Pregabalin Accord

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
09-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
09-01-2023
Public Assessment Report Public Assessment Report (PAR)
06-07-2017

Active ingredient:

pregabalin

Available from:

Accord Healthcare S.L.U.

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Accord ir norādīts kā adjunctive terapija pieaugušajiem ar daļēju lēkmju ar vai bez sekundāras vispārināšanas. Ģeneralizēta Trauksme DisorderPregabalin Accord ir indicēts, lai ārstētu Ģeneralizēta Trauksme (VSD) pieaugušajiem.

Product summary:

Revision: 15

Authorization status:

Autorizēts

Authorization date:

2015-08-28

Patient Information leaflet

                                79
B. LIETOŠANAS INSTRUKCIJA
80
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
PREGABALIN ACCORD 25 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 50 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 75 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 100 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 150 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 200 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 225 MG CIETĀS KAPSULAS,
PREGABALIN ACCORD 300 MG CIETĀS KAPSULAS
_pregabalin _
PIRMS ZĀĻU LIETOŠANAS UZMANĪGI IZLASIET VISU INSTRUKCIJU, JO TĀ
SATUR JUMS SVARĪGU INFORMĀCIJU.
-
Saglabājiet šo instrukciju! Iespējams, ka vēlāk to vajadzēs
pārlasīt.
-
Ja Jums rodas jebkādi jautājumi, vaicājiet ārstam vai farmaceitam.
-
Šīs zāles ir parakstītas tikai Jums. Nedodiet tās citiem. Tās
var nodarīt ļaunumu pat tad, ja šiem
cilvēkiem ir līdzīgas slimības pazīmes.
-
Ja Jums rodas jebkādas blakusparādības, konsultējieties ar ārstu
vai farmaceitu. Tas attiecas arī
uz iespējamām blakusparādībām, kas nav minētas šajā
instrukcijā. Skatīt 4. punktu.
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT:
1.
Kas ir Pregabalin Accord un kādam nolūkam tās lieto
2.
Kas Jums jāzina pirms Pregabalin Accord lietošanas
3.
Kā lietot Pregabalin Accord
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Pregabalin Accord
6.
Iepakojuma saturs un cita informācija
1.
KAS IR PREGABALIN ACCORD UN KĀDAM NOLŪKAM TĀS LIETO
Pregabalin Accord pieder pie zāļu grupas, ko lieto epilepsijas,
neiropātisku sāpju un ģeneralizētas
trauksmes ārstēšanai pieaugušajiem.
Perifērās un centrālās neiropātiskās sāpes
Šīs zāles lieto, lai novērstu pastāvīgas sāpes, ko izraisa
nervu bojājums. Perifērās neiropātiskās sāpes
var rasties dažādu slimību dēļ, piemēram, sakarā ar diabētu
vai jostas rozi. Sāpes var izpausties kā
karstuma sajūta, dedzināšana, tās var būt pulsējošas,
šaujošas, dzelošas, asas, krampjveida, var būt
pastāvīgs sāpīgums, tirpšana, notirpums, adatu durstīšanas
sajūta. Perifērās un centrālās neiropātis
                                
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Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Pregabalin Accord 25 mg cietās kapsulas
Pregabalin Accord 50 mg cietās kapsulas
Pregabalin Accord 75 mg cietās kapsulas
Pregabalin Accord 100 mg cietās kapsulas
Pregabalin Accord 150 mg cietās kapsulas
Pregabalin Accord 200 mg cietās kapsulas
Pregabalin Accord 225 mg cietās kapsulas
Pregabalin Accord 300 mg cietās kapsulas
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Pregabalin Accord 25 mg cietās kapsulas
Katra cietā kapsula satur 25 mg pregabalīna (_pregabalin_).
Pregabalin Accord 50 mg cietās kapsulas
Katra cietā kapsula satur 50 mg pregabalīna (_pregabalin_).
Pregabalin Accord 75 mg cietās kapsulas
Katra cietā kapsula satur 75 mg pregabalīna (_pregabalin_).
Pregabalin Accord 100 mg cietās kapsulas
Katra cietā kapsula satur 100 mg pregabalīna (_pregabalin_).
Pregabalin Accord 150 mg cietās kapsulas
Katra cietā kapsula satur 150 mg pregabalīna (_pregabalin_).
Pregabalin Accord 200 mg cietās kapsulas
Katra cietā kapsula satur 200 mg pregabalīna (_pregabalin_).
Pregabalin Accord 225 mg cietās kapsulas
Katra cietā kapsula satur 225 mg pregabalīna (_pregabalin_).
Pregabalin Accord 300 mg cietās kapsulas
Katra cietā kapsula satur 300 mg pregabalīna (_pregabalin_).
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3.
ZĀĻU FORMA
Cietā kapsula
Pregabalin Accord 25 mg cietās kapsulas
Baltas necaurspīdīgas / baltas necaurspīdīgas, 4. izmēra cietās
želatīna kapsulas ar uzdruku ''PG" uz
kapsulas vāciņa un "25" uz korpusa. Katra kapsula ir aptuveni 14,4
mm gara.
Pregabalin Accord 50 mg cietās kapsulas
Baltas necaurspīdīgas / baltas necaurspīdīgas, 3. izmēra cietās
želatīna kapsulas ar uzdruku ''PG" uz
kapsulas vāciņa un "50" uz korpusa. Katra kapsula ir aptuveni 15,8
mm gara.
Pregabalin Accord 75 mg cietās kapsulas
Sarkanas necaurspīdīgas / baltas necaurspīdīgas, 4. izmēra
cietās želatīna kapsulas ar uzdruku ''PG" uz
kapsulas vāciņa un "75" uz korpusa. Katra kapsula ir aptuveni 14,4
mm gara.
3
Pregab
                                
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Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) pregabalin

pregabalin

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