Pregabalin Pinewood 300 mg hard capsules

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Pregabalin

Mevcut itibaren:

Pinewood Laboratories Ltd

ATC kodu:

N03AX16

INN (International Adı):

Pregabalin

Farmasötik formu:

Capsule, hard

Terapötik alanı:

pregabalin

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2022-10-21

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN PINEWOOD 25 MG HARD CAPSULES,
PREGABALIN PINEWOOD 50 MG HARD CAPSULES,
PREGABALIN PINEWOOD 75 MG HARD CAPSULES,
PREGABALIN PINEWOOD 100 MG HARD CAPSULES,
PREGABALIN PINEWOOD 150 MG HARD CAPSULES, PREGABALIN PINEWOOD 200 MG HARD CAPSULES,
PREGABALIN PINEWOOD 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 further questions, ask your doctor or your 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 Pinewood is and what it is used for
2.
What you need to know before you take Pregabalin Pinewood
3.
How to take Pregabalin Pinewood
4.
Possible side effects
5.
How to store Pregabalin Pinewood
6.
Contents of the pack and other information
1. WHAT PREGABALIN PINEWOOD IS AND WHAT IT IS USED FOR
Pregabalin Pinewood 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 Pinewood 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 Pinewood is used to treat a certain form of epilepsy
(partial seizures with or
withou

Ürün özellikleri

Health Products Regulatory Authority
30 March 2023
CRN00DDLF
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pregabalin Pinewood 300 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Pinewood 300 mg hard capsules:
Each capsule contains 300 mg of pregabalin.
Excipient(s) with known effect:
Each capsule contains 33 mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pregabalin Pinewood 300 mg hard capsules
Size no. 0 hard capsules with white cap and maroon body, with
approximate length of 21 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Pregabalin Pinewood is indicated for the treatment of peripheral and
central neuropathic pain in adults.
_Epilepsy_
Pregabalin Pinewood is indicated as adjunctive therapy in adults with
partial seizures with or without secondary generalisation.
_Generalised Anxiety Disorder_
Pregabalin Pinewood 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