Brieka 200 mg hard capsules

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Pregabalin

זמין מ:

Accord Healthcare Ireland Ltd.

קוד ATC:

N03A

INN (שם בינלאומי):

Pregabalin

כמות:

200 milligram(s)

טופס פרצבטיות:

Capsule, hard

איזור תרפויטי:

ANTIEPILEPTICS

מצב אישור:

Not marketed

תאריך אישור:

2015-08-07

עלון מידע

1
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

מאפייני מוצר

Health Products Regulatory Authority
03 December 2020
CRN00C22Q
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brieka 200 mg hard capsules
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
Capsule, hard.
The 200 mg capsule is light orange, size 1 (19.5 mm), marked “PGB
200” 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 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