BUCCOLAM 7.5 mg ORAL SOLUTION

2. What you need to know before starting to administer BUCCOLAM

Do not administer BUCCOLAM if the patient:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to administer BUCCOLAM if the patient:

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

This medication may cause people to forget what happened after it was administered. Patients should be closely observed after administration of this medication.

This medication should be avoided in patients with a history of alcoholism or drug addiction.

It is more likely that potentially fatal incidents will occur among patients with breathing difficulties or heart problems, especially when higher doses of BUCCOLAM are administered.

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

If you have any doubts about whether any of the above applies to the patient, consult your doctor or pharmacist before administering this medication.

Using BUCCOLAM with other medications

Tell your doctor or pharmacist if the patient is using, has recently used, or may need to use any other medication. If you have any doubts about any medication the patient is taking that may affect the use of BUCCOLAM, consult your doctor or pharmacist.

This is extremely important, as the use of more than one medication at the same time can enhance or weaken the effect of the medications taken.

The effects of BUCCOLAM may be intensified by the following medications:

• antiepileptics (for treating epilepsy), e.g., phenytoin
• antibiotics, e.g., erythromycin, clarithromycin
• antifungals, e.g., ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole
• medications for ulcers, e.g., cimetidine, ranitidine, and omeprazole
• medications used to treat blood pressure, e.g., diltiazem, verapamil
• certain medications used to treat HIV and AIDS, e.g., saquinavir, lopinavir/ritonavir combination
• narcotic analgesics (very strong painkillers), e.g., fentanyl
• medications used to reduce blood fat, e.g., atorvastatin
• medications used to treat nausea, e.g., nabilone
• hypnotics (medications to induce sleep)
• sedating antidepressants (medications to treat depression that cause sleepiness)
• sedatives (medications to help relax)
• anesthetics (medications to relieve pain)
• antihistamines (medications to treat allergies)

The effects of BUCCOLAM may be reduced by the following medications:

• 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 medication may also cause some medications to stop working as well, e.g., levodopa (a medication used to treat Parkinson's disease).

Consult your doctor or pharmacist for more information about medications the patient should avoid while taking BUCCOLAM.

Using BUCCOLAM with food and drinks

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

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

Pregnancy

If the patient who is to receive this medication is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult a doctor before using this medication.

Administration of high doses of BUCCOLAM during the last 3 months of pregnancy may cause abnormal heart rhythm in the fetus. Children born after administration of this medication during delivery may also experience difficulty feeding, breathing difficulties, and poor muscle tone at birth.

Breastfeeding

Tell your 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 medication.

Driving and using machines

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

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

3. How to administer BUCCOLAM

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

Your doctor will prescribe the appropriate dose of BUCCOLAM for your child, usually depending on the child's age. Each dose has a different color, which is shown on the box, tube, and syringe containing the medication.

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

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

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

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

10 years to less than 18 years: 10 mg – orange label package

An oral syringe contains a complete dose. Do not administer 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 equipped with resuscitation equipment.

Preparation for administration of this medication

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

Support the child's head on a cushion or your lap.

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

How to administer this medication

Ask a doctor, pharmacist, or nurse to show you how to take or administer this medication. If in doubt, always ask your doctor, pharmacist, or nurse.

Information on how to administer this medication also appears on the tube label.

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

Step 1

Step 2

Step 3

Step 4

If the child vomits

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

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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, consult a doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

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 patches), 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 (uncontrollable muscle shaking)
• Reduced alertness
• Headache
• Dizziness
• Difficulty coordinating muscles
• Seizures (convulsions)
• Transient memory loss. The duration depends on the amount of BUCCOLAM administered.
• Low blood pressure, slow heart rate, or flushing of the face and neck (redness)
• Laryngeal spasm (contraction of the vocal cords that causes breathing difficulties and noise when breathing)
• Constipation
• Dry mouth
• Fatigue
• Hiccups

Reporting side effects

If you experience any side effects, consult a doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of BUCCOLAM

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

Do not administer this medication after the expiration date stated on the box and on the labels of the tube and oral syringe after EXP. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Keep the oral syringe in the protective plastic tube.

Do not use this medication if the package is open or damaged.

Disposal of oral syringes

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of BUCCOLAM

• The active ingredient is midazolam

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

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

Appearance and Packaging of the Product

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 pre-filled syringe. Each oral syringe is individually packaged in a protective plastic tube. BUCCOLAM is available in boxes containing 4 oral pre-filled 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.