qanastek/EMEA-V3 huggingface dataset:
Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Kwalunkwe garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda użata jew mhux użata għandha tintrema hekk kif jitolbu l- liġijiet lokali jew mreġġa ’ lura l- ispiżerija.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI 9.
Exelon 9.5 mg/ 24 h transdermal patch
Exelon 9. 5 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Kull garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda terħi 9. 5 mg ta ’ rivastigmine kull 24 siegħa.
Each transdermal patch of 10 cm2 contains 18 mg of rivastigmine.
Kull garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda ta ’ 10 cm2 fiha 18 mg ta ’ rivastigmine.
The outside of the backing layer is beige and labelled with “ Exelon”, “ 9.5 mg/ 24 h” and “ BHDI”.
In- naħa ta ’ barra tas- saff ta ’ wara huwa bex u tikkettat b ’ “ Exelon ”, “ 9. 5 mg/ 24 h ” u “ BHDI ”.
Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients 67 treated with Exelon capsules or oral solution can be switched to Exelon transdermal patches as follows: • A patient on a dose of 3 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a dose of 6 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a stable and well tolerated dose of 9 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
73 Biex taqleb minn kapsuli jew soluzzjoni orali għall- garżi li jeħlu minn fuq il- ġilda Mit- tqabbil ta ’ l- esponimenti ta ’ rivastigmine orali u dak minn fuq il- ġilda (ara sezzjoni 5. 2), pazjenti ikkurati bil- kapsuli Exelon jew soluzzjoni orali jistgħu jinqalbu għall- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon kif ġej: • Pazjent fuq doża ta ’ 3 mg/ jum rivastigmine orali jistgħu jinqalbu għal 4. 6 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda. • Pazjent fuq doża ta ’ 6 mg/ jum rivastigmine orali jistgħu jinqalbu għal 4. 6 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda. • Pazjent fuq doża stabbli li jkun jiflaħ sew għaliha ta ’ 9 mg/ jum rivastigmine orali jistgħu jinqalbu għal 9. 5 mg/ 24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda.
4.4 Special warnings and precautions for use
74 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
68 Care must be taken when prescribing Exelon transdermal patches: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases. • to patients with a history of asthma or obstructive pulmonary disease.
Għandha ssir attenzjoni meta jiġu ordnati l- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon: • lill- pazjenti b’ sindrome ta ’ sinus marid jew difetti tal- konduzzjoni (imblukkar sino- atrijali, imblukkar atrijo- ventrikulari) (ara sezzjoni 4. 8). • lill- pazjenti b’ ulċeri attivi fl- istonku jew tad- duwodenu jew pazjenti li huma pridisposti għall - dawn il- kondizzjonijiet għaliex rivastigmine jista ’ jżid is- sekrezzjonijiet ta ’ l- istonku (ara sezzjoni 4. 8). • lill- pazjenti li huma pridisposti li jsofru minn imblukkar ta ’ l- awrina u aċċessjonijiet għaliex il - kolinomimetiċi jistgħu jikkawżaw jew jaggravaw dawn il- mard. • lill- pazjenti li fil- passat sofrew bl- ażżma jew b’ mard ostruttiv tal- pulmun.
Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, beta blockers, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
75 imblukkaturi tal- kanali tal- calcium, sustanzi inotropiċi, mediċini għall- anġina, aġenti mhux setrojdali kontra l- infjammazzjoni, estroġeni, analġesiċi, benzodiażepini u anti- istaminiċi, ma kinetx assoċjata ma ’ tibdil fil- kinetika ta ’ rivastigmine jew żieda fir- riskju ta ’ effetti ħżiena klinikament rilevanti.
69 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Psychiatric disorders
76 Disturbi psikjatriċi
71 cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’ s disease.
B’ dan il- mod, rivastigmine jista ’ jkollu effett li jtejjeb id- difikultajiet ta ’ għarfien li jkunu medjati b’ mod kolinerġiku u li huma assoċjati mal- marda ta ’ Alzheimer.
5.2 Pharmacokinetic properties
79 5. 2 Tagħrif farmakokinetiku
73 Exposure (AUC ∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20– 30% lower when applied to the abdomen or thigh.
Esponiment (AUC∞) għal rivastigmine (u l- metabolu NAP266- 90) kienet l- ogħla meta l- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda kienet applikata man- naħa ta ’ isfel tad- dahar, sider jew parti ta ’ fuq tad- driegħ u madwar 20- 30% aktar baxxa meta tkun applikata ma ’ l- addome jew koxxa.
Metabolism Rivastigmine is rapidly and extensively metabolised with an apparent elimination half-life in plasma of approximately 3.4 hours after removal of the transdermal patch.
80 Metaboliżmu Rivastigmine huwa metaboliżżat malajr u b’ mod estensiv b’ half- life ta ’ eliminazzjoni apparenti ta ’ madwar 3. 4 siegħa wara li titneħħa l- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
74 Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose exceeding 104 times the foreseen clinical exposure.
Rivastigmine ma kienx mutaġeniku f’ ġabra ta ’ testijiet standard in vitro u in vivo, ħlief f’ test ta ’ aberrazzjoni tal- kromosomi f’ limfoċiti umani periferali meta ngħatat doża li qabżet l- 104 darbiet l - esponiment kliniku mbassar.
No evidence of carcinogenicity was found in oral and topical studies in mice and in an oral study in rats at the maximum tolerated dose.
81 Ma nstabet l- ebda evidenza ta ’ kanċeroġeniċità fi studji orali u topiċi fuq ġrieden u fi studju orali fil - firien meta ngħatat id- doża massima tollerata.
75 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Secondary packaging material The sachets are packed in a carton.
82 It- tieni materjal tal- pakkett Il- qratas ippakkjati f’ kartuna.
76 ANNEX II
83 ANNESS II
Capsule, hard Novartis Farmacéutica, S. A.
Kapsula, iebsa Novartis Farmacéutica, S. A.
Planta de Producción Ronda de Santa Maria 158 E-08210 Barberà del Vallès, Barcelona Spain
Planta de Producción Ronda de Santa Maria 158 E- 08210 Barberà del Vallès, Barcelona Spanja
Oral solution Novartis Pharma S. A. S.
Soluzzjoni orali Novartis Pharma S. A. S.
26, rue de la Chapelle F-68333 Huningue France
26, rue de la Chapelle F- 68333 Huningue Franza
Transdermal patch Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Novartis Pharma GmbH Roonstraße 25 D- 90429 Nuremberg Il- Ġermanja
PSURs:
PSUR’ s:
The Marketing Authorisation Holder will submit PSURs every six months for a period of two years after the Commission Decision on the extension of the indication to treat symptomatic mild to moderately severe dementia in patients with idiopathic Parkinson’ s disease, then yearly for two years and then every three years thereafter.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ser jissottometti PSUR’ s kull sitt xhur għal perijodu ta ’ sentejn wara d- Deċiżjoni tal- Kummissjoni sabiex tiġi estiża l- indikazzjoni għall- kura sintomatika ta ’ dimenzja ħafifa għal moderatament severa f’ pazjenti bil- marda ta ’ Parkinson, imbagħad kull sena għal sentejn u kull tlett xhur minn hemm ’ l quddiem.
Pharmacovigilance system:
Sistema ta ’ Farmakoviġilanza:
The Marketing Authorization Holder ensures that the system of pharmacovigilance, as described in version 2 dated 22 July 2008 presented in Module 1.8.1. of the Marketing Authorization, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jaċċerta li sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2 datata 22 Lulju 2008 preżentata f’ Modulu 1. 8. 1 tad- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- Suq, tkun f’ lokha u taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan:
Pjan ta ’ l- Imaniġġjar tar- Riskju:
The Marketing Authorization Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorization Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jintrabat li jwettaq l- istudji u attivitajiet oħra ta ’ farmakoviġilanza dettaljati fil- Pjan ta Farmakoviġilanza, kif deskritta fil- verżjoni 1. 1 tal- Pjan ta ’ l - Imaniġġjar tar- Riskju (RMP) preżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- tqegħid fis- Suq u kwalunkwe aġġornamenti oħrajn ta ’ l- RMP li jsiru wara kif mifthema mis - CHMP.
78 ANNEX III
85 ANNESS III
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
FOLDING BOX
KAXXA LI TINTLEWA
Exelon 1.5 mg hard capsules Rivastigmine
Exelon 1. 5 mg kapsuli ibsin Rivastigmine
1 capsule contains rivastigmine 1.5 mg present as rivastigmine hydrogen tartrate.
Kapsula waħda jkun fiha 1. 5 mg rivastigmine bħala rivastigmine hydrogen tartrate.
28 hard capsules 56 hard capsules 112 hard capsules
28 kapsula iebsa 56 kapsula iebsa 112 kapsula iebsa
To be swallowed whole without crushing or opening.
Għandu jinbela sħiħ mingħajr ma jingidem jew jinfetaħ.
Exelon 1.5 mg
Exelon 1. 5 mg
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
90 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
FOLDING BOX AND BOTTLE LABEL
KAXXA LI TINTLEWA U TIKKETTA TAL- FLIXKUN
250 hard capsules
250 kapsula iebsa
Exelon 1.5 mg [folding box only]
Exelon 1. 5 mg [kaxxa li tintlewa biss]
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Exelon 3.0 mg hard capsules Rivastigmine
Exelon 3. 0 mg kapsuli ibsin Rivastigmine
1 capsule contains rivastigmine 3.0 mg present as rivastigmine hydrogen tartrate.
Kapsula waħda jkun fiha 3. 0 mg rivastigmine bħala rivastigmine hydrogen tartrate.
Exelon 3.0 mg
Exelon 3. 0 mg
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
95 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Exelon 3.0 mg [folding box only]
Exelon 3. 0 mg [kaxxa li tintlewa biss]
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
97 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Exelon 4.5 mg hard capsules Rivastigmine
Exelon 4. 5 mg kapsuli ibsin Rivastigmine
1 capsule contains rivastigmine 4.5 mg present as rivastigmine hydrogen tartrate.
Kapsula waħda jkun fiha 4. 5 mg rivastigmine bħala rivastigmine hydrogen tartrate.
Exelon 4.5 mg
Exelon 4. 5 mg
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
100 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Exelon 4.5 mg [folding box only]
Exelon 4. 5 mg [kaxxa li tintlewa biss]
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Exelon 6.0 mg hard capsules Rivastigmine
Exelon 6. 0 mg kapsuli ibsin Rivastigmine
1 capsule contains rivastigmine 6.0 mg present as rivastigmine hydrogen tartrate.
Kapsula waħda jkun fiha 6. 0 mg rivastigmine bħala rivastigmine hydrogen tartrate.
Exelon 6.0 mg
Exelon 6. 0 mg
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
104 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
105 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Exelon 6.0 mg [folding box only]
Exelon 6. 0 mg [kaxxa li tintlewa biss]
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Exelon 2 mg/ ml oral solution Rivastigmine
Exelon 2 mg/ ml soluzzjoni orali Rivastigmine
Each ml contains 2.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
Kull ml fih 2. 0 mg rivastigmine bħala rivastigmine hydrogen tartrate.
Also contains: sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104) and purified water.
Ikun fih ukoll, sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104) u ilma purifikat.
Store in an upright position.
Aħżen f’ pożizzjoni wieqfa.
Use Exelon oral solution within 1 month of opening the bottle.
Exelon bħala soluzzjoni orali għandha tintuża fi żmien xahar minn meta ’ jinfetaħ il- flixkun.
Exelon 2 mg/ ml [folding box only]
Exelon 2 mg/ ml [kaxxa li tintlewa biss]
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
109 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR UNIT PACK
KARTUNA TA ’ PAKKETT B’ WIEĦED
Exelon 4.6 mg/ 24 h transdermal patch rivastigmine
Exelon 4. 6 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda rivastigmine
1 transdermal patch of 5 cm2 contains 9 mg rivastigmine and delivers 4.6 mg/ 24 h.
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda 1 ta ’ 5 cm2 fiha 9 mg ta ’ rivastigmine u terħi 4. 6 mg/ 24 siegħa.
Also contains: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methyl-methacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer- coated.
Fih ukoll: rita ta ’ polyethylene terephthalate bil- lakka, alpha- tocopherol, poly( butylmethacrylate, methyl- methacrylate), acrylic copolymer, żejt tas- silicone, dimethicone, rita tal- polyester miksi bi fluoropolymer.
7 transdermal patches 30 transdermal patches
7 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda 30 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda
Transdermal use.
Użu minn fuq il- ġilda.
Keep the patch in the sachet until use.
Żomm il- garża fil- qartas sakemm tiġi biex tużha.
Exelon 4.6 mg/ 24 h
Exelon 4. 6 mg/ 24 h
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR INTERMEDIATE PACK
KARTUNA TAL- PAKKETT TAN- NOFS
30 transdermal patches Component of a multipack comprising 2 cartons, each containing 30 sachets.
30 garża li jipprovdu mediċina li tgħaddi minn ġol- ġilda Komponent ta ’ pakkett b’ ħafna li fih 2 kartuniet, kull waħda fiha 30 qartas.
Component of a multipack comprising 3 cartons, each containing 30 sachets.
Komponent ta ’ pakkett b’ ħafna li fih 3 kartuniet, kull waħda fiha 30 qartas.
60 transdermal patches 90 transdermal patches
60 garza li tipprovdi mediċina li tgħaddi minn ġol- ġilda 90 garza li tipprovdi mediċina li tgħaddi minn ġol- ġilda
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
KARTUNA TA ’ BARRA TAL- PAKKETT B’ ĦAFNA (INKLUŻA L- KAXXA Ċ- ĊELESTI)
Multipack comprising 2 cartons, each containing 30 sachets.
Pakkett b’ ħafna li fih 2 kartuniet, kull waħda fiha 30 qartas.
Multipack comprising 3 cartons, each containing 30 sachets.
Pakkett b’ ħafna li fih 3 kartuniet, kull waħda fiha 30 qartas.
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
115 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET
QARTAS
Transdermal use Read the package leaflet before use.
Użu minn fuq il- ġilda Aqra l- fuljett ta ’ tagħrif qabel l- użu.
1 transdermal patch per sachet
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda f’ kull qartas
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Exelon 9.5 mg/ 24 h transdermal patch rivastigmine
Exelon 9. 5 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda rivastigmine
1 transdermal patch of 10 cm2 contains 18 mg rivastigmine and delivers 9.5 mg/ 24 h.
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda 1 ta ’ 10 cm2 fiha 18 mg ta ’ rivastigmine u terħi 9. 5 mg/ 24 siegħa.
Exelon 9.5 mg/ 24 h
Exelon 9. 5 mg/ 24 h
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
118 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
122 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
117 PACKAGE LEAFLET:
124 FULJETT TA ’ TAGĦRIF:
Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules Rivastigmine
Exelon 1. 5 mg kapsuli ibsin Exelon 3. 0 mg kapsuli ibsin Exelon 4. 5 mg kapsuli ibsin Exelon 6. 0 mg kapsuli ibsin Rivastigmine
What Exelon is and what it is used for 2.
X’ inhu Exelon u għalxiex jintuża 2.
Before you take Exelon 3.
Qabel ma tieħu Exelon 3.
How to take Exelon 4.
Kif għandek tieħu Exelon 4.
How to store Exelon 6.
Kif taħżen Exelon 6.
WHAT EXELON IS AND WHAT IT IS USED FOR
X’ INHU EXELON U GĦALXIEX JINTUŻA
Exelon belongs to a class of substances called cholinesterase inhibitors.
Exelon jagħmel parti minn klassi ta ’ sustanzi li jissejħu impedituri ta ’ cholinesterase.
Exelon is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Exelon jintuża għall- kura ta ’ disturbi tal- memorja f’ pazjenti bil- marda ta ’ Alzheimer.
Exelon is used for the treatment of dementia in patients with Parkinson’ s disease.
Exelon jintuża għall- kura ta ’ dimenzja f’ pazjenti bil- marda ta ’ Parkinson.
BEFORE YOU TAKE EXELON
QABEL MA TIEĦU EXELON
Before taking Exelon it is important that you read the following section and discuss any questions you might have with your doctor.
Qabel ma tieħu Exelon huwa importanti li taqra s- sezzjoni li jmiss u li tiddiskuti kull mistoqsijiet li jista ’ jkollok mat- tabib tiegħek.
Do not take Exelon
Tieħux Exelon
- if you are allergic (hypersensitive) to rivastigmine or any of the other ingredients of Exelon.
- jekk int allerġiku (tbati minn sensittività eċċessiva) għal rivastigmine jew sustanzi oħra ta ’
- if you have severe liver problems.
- jekk int għandek problemi serji fil- fwied.
Take special care with Exelon
Oqgħod attent ħafna b’ Exelon
- if you have, or have ever had impaired kidney or liver function, irregular heartbeat, an active
- jekk int għandek, jew qatt kellek problemi fil- funzjoni tal- kliewi jew tal- fwied, taħbit tal- qalb
stomach ulcer, asthma or severe respiratory disease, difficulties in passing urine, or seizures (fits or convulsions).
irregolari, ulċera attiva fl- istonku, ażżma jew mard respiratorju serju, diffikultajiet biex tagħmel l- awrina, jew aċċessjonijiet (attakki tal- qamar jew konvulżjonijiet).
- if you have not taken Exelon for several days, do not take the next dose until you have talked to
- jekk ma tkunx ħadt Exelon għal bosta jiem, tieħux id- doża li jkun imiss qabel ma titkellem mat -
your doctor.
tabib tiegħek.
- if you experience gastro-intestinal reactions such as nausea (feeling sick) and vomiting (being
- jekk tħoss reazzjonijiet gastro- intestinali bħal tqalligħ (tħossok imdardar/ imdardra) u rimettar.
- if you have a low body weight.
- jekk għandek piż baxx tal- ġisem.
- if you suffer from trembling.
- jekk tbati minn tregħid.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Jekk xi waħda minn dawn tapplika għalik, it- tabib tiegħek jista ’ jkollu bżonn josservak aktar mill- qrib waqt li tkun qed tieħu din il- mediċina.
118 The use of Exelon in children and adolescents (age below 18 years) is not recommended.
125 L- użu ta ’ Exelon fit- tfal u fl- adoloxxenti (età taħt it- 18- il sena) m’ huwiex rakkomandat.
If you have to undergo surgery whilst taking Exelon, you should inform the doctor before you are given any anaesthetics, because Exelon may exaggerate the effects of some muscle relaxants during anaesthesia.
Jekk ikollok bżonn ta ’ operazzjoni waqt li tkun qed tieħu Exelon, għandek tgħarraf lit- tabib qabel ma tingħata l- anestetiku, peress li Exelon jista ’ jeżaġera l- effetti ta ’ xi rilassanti tal- muskoli li jingħataw waqt l- anesteżija.
Exelon should not be given at the same time as other medicines with similar effects to Exelon.
Exelon m’ għandux jingħata fl- istess ħin li jkunu qed jittieħdu mediċini oħrajn b’ effetti simili għal Exelon.
Exelon might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’ s disease or to prevent travel sickness).
Exelon jista ’ jtellef mill- ħidma ta ’ mediċini antikolinerġiċi (mediċini użati biex isserraħ uġigħ ta ’ l- istonku jew spażmi, biex jikkuraw il- marda ta ’ Parkinson jew biex jevitaw il- mard ta ’ l - ivvjaġġar).
Pregnancy and breast-feeding It is preferable to avoid the use of Exelon during pregnancy, unless clearly necessary.
Tqala u Treddigħ Ikun aħjar jekk ma tieħux Exelon waqt it- tqala sakemm dan ma jkunx neċċessarju b’ mod ċar.
Tell your doctor if you become pregnant during treatment.
Għid lit - tabib tiegħek jekk toħroġ tqila waqt li tkun qed tieħu l- kura.
Women on Exelon should not breast-feed.
In- nisa li jkunu qed jieħdu Exelon m’ għandhomx ireddgħu.
Driving and using machines Your illness may impair your ability to drive or operate machinery and you must not carry out these activities unless your doctor tells you that it is safe to do so.
Sewqan u tħaddim ta ’ magni Il- mard li għandek jista ’ itelliflek mill- ħila tas- sewqan jew li tħaddem makkinarju, u m’ għandekx tagħmel dawn l- attivitajiet sakemm it- tabib tiegħek ma jgħidlekx li tista ’ tagħmilhom mingħajr periklu.
Exelon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Exelon jista ’ jikkaġuna sturdament u jraqdek, l- aktar fil- bidu tal- kura jew meta tkun qed iżżid id- doża.
If you experience such effects, you should not drive or operate machinery.
Jekk tħoss dawn l- effetti m’ għandekx issuq jew tħaddem makkinarju.
HOW TO TAKE EXELON
KIF GĦANDEK TIEĦU EXELON
Always take Exelon exactly as your doctor has told you.
Dejjem għandek tieħu Exelon skond il- parir tat- tabib.
Swallow the capsules whole with a drink, without opening or crushing them.
Ibla l- kapsuli sħaħ ma ’ xarba, mingħajr ma tiftaħom jew tgħaffiġhom.
You should take Exelon twice a day with food (in the morning and evening).
Għandek tieħu Exelon darbtejn kuljum ma ’ l- ikel (filgħodu u filgħaxija).
Your doctor will tell you what dosage of Exelon to take, starting with a low dose and gradually increasing, depending on how you respond to the treatment.
It- tabib tiegħek igħidlek x’ doża ta ’ Exelon għandek tieħu, u għandek tibda b’ doża baxxa u żżidha bil - mod, skond kif tirrispondi għall- kura.
The highest dose that should be taken is 6.0 mg twice a day.
L- ogħla doża li għandha tittieħed hija ta ’ 6. 0 mg darbtejn kuljum.
If you have not taken Exelon for several days, do not take the next dose until you have talked to your doctor.
Jekk ma tkunx ħadt Exelon għal bosta jiem, m’ għandekx tieħu d- doża li jkun imiss qabel ma titkellem mat- tabib tiegħek.
To benefit from your medicine you should take it every day.
Biex tikseb benefiċċju mill- mediċina għandek teħodha kuljum.
Tell your caregiver that you are taking Exelon.
Għid lil min ikun qed jikkurak li qed tieħu Exelon.
This medicine should only be prescribed by a specialist and your doctor should regularly review whether it is having the desired effect.
Din il- mediċina għandha tiġi ordnata biss minn speċjalista u t- tabib tiegħek għandu jerġa ’ jeżaminak mill- ġdid sabiex jara jekk hux qed ikollha l- effett mixtieq.
Your doctor will monitor your weight whilst you are taking this medicine.
It- tabib tiegħek se jiżnek regolarment waqt li tkun qed tieħu din il- mediċina.
If you take more Exelon than you should Tell your doctor if you find you have accidentally taken more Exelon than you are told to.
Jekk tieħu Exelon aktar milli suppost Għid lit- tabib tiegħek jekk issib li bi żball ħadt aktar Exelon milli kienu qalulek biex tieħu.
You may require medical attention.
Jista ’ jkun li jkollok bżonn kura medika.
Some people who have accidentally taken too much Exelon have experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations.
Xi wħud li bi żball ħadu wisq Exelon kellhom dardir, rimettar, dijarea, pressjoni għolja u alluċinazzjonijiet.
Slow heart beat and fainting may also occur.
Il- qalb tista ’ tibda tħabbat bil- mod u jista ’ wkoll itik ħass ħażin.
If you forget to take Exelon If you find you have forgotten to take your dose of Exelon, wait and take the next dose at the usual time.
Jekk tinsa tieħu Exelon Jekk tinsa tieħu d- doża tiegħek ta ’ Exelon, stenna u ħu d- doża li jkun imiss fil- ħin normali.
Like all medicines, Exelon can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Exelon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You may tend to get side effects most frequently when you start taking your medicine or increase to a higher dose.
Hemm tendenza li spiss ikollok effetti oħra meta tibda tieħu l- mediċina jew meta żżid id- doża.
Side effects will gradually disappear most probably as your body becomes used to the medicine.
L - effetti l- oħra jmorru bil- mod x’ aktarx minħabba li l- ġisem jibda jidra l- mediċina.
Very common side effects (affects more than 1 patient in 10) are dizziness, nausea (feeling sick), vomiting (being sick), diarrhoea, and loss of appetite.
Effetti komuni hafna (jaffettwaw aktar minn pazjent 1 minn kull 10) huma sturdament, dardir (tħossok imdardar), rimettar (tħossok imqalla), dijarea, u telf ta ’ l- aptit.
Common side effects (affects 1 to 10 patients in 100) are: heartburn, stomach pain, headache, agitation, confusion, weakness, fatigue, sweating, a general feeling of being unwell, weight loss and trembling.
Effetti sekondarji komuni (jaffettwaw minn pazjent 1 sa 10 pazjenti minn kull 100) huma: ħruq ta ’ stonku, uġigħ fl- istonku, uġigħ ta ’ ras, aġitazzjoni, konfużjoni, dgħufija, għajja, telf ta ’ piż, rogħda u tħossok ma tiflaħx.
Uncommonly (affects 1 to 10 patients in 1,000), patients have complained of depression, difficulty in sleeping, changes in liver function, fainting or accidentally falling.
B’ mod mhux komuni (jaffetwaw minn pazjent 1 sa 10 pazjenti minn kull 1, 000) pazjenti ilmentaw bid - dipressjoni, bi tbatija fl- irqad, b’ waqgħat jew b’ ħass ħażin.
Rarely (affects 1 to 10 patients in 10,000), patients have experienced chest pain, seizures (fits or convulsions), rashes, gastric and intestinal ulcers.
Rari (jaffettwaw minn pazjent 1 sa 10 pazjenti minn kull 10, 000), kien hemm pazjenti li esperjenzaw uġigħ fis- sider, aċċessjonijiet (attakki tal- qamar jew konvulżjonijiet), raxxijiet, ulċeri gastriċi u ulċeri duodenali.
Very rarely (affects less than 1 patient in 10,000), patients have experienced gastrointestinal haemorrhage (blood in stools or when vomiting), urinary tract infection, inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting), problems with heart rhythm (both fast and slow), high blood pressure, hallucinations, worsening of Parkinson’ s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements).
Rari ħafna (jaffettwaw anqas minn pazjent 1 minn kull 10, 000), kien hemm pazjenti li esperjenzaw emorraġija gastro- intestinali (demm fl- ippurgar jew mar- rimettar), infezzjoniiet fis- sistema ta ’ l - awrina, infjammazzjoni tal- frixa (uġigħ qawwi fil- parti ta ’ fuq ta ’ l- istonku, spiss bid- dardir u rimettar), problemi bir- ritmu tal- qalb (kemm mgħaġġel kif ukoll bil- mod), pressjoni għolja, alluċinazzjonijiet, tibdil fil- funzjoni tal- fwied, u aggravar fil- marda ta ’ Parkinson jew żvilupp ta ’ sintomi simili (ebusija tal- muskoli, rogħda, tabtija biex tiċċaqlaq).
Not known (frequency cannot be estimated from the available data): severe vomiting that can lead to a rupture of the oesophagus (the tube that connects the mouth with the stomach).
Mhux magħruf (ma tistax tittieħed stima mid- data disponibbli): rimettar qawwi li jista ’ jwassal għal tiċrita fl- esofagu (it- tubu li jgħaqqad il- ħalq ma ’ l- istonku).
Patients with dementia associated with Parkinson’ s disease experience some side effects more frequently and also some additional side effects: trembling (very common), difficulty in sleeping, anxiety, restlessness, worsening of Parkinson’ s disease or development of similar symptoms (muscle stiffness, difficulty in carrying out movements), abnormally slow or uncontrollable movements, slow heart beat, too much saliva and dehydration (common), irregular heart beat and poor control of movements (uncommon).
Pazjenti bid- dimenzja assoċjati mal- marda ta ’ Parkinson jesperjenzaw xi effetti sekondarji b’ mod aktar frekwenti u anke xi effetti sekondarji addizzjonali: tregħid (komuni ħafna), diffikultà fl- irqad, ansjetà, nuqqas ta ’ kwiet, taħrix tal- marda ta ’ Parkinson jew żvilupp ta ’ sintomi jixbħuha (ebusija fil- muskoli, tbatija biex tiċċaqlaq), movimenti bil- mod aktar min- normal jew mingħajr kontroll, qalb tħabbat bil - mod, wisq bżiq u deidratazzjoni (komuni), taħbit tal- qalb irregolari u kontroll mhux tajjeb taċ- ċaqlieq (mhux komuni).
Additional side effects which have been reported with Exelon transdermal patches: severe confusion, anxiety, fever (common).
Effetti sekondarji oħra kienu rrappurtati bil- garżi li tipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon: konfużjoni severa, ansjetà, deni (komuni).
Should such symptoms occur, contact your doctor as you may need medical assistance.
Jekk ikun hemm dawn is- sintomi, għandek tgħarraf lit- tabib peress li jista ’ jkollok bżonn assistenza medika.
HOW TO STORE EXELON
KIF TAĦŻEN EXELON
Do not use Exelon after the expiry date which is stated on the carton.
Tużax Exelon wara d- data ta ’ skadenza li tidher fuq il- kartuna.
What Exelon contains
X’ fih Exelon
- The active substance is rivastigmine hydrogen tartrate.
- Is- sustanza attiva hi rivastigmine hydrogen tartrate.
- The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose,
- Is- sustanzi l- oħra huma hypromellose, magnesium stearate, microcrystalline cellulose, colloidal
colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171).
anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172) u titanium dioxide (E171).
Each Exelon 1.5 mg capsule contains 1.5 mg of rivastigmine.
Kull kapsula Exelon ta ’ 3. 0 mg fiha 3. 0 mg rivastigmine.
Each Exelon 3.0 mg capsule contains 3.0 mg of rivastigmine.
Kull kapsula Exelon ta ’ 4. 5 mg fiha 4. 5 mg rivastigmine.
Each Exelon 4.5 mg capsule contains 4.5 mg of rivastigmine.
Kull kapsula Exelon ta ’ 6. 0 mg fiha 6. 0 mg rivastigmine.
What Exelon looks like and contents of the pack Exelon 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “ EXELON 1,5 mg ” on the body.
Id- Dehra ta ’ Exelon u l- kontenuti tal- pakkett Exelon 1. 5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu isfar u kappa safra, b’ timbru aħmar “ EXELON 1, 5 mg ” fuq il- kappa.
Exelon 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ EXELON 3 mg ” on the body.
Exelon 3. 0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu oranġjo u kappa oranġjo, b’ timbru aħmar “ EXELON 3 mg ” fuq il- kappa.
Exelon 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “ EXELON 4,5 mg ” on the body.
Exelon 4. 5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu aħmar u kappa ħamra, b’ timbru aħmar “ EXELON 4, 5 mg ” fuq il- kappa.
Exelon 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ EXELON 6 mg ” on the body.
Exelon 6. 0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl- isfar, għandhom għatu aħmar u kappa oranġjo, b’ timbru aħmar “ EXELON 6 mg ” fuq il- kappa.
They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
Ippakkjati f’ folji li jiġu f’ tliet daqsijiet (28, 56 jew 112- il kapsula) u fliexken tal- plastik ta ’ 250 kapsula, iżda jista ’ jkun li dawn ma ssibhomx f’ pajjiżek.
Marketing Authorisation holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Manufacturer Novartis Farmacéutica, S. A.
Manifattur Novartis Farmacéutica, S. A.
122 PACKAGE LEAFLET:
129 FULJETT TA ’ TAGĦRIF:
The use of Exelon in children and adolescents (age below 18 years) is not recommended.
L- użu ta ’ Exelon fit- tfal u fl- adoloxxenti (età taħt it- 18- il sena) m’ huwiex rakkomandat.
123 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
130 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 Exelon One of the inactive ingredients in Exelon oral solution is sodium benzoate.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Exelon Waħda mis- sustanżi mhux attivi ta ’ Exelon soluzzjoni orali hija sodium benzoate.
Benzoic acid is a mild irritant to the skin, eyes and mucous membranes.
Benzoic acid jista ’ jikkawża irritazzjoni ħafifa tal- ġilda, għajnejn u fil- membrana mukuża.
Remove the oral dosing syringe provided from its protective case.
Neħħi s- siringa pprovduta minn ġol- kontenitur protettiv.
Using this syringe, withdraw the prescribed amount of Exelon oral solution from the container.
Iġbed id- doża ta ’ Exelon soluzzjoni orali, ordnata mit- tabib, minn ġol- flixkun, bl- użu tas- siringa.
Each dose of Exelon oral solution may be swallowed directly from the syringe.
Kull doża ta ’ Exelon soluzzjoni orali tista ’ tittieħed direttament minn ġos- siringa.
If you take more Exelon than you should Tell your doctor if you find you have accidentally taken more Exelon than you are instructed to.
131 Jekk tieħu Exelon aktar milli suppost Għid lit- tabib tiegħek jekk issib li bi żball ħadt aktar Exelon milli kienu qalulek biex tieħu.
124 experienced nausea, vomiting, diarrhoea, high blood pressure and hallucinations.
Xi wħud li bi żball ħadu wisq Exelon kellhom dardir, rimettar, dijarea, pressjoni għolja u alluċinazzjonijiet.
125 Store in an upright position.
Aħżen f’ pożizzjoni wieqfa.
Use Exelon oral solution within 1 month of opening the bottle.
Exelon bħala soluzzjoni orali għandha tintuża fi żmien xhar minn meta jinfetaħ il- flixkun.
Each ml contains rivastigmine hydrogen
jikkorrispondi għal bażi ta ’ rivastigmine ta ’ 2. 0 mg.
- The other ingredients are sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye
- Is- sustanzi l- oħra huma sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye
(E104) and purified water.
(E104) u ilma purifikat.
What Exelon looks like and contents of the pack Exelon oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Id- Dehra ta ’ Exelon u l- kontenuti tal- pakkett Exelon soluzzjoni orali jiġi bħala 50 ml jew 120 ml soluzzjoni ċara, safra (bażi ta ’ 2. 0 mg/ ml), fi flixkun magħmul minn ħġieġ kannella, b’ għatu li ma jinfetaħx mit- tfal, b’ kisja tal- fowm, b’ tubu biex tbill, u b’ tapp li jipożizzjona lilu nnifsu.
Manufacturer Novartis Pharma S. A. S.
Manifattur Novartis Pharma S. A. S.
Nederland Novartis Pharma B. V.
133 Nederland Danmark Novartis Pharma B. V.
127 Instructions for Use:
134 Struzzjonijiet dwar l- użu:
Exelon oral solution
Exelon soluzzjoni orali
Remove oral dosing syringe from its protective case.
Neħħi s- siringa li fiha l- marki tad- dożi fuqa minn ġol- kontenitur protettiv.
Push down and turn child resistant closure to open bottle.
Għafas l- isfel u dawwar, l- għatu li ma jinfetaħx mit- tfal, biex tiftaħ il - flixkun.
Insert nozzle of syringe into opening of white stopper.
Daħħal iż- żennuna tas- siringa ġot- toqba fit- tapp abjad.
Withdraw prescribed amount of Exelon oral solution from bottle.
Iġbed l- ammont ta ’ Exelon soluzzjoni orali li ordna t- tabib minn ġol - flixkun.
Before removing syringe containing prescribed dose from bottle, expel any large bubbles by depressing and withdrawing plunger a few times.
Qabel tneħħi s- siringa mimlija bid- doża minn mal- flixkun, għafas il - barra xi bżieżaq kbar billi timbotta u tiġbed il- planġer għal diversi drabi.
The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.
Il- preżenza ta ’ xi bżieżaq żgħar m’ hi ta ’ ebda ’ importanza u ma taffettwa xejn id- doża bl- ebda mod.
Swallow Exelon oral solution directly from the syringe or first mix in a small glass with water.
Ibla ’ Exelon soluzzjoni orali direttament minn ġos- siringa, jew imħallta ġo tazza ilma żgħira.
Stir and drink the entire mixture.
Ħawwad u ixrob it- taħlita kollha.
After use, wipe outside of syringe with a clean tissue and replace it in its protective case.
Wara l- użu, imsaħ is- siringa b’ biċċa nadifa u poġġiha lura fil- kontenitur protettiv.
Close bottle using child resistant closure.
Għalaq il- flixkun bl- għatu li ma jinfetaħx mit- tfal.
129 PACKAGE LEAFLET:
136 FULJETT TA ’ TAGĦRIF:
Exelon 4.6 mg/ 24 h transdermal patch Exelon 9.5 mg/ 24 h transdermal patch rivastigmine
Exelon 4. 6 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Exelon 9. 5 mg/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda rivastigmine
Before you use Exelon 3.
Qabel ma tuża Exelon 3.
How to use Exelon 4.
Kif għandek tuża Exelon 4.
The active substance of Exelon is rivastigmine.
Is- sustanza attiva f’ Exelon hija rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Rivastigmine jagħmel parti minn klassi ta ’ sustanzi li jissejjħu inibituri tal- cholinesterase.
Exelon is used for the treatment of memory disorders in patients with Alzheimer’ s disease.
Exelon tintuża għall- kura ta ’ disturbi tal- memorja f’ pazjenti bil- marda ta ’ Alzheimer.
BEFORE YOU USE EXELON
QABEL MA TUŻA EXELON
Do not use Exelon
Tużax Exelon
- if you are allergic (hypersensitive) to rivastigmine (the active substance in Exelon) or to any of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal rivastigmine (is- sustanza attiva
the other ingredients listed in section 6 of this leaflet.
f’ Exelon) jew sustanzi oħra elenkati f’ sezzjoni 6 ta ’ dan il- fuljett.
- if you have ever had an allergic reaction to a similar type of medicine.
- jekk qatt xi darba kellek reazzjoni allerġika għal xi mediċina simili.
If this applies to you, tell your doctor and do not apply Exelon transdermal patches.
Jekk dan jgħodd għalik, għid lit- tabib u tapplikax Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda.
- if you have, or have ever had, an irregular heartbeat.
- jekk għandek, jew qatt xi darba kellek, tħabbit tal- qalb irregolari.
- if you have, or have ever had, a stomach ulcer.
- jekk għandek, jew qatt xi darba kellek, ulċera fl- istonku.
- if you have, or have ever had, difficulties in passing urine.
- jekk għandek, jew qatt xi darba kellek, problemi biex tgħaddi l- awrina.
- if you have, or have ever had, seizures.
- jekk għandek, jew qatt xi darba kellek, aċċessjonijiet.
- if you have, or have ever had, asthma or a severe respiratory disease.
- jekk għandek, jew qatt xi darba kellek, ażżma jew mard serju tan- nifs.
- if you have a low body weight.
- jekk għandek piż tal- ġisem baxx.
- if you have impaired liver function.
- jekk għandek funżjoni ħażina tal- fwied.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Jekk xi wieħed minn dawn jgħodd għalik, it- tabib tiegħek jista ’ jkollu bżonn jimmonitorak aktar mill - qrib waqt li tkun fuq din il- mediċina.
If you have not applied a patch for several days, do not apply the next one before you have talked to your doctor.
Jekk ma applikajtx garża għal ħafna jiem, tapplikax il- garża li jmiss qabel ma tkun kellimt lit- tabib tiegħek.
The use of Exelon in children and adolescents (age below 18 years) is not recommended.
L- użu ta ’ Exelon fi tfal u adolexxenti (età taħt it- 18- il sena) mhux rakkomandat.
130 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
137 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.
Exelon might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’ s disease or to prevent travel sickness).
Exelon jista ’ jinterferixxi ma ’ mediċini antikolinerġiċi (mediċini li jintużaw biex itaffu weġgħat fl - istonku jew spażmi, għal kura tal- marda ta ’ Parkinson jew biex jevitaw it- tqallih ta ’ l- ivjaġġar).
If you have to undergo surgery whilst using Exelon transdermal patches, tell your doctor that you are using them because they may exaggerate the effects of some muscle relaxants during anaesthesia.
Jekk ikollok bżonn tagħmel operazzjoni meta tkun qed tuża Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda, għid lit- tabib tiegħek li qed tużahom għax jistgħu jeżaġeraw l- effetti ta ’ xi rilassanti tal- muskoli li jintużaw waqt il- loppju.
Using Exelon with food and drink Food or drink do not affect the use of Exelon transdermal patches because rivastigmine enters the bloodstream through the skin.
Meta tuża Exelon ma ’ l- ikel u max- xorb L- ikel u x- xorb m’ għandux effett fuq l- użu tal- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon għax rivastigmine jidħol fiċ- ċirkolazzjoni tad- demm mill- ġilda.
Pregnancy and breast feeding Tell your doctor if you are pregnant or planning to become pregnant.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk ħriġt tqila jew qed tippjana għat- tqala.
If you are pregnant, the benefits of using Exelon transdermal patches must be assessed against the possible effects on your unborn child.
Jekk ħriġt tqila, il- benefiċċji tal - garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon għandhom jiġu evalwati kontra l- effetti li jista ’ jkun hemm fuq it- tarbija li għada ma twielditx.
You should not breast-feed during treatment with Exelon transdermal patches.
M’ għandekx tredda ’ waqt il- kura b’ garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon.
Driving and using machines Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Sewqan u tħaddim ta ’ magni It- tabib tiegħek sejjer jgħidlek jekk il- marda li għandek tħallikx issuq karozzi u tħaddem magni b’ mod sigur.
Exelon transdermal patches may cause fainting or severe confusion.
Garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon jistgħu jikkawżaw ħass ħażin jew konfużjoni severa.
If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.
Jekk tħossok ħażin jew konfuż m’ għandekx issuq, tuża magni jew tgħamel affarjiet oħra li jeħtieġu l- attenzjoni tiegħek.
HOW TO USE EXELON
KIF GĦANDEK TUŻA EXELON
Always use Exelon transdermal patches exactly as your doctor has told you.
Dejjem għandek tuża l- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon skond il- parir tat - tabib.
IMPORTANT:
IMPORTANTI:
Only wear one Exelon patch at a time.
Ilbes Exelon garża waħda f’ kull ħin.
You must remove the previous day’ s patch before applying a new one.
Għandek tneħħi l- garża tal- jum ta ’ qabel qabel ma tapplika l- ġdida.
Do not cut the patch into pieces.
Taqtax il- garża f’ biċċiet.
How to start treatment Your doctor will tell you which Exelon transdermal patch is most suitable for you. • Treatment usually starts with Exelon 4.6 mg/ 24 h. • The usual daily dose is Exelon 9.5 mg/ 24 h. • Only one transdermal patch should be worn at a time and the transdermal patch should be replaced by a new one after 24 hours.
Kif tibda ’ l- kura It- tabib tiegħek sejjer jgħidlek liema mill- garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Exelon l- aktar li tgħodd għalik. • Il- kura s- soltu tibda b’ Exelon 4. 6 mg/ 24 siegħa. • Id- doża ta ’ kuljum is- soltu tkun Exelon 9. 5 mg/ 24 siegħa. • Għandha tintlibes garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda waħda biss f’ kull ħin u l - garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda għandha tinbidel b’ oħra ġdida wara 24 siegħa.
During the course of the treatment your doctor may adjust the dose to suit your individual needs.
Waqt il- kura t- tabib tiegħek jista ’ jaġġusta d- doża kif ikun jixraq għall- bżonnijiet individwali tiegħek.
If you have not applied a patch for several days, talk to your doctor before applying another one.
Jekk ma applikajtx garża għal bosta ġranet, tkellem lit- tabib tiegħek qabel tapplika oħra.
131 Where to apply Exelon transdermal patches
138 Fejn għandek tapplika Exelon garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda Applika l- garża fuq il- naħa ta ’ fuq jew ta ’ isfel tad- dahar,
- Apply the patch to the upper or lower back, upper arm or
-
chest (avoid breast).
il- parti ta ’ fuq tad- driegħ jew sider (evita ż- żejżiet).
Avoid places where the patch can be rubbed off by tight clothing.
Evita postijiet fejn il- garża tista ’ tgħorok u tinqala bi ħwejjeġ issikkati.
Before you apply a patch, make sure that your skin is:
Qabel ma tapplika garża, aċċerta ruħek li l- ġilda tiegħek hija:
- clean, dry and hairless,
- nadifa, xotta u bla suf,
- free of any powder, oil, moisturiser, or lotion that could
- ħielsa minn kwalunkwe trab, żejt, moisturiser, jew lozzjoni
keep the patch from sticking to your skin properly,
li jistgħu ixekklu l- garża milli teħel sew mal- ġilda tiegħek,
- free of cuts, rashes and/ or irritations.
- ħielsa minn qatgħat, raxxijiet u/ jew irritazzjonijiet.
When changing the patch, apply the new one to a different location of skin each time (for example on the right side of your body one day, then on the left side the next day, and on your upper body one day, then on your lower body the next day).
Meta tkun qed tibdel il- garża, applika l- ġdida f’ post differenti tal- ġilda kull darba (eż. in- naħa tal - lemin ta ’ ġismek f’ ġurnata, imbagħad fuq in- naħa tax- xellug fil- ġurnata li jmiss, u fil- parti ta ’ fuq ta ’ ġismek f’ ġurnata, imbagħad fil- parti ta ’ isfel fil- ġurnata li jmiss.
Do not apply a new patch to that same location of skin twice within 14 days.
Tapplikax il- garża l- ġdida fl- istess post tal- ġilda għal darbtejn fi żmien 14- il jum.