Pregabalin Sandoz GmbH

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-10-2023
Public Assessment Report Public Assessment Report (PAR)
12-10-2023

Active ingredient:

pregabalin

Available from:

Sandoz GmbH

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Product summary:

Revision: 16

Authorization status:

Withdrawn

Authorization date:

2015-06-19

Patient Information leaflet

                                70
B. PACKAGE LEAFLET
Medicinal product no longer authorised
71
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN SANDOZ GMBH 25 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 50 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 75 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 100 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 150 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 200 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 225 MG HARD CAPSULES
PREGABALIN SANDOZ GMBH 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 GmbH is and what it is used for
2. What you need to know before you take Pregabalin Sandoz GmbH
3. How to take Pregabalin Sandoz GmbH
4. Possible side effects
5. How to store Pregabalin Sandoz GmbH
6. Contents of the pack and other information
1.
WHAT PREGABALIN SANDOZ GMBH IS AND WHAT IT IS USED FOR
Pregabalin Sandoz GmbH belongs to a group of medicines used to treat
epilepsy and Generalised
Anxiety Disorder (GAD) in adults.
EPILEPSY:
Pregabalin Sandoz GmbH is used to treat a certain form of epilepsy
(partial seizures with or
without secondary generalisation) in adults. Your doctor will
prescribe Pregabalin Sandoz GmbH for
you to help treat your epilepsy when your current treatment is not
controlling your condition. You
should take Pregabalin Sandoz GmbH in addition to your current
treatment. Pregabalin Sandoz GmbH
is not intended to be used alone, but should always be used in
combination with other anti-epileptic
treatment.
GENERALISED ANXIETY DISORDER:
Pregabalin Sandoz
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Sandoz GmbH 25 mg hard capsules
Pregabalin Sandoz GmbH 50 mg hard capsules
Pregabalin Sandoz GmbH 75 mg hard capsules
Pregabalin Sandoz GmbH 100 mg hard capsules
Pregabalin Sandoz GmbH 150 mg hard capsules
Pregabalin Sandoz GmbH 200 mg hard capsules
Pregabalin Sandoz GmbH 225 mg hard capsules
Pregabalin Sandoz GmbH 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Sandoz GmbH 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Sandoz GmbH 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Sandoz GmbH 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Sandoz GmbH 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Sandoz GmbH 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Sandoz GmbH 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Sandoz GmbH 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Sandoz GmbH 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 GmbH 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 GmbH 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 GmbH 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.
Medicinal product no longer authorised
3
Pregabalin Sandoz GmbH 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
                                
                                Read the complete document

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