Pregabalin Mylan

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2023

Active ingredient:

pregabalín

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Taugakvillaverkur painPregabalin Mylan er ætlað fyrir meðferð af útlimum og central taugaverkir í fullorðnir. EpilepsyPregabalin Mylan er fram eins og venjulega meðferð í fullorðnir með hluta flog með eða án efri almenn ákvörðun er tekin. Almenn Kvíða DisorderPregabalin Mylan er ætlað fyrir meðferð Almenn Kvíða (HIMNUM) hjá fullorðnum.

Product summary:

Revision: 16

Authorization status:

Leyfilegt

Authorization date:

2015-06-24

Patient Information leaflet

                                59
B. FYLGISEÐILL
60
FYLGISEÐILL: UPPLÝSINGAR FYRIR NOTANDA LYFSINS
PREGABALIN MYLAN
25 MG HÖRÐ HYLKI
PREGABALIN MYLAN 50 MG HÖRÐ HYLKI
PREGABALIN MYLAN 75 MG HÖRÐ HYLKI
PREGABALIN MYLAN 100 MG HÖRÐ HYLKI
PREGABALIN MYLAN 150 MG HÖRÐ HYLKI
PREGABALIN MYLAN 200 MG HÖRÐ HYLKI
PREGABALIN MYLAN 225 MG HÖRÐ HYLKI
PREGABALIN MYLAN 300 MG HÖRÐ HYLKI
pregabalín
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ TAKA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins eða lyfjafræðings ef þörf er á frekari
upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þó um sömu sjúkdómseinkenni sé að ræða.
-
Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
Þetta gildir einnig um aukaverkanir
sem ekki er minnst á í þessum fylgiseðli. Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR:
1.
Upplýsingar um Pregabalin Mylan og við hverju það er notað
2.
Áður en byrjað er að nota Pregabalin Mylan
3.
Hvernig nota á Pregabalin Mylan
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Pregabalin Mylan
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM PREGABALIN MYLAN OG VIÐ HVERJU ÞAÐ ER NOTAÐ
Pregabalin Mylan inniheldur virka efnið pregabalín sem tilheyrir
flokki lyfja sem eru notuð við
meðferð við flogaveiki, taugaverkjum og almennri kvíðaröskun
hjá fullorðnum.
ÚTLÆGIR OG MIÐLÆGIR TAUGAVERKIR:
Pregabalin Mylan er notað til meðhöndlunar á langvarandi
verkjum af völdum taugaskemmda. Fjöldi mismunandi sjúkdóma getur
valdið útlægum taugaverkjum,
svo sem sykursýki eða ristill. Verkjatilfinningunni hefur verið
lýst sem: hita, sviða, slætti, skoti, sting,
nístandi, krampa, verk, dofa, tilfinningaleysi, náladofa.
Skapbreytingar, svefntruflanir og þróttleysi
(þreyta) geta einnig fylgt útlægum og miðlægum taugaverkjum og
þeir geta haft
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
Pregabalin Mylan 25 mg hörð hylki
Pregabalin Mylan 50 mg hörð hylki
Pregabalin Mylan 75 mg hörð hylki
Pregabalin Mylan 100 mg hörð hylki
Pregabalin Mylan 150 mg hörð hylki
Pregabalin Mylan 200 mg hörð hylki
Pregabalin Mylan 225 mg hörð hylki
Pregabalin Mylan 300 mg hörð hylki
2.
INNIHALDSLÝSING
Pregabalin Mylan 25 mg hörð hylki
Hvert hart hylki inniheldur 25 mg af pregabalíni.
Pregabalin Mylan 50 mg hörð hylki
Hvert hart hylki inniheldur 50 mg af pregabalíni.
Pregabalin Mylan 75 mg hörð hylki
Hvert hart hylki inniheldur 75 mg af pregabalíni.
Pregabalin Mylan 100 mg hörð hylki
Hvert hart hylki inniheldur 100 mg af pregabalíni.
Pregabalin Mylan 150 mg hörð hylki
Hvert hart hylki inniheldur 150 mg af pregabalíni.
Pregabalin Mylan 200 mg hörð hylki
Hvert hart hylki inniheldur 200 mg af pregabalíni.
Pregabalin Mylan 225 mg hörð hylki
Hvert hart hylki inniheldur 225 mg af pregabalíni.
Pregabalin Mylan 300 mg hörð hylki
Hvert hart hylki inniheldur 300 mg af pregabalíni.
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Hart hylki.
3
Pregabalin Mylan 25 mg hörð hylki
Stærð nr. 4 með ljósferskjulituðum möttum efri hluta og hvítum
möttum neðri hluta, gelatínhylki með
harðri skel sem fyllt er með hvítu til beinhvítu dufti. Áslæg
prentun er á hylkinu sem er merkt með
MYLAN fyrir ofan PB25 með svörtu bleki á efri og neðri hluta
þess.
Pregabalin Mylan 50 mg hörð hylki
Stærð nr. 3 með dökkferskjulituðum möttum efri hluta og hvítum
möttum neðri hluta, gelatínhylki
með harðri skel sem fyllt er með hvítu til beinhvítu dufti.
Áslæg prentun er á hylkinu sem er merkt
með MYLAN fyrir ofan PB50 með svörtu bleki á efri og neðri hluta
þess.
Pregabalin Mylan 75 mg hörð hylki
Stærð nr. 4 með ljósferskjulituðum möttum efri hluta og
ljósferskjulituðum möttum neðri hluta,
gelatínhylki með harðri skel sem fyllt er með hvítu til
beinhvítu dufti. Áslæg prentun er á
                                
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Active ingredient pregabalín

pregabalín

ATC code N03AX16

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INN (International Name) pregabalin

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