Patient leaflet - Buccolam 2.5 mg Oromucosal solution
1. What BUCCOLAM is and what it is used for
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 adults, adolescents, children and infants aged 3 months and above. 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 patient has been diagnosed to have epilepsy.
2. What you need to know before you give BUCCOLAM
Do not give BUCCOLAM if the patient has:
An allergy to midazolam, benzodiazepines
(such as diazepam) or any of the other ingredients of this medicine (listed in section 6)
A disease of the nerves and muscles
causing muscle weakness (myasthenia gravis)
Severe difficulty breathing at rest
(BUCCOLAM can make breathing difficulties worse)
An illness causing frequent interruption of
breathing during sleep (sleep apnoea syndrome)
- Severe liver problems.
Warnings and precautions
Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:
- A kidney, liver or heart condition
A lung condition that causes difficulty
breathing on a regular basis.
This medicine may cause people to forget what happened after they have been given it. Patients should be observed carefully after being given the medicine.
This medicine should be avoided in patients with a medical history of alcohol or drug abuse.
Life threatening incidents are more likely in patients with breathing difficulties or heart problems, especially when higher doses of BUCCOLAM are given.
Children younger than 3 months: BUCCOLAM should not be given to children younger than 3 months since there is not enough information in this age group.
If you are not sure if any of the above applies to the patient, talk to a doctor or pharmacist before giving this medicine. Other medicines and BUCCOLAM
Tell your doctor or pharmacist if the patient is taking, or 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 BUCCOLAM, 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 BUCCOLAM 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, pozaconazole
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 BUCCOLAM 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 BUCCOLAM.
BUCCOLAM 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).
Talk to your doctor or pharmacist about medicines the patient should avoid whilst taking BUCCOLAM.
BUCCOLAM with food and drink
The patient must not drink alcohol while taking BUCCOLAM. Alcohol may increase the sedative effects of this medicine and make them very sleepy.
The patient must not drink grapefruit juice while taking BUCCOLAM. Grapefruit juice may increase the sedative effects of this medicine and make them very sleepy. Pregnancy
If the patient who will be given this medicine is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask a doctor for advice before taking this medicine.
Giving high doses of BUCCOLAM during the last 3 months of pregnancy can cause abnormal heart beat in the unborn child. Babies born after this medicine is administered during childbirth can also have poor suckling, breathing difficulties and poor muscle tone at birth.
Breast-feeding
Tell the doctor if the patient is
breast-feeding. Even though small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to stop
breast-feeding. The doctor will advise if the patient should breast-feed after being given this medicine.
Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine
until you know how it affects you.
It is an offence to drive if this medicine
affects your ability to drive.
However, you would not be committing an
offence if:
o The medicine has been prescribed to
treat a medical or dental problem and
o You have taken it according to the
instructions given by the prescriber or in the information provided with the medicine and
o It was not affecting your ability to
drive safely
Talk to you doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
BUCCOLAM may make the patient sleepy, forgetful or affect their concentration and co-ordination. This may affect their performance at skilled tasks such as driving, riding a bicycle, or using machines.
After receiving this medicine, the patient should not drive a vehicle, ride a bicycle or operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.
BUCCOLAM contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per oral syringe, that is to say essentially ‘sodium-free’.
3. How to give BUCCOLAM
Always give this medicine exactly as a doctor has told you. Check with a doctor or pharmacist if you are not sure.
Dosage
The doctor will prescribe the appropriate dose of BUCCOLAM the patient needs, generally according to the patient 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, the patient 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 and above:
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 patient 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 the patient’s head head with something soft, such as a cushion or your lap. Check that the medicine is the correct dose for the patient, according to their age. 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. 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 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 patient’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 patient’s mouth.
When to call an ambulance
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 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
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 patient is sick (vomits)
Do not give the patient another dose of
BUCCOLAM.
- If the seizure does not stop within 10 minutes, call an ambulance. If you have any further questions on the use of this medicine, ask a 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 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 patient’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, or a pale skin, a weak and rapid pulse, or feeling of loss of consciousness. You may be having a serious allergic reaction. 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 in this leaflet.
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 up to 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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme,
Website: 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 BUCCOLAM 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.
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 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). What BUCCOLAM looks like and contents of the pack
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 and above:
10 mg - orange labelled packaging BUCCOLAM oromucosal solution is a clear colourless to yellowish liquid. It is supplied in an amber coloured pre-filled, single-use oral syringe. Each oral syringe is individually packed in a protective plastic tube. BUCCOLAM is available in cartons containing 2 and 4 pre-filled oral syringes/tubes (of the same dose). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Neuraxpharm Pharmaceuticals, S.L. Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona - Spain
E-mail: medinfo@neuraxpharm.com
Local Representative
Neuraxpharm UK Limited
Tel: 0118 211 4039
Manufacturer
Wasdell Manufacturing Limited
Units 3&4
Gateway West
Greenfinch Way
Newburn
Newcastle upon Tyne
NE15 8NX United Kingdom
This leaflet was last revised in September 2024
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