Sodium valproate 200mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium valproate

Available from:

Zentiva

ATC code:

N03AG01

INN (International Name):

Sodium valproate

Dosage:

200mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5000283598459

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SODIUM VALPROATE ZENTIVA 200MG AND 500MG GASTRO-RESISTANT TABLETS
_▼_
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 or 500mg
Gastro-resistant Tablets
(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
V

Summary of Product characteristics

OBJECT 1
SODIUM VALPROATE 200MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 19-Mar-2018 | Zentiva
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
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6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
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6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
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8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 Gastro-resistant Tablets
2. Qualitative and quantitative composition
Sodium Valproate 200 mg.
3. Pharmaceutical form
Gastro-resistant Tablet.
4. Clinical particulars
4.1 Therapeutic indications
In the treatment of generalised, partial or other epilepsy.
4.2 Posology and method of administration
Sodium Valproate 200 mg Gastro-resistant Tablets are for oral
administration.
Daily dosage requirements vary according to age and body weight.
Sodium valproate tablets may be given twice daily. The tablets should
be swallowed whole