Pregabalin Mylan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-01-2023
Charakterystyka produktu
(SPC)
13-01-2023
Sprawozdanie z oceny publicznego
(PAR)
19-07-2017
Składnik aktywny:
pregabalin
Dostępny od:
Mylan Pharmaceuticals Limited
Kod ATC:
N03AX16
INN (International Nazwa):
pregabalin
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Anxiety Disorders; Epilepsy
Wskazania:
Neuropathic painPregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Podsumowanie produktu:
Revision: 16
Status autoryzacji:
Authorised
Data autoryzacji:
2015-06-24
Ulotka dla pacjenta
B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN MYLAN 25 MG HARD CAPSULES
PREGABALIN MYLAN 50 MG HARD CAPSULES
PREGABALIN MYLAN 75 MG HARD CAPSULES
PREGABALIN MYLAN 100 MG HARD CAPSULES
PREGABALIN MYLAN 150 MG HARD CAPSULES
PREGABALIN MYLAN 200 MG HARD CAPSULES
PREGABALIN MYLAN 225 MG HARD CAPSULES
PREGABALIN MYLAN 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 is and what it is used for
2.
What you need to know before you take Pregabalin Mylan
3.
How to take Pregabalin Mylan
4.
Possible side effects
5.
How to store Pregabalin Mylan
6.
Contents of the pack and other information
1.
WHAT PREGABALIN MYLAN IS AND WHAT IT IS USED FOR
Pregabalin Mylan contains the active substance pregabalin which
belongs to a group of medicines
used to treat epilepsy, neuropathic pain and Generalised Anxiety
Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Pregabalin Mylan is used to treat long lasting pain caused
by damage to the nerves. A variety of diseases can cause peripheral
neuropathic pain, such as diabetes
or shingles. Pain sensations may be described as hot, burning,
throbbing, shooting, stabbing, sharp,
cramping, aching, tingling, numbness, pins and needles. Peripheral and
central neuropathic pain may
also be associated with mood changes, sleep disturbance, fatigue
(tiredness), and can have an impact
on physical and social functioning and overall quality of life.
EPILEPSY:
Pregabalin Mylan is used to treat a certain
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Mylan 25 mg hard capsules
Pregabalin Mylan 50 mg hard capsules
Pregabalin Mylan 75 mg hard capsules
Pregabalin Mylan 100 mg hard capsules
Pregabalin Mylan 150 mg hard capsules
Pregabalin Mylan 200 mg hard capsules
Pregabalin Mylan 225 mg hard capsules
Pregabalin Mylan 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Mylan 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Mylan 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Mylan 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Mylan 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Mylan 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Mylan 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Mylan 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Mylan 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 25 mg hard capsules
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 50 mg hard capsules
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 75 mg hard capsules
No. 4, light peach opaque cap and light peach opaque body, hard-shell
gelatin capsule filled with
white to off-white powder. The capsule is axially printed with MYLAN
over PB75 in black ink on
cap and body.
Pregabalin Mylan 100 mg hard capsules
No. 3, dark peach opaque cap and dark peach opaque body, hard-shell
gelatin capsule filled wi
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