Apictro 50 mg/ml oral solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ethosuximide

Dostopno od:

Neuraxpharm Ireland Limited

Koda artikla:

N03AD01

INN (mednarodno ime):

Ethosuximide

Odmerek:

50 milligram(s)/millilitre

Farmacevtska oblika:

Oral solution

Terapevtsko območje:

ethosuximide

Status dovoljenje:

Not marketed

Datum dovoljenje:

2021-12-03

Navodilo za uporabo

Apictro 50mg/ml oral solution Package Leaflet
1
IE-Version 2022/02
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
APICTRO 50 MG/ML ORAL SOLUTION
Ethosuximide
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 signs of illness 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 Apictro is and what it is used for
2. What you need to know before you take Apictro
3. How to take Apictro
4. Possible side effects
5. How to store Apictro
6. Contents of the pack and other information
1. WHAT APICTRO IS AND WHAT IT IS USED FOR
Apictro
contains the active substance ethosuximide. Ethosuximide is one of a
group of medicines called
anti-epileptic drugs; these medicines are used to treat epilepsy.
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 APICTRO
DO NOT TAKE APICTRO
-
if you are allergic to ethosuximide, other succinimides (group of
medicines to which ethosuximide
belongs) or any other ingredients of this medicine listed in section
6.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Apictro
If you experience movement disorders (see section 4) do not continue
taking Apictro. Please, contact
the nearest doctor who, in the event of significant disturbances, can
administer diphenhydramine as an
antidote by the intravenous route.
Pay special attention to symptoms of bone marrow depression such as
fever, sore throat as well as
bruising. Consult your doctor, if you experience any of these
symptoms.
Your blood count shoul

Lastnosti izdelka

Health Products Regulatory Authority
27 September 2022
CRN00D4HN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apictro 50 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml oral solution contains 50 mg ethosuximide.
Excipients with known effect:
Each ml oral solution contains 0.6 mg methyl-4-hydroxybenzoate (E 218)
and 1.0 mg propylene glycol (E 1520).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ethosuximide gives selective control of absence seizures (petit mal)
even when complicated by grand mal seizures.
It is also indicated for myoclonic astatic epilepsy and juvenile
myoclonic epilepsy of adolescents if other medicinal products are
not effective and/or are not tolerated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, elderly patients and children over 6 years of age: The
treatment is started at a daily dose of 500 mg.
Depending on the patient's tolerance, the dose is increased every five
to seven days in increments of max. 250 mg until control
is achieved with 1000 - 1500 mg daily. Occasionally 2000 mg in divided
doses may be necessary.
The therapeutic plasma level of ethosuximide is normally between 40
and 100 µg/ml but the clinical response should be the
criteria for the regulation of the dosage.
The half-life of ethosuximide in plasma is more than 24 hours so that
the daily dose can be taken as a single dose provided the
medicinal product is well tolerated. Higher daily doses should be
taken in 2 or 3 single doses.
The probability of dose-dependent undesirable effects can be reduced
by careful dosing (small initial dose at the start of
treatment, gradual increase of dose) and by taking the medicinal
product during or after meals.
Anti-epileptic therapies are principally long-term therapies. A
specialist (neurologist, neuropaediatrician) should decide about
the start, duration and discontinuation of ethos