qanastek/EMEA-V3 huggingface dataset:
Zonisamide is 40 - 50% bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i. e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate).
Zonisamide hu mwaħħal sa 40 - 50% mal- proteini tal- plażma tal- bniedem, bi studji in vitro li juru li dan ma jkunx affettwat mill- preżenza ta ’ diversi prodotti mediċinali anti- epilettiċi (i. e., phenytoin, phenobarbitone, carbamazepine, u sodium valproate).
The apparent volume of distribution is about 1.1 – 1.7 l/ kg in adults indicating that zonisamide is extensively distributed to tissues.
Il -
Erythrocyte/ plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
9 proporzjonijiet eritroċiti/ plażma huma ta ’ madwar 15 fil- konċentrazzjonijiet baxxi u ta ’ madwar 3 f’ konċentrazzjonijiet ogħla.
Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
Zonisamide hu metabolat primarjament minn ġor- reductive cleavage taċ- ċirku ta ’ benzisoxazole tal - mediċina prinċipali minn CYP3A4 biex jifforma 2- sulphamoylacetylphenol (SMAP) u wkoll minn N- acetylation.
Parent drug and SMAP can additionally be glucuronidated.
Flimkien ma ’ dan, il- mediċina prinċipali u SMAP jistgħu jkunu glucuronidated.
The metabolites, which could not be detected in plasma, are devoid of anticonvulsant activity.
Il - metaboliti, li ma setgħux ikunu osservati fil- plażma, m’ għandhomx attività kontra l- konvulżjonijiet.
There is no evidence that zonisamide induces its own metabolism.
M’ hemm l- ebda evidenza li zonisamide jikkaġuna l- metaboliżmu tiegħu stess.
Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
It- tneħħija apparent ta ’ zonisamide fl- istat fiss wara l- għoti mill- ħalq hi ta ’ madwar 0. 70 l/ h u l- half - life ta ’ l- eliminazzjoni terminali hi ta ’ madwar 60 siegħa fl- assenza ta ’ inducers ta ’ CYP3A4.
The elimination half-life was independent of dose and not affected by repeat administration.
Il- half - life ta ’ l- eliminazzjoni kienet indipendenti mid- doża u ma kienitx affettwata minn għoti ripetut.
Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30%).
Il - varjazzjoni fil- konċentrazzjonijiet fis- serum jew fil- plażma matul l- intervall tal- perjodu tad- dożaġġ hi baxxa (< 30%).
The main route of excretion of zonisamide metabolites and unchanged drug is via the urine.
Ir- rotta ewlenija tat- tneħħija tal- metaboliti ta ’ zonisamide u tal- mediċina mhux mibdula hi permezz ta ’ l- awrina.
Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/ min); about 15 - 30% of the dose is eliminated unchanged.
It- tneħħija mill- kliewi ta ’ zonisamide mhux mibdul hi relattivament baxxa (madwar 3. 5 ml/ min); madwar 15 - 30% tad- doża hi eliminata mhux mibdula.
9 In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
F’ pazjenti b’ indeboliment tal- kliewi, it- tneħħija mill- kliewi ta ’ dożi waħidhom ta ’ zonisamide kienet korrelata b’ mod pożittiv mat- tneħħija tal- kreatinina.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/ min (see also section 4.2.).
L- AUC tal- plażma ta ’ zonisamide żdiedet b’ 35% f’ pazjenti bi tneħħija tal- kreatinina ta ’ < 20 ml/ min (ara wkoll Sezzjoni 4. 2).
Patients with an impaired liver function:
Pazjenti b’ indeboliment fil- funzjoni tal- fwied:
The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Il- farmakokinetiċi ta ’ zonisamide f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied ma kienux studjati b’ mod adegwat.
No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
L- ebda differenzi klinikament sinifikanti ma kienu osservati fil- farmakokinetiċi bejn persuni żgħażagħ (minn 21- 40 sena) u anzjani (65- 75 sena).
Adolescents (12-18 years):
Adolexxenti (12- 18- il sena):
Limited data indicate that pharmacokinetics in adolescents dosed to steady state at 1, 7 or 12 mg/ kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Informazzjoni limitata tindika li l- farmakokinetiċi fl- adolexxenti li ngħataw doża fl- istat fiss f’ 1, 7 jew 12 mg/ kg kuljum, f’ dożi maqsumin, huma simili għal dawk osservati fl- adulti, wara aġġustament għall- piż tal- ġisem.
Other characteristics
Karatteristiċi oħrajn
No clear Zonegran dose-concentration-response relationship has been defined.
L- ebda relazzjoni ċara ta ’ doża- konċentrazzjoni- rispons ma kienet definita b’ Zonegran.
When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest.
Meta tqabbel l- istess livell ta ’ doża, pazjenti b’ piż totali tal- ġisem ogħla jidhru li kellhom konċentrazzjonijiet iktar baxxi fis- serum fl- istat fiss, iżda dan l- effett jidher li kien relattivament modest.
Age (≥ 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
L- età (≥12- il sena) u s- sess, wara l- aġġustament għall- effetti tal- piż tal- ġisem, m’ għandhom l- ebda effett apparenti fuq l - espożizzjoni għal zonisamide f’ pazjenti epilettiċi matul id- dożaġġ fl- istat fiss.
Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Is- sejbiet ma kienux osservati fl- istudji kliniċi, iżda kienu osservati fil- klieb f’ livelli ta ’ espożizzjoni simili għal dawk ta ’ l- użu kliniku, u dawn kienu bidliet fil- fwied (tkabbir, tibdil fil- kulur kannella skur, tkabbir ħafif ta ’ l- epatoċiti ma ’ korpi lamellari konċentriċi fis- cytoplasm u fis- cytoplasmic vacuolation) assoċjat ma ’ żieda fil- metaboliżmu.
Zonisamide was not genotoxic and has no carcinogenic potential.
Zonisamide ma kienx ġenotossiku u m’ għandu l- ebda potenzjal karċinoġeniku.
Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
Zonisamide kkawża anormalitajiet waqt l- iżvilupp fil- ġrieden, firien, u klieb, u kien embrijoletali fix - xadini, meta mogħti matul il- perjodu ta ’ l- organoġenesi fid- dożaġġ ta ’ zonisamide u livelli tal- plażma materni simili għal, jew iktar baxxi mil- livelli terapewtiċi fil- bnedmin.
Microcrystalline cellulose Hydrogenated vegetable oil Sodium laurilsulfate.
Microcrystalline cellulose Hydrogenated vegetable oil Sodium laurilsulfate.
Capsule shells:
Il- qoxra tal- kapsula:
Gelatin Titanium dioxide (E171) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
Gelatin Titanium dioxide (E171) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
10 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
PVC/ PCTFE/ aluminium blisters, packs of 14, 28, 56, and 84 hard capsules.
Folji tal- PVC/ PCTFE/ aluminju, pakketti ta ’ 14, 28, 56 u 84 kapsula iebsa.
Eisai Limited 3 Shortlands London W6 8EE United Kingdom
Eisai Limited 3 Shortlands London W6 8EE Ir- Renju Unit
10 March 2005
10 ta ’ Marzu, 2005
Zonegran 50 mg hard capsules.
Zonegran 50 mg kapsuli iebsin
Each Zonegran hard capsule contains 50 mg of zonisamide.
Kull kapsula iebsa ta ’ Zonegran fiha 50 mg ta ’ zonisamide.
A white opaque body and a grey opaque cap printed with a logo and “ ZONEGRAN 50” in black.
Korp opak abjad b’ għatu griż li fuqu hemm stampat logo u “ ZONEGRAN 50 ” bl- iswed.
12 Patients with renal impairment
13 Pazjenti b’ indeboliment tal- kliewi
In clinical studies, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic drug doses.
Fi studji kliniċi, tnaqqis fid- doża ta ’ 100 mg f’ intervalli ta ’ ġimgħa ntużaw b’ aġġustament fl- istess ħin ma’ mediċini anti- epilettiċi oħrajn.
Hypersensitivity to zonisamide, to any of the excipients or to sulphonamides.
Sensittività eċċessiva għal zonisamide jew għal xi sustanzi mhux attivi jew għal sulfonamides.
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarley can be fatal.
Reazzjonijiet avversi serji bbażati fuq l- immunità huma assoċjati ma ’ prodotti mediċinali li fihom grupp sulphonamide jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi li jinkludu anemija aplastika, li b’ mod rari ħafna jistgħu jkunu fatali.
Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
14 Każijiet ta ’ agranuloċitosi, tromboċitopenja, lewkopenja, anemija aplastika, panċitopenja u lewkoċitosi kienu rrappurtati.
13 Kidney stones have occurred in patients treated with Zonegran.
Il- ġebel fil- kliewi seħħ f’ pazjenti kkurati b’ Zonegran.
In vitro studies using human liver microsomes show no or little (< 25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at zonisamide levels approximately two- fold or greater than clinically relevant unbound serum concentrations.
15 Studji in vitro bl- użu ta ’ mikrosomi tal- fwied uman juru ftit jew xejn (< 25%) inibizzjoni ta ’ cytochrome isozymes P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 jew 3A4 f’ livelli ta ’ zonisamide ta ’ madwar id- doppju jew iktar mill- konċentrazzjonijiet mhux imwaħħlin fis- serum li huma klinikament rilevanti.
14 Potential for Zonegran to affect other medicinal products
Il- potenzjal għal Zonegran li jaffettwa prodotti mediċinali oħrajn
Oral contraceptives In clinical studies in healthy subjects, steady-state dosing with Zonegran did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Fi studji kliniċi f’ persuni b’ saħħithom, id- dożaġġ fl- istat fiss b’ Zonegran ma affettwax il - konċentrazzjonijiet fis- serum ta ’ ethinylestradiol jew norethisterone f’ kontraċezzjoni orali kombinata.
Steady-state dosing of either ketoconazole (400 mg/ day) or cimetidine (1200 mg/ day) had no clinically relevant effects on the single-dose pharmacokinetics of zonisamide given to healthy subjects.
Id- dożaġġ fl- istat fiss ta ’ jew ketoconazole (400 mg/ kuljum) jew cimetidine (1200 mg/ kuljum) ma kellu l- ebda effetti klinikament rilevanti fuq il- farmakokinetiċi ta ’ doża waħda ta ’ zonisamide mogħtija lil persuni b’ saħħithom.
4.6 Pregnancy and lactation
16 4. 6 Tqala u treddigħ
15 advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jingħataw parir mingħand speċjalista dwar l- effetti possibbli ta ’ Zonegran fuq il- fetu, u r- riskju għandu jiġi diskuss mal- pazjenta fir- rigward tal- benefiċċji qabel tinbeda l- kura.
very common common uncommon rare very rare
komuni hafna komuni Mhux komuni rari rari ħafna
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1,000 < 1/ 100 ≥ 1/ 10,000 < 1/ 1,000 < 1/ 10,000 including isolated reports
≥ 1/ 10 ≥ 1/ 100 < 1/ 10 ≥ 1/ 1, 000 < 1/ 100 ≥ 1/ 10, 000 < 1/ 1, 000 < 1/ 10, 000 inklużi rapporti iżolati
16 System Organ Class (MedDRA terminology)
17 Klassi ta ’ l - Organu tas - Sistema (Terminoloġija MedDRA) Infezzjonijiet u infestazzjonijiet
Infections and infestation
Disturbi fid - demm u fis - sistema limfatika Disturbi fis - sistema immunitarja
Pneumonia Urinary tract infection
Ekkimożi Sensittività eċċessiva
Blood and lymphatic system disorders
Disturbi fil - metaboliżmu u fin- nutrizzjoni
Ecchymosis
Ipokalemija
Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Aċidożi metabolika
Hypersensitivity
Daħk/ tbissim /
Metabolism and nutrition disorders
Alluċinazzjoni
Anorexia
psikjatriċi
Metabolic acidosis
biki patoloġiku
Psychiatric Disorders
Aggressjoni
Agitation Irritability Confusional state Depression
Stat ta ’ konfużjoni Dipressjoni
Affect lability Anxiety Insomnia Psychotic disorder
Ansjetà Nuqqas ta ’ rqad Mard psikotiku
Anger Aggression Suicidal ideation Suicide attempt
Ħsibijiet suwiċidi Tentattiv ta ’ suwiċidju
Hallucination
Konvulżjoni
Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Indeboliment tal- memorja
Ataxia Dizziness Memory impairment Somnolence Diplopia
Puplesija grand mal Sindrome mjasteniku
Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Disturbi fl - għajnejn Disturbi respiratorji, toraċiċi u medjastinali
Convulsion
Ngħas Diplopja
Amnesia Coma Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome Status epilepticus Dyspnoea Pneumonia aspiration Respiratory disorder
Sindrome malinn newroleptiku Status epilepticus Dispnea Aspirazzjoni pnewmonja Mard respiratorju
Abdominal pain Constipation Diarrhoea Dyspepsia Nausea
Uġigħ ta ’ żaqq Stitikezza Dijarea Dispepsja Dardir
Hepatobiliary disorders
Disturbi fil - fwied u fil - marrara
Cholecystitis Cholelithiasis
Koleċistite Kolelitijasi
Hepatocellular damage
Ħsara epatoċellulari
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħtha
Musculoskeletal and connective tissue disorders
Anidrosi Eritema multiforme Ħakk Sindrome ta ’ Stevens - Johnson
Rhabdomyolysis
18
17 System Organ Class (MedDRA terminology)
Klassi ta ’ l - Organu tas - Sistema (Terminoloġija MedDRA) Disturbi muskolu - skeltrali, tal - connective tissue u ta ’ l- għadam
Very Rare
Rari Ħafna Rabdomijolosi
Renal and urinary disorders General disorders and administration site conditions
Disturbi fil - kliewi u fis - sistema urinarja Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
Nephrolithiasis Fatigue Influenza-like illness Pyrexia
Nefrolitijasi Għeja kbira Mard bħal dak ta ’ l- influwenza Deni
Calculus urinary
Ġebla fl- awrina
Hydronephrosis Renal failure Urine abnormality
Idronefrosi Insuffiċjenza renali Anormalità fl- awrina
Investigations
Investigazzjoniji
Decreased bicarbonate
Tnaqqis fil -
Blood creatine phosphokinase increased Blood creatinine increased Blood urea increased Liver function tests abnormal
Żieda fil- creatine
Injury, poisoning and procedural complications
et Korriment, avvelenament u komplikazzjoniji et
In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Flimkien ma ’ dan kien hemm każijiet iżolati ta ’ mewt għal għarrieda u mhux spjegata f’ pazjenti bl - epilessija (Sudden Unexplained Death in Epilepsy Patients - SUDEP) li kienu qed jirċievu Zonegran.
Following a suspected recent overdose, emptying the stomach by gastric lavage or by induction of emesis may be indicated with the usual precautions to protect the airway.
Wara doża eċċessiva ssusspettata riċenti, it- tbattil ta ’ l- istonku permezz ta ’ ħasil gastriku jew permezz ta ’ l- induzzjoni ta ’ l - emesi, jistgħu jkunu indikati bil- prekawzjonijiet tas- soltu biex jipproteġu l- passaġġ tan- nifs.
General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Kura ġenerali ta ’ appoġġ hi indikata, li tinkludi monitoraġġ frekwenti ta ’ sinjali vitali u osservazzjoni mill - 19 qrib.
18 Zonisamide is a benzisoxazole derivative.
Zonisamide hu derivattiv ta ’ benzisoxazole.
Efficacy has been demonstrated with Zonegran in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
L- effikaċja ntweriet b’ Zonegran f’ 4 studji double- blind, ikkontrollati bil- plaċebo għal perjodi li damu sa 24 ġimgħa b’ dożaġġ li ngħata jew darba jew darbtejn kuljum.
These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Dawn l- istudji juru li t- tnaqqis medjan fil- frekwenza parzjali tal- puplesija hu relatat mad- doża ta ’ Zonegran, b’ effikaċja sostnuta f’ dożi ta ’ 300- 500 mg kuljum.
The apparent volume of distribution is about 1.1 – 1.7 l/ kg in adults indicating that zonisamide is extensively distributed to tissues.
Il- volum apparenti tad- distribuzzjoni hu ta ’ madwar 1. 1 – 1. 7 l/ kg fl- adulti, li jindika li zonisamide hu ddistribwit b’ mod estensiv lit- tessut.
Erythrocyte/ plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Il - proporzjonijiet eritroċiti/ plażma huma ta ’ madwar 15 fil- konċentrazzjonijiet baxxi u ta ’ madwar 3 f’ konċentrazzjonijiet ogħla.
Metabolism
20 Metaboliżmu
19 Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
It- tneħħija apparent ta ’ zonisamide fl- istat fiss wara l- għoti mill- ħalq hi ta ’ madwar 0. 70 l/ h u l- half - life ta ’ l- eliminazzjoni terminali hi ta ’ madwar 60 siegħa fl- assenza ta ’ inducers ta ’ CYP3A4.
In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
F’ pazjenti b’ indeboliment tal- kliewi, it- tneħħija mill- kliewi ta ’ dożi waħidhom ta ’ zonisamide kienet korrelata b’ mod pożittiv mat- tneħħija tal- kreatinina.
20 Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
Gelatin Titanium dioxide (E171) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
PVC/ PCTFE/ aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
Folji tal- PVC/ PCTFE/ aluminju, pakketti ta ’ 14, 28, 56 u 84 kapsula iebsa.
Zonegran 100 mg hard capsules.
Zonegran 100 mg kapsuli iebsin
Each Zonegran hard capsule contains 100 mg of zonisamide.
Kull kapsula iebsa ta ’ Zonegran fiha 100 mg ta ’ zonisamide.
A white opaque body and a red opaque cap printed with a logo and “ ZONEGRAN 100” in black.
Korp opak abjad b’ għatu aħmar li fuqu hemm stampat logo u “ ZONEGRAN 100 ” bl- iswed.
Children and adolescents
24 Tfal u adolexxenti
22 Patients with renal impairment
Pazjenti b’ indeboliment tal- kliewi
Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal.
Reazzjonijiet avversi serji bbażati fuq l- immunità li huma assoċjati ma ’ prodotti mediċinali li fihom grupp sulphonamide 25 jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi li jinkludu anemija aplastika, li b’ mod rari ħafna jistgħu jkunu fatali.
23 Kidney stones have occurred in patients treated with Zonegran.
Il- ġebel fil- kliewi seħħ f’ pazjenti kkurati b’ Zonegran.
Effect of Zonegran on cytochrome P450 enzyme
L- effett ta ’ Zonegran fuq l- enzimi ta ’ cytochrome P450
24 Potential for Zonegran to affect other medicinal products
Il- potenzjal għal Zonegran li jaffettwa prodotti mediċinali oħrajn
25 advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jingħataw parir mingħand speċjalista dwar l- effetti possibbli ta ’ Zonegran fuq il- fetu, u r- riskju għandu jiġi diskuss mal- pazjenta fir- rigward tal- benefiċċji qabel tinbeda l- kura.
very common common uncommon rare very rare
komuni hafna komuni Mhux komuni
26 System Organ Class (MedDRA terminology)
rari ≥ 1/ 10, 000 < 1/ 1, 000 rari ħafna
Very Common
< 1/ 10, 000 inklużi rapporti iżolati
Hypersensitivity
Aġitazzjoni Daħk/ tbissim / biki
Metabolism and nutrition disorders
Rabja
Anorexia
Alluċinazzjoni
Hypokalaemia
psikjatriċi
Metabolic acidosis
Irritabilità patoloġiku
Agitation Irritability Confusional state Depression
Stat ta ’ Ansjetà konfużjoni Nuqqas ta ’ rqad Dipressjoni Mard psikotiku
Affect lability Anxiety Insomnia Psychotic disorder
Ħsibijiet suwiċidi Tentattiv ta ’ suwiċidju
Anger Aggression Suicidal ideation Suicide attempt
Atassja Bradifrenija
Nervous system disorders Eye disorders Respiratory, thoracic and mediastinal disorders
Sturdament Disturbi fl -
Ataxia Dizziness Memory impairment Somnolence Diplopia
Koma
Convulsion
Indeboliment tal - attenzjoni memorja Nystagmus Ngħas Parestesija Taħwid fid- diskors Rogħda Diplopja
Amnesia Coma Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome Status epilepticus Dyspnoea Pneumonia aspiration Respiratory disorder
Puplesija grand mal Sindrome mjasteniku Sindrome malinn newroleptiku Status epilepticus Dispnea Aspirazzjoni pnewmonja Mard respiratorju
Hepatobiliary disorders
Disturbi fil- fwied
Cholecystitis Cholelithiasis
Kolelitijasi
Hepatocellular damage
epatoċellulari
Anhidrosis Erythema multiforme Pruritis Stevens-Johnson syndrome
Anidrosi Eritema
Musculoskeletal and connective tissue disorders
29
Rhabdomyolysis
multiforme Ħakk
27 System Organ Class (MedDRA terminology)
Klassi ta ’ l - Organu tas - Sistema (Terminoloġija MedDRA) Disturbi muskolu - skeltrali, tal - connective tissue u ta ’ l- għadam
Very Rare
Rari Ħafna Sindrome ta ’ Stevens- Johnson Rabdomijolosi
Renal and urinary disorders General disorders and administration site conditions
Disturbi fil- kliewi u fis- sistema urinarja Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jittieħed
Hydronephrosis Renal failure Urine abnormality
Idronefrosi Insuffiċjenza renali Anormalità fl - awrina
Investigations
Investigazzjonijie
Decreased bicarbonate
Tnaqqis fil - Tnaqqis fil- piż
Weight decreased
Żieda fil- creatine
Injury, poisoning and procedural complications
t Korriment, avvelenament u komplikazzjonijie t
28 Zonisamide is a benzisoxazole derivative.
Zonisamide hu derivattiv ta ’ benzisoxazole.
Absolute bioavailability is estimated to be approximately 100%.
Il- bijodisponibilità assoluta hi stmata li hi ta ’
29 Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/ h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
It- tneħħija apparent ta ’ zonisamide fl- istat fiss wara l- għoti mill- ħalq hi ta ’ madwar 0. 70 l/ h u l- half - life ta ’ l- eliminazzjoni terminali hi ta ’ madwar 60 siegħa fl- assenza ta ’ inducers ta ’ CYP3A4.
When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest.
L- età (≥12- il sena) u
Age (≥ 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
32 s- sess, wara l- aġġustament għall- effetti tal- piż tal- ġisem, m’ għandhom l- ebda effett apparenti fuq l - espożizzjoni għal zonisamide f’ pazjenti epilettiċi matul id- dożaġġ fl- istat fiss.
30 Capsule shells:
Il- qoxra tal- kapsula:
Gelatin Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
Gelatin Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac Propylene glycol Potassium hydroxide Black iron oxide (E172).
PVC/ PCTFE/ aluminium blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
Folji tal- PVC/ PCTFE/ aluminju, pakketti ta ’ 28, 56, 84, 98 u 196 kapsula iebsin.
31 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
33 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
35 A DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Eisai Limited 3 Shortlands London W6 8EE United Kingdom
Eisai Manufacturing Ltd Titan Court 3 Bishop Square Hatfield Hertfordshire AL10 9NE Ir- Renju Unit
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jinforma lill- Kummissjoni Ewropea dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat minn din id- deċiżjoni.
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TAL- KARTUN TA ’ BARRA
Zonegran 25 mg hard capsules zonisamide
Zonegran 25 mg kapsuli iebsin zonisamide
Each hard capsule contains 25 mg zonisamide
Kull kapsula iebsa ta ’ Zonegran fiha 25 mg ta ’ zonisamide.
Colouring agents E171, E172
Colouring agents E171, E172
14 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules
14- il kapsula iebsa 28- il kapsula iebsa 56- il kapsula iebsa 84- il kapsula iebsa
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EXP (MM/ YYYY)
JIS {XX/ SSSS}
Eisai Ltd., 3 Shortlands, London W6 8EE, United Kingdom.
Eisai Ltd., 3 Shortlands, London W6 8EE, Ir- Renju Unit.
14 capsules 28 capsules 56 capsules 84 capsules
14- kapsula 28 kapsula 56 kapsula 84 kapsula
OUTER CARTON
KAXXA TAL- KARTUN TA ’ BARRA
Zonegran 50 mg hard capsules zonisamide
Zonegran 50 mg kapsuli iebsin zonisamide
Each hard capsule contains 50 mg zonisamide
Kull kapsula iebsa ta ’ Zonegran fiha 50 mg ta ’ zonisamide.
14 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules
14 kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa
Do not store above 30ºC
42 Taħżinx f’ temperatura ’ l fuq minn 30ºC
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TAL- KARTUN TA ’ BARRA
Zonegran 100 mg hard capsules zonisamide
Zonegran 100 mg kapsuli iebsin zonisamide
Each hard capsule contains 100 mg zonisamide
Kull kapsula iebsa ta ’ Zonegran fiha 100 mg ta ’ zonisamide.
Colouring agents sunset yellow FCF (E110), E171, E129 and E172.
Colouring agents sunset yellow FCF (E110), E171, E129 u E172.
See leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal iktar informazzjoni
28 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 196 hard capsules
28 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 98 kapsula iebsa 196 kapsula iebsa
Do not store above 30ºC
45 Taħżinx f’ temperatura ’ l fuq minn 30ºC
28 capsules 56 capsules 84 capsules 98 capsules 196 capsules
28 kapsula 56 kapsula 84 kapsula 98 kapsula 196 kapsula
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Zonegran 25 mg hard capsules Zonegran 50 mg hard capsules Zonegran 100 mg hard capsules (zonisamide)
GĦAL MIN QED JAGĦMEL UŻU MINNHA Zonegran 25 mg kapsuli iebsin Zonegran 50 mg kapsuli iebsin Zonegran 100 mg kapsuli iebsin (zonisamide)
You may need to read it again. • If you have any further questions, ask your doctor or your 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 il- ħsara, anki 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- fuljett:
What Zonegran is and what it is used for 2.
X’ inhu Zonegran u għalxiex jintuża 2.
Before you take Zonegran 3.
Qabel ma tieħu Zonegran 3.
How to take Zonegran 4.
Kif għandek tieħu Zonegran 4.
How to store Zonegran 6.
Kif taħżen Zonegran 6.
WHAT ZONEGRAN IS AND WHAT IT IS USED FOR
X’ INHU ZONEGRAN U GĦALXIEX JINTUŻA
Zonegran contains zonisamide, which is an antiepileptic medicine.
Zonegran fih zonisamide, li hi mediċina anti- epilettika.
Zonegran is used to treat adults who are already taking other antiepileptic medicines but are still experiencing seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Zonegran jintuża għall- kura ta ’ adulti li diġà qed jieħdu mediċini anti- epilettiċi oħrajn, iżda li għadu qed ikollhom puplesiji li jaffettwaw parti tal- moħħ (puplesija parzjali), li jistgħu, jew ma jistgħux ikunu segwiti minn puplesija li taffettwa l- moħħ kollu (ġeneralizzazzjoni sekondarja).
BEFORE YOU TAKE ZONEGRAN
QABEL MA ’ TIEĦU ZONEGRAN
Do not take Zonegran:
Tiħux Zonegran:
- if you are allergic (hypersensitive) to zonisamide or to any of the other ingredients of Zonegran
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal zonisamide jew sustanzi oħra ta ’
(see list of ingredients in Section 6 Further Information).
Zonegran (ara lista ta ’ ingredjenti f’ sezzjoni 6 Aktar tagħrif).
Take special care with Zonegran:
Oqgħod attent ħafna b’ Zonegran:
If you: • are younger than 18 years old.
Jekk: • għandek inqas minn 18- il sena.
Zonegran must not be used during pregnancy or breastfeeding without specialist advice.
Zonegran mhux rakkomandat għalik. • inti tqila, qed tippjana li toħroġ tqila jew taħseb li tista ’ tkun tqila, jew qed tredda ’. • Zonegran m’ għandux jintuża matul it- tqala jew it- treddigħ mingħajr parir mingħand speċjalista.
Women of childbearing age must use contraception while taking Zonegran and for one month after stopping. • are elderly, as your dose of Zonegran may need adjusting, and you may be more likely to develop an allergic reaction or severe skin rash when taking Zonegran (see Section 4 Possible Side Effects). • suffer from liver problems, as your dose of Zonegran may need adjusting. • suffer from kidney problems as your dose of Zonegran may need adjusting. • have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw il- kontraċezzjoni meta jkunu qed jieħdu Zonegran, u għal xahar wara li jieqfu jeħduh. • inti anzjan/ a, għax id- doża tiegħek ta ’ Zonegran jista ’ jkollha bżonn li tiġi aġġustata, u inti tista ’ tkun mistenni aktar li tiżviluppa reazzjoni allerġika jew raxx sever tal- ġilda meta tieħu Zonegran (ara Sezzjoni 4 Effetti sekondarji li jista ’ jkollu). • tbati minn problemi tal- fwied, għax id- doża tiegħek ta ’ Zonegran jista ’ jkollha bżonn ta ’ aġġustament. • tbati minn problemi tal- kliewi, għax id- doża tiegħek ta ’ Zonegran jista ’ jkollha bżonn ta ’ aġġustament.
Reduce the risk of kidney stones by drinking sufficient water.
49 • fil- passat kellek ġebel fil- kliewi, għax jista ’ jkollok żieda fir- riskju li jiżviluppaw iktar ġebel fil - kliewi.
47 • live in a place or are on holiday in a place where the weather is warm.
Naqqas ir- riskju ta ’ ġebel fil- kliewi billi tixrob ammont suffiċjenti ta ’ ilma. • tgħix f’ post jew qiegħed btala f’ post fejn it- temp ikun sħun.
Zonegran can make you perspire less, which can cause your body temperature to increase.
Zonegran jista ’ jikkawża li inti tegħreq inqas, u dan jista ’ jikkawża żieda fit- temperatura ta ’ ġismek.
Reduce the risk of overheating by drinking sufficient water and keeping cool. • weigh less than 40 kg, or have lost a lot of weight as Zonegran can cause you to lose more weight.
Naqqas ir- riskju ta ’ sħana żejda billi tixrob ammont suffiċjenti ta ’ ilma u żżomm ruħek frisk. • tiżen inqas minn 40 kg, jew jekk tlift ħafna piż, għax Zonegran jista ’ jikkawża li titlef iktar piż.
Tell your doctor as this may need to be monitored.
Għid it- tabib tiegħek għax dan jista ’ jkollu bżonn li jiġi mmonitorjat.
If any of these applies to you, tell your doctor before you take Zonegran.
Jekk xi waħda minn dawn tapplika għalik, għid lit- tabib tiegħek qabel ma tieħu Zonegran.
Zonegran belongs to a group of medicines (sulphonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Zonegran jappartieni għal grupp ta ’ mediċini (sulphonamides) li jistgħu jikkawżaw reazzjonijiet allerġiċi severi, raxx sever tal- ġilda, u disturbi tad- demm, li b’ mod rari ħafna jistgħu jkunu fatali.
Contact your doctor immediately if you: • have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction. • have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems. • get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones.
Ikkuntattja it- tabib tiegħek immedjatament jekk: • ikollok diffikultà biex tieħu n- nifs, wiċċ, xufftejn jew ilsien minfuħin, jew raxx sever tal- ġilda, għax dawn is- sintomi jistgħu jindikaw li inti għandek reazzjoni allerġika severa. • għandek uġigħ fil- muskoli jew sensazzjoni ta ’ dgħjufija, għax dan jista ’ jkun sinjal ta ’ kollass anormali tal- muskoli li jista ’ jwassal għal problemi tal- kliewi. • jekk ikollok uġigħ għal għarrieda f’ dahrek jew fl- istonku, ikollok uġigħ meta tagħmel l- awrina jew jekk tinnota demm fl- awrina, għax dan jista ’ jkun sinjal ta ’ ġebel fil- kliewi.
Contact your doctor as soon as possible if you: • have an unexplained skin rash, as this could develop into a more severe skin rash. • feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder.
Ikkuntattja lit- tabib tiegħek malajr kemm jista ’ jkun jekk inti: • ikollok raxx tal- ġilda mhux spjegabbli, għax dan jista ’ jiżviluppa f’ raxx aktar sever. • tħossok għajjien b’ mod mhux tas- soltu jew ikollok id- deni, ikollok uġigħ fil- griżmejn, glandoli minfuħin, jew issib li titbenġel iktar faċilment, għax jista ’ jfisser li għandek disturb fid- demm.
Your doctor may decide that you should stop using Zonegran.
It- tabib tiegħek jista ’ jiddeċiedi li għandek twaqqaf l- użu ta ’ Zonegran.
The effect of zonisamide can be reduced by other medicines you are taking.
L- effett ta ’ zonisamide jista ’ jitnaqqas minn mediċini oħrajn li tkun qed tieħu.
This may require an adjustment of your dose of Zonegran.
Dan jista ’ jkollu bżonn ta ’ aġġustament tad- doża tiegħek ta ’ Zonegran.
Zonegran can be taken with or without food.
Meta tieħu Zonegran ma ’ l- ikel u max- xorb Zonegran jista ’ jittieħed ma ’ l- ikel jew mingħajr l- ikel.
Pregnancy and Breastfeeding
Tqala u Treddigħ
If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.
Jekk inti mara f’ età li jista ’ jkollok it- tfal, għandek tuża kontraċezzjoni adegwata meta tkun qed tieħu Zonegran u għal xahar wara li tkun waqaft tieħu Zonegran.
Tell your doctor immediately if you might be, or are pregnant, or are planning to get pregnant.
Għid lit- tabib tiegħek immedjatament jekk tista ’ tkun tqila, jew jekk inti tqila, jew jekk qed tippjana li toħroġ tqila, għid lit- tabib tiegħek.
You must only take Zonegran during your pregnancy if your doctor tells you to.
Għandek tieħu Zonegran matul it- tqala tiegħek biss jekk it- tabib tiegħek jgħidlek biex tagħmel hekk.
Research has shown an increased risk of birth defects in children of women taking anti-epileptic drugs.
Ir- riċerka wriet riskju ogħla ta ’ difetti tat- twelid fit- tfal ta ’ nisa li jkunu qed jieħdu mediċini anti- epilettiċi.
Do not breastfeed whilst taking, or for one month after stopping Zonegran.
Treddax waqt li tkun qed tieħu Zonegran, jew għal xahar wara li tieqaf tieħu Zonegran.
Zonegran may affect your concentration, ability to react/ respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased.
Zonegran jista ’ jaffettwa l- konċentrazzjoni tiegħek u l- ħila tiegħek li tirreaġixxi/ tirrispondi, u jista ’ jikkawżalek in- ngħas, partikularment fil- bidu tal- kura tiegħek jew wara li d- doża tiegħek tiżdiedlek.
Be especially careful while driving or operating machinery, if Zonegran affects you in this way.
Oqgħod attent b’ mod speċjali meta tkun qed issuq jew tħaddem il- makkinarju, jekk Zonegran jaffettwak b’ dan il- mod.
Important information about some of the ingredients of Zonegran
50 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zonegran
Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), which may cause allergic reactions (see section 6 – Further Information).
Zonegran 100 mg kapsuli iebsin fihom kulur isfar imsejjaħ sunset yellow FCF (E110), li jista ’ jikkawża reazzjonijiet allerġiċi (ara sezzjoni 6 – Aktar tagħrif).
HOW TO TAKE ZONEGRAN
KIF GĦANDEK TIEĦU ZONEGRAN
Always take Zonegran exactly as your doctor has told you.
Dejjem għandek tieħu Zonegran skond il- parir tat- tabib.
• Zonegran capsules must be swallowed whole with water. • Do not chew the capsules. • Zonegran must be taken once or twice daily, as instructed by your doctor. • It you take Zonegran twice a day, take half the daily dose in the morning and half in the evening.
• Il- kapsuli Zonegran għandhom jinbelgħu sħaħ flimkien ma ’ l- ilma. • Tomgħodx il- kapsuli. • Zonegran irid jittieħed darba jew darbtejn kuljum, skond kif jgħidlek it- tabib tiegħek. • Jekk tieħu Zonegran darbtejn kuljum, ħu nofs id- doża ta ’ kuljum filgħodu u n- nofs l- ieħor filgħaxija.
The usual adult dose • The starting dose is 50mg daily taken in two equal doses of 25mg. • This may be increased by up to 100mg at intervals of one to two weeks. • The usual daily dose is between 300mg and 500mg. • Some people respond to lower doses.
Id- doża normali għall- adulti • Id- doża normali tal- bidu hi ta ’ 50 mg kuljum li tittieħed f’ żewġ dożi ta ’ 25 mg. • Din tista ’ tiżdied sa 100 mg f’ intervalli ta ’ ġimgħa jew ġimagħtejn. • Id- doża normali ta ’ kuljum hi bejn 300 mg u 500 mg. • Xi nies jistgħu jirrispondu għal dożi iktar baxxi.
The dose may be increased more slowly if you experience unwanted effects, are elderly or if you suffer from kidney or liver problems.
Id- doża tista ’ tiżdied iktar bil- mod jekk ikollok effetti mhux mixtieqa, int anzjan/ a, jew jekk qed tbati minn problemi tal- kliewi jew tal- fwied.
If you feel that the effect of Zonegran is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ Zonegran hu qawwi jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
If you take more Zonegran than you should
Jekk tieħu aktar Zonegran milli suppost
If you may have taken more Zonegran than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you.
Jekk forsi tieħu iktar Zonegran milli suppost, għid lil xi persuna li qed tieħu ħsiebek (xi qarib jew ħabib/ a), lit- tabib tiegħek jew l- ispiżjar immedjatament, jew ikkuntattja l- eqreb Sezzjoni ta ’ l - emerġenza ta ’ l- isptar, u ħu l- mediċina miegħek.
You may become sleepy and could lose consciousness.
Jista ’ jaqbdek in- ngħas u jista ’ jħossok ħażin.
Do not try to drive.
Tippruvax issuq.
If you forget to take Zonegran
Jekk tinsa tieħu Zonegran
• If you forget to take a dose, don’ t worry: take the next dose when it is due. • Do not take double the dose to make up for the forgotten dose.
• Jekk tinsa tieħu doża, tinkwetax: ħu d- doża li jmiss fil- ħin tagħha. • M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop taking Zonegran
Jekk tieqaf tieħu Zonegran
• Zonegran is meant to be taken as a long-term medicine.
• Zonegran hu maħsub biex jittieħed bħala mediċina fuq tul ta ’ żmien.
Do not reduce your dose or stop your medicine unless your doctor tells you to. • If your doctor advises you to stop taking Zonegran your dose will be reduced gradually to lower the risk of more seizures.
Tnaqqasx id- doża tiegħek jew tieqaf tieħu l- mediċina hlief jekk it- tabib jgħidlek biex tagħmel hekk. • Jekk it- tabib tiegħek jagġtik parir biex tieqaf tieħu Zonegran, id- doża tiegħek ta ’ Zonegran ser titnaqqas gradwalment biex tnaqqas ir- riskju ta ’ iktar puplesiji.
Like all medicines, Zonegran can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zonegran jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Contact your doctor immediately if you:
51 Ikkuntattja it- tabib tiegħek immedjatament jekk:
49 • have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction. • have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems. • get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones.
• ikollok diffikultà biex tieħu n- nifs, wiċċ, xufftejn jew ilsien minfuħin, jew raxx sever tal- ġilda, għax dawn is- sintomi jistgħu jindikaw li inti għandek reazzjoni allerġika severa. • għandek uġigħ fil- muskoli jew sensazzjoni ta ’ dgħjufija, għax dan jista ’ jkun sinjal ta ’ kollass anormali tal- muskoli li jista ’ twassal għal problemi tal- kliewi. • jekk ikollok uġigħ għal għarrieda f’ dahrek jew fl- istonku, ikollok uġigħ meta tagħmel l- awrina jew jekk tinnota demm fl- awrina, għax dan jista ’ jkun sinjal ta ’ ġebel fil- kliewi.
The most common side effects of Zonegran are mild.
L- iktar effetti sekondarji komuni ta ’ Zonegran huma ħfief:
They occur during the first month of treatment and usually decrease with continued treatment.
Dawn iseħħu matul l- ewwel xahar tal- kura u normalment jonqsu mat- tkomplija tal- kura.
Common side effects (likely to affect greater than 1 in every 100 patients) • agitation, irritability, confusion, depression, insomnia, strange or unusual thoughts, feeling anxious or emotional. • poor muscle coordination, dizziness, poor memory, slowed thoughts, drowsiness, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor. • double vision, involuntary movement of the eyes. • kidney stones. • skin rashes, allergic reactions, fever, fatigue, flu-like symptoms. • ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin). • loss of appetite, loss of weight, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic). • nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
Effetti sekondarji komuni (li x’ aktarx li ser jaffettwaw iktar minn 1 minn kull 100 pazjent) • aġitazzjoni, irritabilità, konfużjoni, dipressjoni, nuqqas ta ’ rqad, ħsibijiet strambi jew mhux tas - soltu, tħossok sensazzjoni ansjuż jew emozzjonali. • koordinazzjoni batuta tal- muskoli, sturdament, memorja batuta, ħsibijiet li jdumu ma jiġu, ngħas, telf ta ’ konċentrazzjoni, anormalitajiet fid- diskors, sensazzjoni anormali fil- ġilda (sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar), rogħda. • tara doppju, moviment involontarji ta ’ l- għajnejn. • ġebel fil- kliewi. • raxx tal- ġilda, reazzjonijiet allerġiċi, deni, għeja kbira, sintomi bħal ta ’ l- influwenza. • ekkimożi (tbenġila żgħira kkawżata minn demm li jnixxi minn vini fil- ġilda). • telf ta ’ aptit, telf ta ’ piż, tnaqqis fil- livelli fid- demm tal- bikarbonat (sustanza li timpedixxi tad - demm milli jsir aċidiku). • nawseja, indiġestjoni, uġigħ fl- istonku, dijarea (ippurgar maħlul), stitikezza.
Uncommon side effects (likely to affect 1 to 10 in every 1000 patients) • anger, aggression, thoughts of suicide, suicide attempt. • vomiting. • gall bladder inflammation, gallstones. • urinary stones. • pneumonia and urinary tract infections. • low blood potassium levels, convulsions/ seizures.
Effetti sekondarji mhux komuni (li x’ aktarx li ser jaffettwaw minn 1 minn sa 10 minn kull 1, 000 pazjent) • rabja, aggressjonijiet, ħsibijiet ta ’ suwiċidju, attentat ta ’ suwiċidju. • rimettar. • infjammazzjoni fil- bużżieqa tal- marrara, ġebel fil- marrara. • ġebel fl- awrina. • pnewmonja u infezzjonijiet ta ’ l- apparat urinarju. • livelli baxxi ta ’ potassium fid- demm, konvulżjonijiet/ puplesiji.
Very rare side effects (likely to affect less than 1 in every 10,000 patients): • hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures). • breathing disorders, shortness of breath, inflammation of the lungs. • inflammations of the pancreas (severe pain in the stomach or back) • liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).. • severe rashes (at the same time you may feel unwell or develop a fever), itching. • abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems. • swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily). • decreased sweating, overheating.
Effetti sekondarji rari ħafna (li x’ aktarx li ser jaffettwaw inqas minn 1 minn kull 10, 000 pazjent): jinkludu): • alluċinazzjonijiet, telf ta ’ memorja, koma, sindrome malinn newroleptiku (ma tkunx tista ’ titħarrek, għaraq, deni, inkontinenza), status epilepticus (attakki ta ’ puplesija fit- tul jew ripetuti). • disturbi biex tieħu n- nifs, qtugħ ta ’ nifs, infjammazzjoni tal- pulmuni. • infjammazzjonijiet tal- frixa (uġigħ sever fl- istonku jew fid- dahar) • problemi fil- fwied, insuffiċjenza tal- kliewi, żieda fil- livelli tal- krejatinina fid- demm (prodott li normalment il- kliewi tiegħek għandhom ineħħu). • raxx sever (fl- istess ħin jista ’ jkun li tħossok li m’ intix f’ sikktek jew tiżviluppa d- deni), ħakk. • Kollass anormali tal- muskoli (tista ’ tħoss uġigħ jew dgħjufija fil- muskoli tiegħek) li jista ’ twassal għal problemi tal- kliewi.
STORING ZONEGRAN
KIF TAĦŻEN ZONEGRAN
Keep Zonegran out of the reach and sight of children.
Żomm Zonegran fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Zonegran after the expiry date stated on the blister and the carton.
Tużax Zonegran wara d- data ta ’ skadenza li tidher fuq il- folja u fuq il- kaxxa tal- kartun.
Do not use if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in the medicine.
Tużahx jekk tinnota kwalunkwe ħsara fil- kapsuli, fil- folja jew fil- kaxxa tal- kartun, jew kwalunkwe sinjali viżibbli ta ’ deterjorament fil- mediċina.
Return the pack to your pharmacist.
Ħu l- pakkett lura għand l- ispiżjar tiegħek.
What Zonegran contains The active substance in Zonegran hard capsules is zonisamide.
X’ fih Zonegran Is- sustanza attiva f’ Zonegran kapsuli iebsin hi zonisamide.
Zonegran 25 mg hard capsules contain 25 mg of zonisamide.
Zonegran 25 mg kapsuli iebsin fihom 25 mg ta ’ zonisamide.
Zonegran 50 mg hard capsules contain 50 mg zonisamide.
Zonegran 50 mg kapsuli iebsin fihom 50 mg ta ’ zonisamide.
Zonegran 100 mg hard capsules contain 100 mg zonisamide.
Zonegran 100 mg kapsuli iebsin fihom 100 mg ta ’ zonisamide.
• The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate.
• Is- sustanzi l- oħra li hemm fil- kontenut tal- kapsula huma: microcrystalline cellulose, hydrogenated vegetable oil u sodium laurilsulfate.