Buccolam 2,5 mg solucion bucal

Leaflet:Information for the User

BUCCOLAM 2.5mg Oral Solution

For children from 3 months to less than 1 year

BUCCOLAM 5mg Oral Solution

For children from 1 year to less than 5 years

BUCCOLAM 7.5mg Oral Solution

For children from 5 years to less than 10 years

BUCCOLAM 10mg Oral Solution

For children from 10 years to less than 18 years

Midazolam

Read this leaflet carefully before starting to administer this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for your child, and it should not be given to other people who have the same symptoms as the child to whom it has been prescribed, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is BUCCOLAM and for what it is used

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

3.How to administer BUCCOLAM

4.Possible adverse effects

5.Storage of BUCCOLAM

6.Contents of the package and additional information

BUCCOLAM contains a medicine called midazolam. Midazolam belongs to a group of medicines known as benzodiazepines. BUCCOLAM is used to stop a prolonged sudden seizure in infants, children and adolescents (from 3 months to under 18 years).

In infants from 3 months to under 6 months, treatment should only be administered in a hospital where the patient can be monitored and has resuscitation equipment.

This medicine should only be used by parents/caregivers when the child has been diagnosed with epilepsy.

Do not administer BUCCOLAM if the patient:

• has an allergy to midazolam, benzodiazepines (such as diazepam) or any of the other components of this medication (listed in section 6);
• has a muscle and nerve 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 has been administered. Patients should be closely observed after receiving this medication.

This medication should be avoided in patients with a history of alcoholism or substance abuse.

It is more likely that potentially fatal incidents will occur in 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 a 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.

Use of BUCCOLAM with other medications

Inform your doctor or pharmacist if the patient is using, has used recently or may need to use any other medication. If you have any doubts about any medication the patient is taking and 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 may potentiate or reduce the effect of the medications taken.

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

• antiepileptics (to treat 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 high blood pressure, e.g. diltiazem, verapamil
• some medications used to treat HIV and AIDS, e.g. saquinavir, combination of lopinavir/ritonavir
• opioid 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)
• sedative antidepressants (medications to treat depression that cause sleep)
• sedatives (medications to help relax)
• anesthetics (medications to relieve pain)
• antihistamines (medications to treat allergies)

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

• rifampicin (used to treat tuberculosis)
• xanthines (used to treat asthma)
• St. John's Wort (a plant-based medication). Patients taking BUCCOLAM should avoid this medication.

BUCCOLAM may increase the effect of some muscle relaxants, e.g. baclofen (producing increased sleep). This medication may also make some medications less effective, 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.

Use of 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 sleep.

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

Pregnancy

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

The 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.

Lactation

Inform 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 continue breastfeeding after receiving this medication.

Driving and operating machinery

BUCCOLAM may cause the patient to feel drowsy, forgetful, or have impaired concentration and coordination. This may interfere with the performance of tasks that require skill, such as driving, cycling or operating machinery.

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

Follow exactly the administration instructions of this medication 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, which usually depends on the child's age. Each dose has a different color, which is shown on the box, tube, and syringe that contains the medication.

Your child will receive one of the following specific doses for their age in a labeled container by color:

3 months to under 1 year: 2.5 mg – container with a yellow label

1 year to under 5 years: 5 mg – container with a blue label

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

10 years to under 18 years: 10 mg – container with an orange label

One syringe contains a full dose. Do not administer more than one dose.

Infants from 3 months to under 6 months should only receive treatment in a hospital where the patient can be monitored and has 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 cushioned object, such as a pillow 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 teach you how to take or administer this medication.In case of doubt, always ask your doctor, pharmacist, or nurse.

The information on how to administer this medication is also on the tube label.

BUCCOLAM should not be injected. Do not put any needle in the syringe.

Step 1

Step 2

Step 3

Step 4

If the child vomits

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

• Severe breathing difficulty, e.g.: slow or shallow breathing or blue lips. In very rare cases, breathing may stop.
• Myocardial infarction. Signs may include chest pain that may radiate to the child's neck and shoulders and extend to their 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 type of side effect, consult their doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.

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

• Nausea and vomiting
• Drowsiness or being less conscious

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

• Skin rash, urticaria (hives), 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 real)
• Muscle spasms and muscle tremors (uncontrollable muscle shaking)
• Reduced level of alertness
• Headache
• Dizziness
• Difficulty coordinating muscles
• Seizures (convulsions)
• Transient memory loss. Duration depends on the amount of BUCCOLAM administered.
• Low blood pressure, slow heart rate, or facial and neck redness (rubefaction)
• Laryngeal spasm (contraction of the vocal cords that causes breathing difficulty and noise while breathing)
• Constipation
• Dry mouth
• Fatigue
• Hiccup

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not refrigerate or freeze.

Keep the oral syringe in the plastic protective tube.

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

Disposal of Oral Syringes

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. This will help protect the environment.

BUCCOLAM Composition

• The active ingredient is midazolam

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

The other components are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (to adjust the pH).

Appearance of the product and contents of the 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

BUCCOLAM oral solution is a transparent and colourless liquid. It is supplied in a single-use amber-coloured oral syringe. Each oral syringe is individually packaged in a plastic protective tube. BUCCOLAM is presented in boxes containing 4 pre-filled oral syringes/tubes (of the same dose).

Marketing Authorisation Holder

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí - Barcelona

Spain

Tel: +34 93 602 24 21

E-mail:medinfo@lesvi.com

Responsible for manufacturing

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

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.