BUCCOLAM 5 mg ORAL SOLUTION

2. What you need to know before you give BUCCOLAM

Do not give BUCCOLAM if the patient:

• is allergic to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (listed in section 6);
• has a nerve and muscle disease that causes muscle weakness (myasthenia gravis);
• has serious breathing difficulties at rest (BUCCOLAM may make breathing difficulties worse);
• has a disease that causes frequent interruptions of breathing while sleeping (sleep apnoea syndrome);
• has severe liver problems.

Warnings and precautions

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

• has a kidney, liver, or heart condition;
• has a lung condition that causes breathing difficulties from time to time.

This medicine can make people forget what happened after they have been given it. Patients should be closely watched after being given this medicine.

This medicine should be avoided in patients with a history of alcohol or drug abuse.

It is more likely that life-threatening incidents will occur in patients with breathing difficulties or heart problems, especially when higher doses of BUCCOLAM are given.

Children under 3 months: BUCCOLAM should not be given to children under 3 months due to lack of information in this age group.

If you are unsure about any of the above, talk to your doctor or pharmacist before giving this medicine.

Using BUCCOLAM with other medicines

Tell your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines. If you are unsure about any medicine the patient is taking that may affect the use of BUCCOLAM, talk to your doctor or pharmacist.

This is especially important because using more than one medicine at the same time can increase or decrease the effect of the medicines.

The effects of BUCCOLAM can be increased by the following medicines:

• anti-epileptics (for treating epilepsy), e.g. phenytoin
• antibiotics, e.g. erythromycin, clarithromycin
• antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole
• medicines for ulcers, e.g. cimetidine, ranitidine, and omeprazole
• medicines used to treat blood pressure, e.g. diltiazem, verapamil
• certain medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination
• narcotic painkillers (strong pain relievers), e.g. fentanyl
• medicines used to lower blood fat, e.g. atorvastatin
• medicines used to treat nausea, e.g. nabilone
• sleeping pills (medicines to induce sleep)
• sedating antidepressants (medicines for depression that cause sleepiness)
• sedatives (medicines to help relax)
• anaesthetics (medicines to relieve pain)
• antihistamines (medicines for allergies)

The effects of BUCCOLAM can be reduced by the following medicines:

• rifampicin (used to treat tuberculosis)
• xanthines (used to treat asthma)
• St John's Wort (a herbal medicine). This should be avoided in patients taking BUCCOLAM.

BUCCOLAM may increase the effect of some muscle relaxants, e.g. baclofen (causing increased sleepiness). This medicine may also make some medicines not work as well, e.g. levodopa (a medicine used to treat Parkinson's disease).

Talk to your doctor or pharmacist for more information about medicines that the patient should avoid while taking BUCCOLAM.

Using BUCCOLAM with food and drink

The patient should not drink alcohol while taking BUCCOLAM. Alcohol may increase the sedative effects of this medicine and cause excessive sleepiness.

The patient should not drink grapefruit juice while taking BUCCOLAM. Grapefruit juice may increase the sedative effects of this medicine and cause excessive sleepiness.

Pregnancy

If the patient who is to receive this medicine is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should talk to their doctor before using this medicine.

Giving high doses of BUCCOLAM during the last 3 months of pregnancy may cause abnormal heart rhythms in the baby. Babies born after the mother has been given this medicine during delivery may also have difficulty feeding, breathing difficulties, and low muscle tone at birth.

Breastfeeding

Tell the doctor if the patient is breastfeeding. Although small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to stop breastfeeding. The doctor will advise whether the patient should breastfeed the baby after receiving this medicine.

Driving and using machines

BUCCOLAM may make the patient feel sleepy, forgetful, or affect their concentration and coordination. This may interfere with performing tasks that require skill, such as driving, cycling, or using machines.

After receiving this medicine, the patient should not drive, cycle, or use machines until they have fully recovered. Ask the doctor if you need more information.

3. How to give BUCCOLAM

Follow the instructions for giving this medicine exactly as your doctor has told you. If you are unsure, talk to your doctor or pharmacist again.

Dose

Your doctor will prescribe the correct dose of BUCCOLAM for your child, usually based on the child's age. Each dose has a different colour, which is shown on the box, tube, and syringe that contains the medicine.

Your child will receive one of the following specific doses for their age in a colour-coded pack:

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

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

5 years to less than 10 years: 7.5 mg – pack with purple label

10 years to less than 18 years: 10 mg – pack with orange label

An oral syringe contains a complete dose. Do not give more than one dose.

Infants from 3 months to less than 6 months should only receive treatment in a hospital where the patient can be monitored and where resuscitation equipment is available.

Preparing to give this medicine

If the child has a seizure, let their body move freely, do not try to hold them down. Only move them if they are in danger, for example, near deep water, fire, or sharp objects.

Support the child's head on a soft object, such as a cushion or your lap.

Check that the medicine contains the correct dose for your child, specific to their age.

How to give this medicine

Ask a doctor, pharmacist, or nurse to show you how to take or give this medicine. If you are unsure, always ask your doctor, pharmacist, or nurse.

Information on how to give this medicine is also on the label of the tube.

BUCCOLAMshould not be injected. Do not put a needle in the syringe.

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If the child vomits

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

If you have any other questions about using this medicine, 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

Seek immediate medical attention or call for an ambulance if the patient experiences the following side effects:

• Severe breathing difficulties, e.g. slow or shallow breathing or blue lips. In very rare cases, breathing may stop.
• Heart attack. Signs may include chest pain that may radiate to the neck and shoulders and extend to the left arm.
• Swelling of the face, lips, tongue, or throat that makes it difficult to swallow or breathe.

Other side effects

If the patient experiences any side effects, talk to your doctor, pharmacist, or nurse, even if you think they might be unrelated to the medicine.

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

• Nausea and vomiting
• Sleepiness or being less conscious

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

• Rash, hives (itchy rash), itching

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

• Agitation, restlessness, hostility, anger, or aggression, excitement, confusion, euphoria (excessive feeling of happiness or excitement), or hallucinations (seeing and possibly hearing things that are not really there)
• Muscle spasms and muscle tremors (trembling of the muscles that cannot be controlled)
• Reduced level of alertness
• Headache
• Dizziness
• Difficulty coordinating muscles
• Seizures (fits)
• Temporary loss of memory. The duration depends on the amount of BUCCOLAM given.
• Low blood pressure, slow heart rate, or reddening of the face and neck (flushing)
• Laryngospasm (contraction of the vocal cords that causes difficulty breathing and noise when breathing)
• Constipation
• Dry mouth
• Fatigue
• Hiccups

Reporting 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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 and on the labels of the tube and oral syringe after EXP. The expiry date is the last day of the month shown.

Do not refrigerate or freeze.

Keep the oral syringe in the protective plastic tube.

Do not use this medicine if the pack is open or damaged.

Disposal of oral syringes

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

6. Container contents and additional information

Composition of BUCCOLAM

• The active ingredient is midazolam

• Each 2.5 mg oral syringe contains 2.5 mg of midazolam (as hydrochloride) in 0.5 ml of solution.
• Each 5 mg oral syringe contains 5 mg of midazolam (as hydrochloride) in 1 ml of solution.
• Each 7.5 mg oral syringe contains 7.5 mg of midazolam (as hydrochloride) in 1.5 ml of solution.
• Each 10 mg oral syringe contains 10 mg of midazolam (as hydrochloride) in 2 ml of solution.

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

Appearance of the product and container contents

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

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

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

10 years to less than 18 years: 10 mg – packaging with orange label

BUCCOLAM oral solution is a clear, colorless liquid. It is supplied in a single-use, amber-colored oral syringe. Each oral syringe is individually packaged in a protective plastic tube. BUCCOLAM is available in boxes containing 4 single-use oral syringes/tubes (of the same dose).

Marketing authorization holder

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí - Barcelona

Spain

Tel: +34 93 602 24 21

E-mail: [email protected]

Manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

Ireland

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí - Barcelona

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.