Sodium valproate 500mg gastro-resistant tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Sodium valproate

Dostupné s:

Arrow Generics Ltd

ATC kód:

N03AG01

INN (Mezinárodní Name):

Sodium valproate

Dávkování:

500mg

Léková forma:

Gastro-resistant tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04080100

Informace pro uživatele

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 seriously harm an
unborn child when taken during
pregnancy. If you are a female
able to have a baby you must
use an effective method of birth
control (contraception) without
interruptions during your entire
treatment with Sodium Valproate
Tablets. Your doctor will discuss this
with you but you must also follow
the advice in section 2 of this leaflet.
Schedule an urgent appointment
with your doctor if you want to
become pregnant or if you think
you are pregnant.
Do not stop taking Sodium
Valproate Tablets 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 Sodium
Valproate Tablets you must also read
section 2 of this leaflet carefully and
contact your child’s doctor once
they experience their first period.
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 only.
Do not pass it on to others. It may harm them,
even if their symptoms seem 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 Tablets are and what
they are used for
2. What you need to know before you take
Sodium Valproate Tablets
3. How to take Sodium Valproate Tablets
4. Possible side effects
5. How to store Sodium Valproate Tablets
6. Contents of the pack and other information
1. WHAT SODIUM VALPROATE TABLETS ARE AND
W

Charakteristika produktu

OBJECT 1
SODIUM VALPROATE 500MG GASTRO-RESISTANT
TABLETS
Summary of Product Characteristics Updated 17-Jan-2019 | Wockhardt UK
Ltd
•
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
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
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
Orlept 500mg Gastro-Resistant Tablets
Sodium Valproate Wockhardt 500mg Gastro-Resistant Tablets
2. Qualitative and quantitative composition
Each tablet contains 500mg of Sodium Valproate
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Gastro-resistant tablets.
White to faintly yellowish oval shaped 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
Method of administration
Sodium Valpro