Epilim 200mg/5ml liquid

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Sodium valproate

Dostępny od:

Sanofi

Kod ATC:

N03AG01

INN (International Nazwa):

Sodium valproate

Dawkowanie:

40mg/1ml

Forma farmaceutyczna:

Oral solution

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04080100; GTIN: 5013417101173

Ulotka dla pacjenta

Découpe
303429 - 429
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM 200MG/5ML LIQUID
sodium valproate
IS THIS LEAFL ET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
▼
This medicine is subject to additional monitoring.
This will allow quick identifi cation of new safety
information. You can help by reporting any side eff ects
you may get. See the end of section 4 for how to report
side eff ects.
WARNING
EPILIM LIQUID, SODIUM VALPROATE, CAN SERIOUSLY
HARM AN UNBORN BABY WHEN TAKEN DURING
PREGNANCY. IF YOU ARE A FEMALE ABLE TO HAVE
A BABY YOU SHOULD USE AN EFF ECTIVE METHOD
OF BIRTH CONTROL (CONTRACEPTION) WITHOUT
INTERRUPTION DURING YOUR ENTIRE TREATMENT WITH
EPILIM LIQUID. YOUR DOCTOR WILL DISCUSS THIS
WITH YOU BUT YOU MUST ALSO FOLLOW THE ADVICE IN
SECTION 2 OF THIS LEAFL ET.
SCHEDULE AN URGENT APPOINTMENT WITH YOUR
DOCTOR IF YOU WANT TO BECOME PREGNANT OR IF YOU
THINK YOU ARE PREGNANT.
DO NOT STOP TAKING EPILIM LIQUID UNLESS YOUR
DOCTOR TELLS YOU TO AS YOUR CONDITION MAY
BECOME WORSE.
IF YOU ARE A PARENT OR CAREGIVER OF A FEMALE CHILD
TREATED WITH EPILIM LIQUID, YOU MUST ALSO READ
SECTION 2 OF THIS LEAFL ET CAREFULLY AND CONTACT
YOUR CHILD’S DOCTOR ONCE THEY EXPERIENCE THEIR
FI RST PERIOD.
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leafl et. You may need to read it again
• If you have any further questions, please 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 eff ects, talk to your doctor or
pharmacist. This includes any possible side eff ects
not listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET
1. What Epilim Liquid is and what it is used for
2. What you need to know before you take Epilim
Liquid
3. How to take Epilim Liquid
4. Possible side eff ects
5. How to store Epilim Liquid
6. Contents of the pack and other information
1. WHAT EPILIM LIQ

Charakterystyka produktu

OBJECT 1
EPILIM LIQUID
Summary of Product Characteristics Updated 11-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 Liquid/Sodium Valproate 200 mg/5 ml Liquid
2. Qualitative and quantitative composition
Each 5 ml of liquid contains Sodium Valproate 200.0 mg.
3. Pharmaceutical form
Liquid
4. Clinical particulars
4.1 Therapeutic indications
In the treatment of generalised, partial or other epilepsy.
4.2 Posology and method of administration
Epilim Liquid is for oral administration.
Daily dosage requirements vary according to age and body weight.
Epilim Liquid may be given twice daily. Epilim Liquid should not be
diluted.
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 increased to 35 mg/kg
body weight per day.
Children under 20 kg
20 mg/kg of body weight per day; in severe cases this may be increased
but only in patients in whom
plasma valproic acid levels can be monitored. Above 40 mg/kg/day,
clinical chemistry and
haematological parameters should be monitored.
Us