Pregabalin 200 mg Capsules, Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-08-2019
Summary of Product characteristics
(SPC)
28-08-2019
Active ingredient:
Pregabalin
Available from:
Bristol Laboratories Limited
ATC code:
N03AX; N03AX16
INN (International Name):
Pregabalin
Dosage:
200 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other antiepileptics; pregabalin
Authorization status:
Not marketed
Authorization date:
2017-08-04
Patient Information leaflet
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10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREGABALIN 25 MG CAPSULES, HARD
PREGABALIN 50 MG CAPSULES, HARD
PREGABALIN 75 MG CAPSULES, HARD PREGABALIN 100 MG CAPSULES, HARD PREGABALIN 150 MG CAPSULES, HARD PREGABALIN 200 MG CAPSULES, HARD PREGABALIN 225 MG CAPSULES, HARD PREGABALIN 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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
IS AND WHAT IT IS USED FOR
Pregabalin 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
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
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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 is used to treat a certain form of epilepsy (partial
seizures with or
without secondary generalisation) in adults. Your doctor will
pres
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
27 August 2019
CRN008JGC
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin 200 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg of pregabalin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Orange cap / Orange body size ‘1’ hard gelatin capsules imprinted
with ‘143’ on cap and ‘J’ on body with black ink, filled with
white to off white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy_
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Pregabalin 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 of 150 mg per day.
Based on individual patient response and tolerability, the
dose may be increased to 300 mg per day af
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