Lyrica
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-02-2024
Karatteristiċi tal-prodott
(SPC)
28-02-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
17-03-2023
Ingredjent attiv:
pregabalin
Disponibbli minn:
Upjohn EESV
Kodiċi ATC:
N03AX16
INN (Isem Internazzjonali):
pregabalin
Grupp terapewtiku:
Antiepileptics, , Other antiepileptics
Żona terapewtika:
Epilepsy; Anxiety Disorders; Neuralgia
Indikazzjonijiet terapewtiċi:
Neuropathic painLyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyLyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderLyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Sommarju tal-prodott:
Revision: 61
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2004-07-05
Fuljett ta 'informazzjoni
77
B. PACKAGE LEAFLET
78
PACKAGE LEAFLET: INFORMATION FOR THE USER LYRICA 25 MG HARD CAPSULES, LYRICA 50 MG HARD CAPSULES, LYRICA 75 MG HARD CAPSULES,
LYRICA 100 MG HARD CAPSULES,
LYRICA 150 MG HARD CAPSULES,
LYRICA 200 MG HARD CAPSULES,
LYRICA 225 MG HARD CAPSULES,
LYRICA 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 Lyrica is and what it is used for
2.
What you need to know before you take Lyrica
3.
How to take Lyrica
4.
Possible side effects
5.
How to store Lyrica
6.
Contents of the pack and other information
1.
WHAT LYRICA IS AND WHAT IT IS USED FOR
Lyrica belongs to a group of medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Lyrica 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:
Lyrica is used to treat a certain form of epilepsy (partial seizures
with or without secondary
generalisation) in adults. Your doctor will prescribe Lyrica for you
to help treat your epilepsy when
your current treatment is not
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lyrica 25 mg hard capsules
Lyrica 50 mg hard capsules
Lyrica 75 mg hard capsules
Lyrica 100 mg hard capsules
Lyrica 150 mg hard capsules
Lyrica 200 mg hard capsules
Lyrica 225 mg hard capsules
Lyrica 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyrica 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Lyrica 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Lyrica 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
_ _
Lyrica 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Lyrica 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
_ _
Lyrica 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
_ _
Lyrica 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Lyrica 300 mg hard capsules
Each hard capsule contains 300 mg of pregabalin.
_ _
Excipients with known effect
_ _
Lyrica 25 mg hard capsules
Each hard capsule also contains 35 mg lactose monohydrate.
Lyrica 50 mg hard capsules
Each hard capsule also contains 70 mg lactose monohydrate.
Lyrica 75 mg hard capsules
Each hard capsule also contains 8.25 mg lactose monohydrate.
Lyrica 100 mg hard capsules
Each hard capsule also contains 11 mg lactose monohydrate.
Lyrica 150 mg hard capsules
Each hard capsule also contains 16.50 mg lactose monohydrate.
Lyrica 200 mg hard capsules
Each hard capsule also contains 22 mg lactose monohydrate.
3
Lyrica 225 mg hard capsules
Each hard capsule also contains 24.75 mg lactose monohydrate.
Lyrica 300 mg hard capsules
Each hard capsule also contains 33 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Lyrica 25 mg hard capsules
White marked “VTRS” on the cap and “PGN 25” on the body with
black ink.
Lyrica 50 mg hard capsules
White marked “VTRS” on the cap and “PGN 50” on the body with
black ink. The body is also marked
with a black ban
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