Sodium valproate 200mg5ml oral solution sugar free

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Sodium valproate

Disponibbli minn:

Zentiva

Kodiċi ATC:

N03AG01

INN (Isem Internazzjonali):

Sodium valproate

Dożaġġ:

40mg/1ml

Għamla farmaċewtika:

Oral solution

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 04080100; GTIN: 5000283602583

Fuljett ta 'informazzjoni

PATIENT INFORMATION LEAFLET
SODIUM VALPROATE ZENTIVA 200MG/5ML LIQUID
_▼_
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.
WARNING
Valproate can cause birth defects and problems with early development
of the child if it is taken
during pregnancy. If you are a female of childbearing age you should
use an effective method of
contraception throughout your treatment.
Your doctor will discuss this with you but you should also follow the
advice in section 2 of this
leaflet. Tell your doctor at once if you become pregnant or think you
might be pregnant.
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, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it onto
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 sodium valproate is and what is it used for
2.
What you need to know before you take sodium valproate
3.
How to take sodium valproate
4.
Possible side effects
5.
How to store sodium valproate
6.
Contents of the pack and other information
1.
WHAT SODIUM VALPROATE IS AND WHAT IT IS USED FOR
The name of your medicine is Sodium Valproate Zentiva 200mg/5ml Liquid
(called sodium
valproate throughout this leaflet). This belongs to a group of
medicines called anti-convulsants or
anti-epileptic agents. It works by controlling the activity of the
brain which causes fits or seizures.
It is used to treat epilepsy (fits) in adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM
VALPROATE
DO NOT TAKE SODIUM VALPROATE AND TELL Y

Karatteristiċi tal-prodott

OBJECT 1
SODIUM VALPROATE LIQUID 200MG/5ML
Summary of Product Characteristics Updated 19-Mar-2018 | Zentiva
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
Sodium Valproate Zentiva 200 mg/5 ml Liquid
2. Qualitative and quantitative composition
Sodium valproate Ph. Eur. 200 mg/5 ml
3. Pharmaceutical form
Liquid for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
For oral administration in the treatment of general, partial or other
epilepsy.
4.2 Posology and method of administration
Daily dosage requirements vary according to age and body weight.
Sodium Valproate Liquid may be given twice daily. Sodium Valproate
Liquid should not be diluted.
_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 body weight per
day. 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 per 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.
Use in the Elderly
Although the pharmacokinetics of sodium valproate are modified in the
elderly, they have limited clinical
significance and dosage should be determined by sei