Pregabalin Mylan Pharma
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-04-2022
Charakterystyka produktu
(SPC)
26-04-2022
Sprawozdanie z oceny publicznego
(PAR)
26-04-2022
Składnik aktywny:
pregabalin
Dostępny od:
Mylan S.A.S.
Kod ATC:
N03AX16
INN (International Nazwa):
pregabalin
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Anxiety Disorders; Neuralgia; Epilepsy
Wskazania:
EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2015-06-25
Ulotka dla pacjenta
64
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
65
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN MYLAN PHARMA 25 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 50 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 75 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 100 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 150 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 200 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 225 MG HARD CAPSULES
PREGABALIN MYLAN PHARMA 300 MG HARD CAPSULES
pregabalin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pregabalin Mylan Pharma is and what it is used for
2.
What you need to know before you take Pregabalin Mylan Pharma
3.
How to take Pregabalin Mylan Pharma
4.
Possible side effects
5.
How to store Pregabalin Mylan Pharma
6.
Contents of the pack and other information
1.
WHAT PREGABALIN MYLAN PHARMA IS AND WHAT IT IS USED FOR
Pregabalin Mylan Pharma contains the active substance pregabalin which
belongs to a group of
medicines used to treat epilepsy and Generalised Anxiety Disorder
(GAD) in adults.
EPILEPSY:
Pregabalin Mylan Pharma is used to treat a certain form of epilepsy
(partial seizures with or
without secondary generalisation) in adults. Your doctor will
prescribe Pregabalin Mylan Pharma for
you to help treat your epilepsy when your current treatment is not
controlling your condition. You
should take Pregabalin Mylan Pharma in addition to your current
treatment. Pregabalin Mylan Pharma
is not intended to be used alone, but should always be used in
combination with other anti-epil
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Mylan Pharma 25 mg hard capsules
Pregabalin Mylan Pharma 50 mg hard capsules
Pregabalin Mylan Pharma 75 mg hard capsules
Pregabalin Mylan Pharma 100 mg hard capsules
Pregabalin Mylan Pharma 150 mg hard capsules
Pregabalin Mylan Pharma 200 mg hard capsules
Pregabalin Mylan Pharma 225 mg hard capsules
Pregabalin Mylan Pharma 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Mylan Pharma 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Mylan Pharma 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Mylan Pharma 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Mylan Pharma 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Mylan Pharma 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Mylan Pharma 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Mylan Pharma 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Mylan Pharma 300 mg hard capsules
Each hard capsule contains 300 mg of pregabalin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Pregabalin Mylan Pharma 25 mg hard capsules
Medicinal Product no longer authorised
3
No. 4, light peach opaque cap and white opaque body, hard-shell
gelatin capsule filled with
white to off-white powder. The capsule is axially printed with MYLAN
over PB25 in black ink
on cap and body.
Pregabalin Mylan Pharma 50 mg hard capsules
The 50 mg capsules are No. 3, dark peach opaque cap and white opaque
body, hard-shell gelatin
capsule filled with white to off-white powder. The capsule is axially
printed with MYLAN over
PB50 in black ink on cap and body.
Pregabalin Mylan Pharma 75 mg hard capsules
The 75 mg capsules are No. 4, light peach opaque cap and light peach
opaque body, hard-shell
gelat
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