Pregabalin Mylan

Country: European Union

Language: Latvian

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
Public Assessment Report Public Assessment Report (PAR)
19-07-2017

Active ingredient:

pregabalin

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Neiropātisko painPregabalin Mylan ir indicēts, lai ārstētu perifērās un centrālās neiropātiskas sāpes pieaugušie. EpilepsyPregabalin Mylan ir norādīts kā adjunctive terapija pieaugušajiem ar daļēju lēkmju ar vai bez sekundāras vispārināšanas. Ģeneralizēta Trauksme DisorderPregabalin Mylan ir indicēts, lai ārstētu Ģeneralizēta Trauksme (VSD) pieaugušajiem.

Product summary:

Revision: 16

Authorization status:

Autorizēts

Authorization date:

2015-06-24

Patient Information leaflet

                                64
B. LIETOŠANAS INSTRUKCIJA
65
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
PREGABALIN MYLAN 25 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 50 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 75 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 100 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 150 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 200 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 225 MG CIETĀS KAPSULAS
PREGABALIN MYLAN 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 Mylan un kādam nolūkam tās lieto
2.
Kas Jums jāzina pirms Pregabalin Mylan lietošanas
3.
Kā lietot Pregabalin Mylan
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Pregabalin Mylan
6.
Iepakojuma saturs un cita informācija
1.
KAS IR PREGABALIN MYLAN UN KĀDAM NOLŪKAM TĀS LIETO
Pregabalin Mylan satur aktīvo vielu pregabalīnu, kas pieder zāļu
grupai, ko lieto epilepsijas,
neiropātisku sāpju un ģeneralizētas trauksmes ārstēšanai
pieaugušajiem.
PERIFĒRĀS UN CENTRĀLĀS NEIROPĀTISKĀS SĀPES:
Pregabalin Mylan 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 centrāl
                                
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Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Pregabalin Mylan 25 mg cietās kapsulas
Pregabalin Mylan 50 mg cietās kapsulas
Pregabalin Mylan 75 mg cietās kapsulas
Pregabalin Mylan 100 mg cietās kapsulas
Pregabalin Mylan 150 mg cietās kapsulas
Pregabalin Mylan 200 mg cietās kapsulas
Pregabalin Mylan 225 mg cietās kapsulas
Pregabalin Mylan 300 mg cietās kapsulas
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Pregabalin Mylan 25 mg cietās kapsulas
Katra cietā kapsula satur 25 mg pregabalīna (pregabalin).
Pregabalin Mylan 50 mg cietās kapsulas
Katra cietā kapsula satur 50 mg pregabalīna (pregabalin).
Pregabalin Mylan 75 mg cietās kapsulas
Katra cietā kapsula satur 75 mg pregabalīna (pregabalin).
Pregabalin Mylan 100 mg cietās kapsulas
Katra cietā kapsula satur 100 mg pregabalīna (pregabalin).
Pregabalin Mylan 150 mg cietās kapsulas
Katra cietā kapsula satur 150 mg pregabalīna (pregabalin).
Pregabalin Mylan 200 mg cietās kapsulas
Katra cietā kapsula satur 200 mg pregabalīna (pregabalin).
Pregabalin Mylan 225 mg cietās kapsulas
Katra cietā kapsula satur 225 mg pregabalīna (pregabalin).
Pregabalin Mylan 300 mg cietās kapsulas
Katra cietā kapsula satur 300 mg pregabalīna (pregabalin).
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3
3.
ZĀĻU FORMA
Cietā kapsula.
Pregabalin Mylan 25 mg cietās kapsulas
Nr. 4, tumši oranžs necaurspīdīgs vāciņš un balts
necaurspīdīgs korpuss, želatīna kapsula ar cietu
apvalku, piepildīta ar baltu vai gandrīz baltu pulveri. Kapsulas
sānos ir redzams marķējums ar melnas
krāsas tinti MYLAN, savukārt uz vāciņa korpusa — PB25.
Pregabalin Mylan 50 mg cietās kapsulas
Nr. 3, tumši oranžs necaurspīdīgs vāciņš un balts
necaurspīdīgs korpuss, želatīna kapsula ar cietu
apvalku, piepildīta ar baltu vai gandrīz baltu pulveri. Kapsulas
sānos ir redzams marķējums ar melnas
krāsas tinti MYLAN, savukārt uz vāciņa korpusa — PB50.
Pregabalin Mylan 75 mg cietās kapsulas
Nr. 4, gaiši oranžs necaurspīdīgs vāciņš un
                                
                                Read the complete document

Similar products

Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

Marketed by Mylan Pharmaceuticals Limited

Mylan Pharmaceuticals Limited

INN (International Name) pregabalin

pregabalin

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Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2023
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Public Assessment Report Public Assessment Report German 19-07-2017
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