Epistatus 7.5 mg oromucosal solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

SERB S.A.,

ATC code:

N05CD08

INN (International Name):

Midazolam

Pharmaceutical form:

Oromucosal solution

Therapeutic area:

midazolam

Authorization status:

Marketed

Authorization date:

2022-10-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPISTATUS 2.5 MG OROMUCOSAL SOLUTION
EPISTATUS 5 MG OROMUCOSAL SOLUTION
EPISTATUS 7.5 MG OROMUCOSAL SOLUTION
EPISTATUS 10 MG OROMUCOSAL SOLUTION
midazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 your child or adolescent. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same as those of the
patient for whom this
medicine has been prescribed.
▪
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 Epistatus is and what it is used for
2.
What you need to know before you use Epistatus
3.
How to give Epistatus
4.
Possible side effects
5.
How to store Epistatus
6.
Contents of the pack and other information
1.
WHAT EPISTATUS IS AND WHAT IT IS USED FOR
Epistatus oromucosal solution contains the medicine midazolam, which
belongs to a group of
medicines known as benzodiazepines.
Epistatus is used to stop a prolonged, acute convulsive seizure
(‘fit’) in infants, toddlers, children and
adolescents aged from 3 months to less than 18 years.
In infants from 3 months to less than 6 months, this medicine should
only be used in a hospital setting
where monitoring is possible and resuscitation equipment is available
(see “Warnings and
precautions” for more information).
This medicine must only be given by parents or caregivers where the
patient has been diagnosed with
epilepsy. The patient’s doctor should give the parents or caregivers
instructions on how to give
Epistatus and what to do if the seizure does not stop (see also “How
to give Epistatus”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EPISTATUS
DO NOT GIVE EPISTATUS IF THE PATIENT HAS
▪
an allergy to midazolam, an

Summary of Product characteristics

Health Products Regulatory Authority
25 September 2023
CRN00DQY1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epistatus 7.5 mg oromucosal solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled oral syringe (0.75 ml) contains midazolam maleate
corresponding to 7.5 mg midazolam.
Excipients with known effect
Ethanol 148 mg/dose.
Maltitol, liquid 506 mg/dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal solution.
Clear colourless to pale yellow solution, practically free from
visible particles.
pH 4.8 - 5.6
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Epistatus is indicated for the treatment of prolonged, acute,
convulsive seizures in infants, toddlers, children and adolescents
aged from 3 months to less than 18 years.
Epistatus must only be used by parents / caregivers where the patient
has been diagnosed to have epilepsy.
For infants between 3-6 months of age treatment should be in a
hospital setting where monitoring is possible and
resuscitation equipment is available. See section 4.4.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard doses are indicated below:
Age range
Dose
Labelled packaging colour
3 to 6 months hospital setting
2.5 mg (0.25 ml)
Yellow
> 6 months to < 1 year
2.5 mg (0.25 ml)
Yellow
1 year to < 5 years
5 mg (0.5 ml)
Blue
5 years to < 10 years
7.5 mg (0.75 ml)
Purple
10 years to < 18 years
10 mg (1 ml)
Orange
Carers should only administer a single dose of midazolam. If the
seizure does not stop shortly after administration of
midazolam, emergency medical assistance must be sought, taking into
account prior instructions from the prescribing
physician, or local guidelines. The empty syringe must be given to the
healthcare professional to provide information on the
dose and product received by the patient.
After receiving midazolam, patients should be kept under supervision
by a carer who remains with the patient.
A second or repeat dose when seizures re-occur after an initial
response should not be