Pregabalin Sandoz GmbH

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
12-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-10-2023

Active ingredient:

pregabalín

Available from:

Sandoz GmbH

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Sandoz Kg er fram eins og venjulega meðferð í fullorðnir með hluta flog með eða án efri almenn ákvörðun er tekin. Almenn Kvíða DisorderPregabalin Sandoz Kg er ætlað fyrir meðferð Almenn Kvíða (HIMNUM) hjá fullorðnum.

Product summary:

Revision: 16

Authorization status:

Aftakað

Authorization date:

2015-06-19

Patient Information leaflet

                                70
B. FYLGISEÐILL
Lyfið er ekki lengur með markaðsleyfi
71
FYLGISEÐILL: UPPLÝSINGAR FYRIR NOTANDA LYFSINS
PREGABALIN SANDOZ GMBH 25 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 50 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 75 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 100 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 150 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 200 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 225 MG HÖRÐ HYLKI
PREGABALIN SANDOZ GMBH 300 MG HÖRÐ HYLKI
pregabalín
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
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 þótt 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 Sandoz GmbH og við hverju það er notað
2.
Áður en byrjað er að nota Pregabalin Sandoz GmbH
3.
Hvernig nota á Pregabalin Sandoz GmbH
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Pregabalin Sandoz GmbH
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM PREGABALIN SANDOZ GMBH OG VIÐ HVERJU ÞAÐ ER NOTAÐ
Pregabalin Sandoz GmbH tilheyrir flokki lyfja sem eru notuð við
meðferð á flogaveiki og almennri
kvíðaröskun hjá fullorðnum.
FLOGAVEIKI:
Pregabalin Sandoz GmbH er notað til meðhöndlunar á sérstakri
tegund af flogaveiki
(staðflog með eða án síðkominna alfloga – flogaköst sem byrja
í einum ákveðnum hluta heilans) hjá
fullorðnum. Læknirinn mun ávísa þér Pregabalin Sandoz GmbH
þegar núverandi meðferð dugar ekki
lengur til þess að ná tökum á flogaveikinni. Þú átt að taka
Pregabalin Sandoz GmbH sem
viðbótarmeðferð við
                                
                                Read the complete document

Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
Lyfið er ekki lengur með markaðsleyfi
2
1.
HEITI LYFS
Pregabalin Sandoz GmbH 25 mg hörð hylki
Pregabalin Sandoz GmbH 50 mg hörð hylki
Pregabalin Sandoz GmbH 75 mg hörð hylki
Pregabalin Sandoz GmbH 100 mg hörð hylki
Pregabalin Sandoz GmbH 150 mg hörð hylki
Pregabalin Sandoz GmbH 200 mg hörð hylki
Pregabalin Sandoz GmbH 225 mg hörð hylki
Pregabalin Sandoz GmbH 300 mg hörð hylki
2.
INNIHALDSLÝSING
Pregabalin Sandoz GmbH 25 mg hörð hylki
Hvert hart hylki inniheldur 25 mg pregabalín.
Pregabalin Sandoz GmbH 50 mg hörð hylki
Hvert hart hylki inniheldur 50 mg pregabalín.
Pregabalin Sandoz GmbH 75 mg hörð hylki
Hvert hart hylki inniheldur 75 mg pregabalín.
Pregabalin Sandoz GmbH 100 mg hörð hylki
Hvert hart hylki inniheldur 100 mg pregabalín.
Pregabalin Sandoz GmbH 150 mg hörð hylki
Hvert hart hylki inniheldur 150 mg pregabalín.
Pregabalin Sandoz GmbH 200 mg hörð hylki
Hvert hart hylki inniheldur 200 mg pregabalín.
Pregabalin Sandoz GmbH 225 mg hörð hylki
Hvert hart hylki inniheldur 225 mg pregabalín.
Pregabalin Sandoz GmbH 300 mg hörð hylki
Hvert hart hylki inniheldur 300 mg pregabalín.
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Hart hylki.
Pregabalin Sandoz GmbH 25 mg hörð hylki
Fölgulbrúnn, ógagnsær efri partur og neðri partur, hylki af
stærð 4 (14,3 mm x 5,3 mm), fyllt með
hvítu eða næstum hvítu dufti.
Pregabalin Sandoz GmbH 50 mg hörð hylki
Ljósgulur, ógagnsær efri partur og neðri partur, hylki af stærð
3 (15,9 mm x 5,8 mm), fyllt með hvítu
eða næstum hvítu dufti.
Pregabalin Sandoz GmbH 75 mg hörð hylki
Rauður, ógagnsær efri partur og hvítur, ógagnsær neðri partur,
hylki af stærð 4 (14,3 mm x 5,3 mm),
fyllt með hvítu eða næstum hvítu dufti.
Lyfið er ekki lengur með markaðsleyfi
3
Pregabalin Sandoz GmbH 100 mg hörð hylki
Rauður, ógagnsær efri partur og neðri partur, hylki af stærð 3
(15,9 mm x 5,8 mm), fyllt með hvítu eða
næstum hvítu dufti.
Pregabalin Sand
                                
                                Read the complete document

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