Epaclob 2 mg/ml Oral Suspension

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Clobazam

Dostupné s:

Ethypharm

ATC kód:

N05BA; N05BA09

INN (Mezinárodní Name):

Clobazam

Dávkování:

2 milligram(s)/millilitre

Léková forma:

Oral suspension

Terapeutické oblasti:

Benzodiazepine derivatives; clobazam

Stav Autorizace:

Marketed

Datum autorizace:

2016-11-25

Informace pro uživatele

PREGNANCY, BREAST-FEEDING AND FERTILITY
Pregnancy
Use of this medicine is not recommended during pregnancy and
in women of childbearing potential not using contraception.
If you discover that you are pregnant or are planning to have a
baby, consult your doctor right away to re-assess the need for
treatment. Do not stop taking Epaclob without talking to your
doctor.
A large amount of data has not shown evidence of malformations
associated with the use of benzodiazepines. However, some
studies have shown a potentially increased risk of cleft lip and
palate in newborn babies compared to that in the general
population.
Cleft lip and palate (sometimes called “harelip”) is a deformation
at birth caused by incomplete fusion of the palate and upper lip.
Reduced fetal movement and fetal heart rate variability may
occur after taking Clobazam during the second and/or third
trimester of pregnancy.
If Epalcob is taken at the end of pregnancy or during childbirth,
your baby may show drowsiness (sedation), muscle weakness
(hypotonia or floppy infant syndrome), a drop in body
temperature (hypothermia), difficulty feeding (problems suckling
causing poor weight gain) and breathing problems (respiratory
depression sometimes severe).
If taken regularly in late pregnancy, your baby may get withdrawal
symptoms such as agitation or shaking. In this case the newborn
should be closely monitored during the postnatal period.
Breastfeeding
As clobazam, the active substance in Epaclob oral suspension, is
excreted into breast milk, you must not use Epaclob oral suspension
during breast-feeding.
DRIVING AND USING MACHINES
Clobazam has major influence on the ability to drive and use
machines.
You may feel sleepy or have concentration or memory problems
after taking this medicine.
You may also experience double vision or you may react more
slowly to things. Do not drive or use any tools or machines if you are
affected in this way.
Talk to your doctor if you are not sure whether it is safe for you to
drive while taking this medicine.
EPACLOB

Charakteristika produktu

Health Products Regulatory Authority
15 October 2021
CRN00C2Z7
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epaclob 2 mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 2 mg of Clobazam.
Excipient (s) with known effect:
Each 1 ml of suspension contains 250 mg of sorbitol, 2.06 mg of sodium
methyl hydroxybenzoate and 0.224 mg of sodium
propyl hydroxybenzoate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
An off white viscous suspension with an odour of raspberry.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clobazam may be used as adjunctive therapy in epilepsy in adults or
children over 2 years of age, if standard treatment with
one or more anticonvulsants has failed.
Epaclob oral suspension should only be used in children from 1 month
to 2 years old, under exceptional situations, when there
is a clear epilepsy indication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The oral suspension is suitable for any epilepsy patient in whom the
clinician feels an oral suspension is preferable to clobazam
tablets.
If low doses are required, the 1 mg/ml strength product is the most
suitable presentation. If high doses are required, the 2
mg/ml strength product is the most suitable presentation. In all
cases, treatment should be initiated at the lowest effective
dose with gradual dose increments under careful observation.
Treatment of epilepsy in association with one or more other
anticonvulsants
ADULTS
In epilepsy a starting dose of 5-15 mg/day is recommended, gradually
increasing as necessary up to a maximum of 60 mg
daily.
PAEDIATRIC POPULATION:
When prescribed for children, there may be increased response and
increased susceptibility to adverse reactions, therefore,
these patients require low initial doses and gradual increments under
careful observation.
_Paediatric population aged 2-16 years:_
_Initial_: 5 mg/day (_AGED 6 YEARS AND ABOVE_) or 0.1 mg/kg/day for
younger patients. The dose may b