natgillin/translations-raw huggingface dataset:
What Lamictal tablets look like and contents of the pack Lamictal tablets (all strengths) are square with rounded corners, and pale, yellowish brown in colour.
Tablete Lamictal (vse jakosti) so kvadratne oblike z zaobljenimi vogali in so blede rumeno-rjave barve.
• swelling around your face, or swollen glands in your neck, armpit or groin
• oteklost obraza ali oteklost bezgavk na vratu, v pazduhah ali dimljah,
28 dispersible/chewable tablets
28 disperzibilnih/žvečljivih tablet
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema Zelo redki:
GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist The Netherlands
Nizozemska GlaxoSmithKline BV Huis ter Heideweg 62
Lamictal Dispersible 25mg Starter-Pack Mono 25 mg Dispersible Tablet
Lamictal Dispersible 25mg Starter-Pack Mono 25 mg Disperzibilna tableta Peroralna uporaba
Lamictal 200 mg disperzibilne/žvečljive tablete 200 mg Dispersible/Chewable Tablet
Lamictal 200 mg disperzibilne/žvečljive tablete 200 mg Disperzibilna/žvečljiva tableta
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.
Glede na podatke so malo verjetne interakcije med lamotriginom in zdravili, ki se presnavljajo s citokromom P450.
• swelling around the face (oedema) or swollen glands in the neck, armpit or groin
• oteklost obraza ali oteklost bezgavk na vratu, v pazduhah ali dimljah
However, there is an increased risk of birth defects in babies whose mothers took Lamictal during pregnancy.
Znano pa je, da imajo otroci mater, ki med nosečnostjo jemljejo zdravilo Lamictal, večje tveganje za prirojene hibe.
Each Lamictal 50 mg tablet contains 50 mg lamotrigine.
Ena tableta Lamictal 50 mg vsebuje 50 mg lamotrigina.
Packs of 10, 14, 21, 28, 30, 42, 50, 56 or 60 dispersible/chewable tablets.
Pakiranja z 10, 14, 21, 28, 30, 42, 50, 56 ali 60 disperzibilnimi/žvečljivimi tabletami.
To achieve maintenance, doses may be increased by maximum of 50 - 100 mg every one to two weeks until optimal response is achieved
Za dosego vzdrževalnega odmerka, zvišujte odmerke za največ 50-100 mg na en do dva tedna, dokler ni dosežen optimalen odziv.
100 − 200 mg/day (once a day or two divided doses)
100 -200 mg/dan (enkrat na dan ali v dveh deljenih odmerkih)
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are withdrawn
Ta režim odmerjanja morate uporabiti po ukinitvi zdravil, ki pomembno ne zavirajo niti ne inducirajo glukuronidacije lamotrigina
Each pack contains blisters of 10, 14, 21, 28, 30, 42, 50, 56 or 60 tablets.
Eno pakiranje vsebuje pretisne omote z 10, 14, 21, 28, 30, 42, 50, 56 ali 60 tabletami.
21 dispersible/chewable tablets
21 disperzibilnih/žvečljivih tablet
14 dispersible/chewable tablets
14 disperzibilnih/žvečljivih tablet
Lamictal 100 mg disperzibilne/žvečljive tablete 100 mg Dispersible/Chewable Tablet
Lamictal 100 mg disperzibilne/žvečljive tablete 100 mg Disperzibilna/žvečljiva tableta
Packs of 14, 30, 42, 56, 90 or 100 tablets.
Pakiranja s 14, 30, 42, 56, 90 ali 100 tabletami.
Lamictal Dispersible 25mg Starter-Pack Add-on 25 mg Dispersible Tablet
Lamictal Dispersible 25mg Starter-Pack Add-on 25 mg Disperzibilna tableta Peroralna uporaba
Packs of 10, 30, 50, 56, 60, 90, 100 or 200 dispersible/chewable tablets.
Pakiranja z 10, 30, 50, 56, 60, 90, 100 ali 200 disperzibilnimi/žvečljivimi tabletami.
• skin rash.
• suha usta.
Packs of 30, 50, 56, 60, 90 or 100 tablets.
Pakiranja s 30, 50, 56, 90 ali 100 tabletami.
In patients receiving concomitant therapy with lopinavir/ritonavir, the appropriate treatment regimen should be used (see section 4.2).
Pri bolnikih, ki se sočasno zdravijo z lopinavirjem/ritonavirjem, je treba uporabiti ustrezen režim zdravljenja (glejte poglavje 4.2).
Topiramate
Dojenje
Lamictal 25 mg disperzibilne/žvečljive tablete 25 mg Dispersible/Chewable Tablet
Lamictal 25 mg disperzibilne/žvečljive tablete 25 mg Disperzibilna/žvečljiva tableta
300 mg/day
300 mg/dan
The active ingredient of Lamictal passes into breast milk and may affect your baby.
Î Če dojite ali nameravate dojiti, se posvetujte z zdravnikom Zdravilna učinkovina zdravila Lamictal prehaja v materino mleko in lahko vpliva na otroka.
1.2 mg/kg/day (two divided doses)
1,2 mg/kg/dan (v dveh deljenih odmerkih)
56 dispersible/chewable tablets
56 disperzibilnih/žvečljivih tablet
Lamictal and associated names (see Annex I) 25 mg tablets.
Lamictal in sorodna imena (glejte Dodatek I) 25 mg tablete.
200 dispersible/chewable tablets
200 disperzibilnih/žvečljivih tablet
Lamictal 5 mg disperzibilne/žvečljive tablete 5 mg Dispersible/Chewable Tablet
Lamictal 5 mg disperzibilne/žvečljive tablete 5 mg Disperzibilna/žvečljiva tableta
90 dispersible/chewable tablets
90 disperzibilnih/žvečljivih tablet
0.6 mg/kg/day (two divided doses)
0,6 mg/kg/dan (v dveh deljenih odmerkih)
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSEC5” on one side and “200” on the other.
Bele do umazano bele, večkotne, supereliptične tablete z vonjem po črnem ribezu, označene z "GSEC5" na eni strani in "200" na drugi.
Packs of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 dispersible/chewable tablets.
Pakiranja z 10, 14, 30, 42, 50, 56, 60, 90, 100 ali 200 disperzibilnimi/žvečljivimi tabletami.
Lamictal 2 mg dispersible/chewable tablets are round.
Lamictal 2 mg disperzibilne/žvečljive tablete so okrogle oblike.
30 dispersible/chewable tablets
30 disperzibilnih/žvečljivih tablet
200 mg/day 150 mg/day 100 mg/day
200 mg/dan 150 mg/dan 100 mg/dan
agitation, somnolence, dizziness.
agitiranost, zaspanost, omotica.
Lamictal and associated names (see Annex I) 100 mg tablets.
Lamictal in sorodna imena (glejte Dodatek I) 100 mg tablete.
50 dispersible/chewable tablets
50 disperzibilnih/žvečljivih tablet
The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above (Table 1) and for children and adolescents aged 2 to 12 years (Table 2) are given below.
V preglednici 2 pa so navedeni odmerki za otroke in mladostnike v obdobju od 2. do 12. leta starosti .
100 mg/day 150 mg/day 200 mg/day
100 mg/dan 150 mg/dan 200 mg/dan
Each Lamictal 2 mg dispersible/chewable tablet contains 2 mg lamotrigine.
Ena disperzibilna/žvečljiva tableta Lamictal 2 mg vsebuje 2 mg lamotrigina.
Your doctor will discuss the risks and benefits of breast feeding while you're taking Lamictal, and will check your baby from time to time if you decide to breast feed.
Če se odločite za dojenje, bo od časa do časa pregledal otroka.
100 mg/day (once a day or two divided doses)
100 mg/dan (enkrat na dan ali v dveh deljenih odmerkih)
200 mg/day (two divided doses)
200 mg/dan (v dveh deljenih odmerkih)
2, 5, 25, 50, 100 and 200 mg dispersible/chewable tablets: Calcium carbonate
2-, 5-, 25-, 50-, 100- in 200 mg disperzibilne/žvečljive tablete: kalcijev karbonat delno substituirana hidroksipropilceluloza aluminijev magnezijev silikat natrijev karboksimetilškrob (vrsta A)
0.6 mg/kg/day (once a day or two divided doses)
0,6 mg/kg/dan (enkrat na dan ali v dveh deljenih odmerkih)
10 dispersible/chewable tablets
10 disperzibilnih/žvečljivih tablet
0.3 mg/kg/day (once a day or two divided doses)
0,3 mg/kg/dan (enkrat na dan ali v dveh deljenih odmerkih)
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL7” on one side and “100” on the other.
Bele do umazano bele, večkotne, supereliptične tablete z vonjem po črnem ribezu, označene z "GSCL7" na eni strani in "100" na drugi.
Each pack contains blisters of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 tablets.
Eno pakiranje vsebuje pretisne omote z 10, 14, 30, 42, 50, 56, 60, 90, 100 ali 200 tabletami.
100 mg/day (two divided doses)
100 mg/dan (v dveh deljenih odmerkih)
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.
Če bolnik prejema zdravila, za katera farmakokinetične interakcije z lamotriginom trenutno niso znane (glejte poglavje 4.5), uporabite zvišanje odmerka, priporočeno za sočasno uporabo lamotrigina in valproata.
Primidone
Presnova
100 dispersible/chewable tablets
100 disperzibilnih/žvečljivih tablet
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE7” on one side and “200” on the other.
Bledo rumeno-rjave, večkotne, supereliptične tablete z oznako "GSEE7" na eni in "200" na drugi strani.
Each pack contains blisters of 14, 21, 30, 42, 50, 56 or 100 tablets.
Eno pakiranje vsebuje pretisne omote s 14, 21, 30, 42, 50, 56 ali 100 tabletami.
Starter packs containing 21 or 42 tablets are available for use during the first few weeks of treatment when the dose is being slowly increased.
Za prve tedne zdravljenja, ko se odmerek počasi povečuje, so na voljo začetna pakiranja z 21 ali 42 tabletami.
Each pack contains blisters of 10, 30, 50, 56, 60, 90, 100 or 200 tablets.
Eno pakiranje vsebuje pretisne omote z 10, 30, 50, 56, 60, 90, 100 ali 200 tabletami.
60 dispersible/chewable tablets
60 disperzibilnih/žvečljivih tablet
During monotherapy clinical trials: Uncommon:
Klinična preskušanja z monoterapijo: Pogosti:
Each Lamictal 200 mg dispersible/chewable tablet contains 200 mg lamotrigine.
Ena disperzibilna/žvečljiva tableta Lamictal 200 mg vsebuje 200 mg lamotrigina.
Starter packs containing 21 or 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
Za prve tedne zdravljenja, ko se odmerek počasi povečuje, so na voljo tudi začetna pakiranja z 21 ali 42 tabletami.
Lamictal 50 mg disperzibilne/žvečljive tablete 50 mg Dispersible/Chewable Tablet
Lamictal 50 mg disperzibilne/žvečljive tablete 50 mg Disperzibilna/žvečljiva tableta
Each Lamictal 5 mg dispersible/chewable tablet contains 5 mg lamotrigine.
Ena disperzibilna/žvečljiva tableta Lamictal 5 mg vsebuje 5 mg lamotrigina.
Starter packs containing 42 tablets are available for use during the first few weeks of treatment when the dose is being slowly increased.
Za prve tedne zdravljenja, ko se odmerek počasi povečuje, so na voljo začetna pakiranja z 42 tabletami.
Starter packs containing 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
Za prve tedne zdravljenja, ko se odmerek počasi povečuje, so na voljo tudi začetna pakiranja z 42 tabletami.
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE1” on one side and “50” on the other.
Bledo rumeno-rjave, večkotne, supereliptične tablete z oznako "GSEE1" na eni in "50" na drugi strani.
Lamictal and associated names (see Annex I) 50 mg tablets.
Lamictal in sorodna imena (glejte Dodatek I) 50 mg tablete.
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.
Keep this leaflet.
kožni izpuščaj.
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEC7” on one side and “25” on the other.
Bledo rumeno-rjave, večkotne, supereliptične tablete z oznako "GSEC7" na eni in "25" na drugi strani.
Lamictal 5 mg dispersible/chewable tablets are elongated with curved sides.
Lamictal 5 mg disperzibilne/žvečljive tablete so podolgovate oblike in imajo ukrivljene robove.
1 − 10 mg/kg/day (once a day or two divided doses)
1 - 10 mg/kg/dan (enkrat na dan ali v dveh deljenih odmerkih)
Nervous system disorders During monotherapy clinical trials: Very common:
Klinična preskušanja z monoterapijo: Zelo pogosti:
Lamictal and associated names (see Annex I) 200 mg tablets.
Lamictal in sorodna imena (glejte Prilogo I) 200 mg tablete.
1 − 5 mg/kg/day (once a day or two divided doses)
1 - 5 mg/kg/dan (enkrat na dan ali v dveh deljenih odmerkih)
200 mg Dispersible/Chewable Tablets
200 mg Disperzibilne/žvečljive tablete
200 mg dispersible/chewable tablets:
200 mg disperzibilne/žvečljive tablete:
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCX7” on one side and “50” on the other.
Bele do umazano bele večkotne, supereliptične tablete z vonjem po črnem ribezu, označene z "GSCX7" na eni strani in "50" na drugi.
BOTTLE
Placebo
Each pack contains blisters of 14, 30, 42, 56, 90 or 100 tablets.
Eno pakiranje vsebuje pretisne omote s 14, 30, 42, 56, 90 ali 100 tabletami.
2 mg dispersible/chewable tablets:
2 mg disperzibilne/žvečljive tablete:
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE5” on one side and “100” on the other.
Bledo rumeno-rjave, večkotne, supereliptične tablete z oznako "GSEE5" na eni in "100" na drugi strani.
Each Lamictal 100 mg dispersible/chewable tablet contains 100 mg lamotrigine.
Ena disperzibilna/žvečljiva tableta Lamictal 100 mg vsebuje 100 mg lamotrigina.
HDPE bottles with a child resistant/tamper evident closure.
Stekleničke iz HDPE z zaščitno/za otroke varno zaporko Pakiranja s 30 disperzibilnimi/žvečljivimi tabletami.
25 mg dispersible/chewable tablets:
25 mg disperzibilne/žvečljive tablete:
5 mg dispersible/chewable tablets:
5 mg disperzibilne/žvečljive tablete:
HOW TO STORE LAMICTAL
SHRANJEVANJE ZDRAVILA LAMICTAL
Caution should be exercised when administering Lamictal to patients with renal failure.
Pri bolnikih z ledvično odpovedjo morate Lamictal uporabljati previdno.
Strength Pharmaceutical form
Farmacevtska oblika Pot uporabe
Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets.
Lamictal in sorodna imena (glejte Dodatek I) 100 mg disperzibilne/žvečljive tablete.
Each pack contains blisters of 30, 50, 56, 60, 90 or 100 tablets.
Eno pakiranje vsebuje pretisne omote s 30, 50, 56, 90 ali 100 tabletami.
2 mg Dispersible/Chewable Tablets
2 mg Disperzibilne/žvečljive tablete
Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets.
Lamictal in sorodna imena (glejte Dodatek I) 25 mg disperzibilne/žvečljive tablete.
100 mg dispersible/chewable tablets:
100 mg disperzibilne/žvečljive tablete:
Lamictal 200 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 200 mg disperzibilne/žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
25 mg Dispersible/Chewable Tablets
25 mg Disperzibilne/žvečljive tablete
Each Lamictal 25 mg dispersible/chewable tablet contains 25 mg lamotrigine.
Ena disperzibilna/žvečljiva tableta Lamictal 25 mg vsebuje 25 mg lamotrigina.
General disorders and administration site conditions During bipolar disorder clinical trials: Common:
Splošne težave in spremembe na mestu aplikacije Klinična preskušanja pri bipolarni motnji: Pogosti:
Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets.
Lamictal in sorodna imena (glejte Dodatek I) 200 mg disperzibilne/žvečljive tablete.
50 mg dispersible/chewable tablets:
50 mg disperzibilne/žvečljive tablete:
Nervous system disorders During bipolar disorder clinical trials: Very common:
Klinična preskušanja pri bipolarni motnji: Zelo pogosti:
Lamictal 100 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 100 mg disperzibilne/žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
Steady-state trough plasma concentrations of lamotrigine were not affected by concomitant pregabalin (200 mg, 3 times daily) administration.
Sočasna uporaba pregabalina (200 mg 3-krat na dan) ni vplivala na plazemsko koncentracijo lamotrigina v stanju dinamičnega ravnovesja.
Check with your doctor or pharmacist if you're not sure.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Pregnancy may also alter the effectiveness of Lamictal, so your doctor may take samples of your blood to check the level of Lamictal, and may adjust your dose.
Zato vas bo zdravnik morda napotil na preglede krvi, da bo preveril koncentracijo zdravila Lamictal.
Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets.
Lamictal in sorodna imena (glejte Dodatek I) 2 mg disperzibilne/žvečljive tablete.
200 mg Dispersible or chewable Tablet
200 mg Disperzibilna ali žvečljiva tableta
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 100 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena tableta vsebuje 100 mg lamotrigina.
100 mg Dispersible/Chewable Tablets
100 mg Disperzibilne/žvečljive tablete
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 100 mg disperzibilne/žvečljive tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL5” on one side “25” on the other.
Bele do umazano bele večkotne, supereliptične tablete z vonjem po črnem ribezu, označene z "GSCL5" na eni strani in "25" na drugi.
5 mg Dispersible/Chewable Tablets
5 mg Disperzibilne/žvečljive tablete
Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets.
Lamictal in sorodna imena (glejte Dodatek I) 50 mg disperzibilne/žvečljive tablete.
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 200 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena tableta vsebuje 200 mg lamotrigina.
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 200 mg disperzibilne/žvečljive tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 100 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena disperzibilna/žvečljiva tableta vsebuje 100 mg lamotrigina.
Lamictal 25 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 25 mg disperzibilne/žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
50 mg Dispersible/Chewable Tablets
50 mg Disperzibilne/žvečljive tablete
Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets.
Lamictal in sorodna imena (glejte Dodatek I) 5 mg disperzibilne/žvečljive tablete.
Each Lamictal 50 mg dispersible/chewable tablet contains 50 mg lamotrigine.
Ena disperzibilna/žvečljiva tableta Lamictal 50 mg vsebuje 50 mg lamotrigina.
Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamictal should be gradually decreased over a period of two weeks.
Odmerek Lamictala je treba zniževati postopoma v obdobju dveh tednov, razen v primerih, ko je treba zdravilo zaradi varnosti (npr. izpuščaja) opustiti na hitro.
Gastrointestinal disorders During bipolar disorder clinical trials: Common:
Klinična preskušanja pri bipolarni motnji: Pogosti:
Major depressive episode
Merilo za vključitev hujša depresivna epizoda hujša manična epizoda
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 50 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena tableta vsebuje 50 mg lamotrigina.
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 2 mg disperzibilne/žvečljive tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
Lamictal 50 mg dispersible/chewable tablets are square with rounded corners.
Lamictal 50 mg disperzibilne/žvečljive tablete so kvadratne oblike in imajo zaobljene vogale.
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 100 mg tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 25 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena tableta vsebuje 25 mg lamotrigina.
25 mg Dispersible or chewable Tablet
25 mg Disperzibilna ali žvečljiva tableta
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 25 mg disperzibilne/žvečljive tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 25 mg tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
100 mg Dispersible or chewable Tablet
100 mg Disperzibilna ali žvečljiva tableta
5 mg Dispersible or chewable Tablet
5 mg Disperzibilna ali žvečljiva tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Izgled tablet Lamictal in vsebina pakiranja
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 50 mg disperzibilne/žvečljive tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 5 mg disperzibilne/žvečljive tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 200 mg tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal in sorodna imena (glejte Dodatek I) 50 mg tablete [Glejte Dodatek I - Izpolni država članica] lamotrigin
Î See a doctor as soon as possible or go to the nearest hospital for help.
Če opazite katerega izmed teh simptomov: Î Čim prej pojdite k zdravniku.
Lot
KG
50 mg Dispersible or chewable Tablet
50 mg Disperzibilna ali žvečljiva tableta
Prescribers should assess the need for escalation to maintenance dose when restarting Lamictal in patients who have discontinued Lamictal for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine (see section 4.4).
Tveganje za resen izpuščaj je namreč povezano z visokimi začetnimi odmerki in s prekoračenjem priporočenega zviševanja odmerka lamotrigina (glejte poglavje 4.4).
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 25 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena disperzibilna/žvečljiva tableta vsebuje 25 mg lamotrigina.
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 2 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena disperzibilna/žvečljiva tableta vsebuje 2 mg lamotrigina.
(Starter pack 42 tablets, non-valproate add-on therapy - calender pack showing day numbers): 1 2 3 4 5 6 7 (1 pocket)
(Začetno pakiranje z 42 tabletami, dodatek zdravljenja brez valproata - koledarsko pakiranje z označenimi številkami dni):
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 5 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena disperzibilna/žvečljiva tableta vsebuje 5 mg lamotrigina.
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 50 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena disperzibilna/žvečljiva tableta vsebuje 50 mg lamotrigina.
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 200 mg lamotrigine
NAVEDBA ZDRAVILNE UČINKOVINE Ena <disperzibilna/žvečljiva><disperzibilna> tableta vsebuje 200 mg lamotrigina.
5 mg Soluble Tablet
5 mg Tableta za peroralno raztopino