Administering BUCCOLAM®

Administering BUCCOLAM (midazolam)

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Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions. UK reporting forms and information can be found via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Stores. Adverse events should also be reported to Neuraxpharm UK Ltd by emailing pv-uk@neuraxpharm.com

How to administer BUCCOLAM®?

Information on BUCCOLAM® pre-filled syringe^1</sup<

Clear, colourless to yellowish solution
For oromucosal use (space between the inside of the cheek and the lower gum).
Not for intravenous use.
No needle, intravenous tubing or any other device for parenteral administration should be attached to the syringe.
Keep the oral syringe in the protective plastic tube.
Do not refrigerate or freeze.
Remove the oral syringe cap before use to avoid risk of choking.

Contraindications¹

• Hypersensitivity to the active substance, benzodiazepine or to any of the excipients. (sodium chloride, water for injections, hydrochloric acid and sodium hydroxide)

• Myasthenia gravis.

• Severe respiratory insufficiency.

• Sleep apnea syndrome.

• Severe hepatic impairment.

PIL
3-6 months

For infants between 3-6 months of age treatment should be in a hospital setting

Advise patients and carers to read the Patient Information Leaflet²

See Tolerability section and Summary of Product Characteristics (SmPC)¹ for special warnings and precautions for use, interactions, and other safety-related information.

Steps to follow when administering BUCCOLAM®¹

1

Hold the plastic tube and pull off the cap. Take the syringe out of the tube.

2

Pull the red cap off the tip of the syringe and dispose of it safely.

3

Using the finger and thumb gently pinch and pull back the patient’s cheek.

4

Put the syringe into the back of the space between the inside of the cheek and the lower gum.

5

Slowly press the syringe plunger until the plunger stops. The full amount of solution should be inserted slowly into the space between the gum and the cheek (buccal cavity). If prescribed by your doctor (for larger volumes and/or smaller patients), you can give approximately half the dose slowly into one side of the mouth, then into the other side of the patient’s mouth.

6

Stay with the patient until the seizure is over. Note the time BUCCOLAM® was given and how long the seizure lasted. Stay with the patient until they are fully recovered.

7

Keep the empty syringe to give it to the doctor or paramedic if they have been called.

Recommendations to follow after administering BUCCOLAM®^{1, 2}

If 10 minutes after administering a single dose of midazolam the seizure has not stopped:

Emergency medical assistance must be sought.
In such cases the empty syringe should given to the healthcare professional to provide information on the dose received by the patient.

Parents and carers should only administer a single dose of BUCCOLAM®. Additional doses should not be administered.

If seizures re-occur after an initial response, additional doses should not be administered without prior medical advice.

The time when BUCCOLAM® was administered must be annotated.

Patients should be accompanied, and should not drive a vehicle, ride a bike or operate machinery, until they are fully recovered.

Advise the patient, family member and/ or carer of the following:

When to call an ambulance

ALWAYS follow the treatment advice provided by a healthcare professional. If in any doubt, call for immediate medical help if:

The seizure does not stop within 10 minutes
You’re unable to empty the syringe or you spill some of the contents
The patient’s breathing slows down or stops e.g. slow or shallow breathing or blue lips
You observe signs of a heart attack which may include chest pain or pain that spreads to the neck and shoulders and down the left arm
The patient is sick (vomits) and the seizure does not stop within 10 minutes
You give too much BUCCOLAM and there are signs of overdose which include:
- Drowsiness, tiredness, fatigue
- Confusion or feeling disorientated
- Absence of knee reflex or a response to a pinch
- Breathing difficulties (slow or shallow breathing)
- Low blood pressure (giddiness and feeling faint)
- Coma

If the patient vomits

Do not give the patient another dose of BUCCOLAM.
If the seizure does not stop within 10 minutes, call an ambulance.

Paediatric Demonstration Video

Adult Demonstration video

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References
1. Buccolam 2.5 mg , 5 mg, 7.5 mg and 10 mg Summaries of Product Characteristics
2. Buccolam 2.5 mg , 5 mg, 7.5 mg and 10 mg Patient Information Leaflet

This information is intended for use by healthcare professionals.

NXUK/E/1125/01 December 2025