Depakote 250mg gastro-resistant tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Valproate semisodium

から入手可能:

Sanofi

ATCコード:

N03AG01

INN（国際名）:

Valproate semisodium

投薬量:

250mg

医薬品形態:

Gastro-resistant tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04020300; GTIN: 5000283609131 05000283660231

情報リーフレット

PAG 4
PAG 1
Avance bobina
170 x 315 mm
688590-G-697411
PACKAGE LEAFLET:
INFORMATION FOR THE USER
DEPAKOTE® 250MG AND
500MG TABLETS
valproic acid (as valproate semisodium)
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
‚
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.
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 any further questions, 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 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 Depakote is and what it is used for
2. What you need to know before you take Depakote
3. How to take Depakote
4. Possible side effects
5. How to store Depakote
6. Contents of the pack and other information
1. WHAT DEPAKOTE IS AND WHAT IT IS USED FOR
The name of your medicine is Depakote 250mg
or 500mg Tablets (called Depakote in this leaflet).
Depakote contains a medicine called valproate
semisodium. This belongs to a group of medicines
called mood stabilisers. It works by stabilising the levels
of chemicals in your brain that affect your mood.
Depakote can be used to manage or control mania
(feeling highly excited, enthusiastic, being over-active
and easily irritated or distracted) caused by bipolar
disorder. Bipolar disorder is where the mood changes
between feeling very high (mania) and very low
(depression).
Depakote can be used when lithium cannot be used.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DEPAKOTE
DO NOT TAKE DEPAKOTE AND TELL YOUR DOCTOR IF:
X You are allergic (hypersensitive) t

製品の特徴

OBJECT 1
DEPAKOTE 250MG TABLETS
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
Depakote 250 mg Tablets
2. Qualitative and quantitative composition
Containing 269.10 mg of valproate semisodium* per tablet (equivalent
to 250 mg of valproic acid).
*Valproate semisodium is a stable coordination compound comprised of
sodium valproate and valproic
acid in a 1:1 molar relationship. It is also known as divalproex
sodium (USAN).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet
Oval, orange gastro-resistant tablets.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of manic episode in bipolar disorder when lithium is
contraindicated or not tolerated. The
continuation of treatment after manic episode could be considered in
patients who have responded to
Depakote for acute mania.
4.2 Posology and method of administration
For oral administration. The tablets should be swallowed whole with a
drink of water, and not crushed or
chewed.
The daily dosage should be established according to age and body
weight. The wide variation in
individual sensitivity to Depakote should also be considered.
_Dosage_
Manic episodes in bipolar disorder:
Adults
The daily dosage should be established and controlled individually by
the treating physician. The initial
recommended daily dose is 750 mg. In addition, in clinical trials a
starting dose of 20 mg valproate/kg
body weight has also shown an acceptable safety profile.
Prolonged-release formulations can be given
once or twice daily. The dose should be increased as rapidly as
possible to achieve the lowest therapeutic
dose which produces the desired clinical effect. The daily dose should
be adapted to the clinical response
to establish the