Frequently Asked Questions (FAQ’s)

Questions

Please, always refer to the Patient Information Leaflet (PIL).

What Is Buccolam And What Is It Used For?1

Buccolam contains a medicine called midazolam. Midazolam belongs to a group of medicines known as benzodiazepines. Buccolam is used to stop a sudden, prolonged, convulsive, seizure in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age). In infants from 3 months to less than 6 months it should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available. This medicine must only be used by parents/carers where the child has been diagnosed to have epilepsy.

What Is The Generic Name Of Buccolam?2

  • Oromucosal midazolam 2.5mg in 0.5ml (as hydrochloride).
  • Oromucosal midazolam 5mg in 1ml (as hydrochloride).
  • Oromucosal midazolam 7.5mg in 1.5ml (as hydrochloride).
  • Oromucosal midazolam 10mg in 2ml (as hydrochloride).

How Do I Give Buccolam?1

Please, always refer to the Patient Information Leaflet (PIL).

Always give this medicine exactly as a doctor has told you. Check with a doctor or pharmacist if you are not sure.

Dosage

Your doctor will prescribe the appropriate dose of Buccolam your child needs, generally according to your child’s age. The different doses each have a different colour, which is shown on the carton, the tube and the syringe containing the medicine.

Depending on age, your child will have received one of the following doses, in specifically colour labelled packaging:

  • 3 months to less than 1 year: 2.5 mg – yellow labelled packaging
  • 1 year to less than 5 years: 5 mg – blue labelled packaging
  • 5 years to less than 10 years: 7.5 mg – purple labelled packaging
  • 10 years to less than 18 years: 10 mg – orange labelled packaging

The dose is the full contents of one oral syringe. Do not give more than one dose.

Toddlers aged from 3 months to less than 6 months should only be treated in a hospital setting where monitoring is possible and resuscitation equipment is available.

Preparing to give this medicine

If the child is having a seizure, allow their body to move freely, do not try to restrain them. Only move them if they are in danger from, for example, deep water, fire or sharp objects.

Support your child’s head with something soft, such as a cushion or your lap.

Check that the medicine is the correct dose for your child, according to their age.

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.

The information on how to give this medicine is also shown on the tube label.

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

  • Step 1 Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube.
  • Step 2 Pull the red cap off the tip of the syringe and dispose of it safely.
  • Step 3 Using the finger and thumb gently pinch and pull back the child’s cheek. Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.
  • Step 4 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 child’s mouth.

Can I Give Another Dose Of Buccolam?3

Unless stated on the patient’s Care Plan, never give another dose of Buccolam, even if the seizure does not stop within 10 minutes or if the patients vomits or salivates, never give another dose of Buccolam. Call an ambulance if the seizure does not stop in 10 minutes or if the patient vomits or salivates

Do I Need To Call ‘999’?1

Always follow the treatment advice provided by the patient’s doctor or as explained 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 child’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 child 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

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

Do not give more than the amount of medicine prescribed by a doctor for the patient.

If the child is sick (vomits)

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

Are There Any Side Effects Of Buccolam?1

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

Serious side effects

Seek medical advice immediately or telephone for an ambulance if the patient experiences the following:

  • Severe breathing difficulties e.g. slow or shallow breathing or blue lips. In very rare cases breathing might stop.
  • Heart attack. Signs may include chest pain which may spread to the child’s neck and shoulders and down their left arm.
  • Swelling of the face, lips, tongue or throat which makes it difficult to swallow or breathe.

Other side effects

If the patient gets any side effects, talk to their doctor, pharmacist or nurse. This includes any possible side effects not listed here.

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

  • Feeling and being sick
  • Sleepiness or losing consciousness

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

  • Rash, hives (lumpy rash), itchiness

very rare side effects (may affect 1 in 10,000 people):

  • Agitation, restlessness, hostility, rage or aggression, excitement, confusion, euphoria (an excessive feeling of happiness or excitement), or hallucinations (seeing and possibly hearing things that are not really there)
  • Muscle spasms and muscle tremors (shaking of your muscles that you cannot control)
  • Reduced alertness
  • Headache
  • Dizziness
  • Difficulty co-ordinating muscles
  • Fits (convulsions)
  • Temporary memory loss. How long this lasts depends on how much BUCCOLAM was given
  • Low blood pressure, slow heart rate, or redness of the face and neck (flushing)
  • Laryngospasm (tightening of the vocal cords causing difficult and noisy breathing)
  • Constipation
  • Dry mouth
  • Tiredness
  • Hiccups

How Do I Report A Side Effect Of Buccolam?1

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed here. You can also report side effects directly via the national reporting system (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance
Website: www.hpra.ie

Can I Take Buccolam On Holiday With Me?

Buccolam should always be carried with the patient.

Does It Contain Alcohol?2

Buccolam does not contain alcohol.

How Should Buccolam Be Stored?1

Keep this medicine out of the sight and reach of children. Do not give this medicine after the expiry date which is stated on the carton, tube and oral syringe labels after EXP. The expiry date refers to the last day of that month. Do not refrigerate or freeze. Keep the oral syringe in the protective plastic tube. Do not use this medicine if the packaging has been opened or damaged.

 

What Is The Shelf Life/Expiry?2

  • Buccolam 2.5mg oromucosal solution – 18 months
  • Buccolam 5mg, 7.5mg, 10mg oromucosal solution – 2 years

When Should I Order The Next Box Of Buccolam?

You should order the next box of Buccolam when you need to replace any of the syringes or if the syringes are approaching expiry.

What Is The Purpose Of The Seal On The Lid?3

The sole purpose of the seal on the lid is to keep the syringe in the tube. On occasions the seal for the lid on the protective tube may not be intact. Broken retaining seals do not compromise product quality or syringe use.

Should Buccolam Be Written Into My Child’s Care Plan?

Buccolam should be written into the Care Plan so that everyone who is involved with your child’s care is aware of what Buccolam is, why it has been prescribed and when it might be needed.

Will Our GP Know That My Child Has Been Prescribed Buccolam?

Your GP will have been sent a copy of the Care plan from the specialist who initiated Buccolam and may be requested to take over prescribing Buccolam for your child as often as they need it.

How Long Will My Child Need To Be Prescribed Buccolam?

Your child will need to be prescribed Buccolam for as long as they experience episodes of prolonged, acute, convulsive seizures (PACS).

Who Will Train Me To Use Buccolam?

You should have been trained to use Buccolam when it was initiated in Secondary Care. This is usually carried out by the Epilepsy Nurse Specialist. The Buccolam administration video is also available to aid training and increase confidence.

What Are The Ingredients?1

Buccolam contains:

  • The active substance is midazolam
  • Each 2.5 mg pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution.
  • Each 5 mg pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution.
  • Each 7.5 mg pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution.
  • Each 10 mg pre-filled oral syringe contains 10 mg midazolam (as hydrochloride) in 2 ml solution.

The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).

References:

  1. Buccolam Patient Information Leaflet (PIL). Available at: https://www.medicines.org.uk/emc/files/pil.2768.pdf (accessed 8 June 2021)
  2. Buccolam, Summary of Product Characteristics. Available at: http://www.medicines.org.uk/ (accessed 8 June 2021)
  3. Buccolam Administration Leaflet – How to administer Buccolam. Available at: http://www.buccolam.co.uk/patient/about-buccolam.html (accessed 8 June 2021)

This information is provided as a resource for patients who have been prescribed Buccolam by their doctor or other healthcare professional.

Reporting of adverse events (Healthcare Professionals in the UK)

Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Neuraxpharm. at: pv-uk@neuraxpharm.com