Pregabalin Teva 75mg Capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PREGABALIN

Available from:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

N03AX16

INN (International Name):

PREGABALIN 75 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

PREGABALIN 75 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2015-07-09

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN TEVA 25 MG CAPSULES, HARD
PREGABALIN TEVA 50 MG CAPSULES, HARD
PREGABALIN TEVA 75 MG CAPSULES, HARD
PREGABALIN TEVA 100 MG CAPSULES, HARD
PREGABALIN TEVA 150 MG CAPSULES, HARD
PREGABALIN TEVA 200 MG CAPSULES, HARD
PREGABALIN TEVA 225 MG CAPSULES, HARD
PREGABALIN TEVA 300 MG CAPSULES, HARD
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 Teva is and what it is used for
2.
What you need to know before you take Pregabalin Teva
3.
How to take Pregabalin Teva
4.
Possible side effects
5.
How to store Pregabalin Teva
6.
Contents of the pack and other information
1.
WHAT PREGABALIN TEVA IS AND WHAT IT IS USED FOR
Pregabalin Teva belongs to a group of medicines used to treat epilepsy
and Generalised Anxiety Disorder
(GAD) in adults.
EPILEPSY: Pregabalin Teva is used to treat a certain form of epilepsy
(partial seizures with or without
secondary generalisation) in adults. Your doctor will prescribe
Pregabalin Teva for you to help treat your
epilepsy when your current treatment is not controlling your
condition. You should take Pregabalin Teva in
addition to your current treatment. Pregabalin Teva is not intended to
be used alone, but should always be
used in combination with other anti-epileptic treatment.
GENERALISED ANXIETY DISORDER: Pregabalin Teva is used to treat
Generalised Anxiety Disorder (GAD). The
symptoms of GAD are prolonged excessive anxiety and worry that are
difficult to control. GAD can also
cause

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Teva 25 mg Capsules, hard
Pregabalin Teva 50 mg Capsules, hard
Pregabalin Teva 75 mg Capsules, hard
Pregabalin Teva 100 mg Capsules, hard
Pregabalin Teva 150 mg Capsules, hard
Pregabalin Teva 200 mg Capsules, hard
Pregabalin Teva 225 mg Capsules, hard
Pregabalin Teva 300 mg Capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 25 mg of pregabalin.
Each capsule, hard contains 50 mg of pregabalin.
Each capsule, hard contains 75 mg of pregabalin.
Each capsule, hard contains 100 mg of pregabalin.
Each capsule, hard contains 150 mg of pregabalin.
Each capsule, hard contains 200 mg of pregabalin.
Each capsule, hard contains 225 mg of pregabalin.
Each capsule, hard contains 300 mg of pregabalin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Pregabalin Teva 25 mg are ivory opaque hard gelatine size 3 capsules
with overall closed length 15.9 mm ±
0.3 mm, imprinted by black sign 25 on capsule body, filled with white
to off-white granulated powder.
Pregabalin Teva 50 mg are ivory opaque hard gelatine size 2 capsules
with overall closed length 18.0 mm ±
0.3 mm, imprinted by radial black band on capsule cap and black sign
50 and radial black band on capsule
body, filled with white to off-white granulated powder.
Pregabalin Teva 75 mg are opaque hard gelatine size 3 capsules with
overall closed length 15.9 mm ± 0.3
mm, with pink cap and ivory body imprinted by black sign 75, filled
with white to off-white granulated
powder.
Pregabalin Teva 100 mg are pink opaque hard gelatine size 2 capsules
with overall closed length 18.0 mm ±
0.3 mm, imprinted by black sign 100 on capsule body, filled with white
to off-white granulated powder.
Pregabalin Teva 150 mg are ivory opaque hard gelatine size 2 capsules
with overall closed length 18.0 mm ±
0.3 mm, imprinted by black sign 150 on capsule body, filled with white
to off-white granulated powder.
Pregabalin Teva 200 mg are flesh