Buccolam 10 mg oromucosal solution

Package leaflet: Information for the user

Introduction

Package 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 adults

Midazolam

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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 sudden prolonged seizures 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 only by parents/caregivers 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, to benzodiazepines (such as diazepam), or to any of the other ingredients 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 apnea 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 disease;
• has a lung condition causing periodic breathing difficulties.

Adults:

Consult your doctor or pharmacist before administering BUCCOLAM if:

• you are over 60 years of age;
• you have a chronic illness (such as respiratory failure, or renal, hepatic, or cardiac insufficiency);
• you are debilitated (have an illness causing you to feel very weak, exhausted, and lacking energy).

This medicine may cause patients to forget what happened after it was administered. Patients should be closely observed after administration of 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 respiratory 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 data in this age group.

Elderly patients:

Elderly patients are more sensitive to the effects of benzodiazepines.

If you have any doubts about whether any of the above apply 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 effect of the medicines taken.

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

• antiepileptic drugs (for treating epilepsy), e.g.: phenytoin;
• antibiotics, e.g.: erythromycin, clarithromycin;
• antifungal medicines, 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 fat, e.g.: atorvastatin;
• medicines used to treat nausea, e.g.: nabilone;
• hypnotics (medicines to induce sleep);
• sedative antidepressants (medicines for depression that cause drowsiness);
• sedatives (medicines to help relax);
• anesthetics (medicines to relieve pain);
• antihistamines (medicines for treating 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 certain 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 drink

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 intends to become pregnant, consult your doctor before using this medicine.

Administration of high doses of BUCCOLAM during the last 3 months of pregnancy may cause abnormal fetal heart rate. Infants born after administration of this medicine during delivery may also experience difficulty breastfeeding, breathing problems, and poor muscle tone at birth.

Breast-feeding

Inform the doctor if the patient is breast-feeding. Although small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to discontinue breast-feeding. The doctor will advise whether the patient should breast-feed after receiving this medicine.

Driving and use of machines

BUCCOLAM may make the patient feel drowsy, forgetful, or affect concentration and coordination. This may interfere with 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 the patient, which normally depends on the patient's age. Each dose 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 color-coded container:

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

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

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

10 years and adults: 10 mg – orange labeled container

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

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

Preparation for administering this medicine

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

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

Check that the medicine contains the correct dose for the patient, 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 provided 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

If the patient 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 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 experiences them.

Serious adverse effects

Seek immediate medical attention or call for an ambulance by telephone 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 patient's neck and shoulders and extend to the left arm.
• Swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing, or pale skin, weak and rapid pulse, or feeling of loss of consciousness. The patient may be experiencing a severe allergic reaction.

Other adverse effects

If the patient experiences any adverse effect, consult a 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 (uncontrollable 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 (rubefaction)
• 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 listed in this leaflet.

You may also report them directly through the national reporting system included 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 under EXP. The expiry date refers to 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 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 dispose of medicines and packaging that you no longer need. This will help 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 pack contents

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 colourless to yellowish, clear 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 cartons containing 2 or 4 pre-filled oral syringes/tubes (of the same dose).
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

For further information about this medicinal product, please contact 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.