qanastek/EMEA-V3 huggingface dataset:
Risk Management plan The MAH commits to performing the study and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ikun obbligat li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fil- pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 5 tal - Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat f ’ Sezzjoni 1. 8. 2 tal - Awtorizzazzjoni ta ’ Tqegħid fis- Suq u titdil ieħor tal- RMP sussegwenti maqbul mil CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Addizzjonalment, RMP aġġornat irid jiġi sottomess • Meta informazzjoni ġdida tiġi riċevuta li tista ’ jkollha impatt fuq l- Ipeċifikazzjoni ta ’ Sigurta ’ kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajjiet ta ’ tnaqqis tar- riskju • Sa żmien 60 ġurnata minn meta jintlaħaq stadju importanti (farmakovigilanza jew tnaqqis tar - riskju) • Wara talba tal- EMEA
60 ANNEX III
66 ANNESS III
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Vimpat 50 mg film-coated tablets Lacosamide
Vimpat 50 mg pilloli miksija b’ rita Lacosamide
1 film-coated tablet contains 50 mg lacosamide.
Pillola miksija b’ rita waħda fiha 50 mg lacosamide.
Contains soya-lecithin.
Fih soja- lecithin.
14 film-coated tablets 56 film-coated tablets 168 film-coated tablets
14 pilloli miksija b’ rita 56 pilloli miksija b’ rita 168 pilloli miksija b’ rita
UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium
UCB Pharma SA Allée de la Recherche 60 B- 1070 Brussel Belġju
EU/ 1/ 08/ 470/ 001 14 film-coated tablets EU/ 1/ 08/ 470/ 002 56 film-coated tablets EU/ 1/ 08/ 470/ 003 168 film-coated tablets
EU/ 0/ 00/ 000/ 000 14 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 168 pilloli miksija b’ rita
64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister label
Tabella fuq il- folja
Vimpat 100 mg film-coated tablets Lacosamide
Vimpat 100 mg pilloli miksija b’ rita Lacosamide
1 film-coated tablet contains 100 mg lacosamide.
Pillola miksija b’ rita waħda fiha 100 mg lacosamide.
EU/ 1/ 08/ 470/ 004 14 film-coated tablets EU/ 1/ 08/ 470/ 005 56 film-coated tablets EU/ 1/ 08/ 470/ 006 168 film-coated tablets
EU/ 0/ 00/ 000/ 000 14 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 168 pilloli miksija b’ rita
Vimpat 150 mg film-coated tablets Lacosamide
Vimpat 150 mg pilloli miksija b’ rita Lacosamide
1 film-coated tablet contains 150 mg lacosamide.
Pillola miksija b’ rita waħda fiha 150 mg lacosamide.
14 film-coated tablets 56 film-coated tablets
14 pilloli miksija b’ rita 56 pilloli miksija b’ rita
EU/ 1/ 08/ 470/ 007 14 film-coated tablets EU/ 1/ 08/ 470/ 008 56 film-coated tablets
EU/ 0/ 00/ 000/ 000 14 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 168 pilloli miksija b’ rita
MULTIPACKS ONLY Carton of 168 film-coated tablets containing 3 Cartons of 56 film-coated tablets (with Blue box)
PAKKETTI MULTIPLI BISS Pakkett ta ’ 168 pilloli miksija b’ rita li fihom 3 Pakketti ta ’ 56 pilloli miksija b’ rita( bil- Blue box)
1 film-coated tablet contains 150 mg lacosamide.
Pillola waħda miksija b’ rita waħda fiha 150 mg lacosamide.
Contains soya lecithin.
Fih soja- lecithin.
168 film-coated tablets
168 pilloli miksija b’ rita
72 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY Intermediate Carton Carton of 56 film-coated tablets 150 mg (without Blue Box)
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS Pakkett tan- nofs Pakkett ta ’ 56 pilloli miksija b’ rita 150mg (mingħajr blue box)
56 film-coated tablets
56 pilloli miksija b’ rita
UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium
79 UCB Pharma SA Allée de la Recherche 60 B- 1070 Brussel Belġju
74 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Vimpat 200 mg film-coated tablets Lacosamide
Vimpat 200 mg pilloli miksija b’ rita Lacosamide
1 film-coated tablet contains 200 mg lacosamide.
Pillola miksija b’ rita waħda fiha 200 mg lacosamide.
EU/ 1/ 08/ 470/ 010 14 film-coated tablets EU/ 1/ 08/ 470/ 011 56 film-coated tablets
EU/ 0/ 00/ 000/ 000 14 pilloli miksija b’ rita EU/ 0/ 00/ 000/ 000 56 pilloli miksija b’ rita
1 film-coated tablet contains 200 mg lacosamide.
Pillola waħda miksija b’ rita waħda fiha 200 mg lacosamide.
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY Intermediate Carton Carton of 56 film-coated tablets 200 mg (without Blue Box)
85 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI MULTIPLI BISS Pakkett tan- nofs Pakkett ta ’ 56 pilloli miksija b’ rita 200mg (mingħajr blue box)
UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium
86 UCB Pharma SA Allée de la Recherche 60 B- 1070 Brussel Belġju
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
87 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets
88 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETTI TAL- BIDU TAT- TRATTAMENT Pakkett ta ’ barra – pakkett tal- bidu tat- trattament li fih 4 pakketti ta ’ 14- il- pillola miksija b’ rita
Vimpat 50 mg Vimpat 100 mg Vimpat 150 mg Vimpat 200 mg film-coated tablets Lacosamide
Vimpat 50 mg Vimpat 100 mg Vimpat 150 mg Vimpat 200 mg pilloli miksija b’ rita Lacosamide
Vimpat 50 mg 1 film-coated tablet contains 50 mg lacosamide.
Vimpat 50 mg Pillola waħda miksija b’ rita waħda fiha 50 mg lacosamide.
Vimpat 100 mg 1 film-coated tablet contains 100 mg lacosamide.
Vimpat 100 mg Pillola waħda miksija b’ rita waħda fiha 100 mg lacosamide.
Vimpat 150 mg 1 film-coated tablet contains 150 mg lacosamide.
Vimpat 150 mg Pillola waħda miksija b’ rita waħda fiha 150 mg lacosamide.
Vimpat 200 mg 1 film-coated tablet contains 200 mg lacosamide.
Vimpat 200 mg Pillola waħda miksija b’ rita waħda fiha 200 mg lacosamide.
Treatment initiation pack with 56 film-coated tablets for a 4-week treatment schedule contains:
Il- pakkett tal- bidu tat- trattament b ’ 56 pillola miksija b’ rita għal skeda ta ’ trattament ta ’ 4 ġimgħat fiħ:
14 film-coated tablets of Vimpat 50 mg 14 film-coated tablets of Vimpat 100 mg 14 film-coated tablets of Vimpat 150 mg 14 film-coated tablets of Vimpat 200 mg
14 pilloli miksija b’ rita ta ’ Vimpat 50 mg 14 pilloli miksija b’ rita ta ’ Vimpat 100 mg 14 pilloli miksija b’ rita ta ’ Vimpat 150 mg 14 pilloli miksija b’ rita ta ’ Vimpat 200 mg
84 TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate Carton Carton 14 tablets – week 1
90 PAKKETTI TAL- BIDU TAT- TRATTAMENT TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Pakkett tan- nofs Pakkett 14- il- pillola – ġimgħa 1
1 film-coated tablet contains 50 mg lacosamide.
Pillola waħda miksija b’ rita waħda fiha 50 mg lacosamide.
14 film-coated tablets.
14- il pillola miksija.
86 TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
92 PAKKETT TAL’ BIDU TA ’ TRATTAMENT BISS TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Blister label – week 1
Tabella tal folja – ġimgħa 1
87 TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate Carton Carton 14 tablets – week 2
93 PAKKETTI TAL- BIDU TAT- TRATTAMENT TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Pakkett tan- nofs Pakkett 14- il- pillola – ġimgħa 2
1 film-coated tablet contains 100 mg lacosamide.
Pillola waħda miksija b’ rita waħda fiha 100 mg lacosamide.
89 TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
95 PAKKETT TAL’ BIDU TA ’ TRATTAMENT BISS TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Blister label – week 2
Tabella tal folja – ġimgħa 2
90 TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate Carton Carton 14 tablets – week 3
96 PAKKETTI TAL- BIDU TAT- TRATTAMENT TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Pakkett tan- nofs Pakkett 14- il- pillola – ġimgħa 3
92 TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
98 PAKKETT TAL’ BIDU TA ’ TRATTAMENT BISS TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Blister label – week 3
Tabella tal folja – ġimgħa 3
93 TREATMENT INITIATION PACK ONLY PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate Carton Carton 14 tablets – week 4
99 PAKKETTI TAL- BIDU TAT- TRATTAMENT TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Pakkett tan- nofs Pakkett 14- il- pillola – ġimgħa 4
95 TREATMENT INITIATION PACK ONLY MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
101 PAKKETT TAL’ BIDU TA ’ TRATTAMENT BISS TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
Blister label – week 4
Tabella tal folja – ġimgħa 4
96 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA W L- PAKKETT LI JMISS MAL- PRODOTT
Outer carton / bottle
Pakkett ta ’ barra / flixkun
Vimpat 15 mg/ ml syrup Lacosamide
Vimpat 15 mg/ ml mistura Lacosamide
1 bottle of 465 ml contains 6975 mg lacosamide.
Flixkum wieħed ta ’ 465 ml fih 6975 mg lacosamide.
Contains E420, E217, E219 and E951, sodium.
Fih E420, E217, E219 u E951 -, sodju.
200 ml syrup.
200 ml mistura.
465 ml syrup.
465 ml mistura.
EXP After first opening, bottle may be used for up to 4 weeks.
JIS Wara li jinfetaħ il- flixkun l- ewwel darba, il- flixkun jista ’ jintuża għal mhux iżjed minn 4 ġimgħat.
EU/ 1/ 08/ 470/ 014 200 ml syrup EU/ 1/ 08/ 470/ 015 465 ml syrup
EU/ 0/ 00/ 000/ 000 200 ml mistura EU/ 0/ 00/ 000/ 000 465 ml mistura
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Vimpat 10 mg/ ml solution for infusion Lacosamide
Vimpat 10 mg/ ml soluzzjoni għall- infużjoni Lacosamide
Each ml of solution for infusion contains 10 mg lacosamide.
Kull ml ta ’ soluzzjoni għall- infużjoni fiħ 10 mg lacosamide.
1 vial of 20 ml contains 200 mg lacosamide.
Fjala waħda ta ’ 20 ml fiha 200 mg lacosamide.
Excipients: sodium chloride, hydrochloric acid, water for injection.
Sustanzi mhux attivi: sodium chloride, hydrochloric acid, ilma għall- injezzjoni.
20 ml solution for infusion
20 ml soluzzjoni għall- infużjoni.
Intravenous use.
Użu minn ġol- vina.
Do not store above 25°C.
Taħżinx ‘ l fuq minn 25°C.
99 Any unused solution should be discarded.
Kull soluzzjoni li ma tintużax għandha tintrema.
Justification for not including Braille accepted
Il- ġustifikazzjoni biex ma jiġix inkuż il- Braille ġiet aċċettata.
100 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING
106 TAGĦRIF GĦANDU JIDHER FUQ IL- PAKKETTI EWLENIN
Vial
Fjala
Each ml of solution contains 10 mg lacosamide.
Kull ml ta ’ soluzzjoni għall- infużjoni fiħ 10 mg lacosamide.
1 vial of 20 ml contains 200 mg lacosamide.
Fjala waħda ta ’ 20 ml fih 200 mg lacosamide.
Sodium chloride, hydrochloric acid, water for injection.
Sodium chloride, hydrochloric acid, ilma għall- injezzjoni.
IV use.
Użu minn ġol- vina.
UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium
UCB Pharma SA Allée de la Recherche 60 B- 1070 Brussell Belġju
Justification for not including Braille accepted.
Il- ġustifikazzjoni biex ma jiġix inkuż il- Braille ġiet aċċettata.
103 PACKAGE LEAFLET:
109 FULJETT TA ’ TAGĦRIF:
What Vimpat is and what it is used for 2.
X’ inhu Vimpat u għalxiex jintuża 2.
Before you take Vimpat 3.
Qabel ma tieħu Vimpat 3.
How to take Vimpat 4.
Kif għandek tieħu Vimpat Effetti sekondarji li jista ’ jkollu 4.
How to store Vimpat 6.
Kif taħżen Vimpat 6.
WHAT VIMPAT IS AND WHAT IT IS USED FOR
X’ INHU VIMPAT U GĦALXIEX JINTUŻA
Vimpat is used to treat a certain form of epilepsy (see below) in patients aged 16 years and older.
Vimpat jintuża biex jittratta ċerta forma ta ’ epilessija (ara hawn taħt) f’ pazjenti ta ’ 16- il sena ‘ fuq.
Vimpat is used in addition to other antiepileptic medicines.
Vimpat jintuża billi jiżdied ma ’ mediċini oħra ta ’ kontra l- epilessija.
Vimpat is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
L- epilessija hija kundizzjoni fejn il- pazjenti jkollhom aċċessjonijiet ripetuti. (attaki tal- puplezija) Vimpat jintuża għat- tip ta ’ l- epilessija fejn fil- bidu l- aċċessjoni jkollha effett fuq naħa waħda biss tal - moħħ, imma li jista ’ wara jinfirex għal partijiet akbar fiż- żewġt naħat tal- moħħ (aċċessjonijiet tat- tip ‘ partial- onset ’ kemm b’ ġeneralizzazzjoni sekondarja kif ukoll mingħajr).
BEFORE YOU TAKE VIMPAT
QABEL MA TIEĦU VIMPAT
Do NOT take Vimpat • if you are allergic (hypersensitive) to lacosamide, or to peanuts or soya or any of the other ingredients of Vimpat (listed in Section 6).
Tieħux Vimpat • jekk inti allerġiku (tbagħti minn sensittività eċċessiva) għal lacosamide, għal karawett jew soja jew xi sustanzi oħra ta ’ Vimpat (mliżżla f’ Sezzjoni 6).
If you are not sure whether you are allergic, please discuss with your doctor • if you suffer from a certain type of heart rhythm disorder (second or third degree AV block)
Jekk inti m’ intiex ċert jekk intix allerġiku, jekk jogħġbok kellem lit- tabib tiegħek. • Jekk tbagħti minn ċertu tip ta ’ marda tat- ritmu tal- qalb (blokk AV tat- tieni jew t- tielet grad)
Take special care with Vimpat Please inform your doctor about the following: • if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval, for example medicines used to treat certain types of irregular heart beat or heart failure.
Oqgħod attent ħafna b’ Vimpat Jekk jogħġbok għid lit- tabib dwar dawn li ġejjien: • jekk int qed tieħu xi mediċini li jistgħu jikkawżaw abnormalita`fuq l- ECG (elektrokardjogramma) li tissejjaħ żieda fl- interval PR, per eżempju mediċini li jintużaw fi trattament ta ’ ċerti tipi ta ’ taħbit tal- qalb irregolari jew insuffiċjenza tal- qalb.
If you are not sure if the medicines you are taking could have this effect, discuss this with your doctor. • if you suffer from a severe heart disease such as heart rhythm disorder, heart failure or heart attack
Kellem lit- tabib tiegħek jekk m’ intix ċert jekk il- mediċini li qed tieħu jistgħux ikollhom dan l- effett. • jekk inti tbagħti minn mard tal- qalb sever bħal mard tar- ritmu, insuffiċjenza tal- qalb jew attakk tal- qalb.
Vimpat may cause dizziness, which could increase the risk of accidental injury or a fall.
110 Vimpat jista ’ jikkawża sturdament, li jista ’ jżid ir- riskju ta ’ korriment jew waqgħa.
Therefore, you should be careful until you are used to the effects this medicine might have.
Għalhekk, għandek toqgħod attent sakemm tidhra l- effetti li din il- mediċina jista ’ jkollha.
104 A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves.
Numru żgħir ta ’ nies li jkunu fuq kura b ’ mediċini ta ’ kontra l- epilessija bħal lacosamide kellhom ħsibijiet li jweġġgħu jew joqtlu lilhom infushom.
If at any time you have these thoughts, immediately contact your doctor.
Jekk f’ xi ħin inti jkollok dawn il- ħsibijiet, kellem immedjatament lit- tabib tiegħek.
This is especially important if you take medicines to treat heart problems (see also above "Take special care").
Dan huwa ta ’ importanza speċjali jekk inti qiegħaed tieħu mediċini biex tittratta problemi tal- qalb (ara ukoll hawn fuq “ Oqgħod attent ħafna ”).
Taking Vimpat with food and drink You may take Vimpat with or without food.
Meta tieħu Vimpat ma ’ l- ikel u max- xorb Tista ’ tieħu Vimpat kemm ma ’ l- ikel kif ukoll mingħajr.
It is not advisable to drink alcohol while you are under treatment with Vimpat, because Vimpat could make you feel tired or dizzy.
Mhux irrikkmandat li tixrob l- alkoħol waqt li tkun fuq trattament b’ Vimpat, għaliex Vimpat jista ’ jġegħlek tħossok għajjien jew sturdut.
Drinking alcohol could make these effects worse.
Ix- xorb ta ’ l- alkoħol jista ’ jiggrava dawn l- effetti.
Pregnancy and breast-feeding It is not recommended to take Vimpat if you are pregnant, as the effects of Vimpat on pregnancy and the unborn baby are not known.
Tqala u Treddigħ Mhux irrikkmandat li jittieħed Vimpat jekk inti tqila, għaliex l- effetti ta ’ Vimpat fuq il- tqala u t- tarbija ġol- ġuf mhumiex magħrufin.
Tell your doctor immediately if you are pregnant or planning to become pregnant; he/ she will decide if you should take Vimpat.
Għarraf lit- tabib tiegħek immedjatament jekk inti tqila jew qed tippjana li toħroġ tqila; hu/ hi tiddeċiedi jekk għandekx tieħu Vimpat.
It is not recommended to breast-feed your baby while taking Vimpat, as it is not known if Vimpat passes into the breast milk.
Mhux irrikkmandat li tredda ’ t- tarbija waqt li qed tieħu Vimpat, għaliex mhux magħruf jekk Vimpat jgħaddiex ġol- ħalib ta ’ l- omm.
If you are breast-feeding, please inform your doctor immediately; he/ she will decide if you should take Vimpat.
Għarraf lit- tabib tiegħek immedjatament jekk inti qegħda tredda ’; hu/ hi tiddeċiedi jekk għandekx tieħu Vimpat.
Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Ir- riċerka wriet riskju akbar ta ’ difetti li titwieled bihom f’ tfal ta ’ nisa li jieħdu mediċini ta ’ kontra l - epilessija.
On the other hand effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.
Minn naħa l- oħra, terapija effettiva ta ’ kontra l- epilessija ma tistax tiġi interrotta għaliex jekk il- marda tmur għall- agħar jista ’ jsir ħsara kemm għall- omm kif ukoll għat- tarbija fil- ġuf.
Driving and using machines Vimpat may cause dizziness or blurred vision.
Sewqan u tħaddim ta ’ magni Vimpat jista ’ jikkawża sturdament jew vista mċajpra.
This may affect your ability to drive or operate any tools or machinery.
Dan jista ’ jaffetwa l- ħila tiegħek li ssuq jew li tagħmel użu minn għodda jew tħaddem magni.
You should not drive or use machines until you know whether this medicine affects your ability to perform these activities.
M’ għandekx issuq jew tħaddem magni qabel issir taf jekk din il- mediċina għandiex effett fuq il- ħila tiegħek li tagħmel dawn l- attivitajjiet
Important information about some of the ingredients of Vimpat Vimpat contains soya-lecithin.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Vimpat Vimpat fih soya- lecithin.
Do not take Vimpat tablets if you are allergic to peanuts or soya (see also section 2. ‘ Do not take Vimpat’).
Tieħux pilloli Vimpat jekk inti allerġiku għall- karawett jew soya (ara wkoll sezzjoni 2 ‘ Tieħux Vimpat ’).
HOW TO TAKE VIMPAT
KIF GĦANDEK TIEĦU VIMPAT
Always take Vimpat exactly as your doctor has told you.
Dejjem għandek tieħu Vimpat skond il- parir tat- tabib.
Dosage Vimpat must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Dożaġġ Vimpat għandu jittieħed darbtejn kuljum, darba filgħodu u darba filgħaxija, bejn wieħed u ieħor fl - istess ħin kuljum.
Vimpat is used as a long term treatment.
Vimpat jintuża bħala trattament fit- tul.
The usual starting dose of Vimpat is 100 mg per day - taken twice a day – 50 mg in the morning and 50 mg in the evening.
Id- doża tal- bidu ta ’ Vimpat li ssoltu tingħata hija ta ’ 100 mg kuljum – li tittieħed darbtejn kuljum, 50 mg filgħodu u 50 mg filgħaxija.
Your doctor may increase your daily dose every week by 100 mg, until you reach a so called maintenance dose between 200 mg and 400 mg per day, taken twice a day.
It- tabib tiegħek jista ’ jżid id- doża ta ’ kuljum tiegħek kull ġimgħa b ’ 100 mg, sakemm tilħaqq dik li jgħidulha d- doża ta ’ manteniment ta ’ bejn 200 mg u 400 mg li tittieħed darbtejn kuljum.
You will use this maintenance dose for the long term treatment.
Inti ser tieħu din id- doża ta ’ manteniment fit- trattament fit- tul.
Your doctor may prescribe you a different dose if you have problems with your kidneys.
It- tabib tiegħek jista ’ jiktiblek doża differenti jekk għandek problemi fil- kliewi tiegħek.
How to take the Vimpat tablets You should swallow the Vimpat tablet with a glass of water.
111 Kif tieħu il- pilloli Vimpat Għandek tibla ’ l- pilloli Vimpat ma ’ tazza ilma.
You may take Vimpat with or without food.
Tista ’ tieħu Vimpat kemm ma ’ l- ikel kif ukoll mingħajr.
105 Duration of the treatment with Vimpat Vimpat is used as a long term treatment.
It- tul tat- trattament b ’ Vimpat Vimpat jintuża ’ bħala trattament fit- tul.
You should continue to take Vimpat until your doctor tells you to stop.
Għandek tkompli tieħu Vimpat sakemm it- tabib tiegħek jgħidlek biex tieqaf.
If you take more Vimpat than you should If you have taken more Vimpat than you should, contact your doctor.
Jekk tieħu Vimpat aktar milli suppost Jekk tieħu Vimpat aktar milli suppost, kellem lit- tabib tiegħek.
If you forget to take Vimpat If you miss a dose by a few hours, take it as soon as you remember.
Jekk tinsa tieħu Vimpat Jekk tinsa ’ tieħu doża bi ftit sigħat, ħu d- doża hekk kif tiftakar.
If it is close to your next dose, do n't take the missed tablet anymore.
Jekk ikun wasal il- ħin għad- doża li jmiss, tieħux d- doża li nsejt tieħu.
Just take Vimpat at the next time that you would normally take it.
Ħu Vimpat id- darba li jmiss meta ssolti toħodha.
If you stop taking Vimpat Do not stop taking Vimpat without talking to your doctor, as your symptoms may come back again or become worse.
Jekk tieqaf tieħu Vimpat Tieqafx tieħu Vimpat mingħajr ma tkellem lit- tabib tiegħek, għaliex jistgħu jerġgħu joħorġu l- istess sintomi jew jiggravaw.
If your doctor decides to stop your treatment with Vimpat, he/ she will instruct you about how you should decrease the dose step by step.
Jekk it- tabib tiegħek jiddeċiedi li jwaqqaf it- trattament tiegħek b ’ Vimpat, huwa jew hija ser jagħtik struzzjonijiet ta ’ kif għandek pass wara pass tnaqqas id- doża.
Like all medicines, Vimpat can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Vimpat jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data
Il- frekwenzi ta ’ effetti mhux mixtieqa li jista ’ jkun hemm ġew definiti bil- konvenzjoni li ġejja: komuni ħafna (jaffettwaw iżjed minn 1 sa 10 li jieħduh) komuni (jaffettwaw 1 sa 10 minn 100 li jieħduh) mhux komuni (jaffettwaw 1 sa 10 minn 1, 000 li jieħduh) rari (jaffettwaw 1 sa 10 minn 10, 000 li jieħduh) rari ħafna (jaffettwaw inqas minn 1 minn 10, 000 li jieħduh) mhux magħruf (il- frekwenza ma tistax tiġi mkejla mit- tagħrif eżistenti)
Very common: affects more than 1 user in 10 • Dizziness, headache • Nausea (feeling sick) • Double vision (diplopia)
Komuni ħafna (jaffettwaw iżjed minn 1 sa 10 li jieħduh) • Sturdament, uġigħ ta ’ ras • Dardir (tħossok ma tiflaħx) • Vista doppja (diplowpja)
Common: affects 1 to 10 users in 100 • Problems in keeping your balance, difficulties in coordinating your movements, troubles with your memory, sleepiness, shaking (tremor), trouble thinking or finding words, rapid and uncontrollable movements of the eyes (nystagmus) • Blurred vision • A feeling of "spinning" (vertigo) • Vomiting, constipation, excessive gas in the stomach or bowel • Itching • Fall • Tiredness, difficulties in walking, unusual tiredness and weakness (asthenia) • Depression
Komuni (jaffettwaw 1 sa 10 minn 100 li jieħduh) • Problemi fil- bilanċ tiegħek, diffikultajjiet fil- ko- ordinazzjoni tal- movimenti tiegħek, problemi fil- memorja tiegħek, ngħas, rogħda, problemi biex taħseb jew issib il- kliem, movimenti ta ’ l - għajnejn mgħaġġla u inkontrollabli (nystagmus) • Vista mċajpra • Sensazzjoni li kollox idur bik (vertigo) • Rimettar, stitikezza, gas żejjed fl- istonku jew l- insaren • Ħakk • Waqgħa • Għajja, diffikulta` fil- mixi, għajja mhux tas- soltu u debollezza (astenja) • Depressjoni
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
112 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE VIMPAT
KIF TAĦŻEN VIMPAT
Do not use Vimpat after the expiry date which is stated on the carton and blister.
Tużax Vimpat wara d- data ta ’ skadenza li tidher fuq il- kartuna u il- folja.
This medicinal product does not require any special storage conditions.
Din il- mediċina ma’ għandiex ħtieġa ta ’ kondizzjonijiet speċjali għal ħażna.
What Vimpat contains The active substance is lacosamide.
Is- sustanza attiva hija lacosamide.
One tablet of Vimpat 50 mg contains 50 mg lacosamide.
Pillola waħda ta ’ Vimpat 50 mg fiha 50 mg lacosamide.
One tablet of Vimpat 100 mg contains 100 mg lacosamide.
Pillola waħda ta ’ Vimpat 100 mg fiha 100 mg lacosamide.
One tablet of Vimpat 150 mg contains 150 mg lacosamide.
Pillola waħda ta ’ Vimpat 150 mg fiha 150 mg lacosamide.
One tablet of Vimpat 200 mg contains 200 mg lacosamide.
Pillola waħda ta ’ Vimpat 200 mg fiha 200 mg lacosamide.
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone, magnesium stearate Film-coat: polyvinyl alcohol, polyethylene glycol, talc, soya-lecithin, hypromellose, titanium dioxide (E171), colourants* * The colourants are:
Qalba tal- pilloli: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone, magnesium stearate Kisja ta- rita: polyvinyl alcohol, polyethylene glycol, terra, soja- lecithin, hypromellose, titanium dioxide (E171), sustanzi koloranti * * Is- sustanzi koloranti huma:
50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132) 100 mg tablet: yellow iron oxide (E172) 150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) 200 mg tablet: indigo carmine aluminium lake (E132)
Pilloli 50 mg: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132) Pilloli 100 mg: yellow iron oxide (E172) Pilloli 150 mg: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) Pilloli 200 mg: indigo carmine aluminium lake (E132)
What Vimpat looks like and contents of the pack Vimpat 50 mg are pinkish, oval film-coated tablets with a debossed ‘ SP’ on one side and ‘ 50’ on the other side.
Vimpat 50 mg jagħtu fir- roża, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqxa fuq naħa waħda u ‘ 50 ’ fuq in- naħa l- oħra.
Vimpat 100 mg are dark yellow, oval film-coated tablets with a debossed ‘ SP’ on one side and ‘ 100’ on the other side.
Vimpat 100 mg huma sofor skuri, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqxa fuq naħa waħda u ‘ 100 ’ fuq in- naħa l- oħra.
Vimpat 150 mg are salmon, oval film-coated tablets with a debossed ‘ SP’ on one side and ‘ 150’ on the other side.
Vimpat 150 mg huma ta ’ kulur is- salamur, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqax fuq naħa waħda u ‘ 150 ’ fuq in- naħa l- oħra.
Vimpat 200 mg are blue, oval film-coated tablets with a debossed ‘ SP’ on one side and ‘ 200’ on the other side.
Vimpat 200 mg huma blu, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqax fuq naħa waħda u ‘ 200 ’ fuq in - naħa l- oħra.
Vimpat is available in packs of 14, 56 and 168 film-coated tablets.
Vimpat issibu f’ pakketti ta ’ 14, 56 u 168 pilloli miksija b’ rita.
UCB Pharma SA, Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
UCB Pharma SA, Allée de la Recherche 60, B- 1070 Brussel, Belġju.
10, 40678 Monheim am Rhein, Germany.
10, 40678 Monheim am Rhein, Ġermanja.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
113 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Latvija UCB Pharma Oy Finland Tel: + 358-(9) 2290 100
114 Latvija UCB Pharma Oy Finland Tel: + 358 - (9) 2290 100
108 This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
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109 PACKAGE LEAFLET:
115 FULJETT TA ’ TAGĦRIF:
Vimpat 50 mg film-coated tablets Vimpat 100 mg film-coated tablets Vimpat 150 mg film-coated tablets Vimpat 200 mg film-coated tablets
Vimpat 50 mg pilloli miksija b’ rita Vimpat 100 mg pilloli miksija b’ rita Vimpat 150 mg pilloli miksija b’ rita Vimpat 200 mg pilloli pilloli miksija b’ rita
Vimpat is used to treat a certa in form of epilepsy (see below) in patients aged 16 years and older.
Vimpat jintuża biex jittratta ċerta forma ta ’ epilessija (ara hawn taħt) f’ pazjenti ta ’ 16- il sena ‘ fuq.
Vimpat may cause dizziness, which could increase the risk of accidental injury or a fall.
116 Vimpat jista ’ jikkawża sturdament, li jista ’ jżid ir- riskju ta ’ korriment jew waqgħa.
110 A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves.
Numru żgħir ta ’ nies li jkunu fuq kura b ’ mediċini ta ’ kontra l- epilessija bħal lacosamide kellhom ħsibijiet li jweġġgħu jew joqtlu lilhom infushom.
Tell your doctor immediately if you are pregnant or planning to become pregnant; he/she will decide if you should take Vimpat.
Għarraf lit- tabib tiegħek immedjatament jekk inti tqila jew qed tippjana li toħroġ tqila; hu/ hi tiddeċiedi jekk għandekx tieħu Vimpat.
It is not recommended to breast-feed your baby while taking Vimpat, as it is not known if Vimpat passes into the breast milk.
Mhux irrikkmadat li tredda ’ t- tarbija waqt li qed tieħu Vimpat, għaliex mhux magħruf jekk Vimpat jgħaddiex ġol- ħalib ta ’ l- omm.
If you are breast-feeding, please inform your doctor immediately; he/she will decide if you should take Vimpat.
Għarraf lit- tabib tiegħek immedjatament jekk inti qegħda tredda ’; hu/ hi tiddeċiedi jekk għandekx tieħu Vimpat.
Do not take Vimpat tablets if you are allergic to peanuts or soya (see also section 2. ‘Do not take Vimpat’).
Tieħux pilloli Vimpat jekk inti allerġiku għall- karawett jew soya (ara wkoll sezzjoni 2 ‘ Tieħux Vimpat ’).
Start of the treatment (the first 4 weeks) This pack (treatment initiation pack) is used when you start your treatment with Vimpat.
Il- Bidu tat- trattament (l- ewwel erba ’ ġimgħat) Dan il- pakkett (pakkett tal- bidu tat- trattament) jintuża meta tibda il- kura tiegħek b’ Vimpat.
The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week.
Dan il- pakkett fiħ 4 pakketti differenti għall- ewwel erba ’ ġimgħat tat- trattament, pakkett wieħed għal kull ġimgħa.
Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.
Kull pakkett kellu 14- il- pillola, li jsarrfu f ’ 2 pilloli kuljum għal 7 tijiem.
Each package contains a different dosage strength of Vimpat, so you will increase your dose gradually.
Kull pakkett fih dożaġġ ta ’ qawwa differenti ta ’ Vimpat, sabiex inti żżid id- doża gradwalment.
You will start your treatment with a low dose of Vimpat, usually 50 mg twice a day, and increase it week by week.
117 Inti ser tibda t- trattament tiegħek b’ doża baxxa ta ’ Vimpat li ssoltu tkun ta ’ 50 mg darbtejn kuljum, u iżżidha ġimgħa wara ġimgħa.
The usual dose that may be taken per day for each of the first 4 weeks of treatment is shown in the following table.
Id- doża tas- soltu li tista ’ tittieħed kuljum matul l- ewwel 4 ġimgħat hija murija fit- tabella hawn taħt.
Your doctor will tell you whether you need all 4 packages.
It- tabib tiegħek ser jgħidlek jekk għandekx bżonn l- 4 pakketti kollha.
111 Table:
Tabella:
Start of the treatment (the first 4 weeks) Week
Doża tal- bidu tat- trattament (l- ewwel 4 ġimgħat) Ġimgħa
Package to be used
Pakkett li għndu jintuża
First dose (in the morning)
L- ewwel doża (filgħodu)
Second dose (in the evening)
It- tieni doża (filgħaxija)
TOTAL daily dose
TOTAL doża ta ’ kuljum
Week 1 Package marked "Week 1"
Ġimgħa 1 Pakkett immarkat "Ġimgħa 1"
50 mg (1 tablet Vimpat 50 mg)
50 mg (pillola Vimpat 50 mg waħda)
Week 2
Ġimgħa 2 Pakkett immarkat "Ġimgħa 2"
100 mg (1 tablet Vimpat 100 mg)
100 mg (pillola Vimpat 100 mg waħda)
Package marked "Week 3"
Ġimgħa 3 Pakkett immarkat "Ġimgħa 3"
150 mg (1 tablet Vimpat 150 mg)
150 mg (pillola Vimpat 150 mg waħda)
Week 4
Ġimgħa 4 Pakkett immarkat "Ġimgħa 4"
200 mg (1 tablet Vimpat 200 mg)
200 mg (pillola Vimpat 200 mg waħda)
Maintenance treatment (after the first 4 weeks) After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue your long term treatment.
Wara l- ewwel 4 ġimgħat tat- trattament, it- tabib tiegħek jista ’ jaġġusta d- doża li tkompli tieħu fit - trattament fit- tul.
This dose is called a maintenance dose and will depend on how you respond to Vimpat.
Din id- doża tissejjaħ doża ta ’ manteniment u tkun tiddependi mir- rispons tiegħek għal Vimpat.
For most patients the maintenance dose is between 200 mg and 400 mg per day.
Għall- biċċa l- kbira tal- pazjenti, id- doża ta ’ manteniment hija bejn 200 mg u 400 mg kuljum.
How to take the Vimpat tablets You should swallow the Vimpat tablet with a glass of water.
Kif tieħu il- pilloli Vimpat Għandek tibla ’ l- pilloli Vimpat ma ’ tazza ilma.
Duration of the treatment with Vimpat Vimpat is used as a long term treatment.
It- tul tat- trattament b ’ Vimpat Vimpat jintuża ’ bħala trattament fit- tul.
If it is close to your next dose, don't take the missed tablet anymore.
Jekk ikun wasal il- ħin għad- doża li jmiss, tieħux d- doża li nsejt tieħu.
If your doctor decides to stop your treatment with Vimpat, he/she will instruct you about how you should decrease the dose step by step.
Jekk it- tabib tiegħek jiddeċiedi li jwaqqaf it- trattament tiegħek b ’ Vimpat, huwa jew hija ser jagħtik struzzjonijiet ta ’ kif għandek pass wara pass tnaqqas id- doża.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data
118 Il- frekwenzi ta ’ effetti mhux mixtieqa li jista ’ jkun hemm ġew definiti bil- konvenzjoni li ġejja: komuni ħafna (jaffettwaw iżjed minn 1 sa 10 li jieħduh) komuni (jaffettwaw 1 sa 10 minn 100 li jieħduh) mhux komuni (jaffettwaw 1 sa 10 minn 1, 000 li jieħduh) rari (jaffettwaw 1 sa 10 minn 10, 000 li jieħduh) rari ħafna (jaffettwaw inqas minn 1 minn 10, 000 li jieħduh) mhux magħruf (il- frekwenza ma tistax tiġi mkejla mit- tagħrif eżistenti)
112 Very common: affects more than 1 user in 10 • Dizziness, headache • Nausea (feeling sick) • Double vision (diplopia)
Komuni ħafna: jaffettwaw iżjed minn persuna 1 minn 10 • Sturdament, uġigħ ta ’ ras • Dardir (tħossok ma tiflaħx) • Vista doppja (diplowpja)
Common: affects 1 to 10 users in 100 • Problems in keeping your balance, difficulties in coordinating your movements, troubles with your memory, sleepiness, shaking (tremor), trouble thinking or finding words, rapid and uncontrollable movements of the eyes (nystagmus) • Blurred vision • A feeling of "spinning" (vertigo) • Vomiting, constipation, excessive gas in the stomach or bowel • Itching • Fall • Tiredness, difficulties in walking, unusual tiredness and weakness (asthenia) • Depression
Komuni: jaffettwaw iżjed minn persuna 1 minn 100 • Problemi fil- bilanċ tiegħek, diffikultajjiet fil- ko- ordinazzjoni tal- movimenti tiegħek, problemi fil- memorja tiegħek, ngħas, rogħda, problemi biex taħseb jew issib il- kliem, movimenti ta ’ l - għajnejn mgħaġġla u inkontrollabli (nystagmus) • Vista mċajpra • Sensazzjoni li kollox idur bik (vertigo) • Rimettar, stitikezza, gas żejjed fl- istonku jew l- insaren • Ħakk • Waqgħa • Għajja, diffikulta` fil- mixi, għajja mhux tas- soltu u debollezza (astenja) • Depressjoni
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandiex ħtieġa ta ’ kondizzjonijiet speċjali għal ħażna.
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone, magnesium stearate Film-coat: polyvinyl alcohol, polyethylene glycol, talc, soya-lecithin, hypromellose, titanium dioxide (E171), colourants* * The colourants are:
Qalba tal- pilloli: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), collodial anhydrous silica, crospovidone, magnesium stearate Kisja ta- rita: polyvinyl alcohol, polyethylene glycol, terra, soja- lecithin, hypromellose, titanium dioxide (E171), sustanzi koloranti *
What Vimpat looks like and contents of the pack Vimpat 50 mg are pinkish, oval film-coated tablets with a debossed ‘SP’ on one side and ‘50’ on the other side.
Vimpat 50 mg jagħtu fir- roża, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqxa fuq naħa waħda u ‘ 50 ’ fuq in- naħa l- oħra.
Vimpat 100 mg are dark yellow, oval film-coated tablets with a debossed ‘SP’ on one side and ‘100’
Vimpat 100 mg huma sofor skuri, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqxa fuq naħa waħda u ‘ 100 ’ fuq in- naħa l- oħra.
Vimpat 150 mg are salmon, oval film-coated tablets with a debossed ‘SP’ on one side and ‘150’ on the other side.
Vimpat 150 mg huma ta ’ kulur is- salamur, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqax fuq naħa waħda u ‘ 150 ’ fuq in- naħa l- oħra.
Vimpat 200 mg are blue, oval film-coated tablets with a debossed ‘SP’ on one side and ‘200’ on the other side.
Vimpat 200 mg huma blu, pilloli ovali miksija b’ rita b ’ ‘ SP ’ imnaqqax fuq naħa waħda u ‘ 200 ’ fuq in - naħa l- oħra.
The treatment initiation pack contains 56 film-coated tablets in 4 packages: • the package marked ‘Week 1’contains 14 tablets of 50 mg, • the package marked ‘Week 2’ contains 14 tablets of 100 mg, • the package marked ‘Week 3’ contains 14 tablets of 150 mg, • the package marked ‘Week 4’ contains 14 tablets of 200 mg.
Il- pakkett tal- bidu tat- trattament fiħ 56 pilloli miksija b’ rita f’ 4 pakketti: • il- pakkett immarkat ‘ Ġimgħa 1’ 14- il pillola ta ’ 50 mg, • il- pakkett immarkat ‘ Ġimgħa 2’ 14- il pillola ta ’ 100 mg, • il- pakkett immarkat ‘ Ġimgħa 3’ 14- il pillola ta ’ 150 mg, • il- pakkett immarkat ‘ Ġimgħa 4’ 14- il pillola ta ’ 200 mg.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
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115 PACKAGE LEAFLET:
121 FULJETT TA ’ TAGĦRIF:
Vimpat 15 mg/ml syrup Lacosamide
Vimpat 15 mg/ ml mistura Lacosamide
How to take Vimpat 4.
Kif għandek tieħu Vimpat 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Vimpat 5.
Do NOT take Vimpat • if you are allergic (hypersensitive) to lacosamide, or any of the other ingredients of Vimpat (listed in Section 6).
Tieħux Vimpat • jekk inti allerġiku (tbagħti minn sensittività eċċessiva) għal lacosamide jew xi sustanzi oħra ta ’ Vimpat (mliżżla f’ Sezzjoni 6).
Vimpat may cause dizziness, which could increase the risk of accidental injury or a fall.
Vimpat jista ’ jikkawża sturdament, li jista ’ jżid ir- riskju ta ’ korriment jew waqgħa.
A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves.
122 Numru żgħir ta ’ nies li jkunu fuq kura b ’ mediċini ta ’ kontra l- epilessija bħal lacosamide kellhom ħsibijiet li jweġġgħu jew joqtlu lilhom infushom.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 116 including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Important information about some of the ingredients of Vimpat Vimpat syrup contains: • sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Vimpat Vimpat mistura fiha: • sorbital (tip ta ’ zokkor).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. • sodium.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, għarraf lit- tabib tiegħek qabel ma tieħu din il- mediċina. • sodju.
One graduation mark of syrup contains 0.27 mmol (or 6.3 mg) sodium.
Marka waħda ta ’ kejl fiħ 0. 27 mmol (jew 6. 3 mg) ta ’ sodju.
If you take more than 3 graduation marks of syrup per day and are on a controlled sodium diet, you should take into consideration the amount of sodium in the syrup. • two ingredients called sodium propylhydroxybenzoate-E217 and sodium methylhydroxybenzoate-E219 which may cause allergic reactions (possibly delayed). • aspartame (E951), a source of phenylalanine.
Jekk into tieħu aktar minn tlett marki ta ’ kejl ta ’ mistura kuljum u inti fuq dieta bis- sodju kontrollat, inti għandek tqis l - ammont ta ’ sodju fil- mistura. • żewġt ingredjenti li jisimhom sodium propylhydroxybenzoate- E217 u sodium methylhydroxybenzoate- E219 li jistgħu jikkawżaw reazzjonijiet allerġiċi (li possibilment jiġru wara). • aspartame (E951), li minnu jsir ta ’ phenylalanine.
This substance may be harmful for people with phenylketonuria (a metabolic disease).
Din is- sustanza tista ’ tagħmel il- ħsara lin - nies b’ phenylketonuria (marda metabolika).
The usual starting dose of Vimpat is 100 mg per day - taken twice a day – 50 mg in the morning and 50 mg in the evening.
123 Id- doża tal- bidu ta ’ Vimpat li ssoltu tingħata hija ta ’ 100 mg kuljum – li tittieħed darbtejn kuljum, 50 mg filgħodu u 50 mg filgħaxija.
Your doctor may increase your daily dose every week by 100 mg, until you reach a so called maintenance dose between 200 mg and 400 mg per day, taken twice a day.
It- tabib tiegħek jista ’ jżid id- doża ta ’ kuljum tiegħek kull ġimgħa b ’ 100 mg, sakemm tilħaqq dik li jgħidulha d- doża ta ’ manteniment ta ’ bejn 200 mg u 400 mg kuljum li tittieħed darbtejn kuljum.
How to take the Vimpat syrup Fill the measuring cup to the graduation mark(s) corresponding to your prescribed dose.
Kif tieħu il- mistura Vimpat Imla t- tazza ta ’ kejl sal- marka tal- kejl li tikkorrispondi għad- doża preskritta.
117 Each graduation mark of the measuring cup corresponds to 50 mg (for example 2 graduation marks correspond to 100 mg).
Kull marka ta ’ kejl fit- tazza ta ’ kejl tikkorrispondi għal 50 mg( per eżempju 2 marki ta ’ kejl jikkorrispondu għal 100 mg).
Swallow the dose of syrup, then drink some water.
Għandek tibla ’ l- pilloli Vimpat ma ’ tazza ilma.
Once you have opened the syrup bottle, you must not use it longer than 4 weeks.
La darba ftaħt il- flixkun tal- mistura, ma tistax tużaha għal iżjed minn 4 ġimgħat.
If it is close to your next dose, don't take the missed syrup anymore.
Jekk ikun wasal il- ħin għad- doża li jmiss, tieħux il- mistura li nsejt tieħu.
Just take Vimpat at ythe next time that you would normally take it.
Ħu Vimpat id- darba li jmiss meta ssolti toħodha.
Very common: affects more than 1 user in 10 • Dizziness, headache • Nausea (feeling sick) • Double vision (diplopia)
Komuni ħafna: jaffettwaw iżjed minn persuna 1 minn 10 • Sturdament, uġigħ ta ’ ras • Dardir (tħossok ma tiflaħx) • Vista doppja (diplowpja)
Common: affects 1 to 10 users in 100 • Problems in keeping your balance, difficulties in coordinating your movements, troubles with your memory, sleepiness, shaking (tremor), trouble thinking or finding words, rapid and uncontrollable movements of the eyes (nystagmus) • Blurred vision • A feeling of "spinning" (vertigo) • Vomiting, constipation, excessive gas in the stomach or bowel • Itching • Fall • Tiredness, difficulties in walking, unusual tiredness and weakness (asthenia) • Depression
124 Komuni: jaffettwaw iżjed minn persuna 1 minn 100 • Problemi fil- bilanċ tiegħek, diffikultajjiet fil- ko- ordinazzjoni tal- movimenti tiegħek, problemi fil- memorja tiegħek, ngħas, rogħda, problemi biex taħseb jew issib il- kliem, movimenti ta ’ l - għajnejn mgħaġġla u inkontrollabli (nystagmus) • Vista mċajpra • Sensazzjoni li kollox idur bik (vertigo) • Rimettar, stitikezza, gas żejjed fl- istonku jew l- insaren • Ħakk • Waqgħa • Għajja, diffikulta` fil- mixi, għajja mhux tas- soltu u debollezza (astenja) • Depressjoni
118 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Do not use Vimpat after the expiry date which is stated on the carton and bottle.
Tużax Vimpat wara d- data ta ’ skadenza li tidher fuq il- kartuna u il- folja.
Do not store above 30°C.
Taħżinx ‘ l fuq minn 30 C.
1 ml Vimpat syrup contains 15 mg lacosamide.
1 ml mistura Vimpat fiha 15 mg lacosamide.
The other ingredients are: glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid (anhydrous), acesulfame potassium (E950), sodium propylparahydroxybenzoate (E217), sodium methylparahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.
L- ingredjenti l- oħra huma: glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid (anhydrous), acesulfame potassium (E950), sodium propylparahydroxybenzoate (E217), sodium methylparahydroxybenzoate (E219), propylene glycol, aspartame (E951), maltol, togħma ta ’ frawli (contains propylene glycol, maltol), masking flavour (li fih propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), ilma purifikat.
What Vimpat looks like and contents of the pack Vimpat 15 mg/ml syrup is a clear solution, slightly yellow to yellow-brown in colour.
Vimpat 15 mg/ ml hija soluzzjoni ċara, kemmxejn fl- isfar għal isfer fil- kannella.
Vimpat is available in bottles of 200 ml and 465 ml.
Vimpat issibu f’ flixken ta ’ 200 ml u 465 ml.
A measuring cup with graduation marks (corresponding to 50 mg lacosamide) is provided with the syrup.
Tazza ta ’ kejl bil- marki ta ’ kejl (li jikkorrespondi għal 50 mg lacosamide) hija provduta mal- mistura.
UCB-Group, Schwarz Pharma AG, Alfred-Nobel-Str.
UCB - Group, Schwarz Pharma AG, Alfred- Nobel- Str.
België/Belgique/Belgien UCB Pharma SA /NV Tel/Tél: +32 / (0)2 559 92 00
125 België/ Belgique/ Belgien UCB Pharma SA / NV Tel/ Tél: +32 / (0) 2 559 92 00
Latvija UCB Pharma Oy Finland Tel: + 358-(9) 2290 100
126 UCB Pharma Oy Finland Tel: + 358 - (9) 2290 100
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
2H
120 PACKAGE LEAFLET:
127 FULJETT TA ’ TAGĦRIF:
Vimpat 10 mg/ml solution for infusion Lacosamide
Vimpat 10 mg/ ml soluzzjoni għall- infużjoni Lacosamide
Before you use Vimpat 3.
Qabel ma tuża Vimpat 3.
How to use Vimpat 4.
Kif għandek tuża Vimpat Effetti sekondarji li jista ’ jkollu 4.
Vimpat solution for infusion is an alternative form of treatment for a short period of time, when oral (by mouth) administration is not possible.
Is- soluzzjoni għall- infużjoni Vimpat huwa forma alternattiva tat- trattament għal perjodu ta ’ żmien, meta t- teħid mill- ħalq mhux possibli.
BEFORE YOU USE VIMPAT
QABEL MA TUŻA VIMPAT