Pregabalin Teva 50 mg capsules, hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-03-2024
Summary of Product characteristics
(SPC)
22-03-2024
Active ingredient:
Pregabalin
Available from:
Teva B.V.
ATC code:
N03A
INN (International Name):
Pregabalin
Dosage:
50 milligram(s)
Pharmaceutical form:
Capsule, hard
Administration route:
Oral use
Units in package:
e blisters of 14, 21, 21x1, 56, 56x1, 60, 84, 84x1, 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. andfor the treatment of Generalised Anxiety Disorder (GAD) in adults
Authorization status:
Marketed
Authorization date:
2015-07-24
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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, neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Pregabalin Teva 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 Teva is used to treat a certain form of epilepsy (partial
seizures with or without
secondary generalisation) in adults. Your doctor will p
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
22 March 2024
CRN00F3HZ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin Teva 50 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 50 mg of pregabalin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Pregabalin Teva is indicated for the treatment of peripheral and
central neuropathic pain in adults.
_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.
_Neuropathic pain_
Pregabalin treatment can be started at 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 an interval of 3 to 7
days, and if needed, to a maximum dose of 600 mg per day after an
additional 7-day interval.
_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
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