Information

for the user

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

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

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

Step 1

combination

narcotic analgesics

killers), e.g. fentanyl

(very strong pain

BUCCOLAM ® 7.5 mg oromucosal solution For children aged 5 years to less than 10 years

medicines used to ri e.g. atorvastatin

medicines used to ti nabilone

educe fat in the blood,

:reat nausea, e.g.

Ta thi

ike the syringe out of ie tube.

Hold the plastic tube, break the seal at one end and pull the cap off.

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 excite hallucinations (seei hearing things that Muscle spasms and

ment), or ng and possibly are not really there) I muscle tremors

BUCCOLAM ® 10 mg oromucosal solution For children aged 10 years to less than 18 years

hypnotics (sleep inducing medicines) sedative antidepressants (medicines used

to treat depression

that make you sleepy)

Midaz

olam

Read all of this leaflet carefully, before

sedatives (medicines that relax you) anaesthetics (for pain relief)

you start giving this

medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it

again.

If you have any furt

her questions, ask

your doctor or pharmacist.

This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of

illness are the same

as those of the child

for whom this medicine has been prescribed.

If you see any side effects, talk to your

doctor or pharmacist possible side effects

it. This includes any i not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What BUCCOLAM is

and what it is used for

2.

3.

4.

5.

6.

What you need to know before you give BUCCOLAM

How to give BUCCOLAM

Possible side effects

How to store BUCCOLAM

Contents of the pack and other information

in infants, toddlers, chil (from 3 months to less

Idren and adolescents 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 equip This medicine must onh

iment is available. y be used by

parents/carers where the child has been diagnosed to have epilepsy.

2. What you need to give BUCCOLAM

know before you

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 wea gravis)

kness (myasthenia

Severe difficulty breathing at rest (BUCCOLAM can make breathing

difficulties worse) An illness causing fri breathing during sle< syndrome)

equent interruption of ;ep (sleep apnoea

• Severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:

A kidney, liver or he< A lung condition that breathing on a regul

■art condition it causes difficulty lar 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 should not be given to than 3 months since th information in this age

3 months : BUCCOLAM children younger iere is not enough 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

Tell your doctor or phar

I BUCCOLAM

macist 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. ket

oconazole,

voriconazole, fluconazole, itraconazole, pozaconazole

antihistamines (to t

reat 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. increased drowsiness)

baclofen (causing

. 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 medicines the patient taking BUCCOLAM.

pharmacist about should avoid whilst

BUCCOLAM with food and drink

The patient must not drink alcohol while taking BUCCOLAM. Alcohol may increase the

sedative effects of this them very sleepy.

The patient must not d

medicine and make

rink 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

BUCCOLAM may make forgetful or affect their

the patient sleepy, concentration and

co-ordination. This may affect their

performance at skilled

tasks such as driving,

riding a bicycle, or using machines.

After receiving this me should not drive a vehi

dicine, the patient icle, ride a bicycle or

operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.

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

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 । the syringe containing

Depending on age, y

carton, the tube and the medicine.

our child will have

received one of the following doses, in

specifically colour la

belled 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 thi:

If the child is having a

s medicine

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.

How to give this medicine

Ask a doctor, pharmaci

st 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.

Step 2

Step 3

(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 redness of the face

, slow heart rate, or and neck (flushing)

Step 4

Using the finger and

th

umb gently pinch and

pull back the child’s cheek. Put the tip of the syringe into the back of

th

ie space between the

inside of the cheek and

th

ie lower gum.

Sl

owly press the

syringe plunger until

th

e 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.------

When to call an amb

ulance

ALWAYS follow the treatment advice provided

by the patient’s doctor

or as explained by a

healthcare professiona. If in any doubt, call

for immediate medical

help if:

The seizure does net 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 You observe signs ol

breathing or blue lips f a heart attack which

may include chest pain or pain that

spreads to the neck down the left arm The child is sick (voi

and shoulders and

mits) 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 fee ing disorientated

Absence of knee to a pinch

reflex or a response

Breathing difficu ties (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 (v

• Do not give the path BUCCOLAM.

omits)

ent another dose of

• 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.

effects, although not evi

Serious side effects

erybody gets them.

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

• experiences the followi Severe breathing di

ing:

fficulties 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 si this leaflet.

ide effects not listed in

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

• 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: or search for MHRA Yellow Card in the Google

Play or Apple App Ston By reporting side effect

e.

ts you can help

provide more information on the safety of this medicine.

sodium hydroxide (for

pH adjustment).

Information

for the user

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

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

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

Step 1

combination

narcotic analgesics

killers), e.g. fentanyl

(very strong pain

BUCCOLAM ® 7.5 mg oromucosal solution For children aged 5 years to less than 10 years

medicines used to ri e.g. atorvastatin

medicines used to ti nabilone

educe fat in the blood,

:reat nausea, e.g.

Ta thi

ike the syringe out of ie tube.

Hold the plastic tube, break the seal at one end and pull the cap off.

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 excite hallucinations (seei hearing things that Muscle spasms and

ment), or ng and possibly are not really there) I muscle tremors

BUCCOLAM ® 10 mg oromucosal solution For children aged 10 years to less than 18 years

hypnotics (sleep inducing medicines) sedative antidepressants (medicines used

to treat depression

that make you sleepy)

Midaz

olam

Read all of this leaflet carefully, before

sedatives (medicines that relax you) anaesthetics (for pain relief)

you start giving this

medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it

again.

If you have any furt

her questions, ask

your doctor or pharmacist.

This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of

illness are the same

as those of the child

for whom this medicine has been prescribed.

If you see any side effects, talk to your

doctor or pharmacist possible side effects

it. This includes any i not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What BUCCOLAM is

and what it is used for

2.

3.

4.

5.

6.

What you need to know before you give BUCCOLAM

How to give BUCCOLAM

Possible side effects

How to store BUCCOLAM

Contents of the pack and other information

in infants, toddlers, chil (from 3 months to less

Idren and adolescents 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 equip This medicine must onh

iment is available. y be used by

parents/carers where the child has been diagnosed to have epilepsy.

2. What you need to give BUCCOLAM

know before you

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 wea gravis)

kness (myasthenia

Severe difficulty breathing at rest (BUCCOLAM can make breathing

difficulties worse) An illness causing fri breathing during sle< syndrome)

equent interruption of ;ep (sleep apnoea

• Severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:

A kidney, liver or he< A lung condition that breathing on a regul

■art condition it causes difficulty lar 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 should not be given to than 3 months since th information in this age

3 months : BUCCOLAM children younger iere is not enough 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

Tell your doctor or phar

I BUCCOLAM

macist 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. ket

oconazole,

voriconazole, fluconazole, itraconazole, pozaconazole

antihistamines (to t

reat 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. increased drowsiness)

baclofen (causing

. 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 medicines the patient taking BUCCOLAM.

pharmacist about should avoid whilst

BUCCOLAM with food and drink

The patient must not drink alcohol while taking BUCCOLAM. Alcohol may increase the

sedative effects of this them very sleepy.

The patient must not d

medicine and make

rink 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

BUCCOLAM may make forgetful or affect their

the patient sleepy, concentration and

co-ordination. This may affect their

performance at skilled

tasks such as driving,

riding a bicycle, or using machines.

After receiving this me should not drive a vehi

dicine, the patient icle, ride a bicycle or

operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.

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

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 । the syringe containing

Depending on age, y

carton, the tube and the medicine.

our child will have

received one of the following doses, in

specifically colour la

belled 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 thi:

If the child is having a

s medicine

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.

How to give this medicine

Ask a doctor, pharmaci

st 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.

Step 2

Step 3

(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 redness of the face

, slow heart rate, or and neck (flushing)

Step 4

Using the finger and

th

umb gently pinch and

pull back the child’s cheek. Put the tip of the syringe into the back of

th

ie space between the

inside of the cheek and

th

ie lower gum.

Sl

owly press the

syringe plunger until

th

e 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.------

When to call an amb

ulance

ALWAYS follow the treatment advice provided

by the patient’s doctor

or as explained by a

healthcare professiona. 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 You observe signs ol

breathing or blue lips f a heart attack which

may include chest pain or pain that

spreads to the neck down the left arm The child is sick (voi

and shoulders and

mits) 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 fee ing disorientated

Absence of knee to a pinch

reflex or a response

Breathing difficu ties (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 (v

• Do not give the path BUCCOLAM.

omits)

ent another dose of

• 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.

effects, although not evi

Serious side effects

erybody gets them.

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

• experiences the followi Severe breathing di

ing:

fficulties 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 si this leaflet.

ide effects not listed in

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

• 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: or search for MHRA Yellow Card in the Google

Play or Apple App Ston By reporting side effect

e.

ts you can help

provide more information on the safety of this medicine.

sodium hydroxide (for

pH adjustment).

Information

for the user

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

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

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

Step 1

combination

narcotic analgesics

killers), e.g. fentanyl

(very strong pain

BUCCOLAM ® 7.5 mg oromucosal solution For children aged 5 years to less than 10 years

medicines used to ri e.g. atorvastatin

medicines used to ti nabilone

educe fat in the blood,

:reat nausea, e.g.

Ta thi

ike the syringe out of ie tube.

Hold the plastic tube, break the seal at one end and pull the cap off.

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 excite hallucinations (seei hearing things that Muscle spasms and

ment), or ng and possibly are not really there) I muscle tremors

BUCCOLAM ® 10 mg oromucosal solution For children aged 10 years to less than 18 years

hypnotics (sleep inducing medicines) sedative antidepressants (medicines used

to treat depression

that make you sleepy)

Midaz

olam

Read all of this leaflet carefully, before

sedatives (medicines that relax you) anaesthetics (for pain relief)

you start giving this

medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it

again.

If you have any furt

her questions, ask

your doctor or pharmacist.

This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of

illness are the same

as those of the child

for whom this medicine has been prescribed.

If you see any side effects, talk to your

doctor or pharmacist possible side effects

it. This includes any i not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What BUCCOLAM is

and what it is used for

2.

3.

4.

5.

6.

What you need to know before you give BUCCOLAM

How to give BUCCOLAM

Possible side effects

How to store BUCCOLAM

Contents of the pack and other information

in infants, toddlers, chil (from 3 months to less

Idren and adolescents 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 equip This medicine must onh

iment is available. y be used by

parents/carers where the child has been diagnosed to have epilepsy.

2. What you need to give BUCCOLAM

know before you

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 wea gravis)

kness (myasthenia

Severe difficulty breathing at rest (BUCCOLAM can make breathing

difficulties worse) An illness causing fri breathing during sle< syndrome)

equent interruption of ;ep (sleep apnoea

• Severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:

A kidney, liver or he< A lung condition that breathing on a regul

■art condition it causes difficulty lar 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 should not be given to than 3 months since th information in this age

3 months : BUCCOLAM children younger iere is not enough 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

Tell your doctor or phar

I BUCCOLAM

macist 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. ket

oconazole,

voriconazole, fluconazole, itraconazole, pozaconazole

antihistamines (to t

reat 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. increased drowsiness)

baclofen (causing

. 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 medicines the patient taking BUCCOLAM.

pharmacist about should avoid whilst

BUCCOLAM with food and drink

The patient must not drink alcohol while taking BUCCOLAM. Alcohol may increase the

sedative effects of this them very sleepy.

The patient must not d

medicine and make

rink 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

BUCCOLAM may make forgetful or affect their

the patient sleepy, concentration and

co-ordination. This may affect their

performance at skilled

tasks such as driving,

riding a bicycle, or using machines.

After receiving this me should not drive a vehi

dicine, the patient icle, ride a bicycle or

operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.

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

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 । the syringe containing

Depending on age, y

carton, the tube and the medicine.

our child will have

received one of the following doses, in

specifically colour la

belled 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 thi:

If the child is having a

s medicine

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.

How to give this medicine

Ask a doctor, pharmaci

st 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.

Step 2

Step 3

(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 redness of the face

, slow heart rate, or and neck (flushing)

Step 4

Using the finger and

th

umb gently pinch and

pull back the child’s cheek. Put the tip of the syringe into the back of

th

ie space between the

inside of the cheek and

th

ie lower gum.

Sl

owly press the

syringe plunger until

th

e 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.------

When to call an amb

ulance

ALWAYS follow the treatment advice provided

by the patient’s doctor

or as explained by a

healthcare professiona. If in any doubt, call

for immediate medical

help if:

The seizure does net 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 You observe signs ol

breathing or blue lips f a heart attack which

may include chest pain or pain that

spreads to the neck down the left arm The child is sick (voi

and shoulders and

mits) 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 fee ing disorientated

Absence of knee to a pinch

reflex or a response

Breathing difficu ties (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 (v

• Do not give the path BUCCOLAM.

omits)

ent another dose of

• 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.

effects, although not evi

Serious side effects

erybody gets them.

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

• experiences the followi Severe breathing di

ing:

fficulties 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 si this leaflet.

ide effects not listed in

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

• 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: or search for MHRA Yellow Card in the Google

Play or Apple App Ston By reporting side effect

e.

ts you can help

provide more information on the safety of this medicine.

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

BUCCOLAM oromucosal solution is a clear

colourless liquid. It is s

upplied in an amber

coloured pre-filled, single-use oral syringe. Each oral syringe is individually packed in a

protective plastic tube. in cartons containing 2 syringes/tubes (of the Not all pack sizes may

BUCCOLAM is available i and 4 pre-filled oral same dose). be marketed.

Marketing Authorisation Holder

Laboratorios Lesvi, S.L.

Avda. Barcelona 69

08970 Sant Joan Desp^

Barcelona – Spain

E-mail: medinfo@lesvi

.com

Local Representative

Neuraxpharm UK Limited

Tel: 0118 211 4039

Manufacturer

Wasdell Manufacturing Units 3&4

Gateway West Greenfinch Way Newburn

Newcastle upon Tyne

Limited

NE15 8NX United Kingdom

This leaflet was last

revised in July 2021

Information

for the user

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

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

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

Step 1

combination

narcotic analgesics

killers), e.g. fentanyl

(very strong pain

BUCCOLAM ® 7.5 mg oromucosal solution For children aged 5 years to less than 10 years

medicines used to ri e.g. atorvastatin

medicines used to ti nabilone

educe fat in the blood,

:reat nausea, e.g.

Ta thi

ike the syringe out of ie tube.

Hold the plastic tube, break the seal at one end and pull the cap off.

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 excite hallucinations (seei hearing things that Muscle spasms and

ment), or ng and possibly are not really there) I muscle tremors

BUCCOLAM ® 10 mg oromucosal solution For children aged 10 years to less than 18 years

hypnotics (sleep inducing medicines) sedative antidepressants (medicines used

to treat depression

that make you sleepy)

Midaz

olam

Read all of this leaflet carefully, before

sedatives (medicines that relax you) anaesthetics (for pain relief)

you start giving this

medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it

again.

If you have any furt

her questions, ask

your doctor or pharmacist.

This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of

illness are the same

as those of the child

for whom this medicine has been prescribed.

If you see any side effects, talk to your

doctor or pharmacist possible side effects

it. This includes any i not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What BUCCOLAM is

and what it is used for

2.

3.

4.

5.

6.

What you need to know before you give BUCCOLAM

How to give BUCCOLAM

Possible side effects

How to store BUCCOLAM

Contents of the pack and other information

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 infants, toddlers, chil (from 3 months to less

Idren and adolescents 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 equip This medicine must onh

iment is available. y be used by

parents/carers where the child has been diagnosed to have epilepsy.

2. What you need to give BUCCOLAM

know before you

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 wea gravis)

kness (myasthenia

Severe difficulty breathing at rest (BUCCOLAM can make breathing

difficulties worse) An illness causing fri breathing during sle< syndrome)

equent interruption of ;ep (sleep apnoea

• Severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:

A kidney, liver or he< A lung condition that breathing on a regul

■art condition it causes difficulty lar 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 should not be given to than 3 months since th information in this age

3 months : BUCCOLAM children younger iere is not enough 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

Tell your doctor or phar

I BUCCOLAM

macist 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. ket

oconazole,

voriconazole, fluconazole, itraconazole, pozaconazole

antihistamines (to t

reat 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. increased drowsiness)

baclofen (causing

. 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 medicines the patient taking BUCCOLAM.

pharmacist about should avoid whilst

BUCCOLAM with food and drink

The patient must not drink alcohol while taking BUCCOLAM. Alcohol may increase the

sedative effects of this them very sleepy.

The patient must not d

medicine and make

rink 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

BUCCOLAM may make forgetful or affect their

the patient sleepy, concentration and

co-ordination. This may affect their

performance at skilled

tasks such as driving,

riding a bicycle, or using machines.

After receiving this me should not drive a vehi

dicine, the patient icle, ride a bicycle or

operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.

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

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 । the syringe containing

Depending on age, y

carton, the tube and the medicine.

our child will have

received one of the following doses, in

specifically colour la

belled 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 thi:

If the child is having a

s medicine

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.

How to give this medicine

Ask a doctor, pharmaci

st 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.

Step 2

Step 3

(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 redness of the face

, slow heart rate, or and neck (flushing)

Step 4

Using the finger and

th

umb gently pinch and

pull back the child’s cheek. Put the tip of the syringe into the back of

th

ie space between the

inside of the cheek and

th

ie lower gum.

Sl

owly press the

syringe plunger until

th

e 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.------

When to call an amb

ulance

ALWAYS follow the treatment advice provided

by the patient’s doctor

or as explained by a

healthcare professiona. 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 You observe signs ol

breathing or blue lips f a heart attack which

may include chest pain or pain that

spreads to the neck down the left arm The child is sick (voi

and shoulders and

mits) 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 fee ing disorientated

Absence of knee to a pinch

reflex or a response

Breathing difficu ties (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 (v

• Do not give the path BUCCOLAM.

omits)

ent another dose of

• 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 evi

Serious side effects

erybody gets them.

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

• experiences the followi Severe breathing di

ing:

fficulties 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 si this leaflet.

ide effects not listed in

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

• 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: or search for MHRA Yellow Card in the Google

Play or Apple App Ston By reporting side effect

e.

ts 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.—

Do not use this medicine if the packaging has been opened or damaged.

Disposal of oral syring es

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 to less than 18 years: 10 mg – orange labelled packaging

BUCCOLAM oromucosal solution is a clear

colourless liquid. It is s

upplied in an amber

coloured pre-filled, single-use oral syringe. Each oral syringe is individually packed in a

protective plastic tube. in cartons containing 2 syringes/tubes (of the Not all pack sizes may

BUCCOLAM is available i and 4 pre-filled oral same dose).

be marketed.

Marketing Authorisation Holder

Laboratorios Lesvi, S.L.

Avda. Barcelona 69

08970 Sant Joan Desp^

Barcelona – Spain

E-mail: medinfo@lesvi

.com

Local Representative

Neuraxpharm UK Limited

Tel: 0118 211 4039

Manufacturer

Shire Pharmaceuticals

Ireland Limited

Block 2 & 3 Miesian Plaza 50–58 Baggot Street Lower Dublin 2

D02 Y754

Ireland

This leaflet was last July 2021

revised in

Information

for the user

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

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

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

Step 1

combination

narcotic analgesics

killers), e.g. fentanyl

(very strong pain

BUCCOLAM ® 7.5 mg oromucosal solution For children aged 5 years to less than 10 years

medicines used to ri e.g. atorvastatin

medicines used to ti nabilone

educe fat in the blood,

:reat nausea, e.g.

Ta thi

ike the syringe out of ie tube.

Hold the plastic tube, break the seal at one end and pull the cap off.

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 excite hallucinations (seei hearing things that Muscle spasms and

ment), or ng and possibly are not really there) I muscle tremors

BUCCOLAM ® 10 mg oromucosal solution For children aged 10 years to less than 18 years

hypnotics (sleep inducing medicines) sedative antidepressants (medicines used

to treat depression

that make you sleepy)

Midaz

olam

Read all of this leaflet carefully, before

sedatives (medicines that relax you) anaesthetics (for pain relief)

you start giving this

medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it

again.

If you have any furt

her questions, ask

your doctor or pharmacist.

This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of

illness are the same

as those of the child

for whom this medicine has been prescribed.

If you see any side effects, talk to your

doctor or pharmacist possible side effects

it. This includes any i not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What BUCCOLAM is

and what it is used for

2.

3.

4.

5.

6.

What you need to know before you give BUCCOLAM

How to give BUCCOLAM

Possible side effects

How to store BUCCOLAM

Contents of the pack and other information

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 infants, toddlers, chil (from 3 months to less

Idren and adolescents 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 equip This medicine must onh

iment is available. y be used by

parents/carers where the child has been diagnosed to have epilepsy.

2. What you need to give BUCCOLAM

know before you

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 wea gravis)

kness (myasthenia

Severe difficulty breathing at rest (BUCCOLAM can make breathing

difficulties worse) An illness causing fri breathing during sle< syndrome)

equent interruption of ;ep (sleep apnoea

• Severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:

A kidney, liver or he< A lung condition that breathing on a regul

■art condition it causes difficulty lar 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 should not be given to than 3 months since th information in this age

3 months : BUCCOLAM children younger iere is not enough 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

Tell your doctor or phar

I BUCCOLAM

macist 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. ket

oconazole,

voriconazole, fluconazole, itraconazole, pozaconazole

antihistamines (to t

reat 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. increased drowsiness)

baclofen (causing

. 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 medicines the patient taking BUCCOLAM.

pharmacist about should avoid whilst

BUCCOLAM with food and drink

The patient must not drink alcohol while taking BUCCOLAM. Alcohol may increase the

sedative effects of this them very sleepy.

The patient must not d

medicine and make

rink 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

BUCCOLAM may make forgetful or affect their

the patient sleepy, concentration and

co-ordination. This may affect their

performance at skilled

tasks such as driving,

riding a bicycle, or using machines.

After receiving this me should not drive a vehi

dicine, the patient icle, ride a bicycle or

operate a machine until they have completely recovered. Please discuss with your doctor if you need further advice.

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

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 । the syringe containing

Depending on age, y

carton, the tube and the medicine.

our child will have

received one of the following doses, in

specifically colour la

belled 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 thi:

If the child is having a

s medicine

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.

How to give this medicine

Ask a doctor, pharmaci

st 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.

Step 2

Step 3

(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 redness of the face

, slow heart rate, or and neck (flushing)

Step 4

Using the finger and

th

umb gently pinch and

pull back the child’s cheek. Put the tip of the syringe into the back of

th

ie space between the

inside of the cheek and

th

ie lower gum.

Sl

owly press the

syringe plunger until

th

e 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.------

When to call an amb

ulance

ALWAYS follow the treatment advice provided

by the patient’s doctor

or as explained by a

healthcare professiona. If in any doubt, call

for immediate medical

help if:

The seizure does net 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 You observe signs ol

breathing or blue lips f a heart attack which

may include chest pain or pain that

spreads to the neck down the left arm The child is sick (voi

and shoulders and

mits) 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 fee ing disorientated

Absence of knee to a pinch

reflex or a response

Breathing difficu ties (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 (v

• Do not give the path BUCCOLAM.

omits)

ent another dose of

• 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 evi

Serious side effects

erybody gets them.

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

• experiences the followi Severe breathing di

ing:

fficulties 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 si this leaflet.

ide effects not listed in

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

• 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: or search for MHRA Yellow Card in the Google

Play or Apple App Ston By reporting side effect

e.

ts 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.—

Do not use this medicine if the packaging has been opened or damaged.

Disposal of oral syring es

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.

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 to less than 18 years: 10 mg – orange labelled packaging

BUCCOLAM oromucosal solution is a clear

colourless liquid. It is s

upplied in an amber

coloured pre-filled, single-use oral syringe. Each oral syringe is individually packed in a

protective plastic tube. in cartons containing 2 syringes/tubes (of the Not all pack sizes may

BUCCOLAM is available i and 4 pre-filled oral same dose).

be marketed.

Marketing Authorisation Holder

Laboratorios Lesvi, S.L.

Avda. Barcelona 69

08970 Sant Joan Desp^

Barcelona – Spain

E-mail: medinfo@lesvi

.com

Local Representative Neuraxpharm UK Limited Tel: 0118 211 4039

Manufacturer

Laboratorios Lesvi, S.L.

Avda. Barcelona 69 08970 Sant Joan Desp^ Barcelona – Spain

This leaflet was last

revised in July 2021