OROXELAM 2.5 MG Оральный раствор

Содержание инструкции

1. Oroxelam 2.5 mg oral mucosa solution, 5 mg oral mucosa solution, 7.5 mg oral mucosa solution, 10 mg oral mucosa solution
   1. What is Oroxelam and what is it used for
   2. What you need to know before administering Oroxelam
   3. How to administer Oroxelam
   4. Possible side effects
   5. How to store Oroxelam
   6. Package contents and other information

Oroxelam 2.5 mg oral mucosa solution, 5 mg oral mucosa solution, 7.5 mg oral mucosa solution, 10 mg oral mucosa solution

Midazolam

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 only for your child. Do not give it to other people, even if their symptoms are the same as those of your child for whom it was prescribed, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Oroxelam is and what it is used for
• 2. What you need to know before administering Oroxelam
• 3. How to administer Oroxelam
• 4. Possible side effects
• 5. How to store Oroxelam
• 6. Contents of the pack and other information

1. What is Oroxelam and what is it used for

Oroxelam is an oral mucosal solution containing midazolam. Midazolam belongs to a group of
medicines known as benzodiazepines. Oroxelam is used to stop an acute, prolonged convulsive crisis in children and adolescents (from 3 months to less than 18 years of age).
In children aged between 3 and 6 months it should only be used in a hospital setting, where monitoring is possible
and resuscitation equipment is available.
The patient's doctor must give parents or caregivers instructions on
how to administer Oroxelam, and what to do if the convulsive crisis does not stop.

2. What you need to know before administering Oroxelam

Do not administer Oroxelam if the patient has:

• An allergy to midazolam, to benzodiazepines (such as diazepam) or to any of the other components of this medicine (listed in section 6)
• A disease of the nerves and muscles, which causes muscle weakness (myasthenia gravis)
• Severe difficulty breathing at rest (Oroxelam may worsen breathing difficulties)
• A condition that causes frequent interruptions of breathing during sleep (sleep apnea syndrome)
• Severe liver problems.

Warnings and precautions
Consult your doctor or pharmacist before administering Oroxelam if the patient:

• has a kidney, liver or heart disease
• has a lung disorder that regularly causes difficulty breathing
• drinks regularly large amounts of alcohol or has had problems with alcohol abuse in the past
• regularly takes recreational drugs or has had problems with drug use in the past

This medicine can cause people to forget what happened after it was administered to them. Patients should be kept under close observation after the administration of the medicine.
Potentially fatal incidents are more likely in patients with breathing difficulties or heart problems, especially when high doses of Oroxelam are administered.
If you have any doubts that the patient falls into one of the above cases, consult your doctor or pharmacist before administering this medicine.
Children under 3 months of age:
Oroxelam should not be administered to children under 3 months of age, because there is not enough information in this age group.

Other medicines and Oroxelam
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. If you have any doubts as to whether a medicine taken by the patient may affect the use of Oroxelam, consult your doctor or pharmacist.
This is extremely important, because using more than one medicine at the same time can strengthen or weaken the effect of the medicines themselves.
The effects of Oroxelam 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
• medicines for ulcers, e.g. cimetidine, ranitidine and 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 potent painkillers), e.g. fentanyl
• medicines used to reduce blood fats, e.g. atorvastatin
• medicines used to treat nausea, e.g. nabilone
• hypnotics (medicines that induce sleep)
• sedative antidepressants (medicines used to treat depression that cause drowsiness)
• sedatives (medicines that relax)
• anesthetics (for pain relief)
• antihistamines (for the treatment of allergies).

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

• rifampicin (used to treat tuberculosis)
• xanthines (used to treat asthma)
• St. John's wort (a herbal medicine). It should be avoided in patients taking Oroxelam.

Oroxelam can increase the effect of some muscle relaxants, e.g. baclofen (causing increased drowsiness). This medicine may also prevent some medicines from performing their action, e.g. levodopa (used to treat Parkinson's disease).
The concomitant use of Oroxelam and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness and difficulty breathing (respiratory depression).
Consult your doctor or pharmacist about the medicines that the patient should avoid during treatment with Oroxelam

Oroxelam with food and drink
The patient should not drink alcohol during treatment with Oroxelam. Alcohol can increase the sedative effects of this medicine and cause severe drowsiness.
The patient should not drink grapefruit juice during treatment with Oroxelam. Grapefruit juice can increase the sedative effects of this medicine and cause severe drowsiness.

Pregnancy and breastfeeding
Pregnancy
If the patient to whom this medicine will be administered is pregnant, suspects or is planning a pregnancy, or is breastfeeding, ask your doctor for advice before taking this medicine.
The administration of high doses of Oroxelam during the last 3 months of pregnancy can cause irregular heartbeat in the unborn child. Babies born after the administration of this medicine during labor may also experience poor sucking, difficulty breathing, hypothermia and poor muscle tone at birth.

Breastfeeding
Tell 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 the patient whether to breastfeed after the administration of a single dose of this medicine.

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

Oroxelam contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. essentially “sodium-free”.

3. How to administer Oroxelam

Administer this medicine following the doctor's instructions exactly at all times. If you have any doubts, consult your
doctor or pharmacist. The patient's doctor will give parents/caregivers instructions on
how to administer Oroxelam, and what to do if the convulsive crisis does not stop.

Dosage
Your doctor will prescribe the correct dose of Oroxelam that your child needs, generally based on
the child's age. The different doses each have a different color, indicated on the cardboard packaging,
on the tube and on the syringe containing the medicine.

Based on age, your child will have been prescribed one of the following doses, contained in packaging
identified by different colors:

The dose is the complete contents of one oral administration syringe. Do not administer more than
one dose.
If the convulsive crisis does not stop within 10 minutes of administering midazolam, seek emergency
medical assistance and call an ambulance. A second dose of Oroxelam should not be administered
without first consulting your doctor.

How to prepare to administer this medicine
If the child has a convulsive crisis, allow the body to move freely and do not try to restrain it.
Move them only if they are in danger, for example, deep water, fire, or sharp objects.
Support the child's head with something soft, such as a pillow or your lap.
Check that the medicine is the correct dose for the child, according to the doctor's prescription.

How to administer this medicine
Ask your doctor, pharmacist or nurse to show you how to take or administer this
medicine. Always consult them if you have any doubts.
Information on how to administer this medicine is also provided on the label of the tube.

Oroxelam must not be injected. Do not attach a needle to the syringe.
Step 1
Hold the plastic tube, break the
seal at one end and remove the
cap. Remove the syringe from the tube.

Step 2
Remove the transparent cap from the tip of the
syringe and dispose of it safely.

Step 3
Gently pinch the child's cheek with your index and thumb and pull it back.
Insert the tip of the syringe into the back of the
space between the inside of the cheek and the lower gum.

Step 4
Slowly press the syringe plunger until
it stops.

The entire amount of solution must be
inserted slowly into the space between the gum and
the cheek (buccal cavity).
If prescribed by the doctor (for large volumes and/or
smaller patients), you can administer
slowly about half the dose on one side of the child's mouth
and then the other half on the other side.

When to call an ambulance
ALWAYS follow the treatment advice provided by the patient's doctor or explained by a
healthcare professional. Seek immediate medical assistance if:

• the crisis does not stop within 10 minutes
• you cannot empty the syringe or some of the contents leak out
• the child's breathing slows down or stops, e.g. slow or shallow breathing or blue lips
• you notice symptoms of a heart attack, which may include chest pain or pain radiating to the neck and shoulders and down the left arm
• the child feels sick (vomits) and the convulsive crisis does not stop within 10 minutes
• you administer an excessive amount of Oroxelam

Keep the syringe to show to ambulance personnel or the doctor.
Do not administer an amount of medicine greater than that prescribed by the doctor for the patient. A
second dose of Oroxelam should not be administered without first consulting your doctor.

If the child vomits

• Do not give the patient another dose of Oroxelam.
• If the convulsive crisis does not stop within 10 minutes, call an ambulance.

If you administer more Oroxelam than you should
Seek urgent medical assistance - call an ambulance immediately.
Signs that the patient has been given too much Oroxelam may be:

• sleepiness, tiredness, fatigue
• confusion or feeling disoriented
• loss of coordination
• development of muscle weakness
• low blood pressure - this may make them feel dizzy or faint
• difficulty breathing

Keep the oral administration syringe to show to ambulance personnel or the doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
Seek immediate medical attention or call an ambulance if the patient presents:

• Severe difficulty breathing, e.g. slow or shallow breathing or blue lips. In very rare cases, breathing may stop.
• Heart attack. Symptoms may include chest pain, which may spread to the child's neck and shoulders and down the left arm.
• Swelling of the face, lips, tongue or throat that makes it difficult to swallow or breathe.

Other side effects
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 (trembling of muscles that cannot be controlled)
• Reduced alertness
• Headache
• Dizziness
• Difficulty with muscle coordination
• Convulsions (seizures)
• Temporary memory loss. The duration of this effect depends on the dose of Oroxelam administered.
• Low blood pressure, slowed heart rate or flushing of the face and neck (hot flushes)
• Laryngospasm (stiffening of the vocal cords, causing difficult and noisy breathing)
• Constipation
• Dry mouth
• Fatigue
• Hiccups

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Oroxelam

Keep this medicine out of the sight and reach of children.
Do not administer this medicine after the expiry date which is reported on the package, on the labels of the
tube and of the oral administration syringe after Scad. The expiry date refers to the last day
of that month.
Store the oral administration syringe in the protective plastic tube.
Do not store at a temperature above 30°C.
Do not use this medicine if you notice that the packaging has been opened or damaged.

Disposal of oral administration syringes
Do not dispose of any medicine or oral administration syringes down the drain or with household waste.
Ask your pharmacist how to dispose of medicines that you no longer use. This will help to protect
the environment.

6. Package contents and other information

What Oroxelam contains

• The active ingredient is midazolam
• 2.5 mg - Each pre-filled syringe for oral administration contains midazolam hydrochloride equivalent to 2.5 mg of midazolam in 0.5 ml of solution.
• 5 mg - Each pre-filled syringe for oral administration contains midazolam hydrochloride equivalent to 5 mg of midazolam in 1 ml of solution.
• 7.5 mg - Each pre-filled syringe for oral administration contains midazolam hydrochloride equivalent to 7.5 mg of midazolam in 1.5 ml of solution.
• 10 mg - Each pre-filled syringe for oral administration contains midazolam hydrochloride equivalent to 10 mg of midazolam in 2 ml of solution.

The other ingredients are sodium chloride, purified water, hydrochloric acid and sodium hydroxide (for
pH adjustment).

Description of the appearance of Oroxelam and contents of the pack
2.5 mg - pack with yellow label
5 mg - pack with blue label
7.5 mg - pack with purple label
10 mg - pack with orange label
Oroxelam oral mucosal solution is a clear and colorless liquid.
It is available in a needle-free pre-filled syringe for oral administration, amber colored, with plunger
and closing cap.
Each syringe for oral administration is individually packaged in a protective plastic tube.
Oroxelam is available in cardboard packs containing 2 or 4 pre-filled syringes for oral administration
(of the same strength).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/a
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Laboratorios Liconsa S.A.
Avenida Miralcampo, 7
19200 Azuqueca de Henares
Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:

• SE: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg oral solution.
• FI: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg solution for oral use.
• DE: Midazolam Desitin 2.5 mg, 5 mg, 7.5 mg, 10 mg solution for use in the oral cavity.
• NO: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg mouthwash, solution.
• NL: Midazolam Xiromed 2.5 mg, 5 mg, 7.5 mg, 10 mg solution for oromucosal use.
• DK: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg oral fluid, solution.
• IS: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg oral solution.
• FR: Midazolam Liconsa 2.5 mg, 5 mg, 7.5 mg, 10 mg buccal solution.
• 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 oropharyngeal solution
• ES: Oroxelam 2.5 mg, 5 mg, 7.5 mg, 10 mg oromucosal solution.
• PL: Soloxelam
• IT: Oroxelam

More detailed information on this medicine is available on the European Medicines Agency’s website:
http://www.ema.europa.eu .