qanastek/EMEA-V3 huggingface dataset:
5 mg dispersible/ chewable tablets – where 2 mg dispersible/ chewable tablets are not marketed and 5 mg dispersible/ chewable tablets are the lowest marketed strength :< It should be noted that with the currently available Lamictal 5 mg dispersible/chewable tablet strength, it is not possible to accurately initiate lamotrigine therapy using the recommended dosing guidelines in paediatric patients weighing less than 17 kg. >
Pilloli li jixterdu/ jiġu mimgħuda ta ’ 5 mg – meta pilloli ta ’ 2 mg li jixterdu/ jiġu mimgħuda ma jkunux fis - suq u pilloli Lamictal ta ’ 5 mg li jistgħu jixterdu / jiġu mimgħuda huma l- inqas qawwija fis- suq: < Għandu jiġi nnotat li bil- pilloli li jixterdu/ jiġu mimgħuda Lamictal ta ’ 5 mg li jinsabu fis- suq bħalissa, mhux possibbli li tinbeda terapija ta ’ lamotrigine bl- użu tal- linji gwida dwar dożaġġi rakkomandati f’ pazjenti pedjatriċi li jiżnu inqas minn 17 kg. >
Children below 2 years There are limited data on the efficacy and safety of lamotrigine for adjunctive therapy of partial seizures in children aged 1 month to 2 years (see section 4.4).
Tfal ta ’ taħt is- sentejn Hemm tagħrif limitat dwar l- effikaċja u s- sigurta ’ ta ’ lamotrigine bħala terapija addizjonali ta ’ aċċessjonijiet parzjali fi tfal ta ’ eta minn xahar sa sentejn (ara s- sezzjoni 4. 4).
There are no data in children below 1 month of age.
Ma hemmx tagħrif fi tfal taħt l- eta ’ ta ’ xahar.
Thus Lamictal is not recommended for use in children below 2 years of age.
Għalhekk Lamictal m’ huwiex rakkomandat għall- użu fi tfal taħt l- eta ’ ta ’ sentejn.
If, based on clinical need, a decision to treat is nevertheless taken, see sections 4.4, 5.1 and 5.2.
Jekk, fuq bażi ta ’ bżonn kliniku, xorta tittieħed deċiżjoni biex tingħata l- kura, ara s- sezzjonijiet 4. 4, 5. 1 u 5. 2.
Bipolar disorder
Mard bi- polari
The recommended dose escalation and maintenance doses for adults of 18 years of age and above are given in the tables below.
Id- dożi rakkomandati dwar kif jiżdiedu u jinżammu fil- livelli ta ’ stabbilizzazzjoni meħtieġa fil- każ ta ’ adulti ta ’ 18- il sena u ’ l fuq jidhru fit- tabelli hawn taħt.
The transition regimen involves escalating the dose of lamotrigine to a maintenance stabilisation dose over six weeks (Table 3) after which other psychotropic medicinal products and/ or AEDs can be withdrawn, if clinically indicated (Table 4).
Il- programm ta ’ dożaġġ fi transizzjoni jinvolvi ż- żjieda tad- doża ta ’ lamotrigine għal doża li tistabbilixxi l- livelli meħtieġa ta ’ stabbilizzazzjoni fuq perijodu ta ’ sitt xhur (Tabella 3) u li mbagħad prodotti mediċinali psikotropiċi u/ jew AEDs oħra jistgħu jitwaqqfu, jekk dan ikun klinikament indikat (Tabella 4).
The dose adjustments following addition of other psychotropic medicinal products and/ or AEDs are also provided below (Table 5).
L- aġġustamenti fid- doża wara li jkunu żdiedu prodotti mediċinali psikotropiċi u AEDs oħra jidhru wkoll hawn taħt (Tabella 5).
Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).
Minħabba r- riskju ta ’ raxx id- doża tal- bidu u żjidiet oħra ta ’ wara m’ għandhomx jinqabżu (ara sezzjoni 4. 4).
52 Table 3:
56 Tabella 3:
Adults aged 18 years and above - recommended dose escalation to the maintenance total daily stabilisation dose in treatment of bipolar disorder
Adulti ta ’ minn 18- il sena ’ l fuq – żjieda ta ’ doża rakkomandata għad- doża li tistabbilixxi t- total ta ’ kuljum biex jinkisbu l- livelli meħtieġa ta ’ stabbilizzazzjoni fit- trattament ta ’ mard bi- polari.
Treatment Regimen
Metodu ta ’ Trattament
glucuronidation
Ġimgħa 5
Doses in the range 100 - 400 mg/ day used in clinical trials
Doża ta ’ Stabbilizzazzjoni fil- Mira (Ġimgħa 6) *
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation – see section 4.5):
Monotherapy b’ terapija b’ lamotrigine JEW b’ terapija addizzjonali MINGĦAJR valproate u MINGĦAJR indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5):
This dosage regimen should 12.5 mg/ day
Dan il- programm ta ’ dożaġġ 25 mg/ kuljum 50 mg/ kuljum 100 mg/ kulju 200 mg/ kuljum – doża fil - għandu jintuża flimkien ma ’
25 mg/ day
(darba kuljum) (darba kuljum m
50 mg/ day
mira normali biex
100 mg/ day - usual target
jew żewġ dożi maqsuma)
be used with valproate regardless of any concomitant medicinal products
(darba kuljum jinkiseb l- aħjar rispons jew żewġ dożi (darba kuljum jew żewġ maqsuma) dożi maqsuma)
(given as 25 mg (once a day) (once a day or dose on alternate two divided days) doses)
lamotrigine
for optimal response (once a day or two divided doses) Maximum dose of 200 mg/ day can be used depending on clinical response
Dożi fl- iskala ta ’ 100- 400 mg/ kuljum użati fi provi kliniċi
This dosage regimen should be used without valproate but with:
Terapija addizzjonali B’ valproate (impeditur ta ’ glukuronidazzjoni ta ’ lamotrigine – ara sezzjoni 4. 5) Dan il- programm ta ’ dożaġġ 12. 5 mg/ kuljum 25 mg/ kulju għandu jintuża b’ valproate (mogħtija bħala m (darba ikunu x’ ikunu xi prodotti 25 mg darba iva kuljum) mediċinali oħra li jittieħdu u darba le) flimkien
100 mg/ day (two divided doses)
50 mg/ kuljum 100 mg/ kuljum – id- doża (darba kuljum fil- mira normali biex jew żewġ dożi jinkiseb l- aħjar rispons maqsuma) (darba kuljum jew żewġ dożi maqsuma)
200 mg/ day (two divided doses)
Tista ’ tintuża doża massima ta ’ 200 mg/ kuljum skond ir - rispons kliniku
300 mg/ day in week 6, if necessary increasing to usual target dose of 400 mg/ day in week 7, to
Terapija addizzjonali MINGĦAJR valproate u B’ indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5):
phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ ritonavir
Dan il- programm ta ’ dożaġġ 50 mg/ kuljum 100 mg/ kulju 200 mg/ kulju 300 mg/ kuljum fil - għandu jintuża mingħajr valproate iżda bi: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ ritonavir
achieve optimal response (two divided doses)
Ġimgħa 6, jekk hemm bżonn jiżdiedu għad- doża fil- mira normali ta ’ 400 mg/ kuljum fil- Ġimgħa 7, biex jinkiseb l- aħjar rispons (żewġ dożi maqsuma)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the dose escalation as recommended for lamotrigine with concurrent valproate, should be used.
F’ pazjenti li jkunu jieħdu prodotti mediċinali li għad mhux magħruf jekk il- farmakokinetiċi tagħhom ma ’ lamotrigine jaqblux jew le (ara sezzjoni 4. 5), għandu jintuża l- programm ta ’ dożaġġ miżjud kif rakkomandat għal lamotrigine flimkien ma valproate.
* The Target stabilisation dose will alter depending on clinical response
* Id- doża ta ’ stabbilizzazzjoni fil- Mira tinbidel skond ir- rispons kliniku
53 Table 4:
57 Tabella 4:
Adults aged 18 years and above - maintenance stabilisation total daily dose following withdrawal of concomitant medicinal products in treatment of bipolar disorder Once the target daily maintenance stabilisation dose has been achieved, other medicinal products may be withdrawn as shown below.
Darba li d- doża li tistabbilixxi t- total ta ’ kuljum biex jinkisbu l- livelli meħtieġa tkun stabbilita, prodotti mediċinali oħra jistgħu jitwaqqfu kif jidher hawn taħt.
Current lamotrigine Week 1 stabilisation dose (beginning with (prior to withdrawal) withdrawal)
Doża korrenti ta ’ stabbilizzazzjoni ta ’ lamotrigine (qabel ma jitwaqqaf)
Week 2
Ġimgħa 1 (tibda Ġimgħa 2 malli jitwaqqaf)
Week 3 onwards *
Ġimgħa 3 ’ l quddiem *
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation – see section 4.5), depending on original dose of lamotrigine:
Meta jitwaqqaf valproate (impeditur ta ’ glukuronidazzjoni jiddependi mid- doża oriġinali ta ’ lamotrigine:
When valproate is withdrawn, double the stabilisation dose, not exceeding an increase of more than 100 mg/ week
ta ’ lamotrigine -
100 mg/ day
ara sezzjoni 4. 5), li
200 mg/ day
200 mg/ kulju m
Maintain this dose (200 mg/ day) (two divided doses)
Żomm din id- doża (200 mg/ kuljum) (żewġ dożi maqsuma)
200 mg/ day
200 mg/ kuljum
300 mg/ day
300 mg/ kulju m
400 mg/ day Maintain this dose (400 mg/ day)
400 mg/ day Żomm din id - doża (400 mg/ kuljum)
Withdrawal of inducers of lamotrigine glucuronidation (see section 4.5), depending on original dose of lamotrigine:
Meta jitwaqqfu indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5), skond id- doża oriġinali ta ’ lamotrigine:
This dosage regimen should be used when the following are
Dan il- programm ta ’ dożaġġ għandu jintuża meta jitwaqqfu
400 mg/ day 400 mg/ day
400 mg/ kuljum
300
300 mg/ kulju m
mg/ day
mg/ kulju m
200 mg/ day 200 mg/ day
200 mg/ kulju m
150 mg/ day
150 mg/ kulju 100 m
100 mg/ day
mg/ kulju m
Withdrawal of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Meta jitwaqqfu prodotti mediċinali li MHUMIEX impedituri jew indutturi sostanzjali ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5):
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are withdrawn
Dan il- programm ta ’ dożaġġ għandu jintuża meta jitwaqqfu prodotti mediċinali oħra li mhumiex impedituri jew indutturi sostanzjali ta ’ glukuronidazzjoni ta ’ lamotrigine
Maintain target dose achieved in dose escalation (200 mg/ day; two divided doses) (dose range 100 - 400 mg/ day)
Ibqa ’ fuq id- doża fil- mira miksuba waqt iż- żjieda tad- doża (200 mg/ kuljum; żewġ dożi maqsuma) (skala tad- doża 100- 400 mg/ kuljum)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate, should be used.
F’ pazjenti li jkunu jieħdu prodotti mediċinali li għad mhux magħruf jekk il- farmakokinetiċi tagħhom ma ’ lamotrigine jaqblux jew le (ara sezzjoni 4. 5), għandu jintuża l- programm ta ’ dożaġġ kif rakkomandat għal lamotrigine flimkien ma valproate.
* Dose may be increased to 400 mg/ day as needed
• Id- doża tista ’ tiżdied sa 400 mg/ kuljum kif meħtieġ
54 Table 5:
58 Tabella 5:
Adults aged 18 years and above - adjustment of lamotrigine daily dosing following the addition of other medicinal products in treatment of bipolar disorder There is no clinical experience in adjusting the lamotrigine daily dose following the addition of other medicinal products.
Adulti ta ’ minn 18- il sena ’ l fuq – aġġustament tad- dożaġġ ta ’ kuljum ta ’ lamotrigine wara ż - żjieda ta ’ prodotti mediċinali oħra fit- trattament ta ’ mard bi- polari Għad m’ hawnx esperjenza klinika dwar l- aġġustament tad- dożaġġ ta ’ kuljum ta ’ lamotrigine wara ż- żjieda ta ’ prodotti mediċinali oħra.
However, based on interaction studies with other medicinal products, the following recommendations can be made:
Madankollu, fuq il- bażi ta ’ studji dwar kemm din taqbel ma ’ prodotti mediċinali oħra, jistgħu isiru dawn ir- rakkomandazzjonijiet li ġejjin:
Current lamotrigine stabilisation dose (prior to addition)
Id- doża kurrenti għall - istabbilizzazzjoni ta ’ lamotrigine (qabel iż- żjieda)
Week 1 (beginning with addition)
Ġimgħa 1 (tinbeda biż - żjieda)
Week 3 onwards
Ġimgħa 3 ’ l quddiem
Addition of valproate (inhibitor of lamotrigine glucuronidation – see section 4.5), depending on original dose of lamotrigine:
Żjieda ta ’ valproate (impeditur ta ’ glukuronidazzjoni ta ’ lamotrigine – ara sezzjoni 4. 5), skond id- doża oriġinali ta ’ lamotrigine:
This dosage regimen should be used when valproate is added
Dan il- programm ta ’ dożaġġ għandu jintuża meta jiżdied
100 mg/ day Maintain this dose (100 mg/ day)
100 mg/ kulj Żomm din id- doża um (100 mg/ kuljum)
regardless of any concomitant medicinal products
valproate ikunu x’ ikunu xi prodotti 300 mg/ kuljum mediċinali konkomitanti oħra 400 mg/ kuljum
200 mg/ day Maintain this dose (200 mg/ day)
150 mg/ kul Żomm din id- doża jum (150 mg/ kuljum) 200 mg/ kul Żomm din id- doża jum (200 mg/ kuljum)
Addition of inducers of lamotrigine glucuronidation in patients NOT taking valproate (see section 4.5), depending on original dose of lamotrigine:
Żjieda ta ’ indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine f’ pazjenti li MA JKUNUX jieħdu valproate (ara sezzjoni 4. 5), skond id- doża oriġinali ta ’ lamotrigine:
This dosage regimen should be used when the following are added
Il- programm ta ’ dożaġġ għandu jintuża meta dawn li ġejjin jiżdiedu
400 mg/ day
200 mg/ kul 300 mg/ kulju 400 mg/ kuljum jum m
without valproate:
mingħajr valproate:
150 mg/ day
150 mg/ kuljum
300 mg/ day
150 mg/ kul 225 mg/ kulju 300 mg/ kuljum jum m
100 mg/ day 100 mg/ day
100 mg/ kuljum
200 mg/ day
100 mg/ kul 150 mg/ kulju 200 mg/ kuljum jum m
Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Żjieda ta ’ prodotti mediċinali li MHUMIEX impedituri jew indutturi sostanzjali ta ’ glukuronidazzjoni ta ’ lamotrigine (ara sezzjoni 4. 5):
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are added
Dan il- programm ta ’ dożaġġ għandu jintuża meta jiżdiedu prodotti mediċinali oħra li ma jkunux impedituri jew indutturi sostanzjali ta ’ glukuronidazzjoni ta ’ lamotrigine
Maintain target dose achieved in dose escalation (200 mg/ day; dose range 100-400 mg/ day)
Żomm id- doża fil- mira miksuba fiż- żjieda tad- doża (200 mg/ kuljum; skala ta ’ doża 100- 400 mg/ kuljum
Discontinuation of Lamictal in patients with bipolar disorder In clinical trials, there was no increase in the incidence, severity or type of adverse reactions following abrupt termination of lamotrigine versus placebo.
Meta Lamictal jitwaqqaf f’ pazjenti b’ mard bi- polari Fi provi kliniċi, ma kien hemm ebda żjieda fl- inċidenza, severita ’ jew tipi ta ’ reazzjonijiet avversi wara t - twaqqif f’ salt ta ’ lamotrigine kontra plaċebo.
Therefore, patients may terminate Lamictal without a step-wise reduction of dose.
Għalhekk, il- pazjenti jistgħu iwaqqfu Lamictal mingħajr ma ’ jnaqqsu d- doża ftit ftit.
Children and adolescents below 18 years Lamictal is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
Tfal u adolexxenti taħt it- 18- il sena Lamictal mhuwiex rakkomandat għal tfal taħt it- 18- il sena minħabba nuqqas ta ’ tagħrif dwar sigurta ’ u effikaċja (ara sezzjoni 4. 4).
55 General dosing recommendations for Lamictal in special patient populations
59 Rakkomandazzjonijiet ġenerali dwar dożi ta ’ Lamictal f’ popolazzjonijiet ta ’ pazjenti speċjali
Women taking hormonal contraceptives The use of an ethinyloestradiol/ levonorgestrel (30 µg/ 150 µg) combination increases the clearance of lamotrigine by approximately two-fold, resulting in decreased lamotrigine levels.
Nisa li jkunu jieħdu kontraċettivi ormonali L- użu flimkien ta ’ ethinyloestradiol/ levonorgestrel (30 µg/ 150 µg) iżid it- tneħħija ta ’ lamotrigine bid - doppju, u dan jirriżulta fi tnaqqis ta ’ livelli ta ’ lamotrigine.
Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) may be needed to attain a maximal therapeutic response.
Wara t- titrazzjoni, dożi ogħla stabbiliti ta ’ lamotrigine (sa darbtejn aktar) jistgu ikunu meħtieġa biex jinkiseb l- aħjar riżultat terapewtiku.
During the pill-free week, a two-fold increase in lamotrigine levels has been observed.
Matul il - ġimgħa bla pilloli, ġiet osservata żjieda doppja fil- livelli ta ’ lamotrigine.
Dose-related adverse events cannot be excluded.
Ma jistgħux jiġu esklużi reazzjonijiet avversi relatati mad- dożi.
Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).
Għalhekk, għandha tingħata konsiderazzjoni għall- użu ta ’ kontraċezzjoni mingħajr il- ġimgħa bla pilloli, bħala l- ewwel linja ta ’ terapija (per eżempju, kontraċettivi ormonali kontinwi jew metodi mhux ormonali; ara sezzjonijiet 4. 4 u 4. 5).
Starting hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be increased by as much as two-fold (see sections 4.4 and 4.5).
Meta jinbdew kontraċettivi ormonali f’ pazjenti li jkunu ġa qed jieħdu dożi ta ’ stabbilizzazzjoni ta ’ lamotrigine BLA ma jieħdu indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine Id- doża stabbilita ta ’ lamotrigine tkun teħtieġ, fil- biċċa l- kbira, li tiżdied sa d- doppju (ara sezzjonijiet 4. 4 u 4. 5).
It is recommended that from the time that the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to 100 mg/ day every week, according to the individual clinical response.
Hu rakkomandat li malli tinbeda l- kontraċezzjoni ormonali, id- doża ta ’ lamotrigine tiżdied b’ 50 jew 100 mg/ kuljum kull ġimgħa, skond ir- riżultati kliniċi ta ’ l- individwu.
Dose increases should not exceed this rate, unless the clinical response supports larger increases.
Iż- żjidiet fid- dożi m’ għandhomx jaqbżu din ir- rata, sakemm ir- riżultat kliniku ma jkunx jiffavorixxi żjidiet akbar.
Measurement of serum lamotrigine concentrations before and after starting hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained.
Il- kejl ta ’ konċentrazzjonijiet ta ’ lamotrigine fis- serum qabel u wara li tinbeda l- kontraċezzjoni ormonali jista ’ jiġi kkunsidrat, bħala konferma li l- konċentrazzjoni linja bażi ta ’ lamotrigine tibqa ’ stabbilizzata.
If necessary, the dose should be adapted.
Jekk hemm bżonn, id- doża għandha tiġi adattata.
In women taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i. e. on days 15 to 21 of the pill cycle.
F’ nisa li jkunu fuq kontraċezzjoni ormonali li tinkludi ġimgħa ta ’ trattament mhux attiv (“ ġimgħa bla pilloli ”), għandu jsir monitoraġġ tal- livell ta ’ lamotrigine fis- serum matul it- tielet ġimgħa tat- trattament attiv, jiġifieri fil- 15 sal- 21 jum taċ- ċiklu tal- pilloli.
Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).
Għalhekk, għandu jiġi kkunsidrat l- użu ta ’ kontraċezzjoni mingħajr ma titwaqqaf il- pillola għal ġimgħa, bħala kura prinċipali (per eżempju, kontraċettivi ormonali kontinwi jew metodi mhux ormonali; ara s- sezzjonijiet 4. 4 u 4. 5).
Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5).
Meta jitwaqqfu l- kontraċettivi ormonali f’ pazjenti li jkunu ġa qed jieħdu dożi ta ’ stabbilizzazzjoni ta ’ lamotrigine MINGĦAJR ma jkunu jieħdu indutturi ta ’ glukuronidazzjoni ta ’ lamotrigine Id- doża stabbilita ta ’ lamotrigine tkun teħtieġ, fil- biċċa l- kbira, li titnaqqas sa b’ 50% (ara s- sezzjonijiet 4. 4 u 4. 5).
It is recommended to gradually decrease the daily dose of lamotrigine by 50- 100 mg each week (at a rate not exceeding 25% of the total daily dose per week) over a period of 3 weeks, unless the clinical response indicates otherwise.
Hu rakkomandat li d- doża ta ’ kuljum ta ’ lamotrigine titnaqqas bil- mod b’ 50 - 100 mg / kull ġimgħa (b’ rata li ma taqbiżx il- 25% tad- doża totali ta ’ kuljum kull ġimgħa) fuq perijodu ta ’ tliet ġimgħat, sakemm ir- riżultati kliniċi ma jindikawx mod ieħor.
Measurement of serum lamotrigine concentrations before and after stopping hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained.
Il- kejl ta ’ konċentrazzjonijiet ta ’ lamotrigine fis- serum qabel ma tinbeda u wara li titwaqqaf il- kontraċezzjoni ormonali jista ’ jiġi kkunsidrat, bħala konferma li l - konċentrazzjoni linja bażi ta ’ lamotrigine tibqa ’ stabbilizzata.
In women who wish to stop taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i. e. on days 15 to 21 of the pill cycle.
F’ nisa li jixtiequ jiefqu jieħdu kontraċezzjoni ormonali li tinkludi ġimgħa ta ’ trattament mhux attiv (“ ġimgħa bla pilloli ”), għandu jsir monitoraġġ tal - livell ta ’ lamotrigine fis- serum matul it- tielet ġimgħa tat- trattament attiv, jiġifieri fil- 15 sal- 21 jum taċ- ċiklu tal- pilloli.
Samples for assessment of lamotrigine levels after permanently stopping the contraceptive pill should not be collected during the first week after stopping the pill.
M’ għandhomx jinġabru kampjuni biex ikunu assessjati l- livelli ta ’ lamotrigine wara li titwaqqaf il- pillola kontraċettiva għal dejjem matul l- ewwel ġimgħa wara li tkun twaqqfet il- pillola.
Starting lamotrigine in patients already taking hormonal contraceptives Dose escalation should follow the normal dose recommendation described in the tables.
Meta jinbeda lamotrigine f’ pazjenti li ġa jkunu qed jieħdu kontraċettivi ormonali Iż- żjieda fid- dożaġġ għandha ssir skond ir- rakkomandazzjoni dwar dożi normali deskritta fit- tabelli.
Starting and stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and TAKING inducers of lamotrigine glucuronidation Adjustment to the recommended maintenance dose of lamotrigine may not be required.
Aġġustament tad- doża stabbilizzata rakkomandata ta ’ lamotrigine jista ’ ma jkunx hemm bżonnu.
Elderly (above 65 years) No dosage adjustment from the recommended schedule is required.
Anzjani (’ il fuq minn 65 sena) M’ hemmx bżonn ta ’ aġġustament tad- dożaġġ kif rakkomandat fl- iskeda.
The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).
Il- farmakokinetiċi ta ’ lamotrigine f’ dan il- grupp mhumiex wisq differenti minn dawk ta ’ popolazzjoni adulta mhux tant anzjana (ara sezzjoni 5. 2)
Renal impairment Caution should be exercised when administering Lamictal to patients with renal failure.
Indeboliment tal- kliewi Meta Lamictal jingħata lil pazjenti b’ indeboliment tal- kliewi dan għandu jsir b ’ attenzjoni kbira.
For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients' concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).
Fil- każ ta ’ pazjenti b’ indeboliment tal- kliewi gravi ħafna, id- dożi tal- bidu ta ’ lamotrigine għandhom ikunu bażati fuq il - prodotti mediċinali konkomitanti li jkunu qed jieħdu l- pazjenti; tnaqqis mid- dożi stabbiliti jista ’ jkun effettiv f’ pazjenti b’ indeboliment serju tal- funzjoni tal- kliewi (ara sezzjonijiet 4. 4 u 4. 5).
56 Hepatic impairment Initial, escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment.
60 Indeboliment tal- fwied Id- dożi tal- bidu, dawk li jiżdiedu u dawk ta ’ stabbilizzazzjoni ġeneralment għandhom jitnaqqsu b’ 50% f’ pazjenti b’ indeboliment tal- fwied moderat (Child- Pugh grad B) u b’ 75% f’ dawk b’ indeboliment gravi (Child- Pugh grad Ċ).
Escalation and maintenance doses should be adjusted according to clinical response (see section 5.2).
Id- dożi li jiżdiedu u dawk ta ’ stabbilizzazzjoni għandhom jiġu aġġustati skond ir - riżultat kliniku (ara sezzjoni 5. 2).
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita ’ eċċessiva għas- sustanzi attivi jew għal xi wħud minn dawk mux attivi.
Skin rash
Raxx fil- ġilda
There have been reports of adverse skin reactions, which have generally occurred within the first eight weeks after initiation of lamotrigine treatment.
Dehru rapporti ta ’ reazzjonijiet mhux mixtieqa fil- ġilda, li ġeneralment seħħew fl- ewwel tmien ġimgħat wara li jkun inbeda t- trattament b’ lamotrigine.
The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported.
Fil- parti l- kbira dawn kienu każi ta ’ raxx ħafif li jgħaddi waħdu, biss ġie li kien hemm każi ta ’ raxx serju li jkun jeħtieġ trattament fi sptar u t- twaqqif ta ’ lamotrigine.
These have included potentially life-threatening rashes such as Stevens– Johnson syndrome and toxic epidermal necrolysis (see section 4.8).
Ma ’ dawn kien hemm każijiet ta ’ raxx li jista ’ jipperikola l- ħajja bħas- sindrome Stevens- Johnson u nekroliżi tossika tal- ġilda (ara sezzjoni 4. 8).
In adults enrolled in studies utilizing the current lamotrigine dosing recommendations the incidence of serious skin rashes is approximately 1 in 500 in epilepsy patients.
F’ adulti reġistrati fi studji li jutilizzaw ir- rakkomandazzjonijiet korrenti dwar dożaġġi ta ’ lamotrigine l - inċidenza ta ’ raxx serju fil- ġilda kienet ta’ madwar 1 f’ kull 500 pazjenti epilettiċi.
Approximately half of these cases have been reported as Stevens– Johnson syndrome (1 in 1000).
Madwar nofs dawn il- każi ġew rappurtati bħala sindrome Stevens- Johnson (1 minn kull 1000).
In clinical trials in patients with bipolar disorder, the incidence of serious rash is approximately 1 in 1000.
Fi provi kliniċi fuq pazjenti b’ mard bi - polari, l- inċidenza ta ’ raxx serju kienet ta ’ madwar 1 minn kull 1000.
The risk of serious skin rashes in children is higher than in adults.
Ir- riskju ta ’ raxx serju fit- tfal hu akbar minn dak tal- kbar.
Available data from a number of studies suggest the incidence of rashes associated with hospitalisation in epileptic children is from 1 in 300 to 1 in 100.
Tagħrif li jeżisti minn numru ta ’ studji juri li l - inċidenza ta ’ raxx li kien jeħtieġ sptar għal tfal epilettiċi kien minn 1 kull 300 sa 1 kull 100.
In children, the initial presentation of a rash can be mistaken for an infection, physicians should consider the possibility of a reaction to lamotrigine treatment in children that develop symptoms of rash and fever during the first eight weeks of therapy.
It- tobba għandhom iqisu l- possibilta ’ ta ’ reazzjoni għat- trattament b’ lamotrigine fi tfal li jiżviluppaw sintomi ta ’ raxx u deni fl- ewwel tmien ġimgħat tat- terapija.
Additionally the overall risk of rash appears to be strongly associated with:
Barra dan, ir- riskju ġenerali ta ’ raxx jidher li aktarx ikun assoċjat ma:
high initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see section 4.2)
- dożi inizjali għolja ta ’ lamotrigine li jaqbżu d- doża rakkomandata ta ’ żjieda fit- terapija b’ lamotrigine
-
(ara sezzjoni 4. 2)
concomitant use of valproate (see section 4.2).
- l- użu fl- istess ħin ta ’ valproate (ara sezzjoni 4. 2).
Caution is also required when treating patients with a history of allergy or rash to other AEDs as the frequency of non-serious rash after treatment with lamotrigine was approximately three times higher in these patients than in those without such history.
Għandha wkoll tingħata attenzjoni fit- trattament ta ’ pazjenti bi storja ta ’ allerġija jew raxx għal AEDs oħra għax il- frekwenza ta ’ raxx mhux daqshekk gravi b’ lamotrigine kienet madwar tliet darbiet akbar f’ dawn il - pazjenti minn dawk mingħajr storja bħal dik.
All patients (adults and children) who develop a rash should be promptly evaluated and Lamictal withdrawn immediately unless the rash is clearly not related to lamotrigine treatment.
Il- pazjenti kollha (kbar u żgħar) li jiżviluppaw raxx għandhom jiġu eżaminati mill- ewwel u Lamictal jitwaqqfilhom sakemm ir- raxx ma jkunx biċ- ċar relatat mat- trattament b’ lamotrigine.
It is recommended that Lamictal not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.
Hu rrakkomandat li Lamictal ma jerġgħax jibda jingħata lil pazjenti li kienu waqqfuh minħabba xi raxx li qabel kien assoċjat ma ’ trattament b’ lamotrigine sakemm il- benefiċċju li jista ’ jinkiseb ma jkunx akbar mir- riskju li jittieħed.
Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver (see section 4.8).
Raxx ġie wkoll rappurtat bħala parti ta ’ sindrome ta ’ sensittivita ’ eċċessiva assoċjata ma ’ għamla varjata ta ’ sintomi sistemiċi li jinkludu deni, limfadenopatija, edema fil- wiċċ u anormalitajiet fid- demm u l- fwied (ara sezzjoni 4. 8).
The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation and multiorgan failure.
Is- sindrome turi firxa wiesgħa ta ’ severita ’ klinika u tista ’, għalkemm rari, twassal għal koagulazzjoni mxerrda fil- vini u ħsara f’ diversi partijiet tal- ġisem.
It is important to note that early manifestations of hypersensitivity (for example fever, lymphadenopathy) may be present even though rash is not evident.
Ta ’ min jinnota li jistgħu jidhru sinjali bikrin ta ’ sensittivita ’ eċċessiva (per eżempju deni, limfadenopatija) minkejja li r- raxx ma jkunx tfaċċa.
If such signs and symptoms are present the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Jekk ikun hemm sinjali u sintomi bħal dawn il- pazjent għandu jiġi eżaminat mill- ewwel u Lamictal jitwaqqaf jekk ma tkunx stabbilita xi etjoloġija oħra.
57 Clinical worsening and suicide risk
61 Sitwazzjoni klinika li tmur għall- agħar u riskju ta ’ suwiċidju
Suicidal ideation and behaviours (suicidality) have been reported in patients treated with AEDs in several indications, including epilepsy and bipolar disorder.
Ideat u aġir ta ’ suwiċidju (suwiċidalita ’) ġew irrapurtati f’ pazjenti ittrattati b' AED f' ħafna indikazzjonijiet, fosthom l- epilessija u d- disturb bi- polari.
A meta-analysis of placebo-controlled trials of AEDs (including lamotrigine) showed an increased risk of suicidal behaviour (see section 5.1).
Meta- analiżi ta ’ studji kliniċi, kkontrollati bi plaċebo, ta ’ AED (fosthom lamotrigine) urew riskju akbar ta ’ aġir ta ’ suwiċidju (ara sezzjoni 5. 1).
For AEDs where no such data are available, a similar association with suicide-related events cannot be excluded.
F’ AED fejn ma kienx hemm din id- dat disponibbli, ma tistax tiġi eskluża assoċjazzjoni simili ma ’ eventi relatati ma ’ suwiċidju.
Therefore patients should be monitored for signs of suicidality during treatment with Lamictal.
Għalhekk il- pazjenti għandhom ikunu osservati għal sinjali ta 'suwiċidalita' waqt kura b' Lamictal.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidality emerge.
Pazjenti (u dawk li jieħdu ħsieb il- pazjenti) għandhom jingħataw il- parir li jfittxu parir mediku jekk joħorġu sinjali ta ’ suwiċidalita ’.
In patients with bipolar disorder, worsening of depressive symptoms and/ or the emergence of suicidality may occur whether or not they are taking medications for bipolar disorder, including Lamictal.
F’ pazjenti b’ distubi bi- polari, jistgħu imorru għall- agħar sintomi ta 'dipressjoni u/ jew toħroġ is- suwiċidalita' kemm jekk ikunu qed jieħdu l- mediċini għal disturb bi- polari, inkluż Lamictal, u kemm jekk le.
Therefore patients receiving Lamictal for bipolar disorder should be closely monitored for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes.
Għalhekk pazjenti li qegħdin jirċievu Lamictal għal disturbi bi- polari għandhom ikunu osservati mill- qrib għal sitwazzjoni klinika li marret għall- agħar (inkluż iżvilupp ta ’ sintomi ġodda) u suwiċidalita ’, speċjalment fil - bidu ta ’ kors ta ’ kura, jew fiż- żmien meta jkunu qed jinbidlu d- dożi.
Certain patients, such as those with a history of suicidal behaviour or thoughts, young adults, and those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, may be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Xi pazjenti, bħal dawk li jkollhom storja ta ’ aġir jew ħsibijiet ta ’ suwiċidju, adulti żgħażagħ, u dawk il- pazjenti li jesibixxu ammont sinifikanti ta ’ ideazzjoni ta ’ suwiċidju qabel ma tkun inbdiet il- kura, jistgħu ikollhom riskju akbar ta ’ ħsibijiet ta 'suwiċidju jew attentati ta' suwiċidju, u għandhom jingħataw osservazzjoni mill- qrib waqt il- kura.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who experience clinical worsening (including development of new symptoms) and/ or the emergence of suicidal ideation/ behaviour, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’ s presenting symptoms.
Għandha tingħata konsiderazzjoni li tindbidel is- sistema ta 'kura, kif ukoll il- possibilita' li titwaqqaf il - mediċina, f' pazjenti li jesperjenzaw sitwazzjoni klinika li tmur għall- agħar, (li tinkludi żvilupp ta ’ sintomi ġodda) u/ jew l- emerġenza ta ’ ideazzjoni/ aġir ta ’ suwiċidju, speċjalment jekk dawn is- sintomi ikunu severi, jidhru f’ daqqa, jew ma jkunux parti mis- sintomi li jippreżenta bihom il- pazjent.
Hormonal contraceptives
Kontraċettivi ormonali
Effects of hormonal contraceptives on lamotrigine efficacy The use of an ethinyloestradiol/ levonorgestrel (30 µg/ 150 µg) combination increases the clearance of lamotrigine by approximately two-fold resulting in decreased lamotrigine levels (see section 4.5).
Effetti ta ’ kontraċettivi ormonali fuq l- effikaċja ta ’ lamotrigine L- użu ta ’ kombinazzjoni ta ’ ethinyloestradiol/ levonorgestrel (30 µg/ 150 µg) iżid it- tneħħija ta ’ lamotrigine bid- doppju bir- riżultat ta ’ livelli aktar baxxi ta ’ lamotrigine (ara sezzjoni 4. 5).
A decrease in lamotrigine levels has been associated with loss of seizure control.
Tnaqqis fil- livelli ta ’ lamotrigine ġie assoċjat ma ’ tnaqqis ta ’ kontroll waqt attakk.
Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) will be needed in most cases to attain a maximal therapeutic response.
Wara titrazzjoni, dożi ta ’ stabbilizzazzjoni akbar ta ’ lamotrigine (sa darbtejn akbar) ikunu meħtieġa fil- parti l- kbira ta ’ każijiet biex jinkiseb l- aħjar riżultat terapewtiku.
When stopping hormonal contraceptives, the clearance of lamotrigine may be halved.
Meta l- kontraċettivi ormonali jitwaqqfu, it- tneħħija ta ’ lamotrigine tonqos bin- nofs.
Increases in lamotrigine concentrations may be associated with dose-related adverse events.
Żjidiet fil- konċentrazzjonijiet ta ’ lamotrigine jistgħu ikunu assoċjati ma ’ reazzjonijiet avversi relatati ma ’ dożi.
Patients should be monitored with respect to this.
Il- pazjenti għandhom jiġu monitorjati dwar dan.
In women not already taking an inducer of lamotrigine glucuronidation and taking a hormonal contraceptive that includes one week of inactive treatment (for example "pill-free week"), gradual transient increases in lamotrigine levels will occur during the week of inactive treatment (see section 4.2).
F’ nisa li mhumiex diġa ’ qed jieħdu xi induttur ta ’ glukuronidazzjoni ta ’ lamotrigine u li qed jieħdu kontraċettiv ormonali li jinkludi ġimgħa ta ’ trattament mhux attiv (per eżempju “ ġimgħa bla ebda pilloli ”), iseħħu żjidiet bil- mod u li jgħaddu malajr fil- livelli ta ’ lamotrigine matul il- ġimgħa mingħajr trattament attiv (ara sezzjoni 4. 2).
Variations in lamotrigine levels of this order may be associated with adverse effects.
Varjazzjonijiet bħal dawn fil- livelli ta ’ lamotrigine jistgħu jiġu assoċjati ma ’ reazzjonijiet avversi.
Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods).
Għalhekk, għandu jiġi kkunsidrat l- użu ta ’ kontraċezzjoni mingħajr il- ġimgħa bla pilloli, bħala terapija ta ’ l- ewwel linja (per eżempju, kontraċettivi ormonali kontinwi jew metodi mhux ormonali).
The interaction between other oral contraceptive or HRT treatments and lamotrigine have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters.
L- interazzjoni ma ’ kontraċettivi orali oħra jew trattamenti bl- HRT u lamotrigine ma sarux studji dwarha, għalkemm dawn jistgħu bl- istess mod jaffettwaw il- parametri farmakokinetiċi ta ’ lamotrigine.
Effects of lamotrigine on hormonal contraceptive efficacy An interaction study in 16 healthy volunteers has shown that when lamotrigine and a hormonal contraceptive (ethinyloestradiol/ levonorgestrel combination) are administered in combination, there is a modest increase in levonorgestrel clearance and changes in serum FSH and LH (see section 4.5).
Effetti ta ’ lamotrigine fuq l- effikaċja ta ’ kontraċettivi ormonali Studju dwar interazzjoni f’ 16- il voluntier f’ saħħithom wera li meta lamotrigine u kontraċettiv ormonali (kombinazzjoni ethinyloestradiol/ levonorgestrel) jingħataw flimkien, ikun hemm żjieda żgħira fit- tneħħija ta ’ levonorgestrel u bidliet fis- serum FSH u LH (ara sezzjoni 4. 5).
The impact of these changes on ovarian ovulatory activity is unknown.
L- effett ta ’ dawn il- bidliet fuq l- attivita ’ ovulatorja ta ’ l- ovarju mhux magħruf.
However, the possibility of these changes resulting in decreased contraceptive efficacy in some patients taking hormonal preparations with lamotrigine cannot be excluded.
Madankolu, il- possibilta ’ li bidliet bħal dawn jirriżultaw f’ nuqqas ta ’ effikaċja kontraċettiva f’ xi pazjenti li jieħdu preparazzjonijiet ormonali ma ’ lamotrigine ma tistax tiġi eskluża.
Therefore patients should be instructed to promptly report changes in their menstrual pattern, i. e. breakthrough bleeding.
Għalhekk, il- pazjenti għandhom jiġu mitluba biex jirrappurtaw immedjatament bidliet bħal dawn fil- proċess menstrwali tagħhom, jiġifieri meta titfaċċa xi dmija.
58 Dihydrofolate reductase
62 Dihydrofolate reductase
Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6).
Lamotrigine għandu l- effett ħafif ta ’ impeditur fuq dihydrofolic acid reductase, għalhekk hemm il - possibilta ’ ta ’ xi tfixkil ma ’ folate metabolism waqt terapija fit- tul (ara sezzjoni 4. 6).
However, during prolonged human dosing, lamotrigine did not induce significant changes in the haemoglobin concentration, mean corpuscular volume, or serum or red blood cell folate concentrations up to 1 year or red blood cell folate concentrations for up to 5 years.
Madankollu, matul dożaġġ fit- tul, lamotrigine ma induċiex xi tibdiliet sostanzjali fil- konċentrazzjoni ta ’ l- emoglobina, tal - volum medju korpuskulari, jew tal- konċentrazzjonijiet ta ’ folate fis- serum jew taċ- ċelluli ħomor tad- demm sa sena jew ta ’ konċentrazzjonijiet ta ’ folate fiċ- ċelluli ħomor tad- demm sa 5 snin.
Renal failure
Mard tal- kliewi
In single dose studies in subjects with end stage renal failure, plasma concentrations of lamotrigine were not significantly altered.
Fi studji b’ doża waħda f’ pazjenti b’ mard gravi tal- kliewi, il- konċentrazzjonijiet ta ’ plasma ta ’ lamotrigine ma nbidlux sostanzjalment.
However, accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.
Madankollu, wieħed aktarx għandu jistenna akkumulazzjoni tal- metabolit tal - glukunorid; għalhekk għandha tingħata attenzjoni fil- kura ta ’ pazjenti b’ mard tal- kliewi.
Patients taking other preparations containing lamotrigine
Pazjenti fuq mediċini oħra li jkun fihom lamotrigine
Lamictal should not be administered to patients currently being treated with any other preparation containing lamotrigine without consulting a doctor.
Lamictal m’ għandux jingħata lil pazjenti li jkunu qed jingħataw kura b’ xi mediċini oħra li jkun fihom lamotrigine mingħajr ma jgħidu lit- tabib.
25, 50, 100 and 200 mg tablets:
Pilloli ta ’ 25, 50, 100 u 200 mg:
Excipient of Lamictal tablets
Sustanzi mhux attivi fil- pilloli Lamictal
Lamictal tablets contain lactose monohydrate.
Il- pilloli Lamictal fihom monoidrat tal- lattosju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza ta’ galattosju, b’ defiċjenza ta ’ Lapp lactase jew ta ’ assorbiment ħażin ta ’ glukosju- galattosju m’ għandhomx jieħdu din il- mediċina.
Development in children
Żvilupp fit- tfal
There are no data on the effect of lamotrigine on growth, sexual maturation and cognitive, emotional and behavioural developments in children.
Ma hemmx data fuq l- effett ta ’ lamotrigine fuq żvilupp tal- ġisem, maturita ’ sesswali u żviluppi konoxxittivi, emozzjonali u li għandhom x’ jaqsmu ma ’ l- imġieba fit- tfal.
Precautions relating to epilepsy
Prekawzjonijiet konnessi ma ’ l- epilessija
As with other AEDs, abrupt withdrawal of Lamictal may provoke rebound seizures.
Bħal fil- każ ta ’ AEDs oħra, meta Lamictal jitwaqqaf f’ salt jista ’ jipprovoka ripetizzjoni ta ’ attakki.
Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamictal should be gradually decreased over a period of two weeks.
Jekk ma jkunx hemm biża ’ ta ’ xi affarijiet oħra (per eżempju xi raxx) li jitolbu twaqqif immedjat tal- pillola, id- doża ta ’ Lamictal għandha titnaqqas bil- mod il- mod fuq perijodu ta ’ ġimgħatejn.
There are reports in the literature that severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiorgan dysfunction and disseminated intravascular coagulation, sometimes with fatal outcome.
Fil- letteratura jeżistu rapporti li jgħidu li attakki qawwija konvulsivi inkluż l- istatus epilepticus jistgħu iwasslu għal rabdomilosi, disfunzjoni multiorganika u tixrid ta ’ koagulazzjoni tad- demm fil- vini, xi drabi b’ konsegwenzi fatali.
Similar cases have occurred in association with the use of lamotrigine.
Każi simili seħħew ukoll assoċjati ma ’ l- użu ta ’ lamotrigine.
A clinically significant worsening of seizure frequency instead of an improvement may be observed.
Jista ’ jkun osservat żvilupp klinikament sinifikanti għall- agħar fil- frekwenza ta ’ aċċessjonijiet minflok titjib.
In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type.
F’ pazjenti b’ aktar minn tip wieħed ta ’ aċċessjoni, il- benefiċċju ta ’ kontroll osservat għal tip wieħed ta ’ aċċessjoni għandu jiġi mkejjel kontra xi żvilupp għall- agħar f’ tip ieħor ta ’ aċċessjoni.
Myoclonic seizures may be worsened by lamotrigine.
Aċċessjonijiet mijokloniċi jistgħu imorru għall- agħar b’ lamotrigine.
There is a suggestion in the data that responses in combination with enzyme inducers is less than in combination with non-enzyme inducing antiepileptic agents.
Hemm ħjiel fid- data li risponsi meta użat flimkien ma ’ enzyme inducers huwa anqas minn meta jintuża flimkien ma ’ aġenti anti- epileptiċi li ma humiex enzyme inducers.
The reason is unclear.
Ir- raġuni għal dan m’ huwiex ċar.
In children taking lamotrigine for the treament of typical absence seizures, efficacy may not be maintained in all patients.
Fi tfal li jieħdu lamotrigine għal kura ta ’ aċċessjonijiet ta ’ assenza tipiċi, l- effikaċja tista ’ ma tinżammx fil - pazjenti kollha.
59 Precautions relating to bipolar disorder
63 Prekawzjonijiet konnessi ma ’ mard bi- polari
Children and adolescents below 18 years Treatment with antidepressants is associated with an increased risk of suicidal thinking and behaviour in children and adolescents with major depressive disorder and other psychiatric disorders.
Tfal u adolexxenti taħt it- 18- il sena Il- kura b’ mediċini kontra d- depressjoni hi assoċjata ma ’ riskju akbar ta ’ ħsibijiet u mġiba suwiċidjali fi tfal u adolexxenti b’ mard serju ta ’ depressjoni u mard ieħor psikjatriku.
Interaction studies have only been performed in adults.
Studji dwar meta dawn il - prodotti mediċinali ma jkunux jaqblu ma ’ xulxin saru biss fuq adulti.
UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine.
UDP- glucuronyl transferases ġew identifikati bħala l- enzimi risponsabbli għall- metaboliżmu ta ’ lamotrigine.
There is no evidence that lamotrigine causes clinically significant induction or inhibition of hepatic oxidative drug-metabolising enzymes, and interactions between lamotrigine and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
M’ hemm xejn x’ juri li lamotrigine klinikament jikkawża xi induzzjoni jew li jimpedixxi sostanzjalment l- enzimi ossidattivi tal- fwied li jimmetabolizzaw il- mediċina, u mhux probabbli li lamotrigine u prodotti mediċinali metabolizzati bl- enzimi taċ- ċitokromu P450 ma jkunux jaqblu ma ’ xulxin.
Lamotrigine may induce its own metabolism but the effect is modest and unlikely to have significant clinical consequences.
Lamotrigine jista ’ jinduċi l- metaboliżmu tiegħu stess imma l- effett ikun żgħir u x’ aktarx li ma jkollu ebda konsegwenzi kliniċi.
Effects of other medicinal products on glucuronidation of lamotrigine
Effetti ta ’ prodotti mediċinali oħra fuq il- glukuronidazzjoni ta ’ lamotrigine
Medicinal products that Medicinal products that
Prodotti mediċinali li huma Prodotti mediċinali li huma
Medicinal products that do not
Prodotti mediċinali li mhumiex
significantly inhibit glucuronidation of lamotrigine Valproate
indutturi sinifikanti tal - glukuronidazzjoni ta ’ lamotrigine
significantly induce glucuronidation of lamotrigine Phenytoin Carbamazepine Phenobarbitone Primidone Rifampicin Lopinavir/ ritonavir Ethinyloestradiol/ levonorgestrel combination*
Phenytoin Carbamazepine Phenobarbitone Primidone Rifampicin Lopinavir/ ritonavir Kombinazzjoni * Ethinyloestradiol / levonorgestrel
significantly inhibit or induce glucuronidation of lamotrigine Oxcarbazepine Felbamate Gabapentin Levetiracetam Pregabalin Topiramate Zonisamide Lithium Buproprion Olanzapine
Oxcarbazepine Felbamate Gabapentin Levetiracetam Pregabalin Topiramate Zonisamide Lithium Buproprion Olanzapine
* Other oral contraceptive and HRT treatments have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters (see sections 4.2 and 4.4).
* Trattamenti orali oħra kontraċettivi jew HRT ma ġewx studjati, għalkemm dawn jistgħu bl- istess mod jaffettwaw il- parametri tal- farmakokinetiċi ta ’ lamotrigine (ara sezzjonijiet 4. 2 u 4. 4).
Interactions involving antiepileptic drugs
Interazzjonijiet li jinvolvu mediċini anti- epilettiċi
Valproate, which inhibits the glucuronidation of lamotrigine, reduces the metabolism of lamotrigine and increases the mean half-life of lamotrigine nearly two-fold.
Valproate, li hu impeditur tal- glukuronidazzjoni ta ’ lamotrigine, inaqqas il- metaboliżmu ta ’ lamotrigine u jżid il- medja tal- half- life ta ’ lamotrigine kważi bid- doppju.
In patients receiving concomitant therapy with valproate, the appropriate treatment regimen should be used (see section 4.2).
Għal pazjenti fuq terapija konkomitanti b’ valproate, għandu jiġi wżat il- programm xieraq ta ’ trattament (ara sezzjoni 4. 2).
Certain AEDs (such as phenytoin, carbamazepine, phenobarbitone and primidone) which induce hepatic drug-metabolising enzymes induce the glucuronidation of lamotrigine and enhance the metabolism of lamotrigine.
Xi AEDs (bħal phenytoin, carbamazepine, phenobarbitone u primidone) li jinduċu enzimi tal- fwied li jimmetabolizzaw il- mediċina jinduċu l- glukuronidazzjoni ta ’ lamotrigine u jsaħħu l- metaboliżmu ta ’ lamotrigine.
In patients receiving concomitant therapy with phenytoin, carbamazepine, pheonbarbitone or primidone, the appropriate treatment regimen should be used (see section 4.2).
F’ pazjenti fuq terapija konkomitanti ta ’ phenytoin, carbamazepine, phenobarbitone u primidone, għandu jiġi wżat il- programm xieraq ta ’ trattament (ara sezzjoni 4. 2).