Pregabalin Sandoz GmbH

Country: European Union

Language: Romanian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-10-2023
Public Assessment Report Public Assessment Report (PAR)
12-10-2023

Active ingredient:

pregabalin

Available from:

Sandoz GmbH

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptice,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Sandoz GmbH este indicat ca tratament adjuvant, la adulții cu convulsii parțiale cu sau fără generalizare secundară. Anxietate generalizată DisorderPregabalin Sandoz GmbH este indicat pentru tratamentul Tulburării Anxioase Generalizate (tag) la adulți.

Product summary:

Revision: 16

Authorization status:

retrasă

Authorization date:

2015-06-19

Patient Information leaflet

                                71
B. PROSPECTUL
Produsul medicinal nu mai este autorizat
72
PROSPECT: INFORMAȚII PENTRU UTILIZATOR
PREGABALIN SANDOZ GMBH 25 MG CAPSULE
PREGABALIN SANDOZ GMBH 50 MG CAPSULE
PREGABALIN SANDOZ GMBH 75 MG CAPSULE
PREGABALIN SANDOZ GMBH 100 MG CAPSULE
PREGABALIN SANDOZ GMBH 150 MG CAPSULE
PREGABALIN SANDOZ GMBH 200 MG CAPSULE
PREGABALIN SANDOZ GMBH 225 MG CAPSULE
PREGABALIN SANDOZ GMBH 300 MG CAPSULE
pregabalin
CITIȚI CU ATENȚIE ȘI ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A
ÎNCEPE SĂ LUAȚI ACEST MEDICAMENT
DEOARECE CONȚINE INFORMAȚII IMPORTANTE PENTRU DUMNEAVOASTRĂ.
-
Păstrați acest prospect. S-ar putea să fie necesar să-l recitiți.
-
Dacă aveți orice întrebări suplimentare, adresați-vă medicului
dumneavoastră sau farmacistului.
-
Acest medicament a fost prescris numai pentru dumneavoastră. Nu
trebuie să-l dați altor
persoane. Le poate face rău, chiar dacă au aceleași semne de boală
ca dumneavoastră.
-
Dacă manifestați orice reacții adverse, adresați-vă medicului
dumneavoastră sau farmacistului.
Acestea includ orice posibile reacții adverse nemenționate în acest
prospect. Vezi pct. 4.
CE GĂSIȚI ÎN ACEST PROSPECT:
1.
Ce este Pregabalin Sandoz GmbH și pentru ce se utilizează
2.
Ce trebuie să știți înainte să luați Pregabalin Sandoz GmbH
3.
Cum să luați Pregabalin Sandoz GmbH
4.
Reacții adverse posibile
5.
Cum se păstrează Pregabalin Sandoz GmbH
6.
Conținutul ambalajului și alte informații
1.
CE ESTE PREGABALIN SANDOZ GMBH ȘI PENTRU CE SE UTILIZEAZĂ
Pregabalin Sandoz GmbH aparține unui grup de medicamente utilizate
pentru a trata epilepsia și
tulburarea anxioasă generalizată (TAG) la adulți.
EPILEPSIE:
Pregabalin Sandoz GmbH este utilizat pentru tratamentul anumitor forme
de epilepsie la
adulți (crize epileptice parțiale, cu sau fără generalizare
secundară). Medicul dumneavoastră vă va
prescrie Pregabalin Sandoz GmbH pentru a vă ajuta în tratarea
epilepsiei atunci când tratamentul
obișnuit nu mai controlează boala. Trebuie să luați Pregabal
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
Produsul medicinal nu mai este autorizat
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Pregabalin Sandoz GmbH 25 mg capsule
Pregabalin Sandoz GmbH 50 mg capsule
Pregabalin Sandoz GmbH 75 mg capsule
Pregabalin Sandoz GmbH 100 mg capsule
Pregabalin Sandoz GmbH 150 mg capsule
Pregabalin Sandoz GmbH 200 mg capsule
Pregabalin Sandoz GmbH 225 mg capsule
Pregabalin Sandoz GmbH 300 mg capsule
2.
COMPOZIȚIA CALITATIVĂ ȘI CANTITATIVĂ
Pregabalin Sandoz GmbH 25 mg capsule
Fiecare capsulă conține pregabalin 25 mg.
Pregabalin Sandoz GmbH 50 mg capsule
Fiecare capsulă conține pregabalin 50 mg.
Pregabalin Sandoz GmbH 75 mg capsule
Fiecare capsulă conține pregabalin 75 mg.
Pregabalin Sandoz GmbH 100 mg capsule
Fiecare capsulă conține pregabalin 100 mg.
Pregabalin Sandoz GmbH 150 mg capsule
Fiecare capsulă conține pregabalin 150 mg.
Pregabalin Sandoz GmbH 200 mg capsule
Fiecare capsulă conține pregabalin 200 mg.
Pregabalin Sandoz GmbH 225 mg capsule
Fiecare capsulă conține pregabalin 225 mg.
Pregabalin Sandoz GmbH 300 mg capsule
Fiecare capsulă conține pregabalin 300 mg.
Pentru lista tuturor excipienților, vezi pct. 6.1.
3.
FORMA FARMACEUTICĂ
Capsulă.
Pregabalin Sandoz GmbH 25 mg capsule
Capsulă mărimea 4 cu capac și corp opace, de culoare galben maroniu
pal (14,3 mm x 5,3 mm),
umplută cu pulbere de culoare albă până la aproape albă.
Pregabalin Sandoz GmbH 50 mg capsule
Capsulă mărimea 3, cu capac și corp opace, de culoare galben
deschis (15,9 mm x 5,8 mm), umplută
cu pulbere de culoare albă până la aproape albă.
Pregabalin Sandoz GmbH 75 mg capsule
Capsulă mărimea 4 cu capac opac, de culoare roșie și corp opac, de
culoare albă (14,3 mm x 5,3 mm),
umplută cu pulbere de culoare albă până la aproape albă.
Produsul medicinal nu mai este autorizat
3
Pregabalin Sandoz GmbH 100 mg capsule
Capsulă mărimea 3 cu capac și corp opace, de culoare roșie (15,9
mm x 5,8 mm), umplută cu pulbere
de culoare albă până la aproape albă.
Pregabalin 
                                
                                Read the complete document

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Patient Information leaflet Patient Information leaflet Bulgarian 12-10-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 12-10-2023
Public Assessment Report Public Assessment Report Bulgarian 12-10-2023
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