Pregabalin Zentiva k.s.
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
20-03-2023
Produktets egenskaber
(SPC)
20-03-2023
Offentlige vurderingsrapport
(PAR)
20-03-2023
Aktiv bestanddel:
pregabalin
Tilgængelig fra:
Zentiva k.s.
ATC-kode:
N03AX16
INN (International Name):
pregabalin
Terapeutisk gruppe:
Antiepileptics,
Terapeutisk område:
Anxiety Disorders; Neuralgia; Epilepsy
Terapeutiske indikationer:
Neuropathic painPregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderPregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Produkt oversigt:
Revision: 13
Autorisation status:
Withdrawn
Autorisation dato:
2017-02-27
Indlægsseddel
49
B. PACKAGE LEAFLET
Medicinal product no longer authorised
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN ZENTIVA K.S. 25 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 50 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 75 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 100 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 150 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 200 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 225 MG HARD CAPSULES
PREGABALIN ZENTIVA K.S. 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 k.s. is and what it is used for
2.
What you need to know before you take Pregabalin Zentiva k.s.
3.
How to take Pregabalin Zentiva k.s.
4.
Possible side effects
5.
How to store Pregabalin Zentiva k.s.
6.
Contents of the pack and other information
1.
WHAT PREGABALIN ZENTIVA K.S. IS AND WHAT IT IS USED FOR
Pregabalin Zentiva k.s. 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 k.s. 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
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Zentiva k.s. 25 mg hard capsules
Pregabalin Zentiva k.s. 50 mg hard capsules
Pregabalin Zentiva k.s. 75 mg hard capsules
Pregabalin Zentiva k.s. 100 mg hard capsules
Pregabalin Zentiva k.s. 150 mg hard capsules
Pregabalin Zentiva k.s. 200 mg hard capsules
Pregabalin Zentiva k.s. 225 mg hard capsules
Pregabalin Zentiva k.s. 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Zentiva k.s. 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 k.s. 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 k.s. 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 k.s. 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 k.s. 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 k.s. 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 k.s. 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Excipient with known effect: Each hard capsule also contains 22.5 mg
lactose monohydrate.
Pregabalin Zentiva k.s. 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.
Medicinal product no lo
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