2.5 mg oral solution for children aged 3 months to less than 1 year, 5 mg oral solution for children aged 1 year to under 5 years, 7.5 mg oral solution for children aged 5 years to less than 10 years, and 10 mg oral solution for children aged 10 to under 18 years. 
midazolam

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for your child only. Do not give it to others. It can harm them, even if they show signs of illness similar to your child’s.
  • If you notice any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What BUCCOLAM is and what it is used for 
2. What you need to know before giving BUCCOLAM 
3. How to give BUCCOLAM 
4. Possible side effects 
5. How to store BUCCOLAM 
6. Contents of the packaging 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 called benzodiazepines. BUCCOLAM is used to stop a sudden, prolonged seizure in infants, toddlers, children, and adolescents (from 3 months to under 18 years of age).

In infants aged 3 months to less than 6 months, this medicine should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available.

This medicine should only be used by parents/carers of patients who have been diagnosed with epilepsy.

2. What you need to know before giving BUCCOLAM

Do not give your child BUCCOLAM if he/she:

  • is allergic to midazolam, benzodiazepines (eg diazepam ), or any of the other ingredients of this medicine (listed in section 6)
  • has a disease of the nerves and muscles that causes muscle weakness ( myasthenia gravis )
  • have great difficulty breathing at rest (BUCCOLAM may aggravate breathing difficulties)
  • have a disease that causes a large number of pauses in breathing during sleep (sleep apnea syndrome)
  • have severe liver problems.

Warnings and cautions

Talk to your doctor or pharmacist before giving BUCCOLAM to your child if he/she has:

  • a disease that affects the kidneys, liver, or heart
  • a lung disease that regularly causes breathing difficulties.

This medicine may make you forget what happened after you received it. Patients should be closely monitored after receiving the drug.

This medicine should be avoided in patients who abuse/have abused alcohol or drugs.

The risk of life-threatening incidents is greater for patients with breathing difficulties or heart problems, especially when high doses of BUCCOLAM are given.

Children under 3 months: BUCCOLAM should not be given to children under 3 months as there is not enough information for this age group.

If you are not sure if any of the above applies to your patient, talk to your doctor or pharmacist before giving BUCCOLAM.

Other medicines and BUCCOLAM

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. If you are at all unsure whether a medicine your child is taking affects the effect of BUCCOLAM, talk to your doctor or pharmacist.

This is extremely important because the concomitant use of more than one medicine may enhance or weaken the effect of these medicines.

The effects of BUCCOLAM may be enhanced by medicines such as:

  • antiepileptics (for the treatment of epilepsy ), e.g. phenytoin
  • antibiotics (for the treatment of infections ), e.g. erythromycin, clarithromycin
  • antifungals (for the treatment of fungal infections), e.g. ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole
  • gastric ulcer medications, e.g. cimetidine, ranitidine, and omeprazole
  • drugs for the treatment of blood pressure, e.g. diltiazem, verapamil
  • certain drugs used to treat HIV and AIDS, e.g. saquinavir, combinations of lopinavir and ritonavir
  • narcotic analgesics (very strong painkillers), e.g. fentanyl
  • drugs used to lower blood fats, e.g. atorvastatin
  • medicines for the treatment of nausea, e.g. nabilone
  • hypnotics (sleeping pills)
  • sedative antidepressants (antidepressants that make you sleepy)
  • sedative (sedative) drugs
  • anesthetics (for pain relief)
  • antihistamines (for the treatment of allergies ).

The effects of BUCCOLAM may be attenuated by drugs such as:

  • rifampicin (for the treatment of tuberculosis )
  • xanthines (for the treatment of asthma )
  • St. John’s wort (an herbal preparation). This should be avoided by patients taking BUCCOLAM.

BUCCOLAM may potentiate the effect of certain muscle relaxants, e.g. baclofen (which causes increased drowsiness). This medicine can also prevent other medicines from working properly, e.g. levodopa (used to treat Parkinson’s disease ).

Talk to your doctor or pharmacist about medicines that your child should avoid when taking BUCCOLAM.

BUCCOLAM with food and drink

The patient must not drink alcohol while taking BUCCOLAM. Alcohol may potentiate the sedative effects of this medicine and make the patient very sleepy.

The patient must not drink grapefruit juice while taking BUCCOLAM. Grapefruit juice can enhance the calming effect of this medicine and make the patient very sleepy.

Pregnancy

Consult a physician before giving this medicine if the patient you are giving it to is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby.

High doses of BUCCOLAM given during the last three months of pregnancy can cause abnormal heart rhythms in the fetus. Children born when this medicine has been given during childbirth may have the poor suction capacity, difficulty breathing, and impaired muscle tension at birth.

Breast-feeding

Tell your doctor if the patient is breast-feeding. Even if small amounts of BUCCOLAM are transferred to breast milk, it does not have to be an obstacle to breastfeeding. The doctor decides if the patient should stop breast-feeding after receiving this medicine.

Driving and using machines

BUCCOLAM can make the patient very sleepy, forgetful, or affect the ability to concentrate and coordinate. This can affect his / her ability to perform advanced tasks such as driving, cycling, or using machines.

After receiving this medicine, the patient should not drive, cycle, or use machines until he/she has fully recovered. Discuss this with your doctor if you need further advice.

3. How to give BUCCOLAM

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose

Your doctor will prescribe the most appropriate dose of BUCCOLAM, generally depending on the age of your child. Each dose has a specific color indicated on the carton, case and syringe of the medicine.

Depending on your age, your child has received one of the following doses in a package marked with a special color:

3 months to less than 1 year: 2.5 mg – packaging with the yellow label

1 year to less than 5 years: 5 mg – packaging with the blue label

5 years to under 10 years: 7.5 mg – packaging with purple label

10 years to under 18 years: 10 mg – packaging with the orange label

Each syringe for oral use (in the oral cavity) contains one dose. Do not give more than one dose .

Young children aged 3 months up to 6 months should only be treated in hospitals where monitoring is possible and resuscitation equipment is available.

Preparations for the administration of this drug

If the child has a seizure, do not try to stop him / her from moving. Just make sure he/she is safe from e.g. deep water, fire, or sharp objects.

Support your child’s head with something soft, such as a pillow or your knee.

Check that the dose of the medicine is the correct one for your child depending on his / her age.

How to give this medicine

Ask your doctor, pharmacist, or nurse to show you how to take or take this medicine. Always ask if you are unsure.

The information on how to give this medicine can also be found on the plastic case label.

BUCCOLAM must not be injected. Do not put a needle on the syringe.


Hold the plastic case, break the seal at one end and remove the hat. Remove the syringe from the plastic case.

step 2

Remove the red cap from the syringe tip and dispose of it safely.


Take a gentle grip with your thumb and forefinger and pull back the baby’s cheek. Insert the syringe tip into the back of the space between the inside of the cheek and the gums of the lower jaw.


Slowly push in the syringe plunger until it stops.
The entire amount of medicine should be slowly injected into the space between the gums and the inside of the cheek (oral cavity).
If your doctor has prescribed it (for larger amounts and / or for small patients), you can first give about half of the doseslowly on one side of the oral cavity and then the remaining dose on the other side.

When should you call for an ambulance?

Always use this medicine exactly as your doctor or other healthcare professional has told you. Seek immediate medical attention if you are unsure or if any of the following occur:

  • The attack does not stop within 10 minutes.
  • You can not give the child the entire contents of the syringe or you spill any of the contents.
  • The child begins to breathe more slowly or stops breathing completely, e.g. have slow or shallow breathing or blue lips.
  • You notice signs of a heart attack, which can manifest itself as chest pain or pain that spreads to the neck and shoulders and down the left arm.
  • The child vomits and the attack does not stop within 10 minutes.
  • You have given too much BUCCOLAM and there are signs of overdose which include:
    • Drowsiness, drowsiness, fatigue
    • Confusion or feeling of disorientation (unclear perception of time and space)
    • No knee flexion or no reaction to a pinch
    • Breathing difficulties (slow or shallow breathing)
    • Low blood pressure (dizziness and fainting)
    • Coma

Save the empty syringe so you can show it to your ambulance or doctor.

Do not give more medicines than the doctor has prescribed for the patient.

If the child vomits

  • Do not give the patient more doses of BUCCOLAM
  • If the attack does not stop within 10 minutes, call an ambulance.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects are

Seek medical attention immediately or call an ambulance if the patient has any of the following signs of illness:

  • Severe breathing difficulties, e.g. slow or shallow breathing or blue lips. In very rare cases, breathing may cease.
  • Heart attack. Signs of this can be chest pain that can spread to the baby’s neck/shoulders and shoulders and down into the left arm.
  • Swelling of the face, lips, tongue, or throat which makes it difficult to swallow or breathe.

Other side effects are

If the patient gets any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.

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

  • Nausea and vomiting
  • Drowsiness or unconsciousness

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

  • Rash, hives, and itching

Very rare side effects (may affect up to 1 in 10,000 people):

  • Upset, restlessness, hostility, rage or aggression, elation, confusion, euphoria (an exaggerated feeling of happiness or elation) or hallucinations (visual and sometimes hearing experiences that are not real)
  • Spasms and muscle tremors (tremors in the muscles that you can not control)
  • Impaired attention
  • Headache
  • Dizziness
  • Difficulty coordinating muscle movements
  • Seizures (convulsions)
  • Temporary memory loss. How long this condition lasts depends on how much BUCCOLAM has been given
  • Low blood pressure, low heart rate, or redness on the face and neck
  • Laryngospasm (cramp in the larynx that makes it difficult to breathe and gives rise to loud breathing)
  • Constipation
  • Dry mouth
  • Fatigue
  • Hiccup

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store BUCCOLAM

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label on the carton, case, and syringe for oral use after EXP. or EXP. The expiration date is the last day of the specified month.

Store in a cold place. Do not freeze.

Store the syringe for oral use in the protective plastic case.

Do not use this medicine if the package is opened or damaged.

Disposal of syringes for oral use

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

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

What the medicine looks like and the contents of the pack

3 months to less than 1 year: 2.5 mg – packaging with a yellow label

1 year to less than 5 years: 5 mg – packaging with a blue label

5 years to under 10 years: 7.5 mg – packaging with purple label

10 years to under 18 years: 10 mg – packaging with orange label

BUCCOLAM oral solution is a clear, colorless liquid. It is supplied in a yellow, pre-filled disposable syringe for oral use. Each syringe for oral use is individually packaged in a protective plastic case. BUCCOLAM is available in cartons containing 4 pre-filled syringes for oral use/case (with the same dose ).

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Shire Services BVBA

rue Montoyer 47

1000 Brussels

Belgium

Tel: +44 (0) 1256 894 959

Email: medinfoEMEA@shire.com

Manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

Ireland

Muhammad Nadeem

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