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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: PLGB 16869/0020.
BUCCOLAM 2.5mg, 5mg, 7.5mg and 10 mg oromucosal solution
BUCCOLAM 2.5 mg oromucosal solution
For children aged 3 months to less than 1 year
BUCCOLAM 5 mg oromucosal solution
For children aged 1 year to less than 5 years
BUCCOLAM 7.5 mg oromucosal solution
For children aged 5 years to less than 10 years
BUCCOLAM 10 mg oromucosal solution
For adults and children aged 10 years and above
Midazolam
1. What BUCCOLAM is and what it is used for
2. What you need to know before you give BUCCOLAM
3. How to give BUCCOLAM
4. Possible side effects
5. How to store BUCCOLAM
6. Contents of the pack and other information
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.
Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:
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.
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:
The effects of BUCCOLAM may be reduced by medicines such as:
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.
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.
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.
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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
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.
This medicine contains less than 1 mmol sodium (23 mg) per oral syringe, that is to say essentially ‘sodium-free’.
Always give this medicine exactly as a doctor has told you. Check with a doctor or pharmacist if you are not sure.
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.
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 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.
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.
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:
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 you have any further questions on the use of this medicine, ask a doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical advice immediately or telephone for an ambulance if the patient experiences the following:
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):
Uncommon side effects (may affect up to 1 in 100 people):
Very rare side effects (may affect up to 1 in 10,000 people):
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.
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 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.
The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).
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.
This leaflet was last revised in September 2024