Buccolam 10 mg solucion bucal
Introduction
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 this medicine 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
1. What is BUCCOLAM and what is it 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 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.
2. What you need to know before starting to administer BUCCOLAM
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. The patient 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)
- sedating 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. Newborns born after receiving this medication during delivery may also experience feeding difficulties, 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 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.
3. How to administer BUCCOLAM
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 oral syringe contains a complete 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 restrain 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. No needle should be placed in the syringe.
Step 1
Hold the plastic tube, break the seal at one end, and remove the closure capsule. Remove the syringe from the tube. |
Step 2
Remove the red closure capsule from the syringe tip and dispose of it safely. |
Step 3
With the index finger and thumb, pinch and gently pull the child's cheek back. Place the syringe tip in the space behind the cheek and under the lower gum. |
Step 4
Slowly press the plunger of the syringe until it stops. The entire solution should be slowly introduced into the space between the gum and cheek (oral cavity). If your doctor prescribes it (for larger volumes and/or smaller patients), you can administer half the dose on one side of the mouth and then the other half on the other side of the mouth. |
When to call an ambulance Always follow the treatment recommendations provided by the patient's doctor or as indicated by the healthcare professional. In case of doubt, seek urgent medical help if:
Keep the syringe to show it to the ambulance personnel or doctor. Do not administer more medication than prescribed by the doctor for the patient. |
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.
4. Possible Adverse Effects
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 respiratory distress, e.g., slow or shallow breathing or blue lips. In rare cases, breathing may stop.
- Myocardial infarction. Symptoms 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 prospectus.
Frequent side effects (may affect up to 1 in 10 people):
- Nausea and vomiting
- Drowsiness or reduced consciousness
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 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 flushing (rubefaction)
- Laryngeal spasm (contraction of the vocal cords that causes respiratory difficulty and breathing sounds)
- 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 prospectus. 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.
5. Conservation of BUCCOLAM
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 medicines that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
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 buccal solution is a transparent and colourless liquid. It is supplied in a pre-filled syringe for oral use of amber colour, for single use. Each pre-filled syringe for oral use is individually packaged in a plastic protective tube. BUCCOLAM is presented in boxes containing 4 pre-filled syringes for oral use/tubes (of the same dose).
Marketing Authorisation Holder
Laboratorios Lesvi, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí - Barcelona
Spain
Phone: +34 93 602 24 21
Email:[email protected]
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:
België/Belgique/Belgien Neuraxpharm France Phone:+32 474 62 24 24 | Lietuva Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
???????? Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | Luxembourg/Luxemburg Neuraxpharm France Phone:+32 474 62 24 24 | |
Ceská republika Neuraxpharm Bohemia s.r.o. Phone:+420 495 736 145 | Magyarország Neuraxpharm Bohemia s.r.o. Phone:+36 (30) 542 2071 | |
Danmark Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | Malta Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
Deutschland neuraxpharm Arzneimittel GmbH Phone:+49 2173 1060 0 | Nederland Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
Eesti Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | Norge Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
Ελλ?δα Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | Österreich Neuraxpharm Austria GmbH Phone:+43 2236 389836 | |
España Neuraxpharm Spain, S.L.U. Phone:+34 93 602 24 21 | Polska Neuraxpharm Polska Sp. z.o.o. Phone:+48 505 499 420 | |
France Neuraxpharm France Phone:+33 1.53.62.42.90 | Portugal Neuraxpharm Portugal, Unipessoal Lda Phone:+351 910 259 536 | |
Hrvatska Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 Ireland Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | România Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 Slovenija Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
Ísland Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | Slovenská republika Neuraxpharm Bohemia s.r.o. Phone:+421 255 425 562 | |
Italia Neuraxpharm Italy S.p.A. Phone:+39 0736 980619 | Suomi/Finland Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
Κ?προς Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | Sverige Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | |
Latvija Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 | United Kingdom (Northern Ireland) Laboratorios Lesvi, S.L. Phone:+34 93 602 24 21 |
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.
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