Pregabalin Sandoz
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
22-11-2023
Produktets egenskaber
(SPC)
22-11-2023
Offentlige vurderingsrapport
(PAR)
16-07-2015
Aktiv bestanddel:
pregabalin
Tilgængelig fra:
Sandoz GmbH
ATC-kode:
N03AX16
INN (International Name):
pregabalin
Terapeutisk gruppe:
Antiepileptics,
Terapeutisk område:
Anxiety Disorders; Neuralgia; Epilepsy
Terapeutiske indikationer:
Neuropathic painPregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Produkt oversigt:
Revision: 17
Autorisation status:
Authorised
Autorisation dato:
2015-06-19
Indlægsseddel
71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN SANDOZ 25 MG HARD CAPSULES
PREGABALIN SANDOZ 50 MG HARD CAPSULES
PREGABALIN SANDOZ 75 MG HARD CAPSULES
PREGABALIN SANDOZ 100 MG HARD CAPSULES
PREGABALIN SANDOZ 150 MG HARD CAPSULES
PREGABALIN SANDOZ 200 MG HARD CAPSULES
PREGABALIN SANDOZ 225 MG HARD CAPSULES
PREGABALIN SANDOZ 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 Sandoz is and what it is used for
2. What you need to know before you take Pregabalin Sandoz
3. How to take Pregabalin Sandoz
4. Possible side effects
5. How to store Pregabalin Sandoz
6. Contents of the pack and other information
1.
WHAT PREGABALIN SANDOZ IS AND WHAT IT IS USED FOR
Pregabalin Sandoz 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 Sandoz 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 Sandoz is used to treat a certain form of epilepsy (parti
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Sandoz 25 mg hard capsules
Pregabalin Sandoz 50 mg hard capsules
Pregabalin Sandoz 75 mg hard capsules
Pregabalin Sandoz 100 mg hard capsules
Pregabalin Sandoz 150 mg hard capsules
Pregabalin Sandoz 200 mg hard capsules
Pregabalin Sandoz 225 mg hard capsules
Pregabalin Sandoz 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Sandoz 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Sandoz 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Sandoz 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Sandoz 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Sandoz 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Sandoz 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Sandoz 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Sandoz 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 Sandoz 25 mg hard capsules
Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3
mm), filled with white to
nearly white coloured powder.
Pregabalin Sandoz 50 mg hard capsules
Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm),
filled with white to nearly
white coloured powder.
Pregabalin Sandoz 75 mg hard capsules
Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3
mm), filled with white to
nearly white coloured powder.
3
Pregabalin Sandoz 100 mg hard capsules
Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled
with white to nearly white
coloured powder.
Pregabalin Sandoz 150 mg hard capsules
White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled
with white to nearly white
coloured powder.
Pregabalin Sandoz 200 mg hard capsules
Pale
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