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EPISTATUS 10MG OROMUCOSAL SOLUTION

Active substance(s): MIDAZOLAM MALEATE / MIDAZOLAM MALEATE

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Special Products Ltd

Epistatus UK PIL
130mm

130mm

PACKAGE LEAFLET: INFORMATION FOR THE USER
Epistatus 10 mg oromucosal solution
Midazolam

continued

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.

Step 3

Dispose of the amber sheath cap safely.

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

Step 4

Using your finger and thumb, gently pinch and
pull back the patient’s cheek. Place the tip of the
syringe into the back of the space between the
inside cheek and the lower gum (buccal cavity).

1. WHAT EPISTATUS IS AND WHAT IT IS USED FOR

Epistatus 10 mg oromucosal solution contains the medicine midazolam, which belongs to a group of
medicines known as benzodiazepines.
Epistatus is used to stop a prolonged, convulsive seizure (‘fit’) in children and adolescents aged 10 to less
than 18 years.
This medicine must only be given by parents or caregivers where the patient has been diagnosed with
epilepsy.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPISTATUS

Do not give Epistatus if the patient has:
• An allergy (hypersensitivity) to midazolam, to any other benzodiazepine medicines (such as diazepam
or nitrazepam), or to any of the other ingredients of this medicine (listed in section 6).
• An illness called ‘myasthenia gravis’ (which causes muscle weakness).
• Severe breathing problems.
• Sleep apnoea syndrome (which causes breathing to be frequently interrupted during sleep).
• Severe liver problems.

Step 5

Slowly administer approximately half of the
solution to the buccal cavity on one side of the
mouth, and then administer the remainder
slowly to the other side, by pressing the syringe
plunger until it stops. If it is particularly difficult
to get the syringe into one buccal cavity, then
administer the whole dose over a duration of 4
– 5 seconds into the other buccal cavity.

Epistatus contains a small amount of alcohol; it should not be used if the patient is also taking disulfiram, a
medicine prescribed to deter alcohol use that causes headache, nausea, vomiting and other unpleasant
symptoms when alcohol is ingested.
Warnings and precautions
Talk to the doctor or pharmacist before using Epistatus if the patient:
• Has a long term illness such as breathing problems as this medicine could make your breathing
worse.
• Has kidney, liver or heart problems.
• Has an illness that makes them feel very weak, run down and short of energy.
• Regularly drinks large amounts of alcohol or has had problems with alcohol use in the past (see
‘Epistatus contains ethanol (alcohol)’).
• Regularly takes recreational drugs or has had problems with drug use in the past.
• Is pregnant or thinks they may be pregnant (see ‘Pregnancy and breast-feeding’).
• Has an intolerance to some sugars (see ‘Epistatus contains maltitol’).

If the patient’s condition does not improve
If the patient’s condition does not improve 10 minutes after administering Epistatus, seek emergency
medical assistance – telephone for an ambulance immediately.
If the patient’s condition improves but their seizure (‘fit’) then starts again
Seek emergency medical assistance – telephone for an ambulance immediately.
A second dose of Epistatus should not be given without medical advice.

This medicine may affect the patient’s memory of the period after they have been given it (temporary
memory loss). Patients should be carefully observed after being given this medicine. See also section 4
(possible side effects).

If you give more Epistatus than you should
You should seek emergency medical assistance – telephone for an ambulance immediately.

If you are not sure whether any of the above applies to the patient, please speak to a doctor or pharmacist
before giving this medicine.

Signs that a patient has been given too much Epistatus may be:
• feeling drowsy, lethargic, or confused
• losing their co-ordination (ataxia)
• developing muscle weakness (hypotonia)
• developing low blood pressure (hypotension) – this can make them feel dizzy
• having breathing difficulties, going into a coma.

Children
This medicine should only be given to children and adolescents aged 10 years to less than 18 years.

In particular, tell the doctor or pharmacist if the patient is taking any of the following medicines:
• medicines to treat epilepsy (antiepileptics, such as phenytoin)
• medicines for anxiety or to help them sleep (tranquillisers)
• medicines to make them sleep (hypnotics)
• medicines to make them feel calm or sleepy (sedatives)
• muscle relaxants (such as baclofen)
• medicines for depression
• very strong pain killers (narcotic analgesics, such as fentanyl)
• medicines to treat allergies (antihistamines)
• medicines to treat fungal infections (ketoconazole, voriconazole, fluconazole, itraconazole posaconazole)
• medicines to treat Parkinson’s disease (such as levodopa)
• certain antibiotics known as macrolides (such as erythromycin, clarithromycin or roxithromycin)
• medicines used to treat high blood pressure (such as diltiazem or verapamil)
• medicines for HIV called protease inhibitors (such as saquinavir) and antiretrovirals (such as efavirenz)
• medicines used to treat nausea and/or vomiting (nabilone, aprepitant)
• medicines used to treat ulcers (cimetidine, ranitidine, omeprazole)
• medicines to treat asthma (such as xanthines)
• medicines used to treat high cholesterol (such as atorvastatin)
• medicines used to treat mycobacterial infections such as tuberculosis (for example rifampicin)
• cough medicines containing opiates
• the herbal medicine St John’s Wort
• medicines used to treat bacterial infections (sulfonamide or sulphonamide)
Talk to your doctor or pharmacist about medicines the patient should avoid whilst taking Epistatus.
Operations
If the patient is going to have an inhaled anaesthetic (one that the patient breathes in) for an operation or for
dental treatment, it is important to tell the doctor or dentist that they have been given Epistatus.
Epistatus with food and alcohol
The patient must not drink alcohol if they have been given Epistatus. Alcohol may increase the sedative
effects of Epistatus and make them very sleepy.
The patient must not take grapefruit juice if they have been given Epistatus. Grapefruit juice may increase
the sedative effect of Epistatus and make them more sleepy.
Pregnancy, breast-feeding and fertility
Pregnancy
If the patient is pregnant, thinks she might be pregnant or is planning to have a baby, ask a doctor for advice
before giving this medicine.
Frequent doses of this medicine during the last 3 months of pregnancy or during childbirth can cause
problems for the baby; these can include abnormal heart rhythms, hypothermia (low body temperature),
poor suckling, breathing difficulties and poor muscle tone at birth.
Breast-feeding
Tell a doctor if the patient is breast-feeding. Even though small amounts of this medicine may pass into
breast milk, it may not be necessary to stop breast-feeding. The doctor will advise if the patient should
temporarily stop breast-feeding after being given Epistatus.
Fertility
Animal studies did not show an impairment of fertility.
Driving and using machines
This medicine may make the patient sleepy, forgetful or affect their concentration or coordination. This may
affect their ability to perform skilled tasks such as driving, riding a bicycle or operating machinery. After
receiving this medicine, the patient should not drive, ride a bicycle or operate machinery until they are
completely recovered.
Please discuss with the doctor if you need further advice.
Epistatus contains maltitol
If the patient has been told by their doctor that they have an intolerance to some sugars, tell the doctor
before you give this medicine. May have a mild laxative effect. Calorific value 2.3kcal/g maltitol which
equates to approximately 0.8kcal per single dose of Epistatus.
Epistatus contains ethanol (alcohol)
This medicinal product contains 25 vol % ethanol (alcohol) or 197 mg per dose, equivalent to 5 mL beer, or
2 mL wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or
breast-feeding women, children, and high-risk groups such as patients with liver disease.
3. HOW TO GIVE EPISTATUS

Always give this medicine exactly as a doctor has told you. Check with a doctor or pharmacist if you are not
sure.
Epistatus is for oromucosal use only. It is only to be used in the mouth.
Care must be taken when administering the product to avoid the risk of the patient choking.
Preparing to give this medicine
If the patient is having a seizure (‘fit’), allow their body to move freely and do not try to restrain them. Only
move the patient if they are in danger from the surroundings, for example, a road, open water, hot cooking
appliances, fire or sharp objects.
Support the patient’s head with something soft, such as a cushion or your lap.
Do not use if the medicine has passed the expiry date shown on the secondary packaging and syringe or if
the syringe is damaged.
Do not give this medicine if you notice that the solution is not clear (e.g. if cloudy or white particles are
present).
How to give this medicine
Ask a doctor, pharmacist or nurse to show you how to take or administer this medicine. Always check with
them if you are not sure.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Epistatus can cause side effects, although not everybody gets them.
Seek medical advice immediately or call an ambulance straight away if any of the following side
effects occur as they can be life-threatening:
• An allergic reaction which may include a sudden rash, itching or lumpy rash (hives) and swelling of
the face, lips, tongue or other parts of the body.
• Breathing problems or complications, sometimes causing the breathing to be very slow, shallow or
stop.
• Heart attack. Signs could include chest pain which may spread to the neck and shoulders and down
the left arm.
Life-threatening side effects are more likely to occur in the following patients:
• patients who already have breathing difficulties
• patients who already have heart problems

525mm

525mm

Other medicines and Epistatus
Tell the doctor or pharmacist if the patient is using, has recently used or might use any other medicines
including over-the-counter medicines or herbal medicines. This is extremely important, as using more than
one medicine at the same time can strengthen or weaken the effect of the medicines involved.

The following side effects are common and may affect up to 1 in 10 people:
• sleepiness and losing consciousness
• reduced alertness
• feeling sick or being sick (vomiting)
The following side effects are uncommon and may affect up to 1 in 100 people:
• rash
• hives (lumpy rash)
• itchiness
The following side effects are very rare and may affect up to 1 in 10 000 - they have been reported when
midazolam (the active ingredient in Epistatus) is given as an injection, but may also be relevant to this
medicine:
Effects on behaviour:
• agitation
• hostility, anger or aggression (including physical aggression)
• confusion
• euphoria (an excessive feeling of happiness or excitement)
• hallucinations (seeing and possibly hearing things that are not really there)
Muscle problems:
• muscle spasms and muscle tremors (shaking of the patient’s muscles that they cannot control)
Mental and Nervous system problems:
• headache
• dizziness
• fits
• unusual talkativeness with loss of inhibition, possibly with excessive movement
• difficulty co-ordinating muscles
• temporary memory loss. How long this lasts depends on how much Epistatus the patient was given.
The patient may experience this after their treatment. In isolated cases this has lasted for a long time.
Heart and circulation problems:
• low blood pressure
• slow heart rate
• redness of the face and neck (flushing), fainting or headache
Other:
• hiccup
• constipation
• dry mouth
• tiredness (fatigue)
Reporting of side effects
If the patient gets side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE EPISTATUS

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not put the product in the fridge or freezer.
Store in the original package to protect from light.
Do not use this medicine after the expiry date which is stated on the syringe and container after EXP.
The expiry date refers to the last day of that month.
Do not give this medicine if you notice that the solution is not clear (e.g. cloudy or white particles are
present).
Disposal of oral syringes
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Epistatus contains
• The active ingredient is midazolam (as midazolam maleate). Each 1 mL of Epistatus contains 10 mg
of midazolam.
• The other ingredients are ethanol, saccharin sodium, glycerol, purified water, sodium hydroxide and
liquid maltitol.
See section 2 for further information on ethanol and liquid maltitol.

Step 1

Pull the tamper evident tab on the side of the
polypropylene secondary packaging case, open
it and take the syringe out.

What Epistatus looks like and contents of the pack
Epistatus oromucosal solution is a clear, colourless to pale yellow solution. It is supplied in a pre-filled,
single-use (needle free) oral syringe. Each oral syringe is individually packed in its own container.
Each pre-filled oral syringe contains a single dose of 1mL of Epistatus.
Marketing Authorisation Holder
Special Products Ltd, Unit 16, Trade City, Avro Way, Brooklands Business Park, Weybridge, Surrey,
KT13 0YF, UK.
Manufacturer
Dales Pharmaceuticals Ltd, Skipton, North Yorkshire, BD23 2RW, UK.
This leaflet was last revised in
01/2017
Other sources of information
Detailed information on this medicine is available on the website of
http://www.mhra.gov.uk/public-assessment-reports/

Step 2

Holding the clear finger grips, unscrew the
amber sheath cap in an anti-clockwise direction
and remove the amber sheath cap.

continued

CONFIDENTIAL

Sequence No. 0003

Pg 1

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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