Pregabalin Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2023
Public Assessment Report Public Assessment Report (PAR)
19-07-2017

Active ingredient:

pregabalin

Available from:

Mylan Pharmaceuticals Limited

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

Neuropathic painPregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2015-06-24

Patient Information leaflet

                                B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN MYLAN 25 MG HARD CAPSULES
PREGABALIN MYLAN 50 MG HARD CAPSULES
PREGABALIN MYLAN 75 MG HARD CAPSULES
PREGABALIN MYLAN 100 MG HARD CAPSULES
PREGABALIN MYLAN 150 MG HARD CAPSULES
PREGABALIN MYLAN 200 MG HARD CAPSULES
PREGABALIN MYLAN 225 MG HARD CAPSULES
PREGABALIN MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Pregabalin Mylan
3.
How to take Pregabalin Mylan
4.
Possible side effects
5.
How to store Pregabalin Mylan
6.
Contents of the pack and other information
1.
WHAT PREGABALIN MYLAN IS AND WHAT IT IS USED FOR
Pregabalin Mylan contains the active substance pregabalin which
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 Mylan 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 Mylan is used to treat a certain
                                
                                Read the complete document

Summary of Product characteristics

                                ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Mylan 25 mg hard capsules
Pregabalin Mylan 50 mg hard capsules
Pregabalin Mylan 75 mg hard capsules
Pregabalin Mylan 100 mg hard capsules
Pregabalin Mylan 150 mg hard capsules
Pregabalin Mylan 200 mg hard capsules
Pregabalin Mylan 225 mg hard capsules
Pregabalin Mylan 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Mylan 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Mylan 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Mylan 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
Pregabalin Mylan 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Mylan 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
Pregabalin Mylan 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
Pregabalin Mylan 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Mylan 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 Mylan 25 mg hard capsules
No. 4, light peach opaque cap and white opaque body, hard-shell
gelatin capsule filled with white to
off-white powder. The capsule is axially printed with MYLAN over PB25
in black ink on cap and
body.
Pregabalin Mylan 50 mg hard capsules
No. 3, dark peach opaque cap and white opaque body, hard-shell gelatin
capsule filled with white to
off-white powder. The capsule is axially printed with MYLAN over PB50
in black ink on cap and
body.
Pregabalin Mylan 75 mg hard capsules
No. 4, light peach opaque cap and light peach opaque body, hard-shell
gelatin capsule filled with
white to off-white powder. The capsule is axially printed with MYLAN
over PB75 in black ink on
cap and body.
Pregabalin Mylan 100 mg hard capsules
No. 3, dark peach opaque cap and dark peach opaque body, hard-shell
gelatin capsule filled wi
                                
                                Read the complete document

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Active ingredient pregabalin

pregabalin

ATC code N03AX16

N03AX16

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Mylan Pharmaceuticals Limited

INN (International Name) pregabalin

pregabalin

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Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2023
Public Assessment Report Public Assessment Report Bulgarian 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2023
Public Assessment Report Public Assessment Report Spanish 19-07-2017
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Public Assessment Report Public Assessment Report Danish 19-07-2017
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Public Assessment Report Public Assessment Report German 19-07-2017
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Public Assessment Report Public Assessment Report Estonian 19-07-2017
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Public Assessment Report Public Assessment Report Greek 19-07-2017
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Summary of Product characteristics Summary of Product characteristics French 13-01-2023
Public Assessment Report Public Assessment Report French 19-07-2017
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Public Assessment Report Public Assessment Report Latvian 19-07-2017
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Public Assessment Report Public Assessment Report Hungarian 19-07-2017
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Public Assessment Report Public Assessment Report Maltese 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Dutch 13-01-2023
Public Assessment Report Public Assessment Report Dutch 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Polish 13-01-2023
Public Assessment Report Public Assessment Report Polish 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Portuguese 13-01-2023
Public Assessment Report Public Assessment Report Portuguese 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Romanian 13-01-2023
Public Assessment Report Public Assessment Report Romanian 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Slovak 13-01-2023
Public Assessment Report Public Assessment Report Slovak 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Slovenian 13-01-2023
Public Assessment Report Public Assessment Report Slovenian 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Finnish 13-01-2023
Public Assessment Report Public Assessment Report Finnish 19-07-2017
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Summary of Product characteristics Summary of Product characteristics Swedish 13-01-2023
Public Assessment Report Public Assessment Report Swedish 19-07-2017
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Patient Information leaflet Patient Information leaflet Croatian 13-01-2023
Summary of Product characteristics Summary of Product characteristics Croatian 13-01-2023
Public Assessment Report Public Assessment Report Croatian 19-07-2017

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