qanastek/EMEA-V3 huggingface dataset:
Peak plasma concentrations occur approximately 2.5 hours after oral administration of lamotrigine.
L- akbar konċentrazzjonijiet ta ’ plasma jseħħu madwar 2. 5 sigħat wara li lamotrigine jittieħed mill- ħalq.
Time to maximum concentration is slightly delayed after food but the extent of absorption is unaffected.
Wara l- ikel ikun hemm xi ftit dewmien sa ma tintlaħaq konċentrazzjoni massima imma dan ma jkollu ebda effett fuq l- ammont assorbit.
There is considerable inter-individual variation in steady state maximum concentrations but within an individual, concentrations rarely vary.
Hemm varjazjoni konsiderevoli bejn individwu u ieħor f’ dawk li huma konċentrazzjonijiet massimi steady state, biss konċentrazzjonijiet fl- istess individwu rarament ivarjaw.
Binding to plasma proteins is about 55%; it is very unlikely that displacement from plasma proteins would result in toxicity.
It- twaħħil ma ’ proteini tal- plasma hu madwar 55%; mhu xejn probabbli li t- teħid ta ’ post il- proteini tal - plasma għandu jirriżulta f’ xi tossiċita ’.
The volume of distribution is 0.92 to 1.22 L/ kg.
Il- volum ta ’ distribuzzjoni hu 0. 92 sa 1. 22 L/ kg.
UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine.
UDP- glucuronyl transferases ġew identifikati bħala enzimi risponsabbli għall- metaboliżmu ta ’ lamotrigine.
Lamotrigine induces its own metabolism to a modest extent depending on dose.
Sa ċertu punt lamotrigine jinduċi l- metaboliżmu tiegħu stess u dan jiddependi mid- doża.
However, there is no evidence that lamotrigine affects the pharmacokinetics of other AEDs and data suggest that interactions between lamotrigine and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Madankollu, m’ hemm xejn x’ juri li lamotrigine jaffettwa l- farmakokinetiċi ta ’ AEDs oħra u l- informazzjoni miġbura tindika li mhux mistennija interazzjonijiet bejn lamotrigine u prodotti mediċinali metabolizzati b’ enzimi taċ - ċitokromu P450.
The apparent plasma clearance in healthy subjects is approximately 30 mL/ min.
Milli jidher it- tneħħija ta ’ plasma f’ persuni f’ saħħithom hi ta ’ madwar 30 mL/ min.
Clearance of lamotrigine is primarily metabolic with subsequent elimination of glucuronide-conjugated material in urine.
It- tneħħija ta ’ lamotrigine hi primarjament metabolika bl- eliminazzjoni sussegwenti ta ’ materjal konjugat bi glukuronid fl - awrina.
Less than 10% is excreted unchanged in the urine.
Inqas minn 10% jitneħħa bla ma jinbidel fl- awrina.
Only about 2% of lamotrigine-related material is excreted in faeces.
Madwar 2% biss ta ’ materjal relatat ma ’ lamotrigine jitneħħa mal- ħmieġ.
Clearance and half-life are independent of dose.
It- tneħħija u l- half- life ma jiddependux mid- doża.
The apparent plasma half-life in healthy subjects is estimated to be approximately 33 hours (range 14 to 103 hours).
Jidher li l- half- life tal - plasma f’ persuni f’ saħħithom hi ta ’ madwar 33 siegħa (skala ta ’ 14 sa 103 siegħa).
In a study of subjects with Gilbert's Syndrome, mean apparent clearance was reduced by 32% compared with normal controls but the values are within the range for the general population.
Fi studju ta ’ pazjenti bis - Sindrome Gilbert, jidher li l- medja ta ’ tneħħija tnaqqset bi 32% meta mqabbla ma ’ kontrolli normali imma l - valuri huma fl- iskala applikabbli għall- popolazzjoni ġenerali.
The half-life of lamotrigine is greatly affected by concomitant medicinal products.
Il- half- life ta ’ lamotrigine tiġi affettwata ferm meta dan jittieħed flimkien ma ’ prodotti mediċinali oħra.
Mean half-life is reduced to approximately 14 hours when given with glucuronidation-inducing medicinal products such as carbamazepine and phenytoin and is increased to a mean of approximately 70 hours when co-administered with valproate alone (see section 4.2).
Il - medja tal- half- life titnaqqas b’ madwar 14- il siegħa meta jingħata ma ’ prodotti mediċinali li jinduċu l - glukuronidazzjoni bħal m’ huma carbamazepine u phenytoin u tiżdied għal medja ta ’ madwar 70 siegħa meta mogħti flimkien ma ’ valproate waħdu (ara sezzjoni 4. 2).
Linearity
Linearita ’
The pharmacokinetics of lamotrigine are linear up to 450 mg, the highest single dose tested.
Il- farmakokinetiċi ta ’ lamotrigine huma lineari sa 450 mg, l- ogħla doża waħedha li ġiet ittestjata.
Children Clearance adjusted for body weight is higher in children than in adults with the highest values in children under five years.
Tfal It- tneħħija aġġustata skond il- piż tal- ġisem hi ogħla fit- tfal milli fl- adulti bl- ogħla valuri fit- tfal taħt il- ħames snin.
The half-life of lamotrigine is generally shorter in children than in adults with a mean value of approximately 7 hours when given with enzyme-inducing medicinal products such as carbamazepine and phenytoin and increasing to mean values of 45 to 50 hours when co-administered with valproate alone (see section 4.2).
Il- half- life ta ’ lamotrigine hi ġeneralment iqsar fit- tfal milli fil- kbar b’ valur medju ta ’ madwar 7 sigħat meta mogħti ma ’ prodotti mediċinali li jinduċu enzimi bħal carbamazepine u phenytoin u tiżdied għal valuri medji ta ’ 45 sa 50 siegħa meta mogħti flimkien ma ’ valproate waħdu (ara sezzjoni 4. 2).
69 Infants aged 2 to 26 months In 143 paediatric patients aged 2 to 26 months, weighing 3 to 16 kg, clearance was reduced compared to older children with the same body weight, receiving similar oral doses per kg body weight as children older than 2 years.
73 Trabi ta ’ bejn 2 u 26 xahar Fi 143 pazjent pedjatriku ta ’ bejn 2 u 26 xahar, u li jiżnu minn 3 sa 16 kg, it- tneħħija kienet anqas meta mqabbla ma ’ tfal akbar bl- istess piż tal- ġisem, li kienu qed jirċievu l- istess dożi mill- ħalq kull kg ta ’ piż tal - ġisem bħal tfal akbar minn sentejn.
The mean half-life was estimated at 23 hours in infants younger than 26 months on enzyme-inducing therapy, 136 hours when co-administered with valproate and 38 hours in subjects treated without enzyme inducers/ inhibitors.
Il- medja ta ’ half- life kienet stimata għal 23 siegħa fi trabi iżgħar minn 26 xahar fuq terapija li tinduċi l- enżimi, 136 siegħa meta ingħatat flimkien ma ’ valproate u 38 siegħa f’ suġġetti trattati mingħajr indutturi/ inibituri ta ’ l- enżimi.
The inter-individual variability for oral clearance was high in the group of paediatric patients of 2 to 26 months (47%).
Il- varjabilita ’ bejn l- individwi fejn tidħol tneħħija mill- ħalq kienet għolja fil- grupp ta ’ pazjenti pedjatriċi ta ’ 2- 26 xahar (47%).
The predicted serum concentration levels in children of 2 to 26 months were in general in the same range as those in older children, though higher Cmax levels are likely to be observed in some children with a body weight below 10 kg.
Il- livelli ta ’ konċentrazzjoni fis- serum previsti fi tfal ta ’ bejn 2 u 26 xahar kienu in ġenerali fl- istess skala ta ’ dawk fi tfal akbar, għalkemm livelli ta ’ Cmax aktar għolja huma aktar possibli li jkunu osservati f' xi tfal b’ piż tal- ġisem ta ’ anqas minn 10kg.
Elderly Results of a population pharmacokinetic analysis including both young and elderly patients with epilepsy, enrolled in the same trials, indicated that the clearance of lamotrigine did not change to a clinically relevant extent.
Anzjani Riżultati minn analiżi ta ’ farmakokinetiċi ta ’ popolazzjoni li jinkludu kemm pazjenti żgħar u kemm kbar b’ epilessija, reġistrati fl- istess provi, indikaw li t- tneħħija ta ’ lamotrigine ma ’ nbidlitx b’ xi mod ta ’ rilevanza klinika.
After single doses apparent clearance decreased by 12% from 35 mL/ min at age 20 to 31 mL/ min at 70 years.
Wara l- għoti ta ’ dożi waħedhom deher li t- tneħħija naqset bi 12% minn 35 mL/ min fl- eta ’ ta ’ 20 sa 31 mL/ min fl- eta ’ ta ’ 70 sena.
The decrease after 48 weeks of treatment was 10% from 41 to 37 mL/ min between the young and elderly groups.
It- tnaqqis wara 48 ġimgħa ta ’ trattament kien ta ’ 10% minn 41 sa 37 mL/ min bejn il- gruppi żgħar u kbar.
In addition, pharmacokinetics of lamotrigine was studied in 12 healthy elderly subjects following a 150 mg single dose.
Barra dan, il- farmakokinetiċi ta ’ lamotrigine ġew studjati fi 12- il pazjent anzjan wara doża ta ’ 150 mg.
The mean clearance in the elderly (0.39 mL/ min/ kg) lies within the range of the mean clearance values (0.31 to 0.65 mL/ min/ kg) obtained in nine studies with non-elderly adults after single doses of 30 to 450 mg.
It- tneħħija medja fl- anzjani (0. 39 mL/ min/ kg) qiegħda fl- iskala tal- valuri tal- medja ta ’ tneħħija (0. 31 sa 0. 65 mL/ min/ kg) li ħarġu minn disgħa studji fuq adulti mhux anzjani wara dożi waħedhom ta ’ 30 sa 450 mg.
Renal impairment Twelve volunteers with chronic renal failure, and another six individuals undergoing hemodialysis were each given a single 100 mg dose of lamotrigine.
Indeboliment tal- kliewi Tnax il- voluntier bi ħsara kronika fil- fwied, u sitta oħra li kienu fuq emodijalisi ingħataw doża waħda ta ’ 100 mg lamotrigine kull wieħed.
Mean clearances were 0.42 mL/ min/ kg (chronic renal failure), 0.33 mL/ min/ kg (between hemodialysis) and 1.57 mL/ min/ kg (during hemodialysis), compared with 0.58 mL/ min/ kg in healthy volunteers.
It- tneħħijiet medji kienu 0. 42 mL/ min/ kg ((ħsara kronika fil- fwied), 0. 33 mL/ min/ kg (bejn l- emodijalisi) u 1. 57 mL/ min/ kg (waqt l- emodijalisi), meta mqabbla ma ’ 0. 58 mL/ min/ kg f’ voluntieri f’ saħħithom.
Mean plasma half-lives were 42.9 hours (chronic renal failure), 57.4 hours (between hemodialysis) and 13.0 hours (during hemodialysis), compared with 26.2 hours in healthy volunteers.
Il- medja ta ’ half- lives fil- plasma kienet 42. 9 sigħat (ħsara kronika fil- fwied), 57. 4 sigħat (bejn l- emodijalisi) u 13. 0 sigħat (waqt l- emdodijalisi), meta mqabbla ma ’ 26. 2 sigħat fil- każ ta ’ voluntieri f’ saħħithom.
On average, approximately 20% (range = 5.6 to 35.1) of the amount of lamotrigine present in the body was eliminated during a 4-hour hemodialysis session.
Bħala medja, madwar 20% (skala = 5. 6 sa 35. 1) mill- ammont ta ’ lamotrigine preżenti fil- ġisem ġie eliminat waqt sessjoni ta ’ 4 sigħat emodijalisi.
For this patient population, initial doses of lamotrigine should be based on the patient’ s concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.2 and 4.4).
Għal dil- popolazzjoni ta ’ pazjenti, id - dożi inizjali ta ’ lamotrigine għandhom ikunu bbażati fuq il- prodotti mediċinali li jkunu jittieħdu fl- istess ħin; dożi mnaqqsa ta ’ stabbilizzazzjoni jistgħu jkunu effettivi għal pazjenti b’ indeboliment sinifikanti tal - funzjonament tal- kliewi (ara sezzjonijiet 4. 2 u 4. 4).
Hepatic impairment A single dose pharmacokinetic study was performed in 24 subjects with various degrees of hepatic impairment and 12 healthy subjects as controls.
Indeboliment tal- fwied Studju farmakokinetiku bażat fuq doża waħda twettaq f’ 24 persuna b’ diversi livelli ta ’ indeboliment tal - fwied u fi 12- il persuna f’ saħħithom bħala kontrolli.
The median apparent clearance of lamotrigine was 0.31, 0.24 or 0.10 mL/ min/ kg in patients with Grade A, B, or C (Child-Pugh Classification) hepatic impairment, respectively, compared with 0.34 mL/ min/ kg in the healthy controls.
Deher li l- medja ta ’ tneħħija ta ’ lamotrigine kienet ta ’ 0. 31, 0. 24 jew 0. 10 mL/ min/ kg f’ pazjenti bi Grad A, B jew Ċ (Klassifikazzjoni Child- Pugh) ta ’ indeboliment tal- fwied, rispettivament, meta mqabbel ma’ 0. 34 mL/ min/ kg f’ kontrolli f’ saħħithom.
Initial, escalation and maintenance doses should generally be reduced in patients with moderate or severe hepatic impairment (see section 4.2).
Dożi inizjali, dożi li jkunu jiżdiedu, u dożi ta ’ stabbilizzazzjoni ġeneralment għandhom jitnaqqsu f’ pazjenti b’ indeboliment moderat jew qawwi tal- fwied (ara sezzjoni 4. 2).
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Informazzjoni mhux klinika bażata fuq studji dwar sigurta ’ farmakoloġika, tossiċita ’ minn dożi ripetuti, u potenzjal ta ’ ġenotossiċita ’ u karċinoġenika fil- bniedem turi li m’ hemm ebda periklu speċjali.
In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but reduced foetal weight and retarded skeletal ossification were observed, at exposure levels below or similar to the expected clinical exposure.
Fi studji dwar tossiċita ’ riproduttiva u dik ta ’ żvilupp fi ġrieden u fniek, ebda effetti teratoġeniċi ma ġew osservati ħlief tnaqqis ta ’ piż tal- fetu u ossifikazzjoni skeletrika ritardjata, f’ livelli ta ’ esponiment inqas jew simili għal dawk mistennija f’ esponiment kliniku.
Since higher exposure levels could not be tested in animals due to the severity of maternal toxicity, the teratogenic potential of lamotrigine has not been characterised above clinical exposure.
Billi livelli ta ’ esponiment ogħla ma setgħux jiġu ttestjati fuq annimali minħabba s- severita ’ ta ’ tossiċita ’ materna, il- potenzjal teratoġeniku ta ’ lamotrigine ma ġiex karatterizzat ’ il fuq minn esponiment kliniku.
In rats, enhanced foetal as well as post-natal mortality was observed when lamotrigine was administered during late gestation and through the early post-natal period.
Fil- ġrieden, żjieda fl- imwiet ta ’ feti u ta ’ wara t- twelid kienet osservata meta lamotrigine ingħata fl- aħħar tat- tqala u matul l- ewwel jiem ta ’ wara t- twelid.
These effects were observed at the expected clinical exposure.
Dawn l- effetti ġew osservati f’ esponiment kliniku kif mistenni.
70 In juvenile rats, an effect on learning in the Biel maze test, a slight delay in balanopreputial separation and vaginal patency and a decreased postnatal body weight gain in F1 animals were observed at exposures approximately two-times higher than the therapeutic exposures in human adults.
74 Fi ġrieden żgħar ġew osservati effetti fuq kif jitgħallmu bit- test Biel maze, ftit dewmien fis- separazjoni balanoprepuzjali u fil- patenza vaġinali, u tnaqqis fir- rata ta ’ żjieda fil- piż ta ’ wara t- twelid f’ annimali F1 f’ esponimenti ta ’ madwar darbtejn aktar mill- esponimenti terapewtiċi fi bnedmin adulti.
Animal experiments did not reveal impairment of fertility by lamotrigine.
Esperimenti fuq annimali ma wrew ebda indeboliment ta ’ fertilita ’ b’ lamotrigine.
Lamotrigine reduced foetal folic acid levels in rats.
Lamotrigine naqqas il - livelli ta ’ aċidu foliku fil- fetu tal- ġrieden.
Folic acid deficiency is assumed to be associated with an enhanced risk of congenital malformations in animals as well as in humans.
Hu maħsub li n- nuqqas ta ’ aċidu foliku hu assoċjat ma ’ riskju akbar ta ’ malformazzjonijiet konġenitali f’ annimali kif ukoll fil- bniedem.
Lamotrigine caused a dose-related inhibition of the hERG channel tail current in human embryonic kidney cells.
Lamotrigine ikkawża inibizzjoni relatata mad- dożi ta ’ l- hERG channel tail current fiċ- ċelluli embrijoniċi tal- kliewi fil- bniedem.
The IC50 was approximately nine-times above the maximum therapeutic free concentration.
L- IC50 kien madwar disgħa darbiet aktar ’ il fuq mill- konċentrazzjoni massima bla terapija.
Lamotrigine did not cause QT prolongation in animals at exposures up to approximately two-times the maximum therapeutic free concentration.
Lamotrigine ma kkawża ebda tul żejjed ta ’ QT f’ annimali b’ esponiment ta ’ madwar darbtejn aktar mill- konċentrazzjoni massima bla terapija.
In a clinical study, there was no clinically significant effect of lamotrigine on QT interval in healthy adult volunteers (see section 5.1).
Fi studju kliniku, me kien hemm ebda effett ta ’ sinifikanza klinika ta ’ lamotrigine fuq l- intervall QT f’ voluntieri adulti f’ saħħithom (ara sezzjoni 5. 1).
25, 50, 100 and 200 mg tablets:
Pilloli ta ’ 25, 50 100 u 200 mg:
Lactose monohydrate Microcrystalline cellulose Povidone K30 Sodium starch glycolate (Type A) Iron oxide yellow (E172) Magnesium stearate.
Lactose monohydrate Microcrystalline cellulose Povidone K30 Sodium starch glycolate (Type A) Iron oxide yellow (E172) Magnesium stearate.
2, 5, 25, 50, 100 and 200 mg dispersible/ chewable tablets:
2, 5, 25, 50, 100 u 200 mg pilloli li jixterdu/ jiġu mimgħuda:
Calcium carbonate Low-substituted hydroxypropyl cellulose Aluminium magnesium silicate Sodium starch glycolate (Type A) Povidone K30 Saccharin sodium Magnesium stearate Blackcurrant flavour.
Calcium carbonate Low- substituted hydroxypropyl cellulose Aluminium magnesium silicate Sodium starch glycolate (Type A) Povidone K30 Saccharin sodium Magnesium stearate Togħma ta ’ ribes.
25, 50, 100 and 200 mg tablets, 5, 25, 50, 100 and 200 mg dispersible/ chewable tablets:
Pilloli ta ’ 25, 50, 100 u 200 mg, pilloli li jixterdu/ jiġu mimgħuda ta ’ 5, 25, 50, 100 u 200 mg:
Three years.
Tliet snin
Two years.
Pilloli ta ’ 2 mg li jixterdu/ jiġu mimgħuda Sentejn
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jeħtieġ ebda kondizzjonijiet speċjali għall- ħażna.
71 6.5 Nature and contents of container
75 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
PVC/ aluminium foil blister.
Folja blister tal- PVC/ aluminju.
Packs of 14, 21, 30, 42, 50, 56 or 100 tablets.
Pakketti ta ’ 14, 21, 30, 42, 50, 56 jew 100 pilloli.
Starter pack of 21 or 42 tablets.
Pakkett ta ’ 21 jew 42 pilloli biex tibda bih.
PVC/ aluminium foil blister.
Folja blister tal- PVC/ aluminju
Packs of 14, 30, 42, 56, 90 or 100 tablets.
Pakketti ta ’ 14, 30, 42, 56, 90 jew 100 pillola.
Starter pack of 42 tablets.
Pakkett ta ’ 42 pilloli biex tibda bih.
Packs of 30, 50, 56, 60, 90 or 100 tablets.
Pakketti ta ’ 30, 50, 56, 60, 90 jew 100 pillola.
200 mg tablets:
Pilloli ta ’ 200 mg:
Packs of 30, 56 or 100 tablets.
Pakketti ta ’ 30, 56 jew 100 pillola
HDPE bottles with a child resistant/ tamper evident closure.
Fliexken HDPE li ma jħallux tfal jiftħuhom jew jagħlquhom u juru evidenza jekk jiġu mbagħbsa
Packs of 30 dispersible/ chewable tablets.
Pakketti ta ’ 30 pilloli jixterdu/ jiġu mimgħuda
PVC/ PVdC/ aluminium foil blister.
Folja blister tal- PVC/ PVdC/ aluminju.
Packs of 10, 14, 28, 30, 50 or 56 dispersible/ chewable tablets.
Pakketti ta ’ 10, 14, 28, 30, 50 jew 56 pilloli li jixterdu/ jiġu mimgħuda.
25 mg dispersible/ chewable tablets:
Pilloli ta ’ 25 mg li jixterdu/ jiġu mimgħuda:
Packs of 10, 14, 21, 28, 30, 42, 50, 56 or 60 dispersible/ chewable tablets.
Pakketti ta ’ 10, 14, 21, 28, 30, 42, 50, 56 jew 60 pilloli li jixterdu/ jiġu mimgħuda.
Starter pack of 21 or 42 dispersible/ chewable tablets.
Pakkett ta ’ 21 jew 42 pilloli li jixterdu/ jiġu mimgħuda biex tibda bih.
Packs of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 dispersible/ chewable tablets.
Pakketti ta ’ 10, 14, 30, 42, 50, 56, 60, 90, 100 jew 200 jixterdu/ jiġu mimgħuda.
Starter pack of 42 dispersible/ chewable tablets.
Pakkett ta ’ 42 pilloli jixterdu/ jiġu mimgħuda biex tibda bih
100 mg dispersible/ chewable tablets:
Pilloli ta’ 100 mg jixterdu/ jiġu mimgħuda:
Packs of 10, 30, 50, 56, 60, 90, 100 or 200 dispersible/ chewable tablets.
Pakketti ta ’ 10, 30, 50, 56, 60, 90, 100 jew 200 pilloli jixterdu/ jiġu mimgħuda.
200 mg dispersible/ chewable tablets:
Pilloli ta ’ 200 mg jixterdu/ jiġu mimgħuda:
PVC/ PVdC/ aluminium foil blister.
Folja blister tal- PVC/ PVdC/ aluminju
Packs of 10, 30, 50, 56, 60, 90, 100 or 200 dispersible/ chewable tablets.
76 Pakketti ta ’ 10, 30, 50, 56, 60, 90, 100 jew 200 jixterdu/ jiġu mimgħuda.
72 Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali
[See Annex I - To be completed nationally]
(Ara l- Anness I – jitkompla fuq bażi nazzjonali)
[To be completed nationally]
(Jitkompla fuq bażi nazzjonali)
[To be completed nationally]
{XX/ SSSS} (Jitkompla fuq bażi nazzjonali)
73 LABELLING
77 TIKKETTA
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara l- Anness) pilloli ta ’ 25 mg (Ara l- Anness I – Biex jitkompla fuq bażi nazzjonali) Lamotrigine
Each tablet contains 25 mg lamotrigine
Kull pillola fiha 25 mg lamotrigine
Contains lactose monohydrate – see package leaflet for further information
Fiha monoidrat tal- lattosju – ara l- fuljett fil- pakkett għal aktar tagħrif
14 tablets 21 tablets 30 tablets 42 tablets 50 tablets 56 tablets 100 tablets Starter pack 21 tablets, valproate add-on therapy Starter pack 42 tablets, monotherapy
14- il pillola 21 pillola 30 pillola 42 pillola 50 pillola 56 pillola 100 pillola Pakkett tal- bidu 21 pillola, valproate terapija add- on Pakkett tal- bidu 42 pillola, monoterapija
Oral use Do not chew or crush Read the package leaflet before use
Jittieħed mill- ħalq M’ għandekx tomgħod jew tfarrak il- pillola Aqra l- fuljett qabel l- użu
EXP {MM YYYY}
DATA TA ’ META JISKADI
[See Annex I - To be completed nationally]
(Ara Anness I - Biex timtela mill- pajjiż partikolari)
[To be completed nationally]
(Biex timtela mill- pajjiż partikolari)
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 25 mg (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
[See Annex I - To be completed nationally]
(Ara Anness I – Biex timtela mill- pajjiż partikolari)
(Starter pack 21 tablets, valproate add-on therapy – calender pack showing day numbers):
(Pakkett biex tibda ta ’ 21 tablets, valproate terapija add- on – pakkett kalendarju li juri n- numru ta ’ ġranet):
1 2 3 4 5 6 7 (one pocket) 8 9 10 11 12 13 14 (one pocket) 15 16 17 18 19 20 21 (two pockets) 22 23 24 25 26 27 28 (two pockets)
1 3 5 7 9 11 13 (kontenitur wieħed) 2 4 6 8 10 12 14 (mingħajr kontenitur) 15 17 19 21 23 25 27 (kontenitur wieħed) 16 18 20 22 24 26 28 (kontenitur wieħed)
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (Ara Anness I), pilloli ta ’ 50 mg (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
STATEMENT OF ACTIVE SUBSTANCE
TAGĦRIF DWAR SUSTANZA ATTIVA
Each tablet contains 50 mg lamotrigine
Kull pillola fiha 50 mg lamotrigine
14 tablets 30 tablets 42 tablets 56 tablets 90 tablets 100 tablets Starter pack 42 tablets, non-valproate add-on therapy
14 – il pillola 30 pilloli 42 pilloli 56 pilloli 90 pilloli 100pilloli Pakkett tal- bidu 42 pilloli valproate terapija add- on
[See Annex I - To be completed nationally]
(Ara AnnessI – Biex timtela mill- pajjiż partikolari)
[To be completed nationally]
Biex timtela mill- pajjiż partikolari
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 50 mg (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
(Starter pack 42 tablets, non-valproate add-on therapy – calender pack showing day numbers):
(Pakkett biex tibda ta ’ 42 tablets, valproate terapija add- on – pakkett kalendarju li juri n- numru ta ’ ġranet):
1 2 3 4 5 6 7 (1 pocket) 8 9 10 11 12 13 14 (1 pocket) 15 16 17 18 19 20 21 (2 pockets) 22 23 24 25 26 27 28 (2 pockets)
1 2 3 4 5 6 7 (kontenitur wieħed) 8 9 10 11 12 13 14 (kontenitur wieħed) 15 16 17 18 19 20 21 (2 kontenituri) 22 23 24 25 26 27 28 (2 kontenituri)
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA
Lamictal and associated names (see Annex I) 100 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 100 mg (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each tablet contains 100 mg lamotrigine
Kull pillola fiha 100 mg lamotrigine
30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 100 tablets
30 pillola 50 pillola 60 pillola 56 pillola 90 pillola 100 pillola
[See Annex I - To be completed nationally]
(Arra AnnessI – Biex timtela mill- pajjiż partikolari)
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
[See Annex I - To be completed nationally]
(Ara l- Anness I – Jitkompla fuq bażi nazzjonali)
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA
Lamictal and associated names (see Annex I) 200 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 200 mg (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each tablet contains 200 mg lamotrigine
Kull pillola fiha 200 mg lamotrigine
30 tablets 56 tablets 100 tablets
30 pillola 56 pillola 100pillola
[To be completed nationally]
Jitkompla fuq bażi nazzjonali
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
86 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
90 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Lamictal and associated names (see Annex I) 2 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara l- Anness I), pilloli ta ’ 2 mg < li jixterdu/ jiġu mimgħuda > < li jixterdu > (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each dispersible/ chewable tablet contains 2 mg lamotrigine
Kull pillola (li tixtered/ tiġi mimgħuda fiha 2 mg lamotrigine
30 dispersible/ chewable tablets
30 pilloli li jixterdu/ jiġu mimgħuda
Oral use Read the package leaflet before use
Jittieħed mill- ħalq Aqra l- fuljett qabel l- użu
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 5 mg li jixterdu/ jiġu mimgħuda (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each dispersible/ chewable tablet contains 5 mg lamotrigine
Kull pillola (li tixtered/ tiġi mimgħuda fiha 5 mg lamotrigine
10 dispersible/ chewable tablets 14 dispersible/ chewable tablets 28 dispersible/ chewable tablets 30 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets
10 pilloli li jixterdu/ jiġu mimgħuda li jixterdu 14 pilloli li jixterdu/ jiġu mimgħuda li jixterdu 28 pilloli li jixterdu/ jiġu mimgħuda li jixterdu 30 pilloli li jixterdu/ jiġu mimgħuda li jixterdu 50 pilloli li jixterdu/ jiġu mimgħuda 56 pilloli li jixterdu/ jiġu mimgħuda
90 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 5 mg (li jixterdu/ jiġu mimgħuda (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
95 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 25 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 25 mg li jixterdu/ jiġu mimgħuda (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each dispersible/ chewable tablet contains 25 mg lamotrigine
Kull pillola (li tixtered/ tiġi mimgħuda fiha 25 mg lamotrigine
10 dispersible/ chewable tablets 14 dispersible/ chewable tablets 21 dispersible/ chewable tablets 28 dispersible/ chewable tablets 30 dispersible/ chewable tablets 42 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets Starter pack 21 dispersible/ chewable tablets, valproate add-on therapy Starter pack 42 dispersible/ chewable tablets, monotherapy
10 pilloli li jixterdu/ jiġu mimgħuda 14 pilloli li jixterdu/ jiġu mimgħuda 21 pilloli li jixterdu/ jiġu mimgħuda 28 pilloli li jixterdu/ jiġu mimgħuda 30 pilloli li jixterdu/ jiġu mimgħuda 42 pilloli li jixterdu/ jiġu mimgħuda 50 pilloli li jixterdu/ jiġu mimgħuda 56 pilloli li jixterdu/ jiġu mimgħuda 60 pilloli li jixterdu/ jiġu mimgħuda Pakkett tal- bidu 21 pillola li jixterdu/ jiġu mimgħuda valproate terapija add- on Pakkett tal- bidu 42 pillola li jixterdu/ jiġu mimgħuda valproate terapija add- on
[To be completed nationally]
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
15.
Biex timtela mill- pajjiż partikolari 15.
93 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
97 TAGĦRIF LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Lamictal and associated names (see Annex I) 25 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara l- Anness I), pilloli ta ’ 25 mg li jixterdu/ jiġu mimgħuda (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
(Starter pack 21 tablets, valproate add-on therapy – calender pack showing day numbers):
(Pakkett tal- bidu 21 tablets, valproate terapija add- on – pakkett kalendarju li juri n- numru ta ’ ġranet):
1 3 5 7 9 11 13 (one pocket) 2 4 6 8 10 12 14 (no pocket) 15 17 19 21 23 25 27 (one pocket) 16 18 20 22 24 26 28 (one pocket)
1 3 5 7 9 11 13 (kontenitur wieħed) 2 4 6 8 10 12 14 (kontenitur wieħed) 15 17 19 21 23 25 27 (kontenitur wieħed) 16 18 20 22 24 26 28 (kontenitur wieħed)
(Starter pack 42 tablets, monotherapy – calender pack showing day numbers):
(Pakkett tal- bidu 42 tablets, monoterapija – pakkett kalendarju li juri n- numru ta ’ ġranet):
1 2 3 4 5 6 7 (one pocket) 8 9 10 11 12 13 14 (one pocket) 15 16 17 18 19 20 21 (two pockets) 22 23 24 25 26 27 28 (two pockets)
1 2 3 4 5 6 7 (kontenitur wieħed) 8 9 10 11 12 13 14 (kontenitur wieħed) 15 16 17 18 19 20 21 (żewġ kontenituri) 22 23 24 25 26 27 28 (żewġ kontenituri)
94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 50 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 50 mg li jixterdu/ jiġu mimgħuda (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each dispersible/ chewable tablet contains 50 mg lamotrigine
Kull pillola (li tixtered/ tiġi mimgħuda fiha 50 mg lamotrigine
10 dispersible/ chewable tablets 14 dispersible/ chewable tablets 30 dispersible/ chewable tablets 42 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets 90 dispersible/ chewable tablets 100 dispersible/ chewable tablets 200 dispersible/ chewable tablets Starter pack 42 dispersible/ chewable tablets, non-valproate add-on therapy
10 pilloli li jixterdu/ jiġu mimgħuda 14 pilloli li jixterdu/ jiġu mimgħuda 30 pilloli li jixterdu/ jiġu mimgħuda 42 pilloli li jixterdu/ jiġu mimgħuda 50 pilloli li jixterdu/ jiġu mimgħuda 56 pilloli li jixterdu/ jiġu mimgħuda 60 pilloli li jixterdu/ jiġu mimgħuda 90 pilloli li jixterdu/ jiġu mimgħuda li jixterdu 100 pilloli li jixterdu/ jiġu mimgħuda 200 pilloli li jixterdu/ jiġu mimgħuda Pakkett tal- bidu 42 pillola li jixterdu/ jiġu mimgħuda, mhux valproate terapija add- on
96 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
100 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
(Starter pack 42 tablets, non-valproate add-on therapy – calender pack showing day numbers):
(Pakkett biex tibda ta ’ 42 tablets, mhux valproate terapija add- on – pakkett kalendarju li juri n- numru ta ’ ġranet):
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
101 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 100 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara l- Anness I), pilloli ta ’ 100 mg < li jixterdu/ jiġu mimgħuda > < li jixterdu > (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each dispersible/ chewable tablet contains 100 mg lamotrigine
Kull pillola (li tixtered/ tiġi mimgħuda li tixtered fiha 100 mg lamotrigine
10 dispersible/ chewable tablets 30 dispersible/ chewable tablets 50 dispersible/ chewable tablets 56 dispersible/ chewable tablets 60 dispersible/ chewable tablets 90 dispersible/ chewable tablets 100 dispersible/ chewable tablets 200 dispersible/ chewable tablets
10 pilloli li jixterdu/ jiġu mimgħuda 30 pilloli li jixterdu/ jiġu mimgħuda 50 pilloli li jixterdu/ jiġu mimgħuda 56 pilloli li jixterdu/ jiġu mimgħuda 60 pilloli li jixterdu/ jiġu mimgħuda 90 pilloli li jixterdu/ jiġu mimgħuda 100 pilloli li jixterdu/ jiġu mimgħuda 200 pilloli li jixterdu/ jiġu mimgħuda
Oral use Read the package leaflet before use
Jittieħdu mill- ħalq Aqra l- fuljett qabel l- użu
99 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
103 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Lamictal and associated names (see Annex I) 100 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 100 mg li jixterdu/ jiġu mimgħuda (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara l- Anness I), pilloli ta ’ 200 mg < li jixterdu/ jiġu mimgħuda > < li jixterdu > (Ara Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
Each dispersible/ chewable tablet contains 200 mg lamotrigine
Kull pillola (li tixtered/ tiġi mimgħuda fiha 200 mg lamotrigine
102 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal u ismijiet assoċjati (ara Anness I), pilloli ta ’ 200 mg li jixterdu/ jiġu mimgħuda (Ara l- Anness I – Biex timtela mill- pajjiż partikolari) Lamotrigine
103 PACKAGE LEAFLET
107 FULJETT TA ’ TAGĦRIF
104 PACKAGE LEAFLET:
108 FULJETT TA ’ TAGĦRIF:
Lamictal and associated names (see Annex I) 25 mg tablets Lamictal and associated names (see Annex I) 50 mg tablets Lamictal and associated names (see Annex I) 100 mg tablets Lamictal and associated names (see Annex I) 200 mg tablets Lamictal and associated names (see Annex I) 2 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 25 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 50 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 100 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets
Lamictal u ismijiet assoċjati (ara Anness I) Pilloli ta ’ 2mg li jixterdu/ jiġu mimgħuda Lamictal u ismijiet assoċjati (ara Anness I) Pilloli ta ’ 5mg li jixterdu/ jiġu mimgħuda Lamictal u ismijiet assoċjati (ara Anness I) Pilloli ta ’ 25mg li jixterdu/ jiġu mimgħuda Lamictal u ismijiet assoċjati (ara Anness I) Pilloli ta ’ 50mg li jixterdu/ jiġu mimgħuda Lamictal u ismijiet assoċjati (ara Anness I) Pilloli ta ’ 100mg li jixterdu/ jiġu mimgħuda Lamictal u ismijiet assoċjati (ara Anness I) Pilloli ta ’ 100mg li jixterdu/ jiġu mimgħuda
[See Annex I – To be completed nationally]
(Ara Anness I – Biex timtela mill- pajjiż partikolari)
You may need to read it again.
Jista jkollok bżonn terġa tarah.
This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek personalment.
It may harm them, even if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
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.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
In this leaflet 1 What Lamictal is and what it is used for 2 Before you take Lamictal 3 How to take Lamictal 4 Possible side effects 5 How to store Lamictal 6 Further information
Aktar tagħrif
WHAT LAMICTAL IS AND WHAT IT IS USED FOR
X’ INHU LAMICTAL U GĦALXIEX JINTUŻA
Lamictal belongs to a group of medicines called anti-epileptics.
Lamictal jifforma parti mill- grupp ta ’ mediċini msejħa anti- epilettiċi.
It is used to treat two conditions — epilepsy and bipolar disorder.
Jintuża fit- trattament ta ’ żewġ kondizzjonijiet – epilessija u mard bi- polari.
Lamictal treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits). • For adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines, to treat epilepsy.
Lamictal jikkura l- epilessija billi jimblokka s- sinjali fil- moħħ li jagħtu bidu għal attakki epilettiċi. • Fil- każ ta ’ adulti u tfal ta ’ 13- il sena ’ l fuq, Lamictal jista ’ jintuża waħdu jew ma ’ mediċini oħra, fit - trattament ta ’ epilessija.
Lamictal can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome. • For children aged between 2 and 12 years, Lamictal can be used with other medicines, to treat those conditions.
Lamictal jista ’ jintuża wkoll ma ’ mediċini oħra biex jikkura l- aċċessjonijiet li jseħħu b’ kondizzjoni msejħa sindrome Lennox- Gastaut. • Fil- każ ta ’ tfal bejn sentejn u 12- il sena, Lamictal jista ’ jintuża ma ’ mediċini oħra fit- trattament ta ’ dawn il- kondizzjonijiet.
It can be used on its own to treat a type of epilepsy called typical absence seizures.
Jista ’ jintuża waħdu fit- trattament ta ’ tip ta ’ epilessija li tissejjaħ aċċessjonijiet tipiċi ta ’ assenza.
Lamictal also treats bipolar disorder.
Lamictal jintuża wkoll fit- trattament ta ’ mard bi- polari.
People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair).
Persuni b’ mard bi- polari (kultant imsejjaħ manija ta ’ depressjoni) jkollhom umuri estremi minn ħin għal ieħor, b’ perijodi ta ’ manija (eċċitament jew ewforija) li jinbidlu f’ perijodi ta ’ depressjoni (dwejjaq kbar jew disprament).
For adults aged 18 years and over, Lamictal can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder.
F’ adulti ta ’ 18- il sena ’ l fuq, Lamictal jista ’ jintuża waħdu jew ma ’ mediċini oħra, biex jgħin fil- prevenzjoni ta ’ perijodi ta ’ depressjoni li jseħħu f’ mard bi- polari.
It is not yet known how Lamictal works in the brain to have this effect.
Għad mhux magħruf jekk Lamictal jaħdimx fil- moħħ biex ikollu dan l- effett.
105 2.
109 2.
BEFORE YOU TAKE LAMICTAL
QABEL TIEĦU LAMICTAL
Do not take Lamictal: • if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamictal (listed in Section 6).
Tieħux Lamictal: • Jekk int allerġiku (għandek sensittivita ’ eċċessiva) għal lamotrigine jew xi wieħed mill - ingredjenti l- oħra ta ’ Lamictal (elenkati fis- sezzjoni 6).
If this applies to you:
Jekk dan jgħodd għalik:
Tell your doctor, and don’ t take Lamictal.
Għid lit- tabib tiegħek, u tieħux Lamictal.
Take special care with Lamictal Your doctor needs to know before you take Lamictal: • if you have problems with your kidneys • if you have ever developed a rash when you’ ve taken lamotrigine or other medicines for epilepsy • if you are already taking medicine that contains lamotrigine.
Oqgħod attent ħafna meta tieħu Lamictal Qabel tieħu Lamictal, it- tabib għandu jkun jaf: • Jekk għandekx xi problemi fil- kliewi • Jekk qattx kellek xi raxx meta ħadt lamotrigine jew xi mediċini oħra għall- epilessija. • Jekk intix qed tieħu diġa ’ xi mediċina li fiha lamotrigine.
If any of these applies to you:
Jekk xi waħda minn dawn tgħodd għalik:
Tell your doctor, who may decide to lower your dose, or that Lamictal is not suitable for you.
Għid lit- tabib, għax għandu mnejn jiddeċiedi li jnaqqaslek id- doża jew jgħidlek li Lamictal mhux tajjeb għalik.
Watch out for important symptoms If you develop any of these symptoms after you start taking Lamictal, get a doctor’ s help straight away: • an unusual skin reaction, such as redness or rashes • a sore mouth or eyes • a high temperature (fever), flu-like symptoms or drowsiness • swelling around your face, or swollen glands in your neck, armpit or groin • unexpected bleeding or bruising, or your fingers turning blue • a sore throat, or more infections (such as colds) than usual.
Oqgħod attent għal sintomi importanti Kekk jitfaċċawlek xi sintomi bħal dawn li ġejjin wara li tibda tieħu Lamictal, itlob l– għajnuna tat- tabib mill - ewwel: • reazzjoni mhux tas- soltu fil- ġilda, bħal ħmura jew xi raxx • ħruq fil- ħalq jew fl- għajnejn • deni qawwi, sintomi ta ’ influwenza jew nagħas • nefħa fil- wiċċ, jew glandoli minfuħa fl- għonq, taħt id- dirgħajn jew fl- irqiq ta ’ bejn il- koxxa u ż - żaqq • ħruġ mhux mistenni ta ’ demm jew tbenġil, jew swaba jsiru vjola • ħruq fil- gerżuma, jew infezzjonijiet (bħal riħ) aktar mis- soltu.
These symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if you start on too high a dose or if your dose is increased too quickly, or if you’ re taking Lamictal with another medicine called valproate.
Dawn is- sintomi aktarx jidhru fl- ewwel xhur tat- trattament b’ Lamictal, speċjalment jekk tibda b’ dożi għolja jew iżżid id- dożi f’ salt, jew jekk tieħu Lamictal flimkien ma ’ mediċina oħra jisimha valproate.
Children are more likely to be affected than adults.
It- tfal aktarx jiġu affettwati aktar mill- kbar.
The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated.
Is- sintomi mniżżla hawn fuq jistgħu jiżviluppaw fi problemi akbar, bħal ħsarat f’ xi organu tal- ġisem jew xi kondizzjoni kerha ħafna fil- ġilda, jekk dawn ma jiġux trattati.
If you notice any of these symptoms:
Jekk tara xi sintomi bħal dawn:
See a doctor as soon as possible.
Ara tabib mill- aktar fis.
Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamictal.
It- tabib tiegħek għandu mnejn jiddeċiedi li jagħmillek xi testijiet tal- fwied, tal- kliewi jew tad- demm, u jista ’ wkoll jgħidlek biex ma tibqax tieħu Lamictal.
Thoughts of harming yourself or suicide People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide.
Ħsibijiet biex tagħmel ħsara lilek innifsek jew suwiċidju Nies b’ disturb bi- polari jistgħu xi kultant ikollhom ħsibijiet biex jagħmlu l- ħsara lilhom infushom jew jikkomettu suwiċidju.
If you have bipolar disorder, you may be more likely to think like this: • when you first start treatment • if you have previously had thoughts about harming yourself or about suicide • if you are under 25 years old.
Jekk għandek disturb bi- polari, jista ’ jkun aktar possibli li taħseb hekk: • meta l- ewwel tibda l- kura • jekk qabel kellek ħsibijiet biex tagħmel ħsara lilek innifsek jew dwar suwiċidju • jekk inti taħt il- 25 sena.
Occasionally, people with epilepsy may also have thoughts of harming themselves or committing suicide.
Kultant, nies b’ epilessija jista ’ ukoll ikollhom ħsibijiet biex jagħmlu ħsara lilhom infushom jew jikkommettu suwiċidju.
A small number of people being treated with Lamictal for bipolar disorder or epilepsy have had these thoughts.
Numru żgħir ta ’ nies li kienu fuq kura b’ Lamictal għal disturb bi- polari jew epilessija kellhom dawn il- ħsibijiet.
If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you’ re taking Lamictal:
Jekk għandek ħsibijiet jew esperjenzi li jinkwetawk, jew jekk tinnota li tħossok agħar jew tiżviluppa sintomi ġodda waqt li tkun qed tieħu Lamictal:
See a doctor as soon as possible or go to the nearest hospital for help.
Ara tabib mill- aktar fis jew mur fl- eqreb sptar għall- għajnuna
Some patients may experience severe seizures, which may cause serious health problems.
Jekk qed tieħu Lamictal għal epilessija L- aċċessjonijiet f’ ċerti tipi ta ’ epilessija jista ’ xi kultant imorru għall- agħar jew jiġru aktar spiss waqt li tkun qed tieħu Lamictal.
If your seizures happen more often, or if you experience a severe seizure while you’ re taking Lamictal:
Xi pazjenti jista ’ jkollhom aċċessjonijiet qawwija, li jistgħu jikkaġunaw problemi serji
106 See a doctor as soon as possible.
Ara tabib kemm jista ’ jkun malajr
Lamictal should not be given to people aged under 18 years to treat bipolar disorder.
Lamictal m’ għandux jingħata lil persuni taħt it- 18- il sena għat- trattament ta ’ mard bi- polari.
Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years.
Mediċini għad- depressjoni u għal mard ieħor mentali iżidu r- riskju ta ’ ħsibijiet u mġiba ta ’ suwiċidju fit- tfal u adolexxenti taħt it- 18- il sena.
Taking other medicines Tell your doctor or pharmacist if you’ re taking any other medicines, if you’ ve taken any recently, or if you start taking new ones — these include herbal medicines or other medicines you bought without a prescription.
Teħid ta ’ mediċini oħra Għid lit- tabib jew lill- ispiżjar tiegħek jekk tkun qed tieħu xi mediċini oħra jew tkun ħadthom reċentement, jew jekk tibda tieħu xi mediċini ġodda – dawn jinkludu mediċini minn ħxejjex jew xi mediċini oħra li tkun xtrajt mingħajr riċetta.
If you are taking certain medicines, your doctor may need to check the dose of Lamictal.
Jekk qed tieħu ċerti mediċini, it- tabib tiegħek jista ’ jħoss il- bżonn li jiċċekkja d- doża ta ’ Lamictal.
These include: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy • lithium, used to treat mental health problems • bupropion, used to treat mental health problems or to stop smoking Tell your doctor if you are taking any of these.
Fost dawn hemm: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate jew zonisamide, li jintużaw għall- epilessija • litju, li jintuża fil- kura ta ’ problemi ta ’ saħħa mentali • bupropion, li jintuża fil- kura ta ’ problemi ta ’ saħħa mentali jew biex jitwaqqaf it- tipjip Għid lit- tabib tiegħek jekk tkun qed tieħu xi waħda minn dawn il- mediċini.
Some medicines interact with Lamictal or make it more likely that you’ ll have side effects.
Xi mediċini ma jaqblux ma ’ Lamictal jew iżidu l- probabbilta ’ ta ’ effetti sekondarji.
These include: • valproate, used to treat epilepsy and mental health problems • carbamazepine, used to treat epilepsy and mental health problems • phenytoin, primidone or phenobarbitone, used to treat epilepsy • olanzapine, used to treat mental health problems • risperidone, used to treat mental health problems • rifampicin, which is an antibiotic • a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection • hormonal contraceptives, such as the Pill (see below).
Fost dawn hemm: • valproate, li jintuża fil- kura ta ’ l- epilessija u fi problemi ta ’ saħħa mentali • carabamazepine, li jintuża fil- kura ta ’ l- epilessija u fi problemi ta ’ saħħa mentali • phenytoin, primidone jew phenobarbitone, li jintużaw fil- kura ta ’ l- epilessija • olanzapine, li jintuża fil- kura ta ’ problemi ta ’ saħħa mentali • risperidone, li jintuża fil- kura ta ’ problemi ta ’ saħħa mentali • rifampicin, li hu antibijotiku • taħlita ta ’ lopinavir u ritonavir, li tintuża fil- kura ta ’ l- infezzjoni mill- Virus ta ’ l - Immunodefiċjenza fil- Bniedem (HIV) • kontraċettivi ormonali, bħal ma hi l- Pillola (ara hawn taħt).