Pregabalin Zentiva
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-03-2024
Charakterystyka produktu
(SPC)
19-03-2024
Sprawozdanie z oceny publicznego
(PAR)
27-07-2015
Składnik aktywny:
pregabalin
Dostępny od:
Zentiva, k.s.
Kod ATC:
N03AX16
INN (International Nazwa):
pregabalin
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Anxiety Disorders; Epilepsy
Wskazania:
Neuropathic pain , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. , Epilepsy , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. , Generalised anxiety disorder , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2015-07-17
Ulotka dla pacjenta
58
B. PACKAGE LEAFLET
59
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN ZENTIVA 25 MG HARD CAPSULES
PREGABALIN ZENTIVA 50 MG HARD CAPSULES
PREGABALIN ZENTIVA 75 MG HARD CAPSULES
PREGABALIN ZENTIVA 100 MG HARD CAPSULES
PREGABALIN ZENTIVA 150 MG HARD CAPSULES
PREGABALIN ZENTIVA 200 MG HARD CAPSULES
PREGABALIN ZENTIVA 225 MG HARD CAPSULES
PREGABALIN ZENTIVA 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 Zentiva is and what it is used for
2.
What you need to know before you take Pregabalin Zentiva
3.
How to take Pregabalin Zentiva
4.
Possible side effects
5.
How to store Pregabalin Zentiva
6.
Contents of the pack and other information
1.
WHAT PREGABALIN ZENTIVA IS AND WHAT IT IS USED FOR
Pregabalin Zentiva 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 Zentiva 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 Zentiva is used to treat a certain form of ep
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Zentiva 25 mg hard capsules
Pregabalin Zentiva 50 mg hard capsules
Pregabalin Zentiva 75 mg hard capsules
Pregabalin Zentiva 100 mg hard capsules
Pregabalin Zentiva 150 mg hard capsules
Pregabalin Zentiva 200 mg hard capsules
Pregabalin Zentiva 225 mg hard capsules
Pregabalin Zentiva 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Zentiva 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 47.57 mg lactose monohydrate.
Pregabalin Zentiva 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 5 mg lactose monohydrate.
Pregabalin Zentiva 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 7.5 mg lactose monohydrate.
Pregabalin Zentiva 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 10 mg lactose monohydrate.
Pregabalin Zentiva 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 15 mg lactose monohydrate.
Pregabalin Zentiva 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 20 mg lactose monohydrate.
Pregabalin Zentiva 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
3
Excipient with known effect
Each hard capsule also contains 22.5 mg lactose monohydrate.
Pregabalin Zentiva 300 mg hard capsules
Each hard capsule contains 300 mg of pregabalin.
Excipient with known effect
Each hard capsule also contains 30 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Pregabalin Zentiva 25 mg hard capsules
Light grey cap and light grey body; approx. 15,9 mm in length, hard
gela
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