Episenta 1000mg modified-release granules sachets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Sodium valproate

Disponibil de la:

Desitin Pharma Ltd

Codul ATC:

N03AG01

INN (nume internaţional):

Sodium valproate

Dozare:

1gram

Forma farmaceutică:

Modified-release granules

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04080100; GTIN: 5060061160308 04031649003530

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
▼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.
EPISENTA 500MG PROLONGED-RELEASE GRANULES
EPISENTA 1000MG PROLONGED-RELEASE GRANULES
(sodium valproate)
(Referred to in this leaflet as Episenta)
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 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 Episenta is and what it is used for
2.
What you need to know before you take Episenta
3.
How to take Episenta
4.
Possible side effects
5.
How to store Episenta
6.
Contents of the pack and other information
1.
WHAT EPISENTA IS AND WHAT IT IS USED FOR
Episenta contains the active substance sodium valproate, which belongs
to a group of medicines called
antiepileptics which are used to control epileptic seizures and mania.
Episenta is used in the treatment of
•
various types of epilepsy (seizures)
•
mania, where you may feel very excited, elated, agitated, enthusiastic
or hyperactive. Mania occurs
in an illnes

Caracteristicilor produsului

OBJECT 1
EPISENTA 1000MG PRO-LONGED RELEASE GRANULES
Summary of Product Characteristics Updated 20-Apr-2017 | Desitin
Pharma 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
Episenta
®
1000 mg prolonged-release granules
2. Qualitative and quantitative composition
Each sachet of prolonged-release granules contains 1000 mg sodium
valproate
Excipient(s) with known effect: 6 mmol (137.9 mg) sodium per dose
For the full list of excipients see section 6.1
3. Pharmaceutical form
Prolonged-release granules.
White or almost white, round, film-coated prolonged-release granules.
4. Clinical particulars
4.1 Therapeutic indications
Sodium valproate is used in the:
• treatment of all forms of epilepsy.
• 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
sodium valproate for acute mania.
4.2 Posology and method of administration
Female children, female adolescents, women of childbearing potential
and pregnant women
Episenta
®
should be initiated and supervised by a specialist experienced in the
management of epilepsy or
bipolar disorder. Treatment should only be initiated if other
treatments are ineffective or not tolerated (see
section 4.4 and 4.6) and the benefit and risk should be carefully
reconsidered at regular treatment reviews.
Preferably Episenta
®
should be prescribed as monotherapy and at the lowest effective dose,
if possible as
a prolonged release formulation to avoid high peak plasma
concentrations. The daily dose should be
divided into at least two single doses.
Posology
_Treatment in all forms of epilepsy: _
Dosage requirements vary according to age and body weight and should
be adjusted individually to
achieve adequat