What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16786/0003 .


Epistatus 10 mg Oromucosal Solution

Package leaflet: Information for the user

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 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. 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.

2. What you need to know before you use Epistatus

Do not give Epistatus if the patient has:

  • An allergy to midazolam, to any other benzodiazepine (such as diazepam or nitrazepam), or any of the other ingredients of this medicine (listed in section 6).
  • An illness called ‘myasthenia gravis’ (which causes muscle weakness).
  • Severe breathing problems (Epistatus can make breathing difficulties worse).
  • Sleep apnoea syndrome (which causes breathing to be frequently interrupted during sleep).
  • Severe liver problems.

Warnings and precautions

Talk to the doctor or pharmacist before using Epistatus if the patient:

  • Has a lung condition causing 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.

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

Children

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

Other medicines and Epistatus

Tell the doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines. If you have any doubt about whether any medicine the patient is taking may affect the use of Epistatus, please speak to your doctor or pharmacist.

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 effects of Epistatus may be intensified by medicines such as:

  • antiepileptics, (for treating epilepsy) e.g. phenytoin
  • antibiotics, e.g. erythromycin, clarithromycin
  • antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole
  • anti-ulcer medicines, e.g. cimetidine, ranitidine and omeprazole
  • medicines used to treat blood pressure, e.g. diltiazem, verapamil
  • some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination
  • narcotic analgesics (very strong pain killers), e.g. fentanyl
  • medicines used to reduce fat in the blood, e.g. atorvastatin
  • medicines used to treat nausea, e.g. nabilone
  • hypnotics (sleep inducing medicines)
  • sedative antidepressants (medicines used to treat depression that make you sleepy)
  • sedatives (medicines that relax you)
  • anaesthetics (for pain relief)
  • antihistamines (to treat allergies).

The effects of Epistatus may be reduced by medicines such as:

  • rifampicin (used to treat tuberculosis)
  • xanthines (used to treat asthma)
  • St John’s Wort (a herbal medicine). This should be avoided in patients taking Epistatus.

Epistatus may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness). This medicine may also stop some other medicines from working as well, e.g. levodopa (used to treat Parkinson’s disease).

Concomitant use of Epistatus and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Epistatus together with opioids the dose and duration of concomitant opiod treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Epistatus contains a small amount of alcohol and therefore should not be co-administered with disulfiram.

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 drink

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 drink grapefruit juice while taking 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.

See also section “Epistatus contains ethanol (alcohol)”.

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 2.3 kcal/g maltitol which equates to approximately 0.8 kcal 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.

Epistatus contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

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. 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.

Epistatus is for oromucosal use only which means that 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.

The recommended dose for children and adolescents aged 10 to less than 18 years of age is 10 mg. The dose is the full contents of one oral syringe. Do not give more than one dose without prior medical advice.

Keep the patient under supervision after he/she has been given Epistatus and stay with the patient.

Epistatus must not be injected. Do not attach a needle to the syringe.

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.

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.

Step 1

Pull the tamper evident tab on the side of the plastic outer case, open it and take the syringe out.

Step 2

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

Step 3

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).

Step 4

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. Dispose of the syringe and cap safely.

If the patient’s condition does not improve

Seek emergency medical assistance – telephone for an ambulance immediately – if the patient’s seizure does not stop shortly after administering Epistatus.

Follow the instruction you have received from the patient’s doctor on how to act in this situation.

A second dose of Epistatus should not be given without medical advice.

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.

The empty syringe must be given to the ambulance staff or doctor to provide information on the dose and product received by the patient.

If you give more Epistatus than you should

You should seek emergency medical assistance – telephone for an ambulance immediately.

Signs that a patient has been given too much Epistatus may be:

  • Drowsiness, tiredness, fatigue
  • Confusion or feeling disorientated
  • losing their co-ordination
  • developing muscle weakness
  • low blood pressure – this can make them feel dizzy and faint
  • breathing difficulties

Keep the syringe to show to the ambulance staff or doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Seek medical advice immediately or call an ambulance straight away if any of the following side effects occur:

  • Severe breathing difficulties e.g. slow or shallow breathing or blue lips. In very rare cases breathing might stop.
  • Cardiac arrest (heart stopped) reported in very rare cases. Signs include loss of consciousness associated with no pulse.

Other side effects

Common side effects (may affect up to 1 in 10 people):

  • Sleepiness or losing consciousness, muscle spasms and muscle tremors (shaking of your muscles that you cannot control), reduced alertness, headache, dizziness
  • Feeling and being sick
  • Tiredness

Uncommon side effects (may affect up to 1 in 100 people):

  • Agitation, hallucinations (seeing and possibly hearing things that are not really there)
  • Temporary memory loss
  • Rash, hives (lumpy rash), itchiness

Very rare side effects (may affect up to 1 in 10,000 people):

  • Aggression, difficulty co-ordinating muscles, physical assault
  • Fits (convulsions), restlessness
  • Low blood pressure, slow heart rate, or redness of the face and neck (flushing)
  • Breathlessness
  • Constipation
  • Dry mouth
  • Hiccups

Frequency not known (cannot be estimated from the available data):

  • Rage, confusion, hostility, euphoria (an excessive feeling of happiness or excitement)
  • Thrombosis (local coagulation or clotting of the blood in a part of the circulatory system), laryngospasm (tightening of the vocal cords causing difficult and noisy breathing), respiratory arrest

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 label and orange carton after EXP. The expiry date refers to the last day of that month.

Do not give this medicine if you notice that the syringe has been damaged or if 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 substance is midazolam (as midazolam maleate). Each pre filled, oral syringe (1 mL) contains midazolam maleate corresponding to 10 mg 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.

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 1 mL of Epistatus.

Marketing Authorisation Holder

Veriton Pharma Ltd
Unit 16, Trade City
Avro Way
Brooklands Business Park
Weybridge
Surrey
KT13 0YF
UK

Manufacturer

Torbay and South Devon NHS Foundation Trust
Torbay Pharmaceuticals
Wilkins Drive
Paignton
Devon
TQ4 7FG
UK

This leaflet was last revised in February 2019.

PIL/T8715N/1