Pregabalin Clonmel 225 mg capsules, hard

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Pregabalin

থেকে পাওয়া:

Clonmel Healthcare Ltd

এটিসি কোড:

N03AX; N03AX16

INN (আন্তর্জাতিক নাম):

Pregabalin

ডোজ:

225 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

থেরাপিউটিক এলাকা:

Other antiepileptics; pregabalin

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2018-01-12

তথ্য লিফলেট

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN CLONMEL 25MG CAPSULES, HARD
PREGABALIN CLONMEL 50MG CAPSULES, HARD
PREGABALIN CLONMEL 75MG CAPSULES, HARD
PREGABALIN CLONMEL 100MG CAPSULES, HARD
PREGABALIN CLONMEL 150MG CAPSULES, HARD
PREGABALIN CLONMEL 200MG CAPSULES, HARD
PREGABALIN CLONMEL 225MG CAPSULES, HARD
PREGABALIN CLONMEL 300MG 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 Clonmel is and what it is used for
2. What you need to know before you take Pregabalin Clonmel
3. How to take Pregabalin Clonmel
4. Possible side effects
5. How to store Pregabalin Clonmel
6. Contents of the pack and other information
1. WHAT PREGABALIN CLONMEL IS AND WHAT IT IS USED FOR
Pregabalin Clonmel 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 Clonmel 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 Clonmel is used to treat a certain form of epilepsy
(par

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
27 May 2021
CRN00C26X
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin Clonmel 225 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 225 mg of pregabalin.
Excipient with known effect
Each capsule, hard contains 24.75 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
The 225 mg capsule is a white and light orange capsule, size 1
(approximately 19 mm). The body is marked with a black circular
line.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Pregabalin Clonmel is indicated for the treatment of peripheral and
central neuropathic pain in adults.
_Epilepsy_
Pregabalin Clonmel is indicated as adjunctive therapy in adults with
partial seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Pregabalin Clonmel 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 ind