Pregabalin Accord
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
09-01-2023
Karatteristiċi tal-prodott
(SPC)
09-01-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
06-07-2017
Ingredjent attiv:
pregabalin
Disponibbli minn:
Accord Healthcare S.L.U.
Kodiċi ATC:
N03AX16
INN (Isem Internazzjonali):
pregabalin
Grupp terapewtiku:
Antiepileptics,
Żona terapewtika:
Anxiety Disorders; Epilepsy
Indikazzjonijiet terapewtiċi:
EpilepsyPregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Sommarju tal-prodott:
Revision: 15
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2015-08-28
Fuljett ta 'informazzjoni
78
B. PACKAGE LEAFLET
79
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN ACCORD 25 MG HARD CAPSULES,
PREGABALIN ACCORD 50 MG HARD CAPSULES,
PREGABALIN ACCORD 75 MG HARD CAPSULES,
PREGABALIN ACCORD 100 MG HARD CAPSULES,
PREGABALIN ACCORD 150 MG HARD CAPSULES,
PREGABALIN ACCORD 200 MG HARD CAPSULES,
PREGABALIN ACCORD 225 MG HARD CAPSULES,
PREGABALIN ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Pregabalin Accord
3.
How to take Pregabalin Accord
4.
Possible side effects
5.
How to store Pregabalin Accord
6.
Contents of the pack and other information
1.
WHAT PREGABALIN ACCORD IS AND WHAT IT IS USED FOR
Pregabalin Accord belongs to a group of medicines used to treat
epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain
This medicine 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
This medicine is used to treat a certain form of epilepsy (partial
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Accord 25 mg hard capsules
Pregabalin Accord 50 mg hard capsules
Pregabalin Accord 75 mg hard capsules
Pregabalin Accord 100 mg hard capsules
Pregabalin Accord 150 mg hard capsules
Pregabalin Accord 200 mg hard capsules
Pregabalin Accord 225 mg hard capsules
Pregabalin Accord 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Accord 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Accord 50 mg hard capsules
Each hard capsule contains50 mg of pregabalin.
Pregabalin Accord 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Accord 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Accord 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Accord 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Accord 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Accord 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 Accord 25 mg hard capsules
White opaque/ White opaque, size “4” hard gelatin capsules
imprinted with ‘‘PG’ on cap and ‘25’ on
body. Each capsule is approximately 14.4 mm in length.
Pregabalin Accord 50 mg hard capsules
White opaque/ White opaque, size “3” hard gelatin capsules
imprinted with ‘PG’ on cap and ‘50’ on
body. Each capsule is approximately 15.8 mm in length.
Pregabalin Accord 75 mg hard capsules
Red opaque/ White opaque, size “4” hard gelatin capsules imprinted
with ‘PG’ on cap and ‘75’ on
body. Each capsule is approximately 14.4 mm in length.
Pregabalin Accord 100 mg hard capsules
3
Red opaque/ Red opaque, size “3” hard gelatin capsules imprinted
with ‘PG’ on cap and ‘100’ on
body. Each capsule is approximately 15.8 mm in length.
Pregabalin Accord 15
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