Mypreg 300 mg hard capsules

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Pregabalin

متاح من:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC رمز:

N03AX; N03AX16

INN (الاسم الدولي):

Pregabalin

جرعة:

300 milligram(s)

الشكل الصيدلاني:

Capsule, hard

المجال العلاجي:

Other antiepileptics; pregabalin

الوضع إذن:

Not marketed

تاريخ الترخيص:

2018-05-18

نشرة المعلومات

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYPREG 25 MG HARD CAPSULES
MYPREG 50 MG HARD CAPSULES
MYPREG 75 MG HARD CAPSULES
MYPREG 100 MG HARD CAPSULES
MYPREG 150 MG HARD CAPSULES
MYPREG 200 MG HARD CAPSULES
MYPREG 225 MG HARD CAPSULES
MYPREG 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 Mypreg is and what it is used for
2.
What you need to know before you take Mypreg
3.
How to take Mypreg
4.
Possible side effects
5.
How to store Mypreg
6.
Contents of the pack and other information
1.
WHAT MYPREG IS AND WHAT IT IS USED FOR
Mypreg contains the active substance pregabalin which belongs to a
group of medicines used to treat
epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in
adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
Mypreg 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:
Mypreg is used to treat a certain form of epilepsy (partial seizures
with or without
secondary generalisation) in adults. Your doctor will prescribe Mypreg
for you to help treat your
epilep

خصائص المنتج

Health Products Regulatory Authority
19 November 2020
CRN009XZN
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mypreg 300 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 300 mg of pregabalin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
A No. 0, light peach opaque cap and whiteopaque body, hard-shell
gelatin capsule filled with white to off-white powder. The
capsule is axially printed with MYLAN over PB300 in black ink on cap
and body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Mypreg is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy_
Mypreg is indicated as adjunctive therapy in adults with partial
seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Mypreg 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 increase