qanastek/EMEA-V3 huggingface dataset:
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines.
Trankwiliżżazzjoni, amnesija, nuqqas ta ’ konċentrazzjoni u diżabilità fil- funzjoni tal- muskoli, jistgħu jkunu l- effetti negattivi fuq il- ħila biex issuq u tħaddem magni.
If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased (see section 4.5).
Jekk ikun hemm nuqqas ta ’ irqad, x’ aktarx li tonqos l- attenzzjoni (ara sessjoni 4. 5).
Caution is recommended for patients performing skilled tasks.
Hu rakkomandat li pazjenti li jagħmlu xogħolijiet tas- sengħa għandhom jużaw l- akbar attenzjoni.
The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea.
Effetti mhux mixtieqa l- aktar komuni huma amnesija, paraestesija, ngħas tqil, ċiklu mqalleb ta ’ menstrwazzjoni
Frequencies are defined as Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000) not known (cannot be estimated from the available data)
Komuni ħafna (> 1/ 10) Komuni (> 1/ 100 sa < 1/ 10) Mhux komuni (> 1/ 1000 sa < 1/ 100) Rari:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
(> 1/ 10, 000 sa < 1/ 1000) Rari ħafna:
Organ/ System (Frequency)
(< 1/ 10, 000) Frekwenza mhix stabbilita
Adverse Reactions
Organu/ Sistema (Frekwenza)
Nervous system disorders
Reazzjonijiet mhux mixtieqa
See also below under Amnesia
Taqlib fis- sistema nervuża Komuni Mhux komuni
amnesia, paraesthesia, somnolence ataxia/ coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
amnesija, paraestesija, ħedla tan- ngħas, ataksja nuqqas ta ’ koordinazzjoni, sturdament, nuqqas ta ’ konċentrazzjoni, mejt, parosmija; diskors mħawwad (dysarthria, diskors mhux ċar);
Eye disorders Uncommon:
6 Għajnejn Mhux komuni
visual impairment, diplopia
Problemi ta ’ viżjoni, tara doppju
Ear and labyrinth disorders
Widnejn
hyperacusis
Tisma ’ aktar
6 Gastrointestinal disorders Uncommon:
Taqlib Gastrointenstinali Mhux komuni
nausea
Dardir
Frequency not known:
Ġilda Sensittivita għal dawl qawwi Mhux komuni Frekwenza mhix stabbilita
photosensitivity reaction angioedema
Nefħa tal- ġilda bl- ilma
Metabolism and nutrition disorders Uncommon:
Metaboliżmu ta ’ l- ikel
anorexia
Mhux komuni
General disorders and administration site conditions
nuqqas ta ’ aptit u problemi biex tiekol
Uncommon:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni
asthenia, malaise
astenja, telqa tal - ġisem
Immune system disorders Very rare:
Taqlib fis- Sistema Immuni
anaphylactic/ anaphylactoid reactions
Rari ħafna:
Hepatobiliary disorders
reazzjonijiet anafilattiċi/ ta ’ sintomi anafilattiċi
Frequency not known:
Fwied u frixa Frekwenza mhix stabbilita
hepatotoxicity (mostly described as transaminase increased)
epatotossiċità (deskritta l- aktar bħala livelli għoljin ta ’ transaminase)
Reproductive system and breast disorders Common:
Disturbi fis- sistema riproduttiva u fis- sider
dysmenorrhea
Komuni
Psychiatric disorders
ċiklu mqalleb ta ’ menstrwazzjoni
Uncommon:
Taqlib Psikjatriku Mhux komuni:
depersonalisation, hallucinations, depression, confusional state, apathy
apatija, konfużjoni, nuqqas ta ’ personalita`, dipressjoni, alluċinazzjoniet,
Frequency not known:
Frekwenza mhix stabbilita:
somnambulism
sonnambuliżmu
See also below under Depression and Psychiatric and “ paradoxical” reactions
Ara wkoll taħt Amnesija, Dipressjoni u Reazzjonijiet Psikjatriċi u “ paradossali ”
Amnesia Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher dosages.
Amnesija Amnesija li teffettaw il- memorja ta ’ qabel, tista ’ isseħħ meta jintużaw mediċini ta ’ terapija rakkomandati; ir- riskju jiżdied skond kemm tkun kbira id- doża.
Amnestic effects may be associated with inappropriate behaviour (see section 4.4).
(ara sezzjoni 4. 4).
Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.
Dipressjoni Dipressjoni li kienet teżisti qabel, tista ’ tinkixef u titfaċċa waqt li qed jittieħed il - benżodjażepin jew prodott simili għall- benżodjażepin.
Psychiatric and “ paradoxical” reactions Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character, and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents.
Reazzjonijiet Psikjatriċi u “ paradossali ” Reazzjonijiet bħal nuqqas ta ’ sabar, aġitazzjoni, burdati ħżiena, nuqqas ta ’ mistħija, aggressivita, ħsibijet abnormali, delużjonijiet, rabja, ħmir il- lejl, nuqqas ta ’ personalità, alluċinazzjonijiet, psikosi, mġiba mhux flokha, estrovertiżmu li hu barra mill- karattru, u effetti ta ’ imġiba avversa huma magħrufa li ġraw meta intuża benżodjażepin u prodotti simili għall- benżodjażepin.
Such reactions are more likely to occur in the elderly.
Dawn ir - reazzjonijiet jiġru l- aktar fl- anzjani.
Psychic dependence may occur.
7 Dipendenza L- użu (anke ta ’ dożi terepawtiċi) jistgħu iwasslu għall- iżvilupp ta ’ dipendenza fiżika: it- twaqqif tat - terapija tista ’ tirriżulta f’ fenomeni kemm ta ’ nuqqas jew ta ’ ritorn tal- fenominu tas- sintomi (ara sezzjoni 4. 4.) Dipendenza psikika tista ’ isseħħ.
Abuse of benzodiazepines and benzodiazepine-like active substances has been reported.
Ġew rappurtati abbużi minn benżodjażepin u mediċini simili għall- benżodjażepin.
There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose levels in humans have not been determined.
L- esperjenza klinika fuq l- effetti ta ’ doża eċċessiva ta ’ Sonata huma limitati, u l- livelli ta ’ dożi eċċessivi fil- bniedem għandhom ma ġewx determinati.
As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).
Bħal kull benżodjażepin ieħor jew prodotti oħra simili għall- benżodjażepin, doża eċċessiva mhix ta ’ periklu għall- ħajja sakemm ma tkunx ittieħdet ma xi depressant ieħor tas- CNS (inkluż l- alkoħol).
7 In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Fl- immaniġjar ta ’ doża eċċessiva ta ’ xi prodott mediċinali, wieħed għandu jżomm f’ moħħu li jistgħu jkunu ittieħdu diversi prodotti oħra.
Following overdose with oral benzodiazepine or benzodiazepine-like agents, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious.
Jekk tkun ittieħdet doża eċċessiva mill- ħalq ta ’ benżodjażepin ieħor jew bħal prodotti oħra simili għall- benżodjażepin, ir- rimettar għandu jkun inkurraġut meta il- pazjent ikun f’ sensih, jew it- tindif ta ’ l- imsaren jekk il- pazjent inkun mitluf minn sensih.
If there is no advantage in emptying the stomach, activated charcoal should be given to reduce the absorption.
Jekk ma hemm l- ebda vantaġġ li jiżvojta l- istonku, faħam attivat għandu jingħata biex jonqos l- assorbiment.
Special attention should be paid to respiratory or cardiovascular functions in intensive care.
Attenzjoni speċjali għandha tingħata għall - funzjonijiet respiratorji u kardjovaskulari meta tingħata kura intensiva.
Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Doża eċċessiva ta ’ benżodjażepin jew prodotti oħra simili għall- benżodjażepin ġeneralment tintwera fis- sistema nervuża b’ qawwa li tvarja minn ngħas tqil għall- koma.
In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
F’ każijiet aktar serji, is- sintomi jistgħu jkunu ataxja, ipotomnija, pressjoni baxxa, depressjoni respiratorja, f’ każijiet rari ta’ koma u f’ każijiet rari ħafna mewt.
Chromaturia (blue-green urine discolouration) has been reported with zaleplon overdose.
Il- kromaturja (tibdil fil- kulur ta ’ l- awrina għal kaħlani- ħadrani) ġiet rapportata b’ doża eċċessiva ta ’ zaleplon.
Flumazenil may be useful as an antidote.
Flumazenil jista ’ jkun utli bħala kura.
Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Sonata overdose.
Studji fuq l- annimali juru li flumazenil hu oppost għal zaleplon u għandu jkun kunsidrat fl- immaniġjar tad- doża eċċessiva ta ’ Sonata.
Pharmacotherapeutic Group:
Grupp Farmakoterapewtiku:
Benzodiazepine related drugs, ATC Code N05CF03
Mediċini Relatati mal- Benżodjażepini, ATC Kodiċi N05CF03
Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and other hypnotics.
Zaleplon hu pyrażolopirimidine ipnotiku, li għandu struttura differenti minn mediċini benżodjażepini u mediċini ipnotiċi oħra.
Zaleplon binds selectively to the benzodiazepine type I receptor.
Zaleplon jaqbad selettivament ma ’ reċetturi tal- benżodjażepini tat- tip I.
Zaleplon’ s pharmacokinetic profile shows rapid absorption and elimination (see section 5.2).
Il- profil farmakokinetiku ta’ zaleplon juri li l- assorbiment u l- eliminazzjoni hi ta ’ malajr.
In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Sonata.
Flimkien mas- sottotip tal- karaterristiċi ta ’ tagħqid mar- riċettur, b’ selettività għolja u b’ affinita baxxa għal riċetur tat- tip 1 għal benżodjażepin, dawn il- propjetajiet huma responsabbli għal karaterristiċi globali ta ’ Sonata.
Sonata’ s efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
L- effikaċja ta ’ Sonata kienet imkejjla kemm fi studji fuq l- irqad li saru fil- laboratorji fejn intużaw miżuri oġġettivi polisomnigrafi (PSG) ta ’ l- irqad, kif ukoll fi studji fuq pazjenti barra mill- isptar fejn kienu użati kwestjonarji.
In these studies, patients were diagnosed with primary (psychophysiological) insomnia.
F’ dawn l- istudji, il- pazjenti kienu identifikati għax primarjament kienu ibatu minn insomnija (piskofiżjoloġika).
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg.
In- nuqqas ta ’ rqad fl- istudji ta ’ pazjenti barra mill- isptar ġie imnaqqas b’ Sonata 10mg, sa 4 ġimgħat f’ pazjenti li ma kenux anzjani.
In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was consistently decreased with Sonata 10 mg compared with placebo in 2-week studies.
F’ pazjenti anzjani, in- nuqqas ta ’ rqad kien imnaqqas b’ mod sinjifikattiv b’ doża ta ’ 5mg Sonata u kien imnaqqas b’ mod konformi b’ Sonata 10mg meta komparat
This decreased sleep latency was significantly different from that observed with placebo.
Dan it- tnaqqis fin- nuqqas t’ irqad kien sinifikament different minn dak osservat bil- plaċebo.
Results from the 2- and 4- week studies showed that no pharmacological tolerance developed with any dose of Sonata.
Riżultati minn studji ta ’ ġimagħtejn u erba ’ ġimgħat juru li l- ebda toleranza farmakoloġika ma żviluppat b’ xi doża ta ’ Sonata.
In Sonata studies using objective PSG measures, Sonata 10 mg was superior to placebo in decreasing sleep latency and increasing sleep duration during the first half of the night.
Fi studji ta ’ Sonata fejn intużaw il- kejlijiet oġġettivi tal- PSG, Sonata ta ’ 10mg kienet superjuri għal - plaċebo biex jonqos in- nuqqas ta ’ rqad u biex tiżdied id- dewmien tar- raqda fl- ewwel nofs tal- lejl.
Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Sonata uriet li iżżomm l- istadji ta ’ l- irqad, fi studji kontrollati fejn ġie mkejjel il- perċentwali ta ’ żmien ta ’ l- irqad ta ’ kull stadju.
Absorption Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations are reached in approximately 1 hour.
Assorbiment Zaleplon hu assorbit malajr u kważi kompletament wara li jittieħed mill- ħalq, u l- konċentrazzjonijiet għoljin jintlaħqu f’ madwar siegħa.
At least 71% of the orally-administered dose is absorbed.
Mill- anqas 71% tad- doża meħuda mill- ħalq hi assorbita.
Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately 30%.
Zaleplon jgħaddi mill- metaboliżmu presistemiku, li jirriżulta f’ bijodisponibbilità assoluta ta ’ madwar 30%.
Distribution Zaleplon is lipophilic with a volume of distribution of about 1.4±0.3 l/ kg following intravenous administration.
Distribuzzjoni Zaleplon hu lipofiliku b’ volum ta ’ distribuzzjoni ta ’ madwar 1. 4±0. 3 l/ kg wara amministrazzjoni fil - vini.
The in vitro plasma protein binding is approximately 60%, suggesting little risk of active substance interaction due to protein binding.
Il- proteini tal- plażma in vitro huma ta ’ madwar 60%, li jissuġġerixxu li hemm risku żgħir ta ’ azzjoni mediċinali reċiproka minħabba l- għaqda tal- proteini.
Metabolism Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon.
Metaboliżmu Zaleplon hu primarjalment metaboliżżat b’ aldehyde oxidase għall- forma 5- oxo- zaleplon.
Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon.
Barra dan zaleplon hu metabolizzat minn CYP3A4 sabiex jifforma desethylzaleplon li hu metaboliżat aktar b’ aldehyde oxidase biex jifforma 5- oxo- desethylzaleplon.
The oxidative metabolites are further metabolised by conjugation via glucuronidation.
Il- metaboliti ossidattiv huma mobilizzati aktar bl- għaqda via gluċuronidazzjoni.
All of zaleplon’ s metabolites are inactive in both animal behavioural models and in vitro activity assays.
Il- metaboliti kollha ta ’ zaleplon m’ humiex attivi kemm fl - imġiba ta ’ l- annimali kif ukoll bħala mudelli meta ittestjati attivament.
Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/ day.
Il- konċentrazzjonijiet ta’ zaleplon fil- plażma jiżdiedu linjarment mad- doża u zaleplon ma juri l- ebda sinjali ta ’ akkummulazzjoni wara l- amministrazzjoni sa 30 mg/ jum..
The elimination half-life of zaleplon is approximately 1 hour.
Zaleplon għandu half- life t ’ eliminazzjoni ta ’ madwar siegħa.
Excretion Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Tneħħija ta ’ skart mil- ġisem Zaleplon joħroġ f’ forma ta ’ metaboliti inattivi, l- aktar fl- awrina (71%) u fl- iskart tal- ġisem (17%).
Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide metabolite.
Sebgħa u ħamsin fil- mija (57%) tad- doża hi miġbura mill- awrina fil- forma ta ’ 5- oxo- zaleplon u fil - metaboliti glukuronidi tiegħu, 9% oħra huma miġbura bħala 5- oxo- desethylzaleplon u fil- metaboliti gluċuronidi tiegħu.
The remainder of the urinary recovery consists of minor metabolites.
Il- bqija ta ’ l- awrina miġbura ikun fiha metaboliti minuri.
The majority of the faecal recovery consists of 5-oxo-zaleplon.
Il- parti l- kbira ta ’ l - iskart tal- ġisem miġbur ikun fih 5- oxo- zaleplon.
Hepatic Impairment Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism.
Insuffiċjenza tal- fwied Zaleplon hu metaboliżżat primarjament mill- fwied u jgħaddi b’ mod sinifikattiv minn metaboliżmu sistematiku.
Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy subjects.
Dan wassal għal żjiedet ras għar- ras fil- Cmax u AUC (sa 4 darbiet u sa 7 darbiet f’ pazjenti kompensati u mhux kompensati, rispettivament) meta mqabbla ma ’ pażjenti b’ saħħithom.
The dose of zaleplon should be reduced in patients with mild to moderate hepatic impairment, and zaleplon is not recommended for use in patients with severe hepatic impairment.
Id- doża ta ’ zaleplon għandha tkun imnaqqsa f’ pazjenti li għandhom insuffiċjenza tal- fwied moderat, u zaleplon mhux rakkomandat għal- użu ta ’ pazjenti b’ insuffiċjenza tal- fwied sever.
Renal Impairment The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 40 to 89 ml/ min) and moderate (20 to 39 ml/ min) renal impairment, and in patients on dialysis.
Insuffiċjenza renali Id- doża unika farmakokinetika ta ’ zaleplon kienet studjat fuq pazjenti li kellhom indeboliment renali bejn ħafif (tneħħija ta ’ krejatinina 40 sa 89 ml/ min) u moderat (20 sa 39 ml/ min), u f’ pazjenti li kienu fuq dijalisi.
In patients with moderate impairment and those on dialysis there was a reduction of approximately 23% in peak plasma concentration compared to healthy volunteers.
F’ pazjenti li kellhom indeboliment moderat u dawk li kienu fuq dijalisi kien hemm riduzzjoni ta ’ madwar 23% fil- konċentrazzjoni tal- plażma fl- aqwa tagħha meta komparati ma ’ voluntiera b’ saħħithom.
The extent of exposure to zaleplon was similar among all groups.
It- tul ta ’ żmien ta ’ dawk li kienu esposti għal zaleplon kien simili għall- gruppi kollha.
Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Għalhekk, l- ebda aġġustament fid- doża ma hu neċessarju f’ pazjenti li għandhom insuffiċjenza renali bejn ħafif u moderat.
Zaleplon has not been adequately studied in patients with severe renal impairment.
Zaleplon ma ġiex studjat sewwa f’ pazjenti li għandhom insuffiċjenza renali sever.
5.3 Preclinical safety data
9 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Repeated oral administration of zaleplon to rats and dogs elicited increases in liver and adrenal weights; however, these increases occurred at high multiples of the maximum therapeutic dose, were reversible, were not associated with degenerative microscopic changes in liver or adrenal glands, and were consistent with effects in animals with other compounds that bind to benzodiazepine receptors.
Ma dan kollu dwan iż- żjidiet ġraw meta id- doża terapewtika massima ingħatat f’ multipli għoljin, kienu riversibli, ma kenux assoċjati ma bdil mikroskopiku deġenerattiv fil- fwied jew fil- glandoli adrenali, u kien konsistenti f’ annimali ma ’ taħlitiet oħra li jgħaqqdu mar- riċevituri benżodijazepini.
Oral administration of zaleplon
Fi studju ta ’ tlett xhur fuq klieb li ma kenux daħlu fil- pubertà instab li kien hemm tnaqqis sinifikanti fil- piż kemm tal- prostata kif ukoll tal- bajd b’ doża terapewtika massima.
9 to rats for 104 consecutive weeks at dosage levels up to 20 mg/ kg/ day did not result in compound- related tumorigenicity.
L- amministrazzjoni mill- ħalq ta’ zaleplon fil- firien għal 104 ġimgħa konsekuttiva b’ dożi ta ’ livell sa 20mg/ kg/ jum ma spiċċawx li jiproduċċu tumuri komplessi- relatati.
Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥ 100 mg/ kg/ day) elicited a statistically significant increase in benign but not in malignant liver tumors.
L- amministrazzjoni mill- ħalq ta ’ zaleplon fil- ġrieden għal 65 jew 104 ġimgħa konsekuttiva b’ dożi għoljin ta ’ livelli (≥100 mg/ kg/ jum) urew żjieda statistikament sinifikanti f’ tumuri beninni, iżda mhux f’ tumuri malinni tal- fwied.
The increased incidence of benign liver tumors in mice was likely an adaptive event.
Iż- żjieda ta ’ inċidenza ta ’ tumuri beninni tal- fwied fil- ġrieden kienet x’ aktarx episodju ta ’ addattament.
Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Sonata at recommended doses in humans.
Kollox ma ’ kollox, ir- riżultati ta ’ qabel studji kliniċi ma jurux li hemm periklu sinjifikanti għall - bniedem bl- użu ta ’ Sonata skond id- dożi rakkomandati.
Capsule core Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, silicon dioxide.
Il- qoxra tal- kapsula: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, silicon dioxide.
Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
L- inka fuq il- qoxra fiha dawn l- ingredjenti li jmiss (gold ink S- 13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
6.4 Special precautions for storage
10 6. 4 Prekawzjonijiet specjali għall- ħażna
Do not store above 30ºC.
Taħżinx f’ temperatura ta ’ ’ l fuq minn 30º C.
PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters.
Pakketti ta ’ kapsuli tal- PVC / PVDC ta ’ folja ta ’ l- aluminjum ta ’ 7, 10 u 14- il kapsula.
10 6.6 Special precautions for disposal and handling
6. 6 Prekawzjonijiet speċjali għar- rimi
Sonata has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will change colour and become cloudy.
Sonata hi ddisinjata li jekk il- kontenut tal- kapsula jinħall f’ likwidu, il- likwidu ibiddel kuluru u jsir mċajpar.
Meda AB Pipers väg 2A S-170 09 Solna Sweden
Meda AB Pipers väg 2 S- 170 09 Solna Svezia
DATE OF FIRST AUTHORISATION/ RENEWAL OF AUTHORISATION
DATA TA ’ L- EWWEL AWTORIAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
12 March 1999 Date of latest renewal:
12 ta ’ Marzu 1999 Data ta ’ tiġdid:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Aktar informazzjoni tinsab fuq il- websajt ta ’ L_ EMEA http: // www. emea. europa. eu
Sonata 10 mg hard capsules
Sonata 10 mg kapsuli iebsin
Each capsule contains 10 mg of zaleplon.
Kull kapsula fiha 10 mg ta ’ zaleplon
Lactose monohydrate 49 mg.
Sustanzi mhux attivi: lactose monohydrate 49 mg.
Capsules have an opaque white hard shell with pink band, “ W” and the strength “ 10 mg”.
Kapsuli li għandhom il- qoxra iebsa ta ’ kulur abjad opak, u kanella ċar opak, b’ ċirku ta ’ kulur tad - deheb, “ W ” u d- doża “ 10 mg ”.
12 Renal impairment No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients.
L- ebda aġġustament fid- doża ma hi meħtieġa għal pazjenti li għandhom insuffiċjenza renali li tkun bejn ħafifa u moderata, għaliex il- farmakokinetiċi ta ’ Sonata ma jitbidlux f’ pazjenti bħal dawn.
4.4 Special warnings and precautions for use
4. 5 Twissijiet speċjali u prekawzjonijiet għall- użu
Other complex behaviors (e. g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Imġieba kumplessa oħra (e. g., preparazzjoni u teħid ta ’ l- ikel, isiru telefonati, atti sesswali) ġew rapportati f’ pazjenti li ma kinux kompletament imqajjmin wara li ħadu sedattiv- ipnotiku.
Due to zaleplon ’ s short plasma half-life alternative therapy should be considered if early morning awakening is experienced.
Minħabba li zaleplon jonqos bin- nofs f’ qasir żmien fil- plażma (short plasma half- life), terapija alternattiva għandha tkun ikkunsidrata jekk il- pazjent iqum kmieni fil- għodu.
(See section 4.5).
Meta Sonata tittieħed flimkien ma ’ prodotti mediċinali oħra magħrufa li jinfluwenzaw CYP3A4, hu mistenni li jkun hemm bidla fil- konċentrazzjoniet tal- plażma ta ’ zaleplon (Ara sezzjoni 4. 5).
These may consist of 13 headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
13 dipendenza fiżika tiżvillupa, il- waqfien tat- trattament ħesrem jkun akkumpanjat minn sintomi ta ’ iżolament.
Renal impairment Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
14 Insuffiċjenza renali Sonata mhux indikat għal dawk il- pazjenti b’ insuffiċjenza renali gravi peress li ma ġiex studjat sewwa fuq dawn il- pazjenti.
14 Respiratory insufficiency Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Insuffiċjenza respiratorja Wieħed għandu joqgħod attent meta jippreskribi prodotti sedattivi lill- pazjenti li għandhom insuffiċjenza respiratorja kronika.
Psychosis Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Mard psikotiku L- użu tal- benżodjażepin u prodotti simili għall- benżodjażepin m’ humiex rakkomandati bħala trattament primarju għall- mard psikotiku.
15 4.6 Pregnancy and lactation
15 Sonata ma teffettwax il- profili tal- farmakokinetika u tal- farmakodinamika ta ’ digoxin u ta ’ warfarin, żewġ komponenti li għandhom indiċi terapewtiċi dojoq.
If the medicinal product is prescribed to a woman of child- bearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.
Jekk il - prodott mediċinali jiġi preskritt lil mara li jista ’ jkollha t- tfal, hi għandha tkun imwissiha biex tgħid lit - tabib rigward it- twaqqif tal- prodott mediċinali, jekk ikollha l- ħsieb li toħroġ tqila jew tissuspetta li hi tqila.
4.7 Effects on ability to drive and use machines
4. 8 Effetti fuq il- ħila biex issuq u tħaddem magni
16
16 Għajnejn Mhux komuni
Uncommon:
Widnejn
hyperacusis
Mhux komuni
Gastrointestinal disorders
Tisma ’ aktar
Uncommon:
Taqlib Gastrointenstinali Mhux komuni
Metabolism and nutrition disorders
Metaboliżmu ta ’ l- ikel
anorexia
nuqqas ta ’ aptit u problemi biex tiekol
General disorders and administration site conditions Uncommon:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni
Immune system disorders
Taqlib fis- Sistema Immuni
anaphylactic/ anaphylactoid reactions
reazzjonijiet anafilattiċi/ ta ’ sintomi anafilattiċi
Hepatobiliary disorders Frequency not known:
Fwied u frixa Frekwenza mhix stabbilita
dysmenorrhea
ċiklu mqalleb ta ’ menstrwazzjoni
Psychiatric disorders Uncommon:
Taqlib Psikjatriku Mhux komuni:
Psychiatric and “ paradoxical” reactions Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents.
Reazzjonijiet Psikjatriċi u “ paradossali ” Reazzjonijiet bħal nuqqas ta ’ sabar, aġitazzjoni, burdati ħżiena, nuqqas ta ’ mistħija, aggressivita, ħsibijet abnormali, delużjonijiet, rabja, ħmir il- lejl, nuqqas ta ’ personalità, alluċinazzjonijiet, psikosi, mġiba mhux flokha, estrovertiżmu li hu barra mill- karattru, u effetti ta ’ imġiba avversa huma magħrufa li ġraw meta intuża benżodjażepin u prodotti simili għall- benżodjażepin.
Psychic dependence may occur.
17 Dipendenza L- użu (anke ta ’ dożi terepawtiċi) jistgħu iwasslu għall- iżvilupp ta ’ dipendenza fiżika: it- twaqqif tat - terapija tista ’ tirriżulta f’ fenomeni kemm ta ’ nuqqas jew ta ’ ritorn tal- fenominu tas- sintomi (ara sezzjoni 4. 4.) Dipendenza psikika tista ’ isseħħ.
17 4.9 Overdose
4. 9 Doża eċċessiva
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Fl- immaniġjar ta ’ doża eċċessiva ta ’ xi prodott mediċinali, wieħed għandu jżomm f’ moħħu li jistgħu jkunu ittieħdu diversi prodotti oħra.
In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Sonata.
Flimkien mas- sottotip tal- karaterristiċi ta ’ tagħqid mar- riċettur, b’ selettività għolja u b’ affinita baxxa għal riċetur tat- tip 1 għal benżodjażepin, dawn il- propjetajiet huma ontrollati għal karaterristiċi globali ta ’ ontro.
Sonata’ s efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
L- effikaċja ta ’ ontro kienet imkejjla kemm fi ontr fuq l- irqad li saru fil- laboratorji fejn intużaw ontro oġġettivi polisomnigrafi (PSG) ta ’ l- irqad, kif ukoll fi ontr fuq ontroll barra mill- isptar fejn kienu użati kwestjonarji.
In these studies, patients were diagnosed with primary (psychophysiological) insomnia.
F’ dawn l- istudji, il- pazjenti kienu ontrollati għax primarjament kienu ibatu minn insomnija (piskofiżjoloġika).
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg.
In- nuqqas ta ’ rqad fl- istudji ta ’ ontroll barra mill- isptar ġie imnaqqas b’ Sonata 10mg, sa 4 ġimgħat f’ pazjenti li ma kenux ontrol.
In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was consistently decreased with Sonata 10 mg compared with placebo in 2-week studies.
F’ pazjenti ontrol, in- nuqqas ta ’ rqad kien imnaqqas b’ mod sinjifikattiv b’ doża ta ’ 5mg ontro u kien imnaqqas b’ mod ontroll b’ Sonata 10mg meta komparat
Sonata has been shown to
18 mal- plaċebo fi ontr ta ’ ġimagħtejn. ontro- tnaqqis fin- nuqqas t’ irqad kien sinifikament different minn dak osservat bil- plaċebo. ontrolla minn ontr ta ’ ġimagħtejn u erba ’ ġimgħat juru li l- ebda ontrollat farmakoloġika ma żviluppat b’ xi doża ta ’ ontro.
18 preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Fi ontr ta ’ ontro fejn intużaw il- kejlijiet oġġettivi tal- PSG, ontro ta ’ 10mg kienet superjuri għal - plaċebo biex jonqos in- nuqqas ta ’ rqad u biex tiżdied id- dewmien tar- raqda fl- ewwel nofs tal- lejl. ontro uriet li iżżomm l- istadji ta ’ l- irqad, fi ontr ontrollati fejn ġie mkejjel il- perċentwali ta ’ żmien ta ’ l- irqad ta ’ kull stadju.
Distribution Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/ kg following intravenous administration.
Distribuzzjoni Zaleplon hu lipofiliku b’ volum ta ’ distribuzzjoni ta ’ madwar 1. 4±0. 3 l/ kg wara amministrazzjoni fil - vini.
Hepatic Impairment Zaleplon is metabolized primarily by the liver and undergoes significant presystemic metabolism.
Insuffiċjenza tal- fwied Zaleplon hu metaboliżżat primarjament mill- fwied u jgħaddi b’ mod sinifikattiv minn metaboliżmu sistematiku.
5.3 Preclinical safety data
19 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
19 In a three month study in prepubescent dogs there was significant reduction in the weight of both prostate and testes at high multiples of the maximum therapeutic dose.
Fi studju ta ’ tlett xhur fuq klieb li ma kenux daħlu fil- pubertà instab li kien hemm tnaqqis sinifikanti fil- piż kemm tal- prostata kif ukoll tal- bajd b’ doża terapewtika massima.
Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/ kg/ day did not result in compound- related tumorigenicity.
L- amministrazzjoni mill- ħalq ta’ zaleplon fil- firien għal 104 ġimgħa konsekuttiva b’ dożi ta ’ livell sa 20mg/ kg/ jum ma spiċċawx li jiproduċċu tumuri komplessi- relatati.
Capsule core Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Il- qalba tal- kapsula Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate, silicon dioxide.
Il- qoxra tal- kapsula: gelatin, titanium dioxide (E171), sodium lauryl sulphate, silicon dioxide.
Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
L- inka fuq il- qoxra fiha dawn l- ingredjenti li jmiss (pink ink SW- 1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
6.4 Special precautions for storage
20 6. 4 Prekawzjonijiet specjali għall- ħażna
6.6 Special precautions for disposal and handling
6. 6 Prekawzjonijiet speċjali għar- rimi
CONDITIONS OF THE MARKETING AUTHORISATION
KONDIZZJONIJIET TA ’ AWTORIZZAZZJONI GĦALL – KUMMERĊ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tas- sid tal- manifattur responsabbli għall- ħruġ tal- lott
Kildare, Ireland
Kildare, L- Irlanda
CONDITIONS OF THE MARKETING AUTHORISATION
KONDIZZJONIJIET TA ’ AWTORIZZAZZJONI TAL- KUMMERĊ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ SID L- AWTORIZZAZZJONI TAL- KUMMERĊ
Medicinal product subject to medical prescription.
Prodott mediċinali suġġett għall- preskrizzjoni tat- tabib
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ SIGURTA ’ U EFFETTIVITA ’ TAL- PRODOTT MEDIĊINALI
23 ANNEX III LABELLING AND PACKAGE LEAFLET
23 ANNESS III
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 5 MG – PACK SIZES 7, 10 AND 14 CAPSULES
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TAL- PAKKETT TA ’ BARRA TEST GĦAL KARTUN TA ’ FOLJI TA ’ SONATA 5 MG KAPSULI – PAKETTI TA ’ 7, 10 U 14- IL KAPSULA
Sonata 5 mg hard capsules zaleplon
Sonata 5 mg kapsuli iebsin zaleplon
Each hard capsule contains 5 mg zaleplon
Kull kapsula Sonata fiha 5 mg zaleplon
LIST OF EXCIPIENTS
LISTA TA’ SUSTANZI MHUX ATTIVI
Also contains: lactose monohydrate See leaflet for further information.
Hemm ukoll: lactose monohydrate, Ara l- fuljett għal aktar informazzjoni
7 hard capsules 10 hard capsules 14 hard capsules
7 kapsuli iebsin 10 kapsuli iebsin 14- il kapsula iebsin
Oral use
Jittieħed mill- ħalq.
Do not store above 30ºC.
Taħżinx f’ temperatura ’ l fuq minn 30º C.
26 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
EU/ 1/ 99/ 102/ 001 7 capsules EU/ 1/ 99/ 102/ 002 10 capsules EU/ 1/ 99/ 102/ 003 14 capsules
EU/ 1/ 99/ 102/ 001 7 kapsuli EU/ 1/ 99/ 102/ 002 10 kapsuli EU/ 1/ 99/ 102/ 003 14- il kapsula
BATCH NUMBER
NUMRU TAL LOTT
Medicinal product subject to medical prescription
Prodott mediċinali jingħata b’ riċetta tat- tabib.
INSTRUCTIONS ON USE
INSTRUZZJONIJIET DWAR L- UŻU
27 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI TEST GĦAL FOLJI TA ’ SONATA 5 MG KAPSULI
Sonata 5 mg hard capsules zaleplon
Sonata 5 mg kapsuli iebsin (zaleplon)
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG – PACK SIZES 7, 10 AND 14 CAPSULES
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTUNA TAL- PAKKETT TA ’ BARRA TEST GĦAL KARTUN TA ’ FOLJI TA ’ SONATA 10 MG KAPSULI – PAKETTI TA ’ 7, 10 U 14- IL KAPSULA
NAME OF THE MEDICINAL PRODUCT
L- ISEM TAL - PRODOTT MEDIĊINALI
Sonata 10 mg hard capsules zaleplon
Sonata 10 mg kapsuli iebsin zaleplon
Each hard capsule contains 10 mg zaleplon
Kull kapsula Sonata fiha 10mg zaleplon
Also contains: lactose monohydrate See leaflet for further information.
Hemm ukoll: lactose monohydrate Ara l- fuljett għal aktar informazzjoni.
Read the package leaflet before use Oral use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
29 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Meda AB Pipers väg 2A S-170 09 Solna Sweden
Meda AB Pipers väg 2 170 09 Solna Svezia
MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I TA ’ AWTORIZZAZZJONI GĦALL- KUMMERĊ
EU/ 1/ 99/ 102/ 004 7 capsules EU/ 1/ 99/ 102/ 005 10 capsules EU/ 1/ 99/ 102/ 006 14 capsules
EU/ 1/ 99/ 102/ 004 7 kapsuli EU/ 1/ 99/ 102/ 005 10 kapsuli EU/ 1/ 99/ 102/ 006 14- il kapsula
Medicinal product subject to medical prescription
Prodott mediċinali li jingħata b’ riċetta tat- tabib.
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 10 MG CAPSULE BLISTERS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI TEST GĦAL FOLJI TA ’ SONATA 10 MG KAPSULI
32 PACKAGE LEAFLET:
32 FULJETT DWAR IL- PAKKETT:
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
Aqra sewwa dan il- fuljett kollu qabel tibda tieħu din il- mediċina. – Żomm dan il- fuljett.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. – Jekk ikollok aktar mistoqsijiet staqsi lit- tabib jew lill- ispiżjar tiegħek. – Din il- mediċina ġiet mogħtija lilek.
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.
Tista ’ tagħmlilhom ħsara anke jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
In this leaflet:
F’ dan il- fuljettt:
What Sonata is and what it is used for 2.
X’ inhu Sonata u għalfejn jintuża 2.
Before you take Sonata 3.
Qabel tieħu Sonata 3.
How to take Sonata 4.
Kif jittieħed Sonata 4.
Possible side effects 5.
L- effetti mhux mixtieqa li jista ’ jħalli 5.
How to store Sonata 6.
Kif taħżen Sonata 6.
Further information
Informazzjoni oħra
WHAT SONATA IS AND WHAT IT IS USED FOR
X’ INHU SONATA U GĦALFEJN JINTUŻA
Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Sonata huwa prodott mediċinali tal- klassi benzodiazepines, li għandhom effett ipnotiku.
Sonata will help you to sleep.
Sonata hija kapsula li tgħinek torqod.
Sleeping problems do not usually last long, and most people only need a short course of treatment.
Problemi ta ’ l- irqad ma tantx ikunu għal żmien twil u ħafna nies ikollhom bżonn kors ta ’ trattament qasir.
The duration of treatment should usually vary from a few days to two weeks.
Iż- żmien għal dan it- trattament ivarja minn ftit ġranet għall - ġimagħtejn.
If you still have problems sleeping after you have finished your capsules, contact your doctor again.
Jekk jibqa ’ ikollok problemi tal- irqad wara li tkun spiċċajt il- kapsuli, ara lit- tabib tiegħek mill- ġdid.
BEFORE YOU TAKE SONATA
QABEL TIEĦU SONATA
Do not take Sonata if you have
Tieħux Sonata:
• hypersensitivity (an allergy) to zaleplon or to any other ingredients of Sonata • sleep apnoea syndrome (stopping breathing for short periods while asleep) • severe kidney or liver problems • myasthenia gravis (very weak or tired muscles) • severe breathing or chest problems
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal zaleplon jew xi sustanzi oħra ta ’ Sonata, li jinkludu indigo carmine (E132) • tbati minn apnea waqt l- irqad (waqfien ta ’ nifs għall- ħinijiet qosra waqt l- irqad) • problemi gravi tal- kliewi u tal- fwied • myasthenia gravis (muskoli dgħajfa ħafna jew għajjiena) • problemi fit- teħid tan- nifs jew problemi tas- sider
If you are in any doubt about whether you have any of these conditions, do ask your doctor.
Jekk inti fid- dubju li għandek xi waħda minn dawn il- kondizzjonijiet staqsi lit- tabib tiegħek.
Children under 18 years of age must not take Sonata.
Tfal taħt it- 18- il sena m’ għandhomx jingħataw Sonata.
Take special care with Sonata
Oqgħod attent ħafna b’ Sonata:
• Never drink alcohol while you are being treated with Sonata.
• Qatt tixrob alkoħol meta tkun qed tiġi ittrattat b’ Sonata.
Alcohol can increase the undesirable effects of any medicine taken to help you sleep. • Use with extreme caution if you have ever been addicted to medicines or alcohol. • If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them.
L- alkoħol jista ’ iżid l- effetti mhux mixtieqa ta ’ kull mediċina li tgħinek fl- irqad. • Uża attenzjoni akbar jekk inti xi darba kont tabbuża bl - alkoħol jew mediċini. • Jekk qed tieħu xi mediċini li jappartjenu għal grupp ta ’ mediċini li jinduċu l- irqad, li jinkludu Sonata, hemm il- possibilità li tista ’ ssir dipendenti fuqhom. • Tużax Sonata jew xi mediċina oħra ta ’ l- irqad għal aktar żmien milli jgħidlek it- tabib.
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
33 • Tiħux it- tieni doża ta ’ Sonata fl- istess lejl. • Jekk tibqa ’ ma tistax torqod kellem lit- tabib tiegħek • Nuqqas ta ’ sabar, aġitazzjoni, irritabilita, aggressjoni, ħsibijiet mhux tas- soltu, delużjoni, ħmar il- lejl, alluċinazzjonijiet, psikożi, mġieba mhux tas- soltu ġew innotati f’ nies li uzaw mediċina tal- irqad bħal Sonata.
These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Dawn is- sintomi jistgħu ikunu kaġun tas- sustanza, spontanji jew minħabba mard fiżiku jew pisikjatriku.
33 • Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to. • Do not use a second dose of Sonata within a single night. • If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor. • There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
Jekk taħseb li għandek xi wieħed minn dawn is- sintomi ara lit- tabib tiegħek. • Hemm iċ- ċans li tista ’ jkollok esperjenza temporanja ta ’ ċerta tip ta ’ telf ta ’ memorja (amnesija) u nuqqas ta ’ ko- ordinazzjoni meta tieħu mediċina tal- irqad.
This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata. • There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event.
Din tista ’ ħafna drabi tiġi evitata jekk iżżomm ruħek inattiv sa 4 sigħat wara li tieħu Sonata. • Hemm ċans li tista ’ tesperjenza somnambuliżmu (ħmar il- lejl), li jinkludi t- teħid ta ’ ikel jew sewqan meta persuna ma tkunx imqajjma sew mingħajr ebda memorja tal- każ.
If you experience these events, contact your doctor immediately. • Rare cases of severe allergic reactions have been reported.
Jekk tesperjenza dawn il- każijiet, ikkuntattja t- tabib tiegħek minnufih. • Każijiet rari ta ’ reazzjonijiet allerġiċi severi ġew irrapportati.
An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting.
Reazzjoni allerġiċi jinkludu raxx, ħakk, diffikultà biex tieħu n- nifs jew nefħa fil- wiċċ, ix- xofftejn, il- griżmejn jew l- ilsien.
If you experience any of these events, contact your doctor immediately.
Jekk tħoss li jkollok xi wieħed minn dawn il- każijiet, ikkuntattja lit- tabib tiegħek minnufih.
Do not take any other medicines without asking your doctor or pharmacist first.
Tieħux mediċini oħra qabel ma tkellem lit- tabib jew lill- ispiżjar tiegħek.
This includes medicines that can be bought without a prescription.
Dan jista ’ jinkludi mediċini li tista ’ tixtri mingħajr riċetta tat- tabib.
Some can cause drowsiness and should not be taken while taking Sonata.
Xi wħud jistgħu jikkaġunaw in- ngħas u m’ għandhomx jittieħdu meta tieħu Sonata.
When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Meta Sonata tittieħed ma ’ mediċini oħra li jaġixxu fuq il- moħħ, il- kombinazzjoni tista ’ tagħmlhek aktar bi ngħas milli suppost.
Be aware that such combinations may cause you to feel drowsy the next day.
Kun konxju li kombinazzjonijiet bħal dawn jistgħu jġagħluk tħossok bi ngħas l- għada.
These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/ sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/ convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines).
Dawn il- mediċini jinkludu: sustanzi li jintużaw biex jittrattaw kundizzjonijiet mentali (anti- psikotiċi, ipnotiċi, anksjolitiċi/ sedattivi, mediċini kontra d- dipressjoni), mediċini qawwija użati għal soliev ta ’ l- uġigħ (analġesiċi narkotiċi) mediċini użati għat- trattament ta ’ puplesiji/ aċċessjonijiet (mediċini ta ’ kontra l- epilessija), anesteteiċi, u mediċini użati biex jittrattaw l- allerġiji (mediċini sedattivi kontra l- ħistamini).
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).
Għandek tgħarraf lit- tabib jew lill- ispiżjar tiegħek jekk inti qed tieħu cimetidine (mediċina ta ’ l - istonku) jew erythromycin (antibijotiku).
Taking Sonata with food and drink
Meta tieħu Sonata ma l- ikel u max- xorb:
It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly.
Mhux rakkomandabli li tieħu Sonata ma ’ jew eżatt wara ikla kbira għax din tista ’ iġib dewmien biex tibda taħdem.
Swallow the capsule(s) with a small glass of water.
Ibla il- kapsula/ kapsoli ma ftit ilma.
Never drink alcohol while you are being treated with Sonata (see “ Take Special care with Sonata ”).
(ara “ Ħu attenzjoni speċjali b’ Sonata ”).
Tell your doctor if you are or intend to become pregnant.
Għid lit- tabib tiegħek jekk inti jew għandek ħsieb li toħroġ tqila.
Sonata should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy.
Sonata m’ għandiex tingħata f’ każijiet bħal dawn, għaliex għad m’ hemmx tagħrif kliniku biżżejjed biex titkejjel kemm hi ta ’ bla periklu magħtul it- tqal.
Tell your doctor if you are breast-feeding.
Għid lit- tabib tiegħek jekk int qed tredda ’.
Sonata should not be taken at this time because there is not enough clinical data available to assess its safety during breast-feeding.
Sonata m’ għandiex tittieħed f’ dan iż- żmien, għaliex għad m’ hemmx tagħrif kliniku biżżejjed biex titkejjel kemm hi ta ’ bla periklu magħtul it- treddigħ.
34 Driving and using machines
Sewqan u tħaddim ta ’ magni
Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Sonata jista ’ jħeddlek, jikkawza nuqqas ta ’ konċentrazzjoni jew telf ta’ memorja jew indeboliment fil - muskoli.
This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication.
Dan l- effett jinħass l- aktar meta tkun irqadt inqas minn 7 jew 8 sigħat wara li tkun ħadt il - medicina.
If affected do not drive or operate machinery.
Jekk tħossok hekk issuqx jew tħaddimx makkinarju.
Important information about some of the ingredients of Sonata
34 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Sonata