Buccolam 7.5 mg oromucosal solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

BUCCOLAM 2.5mg oral solution

For children aged 3 months to less than 1 year

BUCCOLAM 5mg oral solution

For children aged 1 to less than 5 years

BUCCOLAM 7.5mg oral solution

For children aged 5 to less than 10 years

BUCCOLAM 10mg oral solution

For children aged 10 years and adults

Midazolam

Read this entire leaflet carefully before you start administering this medicine, because it contains important information for you.

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

Contents of this leaflet

1. What BUCCOLAM is and what it is used for
2. What you need to know before administering BUCCOLAM
3. How to administer BUCCOLAM
4. Possible side effects
5. How to store BUCCOLAM
6. 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 prolonged, sudden epileptic seizure in infants from 3 months of age up to adults.

In infants from 3 months to less than 6 months of age, treatment should be administered only in a hospital setting where the patient can be monitored and resuscitation equipment is available.

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

2. What you need to know before administering BUCCOLAM

Do not administer BUCCOLAM if the patient:

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

Warnings and precautions

Children

Consult your doctor or pharmacist before administering BUCCOLAM if the patient:

• has kidney, liver, or heart problems;
• has a lung condition causing periodic breathing difficulties.

Adults:

Consult your doctor or pharmacist before administering BUCCOLAM if:

• you are over 60 years old;
• you have a chronic illness (such as respiratory failure, or kidney, liver, or heart failure);
• you are debilitated (have an illness that makes you feel very weak, exhausted, and lacking energy).

This medicine may cause patients to forget events that occurred after it was administered. Patients should be closely observed after receiving this medicine.

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

Potentially life-threatening events are more likely to occur in patients with breathing difficulties or heart problems, especially when higher doses of BUCCOLAM are administered.

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

Elderly patients:

Elderly patients are more sensitive to the effects of benzodiazepines.

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

Use of BUCCOLAM with other medicines

Inform your doctor or pharmacist if the patient is taking, has recently taken, or might need to take any other medicines. If you have any questions about any medicine the patient is taking that might affect the use of BUCCOLAM, consult your doctor or pharmacist.

This is extremely important, as using more than one medicine at the same time may increase or reduce the effects of the medicines taken.

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

• antiepileptics (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, omeprazole;
• medicines used to treat high blood pressure, e.g.: diltiazem, verapamil;
• some medicines used for HIV and AIDS, e.g.: saquinavir, lopinavir/ritonavir combination;
• narcotic analgesics (strong painkillers), e.g.: fentanyl;
• medicines used to lower blood fats, e.g.: atorvastatin;
• medicines used to treat nausea, e.g.: nabilone;
• hypnotics (medicines to induce sleep);
• sedative antidepressants (medicines to treat depression that cause drowsiness);
• sedatives (medicines to help relaxation);
• anaesthetics (medicines to relieve pain);
• antihistamines (medicines to treat allergies).

The effects of BUCCOLAM may 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 drowsiness). This medicine may also cause some medicines to become less effective, e.g.: levodopa (a medicine used to treat Parkinson’s disease).

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

Use of BUCCOLAM with food and drinks

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

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

Pregnancy

If the patient to receive this medicine is pregnant or breastfeeding, thinks she might be pregnant, or plans to become pregnant, consult your doctor before using this medicine.

Administering high doses of BUCCOLAM during the last 3 months of pregnancy may cause abnormal heart rhythm in the unborn baby. Babies born after administration of this medicine during delivery may also experience difficulty breastfeeding, breathing problems, and poor muscle tone at birth.

Breastfeeding

Inform 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 after receiving this medicine.

Driving and using machines

BUCCOLAM may cause the patient to feel drowsy, forget things, or experience impaired concentration and coordination. This may interfere with performing tasks requiring skill, such as driving, cycling, or operating machinery.

After receiving this medicine, the patient must not drive, cycle, or operate machinery until fully recovered. Ask your doctor if you need further information.

BUCCOLAM contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per oral syringe; i.e., essentially “sodium-free”.

3. How to administer BUCCOLAM

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Your doctor will prescribe the appropriate BUCCOLAM dose for your child, which is normally based on the patient's age. Each of the doses has a different color, shown on the box, tube, and syringe containing the medicine.

Depending on age, the patient will receive one of the following age-specific doses in a container specifically labeled by color:

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

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

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

10 years to adults: 10 mg – container with orange label

One oral syringe contains one complete dose. Do not administer more than one dose.

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

Preparation for administration of this medicine

If the patient is having a seizure, allow their body to move freely; do not attempt to restrain them. Only move them if they are in danger due to proximity to, for example, deep water, fire, or sharp objects.

Support the patient's head on a padded object such as a pillow or on your lap.

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

How to administer this medicine

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

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

BUCCOLAM must not be injected. Do not attach any needle to the syringe.

Step 1

Step 2

Step 3

Step 4

When to call an ambulance

ALWAYS follow the treatment recommendations provided by the patient's doctor or as advised by a healthcare professional. If in doubt, seek urgent medical assistance if:

• The seizure does not stop within 10 minutes.

• You are unable to empty the syringe or spill some of its contents.

• The patient's breathing slows down or stops (e.g., slow or shallow breathing, blue lips).

• You observe signs of myocardial infarction, which may include chest pain or pain radiating to the neck and shoulders and extending to the left arm.

• The patient vomits and the seizure does not stop within 10 minutes.

• You administer too much BUCCOLAM and observe signs of overdose, including:

• Drowsiness, tiredness, fatigue

• Confusion or disorientation

• Absence of knee reflex or response to pinching

• Breathing difficulties (slow or shallow breathing)

• Low blood pressure (dizziness, feeling faint)

• Coma

Keep the syringe to show it to the ambulance personnel or doctor.

Do not administer more medication than prescribed by the patient's doctor.

If the patient 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects

Seek immediate medical attention or call for an ambulance if the patient experiences any of the following adverse 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 spread to the child's neck and shoulders and extend to their left arm.
• Swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing.

Other adverse effects

If the patient experiences any adverse effect, consult their doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

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

• Nausea and vomiting
• Drowsiness or reduced level of consciousness

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

• Skin rash, urticaria (hives), itching

Very rare adverse 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 (involuntary shaking of muscles)
• 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 redness of the face and neck (flushing)
• Laryngospasm (contraction of the vocal cords causing breathing difficulty and noisy breathing)
• Constipation
• Dry mouth
• Fatigue
• Hiccups

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BUCCOLAM

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

Do not use this medicine after the expiry date stated on the carton and on the labels of the tube and the oral syringe, indicated after EXP. The expiry date refers to 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 packaging is open or damaged.

Disposal of oral syringes

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of BUCCOLAM

• The active substance is midazolam.

• Each 2.5 mg pre-filled oral syringe contains 2.5 mg of midazolam (as hydrochloride) in 0.5 ml of solution.

• Each 5 mg pre-filled oral syringe contains 5 mg of midazolam (as hydrochloride) in 1 ml of solution.

• Each 7.5 mg pre-filled oral syringe contains 7.5 mg of midazolam (as hydrochloride) in 1.5 ml of solution.

• Each 10 mg pre-filled oral syringe 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 pH).

Nature of the product and contents of the pack

Under 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 adults: 10 mg – pack with orange label

BUCCOLAM oral solution is a clear, colourless to yellowish liquid. It is supplied in an amber-coloured, single-use, pre-filled oral syringe. Each oral syringe is individually packaged in a protective plastic tube.

BUCCOLAM is available in cardboard boxes containing 2 or 4 pre-filled oral syringes/tubes (of the same strength).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí - Barcelona

Spain

Tel: +34 93 475 96 00

E-mail: [email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona - Spain

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

More information about this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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