Leaflet: information for the user

Oroxelam 2.5 mg oral solution

Oroxelam 5 mg oral solution

Oroxelam 7.5 mg oral solution

Oroxelam 10 mg oral solution

midazolam

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Oroxelam oral solution contains a medicine called midazolam. Midazolam belongs to a group of medicines known as benzodiazepines.

Oroxelam is used to stop a sudden and prolonged seizure in infants from 3 months to adults.

In infants from 3 months to less than 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 patient has been diagnosed with epilepsy.

• No use Oroxelam if the patient has:
• allergy to midazolam, benzodiazepines (such as diazepam) or any of the other components of this medication (listed in section 6);
• nerve and muscle disease that causes muscle weakness (myasthenia gravis);
• serious breathing difficulties at rest (Oroxelam may worsen breathing difficulties);
• disease that causes frequent interruptions of breathing while sleeping (sleep apnea syndrome);
• severe liver disease.

Warnings and precautions:

Children:

Consult your doctor or pharmacist before starting to use Oroxelam if the patient:

• has a kidney, liver or heart condition;
• has a lung condition that causes periodic breathing difficulties.

Adults:

Consult your doctor or pharmacist before starting to use Oroxelam if:

• You are over 60 years old.
• You have a chronic disease (such as respiratory failure, or renal, hepatic or cardiac insufficiency).
• You are debilitated (you have a disease that makes you feel very weak, exhausted and without energy).

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 drug addiction.

It is more likely that potentially fatal incidents will occur in patients with breathing difficulties or heart problems, especially when higher doses of Oroxelam are administered.

Children under 3 months: Oroxelam should not be administered to children under 3 months due to lack of information in this age group.

Older patients:

Older patients are more sensitive to the effects of benzodiazepines.

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

Other medications and Oroxelam

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 Oroxelam, 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 Oroxelam 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 sedatives), 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 Oroxelam 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 Oroxelam should avoid this herb.

Oroxelam 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 on medications that the patient should avoid while taking Oroxelam.

Use of Oroxelam with food and drinks

The patient should not drink alcohol while taking Oroxelam. Alcohol may increase the sedative effects of this medication and cause excessive sleep.

The patient should not drink grapefruit juice while taking Oroxelam. 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 pregnant or breastfeeding, or if she thinks she may be pregnant or intends to become pregnant, consult your doctor before using this medication.

The administration of high doses of Oroxelam during the last 3 months of pregnancy may cause abnormal fetal heartbeat. Newborns 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 Oroxelam 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 a single dose of this medication.

Driving and operating machinery

Oroxelam may cause the patient to feel drowsy, forget things 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.

Oroxelam contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per oral syringe, which is essentially "sodium-free".

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 Oroxelam, which will normally depend on the patient's age. Each dose has a different color, which is shown on the box, tube, and syringe that contains the medication.

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

One oral 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 patient 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 patient's head on a cushioned object, such as a pillow or their lap. Check that the medication contains the correct dose for the patient, according 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 found on the tube label.

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

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:

• The seizure does not subside within 10 minutes.
• You are unable to empty the syringe or spill some of it.
• The patient's breathing slows down or stops (e.g., slow or shallow breathing or 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 subside within 10 minutes.
• You administer too much Oroxelam and observe signs of overdose, which include:
• • Drowsiness, fatigue, or exhaustion
  • Confusion or disorientation
  • Absence of knee reflex or response to a pinch
  • Respiratory difficulties (slow or shallow breathing)
  • Low blood pressure (dizziness and sensation of fainting)
  • Coma

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 patient vomits

• Do not administer another dose of Oroxelam to the patient.
• 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 severe side effects:

• Severe breathing difficulty, 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 patient'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, or pale skin, weak pulse, and rapid heart rate, or feeling of loss of consciousness. It is possible that the patient is having a severe allergic reaction.

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 that does not appear in this prospectus.

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

• Feeling and being sick (nausea and vomiting).
• Drowsiness or being less conscious

Infrequent 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. The duration depends on the amount of Oroxelam 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. 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 use this medication after the expiration date that appears on the packaging and on the labels of the tube and oral syringe, after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C

Keep the oral syringe in the plastic protective tube. Do not use this medication if the packaging is open or damaged.

Elimination of the oral syringes

Medicines should not be thrown away through the drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need.By doing so, you will help protect the environment.

Composition of oroxelam

The active principle is midazolam

• Oroxelam 2.5 mg - Each preloaded syringe for oral use contains midazolam hydrochloride equivalent to 2.5 mg of midazolam in 0.5 ml of solution.
• Oroxelam 5 mg - Each preloaded syringe for oral use contains midazolam hydrochloride equivalent to 5 mg of midazolam in 1 ml of solution.
• Oroxelam 7.5 mg - Each preloaded syringe for oral use contains midazolam hydrochloride equivalent to 7.5 mg of midazolam in 1.5 ml of solution.
• Oroxelam 10 mg - Each preloaded syringe for oral use contains midazolam hydrochloride equivalent to 10 mg of midazolam in 2 ml of solution.

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

Appearance of the product and contents of the package

Oroxelam 2.5 mg – package with a yellow label

Oroxelam 5 mg – package with a blue label

Oroxelam 7.5 mg – package with a purple label

Oroxelam 10 mg – package with an orange label

Oroxelam oral solution is a transparent and colorless liquid.

It is presented in an amber-colored oral syringe without a needle, with a plunger and stopper. Each oral syringe is individually packaged in a plastic protective tube.

Oroxelam is presented in boxes containing 2 or 4 preloaded oral syringes (of the same dose).

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares.

Guadalajara.

Spain

Responsible manufacturer

Laboratorios Liconsa S.A.

Av. de Miralcampo, 7

19200 Azuqueca de Henares

Guadalajara.

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

SE:Midazolam medical valley 2.5 mg, 5 mg, 7.5 mg, 10 mg munhålelösning.

FI:Midazolam medical valley 2.5 mg, 5 mg, 7.5 mg, 10 mg liuos suuonteloon.

DE:Midazaxiro 2.5 mg, 5 mg, 7.5 mg, 10 mg lösung zur Anwendung in der Mundhöhle.

NO:Midazolam medical valley 2.5 mg, 5 mg, 7.5 mg, 10 mg munnvann, oppløsning.

NL:Midazolam xiromed 2.5 mg, 5 mg, 7.5 mg, 10 mg oplossing voor oromucosaal gebruik.

DK:Midazolam medical valley 2.5 mg, 5 mg, 7.5 mg, 10 mg mundhulevæske, opløsning.

IS:Midazolam medical valley 2.5 mg, 5 mg, 7.5 mg, 10 mg munnholslausn.

FR:Midazolam liconsa 2.5 mg, 5 mg, 7.5 mg, 10 mg solution buccale.

IE:Midazolam liconsa 2.5 mg, 5 mg, 7.5 mg, 10 mg oromucosal solution.

RO:Midazolam desitin 2.5 mg, 5 mg, 7.5 mg, 10 mg solu?ie bucofaringiana.

ES:Oroxelam 2,5 mg, 5 mg, 7,5 mg, 10 mg solución bucal

PL:Soloxelam.

IT:Oroxelam.

Last review date of this leaflet:March2025

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es