Sodium Valproate Wockhardt 200mg Gastro-Resistant Tablets

Riik: Suurbritannia

keel: inglise

Allikas: myHealthbox

Toimeaine:

Sodium Valproate

Saadav alates:

Wockhardt UK Ltd

ATC kood:

N03AG01

INN (Rahvusvaheline Nimetus):

Sodium Valproate

Annus:

200mg

Ravimvorm:

Enteric coated tablet

Manustamisviis:

Oral use

Ühikuid pakis:

bottles containing 100 tablets; pack sizes of 10, 50, 60 or 100 tablets

Retsepti tüüp:

POM - Prescription Only Medicine

Valmistatud:

Desitin Arzneimittel

Terapeutiline rühm:

Antiepileptics

Näidustused:

in the treatment of generalised, partial or other epilepsy.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2007-07-24

Infovoldik

MEASURE BAR SHOULD BE 150MM AT 100% SCALE 
Customer
Description
Item Code
Profile
Size
Min. Point Size
Market
Language
Proof By
Proof No.
Date
Artwork No.
Pharma
Code
Colours Used
Wockhardt UK Limited
Sodium Valproate tablet leaflet
103995/8
See uploaded pdf
210 x 297mm
matt.pirie-scott
2
20/05/2015
570085
Process Black
Keyline (non-printing)
[e-mail]
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PACKAGE LEAFLET INFORMATION FOR THE USER
SODIUM VALPROATE 200MG AND 500MG  
GASTRO-RESISTANT 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. 
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 
USING 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 personally 
and you should not pass it on to others. It may harm 
them, even if their symptoms are the same as yours.
-  If you get

Toote omadused

Orlept 200mg Gastro­Resistant Tablets
Summary of Product Characteristics Updated 21­Aug­2015 | Wockhardt UK Ltd
 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
Orlept 200mg Gastro­Resistant Tablets
Sodium Valproate Wockhardt 200mg Gastro­Resistant Tablets
2. Qualitative and quantitative composition
Each tablet contains 200mg of Sodium Valproate
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Gastro­resistant tablets.
White to faintly yellowish round bevel edged tablets.
4. Clinical particulars
4.1 Therapeutic indications
For oral administration in the treatment of generalised, partial or other epilepsy.
4.2 Posology and method of administration
Sodium Valproate 200mg Gastro­Resistant Tablets are for oral administration.
Daily dosage requirements vary according to age and body weight.
Tablets may be given twice daily.
Tablets should be swallowed whole and not crushed or chewed.
_Dosage:_
Usual requirements are as follows:
Adults:
Dosage should start at 600mg daily increasing by 200mg at three­day intervals until control is achieved. This is
generally within the dosage range 1000mg to 2000mg per day i.e. 20­30mg/kg body weight daily. Where adequate
control is not achieved within this range the dose may be further increased to a maximum of 2500mg per day.
Children over 20kg:
Initial dosage should be 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is
usually within the range 20­30mg/kg body weight per day. Where adequate control is not achieved within this range the
dose may be i