PREGABALIN TEVA 225 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-08-2015
Summary of Product characteristics
(SPC)
15-07-2016
Active ingredient:
PREGABALIN
Available from:
Teva B.V.
ATC code:
N03A
INN (International Name):
PREGABALIN
Dosage:
225 Milligram
Pharmaceutical form:
Capsules Hard
Administration route:
Oral use
Units in package:
e blisters of 14, 14x1, 56, 56x1, 60, 100, 100x1 or 120 capsules.
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
TEVA UK Ltd, Merckle GmbH, PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Therapeutic group:
Antiepileptics, other antiepileptics
Therapeutic area:
ANTIEPILEPTICS
Therapeutic indications:
It a is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation and for the treatment of Generalised Anxiety Disorder (GAD) in adults
Authorization status:
Authorised
Authorization date:
2015-07-24
Patient Information leaflet
2
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-ep
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin Teva 225 mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 225 mg of pregabalin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Pregabalin Teva 225 mg are opaque hard gelatine size 1 capsules with overall closed length 19.4 mm ± 0.3 mm, with
flesh cap and ivory body imprinted by black sign 225, filled with white to off-white granulated powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Epilepsy_
Pregabalin Teva is indicated as adjunctive therapy in adults with partial seizures with or without secondary
generalisation.
_Generalised Anxiety Disorder_
Pregabalin Teva is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose range is 150 to 600 mg per day given in either two or three divided doses.
_Epilepsy_
Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses.
Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The
maximum dose of 600 mg per day may be achieved after an additional week.
_Generalised Anxiety Disorder_
The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be
reassessed regularly.
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and
tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be
increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.
_Discontinuation of pregabalin_
Read the complete document
