Moventig

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-12-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-12-2023
Public Assessment Report Public Assessment Report (PAR)
17-12-2014

Active ingredient:

naloxegol oxalate

Available from:

Kyowa Kirin Holdings B.V.

ATC code:

A06AH03

INN (International Name):

naloxegol

Therapeutic group:

Periferali tal-opioid antagonisti tar-riċettur-Mediċini għall-istitikezza

Therapeutic area:

Constipation; Opioid-Related Disorders

Therapeutic indications:

Trattament ta 'stitikezza kkawżata mill-opjojdi (OIC) f'pazjenti adulti li kellhom rispons inadegwat għal-lassattiv (i).

Product summary:

Revision: 15

Authorization status:

Awtorizzat

Authorization date:

2014-12-07

Patient Information leaflet

                                27
B. FULJETT TA’ TAGĦRIF
28
FULJETT TA’ TAGĦRIF:
INFORMAZZJONI GĦALL-PAZJENT
MOVENTIG 12.5 MG PILLOLI MIKSIJIN B’RITA
MOVENTIG 25 MG PILLOLI MIKSIJIN B’RITA
naloxegol
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju, kellem lit-tabib, lill-ispiżjar
jew lill-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Moventig u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Moventig
3.
Kif għandek tieħu Moventig
4.
Effetti sekondarji possibbli
5.
Kif taħżen Moventig
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU MOVENTIG U GĦALXIEX JINTUŻA
Moventig fih is-sustanza attiva naloxegol. Hija mediċina użata
fl-adulti biex tikkura stitikezza
ikkawżata speċifikament minn mediċini għall-uġigħ, li jissejħu
opjojdi, (eż. morfina, oxycodone,
fentanyl, tramadol, koedina) li jittieħdu fuq bażi regolari.
Tintuża meta l-lassattivi ma pprovdewx
solliev aċċettabbli għal stitikezza.
L-istitikezza relatata mal-opjojdi tista’ tirriżulta f’sintomi
bħal:
•
uġigħ fl-istonku
•
strapazz tar-rektum (ikollok bżonn tagħmel sforz kbir ħafna biex
tkun tista’ tipporga, li jista’
wkoll jikkawża uġigħ fl-anus meta timbotta)
•
ippurgar iebes (ippurgar li jkunu iebes "ġebla")
•
tbattil mhux komplut tar-rektum (wara li jkollok moviment tal-imsaren,
is-sensazzjoni bħallikieku
li għad trid tipporga iżjed)
F’pazjenti bi stitikezza li jieħdu opjojdi, li ppruvaw għallinqas
lassattiv wieħed u kellhom serħan
inkomplet minn stitikezz
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Moventig 12.5 mg pilloli miksijin b’rita
Moventig 25 mg pilloli miksijin b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Moventig 12.5 mg pilloli miksijin b’rita
Kull pillola miksija b’rita fiha naloxegol oxalate ekwivalenti għal
12.5 mg naloxegol.
Moventig 25 mg pilloli miksijin b’rita
Kull pillola miksija b’rita fiha naloxegol oxalate ekwivalenti għal
25 mg naloxegol.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Moventig 12.5 mg pillola miksija b’rita (pillola).
Pillola vjola, 10.5x5.5 mm, ovali.
Moventig 25 mg pillola miksija b’rita (pillola).
Pillola vjola, 13x7 mm, ovali.
Il-pilloli huma mnaqqxa b’"nGL" fuq naħa waħda u bil-qawwa
tal-pillola fuq in-naħa l-oħra.
4
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Moventig huwa indikat għall-kura ta’ stitikezza kkaġunata minn
opjojdi (OIC - opioid-induced
constipation) f’pazjenti adulti li kellhom rispons inadegwat għal
lassattiv(i).
Għal definizzjoni ta’ rispons mhux adegwat għal lassativ(i), ara
sezzjoni 5.1.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Id-doża rakkomandata ta’ Moventig hija 25 mg darba kuljum.
Moventig jista’ jintuża mal-lassattivi jew mingħajrhom.
It-trattament b’Moventig għandu jitwaqqaf
meta titwaqqaf it-terapija sistemika tal-opjojdi.
_Popolazzjonijiet speċjali_
_Anzjani_
Ma huwa rrakkomandat ebda aġġustament skont l-età (ara sezzjoni
5.2).
_Indeboliment tal-kliewi_
Id-doża tal-bidu għall-pazjenti b’insuffiċjenza tal-kliewi
moderata jew severa hija 12.5 mg. Jekk
iseħħu effetti sekondarji li jħallu impatt fuq it-tolerabbiltà,
naloxegol għandu jitwaqqaf. Id-doża tista’
tiżdied għal 25 mg, jekk 12.5 mg hija ttollerata sew mill-pazjent
(ara sezzjoni 5.2).
Ma huwa meħtieġ ebda aġġustament tad-doża għal pazjenti
b’indeboliment ħafif tal-kliewi.
3
_Indeboliment tal-fwied_
Ma huwa meħtieġ ebda aġġustament fid-doża b’indebol
                                
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Similar products

Active ingredient naloxegol oxalate

naloxegol oxalate

ATC code A06AH03

A06AH03

Marketed by Kyowa Kirin Holdings B.V.

Kyowa Kirin Holdings B.V.

INN (International Name) naloxegol

naloxegol

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Patient Information leaflet Patient Information leaflet Bulgarian 13-12-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-12-2023
Public Assessment Report Public Assessment Report Bulgarian 17-12-2014
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Summary of Product characteristics Summary of Product characteristics Spanish 13-12-2023
Public Assessment Report Public Assessment Report Spanish 17-12-2014
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Public Assessment Report Public Assessment Report Czech 17-12-2014
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Public Assessment Report Public Assessment Report Danish 17-12-2014
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Public Assessment Report Public Assessment Report German 17-12-2014
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Public Assessment Report Public Assessment Report Estonian 17-12-2014
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Public Assessment Report Public Assessment Report Greek 17-12-2014
Patient Information leaflet Patient Information leaflet English 13-12-2023
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Public Assessment Report Public Assessment Report English 17-12-2014
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