Epilim Chrono 200 tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Sodium valproate

Sẵn có từ:

Sanofi

Mã ATC:

N03AG01

INN (Tên quốc tế):

Sodium valproate

Liều dùng:

200mg

Dạng dược phẩm:

Modified-release tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 04080100; GTIN: 5000283598022 05000283660347

Tờ rơi thông tin

Patient Information Leaflet
EPILIM
® CHRONO
® 200 CONTROLLED RELEASE TABLETS
EPILIM
® CHRONO
® 300 CONTROLLED RELEASE TABLETS
EPILIM
® CHRONO
® 500 CONTROLLED RELEASE TABLETS
(sodium valproate)
This medicine is subject to additional monitoring. This will allow
quick
identification of new safety information. You can help by reporting
any side
effects you may get. See the end of section 4 for how to report side
effects.
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. Do not pass it on to
others.
It may harm them even if their symptoms 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 Epilim Chrono is and what it is used for
2.
What you need to know before you take Epilim Chrono
3.
How to take Epilim Chrono
4.
Possible side effects
5.
How to store Epilim Chrono
6.
Contents of the pack and other information
1.
WHAT EPILIM CHRONO IS AND WHAT IT IS USED FOR
WHAT EPILIM CHRONO IS
The name of your medicine is Epilim Chrono 200, 300 or 500mg
Controlled Release Tablets (called Epilim Chrono in this leaflet).
“Controlled release” means that the active ingredient sodium
valproate is
slowly released from the tablets over a period of time.
WHAT EPILIM CHRONO CONTAINS
Epilim Chrono contains sodium valproate. It belongs to a group of
medicines called anti-convulsants or anti-epileptic agents. It works
by
helping to calm the brain down.
WHAT EPILIM CHRONO IS USED FOR
Epilim Chrono is used to treat epilepsy (fits) in adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPILIM CHRONO
DO NOT TAKE EPILIM CHRONO AND TELL YOUR DOCTOR IF:
x
You are allergic (hypersensitive) to sodium valproate or any of the
other ingredien

Đặc tính sản phẩm

OBJECT 1
EPILIM CHRONO 200MG
Summary of Product Characteristics Updated 16-May-2018 | SANOFI
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Epilim Chrono 200 Controlled Release
2. Qualitative and quantitative composition
Active Constituents
Each tablet contains 133.2 mg Sodium Valproate and 58.0 mg Valproic
Acid equivalent to 200 mg
sodium valproate.
3. Pharmaceutical form
Prolonged Release Tablet
4. Clinical particulars
4.1 Therapeutic indications
Treatment of generalised, partial or other epilepsy.
4.2 Posology and method of administration
Epilim Chrono Controlled Release Tablets are for oral administration.
Epilim Chrono is a prolonged release formulation of Epilim which
reduces peak concentration and
ensures more even plasma concentrations throughout the day.
Epilim Chrono may be given once or twice daily. The tablets should be
swallowed whole and not crushed
or chewed.
Daily dosage requirements vary according to age and body weight.
In patients where adequate control has been achieved Epilim Chrono
formulations are interchangeable
with other Epilim conventional or prolonged release formulations on an
equivalent daily dosage basis.
_Dosage_
Usual requirements are as follows:
Adults
Dosage should start at 600 mg daily increasing by 200 mg at three-day
intervals until control is achieved.
This is generally within the dosage range 1000 mg – 2000 mg per day,
i.e. 20 – 30 mg/kg/day body
weight. Where adequate control is not achieved within this range the
dose may be further increased to
2500 mg per day.
Children over 20 kg
Initial dosage should be 400 mg/day (irrespective of weight) with
spaced increases until control is
achieved; this is usually within the range 20 – 30 mg/kg body weight
per day. Where adequate control is
not achieved within this range the dose may be in