Emeside 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ethosuximide

Available from:

Fontus Health Ltd

ATC code:

N03AD01

INN (International Name):

Ethosuximide

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5050204100339

Patient Information leaflet

85A/L/y/2
Emeside 250 mg Capsules
ethosuximide
_Continued over page_
What is in this leaflet
1. What Emeside Capsules are and what they are used for
2. What you need to know before you take Emeside
Capsules
3. How to take Emeside Capsules
4. Possible side effects
5. How to store Emeside Capsules
6. Contents of the pack and other information
1. What Emeside Capsules are and what they are
used for
Emeside Capsules contain ethosuximide which is an
anti-epileptic.
It is used to control epilepsy in children and adults.
Epilepsy is a condition where you have repeated seizures (fits).
Ethosuximide is used to control brief, sudden loss of
consciousness (absence seizures, also called petit mal), and
uncontrolled jerking movements (myoclonic seizures).
2. What you need to know before you take Emeside
Capsules
Do not take Emeside Capsules :
• if you are allergic to ethosuximide, other similar medicines
called succinimides, or any of the other ingredients of this
medicine (listed in section 6)
• if you are allergic to soya oil (see end of this section)
• if you have porphyria (a metabolism disorder which causes
abdominal pains and mental disorder).
If any of the above apply to you, speak to your doctor or
pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Emeside
Capsules:
• if you have liver or kidney disease
• if you are pregnant or planning a pregnancy, or if you are
breast-feeding.
A small number of people being treated with anti-epileptics such
as ethosuximide have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
Other medicines and Emeside Capsules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may be affected by ethosuximide or they may
affect how well ethosuximide will work. Tell your doctor or
pharmacist if you are taking:
• isoniazid, a medicine used for certain types of infections
• other medicines to control epilepsy, in par

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Emeside Capsules
Ethosuximide Essential Generics 250 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg ethosuximide.
Excipient with known effect
Each capsule contains 0.60 mg sodium ethyl hydroxybenzoate, 0.60 mg
sodium propyl
hydroxybenzoate and traces of soya lecithin
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules.
The capsules are clear oval soft gelatin capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ethosuximide 250 mg Capsules gives selective control of absence
seizures (petit mal) even
when complicated by grand mal.
It is also indicated for myoclonic seizures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the Elderly and Children over 6 Years _
Start with a small dose - 500mg daily with increments of 250mg every
five to seven days until
control is achieved with 1000 - 1500 mg daily. Occasionally 2000 mg in
divided doses may
be necessary.
_ _
_Paediatric population aged 0-6 years _
Children aged 0-6 years old and those who are unable to swallow
capsules should be given
ethosuximide oral liquid. Currently available clinical trial data
regarding the use of
ethosuximide in the paediatric population are described in section
5.1.
Effective plasma levels of ethosuximide normally lie between 40 and
100 mcg per ml, but the
clinical response should be the criteria for the regulation of the
dosage. The half-life of
ethosuximide in the plasma is more than 24 hours but the daily dose if
large is more
comfortably divided between morning and evening.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Hypersensitivity to succinimides.
•
Hypersensitivity to soya oil (see section 4.4).
•
Porphyrias.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Suicidal behaviour
Suicidal ideation and behaviour have been reported in patients treated
with anti-epileptic
agents in several indications. A met