Pregabalin Pfizer

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pregabalin

Available from:

Upjohn EESV

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

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

Product summary:

Revision: 29

Authorization status:

Authorised

Authorization date:

2014-04-10

Patient Information leaflet

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN PFIZER 25 MG HARD CAPSULES,
PREGABALIN PFIZER 50 MG HARD CAPSULES,
PREGABALIN PFIZER 75 MG HARD CAPSULES,
PREGABALIN PFIZER 100 MG HARD CAPSULES,
PREGABALIN PFIZER 150 MG HARD CAPSULES,
PREGABALIN PFIZER 200 MG HARD CAPSULES,
PREGABALIN PFIZER 225 MG HARD CAPSULES,
PREGABALIN PFIZER 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 Pfizer is and what it is used for
2.
What you need to know before you take Pregabalin Pfizer
3.
How to take Pregabalin Pfizer
4.
Possible side effects
5.
How to store Pregabalin Pfizer
6.
Contents of the pack and other information
1.
WHAT PREGABALIN PFIZER IS AND WHAT IT IS USED FOR
Pregabalin Pfizer 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 Pfizer 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 Pfizer is used to treat a certain form of epilepsy

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Pfizer 25 mg hard capsules
Pregabalin Pfizer 50 mg hard capsules
Pregabalin Pfizer 75 mg hard capsules
Pregabalin Pfizer 100 mg hard capsules
Pregabalin Pfizer 150 mg hard capsules
Pregabalin Pfizer 200 mg hard capsules
Pregabalin Pfizer 225 mg hard capsules
Pregabalin Pfizer 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Pfizer 25 mg hard capsules
Each hard capsule contains 25 mg of pregabalin.
Pregabalin Pfizer 50 mg hard capsules
Each hard capsule contains 50 mg of pregabalin.
Pregabalin Pfizer 75 mg hard capsules
Each hard capsule contains 75 mg of pregabalin.
_ _
Pregabalin Pfizer 100 mg hard capsules
Each hard capsule contains 100 mg of pregabalin.
Pregabalin Pfizer 150 mg hard capsules
Each hard capsule contains 150 mg of pregabalin.
_ _
Pregabalin Pfizer 200 mg hard capsules
Each hard capsule contains 200 mg of pregabalin.
_ _
Pregabalin Pfizer 225 mg hard capsules
Each hard capsule contains 225 mg of pregabalin.
Pregabalin Pfizer 300 mg hard capsules
Each hard capsule contains 300 mg of pregabalin.
_ _
Excipients with known effect
Pregabalin Pfizer 25 mg hard capsules
Each hard capsule also contains 35 mg lactose monohydrate.
Pregabalin Pfizer 50 mg hard capsules
Each hard capsule also contains 70 mg lactose monohydrate.
Pregabalin Pfizer 75 mg hard capsules
Each hard capsule also contains 8.25 mg lactose monohydrate.
Pregabalin Pfizer 100 mg hard capsules
Each hard capsule also contains 11 mg lactose monohydrate.
Pregabalin Pfizer 150 mg hard capsules
Each hard capsule also contains 16.50 mg lactose monohydrate.
Pregabalin Pfizer 200 mg hard capsules
Each hard capsule also contains 22 mg lactose monohydrate.
3
Pregabalin Pfizer 225 mg hard capsules
Each hard capsule also contains 24.75 mg lactose monohydrate.
Pregabalin Pfizer 300 mg hard capsules
Each hard capsule also contains 33 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard cap