qanastek/EMEA-V3 huggingface dataset:
Concomitant use of N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
L- użu fl- istess ħin ta ’ antagonisti- N- methyl- D- aspartate (NMDA) oħra bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
18 Minbarra hekk, il- pH ta ’ l- awrina tista ’ titla minħabba każijiet ta ’ aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal- passaġġ awrinarju b’ Proteus bacteria.
18 In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Fil- parti l- kbira tal- provi kliniċi, pazjenti li ftit qabel kellhom infart mijokardijaku, insuffiċjenza mhux kompensata tal- qalb konġestiva (NYHA III- IV), jew pressjoni għolja mhux kontrollata kienu esklużi.
The 10 mg film-coated tablets contain lactose monohydrate.
Il- pilloli miksija b’ rita fihom lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, nuqqas ta ’ Lapp lactase jew mal assorbiment ta ’ glucose - galactose m’ għandhomx jieħdu din il- mediċina.
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
• Il- mod kif jaħdem jindika li l- effeti ta ’ L- Dopa, agonisti dopaminerġiċi, u antikolinerġiċi jistgħu jkunu aktar qawwija meta jingħataw flimkien ma ’ antaginisti ta ’ NMDA bħal memantine.
Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Meta memantine jingħata flimkien ma ’ aġenti antispasmodiċi, dantolene jew baclofen, jista ’ jibdlilhom l- effetti tagħhom u jista ’ jkun hemm bżonn ta ’ bidla fid- doża. • L- użu ta ’ memantine u amantadine għandu jkun evitat, minħabba r- riskju ta ’ psikożi farmakotossika.
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Studji fl- annimali jindikaw li jista ’ jeffettwa l- iżvilupp fl- utru b’ livelli ta ’ esponiment, li huma identici jew ikunu ħarira ogħla mill - esponiment fil- bniedem (ara sezzjoni 5. 3).
4.7 Effects on ability to drive and use machines
19 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
19 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse events were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal severa, b’ 1, 784 pazjent ikkurat b’ Ebixa u 1, 595 pazjent ikkurati bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Ebixa ma kinitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Ir- reazzjonijiet avversi huma mniżżla skond il- klassi tas- sistema ta ’ l- organi, bil- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10) komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax ikun stmat mit- tagħrif li hemm).
Cardiac disorders Nervous system disorders
Disturbi fis- sistema nervuża
Relative large overdoses (200 mg and 105 mg/ day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/ or diarrhoea or no symptoms.
Fil- każijiet ta ’
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/ or of gastrointestinal origin (vomiting and diarrhoea).
20 doża eċċessiva taħt il- 140 mg jew doża mhux magħrufa il- pazjenti wrew sintomi li kienu ġejjin mis- sistema nervuża ċentrali (konfużjoni, tħeddil, ngħas, vertiġini, aġitazzjoni, imġieba aggressiva, alluċinazzjoni, u disturbi fil- qagħda tal- mixi) u/ jew ta ’ natura gastro- intestinali (rimettar u dijarea).
20 In another case of a large overdose, the patient also survived and recovered.
F’ każ ieħor ta ’ doża eċċessiva kbira, il- pazjent ukoll baqa ħaj u rkupra.
The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Il- pazjent kellu sintomi fuq is- sistema nervuża ċentrali fosthom, irrikwiezza, psikożi, alluċinazzjonijiet tal- vista, pro- aċċessjonijiet, ngħas, sturdament u telf mis- sensi.
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Aktar evidenza qed tindika li l- funzjoni ħażina ta ’ newrotrasmissjoni glutamaterġika, b’ mod partikolari fir- riċetturi- NMDA, jagħtu kontribut kemm għall- espressjoni tas- sintomi kif ukoll għall- avvanz ta ’ dimenzja newrodiġenerattiva.
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer’ s disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Studju pivitali b’ terapija waħda f’ popolazzjoni ta ’ pazjenti li kienu qed ibatu mill- marda ta ’ Alzheimer moderata għal severa (eżami żgħir ħafna ta ’ l- istat mentali (MMSE) punteġġ totali fil- linja bażi ta ’ 3 - 14) kien jinkludi total ta ’ 252 outpatient.
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
L- istudju wera effetti tajbin tal- kura b’ memantine meta mqabbla ma ’ plaċebo mas- 6 xahar (analiżi tal- każijiet għall- impressjoni ta ’ bidla skond l- intervista tat- tabib (CIBIC- plus): p=0. 025; studju kooperattiv tal- marda ta ’ Alzheimer (ADCS- ADLsev): p=0. 003; Batterija ta ’ indeboliment sever (SIB): p=0. 002).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Skala ta ’ assessjar tal- marda ta ’ Alzheimer (ADAS- cog) (p=0. 003) u CIBIC- plus (p=0. 004) f’ Ġimgħa 24 bl- aħħar osservazzjoni miġjuba ’ l quddiem (LOCF).
A meta-analysis of patients with moderate to severe Alzheimer’ s disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Meta
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs.
21 pazjenti deher li marru għall- agħar fit- tlett oqsma, ir- riżultati wrew effett statistikament sinifikanti ta ’ memantine biex jevita li jmorru għall- agħar, darbtejn aktar mill- pazjenti ikkurati bi plaċebo hekk kif pazjenti kkurati b’ memantine marru għall- agħar fit- tlett oqsma (21% vs.
21 Absorption:
Assorbiment:
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ ml (0.5 - 1 µmol) with large interindividual variations.
Dożi ta ’ 20 mg kuljum jwasslu għal konċentrazzjonijiet ta ’ memantine fil- plażma fi stat fiss f’ medda ta ’ bejn 70 sa 150 ng/ ml (0. 5 - 1 µmol) b’ varjazzjonijiet kbar bejn individwu. u ieħor.
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/ serum ratio of 0.52 was calculated.
Meta ngħataw dożi ta ’ 5 sa 30 mg kuljum, il- proporzjon tal- medja ta ’ fluwidu ċerebrospinali (CSF) / serum kien kalkolat 0. 52.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
B’ doża ta ’ 20 mg memantine kuljum il- livelli fil- fluwidu CSF qablu mal- valur- ki (ki = kostanti ta ’ l- impediment) ta ’ memantine, li hija 0. 5µmol fil- kortiċi ta ’ quddiem tal- bniedem.
The clinical relevance of these findings is unknown.
22 dawn ir- riżultati m’ humiex magħrufa.
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Il- qalba tal- pilloli miksija b’ rita ta ’ 5/ 15/ 20 mg Microcrystalline cellulose Croscacarmellose sodium Colloidal anhydrous silica Magnesium stearate
Hypromellose Macrogol 400 Titanium dioxide (E 171)
Il- kisja tal- pilloli miksija b’ ritata ’ 5/ 15/ 20 mg Hypromellose Macrogol 400 Titanium dioxide (E 171)
Iron oxide yellow and red (E 172)
Sustanza addizzjonali għal pilloli miksija b’ rita ta ’ 15 mg u 20 mg Iron oxide yellow u red (E 172)
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
Il- qalba tal- pillola miksija b’ rita ta ’ 10 mg Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
Methacrylic acid - ethyl acrylate copolymer (1:1) Sodium lauryl sulphate Polysorbate 80 Talc Triacetin Simethicone emulsion
Il- qoxra tal- pillola miksija b’ rita ta ’ 10 mg Methacrylic acid - ethyl acrylate copolymer (1: 1) Sodium lauryl sulphate Polysorbate 80 Talc Triacetin Simethicone emulsion
6.5 Nature and contents of container
23 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Each pack contains 28 film-coated tablets in 4 PVDC/ PE/ PVC/ Al-blister or PP/ Al-blisters with 7 film- coated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film- coated tablets of 20 mg.
Kull pakkett fih 28 pillola miksija b’ rita f’ 4 folji ta ’ PVDC/ PE/ PVC/ Al jew folji ta ’ PP/ Al għal 7 pilloli miksijin b’ rita ta ’ 5 mg, 7 pilloli miksijin b’ rita ta ’ 10 mg, 7 pilloli miksijin b’ rita ta ’ 15 mg, 7 pilloli miksijin b’ rita ta ’ 20 mg,
08/ 05/ 2008 Date of latest renewal:
08/ 05/ 2008 Data ta ’ l- aħħar tiġdid:
Pale red to grey-red, oval-oblong film-coated tablets with imprint “ 20 ” on one side and imprint “ MEM” on the other side.
Il- pilloli miksija b’ rita ta ’ 20 mg huma ħomor ċari għal ħomor griżi, pilloli miksija b’ rita li huma ovali- oblong b’ intaljar ta ’ ‘ 20 ’ fuq naħa u ‘ MEM ’ fuq naħa oħra.
The film- coated tablets can be taken with or without food.
Il- pilloli miksija b’ rita jistgħu jittieħdu fuq l- ikel jew fuq stonku vojt.
The maximum daily dose is 20 mg per day.
Id- doża ta ’ manteniment rakkomandata hija ta ’ 20 mg kuljum.
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Sabiex jitnaqqas ir- riskju ta ’ effetti mhux mixtieqa d- doża ta ’ manteniment tinkiseb billi tittella ’ bil- mod minn doża ta ’ 5 mg fil- ġimgħa għall- ewwel 3 ġimgħat kif ġej:
For up-titration other tablet strengths are available.
Sabiex tiżdid it- titrazzjoni hemm pilloli b’ aktar qawwiet.
The patient should take one 5 mg film-coated tablet per day for 7 days.
Il- pazjent għandu jieħu pillola waħda miksija b’ rira ta ’ 5 mg kuljum għal 7 t’ ijiem.
The patient should take one 10 mg film-coated tablet per day for 7 days.
Il- pazjent għandu jieħu pillola miksija b’ rita ta ’ 10 mg kuljum għal 7 t’ ijiem.
Week 3 (day 15-21):
It- 3 ġimgħa (jum 15- 21):
The patient should take one 15 mg film-coated tablet per day for 7 days.
Il- pazjent għandu jieħu pillola miksija b’ rita ta ’ 15 mg kuljum għal 7 t’ ijiem.
The patient should take one 20 mg film-coated tablet per day.
Il- pazjent għandu jieħu pillola miksija b’ rita ta ’ 20 mg kuljum.
The recommended maintenance dose is 20 mg per day.
25 Doża ta ’ manteniment Id- doża ta ’ manteniment rakkomandata hi ta ’ 20 mg kuljum.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
Minn studji kliniċi, id- doża rakkomandata għal pazjenti li għandhom ’ l fuq minn 65 sena hija 20 mg kuljum (żewġ pilloli darba kuljum) kif spjegat hawn fuq.
If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/ day according to standard titration scheme.
Jekk il- pazjent ikun jittollerha sew wara mill- anqas 7 t’ ijiem ta ’ kura, id- doża tista ’ tiġi mużjuda sa 20 mg/ jum skond l- iskema standard ta ’ kif għandha tiżdied.
Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Meta memantine jingħata flimkien m ’ aġenti antispasmodiċi, dantolene jew baclofen, jista ’ jibdlilhom l- effetti tagħhom u jista ’ jkun hemm bżonn ta ’ bidla fid- doża.
The 26 same may be true for ketamine and dextromethorphan (see also section 4.4).
Dan jista ’ jgħodd ukoll għal ketamine u dextromethorphan (ara wkoll sezzjoni 4. 4).
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Studji fl- annimali jindikaw li jista ’ jeffettwa kemm jikber fl- utru b’ livelli ta ’ esponiment, li huma identici jew ikunu ħarira ogħla mill- esponiment fil- bniedem (ara sezzjoni 5. 3).
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse events were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal severa, b’ 1, 784 pazjent ikkurat b’ Ebixa u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Ebixa ma kinitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Ir- reazzjonijiet avversi huma mniżżla skond il- klassi tas- sistema ta ’ l- organi, bil- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10) komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), rari
27 Cardiac disorders Nervous system disorders
27 (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax ikun stmat mit- tagħrif li hemm).
Only limited experience with overdose is available from clinical studies and post-marketing experience.
Hemm biss esperjenza limitata b’ doża eċċessiva minn studji kliniċi u esperjenza wara t- tqegħid fis - suq.
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/ or of gastrointestinal origin (vomiting and diarrhoea).
Fil- każijiet ta ’ doża eċċessiva taħt il- 140 mg jew doża mhux magħrufa il- pazjenti wrew sintomi li kienu ġejjin mis- sistema nervuża ċentrali (konfużjoni, tħeddil, ngħas, vertiġini, aġitazzjoni, imġieba aggressiva, alluċinazzjoni, u disturbi fil- qagħda tal- mixi) u/ jew ta ’ natura gastro- intestinali (rimettar u dijarea).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Fl- aktar każ estrem ta ’ doża eċċessiva, il- pazjent irnexxielu jibqa ħaj meta ħa b’ mod orali 2000 mg memantine b’ effetti fuq is- sistema nervuża ċentrali (koma għal 10- ijiem, u wara kellu diplopja u aġitazzjoni).
The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Il- pazjent kellu sintomi fuq is- sistema nervuża ċentrali fosthom, ma setgħax joqod bi kwietu, psikożi, alluċinazzjonijiet tal- vista, pro- aċċessjonijiet, ngħas, sturdament u telf mis- sensi.
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer’ s disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Studji kliniċi: Studju pivitali b’ terapija waħda f’ popolazzjoni ta ’ pazjenti li kienu qed ibatu mill- marda ta ’ Alzheimer moderata għal severa (eżami żgħir ħafna ta ’ l- istat mentali (MMSE) punteġġ totali fil - linja bażi ta ’ 3 - 14) kien jinkludi total ta ’ 252 outpatient.
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
L- istudju wera effetti tajbin tal- kura b’ memantine meta mqabbla ma ’ plaċebo mas- 6 xahar (analiżi tal- każijiet għall- impressjoni ta ’ bidla skond l- intervista tat- tabib (CIBIC- plus): p=0. 025; studju kooperattiv tal- marda ta ’ Alzheimer (ADCS - ADLsev): p=0. 003; Batterija ta ’ indeboliment sever (SIB): p=0. 002).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Skala ta ’ assessjar tal- marda ta ’ Alzheimer (ADAS- cog) (p=0. 003) u CIBIC- plus (p=0. 004) f’ Ġimgħa 24 bl- aħħar osservazzjoni miġjuba ’ l quddiem (LOCF).
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
29 Eliminazzjoni: Memantine jitneħħa b’ mod mono- esponenzjali b ’ t½ terminali ta ’ 60 sa 100 siegħa.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
B’ doża ta ’ 20 mg memantine kuljum il- livelli fil- fluwidu CSF qablu mal- valur- ki (ki = kostanti ta ’ l- impediment) ta ’ memantine, li hija 0. 5µmol fil- kortiċi anterjuri tal- bniedem.
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Tablet coat:
Kisja tal- pillola:
Hypromellose Macrogol 400 Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
Hypromellose Macrogol 400 Titanium dioxide (E 171)
30 6.2 Incompatibilities
30 Iron oxide yellow u red (E 172)
Blister packs containing 14 film-coated tablets per PVDC/ PE/ PVC/ Al-blister or PP/ Al-blister strip.
Pakketti b’ folji li fihom 14- il pillola miksija b’ rita għal PVDC/ PE/ PVC/ Al jew folja strixxa ta ’ PP/ Al.
Pack sizes of 14, 28, 42, 49 x 1, 56, 56 x 1, 70, 84, 98, 98 x 1, 100 x 1, 112 or 840 (20 x 42) film- coated tablets are presented.
Daqsijiet tal- pakkett ta ’ 14, 28, 42, 56, 56 x 1, 70, 84, 98, 98 x 1, 100 x 1, 112 jew 840 (20 x 42) pillola huma disponibbli.
The pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Id- daqsijiet tal- pakkett huma 49 x 1, 56 x1, 98 x 1 u 100 x 1 ta ’ pilloli miksijin b’ rita f’ doża waħda f’ kull folja
31 ANNEX II
31 ANNESS II
MANUFACTURNG AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby DENMARK
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby ID- DANIMARKA
The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 (12 November 2007) presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 4. 0 (datata 12 ta ’ Novembru 2007) preżentata f’ Modulu 1. 8. 1 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed taħdem, qabel u waqt li l - prodott ikun fis- suq.
Risk Management Plan
Pjan ta ’ Ġestjoni tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (8 February 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif deskritt f’ verżjoni 1 tal - Pjan ta ’ Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskju għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess żmien tar- Rapport Perijodiku ta’ Aġġornament dwar is- Sigurtà (PSUR) li jmiss.
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
Barraminhekk, RMP aġġornat għandu jiġi sottomess • Meta jasal tagħrif ġdid li jista ’ jkollu impatt fuq l- Ispeċifikazzjoni Speċjali attwali, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi ħmien 60 jum minn meta jkun intlaħaq tragward importanti (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
Periodic Safety Update Reports (PSURs) The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Rapporti Perijodiċi ta ’ Aġġornament dwar is- Sigurtà (PSURs) Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq ser ikompli jissottometti PSURs kull sena, sakemm ma jkunx speċifijat mod ieħor mis- CHMP.
33 ANNEX III
33 ANNESS III
CARTON FOR BLISTER PACK
KARTUNA GĦAL PAKKETT TA ’ FOLJI
Ebixa 10 mg film-coated tablets Memantine hydrochloride
Ebixa 10 mg pilloli miksijin b’ rita Memantine hydrochloride
Each film-coated tablet contains 10 mg memantine hydrochloride (equivalent to 8.31 mg memantine).
Kull pillola miksija b’ rita fiha 10 mg memantine hydrochloride (ekwivalenti għal 8. 31 mg memantine).
The film-coated tablets also contain lactose monohydrate.
Il- pilloli miksijin b’ rita fihom ukoll lactose monohydrate.
See package leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
Film-coated tablets.
Pilloli miksijin b’ rita.
14 film-coated tablets.
14- il pillola miksija b’ rita.
28 film-coated tablets.
28 pillola miksija b’ rita.
50 film-coated tablets.
30 pillola miksija b’ rita 42 pillola miksija b’ rita 49 x 1 pillola miksija b’ rita 50 pillola miksija b’ rita.
56 film-coated tablets.
56 pillola miksija b’ rita.
56 x 1 film-coated tablets.
56 x 1 pillola miksija b’ rita.
70 film-coated tablets.
70 pillola miksija b’ rita.
84 film-coated tablets.
84 pillola miksija b’ rita.
98 film-coated tablets.
98 pillola miksija b’ rita.
98 x 1 film-coated tablets.
98 x 1 pillola miksija b’ rita.
100 film-coated tablets.
100 pillola miksija b’ rita.
100 x 1 film-coated tablets.
100 x 1 pillola miksija b’ rita.
112 film-coated tablets.
112- il pillola miksija b’ rita.
There are no special storage instructions.
M’ hemmx istruzzjonijiet dwar ħażna speċjali.
EU/ 1/ 02/ 219/ 016 14 film-coated tablets.
EU/ 1/ 02/ 219/ 016 14- il pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 007 28 film-coated tablets.
EU/ 1/ 02/ 219/ 007 28 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 001 30 film-coated tablets.
EU/ 1/ 02/ 219/ 001 30 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 017 42 film-coated tablets.
EU/ 1/ 02/ 219/ 017 42 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 010 49 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 010 49 x 1 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 002 50 film-coated tablets.
EU/ 1/ 02/ 219/ 002 50 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 008 56 film-coated tablets.
EU/ 1/ 02/ 219/ 008 56 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 014 56 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 014 56 x 1 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 018 70 film-coated tablets.
EU/ 1/ 02/ 219/ 018 70 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 019 84 film-coated tablets.
EU/ 1/ 02/ 219/ 019 84 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 020 98 film-coated tablets.
EU/ 1/ 02/ 219/ 020 98 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 015 98 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 015 98 x 1 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 003 100 film-coated tablets.
EU/ 1/ 02/ 219/ 003 100 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 011 100 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 011 100 x 1 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 009 112 film-coated tablets.
EU/ 1/ 02/ 219/ 009 112- il pillola miksija b’ rita.
Lot {number}
LOTT {numru}
Ebixa 10 mg tablets
Ebixa pilloli ta ’ 10 mg
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 98 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA GĦAL 98 PILLOLA BHALA PAKKETT INTERMEDJU / KOMPONENT TA ’ MULTIPAKK (MINGĦAJR IL- KAXXA BLU)
98 tablets.
30 pillola.
Component of a multipack comprising 10 packs, each containing 98 film-coated tablets.
Komponent ta ’ multipakk li fih 10 pakketti li f’ kull wieħed hemm 98 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 021 98 film-coated tablets.
EU/ 1/ 02/ 219/ 021 98 pillola miksija b’ rita
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA GĦAL 50 PILLOLA BHALA PAKKETT INTERMEDJU / KOMPONENT TA ’ MULTIPAKK (MINGĦAJR IL- KAXXA BLU)
50 tablets.
50 pillola.
Component of a multipack comprising 20 packs, each containing 50 film-coated tablets.
Komponent ta ’ multipakk li fih 20 pakkett li f’ kull wieħed hemm 50 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 012 50 film-coated tablets.
EU/ 1/ 02/ 219/ 012 50 pillola miksija b’ rita.
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (10 x 98 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA IT- TIKKETTA TAT- TGEŻWIR TA ’ BARRA FUQ IL- MULTIPAKKS (10x98 PILLOLA) IMGEŻWRA FIL- FOJL (LI JINKLUDI L- KAXXA BLU)
Ebixa 10 mg film-coated tablets Memantine hydrochloride
Ebixa 10 mg pilloli miksija b’ rita Memantine hydrochloride
Multipack comprising 10 packs, each containing 98 film-coated tablets.
Multipakk li fih 10 pakketti li f’ kull wieħed hemm 98 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 021 10 x 98 film-coated tablets.
EU/ 1/ 02/ 219/ 021 10 x 98 pillola miksija b’ rita
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20 x 50 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA IT- TIKKETTA TAT- TGEŻWIR TA ’ BARRA FUQ IL- MULTIPAKKS (20x50 PILLOLA) IMGEŻWRA FIL- FOJL (LI JINKLUDI L- KAXXA BLU)
Multipack comprising 20 packs, each containing 50 film-coated tablets.
Multipakk li fih 20 pakkett li f’ kull wieħed hemm 50 pillola miksija b’ rita.
EU/ 1/ 02/ 219/ 012 20 x 50 film-coated tablets.
EU/ 1/ 02/ 219/ 012 20 x 50 pillola miksija b’ rita.
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOR TABLETS
FOLJA GĦALL- PILLOLI
EXP {MM/ YYYY} See embossed stamp.
JIS {XX/ SSSS} Ara t- timbru intaljat.
Lot {number} See embossed stamp.
Lott {numru} Ara t- timbru intaljat
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
CARTON AND LABEL FOR BOTTLE
KARTUNA U TIKKETTA GĦAL FLIXKUN
Ebixa 10 mg/ g oral drops, solution Memantine hydrochloride
Ebixa 10 mg/ g qtar orali, soluzzjoni Memantine hydrochloride
1 g solution (20 drops) contains 10 mg memantine hydrochloride (equivalent to 8.31 mg memantine).
1 g ta ’ soluzzjoni (20 taqtira) fiha 10 mg memantine hydrochloride (ekwivalenti għal 8. 31 mg memantine).
The solution also contains potassium sorbate and sorbitol E420.
Is- soluzzjoni fiha wkoll potassium sorbate u sorbitol E420.
20 g.
Qtar orali, soluzzjoni 20 g.
When opened, use within 3 months.
Meta jinfetaħ, uża fi żmien 3 xhur.
EU/ 1/ 02/ 219/ 006 100 g.
EU/ 1/ 02/ 219/ 004 20 g EU/ 1/ 02/ 219/ 005 50 g EU/ 1/ 02/ 219/ 006 100g
Ebixa 10 mg/ g solution
Ebixa soluzzjoni 10 mg/ g
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
CARTON AND LABEL FOR 50 g BOTTLE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
KARTUNA U TIKKETTA GĦAL FLIXKUN TA ’ 50 g BHALA PAKKETT INTERMEDJU / KOMPONENT TA ’ MULTIPAKK (MINGĦAJR IL- KAXXA BLU)
Component of a multipack comprising 10 packs, each containing 1 bottle with 50 g oral drops, solution.
Qtar orali, soluzzjoni, 50 g Komponent ta ’ multipakk li jikkonsisti minn 10 pakketti, kull wieħed minnhom fihom flixkun 1 b’ 50 g qtar orali, soluzzjoni.
Ebixa 10 mg/ g solution
Ebixa 10 mg/ g soluzzjoni
OUTER WRAPPER LABEL ON MULTIPACKS (10 x 50 g DROPS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
TIKKETTA TAT- TGEŻWIR TA ’ BARRA FUQ IL- MULTIPAKKS (10 x 50 g QTAR) MGEŻWRA FIL- FOJL (LI JINKLUDI L- KAXXA BLU)
Multipack comprising 10 packs, each containing 1 bottle with 50 g oral drops, solution.
Multipakk li jikkonsisti minn 10 pakketti, kull wieħed minnhom fihom flixkun 1 b’ 50 g qtar orali,. soluzzjoni.
When opened, use within 3 months.
Meta jinfetaħ, uża fi żmien 3 xhur..
Lundbeck A/ S Ottiliavej 9, DK-2500 Valby Denmark
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby Id- Danimarka.
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR 28 TABLETS – TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
KARTUNA GĦAL 28 PILLOLA - TRATTAMENT GĦAL PAKKETT TAL- BIDU - TRATTAMENT SKEDAT FUQ 4 ĠIMGĦAT
Memantine hydrochloride
Ebixa 10 mg pilloli miksijin b’ rita Ebixa 15 mg pilloli miksijin b’ rita Ebixa 20 mg pilloli miksijin b’ rita Memantine hydrochloride
Ebixa 10 mg film-coated tablets contain lactose monohydrate.
Ebixa 10 mg pilloli miksijn b’ rita fihom lactose monohydrate.
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains:
Kull pakkett ta ’ 28 pillola miksija b’ rita għal trattament skedat ta ’ 4 ġimgħat fih:
7 film-coated tablets of Ebixa 5 mg 7 film-coated tablets of Ebixa 10 mg 7 film-coated tablets of Ebixa 15 mg 7 film-coated tablets of Ebixa 20 mg
7 pilloli miksijin b’ rita ta ’ Ebixa 5 mg 7 pilloli miksijin b’ rita ta ’ Ebixa 10 mg 7 pilloli miksijin b’ rita ta ’ Ebixa 15 mg 7 pilloli miksijin b’ rita ta ’ Ebixa 20 mg
Once daily
Darba kuljum
For continuation of your treatment please consult your doctor.
Għal kontinwazzjoni tat- trattament tiegħek jekk jogħġbok ikkonsulta t- tabib tiegħek.
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby Denmark
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby Id- Danimarka
EU/ 1/ 02/ 219/ 022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets.
EU/ 1/ 02/ 219/ 022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets.
EU/ 1/ 02/ 219/ 036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg pilloli miksijin b’ rita.
Ebixa 5 mg,10 mg, 15 mg, 20 mg tablets
Ebixa pilloli ta ’ 5 mg, 10 mg, 15, mg, 20 mg
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA GĦAL PAKKETT TA ’ FOLJI
Ebixa 20 mg film-coated tablets Memantine hydrochloride
Ebixa 20 mg pilloli miksijin b’ rita Memantine hydrochloride
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Kull pillola miksija b’ rita fiha 20 mg memantine hydrochloride (ekwivalenti għal 16. 62 mg memantine).
112 film-coated tablets.
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 42 pillola miksija b’ rita 49 x 1 pillola miksija b’ rita 56 pillola miksija b’ rita 56 x 1 pillola miksija b’ rita 70 pillola miksija b’ rita 84 pillola miksija b’ rita 98 pillola miksija b’ rita 98 x 1 pillola miksija b’ rita 100 x 1 pillola miksija b’ rita 112 pillola miksija b’ rita 840 (20 x 42) pillola miksija b’ rita
55 EXP {MM/ YYYY}
JIS {XX/ SSSS}
EU/ 1/ 02/ 219/ 023 14 film-coated tablets.
EU/ 1/ 02/ 219/ 023 14 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 024 28 film-coated tablets.
EU/ 1/ 02/ 219/ 024 28 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 025 42 film-coated tablets.
EU/ 1/ 02/ 219/ 025 42 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 026 49 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 026 49 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 027 56 film-coated tablets.
EU/ 1/ 02/ 219/ 027 56 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 028 56 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 028 56 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 029 70 film-coated tablets.
EU/ 1/ 02/ 219/ 029 70 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 030 84 film-coated tablets.
EU/ 1/ 02/ 219/ 030 84 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 031 98 film-coated tablets.
EU/ 1/ 02/ 219/ 031 98 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 032 98 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 032 98 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 033 100 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 033 100 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 034 112 film-coated tablets.
EU/ 1/ 02/ 219/ 034 112 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 037 14 film-coated tablets.
EU/ 1/ 02/ 219/ 037 14 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 038 28 film-coated tablets.
EU/ 1/ 02/ 219/ 038 28 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 039 42 film-coated tablets.
EU/ 1/ 02/ 219/ 039 42 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 040 49 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 040 49 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 041 56 film-coated tablets.
EU/ 1/ 02/ 219/ 041 56 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 042 56 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 042 56 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 043 70 film-coated tablets.
EU/ 1/ 02/ 219/ 043 70 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 044 84 film-coated tablets.
EU/ 1/ 02/ 219/ 044 84 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 045 98 film-coated tablets.
EU/ 1/ 02/ 219/ 045 98 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 046 98 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 046 98 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 047 100 x 1 film-coated tablets.
EU/ 1/ 02/ 219/ 047 100 x 1 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 048 112 film-coated tablets.
EU/ 1/ 02/ 219/ 048 112 pilloli miksijin b’ rita.
Ebixa 20 mg tablets
Ebixa pilloli ta ’ 20 mg
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 42 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Kull pillola miksija b’ rita fiha 20 mg memantine hydrochloride ekwivalenti għal 16. 62 mg memantine.
Component of a multipack comprising 20 packs, each containing 42 film-coated tablets.
43 pillola Komponent ta ’ multipakk li jikkonsisti minn 20 pakkett kull wieħed minnhom fih 42 pillola miksija b’ rita..
Not for separate sale.
M’ għandux jinbiegħ separatament.
EU/ 1/ 02/ 219/ 035 42 film-coated tablets.
EU/ 1/ 02/ 219/ 035 42 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 049 42 film-coated tablets.
EU/ 1/ 02/ 219/ 049 42 pilloli miksijin b’ rita.
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20 x 42 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Kull pillola miksija b’ rita fiha 20 mg memantine hydrochloride ekwivalenti għal 16. 62 mg memantine).
Multipack comprising 20 packs, each containing 42 film-coated tablets.
Multipakk li jikkonsisti minn 20 pakkett kull wieħed minnhom fih 42 pillola miksija b’ rita...
EU/ 1/ 02/ 219/ 035 20 x 42 film-coated tablets.
EU/ 1/ 02/ 219/ 035 20 x 42 pilloli miksijin b’ rita.
EU/ 1/ 02/ 219/ 049 20 x 42 film-coated tablets.
EU/ 1/ 02/ 219/ 049 20 x 42 pilloli miksijin b’ rita.
Ebixa 20 mg tablets
Ebixa pilloli ta ’ 16 mg
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
62 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Lot {number} See embossed stamp.
Lott {numru} Ara t- timbru intaljat.
Read all of this leaflet carefully before you start taking this medicine
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżja tiegħek.
In this leaflet:
F’ dan il- fuljett
What Ebixa is and what it is used for 2.
X’ inhu Ebixa u għalxiex jintuża 2.
Before you take Ebixa 3.
Qabel ma tieħu Ebixa 3.
How to take Ebixa 4.
Kif għandek tieħu Ebixa 4.
How to store Ebixa 6.
Kif taħżen Ebixa 6.
WHAT EBIXA IS AND WHAT IT IS USED FOR
X’ INHU EBIXA U GĦALXIEX JINTUŻA
How does Ebixa work
Kif jaħdem Ebixa
Ebixa belongs to a group of medicines known as anti-dementia medicines.
Ebixa jagħmel parti minn grupp ta ’ mediċini magħrufa bħala mediċini kontra d- dimenzja.
Memory loss in Alzheimer’ s disease is due to a disturbance of message signals in the brain.
It- telf tal- memorja fil- marda ta ’ Alzheimer jiġi minħabba disturbi fis- sinjali tal- messaġġi fil- moħħ.
The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Il- moħħ fih l- hekk imsejjħa riċetturi- N- methyl- D- aspartate (NMDA) li jieħdu sehem fit- trasmissjoni tas- sinjali fin- nervituri importanti għat- tagħlim u l- memorja.
Ebixa belongs to a group of medicines called NMDA- receptor antagonists.
Ebixa jagħmel parti minn grupp ta ’ mediċini li jissejħu antagonisti tar- riċettur- NMDA.
Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Ebixa jaħdem fuq dawn ir- riċetturi- NMDA u jtejjeb it- trasmissjoni tas- sinjali fin- nervituri u l- memorja.
What is Ebixa used for
Għalxiex jintuża Ebixa
Ebixa is used for the treatment of patients with moderate to severe Alzheimer’ s disease.
Ebixa jintuża għall- kura ta ’ pazjenti bil- marda ta ’ Alzheimer minn moderata għal severa.
BEFORE YOU TAKE EBIXA
QABEL MA TIEĦU EBIXA
Do not take Ebixa
Tieħux Ebixa
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal memantine hydrochloride jew sustanzi
of Ebixa tablets (see section 6).
oħra tal- pilloli Ebixa (ara sezzjoni 6)
Take special care with Ebixa
Oqgħod attent ħafna b’ Ebixa
- if you have a history of epileptic seizures
- jekk fil- passat kellek aċċessjonijiet ta ’ epilessija
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering
- jekk ftit ilu kellek xi infart mijokardijaku (attakk f’ qalbek), jew jekk qed tbati minn insuffiċjenza
from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
tal- qalb konġestiva jew minn pressjoni għolja li ma tistax tikkontrollha (pressjoni għolja tad- demm)
In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
F’ dawn il- każijiet il- kura għandha tkun sorveljata bir- reqqa, u l- benefiċċju kliniku ta ’ Ebixa jiġi evalwat mill- ġdid mit- tabib tiegħek fuq bażi regolari.
64 If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
65 Jekk tbati minn indeboliment renali (problemi fil- kliewi), it- tabib tiegħek għandu jżommlok il - funzjoni tal- kliewi taħt osservazzjoni mill- qrib u jekk ikun hemm bżonn jadatta d- dożi ta ’ memantine kif ikun jixraq.
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
L- użu ta ’ prodotti mediċinali msejjħa amantadine (għat- trattament tal- marda ta ’ Parkinson), ketamine (sustanza li ġeneralment tingħatabħala loppju), dextromethorphan (ġeneralment użata għas- sogħla) u antagonisti oħra ta ’ NMDA fl- istess ħin għandu jkun evitat.
Ebixa is not recommended for children and adolescents under the age of 18 years.
Ebixa mhux rakkomandat fit- tfal u adolexxenti taħt it- 18- il sena.
In particular, Ebixa may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
B’ mod partikolari, Ebixa jista ’ jibdel l- effetti tal- mediċini li ġejjin u d- doża tagħhom jista ’ jkollha bżonn tinbidel mit- tabib tiegħek.
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (jew kwalunkwe kombinazzjoni ma ’ hydrochlorothiazide) antikolinerġiċi (sustanzi li ġeneralment jintużaw għall- kura ta ’ disturbi fil- movimenti jew spażmi fl - imsaren) mediċini kontra l- aċċessjonijiet (mediċini li jintużaw biex ikunu evitati jew iserrħu l- aċċessjonijiet) barbiturati (sustanzi li ġeneralment jintużaw biex jgħinuk torqod) agonisti dopaminerġiċi (sustanzi bħal L- dopa, bromocriptine) newrolettiċi (sustanzi li jintużaw għall- kura ta ’ disturbi tal- moħħ) nediċini orali kontra l- koagulazzjoni tad- demm
If you go into hospital, let your doctor know that you are taking Ebixa.
Jekk tmur l- isptar għarraf lit- tabib tiegħek li qed tieħu Ebixa
Taking Ebixa with food and drink
Meta tieħu Ebixa ma ’ l- ikel u max- xorb
You should inform your doctor if you have recently changed or intend to change your diet substantially (e. g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Għandek tgħarraf lit- tabib tiegħek jekk dan l- aħħar bdilt id- dieta tiegħek jew bi ħsiebek tibdel id- dieta tiegħek b’ mod sostanzjali (eż minn dieta normali għal waħda veġetarjana stretta) jew jekk qed tbati minn stat ta ’ aċidożi tubulari renali (RTA, jiżdiedu s- sustanzi li jiffurmaw l- aċidu fid- demm minħabba funzjoni renali batuta (il- kliewi ma jaħdmux tajjeb)) jew infezzjonijiet severi tal- passaġġ awrinarju (struutura li minnha tgħaddi l- awrina), għax it- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża tal - mediċina tiegħek.
Tell your doctor if you are pregnant or planning to become pregnant.
Għid lit- tabib tiegħek jekk ħriġt tqila jew qed tippjana li toħroġ tqila.
The use of memantine in pregnant women is not recommended.
L- użu ta ’ memantine f’ nisa waqt it- tqala mhux rakkomandat.
Women taking Ebixa should not breast-feed.
Nisa li qed jieħdu Ebixa m’ għandhomx ireddgħu.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Sewqan u tħaddim ta ’ magni It- tabib tiegħek ser jgħidlek jekk il- marda tiegħek tħallikx issuq u tħaddem magni b’ mod sigur.
Also, Ebixa may change your reactivity, making driving or operating machinery inappropriate.
Minbarra hekk, Ebixa jista ’ jibdillek il- ħila biex tirreaġixxi, u għalhekk ma jkunx xieraq li ssuq jew tħaddem magni.
Important information about some of the ingredients of Ebixa
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ebixa
65 This medicinal product contains lactose.
66 Dan il- prodott mediċinali fih ukoll lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li xi tipi ta ’ zokkor ma jaqblux miegħek, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Your doctor will advise you.
It- tabib tiegħek għandu jagħtik il- parir dovut.
HOW TO TAKE EBIXA
KIF GĦANDEK TIEĦU EBIXA
Always take Ebixa exactly as your doctor has told you.
Dejjem għandek tieħu Ebixa skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you arenot sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The recommended dose of Ebixa for adults and elderly patients is 20 mg once a day.
Id- doża rakkomandata ta ’ Ebixa għall- adulti u pazjenti anzjani hija 20 mg (2x pillola 1) kuljum.
In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
Sabiex tnaqqas ir- riskju ta ’ effetti sekondarji din id- doża tinkiseb bil- mod bl- iskema ta ’ kura ta ’ kuljum kif ġej:
week 1
ġimgħa 1
half a 10 mg tablet
nofs pillola ta ’ 10 mg
week 2
ġimgħa 2
one 10 mg tablet
pillola waħda ta ’ 10 mg
week 3
ġimgħa 3
one and a half 10 mg tablet
pillola u nofs ta ’ 10 mg
week 4 and beyond
minn ġimgħa 4 ’ l quddiem
two 10 mg tablets once a day
żewġ pillolli ta ’ 10 mg darba kuljum
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week.
Id- doża tas- soltu tal- bidu hija nofs pillola darba kuljum (1x5 mg) għall- ewwel ġimgħa.
This is increased to one tablet once a day (1x10 mg) in the second week and to 1and a half tablet once a day in the third week.
Din tiżdied għal pillola waħda darba kuljum (1x10 mg) fit- tieni ġimgħa u għal pillola waħda u nofs darba kuljum fit- tielet ġimgħa.
From the fourth week on, the usual dose is 2 tablets once a day (1x20 mg).
Mir- 4 ġimgħa ’ l quddiem, id- doża li ġeneralment tingħata hija ta ’ 2 pilloli darba kuljum (1x20 mg).
Dosage in patients with impaired kidney function
Dożaġġ f’ pazjenti b’ indeboliment tal- funzjoni tal- kliewi
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Jekk għandek indeboliment tal- funzjoni tal- kliewi, it- tabib tiegħek ser jiddeċiedi dwar doża li tkun tixraq għal kundizzjoni tiegħek.
In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
F’ dan il- każ, il- funzjoni tal- kliewi għandha tkun eżaminata mit- tabib tiegħek f’ intervalli speċifikati.
Ebixa should be administered orally once a day.
Ebixa għandha tingħata b’ mod orali darba kuljum.