natgillin/translations-raw huggingface dataset:
Lamictal og tilknyttede navne (se bilag I) 25 mg tabletter Lamictal og tilknyttede navne (se bilag I) 50 mg tabletter Lamictal og tilknyttede navne (se bilag I) 100 mg tabletter Lamictal og tilknyttede navne (se bilag I) 200 mg tabletter Lamictal og tilknyttede navne 2 mg dispergible tabletter / tyggetabletter Lamictal og tilknyttede navne 5 mg dispergible tabletter / tyggetabletter Lamictal og tilknyttede navne 25 mg dispergible tabletter / tyggetabletter Lamictal og tilknyttede navne 50 mg dispergible tabletter / tyggetabletter Lamictal og tilknyttede navne 100 mg dispergible tabletter / tyggetabletter Lamictal og tilknyttede navne 200 mg dispergible tabletter / tyggetabletter
Lamictal and associated names (see Annex I) 25 mg tablets Lamictal and associated names (see Annex I) 50 mg tablets Lamictal and associated names (see Annex I) 100 mg tablets Lamictal and associated names (see Annex I) 200 mg tablets Lamictal and associated names (see Annex I) 2 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 25 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 50 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 100 mg dispersible/ chewable tablets Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets
[Se bilag I – udfyldes nationalt]
[See Annex I – To be completed nationally]
- Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
If you have any further questions, ask your doctor or pharmacist.
- Lægen har ordineret Lamictal til dig personligt.
This medicine has been prescribed for you.
Yderligere oplysninger
In this leaflet 1 What Lamictal is and what it is used for 2 Before you take Lamictal 3 How to take Lamictal 4 Possible side effects 5 How to store Lamictal 6 Further information
- Hos voksne og børn i alderen 13 år og derover.
Lamictal belongs to a group of medicines called anti-epileptics.
Lamictal kan anvendes alene eller sammen med
It is used to treat two conditions — epilepsy and bipolar disorder.
Lamictal kan også anvendes sammen med andet medicin til behandling af de anfald, der opstår i forbindelse med tilstanden Lennox- Gastaut - syndrom,
Lamictal treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits). • For adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines, to treat epilepsy.
Lamictal kan anvendes sammen med andre lægemidler til
Lamictal can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome. • For children aged between 2 and 12 years, Lamictal can be used with other medicines, to treat those conditions.
106 2.
105 2.
- hvis du er overfølsom (allergisk) over for lamotrigin eller et af de øvrige indholdsstoffer.
Do not take Lamictal: • if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of Lamictal (listed in Section 6).
Hvis dette gælder for dig, skal du fortælle det til lægen og lade være med at tage Lamictal.
If this applies to you:
- om du har problemer med nyrerne
Tell your doctor, and don’ t take Lamictal.
- om du nogensinde har fået udslæt, mens du har taget lamotrigin eller andre lægemidler til
Take special care with Lamictal Your doctor needs to know before you take Lamictal: • if you have problems with your kidneys • if you have ever developed a rash when you’ ve taken lamotrigine or other medicines for epilepsy • if you are already taking medicine that contains lamotrigine.
behandling af epilepsi
If any of these applies to you:
- om du allerede tager medicin, der indeholder lamotrigin.
Tell your doctor, who may decide to lower your dose, or that Lamictal is not suitable for you.
Hvis noget af dette gælder for dig, skal du fortælle det til lægen, som kan nedsætte din dosis eller beslutte, at Lamictal ikke er en hensigtsmæssig behandling for dig.
Watch out for important symptoms If you develop any of these symptoms after you start taking Lamictal, get a doctor’ s help straight away: • an unusual skin reaction, such as redness or rashes • a sore mouth or eyes • a high temperature (fever), flu-like symptoms or drowsiness • swelling around your face, or swollen glands in your neck, armpit or groin • unexpected bleeding or bruising, or your fingers turning blue • a sore throat, or more infections (such as colds) than usual.
Der er størst sandsynlighed for, at disse symptomer opstår i løbet af de første måneder af behandlingen med Lamictal, særligt hvis du får en for høj dosis til at starte med, hvis din dosis bliver øget for hurtigt, eller hvis du tager Lamictal sammen med et andet lægemiddel, der hedder valproat.
These symptoms are more likely to happen during the first few months of treatment with Lamictal, especially if you start on too high a dose or if your dose is increased too quickly, or if you’ re taking Lamictal with another medicine called valproate.
De ovennævnte symptomer kan udvikle sig til mere alvorlige problemer, f. eks. organsvigt eller en meget svær hudtilstand, hvis de ikke bliver behandlet.
The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated.
Skal du søge læge så hurtigt som muligt.
See a doctor as soon as possible.
Lægen kan beslutte at foretage undersøgelser af din lever, dine nyrer eller dit blod, og du får muligvis at vide, at du skal holde op med at tage Lamictal.
Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamictal.
Tanker om at skade dig selv eller selvmord Patienter med bipolar sygdom kan sommetider have tanker om at skade sig selv eller begå selvmord.
Thoughts of harming yourself or suicide People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide.
Hvis du har bipolar sygdom, kan du have disse tanker: • når du starter behandlingen • hvis du tidligere har haft tanker om at skade dig selv eller om selvmord • hvis du er under 25 år.
If you have bipolar disorder, you may be more likely to think like this: • when you first start treatment • if you have previously had thoughts about harming yourself or about suicide • if you are under 25 years old.
Sommetider kan epilepsi- patienter også have tanker om at skade sig selv eller begå selvmord.
Occasionally, people with epilepsy may also have thoughts of harming themselves or committing suicide.
Hvis du har foruroligende tanker eller oplevelser, eller hvis du bemærker, at du får det værre eller udvikler nye symptomer, mens du tager Lamictal: skal du søge læge så hurtigt som muligt eller tage på det nærmeste hospital for at få hjælp.
See a doctor as soon as possible or go to the nearest hospital for help.
Hvis du tager Lamictal til behandling af epilepsi Nogle typer af epileptiske anfald kan sommetider blive værre eller forekomme oftere mens du tager Lamictal.
If you’ re taking Lamictal for epilepsy The seizures in some types of epilepsy may occasionally become worse or happen more often while you’ re taking Lamictal.
Hvis du oftere får anfald, eller hvis du oplever et svært anfald, mens du tager Lamictal:
If your seizures happen more often, or if you experience a severe seizure while you’ re taking Lamictal:
107 skal du søge læge så hurtigt som muligt.
106 See a doctor as soon as possible.
Dette gælder også medicin, som ikke er købt på recept.
Taking other medicines Tell your doctor or pharmacist if you’ re taking any other medicines, if you’ ve taken any recently, or if you start taking new ones — these include herbal medicines or other medicines you bought without a prescription.
Fortæl det til lægen, hvis du tager et eller flere af disse lægemidler.
These include: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy • lithium, used to treat mental health problems • bupropion, used to treat mental health problems or to stop smoking Tell your doctor if you are taking any of these.
Noget medicin påvirker den måde, Lamictal virker på, eller gør det mere sandsynligt, at du får bivirkninger.
Some medicines interact with Lamictal or make it more likely that you’ ll have side effects.
Den medicin omfatter: • Valproat, der anvendes til behandling af epilepsi og psykiske problemer • Carbamazepin, der anvendes til behandling af epilepsi og psykiske problemer • Phenytoin, primidon eller phenobarbital, der anvendes til behandling af epilepsi • Olanzapin, der anvendes til behandling af psykiske problemer • Risperidon, der anvendes til behandling af psykiske problemer • Rifampicin, der er et antibiotikum • En kombination af lopinavir og ritonavir, der anvendes til behandling af infektion med humant immundefektvirus (HIV) • Hormonale svangerskabsforebyggende midler, f. eks. p- piller (se nedenfor).
These include: • valproate, used to treat epilepsy and mental health problems • carbamazepine, used to treat epilepsy and mental health problems • phenytoin, primidone or phenobarbitone, used to treat epilepsy • olanzapine, used to treat mental health problems • risperidone, used to treat mental health problems • rifampicin, which is an antibiotic • a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection • hormonal contraceptives, such as the Pill (see below).
Fortæl det til lægen, hvis du tager, begynder at tage eller holder op med at tage nogle af disse lægemidler.
Tell your doctor if you are taking, or if you start or stop taking, any of these.
Hormonale svangerskabsforebyggende midler (f. eks. p- piller) kan påvirke effekten af Lamictal Lægen kan anbefale, at du bruger en bestemt form for hormonalt svangerskabsforebyggende middel eller en anden svangerskabsforebyggende metode, f. eks. kondomer, pessar eller spiral.
Hormonal contraceptives (such as the Pill) can affect the way Lamictal works Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil.
Hvis du bruger et hormonalt svangerskabsforebyggende middel som p- piller, kan lægen tage blodprøver for at kontrollere niveauet af Lamictal i dit blod.
If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamictal.
Tal med lægen, der vil drøfte egnede svangerskabsforebyggende metoder med dig.
Talk to your doctor, who will discuss suitable methods of contraception with you.
Lamictal kan også påvirke den måde, som hormonale svangerskabsforebyggende midler virker på, selvom det ikke er sandsynligt, at de bliver mindre effektive.
Lamictal can also affect the way hormonal contraceptives work, although it’ s unlikely to make them less effective.
Hvis du bruger et hormonalt svangerskabsforebyggende middel, og du bemærker ændringer i dit menstruationsmønster, f. eks. gennembrudsblødning eller pletblødning mellem menstruationerne:
If you are using a hormonal contraceptive, and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods:
Graviditet og amning Tal med lægen, hvis du er gravid, måske er gravid eller planlægger at blive gravid.
Pregnancy and breast feeding Talk to your doctor if you’ re pregnant, if you might be pregnant, or if you’ re planning to become pregnant.
Du må ikke ophøre med epilepsibehandlingen, mens du er gravid.
You should not stop treatment for your epilepsy while you’ re pregnant.
Lægen kan anbefale, at du tager ekstra folsyre, hvis du planlægger at blive gravid samt under graviditeten.
Your doctor may advise you to take extra folic acid if you’ re planning to become pregnant and while you’ re pregnant.
Det kan være nødvendigt at justere dosis.
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.
108 Tal med lægen, hvis du ammer eller planlægger at amme.
107 Talk to your doctor if you’ re breast feeding or planning to breast feed.
Lægen vil orientere dig om risiciene og fordelene ved at amme, mens du tager Lamictal, og undersøge dit barn fra tid til anden, hvis du vælger at amme.
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.
Trafik - og arbejdssikkerhed Lamictal kan forårsage svimmelhed og dobbeltsyn.
Driving and using machines Lamictal can cause dizziness and double vision.
Du må kun køre bil, motorcykel, cykle eller arbejde med værktøj eller maskiner, hvis du er sikker på, at du ikke er påvirket.
Don’ t drive or operate machines unless you are sure you’ re not affected.
Vigtig information om nogle af de øvrige indholdsstoffer i Lamictal Lamictal- tabletterne indeholder små mængder af en sukkerart, der kaldes lactose.
Important information about some of the ingredients of Lamictal Lamictal tablets contain small amounts of a sugar called lactose.
Hvis du ikke kan tåle lactose eller andre sukkerarter Tal med lægen, og lad være med at tage Lamictal.
Tell your doctor, and don’ t take Lamictal.
SÅDAN SKAL DU TAGE LAMICTAL
HOW TO TAKE LAMICTAL
Er du i tvivl, så spørg lægen eller på apoteket.
Check with your doctor or pharmacist if you’ re not sure.
Dosis Det kan tage et stykke tid at finde frem til den optimale dosis Lamictal.
How much Lamictal to take It may take a while to find the best dose of Lamictal for you.
Dosis afhænger af: • Din alder • Om du tager Lamictal sammen med andre lægemidler • Om du har problemer med nyrerne eller leveren.
The dose you take will depend on: • your age • whether you are taking Lamictal with other medicines • whether you have problems with your kidneys or liver.
Den maksimale dosis er 400 mg om dagen.
For children aged 2 to 12 years, the effective dose depends on their body weight — usually, it’ s between 1 mg and 15 mg for each kilogram of the child’ s weight, up to a maximum of 400 mg daily.
Sådan skal du tage Lamictal Tabletter:
How to take your dose of Lamictal Tablets:
Lægen kan også råde dig til at begynde eller holde op med at tage andre lægemidler, afhængigt af hvilken tilstand du behandles for, og hvordan du responderer på behandlingen. • Synk tabletterne hele.
Your doctor may also advise you to start or stop taking other medicines, depending on what condition you’ re being treated for and the way you respond to treatment. • Swallow your tablets whole.
Du må ikke knække, tygge eller knuse dem. • Tag altid hele den dosis, som lægen har ordineret.
Don’ t break, chew or crush them. • Always take the full dose that your doctor has prescribed.
Dispergible tabletter / tyggetabletter:
Dispersible/ chewable tablets:
Lamictal kan tages sammen med eller uden mad. • Tag altid hele den dosis, som lægen har ordineret.
You can take it with or without food. • Always take the full dose that your doctor has prescribed.
Lægen kan også råde dig til at begynde eller holde op med at tage anden medicin, afhængigt af hvilken tilstand du behandles for, og hvordan du responderer på behandlingen.
108 Your doctor may also advise you to start or stop taking other medicines, depending on what condition you’ re being treated for and the way you respond to treatment.
109 Du kan tage Lamictal dispergible tabletter / tyggetabletter ved at synke dem hele med lidt vand, tygge dem eller opløse dem i vand.
You can take Lamictal dispersible/ chewable tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water:
Hvis du opløser tabletten:
To make a liquid medicine: • Put the tablet in a glass with at least enough water to cover the whole tablet. • Either stir to dissolve, or wait for about a minute, until the tablet is fully dissolved. • Drink all the liquid. • Add a little more water to the glass and drink that, to make sure you’ ve taken all the medicine.
- Læg tabletten i et glas med tilstrækkeligt vand til mindst at dække hele tabletten.
If you take more Lamictal than you should If anyone takes too much Lamictal:
- Rør rundt for at opløse tabletten, eller vent i ca.
Contact a doctor or pharmacist immediately.
1 minut, indtil tabletten er helt opløst.
If possible, show them the Lamictal packet.
- Drik al væsken.
Someone who has taken too much Lamictal may have any of these symptoms: • rapid, uncontrollable eye movements (nystagmus) • clumsiness and lack of co-ordination, affecting their balance (ataxia) • loss of consciousness or coma.
- Hæld lidt mere vand i glasset, og drik det for at sikre, at du har taget al medicinen.
If you forget to take Lamictal Don’ t take extra tablets or a double dose to make up for a forgotten dose.
Hvis du har taget for meget Lamictal Hvis du har taget for meget Lamictal Kontakt lægen eller apoteket omgående.
Ask your doctor for advice on how to start taking it again.
Medbring denne indlægsseddel og/ eller pakningen, hvis du har mulighed for det.
It’ s important that you do this.
Hvis du har taget for meget Lamictal, kan der opstå et eller flere af følgende symptomer:
Don’ t stop taking Lamictal without advice Take Lamictal for as long as your doctor recommends.
- Hurtige, ukontrollerede øjenbevægelser (nystagmus)
If you suddenly stop taking Lamictal, your epilepsy may come back or get worse.
- Klodsethed og manglende koordinationsevne, hvilket påvirker balancen (ataksi)
But you should still talk to your doctor first, if you want to stop taking Lamictal.
- Bevidstløshed eller koma.
POSSIBLE SIDE EFFECTS
Hvis du har glemt at tage Lamictal Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
Like all medicines, Lamictal can cause side effects, but not everyone gets them.
Hvis du har glemt at tage en dosis af Lamictal:
Symptoms of these reactions include: • skin rashes or redness • a sore mouth or eyes • a high temperature (fever), flu-like symptoms or drowsiness
Det er vigtigt, at du gør dette.
109 • swelling around your face, or swollen glands in your neck, armpit or groin • unexpected bleeding or bruising, or your fingers turning blue • a sore throat, or more infections (such as colds) than usual.
Du må ikke holde op med at tage Lamictal uden rådgivning.
In many cases, these symptoms will be signs of less serious side effects.
Tag Lamictal i den periode, som lægen foreskriver.
But you must be aware that they are potentially serious — so, if you notice any of these symptoms:
Afbryd ikke behandlingen, medmindre lægen beder dig om det.
Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamictal.
Hvis du pludselig holder op med at tage Lamictal, kan epilepsien vende tilbage eller blive værre.
Very common side effects These may affect more than 1 in 10 people: • headache • feeling dizzy • feeling sleepy or drowsy • clumsiness and lack of co-ordination (ataxia) • double vision or blurred vision • feeling sick (nausea) or being sick (vomiting) • skin rash.
Hvis du tager Lamictal til behandling af bipolar sygdom Det kan tage lidt tid, før Lamictal virker, og at du kan mærke effekten.
Common side effects These may affect up to 1 in 10 people: • aggression or irritability • rapid, uncontrollable eye movements (nystagmus) • shaking or tremors • difficulty in sleeping • diarrhoea • dry mouth • feeling tired • pain in your back or joints, or elsewhere.
Du skal dog stadig rådføre dig med lægen først, hvis du ønsker at holde op med at tage Lamictal.
Rare side effects These may affect up to 1 in 1,000 people: • itchy eyes, with discharge and crusty eyelids (conjunctivitis) • a rare skin condition, with severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area (Stevens– Johnson syndrome).
110 4.
110
BIVIRKNINGER
• •
Lamictal kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
a high temperature (fever) swell ing around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy)
Allergisk reaktion eller mulig alvorlig hudreaktion: søg øjeblikkelig lægehjælp.
•
Disse symptomer er i mange tilfælde tegn på mindre alvorlige bivirkninger.
in people who already have Parkinson’s disease, worsening of the symptoms.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
If you get side effects If any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
Opbevares utilgængeligt for børn.
Keep Lamictal out of the sight and reach of children.
Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
Lamictal does not require any special storage conditions.
Spørg på apoteket, hvordan du skal aflevere medicinrester.
If you have any unwanted Lamictal tablets, don’t dispose of them in your waste water or your household rubbish.
Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
Take them back to your pharmacist, who will dispose of them in a way that won’t harm the environment.
Aktivt stof: lamotrigin.
What Lamictal tablets contain The active substance is lamotrigine.
Aktivt stof: lamotrigin.
What Lamictal dispersible/chewable tablets contain The active substance is lamotrigine.
112 Lamictals udseende og pakningsstørrelse Lamictal- tabletter (alle styrker) er kvadratiske med afrundede hjørner og lyse og gulligbrune i farven.
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.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all listed pack sizes may be available in your country.
Lamictal 25 mg tabletter er påtrykt 'GS SEC7' på den ene side og '25' på den anden side.
Lamictal 25 mg tablets are marked ‘GSEC7’ on one side and ‘25’ on the other.
Lamictal 50 mg tabletter er påtrykt 'GS SEE1' på den ene side og '50' på den anden side.
Lamictal 50 mg tablets are marked ‘GSEE1’ on one side and ‘50’ on the other.
Lamictal 100 mg tabletter er påtrykt 'GS SEE5' på den ene side og '100' på den anden side.
Lamictal 100 mg tablets are marked ‘GSEE5’ on one side and ‘100’ on the other.
Lamictal 200 mg tabletter er påtrykt 'GS SEE7' på den ene side og '200' på den anden side.
Lamictal 200 mg tablets are marked ‘GSEE7’ on one side and ‘200’ on the other.
Lamictal dispergible tabletter / tyggetabletters udseende og pakningsstørrelse Lamictal dispergible tabletter / tyggetabletter (alle styrker) er hvide til offwhite og kan være en anelse spættede.
111 What Lamictal dispersible/chewable tablets look like and contents of the pack Lamictal dispersible/chewable tablets (all strengths) are white to off-white, and may be slightly mottled.
De er påtrykt 'LTG' over tallet '2' på den ene side, og den anden side har to overlappende ovale figurer, der ligger vinkelret på hinanden.
They are marked ‘LTG’ above the number ‘2’ on one side; and with two ovals overlapping at right angles on the other.
De er påtrykt 'GS CL2' på den ene side og '5' på den anden side.
They are marked ‘GS CL2’ on one side; and ‘5’ on the other.
De er påtrykt 'GS CL5' på den ene side og '25' på den anden side.
They are marked ‘GSCL5’ on one side; and ‘25’ on the other.
De er påtrykt 'GS CX7' på den ene side og '50' på den anden side.
They are marked ‘GSCX7’ on one side; and ‘50’ on the other.
De er påtrykt 'GS CL7' på den ene side og '100' på den anden side.
They are marked ‘GSCL7’ on one side; and ‘100’ on the other.
De er påtrykt 'GS EC5' på den ene side og '200' på den anden side.
They are marked ‘GSEC5’ on one side; and ‘200’ on the other.
{navn og adresse} < {tlf.} > < {fax} > < {e- mail} >
{Name and address} < {tel} > < {fax} > < {e-mail} >
Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Storbritannien.
Manufacturer: < Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom. >
GlaxoSmithKline Pharmaceuticals S. A., Ul.
< GlaxoSmithKline Pharmaceuticals S.A., Ul.
Grunwaldzka 189, 60- 322 Poznan, Polen.
Grunwaldzka 189, 60-322 Poznan, Poland. >