Brieka 25 mg Hard Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
11-04-2018
Summary of Product characteristics
(SPC)
30-06-2018
Active ingredient:
Pregabalin
Available from:
Actavis Group PTC ehf
ATC code:
N03A
INN (International Name):
Pregabalin
Dosage:
25 milligram(s)
Pharmaceutical form:
Capsule, hard
Administration route:
Oral use
Units in package:
14, 21, 30, 56, 60, 84, 90 or 100 capsules
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Balkanpharma-Dupnitsa AD
Therapeutic group:
Antiepileptics, other antiepileptics
Therapeutic area:
ANTIEPILEPTICS
Therapeutic indications:
It 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:
Marketed
Authorization date:
2015-08-07
Patient Information leaflet
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRIEKA 25 MG HARD CAPSULES
BRIEKA 50 MG HARD CAPSULES
BRIEKA 75 MG HARD CAPSULES
BRIEKA 100 MG HARD CAPSULES
BRIEKA 150 MG HARD CAPSULES
BRIEKA 200 MG HARD CAPSULES
BRIEKA 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 Brieka is and what it is used for
2.
What you need to know before you take Brieka
3.
How to take Brieka
4.
Possible side effects
5.
How to store Brieka
6.
Contents of the pack and other information
1.
WHAT BRIEKA IS AND WHAT IT IS USED FOR
Brieka belongs to a group of medicines used to treat epilepsy,
neuropathic pain and Generalised
Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN: Brieka 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: Brieka is used to treat a certain form of epilepsy (partial
seizures with or without secondary
generalisation) in adults. Your doctor will prescribe Brieka for you
to help treat your epilepsy when
your current treatment is not controlling your condition. You should
take Brieka in addi
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brieka 25 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 25 mg of pregabalin
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
The 25 mg capsule is white, size 4 (14.5 mm), marked “PGB 25” on
the body with black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Brieka is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy_
Brieka is indicated as adjunctive therapy in adults with partial
seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Brieka 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
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