra forhåndværende data).
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Synsforstyrrelser, sløret syn og nedsat synsskarphed
visual disturbance including vision blurred and visual acuity reduced
De mest almindelige (≥ 5%) rapporterede bivirkninger hos patienter med Restless Legs Syndrom, er kvalme, hovedpine, svimmelhed og træthed.
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
19 I et placebo- kontrolleret polysomnografi- studie over 3 uger reducerede Sifrol signifikant antallet af periodiske benbevægelser mens forsøgspersonerne var sengeliggende.
In a placebo-controlled polysomnography study over 3 weeks SIFROL significantly reduced the number of periodic limb movements during time in bed.
Sifrol 0, 35 mg tabletter
SIFROL 0.35 mg tablets
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Ascending – Dose Schedule of SIFROL
Sifrol 0, 35 mg tabletter indeholder 0, 35 mg pramipexolbase (som 0, 5 mg pramipexol dihydrochloridmonohydrat).
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
Da der i litteraturen refereres til doser af pramipexol i saltformen, er pramipexolsalt desuden anført i parentes.
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Alle hjælpestoffer er anført under pkt.
Dose Schedule of SIFROL
LÆGEMIDDELFORM
As long-term efficacy of SIFROL in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Beskrivelse flad, rund, 6 mm i diameter, ingen delekærv flad, oval, 7, 86 x 5, 63 mm, delekærv på begge sider flad, oval, 10, 59 x 7, 59 mm, delekærv på begge sider flad, rund, 9 mm i diameter, delekærv på begge sider flad, rund, 11 mm i diameter, delekærv på begge sider
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL.
Sifrol er indiceret til behandling af tegn og symptomer på idiopatisk Parkinsons sygdom.
abnormal dreams, behavioural symptoms of impulse control disorders and compulsions; confusion, hallucinations, insomnia, restlessness
Sifrol kan gives, som monoterapi eller i kombination med levodopa i hele sygdomsforløbet herunder i de sene stadier, når effekten af levodopa klinger af eller bliver ustabil, og svingninger i den terapeutiske effekt opstår.
compulsive shopping, delusion, hypersexuality, libido disorder, paranoia, pathological gambling
Sifrol er indiceret til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome i doser optil 0, 54 mg base (0, 75 mg salt) (se pkt.
Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
22 Skema for øgning af dosis for Sifrol
Ascending – Dose Schedule of SIFROL
24 Pludselig opståede søvnanfald og somnolens Sifrol er blevet forbundet med somnolens og episoder med pludselig opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Sudden onset of sleep and somnolence SIFROL has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Unormale drømme, hukommelsestab, usædvanlig adfærd med symptomer på manglende impulskontrol og tvangshandlinger såsom uhæmmet madindtagelse, tvangshandling, der fører til overdrevent indkøbsmønster, hyperseksualitet og ludomani; konfusion, forstoppelse, vrangforestillinger, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hyperfagi, hypotension, søvnløshed, libido forstyrrelser, kvalme, paranoia, perifert ødem, kløe, udslæt og anden overfølsomhed, rastløshed, somnolens, pludeselig opstået søvn, synkope, synsforstyrrelser, sløret syn og nedsat synsskarphed, opkastning, vægttab, vægtøgning.
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus and rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.