Buccolam

Package leaflet: Information for the user

BUCCOLAM 2.5 mg oral solution

For children from 3 months to less than 1 year of age
BUCCOLAM 5 mg oral solution
For children from 1 year to less than 5 years of age
BUCCOLAM 7.5 mg oral solution
For children from 5 years to less than 10 years of age
BUCCOLAM 10 mg oral solution
For children from 10 years of age and adults
Midazolam
Please read this leaflet carefully before administering this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. 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 sudden, prolonged seizure in children and adults.
In children aged between 3 and 6 months, it should be used only in a hospital setting, where monitoring is possible and resuscitation equipment is available.
This medicine should only be used by parents/caregivers of patients who have received a diagnosis of epilepsy.

2. What you should know before administering BUCCOLAM

Do not administer BUCCOLAM if the patient has:

• An allergy to midazolam, benzodiazepines (such as diazepam), or to any of the other ingredients of this medicine (listed in section 6)
• A nerve and muscle disorder causing muscle weakness (myasthenia gravis)
• Severe breathing difficulties at rest (BUCCOLAM may worsen breathing difficulties)
• A condition causing frequent interruptions in breathing during sleep (sleep apnoea syndrome)
• Severe liver problems.

Warnings and precautions
Children
Talk to your doctor or pharmacist before administering BUCCOLAM if the patient:

• Has kidney, liver, or heart disease
• Has a lung disorder that periodically causes breathing difficulties.

Adults:
Talk to your doctor or pharmacist before taking BUCCOLAM if:

• You are over 60 years of age.
• You have a long-term illness (such as respiratory problems or kidney, liver, or heart disease).
• You are debilitated (have an illness that makes you feel very weak, exhausted, and lacking energy).

This medicine may cause patients to forget what happened after it was administered. Patients must be closely monitored after administration of the medicine.
This medicine should be avoided in patients with a history of alcohol or drug abuse.
Potentially fatal incidents are more likely in patients with breathing difficulties or heart problems, especially when high doses of BUCCOLAM are administered.
Children under 3 months of age: BUCCOLAM must not be administered to children under 3 months of age, as there is insufficient information available for this age group.
Elderly: Elderly patients are more sensitive to the effects of benzodiazepines.
If you have any doubts whether the patient falls into any of the above categories, consult your doctor or pharmacist before administering this medicine.

Other medicines and BUCCOLAM
Tell your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines. If you have any doubts about whether a medicine taken by the patient could affect the use of BUCCOLAM, consult your doctor or pharmacist.
This is extremely important because using more than one medicine at the same time may strengthen or weaken the effects of the medicines.
The effects of BUCCOLAM may be intensified by medicines such as:

• Antiepileptics (for the treatment of epilepsy), e.g. phenytoin
• Antibiotics, e.g. erythromycin, clarithromycin
• Antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole
• Anti-ulcer medicines, e.g. cimetidine, ranitidine, omeprazole
• Medicines used to treat blood pressure, e.g. diltiazem, verapamil
• Some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination
• Narcotic analgesics (very strong painkillers), e.g. fentanyl
• Medicines used to lower blood lipids, e.g. atorvastatin
• Medicines used to treat nausea, e.g. nabilone
• Hypnotics (medicines that induce sleep)
• Sedative antidepressants (medicines for treating depression that cause drowsiness)
• Sedatives (medicines that relax)
• Anaesthetics (to relieve pain)
• Antihistamines (for treating allergies).

The effects of BUCCOLAM may be reduced by medicines such as:

• 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 prevent some medicines from working properly, e.g. levodopa (used to treat Parkinson’s disease).
Consult your doctor or pharmacist about which medicines the patient should avoid during treatment with BUCCOLAM.

BUCCOLAM with food and drinks
The patient must not consume alcohol during treatment with BUCCOLAM. Alcohol may increase the sedative effects of this medicine and cause severe drowsiness.
The patient must not drink grapefruit juice during treatment with BUCCOLAM. Grapefruit juice may increase the sedative effects of this medicine and cause severe drowsiness.

Pregnancy
If the patient to whom this medicine will be administered is pregnant, suspects she may be pregnant, is planning a pregnancy, or is breastfeeding, consult your doctor before taking this medicine.
Administration of high doses of BUCCOLAM during the last 3 months of pregnancy may cause irregular heartbeat in the newborn. Babies born after administration of this medicine during labour may also show poor sucking, breathing difficulties, and low muscle tone at birth.

Breast-feeding
Inform your doctor if the patient is breast-feeding. Although small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to stop breast-feeding. Your doctor will advise the patient whether she can breast-feed after administration of this medicine.

Driving and using machines
BUCCOLAM may cause drowsiness, forgetfulness, or affect concentration and coordination. This may impair performance of tasks requiring skill, such as driving vehicles, riding a bicycle, or operating machinery.
After administration of this medicine, the patient must not drive vehicles, ride a bicycle, or operate machinery until fully recovered. Consult your doctor if you need further advice.

BUCCOLAM contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per oral syringe, i.e. essentially ‘sodium-free’.

3. How to administer BUCCOLAM

Administer this medicine exactly as directed by the doctor. If in doubt,
consult the doctor or pharmacist.
Dosage
The doctor will prescribe the correct dose of BUCCOLAM required by the patient, usually based on
the patient's age. Different doses each have a different colour, indicated on the cardboard packaging,
on the tube, and on the syringe containing the medicine.
Depending on age, the patient will have been prescribed one of the following doses, contained in
packs distinguished by different colours:
from 3 months to less than 1 year: 2.5 mg - pack with yellow label
from 1 year to less than 5 years: 5 mg - pack with blue label
from 5 years to less than 10 years: 7.5 mg - pack with purple label
from 10 years to adults: 10 mg - pack with orange label
The dose is the complete contents of one oral syringe. Do not administer more than one dose.
For children aged from 3 to less than 6 months, treatment must be carried out exclusively in a
hospital setting, where monitoring is possible and resuscitation equipment is available.
How to prepare for administering this medicine
If the patient is having a seizure, allow the body to move freely and do not try to restrain it. Only move
the patient if they are in danger, for example near deep water, fire, or sharp objects.
Support the patient's head with something soft, such as a pillow or your lap.
Check that the medicine is the correct dose for the patient according to age.
How to administer this medicine
Ask a doctor, pharmacist, or nurse to show you how to take or administer this medicine. Always consult them if you have any doubts.
Instructions on how to administer this medicine are also provided on the label of the tube.
BUCCOLAM must not be injected. Do not attach a needle to the syringe.
Step 1

Hold the plastic tube and remove the cap. Remove the syringe from the tube.

Phase 2

Remove the red cap from the tip of the syringe and dispose of it safely.

Phase 3

With your index finger and thumb, gently pinch the patient's cheek and pull it backward. Insert the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.

Phase 4

Slowly push the syringe plunger until it stops. The entire amount of solution should be slowly administered into the space between the gum and the cheek (buccal cavity). If directed by the physician (for larger volumes and/or smaller patients), approximately half the dose may be slowly administered into one side of the patient's mouth, followed by the other half into the opposite side.

When to call an ambulance
ALWAYS FOLLOW the treatment advice provided by the patient's doctor or explained by a
healthcare professional. If in doubt, seek immediate medical assistance if:

• The seizure does not stop within 10 minutes.
• You are unable to empty the syringe or some of the contents leak out.
• The patient's breathing slows down or stops, e.g. slow breathing, shallow breathing or blue lips.
• Symptoms of a heart attack occur, which may include chest pain or pain spreading to the neck and shoulders and radiating down the left arm.
• The patient vomits and the seizure does not stop within 10 minutes.
• An excessive dose of BUCCOLAM is administered and signs of overdose occur, such as: drowsiness, tiredness, fatigue, confusion or disorientation, absence of knee reflex or no response to pinching, difficulty breathing (slow or shallow breathing), low blood pressure (dizziness or feeling faint), coma.

Keep the syringe to show to the ambulance personnel or doctor.
Do not administer more medicine than the dose 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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Consult your doctor immediately or call an ambulance if the patient experiences:

• Severe breathing difficulties, for example slow breathing, shallow breathing or blue lips. In very rare cases breathing may stop.
• Heart attack. Symptoms may include chest pain, which may spread to the patient's neck and shoulders and radiate down the left arm.
• Swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing, or paleness, weak and rapid heartbeat, or feeling faint. This could be a severe allergic reaction.

Other side effects

If the patient experiences any side effect, including those not listed in this leaflet, contact a doctor, pharmacist or nurse.

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

• Nausea and vomiting
• Drowsiness or loss of consciousness

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

• Skin rash, urticaria (skin rash with swelling), itching

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

• Agitation, restlessness, hostility, anger or aggression, excitement, confusion, euphoria (an excessive feeling of happiness or excitement), or hallucinations (seeing and in some cases hearing things that are not there)
• Muscle spasms and muscle tremors (involuntary muscle trembling)
• Reduced alertness
• Headache
• Dizziness
• Difficulty with muscle coordination
• Seizures (convulsions)
• Temporary memory loss. The duration of this effect depends on the dose of BUCCOLAM administered.
• Low blood pressure, slowed heart rate, or redness of the face and neck (flushing)
• Laryngospasm (stiffening of the vocal cords, causing difficult and noisy breathing)
• Constipation
• Dry mouth
• Fatigue
• Hiccups

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BUCCOLAM

Keep this medicine out of the sight and reach of children.
Do not administer this medicine after the expiry date stated on the carton, on the tube labels, and on the oral syringe. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Keep the oral syringe in the protective plastic tube.
Do not use this medicine if the packaging has been opened or damaged.
Disposal of oral syringes
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BUCCOLAM contains

• 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 (for pH adjustment).
Description of the appearance of BUCCOLAM and contents of the pack
From 3 months to less than 1 year: 2.5 mg – pack with yellow label
From 1 year to less than 5 years: 5 mg – pack with blue label
From 5 years to less than 10 years: 7.5 mg – pack with purple label
From 10 years to adults: 10 mg – pack with orange label
BUCCOLAM oromucosal solution is a clear, colourless to slightly yellow 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 packs containing 2 or 4 pre-filled oral syringes/tubes (of the same strength).
Not all pack sizes may be marketed.
Marketing Authorisation 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 Authorisation Holder:
België/Belgique/Belgien Lietuva
Neuraxpharm Belgium Neuraxpharm Pharmaceuticals, S.L.
Tél/Tel: +32 (0)2 732 56 95 Tel:+34 93 475 96 00
България Luxembourg/Luxemburg
Direct Pharma Logistics BG LTD. Neuraxpharm France
Teл.: +40 217 961 566 Tél/Tel: +32 474 62 24 24
Česká republika Magyarország
Neuraxpharm Bohemia s.r.o. Neuraxpharm Hungary Kft.
Tel: +420 739 232 258 Tel.: +3630 464 6834
Danmark Malta
Neuraxpharm Sweden AB Neuraxpharm Pharmaceuticals, S.L.
Tlf:+46 (0)8 30 91 41 Tel.:+34 93 475 96 00
(Sverige)
Deutschland Nederland
neuraxpharm Arzneimittel GmbH Neuraxpharm Netherlands B.V.
Tel: +49 2173 1060 0 Tel.: +31 70 208 5211
Eesti Norge
Neuraxpharm Pharmaceuticals, S.L. Neuraxpharm Sweden AB
Tel: +34 93 475 96 00 Tlf:+46 (0)8 30 91 41
(Sverige)
Ελλάδα Österreich
Brain Therapeutics IKE Neuraxpharm Austria GmbH
Τηλ: +302109931458 Tel.:+ 43 (0) 1 208 07 40
España Polska
Neuraxpharm Spain, S.L.U. Neuraxpharm Polska Sp. z.o.o.
Tel: +34 93 475 96 00 Tel.: +48 783 423 453
France Portugal
Neuraxpharm France Neuraxpharm Portugal, Unipessoal Lda
Tél: +33 1.53.62.42.90 Tel: +351 910 259 536
Hrvatska România
Salvus d.o.o. Direct Pharma Logistics SRL
T +385 49 326 550 Telefon/Fax: +40 217 961 566
Ireland Slovenija
Neuraxpharm Ireland Ltd Salvus MED d.o.o.
Tel: +353 (0)1 428 7777 T +386 51 334 197
Ísland Slovenská republika
Neuraxpharm Sweden AB Neuraxpharm Slovakia a.s.
Sími: +46 (0)8 30 91 41 Tel: +421 255 425 562
(Svíþjóð)
Italia Suomi/Finland
Neuraxpharm Italy S.p.A. Neuraxpharm Sweden AB
Tel: +39 0736 980619 Puh/Tel: +46 (0)8 30 91 41
(Ruotsi/Sverige)
Κύπρος Sverige
Brain Therapeutics IKE Neuraxpharm Sweden AB
Τηλ: +302109931458 Tel: +46 (0)8 30 91 41
Latvija
Neuraxpharm Pharmaceuticals, S.L.
Tel: +34 93 475 96 00
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.