natgillin/translations-raw huggingface dataset:
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disorder Once the target daily maintenance stabilisation dose has been achieved, other medicinal products may be withdrawn as shown below.
Odrasli od 18. leta naprej – vzdrževalni stabilizacijski celotni dnevni odmerek po prenehanju sočasne uporabe drugih zdravil pri zdravljenju bipolarne motnje Ko je ciljni dnevni vzdrževalni stabilizacijski odmerek dosežen, lahko ukinete druga zdravila, kot je prikazano spodaj.
Current lamotrigine Week 1 stabilisation dose (beginning with (prior to withdrawal) withdrawal)
1. teden (začetek opuščanja)
Week 3 onwards *
3. teden in naprej
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation – see section 4.5), depending on original dose of lamotrigine:
Ukinitev valproata (zaviralec glukuronidacije lamotrigina – glejte poglavje 4. 5), odvisno od prvotnega odmerka lamotrigina:
When valproate is withdrawn, double the stabilisation dose, not exceeding an increase of more than 100 mg/ week
Po ukinitvi valproata podvojite stabilizacijski odmerek, vendar ne prekoračite zviševanja odmerka po 100 mg/ teden
100 mg/ day
100 mg/ dan
200 mg/ day
200 mg/ dan
Maintain this dose (200 mg/ day) (two divided doses)
Vzdržujte ta odmerek (200 mg/ dan) (v dveh deljenih odmerkih)
300 mg/ day
300 mg/ dan
400 mg/ day Maintain this dose (400 mg/ day)
400 mg/ dan Vzdržujte ta odmerek (400 mg/ dan)
Withdrawal of inducers of lamotrigine glucuronidation (see section 4.5), depending on original dose of lamotrigine:
Ukinitev induktorjev glukuronidacije lamotrigina (glejte poglavje 4. 5), odvisno od prvotnega odmerka lamotrigina:
This dosage regimen should be used when the following are
Ta režim odmerjanja morate uporabiti po ukinitvi naslednjih
400 mg/ day 400 mg/ day
400
mg/ day
mg/ dan
withdrawn:
zdravil:
300 mg/ day 300 mg/ day
300
150 mg/ day
150 mg/ dan
phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ ritonavir
fenitoina karbamazepina fenobarbitona primidona rifampicina lopinavirja/ ritonavirja
200 mg/ day 200 mg/ day
200 mg/ dan 200 mg/ dan
Withdrawal of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Ukinitev zdravil, ki pomembno ne zavirajo NITI ne inducirajo glukuronidacije lamotrigina NITI (glejte poglavje 4. 5):
Maintain target dose achieved in dose escalation (200 mg/ day; two divided doses) (dose range 100 - 400 mg/ day)
(razpon odmerkov od 100 do 400 mg/ dan)
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.
Če bolnik prejema zdravila, za katera farmakokinetične interakcije z lamotriginom trenutno niso znane (glejte poglavje 4. 5), uporabite režim zdravljenja, priporočen za sočasno jemanje lamotrigina in valproata.
* Dose may be increased to 400 mg/ day as needed
* Odmerek se lahko zviša na 400 mg/ dan, če je potrebno.
54 Table 5:
51 Preglednica 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.
Odrasli od 18. leta naprej – prilagoditev dnevnega odmerjanja lamotrigina po dodatku drugih zdravil pri zdravljenju bipolarne motnje Kliničnih izkušenj s prilagajanjem dnevnega odmerka lamotrigina po dodajanju drugih zdravil ni.
Week 3 onwards
3. teden in naprej
This dosage regimen should be used when valproate is added
Ta režim odmerjanja morate uporabiti po dodatku valproata, ne
100 mg/ day Maintain this dose (100 mg/ day)
100 mg/ dan Vzdržujte ta odmerek (100 mg/ dan)
regardless of any concomitant medicinal products
glede na morebitna sočasno uporabljana zdravila
400 mg/ day
300 mg/ dan 400 mg/ dan
200 mg/ day Maintain this dose (200 mg/ day)
150 mg/ dan Vzdržujte ta odmerek (150 mg/ dan) 200 mg/ dan Vzdržujte ta odmerek (200 mg/ dan)
Addition of inducers of lamotrigine glucuronidation in patients NOT taking valproate (see section 4.5), depending on original dose of lamotrigine:
Dodatek induktorjev glukuronidacije lamotrigina pri bolnikih, ki NE jemljejo valproata (glejte poglavje 4. 5), odvisno od prvotnega odmerka lamotrigina:
This dosage regimen should be used when the following are added
Ta režim odmerjanja morate uporabiti, kadar dodate katerega od
200 mg/ day 300 mg/ day
200 mg/ dan 300 mg/ dan
400 mg/ day
400 mg/ dan
without valproate:
naslednjih zdravil brez uporabe valproata:
150 mg/ day 225 mg/ day
150 mg/ dan 225 mg/ dan
100 mg/ day 100 mg/ day
100 mg/ dan
150 mg/ day
100 mg/ dan 150 mg/ dan
Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Dodatek zdravil, ki pomembno ne zavirajo NITI ne inducirajo glukuronidacije lamotrigina (glejte poglavje 4. 5):
Maintain target dose achieved in dose escalation (200 mg/ day; dose range 100-400 mg/ day)
Vzdržujte ciljni odmerek, dosežen pri zviševanju odmerka (200 mg/ dan; razpon odmerkov od 100 do 400 mg/ dan)
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.
Če bolnik jemlje zdravila, za katera farmakokinetične interakcije z lamotriginom trenutno niso znane (glejte poglavje 4. 5), uporabite režim zdravljenja, priporočen za sočasno jemanje lamotrigina in valproata.
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).
Otroci in mladostniki do 18. leta Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba Lamictala ni priporočljiva pri otrocih do 18. leta starosti (glejte poglavje 4. 4).
55 General dosing recommendations for Lamictal in special patient populations
52 Splošna priporočila za odmerjanje Lamictala v posebnih populacijah bolnikov
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.
Ženske, ki jemljejo hormonske kontraceptive Uporaba kombinacije etinilestradiol/ levonorgestrel (30 µg/ 150 µg) za približno dvakrat poveča očistek lamotrigina in tako zmanjša koncentracijo lamotrigina.
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).
Zato morajo imeti pri izbiri kontracepcije prednost takšni načini, ki ne vključujejo tedna brez tablet (npr. stalni hormonski kontraceptivi ali nehormonski načini; glejte poglavji 4. 4 in 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).
Uvedba hormonskih kontraceptivov pri bolnicah, ki že jemljejo vzdrževalne odmerke lamotrigina in NE prejemajo induktorjev glukuronidacije lamotrigina Vzdrževalni odmerek lamotrigina bo večinoma potrebno zvišati, celo do dvakrat (glejte poglavji 4. 4 in 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.
Priporočljivo je, da ob začetku uporabe hormonskega kontraceptiva odmerek lamotrigina zvišate za 50 do 100 mg/ dan vsak teden, v skladu s kliničnim odzivom posamezne bolnice.
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.
Če ženska uporablja hormonski kontraceptiv, ki vključuje teden brez učinkovin ("teden brez tablet"), je treba koncentracijo lamotrigina v serumu kontrolirati v 3. tednu uporabe učinkovin, tj. od 15. do 21. dneva ciklusa kontracepcijskih tablet.
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).
Zato morajo imeti pri izbiri kontracepcije prednost načini, ki ne vključujejo tedna brez tablet (npr. stalni hormonski kontraceptivi ali nehormonski načini; glejte poglavji 4. 4 in 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).
Prenehanje uporabe hormonskih kontraceptivov pri bolnicah, ki že jemljejo vzdrževalne odmerke lamotrigina in NE jemljejo induktorjev glukuronidacije lamotrigina Vzdrževalni odmerek lamotrigina je večinoma treba znižatii, celo za 50% (glejte poglavji 4. 4 in 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.
Priporočljivo je, da dnevni odmerek lamotrigina postopno znižujete za 50- 100 mg na teden (in ne za več kot 25% celotnega dnevnega odmerka na teden) v obdobju 3 tednov, če klinični odziv ne narekuje drugače.
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.
Priporočljivo je merjenje koncentracije lamotrigina v serumu pred začetkom uporabe hormonskih kontraceptivov in potem; tako se lahko prepričate, da se je vzdrževana koncentracija lamotrigina ohranila.
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.
Če ženska želi prenehati uporabljati hormonski kontraceptiv, ki vključuje teden brez učinkovin ("teden brez tablet"), je treba koncentracijo lamotrigina v serumu kontrolirati v 3. tednu uporabe učinkovin, tj. od 15. do 21. dneva ciklusa kontracepcijskih tablet.
Elderly (above 65 years) No dosage adjustment from the recommended schedule is required.
Starejši bolniki (nad 65 let) Ni potrebna prilagoditev od priporočenega režima odmerjanja.
The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).
Farmakokinetika lamotrigina se v tej starostni skupini ne razlikuje bistveno od farmakokinetike v mlajši populaciji (glejte poglavje 5. 2).
Renal impairment Caution should be exercised when administering Lamictal to patients with renal failure.
Ledvična okvara Pri bolnikih z ledvično odpovedjo morate Lamictal uporabljati previdno.
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).
Pri bolnikih z ledvično odpovedjo v zadnji fazi morajo začetni odmerki lamotrigina temeljiti na sočasni uporabi drugih zdravil; pri bolnikih s pomembno okvarjenim delovanjem ledvic pa so lahko učinkoviti že nižji vzdrževalni odmerki (glejte poglavji 4. 4 in 5. 2).
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.
Okvara jeter Na splošno je treba začetne odmerke, zviševanje odmerkov in vzdrževalne odmerke pri bolnikih z zmerno okvaro jeter (Child- Pugh B) zmanjšati za približno 50%, pri bolnikih s hudo okvaro jeter (Child- Pugh C) pa
Escalation and maintenance doses should be adjusted according to clinical response (see section 5.2).
Zviševanje odmerkov in vzdrževalne odmerke morate prilagoditi kliničnemu odzivu (glejte poglavje 5. 2).
These have included potentially life-threatening rashes such as Stevens– Johnson syndrome and toxic epidermal necrolysis (see section 4.8).
Stevens- Johnsonov sindrom in toksična epidermalna nekroliza (glejte poglavje 4. 8).
Approximately half of these cases have been reported as Stevens– Johnson syndrome (1 in 1000).
Približno polovica teh primerov je bila opisana kot Stevens- Johnsonov sindrom (1 na 1000).
high initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see section 4.2)
visokimi začetnimi odmerki lamotrigina in prekoračenjem priporočenega zviševanja odmerka lamotrigina (glejte poglavje 4. 2),
concomitant use of valproate (see section 4.2).
sočasno uporabo valproata (glejte poglavje 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.
Previdnost je potrebna tudi pri zdravljenju bolnikov z anamnezo alergije ali izpuščaja pri uporabi drugih antiepileptikov, kajti pogostnost ne- resnih izpuščajev je bila pri takšnih bolnikih po zdravljenju z lamotriginom približno trikrat večja kot pri bolnikih brez takšne anamneze.
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).
Izpuščaj je opisan tudi kot del preobčutljivostnega sindroma, ki ga spremlja različni sistemski simptomi, vključno z zvišano telesno temperaturo, limfadenopatijo, edemom obraza in nepravilnostmi krvi in jeter (glejte poglavje 4. 8).
The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation and multiorgan failure.
Sindrom se lahko kaže v širšem obsegu, je klinično resen, v redkih primerih lahko povzroči diseminirano intravaskularno koagulacijo in odpovedovanje različnih organov.
If such signs and symptoms are present the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Če ni mogoče ugotoviti druge etiologije, je treba z zdravljenjem Lamictala prekiniti.
57 Clinical worsening and suicide risk
54 Klinično poslabšanje in tveganje za samomor
A meta-analysis of placebo-controlled trials of AEDs (including lamotrigine) showed an increased risk of suicidal behaviour (see section 5.1).
Metaanaliza s placebom kontroliranih preskušanj antiepileptičnih zdravil (vključno z lamotriginom) je pokazala večje tveganje za pojav samomorilnega vedenja (glejte poglavje 5. 1).
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.
Pri bolnikih z bipolarno motnjo se lahko pojavi poslabšanje depresivnih simptomov in/ ali samomorilnost ne glede na to, ali jemljejo zdravila za bipolarno motnjo, vključno z zdravilom Lamictal.
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.
Takšne bolnike je zato med zdravljenjem treba skrbno spremljati.
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.
To še zlasti velja, če so simptomi hudi, se pojavijo nenadoma oz. niso bili del bolnikovih začetnih simptomov.
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).
Vpliv hormonskih kontraceptivov na učinkovitost lamotrigina Uporaba kombinacije etinilestradiol/ levonorgestrel (30 µg/ 150 µg) za približno dvakrat poveča očistek lamotrigina in tako zmanjša koncentracijo lamotrigina (glejte poglavje 4. 5).
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).
Pri ženskah, ki ne prejemajo induktorja glukuronidacije lamotrigina in ki sočasno uporabljajo hormonske kontraceptive, se v tednu neaktivnega zdravljenja (npr. "teden brez tablete") koncentracija lamotrigina postopoma prehodno poveča (glejte poglavje 4. 2).
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).
Vpliv lamotrigina na učinkovitost hormonskih kontraceptivov Študija medsebojnega delovanja pri 16 zdravih prostovoljkah je pokazala, da sočasna uporaba lamotrigina in hormonskega kontraceptiva (kombinacije etinilestradiola/ levonorgestrela) povzroči zmerno povečanje očistka levonorgestrela in spremembe FSH in LH v serumu (glejte poglavje 4. 5).
However, the possibility of these changes resulting in decreased contraceptive efficacy in some patients taking hormonal preparations with lamotrigine cannot be excluded.
Vpliv teh sprememb na ovulacijsko aktivnost jajčnikov ni znan, vendar pri nekaterih bolnicah ni mogoče izključiti zmanjšane učinkovitosti kontraceptiva, ki so sočasno prejemale hormonske pripravke in lamotrigin.
Therefore patients should be instructed to promptly report changes in their menstrual pattern, i. e. breakthrough bleeding.
Zato morate bolnicam naročiti, naj takoj sporočijo spremembe v menstruacijskem ciklusu, npr. vmesne krvavitve.
58 Dihydrofolate reductase
55 Dihidrofolat- reduktaza
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).
Lamotrigin rahlo zavira dihidrofolat- reduktazo, zato med dolgotrajnim zdravljenjem obstaja možnost ovirane presnove folata (glejte poglavje 4. 6).
25, 50, 100 and 200 mg tablets:
25 -, 50 -, 100 - in 200 mg tablete:
Excipient of Lamictal tablets
Pomožna snov v tableti Lamictal
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze, ne smejo jemati tega zdravila.
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.
V literaturi so opisani primeri, hudih epileptičnih napadov, vključno s status epilepticus- om, ki lahko povzročijo rabdomiolizo, disfunkcijo različnih organov in diseminirano intravaskularno koagulacijo, včasih s smrtnim izidom.
59 Precautions relating to bipolar disorder
Previdnostni ukrepi pri bipolarni motnji
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.
Otroci in mladostniki do 18. leta Pri otrocih in mladostnikih s hudo depresivno motnjo in drugimi psihiatričnimi motnjami je zdravljenje z antidepresivi povezano z večjim tveganjem za samomorilne misli in samomorilno vedenje.
4.5 Interaction with other medicinal products and other forms of interaction
56 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine.
Ugotovljeno je, da so za presnovo lamotrigina odgovorni encimi UDP- glukuronil- transferaze.
Effects of other medicinal products on glucuronidation of lamotrigine
Vpliv drugih zdravil na glukuronidacijo lamotrigina
Medicinal products that Medicinal products that
Zdravila, ki pomembno Zdravila, ki pomembno
Medicinal products that do not
Zdravila, ki pomembno ne
significantly inhibit glucuronidation of lamotrigine Valproate
zavirajo glukuronidacijo lamotrigina valproat
significantly induce glucuronidation of lamotrigine Phenytoin Carbamazepine Phenobarbitone Primidone Rifampicin Lopinavir/ ritonavir Ethinyloestradiol/ levonorgestrel combination*
inducirajo glukuronidacijo lamotrigina fenitoin karbamazepin fenobarbiton primidon rifampicin lopinavir/ ritonavir kombinacija etinilestradiola/ levonorgestrela *
significantly inhibit or induce glucuronidation of lamotrigine Oxcarbazepine Felbamate Gabapentin Levetiracetam Pregabalin Topiramate Zonisamide Lithium Buproprion Olanzapine
zavirajo niti ne inducirajo glukuronidacije lamotrigina okskarbazepin felbamat gabapentin levetiracetam pregabalin topiramat zonisamid litij buproprion olanzapin
* 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).
* Drugi peroralni kontraceptivi in HNZ niso raziskani, a verjetno lahko na farmakokinetične parametre lamotrigina vplivajo podobno (glejte poglavji 4. 2 in 4. 4).
In patients receiving concomitant therapy with valproate, the appropriate treatment regimen should be used (see section 4.2).
Za bolnike, ki se sočasno zdravijo z valproatom, morate uporabiti ustrezen režim zdravljenja (glejte poglavje 4. 2).
In patients receiving concomitant therapy with phenytoin, carbamazepine, pheonbarbitone or primidone, the appropriate treatment regimen should be used (see section 4.2).
Za bolnike, ki se sočasno zdravijo s fenitoinom, karbamazepinom, fenobarbitonom ali primidonom, morate uporabiti ustrezen režim zdravljenja (glejte poglavje 4. 2).
There have been reports of central nervous system events including dizziness, ataxia, diplopia, blurred vision and nausea in patients taking carbamazepine following the introduction of lamotrigine.
Pri bolnikih, ki so jemali karbamazepin, so po začetku zdravljenja z lamotriginom poročali o učinkih na osrednje živčevje, vključno z omotico, ataksijo, dvojnim ali zamegljenim vidom in navzejo.
60 doses of 200 mg lamotrigine and 1200 mg oxcarbazepine, oxcarbazepine did not alter the metabolism of lamotrigine and lamotrigine did not alter the metabolism of oxcarbazepine.
Toda v prospektivni študiji zdravih odraslih prostovoljcev, ki so jemali 200 mg lamotrigina in 1200 mg okskarbazepina, okskarbazepin ni spremenil presnove lamotrigina, lamotrigin pa ni spremenil presnove okskarbazepina.
Therefore in patients receiving concomitant therapy with oxcarbazepine, the treatment regimen for lamotrigine adjunctive therapy without valproate and without inducers of lamotrigine glucuronidation should be used (see section 4.2).
Zato je treba pri bolnikih, ki sočasno dobivajo okskarbazepin, uporabiti režim zdravljenja za dodatno zdravljenje z lamotriginom brez valproata in brez induktorjev glukuronidacije lamotrigina (glejte poglavje 4. 2).