SOLOXELAM

Package leaflet: Information for the user

Soloxelam, 2.5 mg, oral solution
Soloxelam, 5 mg, oral solution
Soloxelam, 7.5 mg, oral solution
Soloxelam, 10 mg, oral solution
Midazolam
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Soloxelam is and what it is used for
2. Important information before taking Soloxelam
3. How to take Soloxelam
4. Possible side effects
5. How to store Soloxelam
6. Contents of the pack and other information

1. What Soloxelam is and what it is used for

Soloxelam oral solution contains the active substance called midazolam.
Midazolam belongs to a group of medicines known as benzodiazepines.
Soloxelam is used to stop sudden, prolonged seizures in infants from the age of 3 months, children, adolescents, and adults.
In infants aged from 3 months up to below 6 months, this medicine should only be used in a hospital setting where patient monitoring is possible and resuscitation equipment is available.
This medicine may be administered by parents/caregivers only if the patient has been diagnosed with epilepsy.

2. Important information before administering Soloxelam

When not to give Soloxelam

• if the patient is allergic to midazolam, benzodiazepines (such as diazepam), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a nerve and muscle disorder causing muscle weakness (myasthenia gravis);
• if the patient has significant breathing difficulties at rest (Soloxelam may worsen breathing difficulties);
• if the patient has a condition in which breathing disturbances during sleep are common (sleep apnoea syndrome);
• if the patient has severe liver function impairment.

Warnings and precautions
Children:
Before starting Soloxelam, discuss with a doctor or pharmacist if the patient has:

• kidney, liver or heart problems;
• a lung disease causing persistent breathing difficulties.

Adults:
Before starting Soloxelam, discuss with a doctor or pharmacist if:

• the patient is over 60 years old;
• the patient has a chronic illness (e.g. breathing difficulties, kidney, liver or heart problems);
• the patient is debilitated (has a condition causing extreme weakness, exhaustion and lack of energy).

This medicine may cause patients to forget what happened after administration. After administration, patients must be closely monitored.
Avoid administering the medicine to patients who abuse alcohol or drugs.
Life-threatening events may occur more frequently in patients with respiratory or cardiac function disorders, especially after high doses of Soloxelam.
Children under 3 months of age:
Soloxelam should not be given to children under 3 months of age due to insufficient data in this age group.
Elderly patients:
Elderly patients are more sensitive to the effects of benzodiazepines.
If in doubt whether any of the above conditions apply to the patient, consult a doctor or pharmacist before administering this medicine.

Soloxelam and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. If in doubt whether any other medicine the patient is taking may affect the use of Soloxelam, consult a doctor or pharmacist.
This is extremely important because taking more than one medicine at the same time may increase or reduce the effects of these medicines.

The effect of Soloxelam may be increased by medicines such as:

• antiepileptic drugs (used to treat epilepsy), e.g. phenytoin;
• antibiotics, e.g. erythromycin, clarithromycin;
• antifungal medicines, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole;
• medicines used to treat peptic ulcer disease, e.g. cimetidine, ranitidine and omeprazole;
• medicines used to treat high blood pressure, e.g. diltiazem, verapamil;
• some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination;
• opioid analgesics (very strong painkillers), e.g. fentanyl;
• medicines used to lower blood lipid levels, e.g. atorvastatin;
• medicines used to treat nausea, e.g. nabilone;
• sleeping medicines;
• sedative antidepressants (medicines used to treat depression that cause drowsiness);
• sedatives;
• anaesthetics (used to relieve pain);
• antihistamines (used to treat allergies).

The effect of Soloxelam 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 medicine should be avoided in patients taking Soloxelam.

Soloxelam may enhance the effect of certain muscle relaxants, e.g. baclofen (causing increased drowsiness). This medicine may also inhibit the effect of certain medicines, e.g. levodopa (a medicine used to treat Parkinson’s disease).
Consult a doctor or pharmacist for information on which medicines to avoid during treatment with Soloxelam.

Soloxelam with food and drink
Do not drink alcohol during treatment with Soloxelam. Alcohol may enhance the sedative effect of the medicine and cause increased drowsiness.
Do not drink grapefruit juice during treatment with Soloxelam. Grapefruit juice may enhance the sedative effect of the medicine and cause increased drowsiness.

Pregnancy
If the patient to be treated with this medicine is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Administration of high doses of Soloxelam during the last 3 months of pregnancy may cause heart rhythm disturbances in the unborn child. Infants born to mothers who took this medicine during labour may be born with weak sucking reflex, breathing difficulties and reduced muscle tone.

Breast-feeding
Inform the doctor if the patient is breast-feeding. Small amounts of Soloxelam may pass into human milk, but interruption of breast-feeding may not be necessary. The doctor will decide whether the patient may breast-feed after administration of this medicine.

Driving and operating machinery
Soloxelam may cause drowsiness, memory impairment, or reduce concentration and coordination in patients. These effects may impair performance of skilled tasks such as driving vehicles, cycling, or operating machinery.
After administration of this medicine, do not drive, cycle, or operate machinery until full recovery of abilities. Consult a doctor if further information is needed.

Soloxelam contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per filled oral syringe, meaning the medicine is considered "sodium-free".

3. How to use Soloxelam

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Dosage
The doctor will prescribe the appropriate dose of Soloxelam for the patient, generally based on
the patient's age. Different doses are indicated by different colours used to mark the box, tube, and
syringe containing the medicine.
Depending on age, the patient will receive one of the following doses, from a package
specifically colour-coded as follows:

The dose consists of the entire contents of one oral syringe. Do not administer more than one
dose.
Infants aged from 3 months up to below 6 months should only be treated in a hospital setting where
patient monitoring is possible and resuscitation equipment is available.
Preparing this medicine for administration
If the patient is having a seizure, allow free movement of the body; do not attempt to restrain them.
Move the patient only if there is a risk, for example if they are near deep water, fire, or sharp objects.
Protect the patient’s head with something soft, such as a pillow or by placing the patient’s head on your knees.
Check that the dose of the medicine is correct for the patient and appropriate for the patient’s age.
How to administer this medicine
Ask your doctor, pharmacist, or nurse to show you how to take or administer this medicine. If in doubt, always consult them for advice.
Instructions on how to administer this medicine are also provided on the tube label.
Do not inject Soloxelam medicine. Do not attach a needle to the syringe.
Step 1

Holding the plastic tube, tear off the seal at one end and remove the cap. Remove the syringe from the tube.
Step 2

Remove the transparent cap from the end of the syringe and dispose of it safely.
Step 3
Gently grasp the patient’s cheek with thumb and finger

and pull it away. Insert the tip of the syringe deep between the inside of the cheek and the lower gum.
Step 4

Slowly push the plunger of the syringe until it stops.
The entire volume of the solution should be slowly administered into the space between the gum and the cheek (into the oral cavity).
If necessary (in cases of larger volumes and/or smaller patients), slowly administer approximately half of the dose on one side of the oral cavity, then slowly administer the remaining half on the other side of the patient’s oral cavity.
When to call emergency services
ALWAYS follow the instructions of the treating doctor or healthcare professional. If in any doubt, immediately seek medical help if:

• the seizure does not stop within 10 minutes;
• emptying the syringe is impossible or part of its contents has been spilled;
• the patient begins breathing more slowly or stops breathing, i.e. breathing becomes slow and shallow or the patient’s lips turn blue;
• symptoms of a heart attack occur, which may include chest pain or pain radiating to the neck, shoulders, and down the left arm;
• the patient vomits and the seizure does not stop within 10 minutes;
• an overdose of Soloxelam has been administered and symptoms of overdose occur, including:
  o drowsiness, tiredness, feeling exhausted;
  o confusion or feeling disoriented;
  o absence of knee reflex or no response to pinching;
  o difficulty breathing (slowed or shallow breathing);
  o low blood pressure (dizziness and feeling faint);
  o coma.

Keep the syringe to show to emergency personnel or the doctor.
Do not administer a dose of medicine larger than that prescribed to the patient by the doctor.
If the patient vomits

• Do not administer another dose of Soloxelam to the patient.
• If the seizure does not stop within 10 minutes, call emergency services.

If you have any further doubts regarding 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 will experience them.

Serious side effects

Seek immediate medical attention or call an ambulance if the patient experiences:

• severe breathing difficulties, e.g. slow and shallow breathing or bluish lips. In very rare cases, breathing may stop;
• heart attack. Symptoms may include chest pain which may radiate to the neck, shoulders and down the patient's left arm;
• swelling of the face, lips, tongue or throat, making swallowing or breathing difficult, or pale skin, weak and rapid pulse, or feeling faint. These may indicate a serious allergic reaction.

Other side effects

If any side effects occur, consult a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Common side effects (may occur in less than 1 in 10 people):

• nausea and vomiting;
• drowsiness or loss of consciousness.

Uncommon side effects (may occur in less than 1 in 100 people):

• rash, urticaria (hives), itching.

Very rare side effects (may occur in less than 1 in 10,000 people):

• agitation, restlessness, hostility, anger or aggression, excitement, confusion, euphoria (excessive feeling of happiness or excitement), or hallucinations (seeing or hearing things that do not exist in reality);
• muscle spasms and muscle tremors (involuntary muscle twitching);
• reduced alertness;
• headache;
• dizziness;
• difficulty with muscle coordination;
• seizures (convulsions);
• temporary memory loss. The duration depends on the amount of Soloxelam administered to the patient;
• low blood pressure, slow heart rate, or redness of the face and neck (hot flushes);
• laryngospasm (tightening of the vocal cords causing breathing difficulties and loud breathing);
• constipation;
• dry mouth;
• fatigue;
• hiccups.

Reporting of side effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Soloxelam

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, tube and oral syringe following EXP. The expiry date refers to the last day of the stated month.
Store the oral syringe in its protective plastic tube.
Do not store above 30°C.
Do not use this medicine if the packaging has been previously opened 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 no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Soloxelam contains

• The active substance is midazolam.
• 2.5 mg - each oral syringe contains 2.5 mg of midazolam (as hydrochloride) in 0.5 mL of solution.
• 5 mg - each oral syringe contains 5 mg of midazolam (as hydrochloride) in 1 mL of solution.
• 7.5 mg - each oral syringe contains 7.5 mg of midazolam (as hydrochloride) in 1.5 mL of solution.
• 10 mg - each oral syringe contains 10 mg of midazolam (as hydrochloride) in 2 mL of solution.

The other ingredients are: sodium chloride, purified water, hydrochloric acid and sodium hydroxide (for pH adjustment).
What Soloxelam looks like and contents of the pack
2.5 mg - pack marked with yellow color.
5 mg - pack marked with blue color.
7.5 mg - pack marked with purple color.
10 mg - pack marked with orange color.
Soloxelam is a clear solution for oral use.
The medicine is supplied in an orange pre-filled oral syringe, without needle, with plunger and cap.
Each oral syringe is individually packed in a protective plastic tube.
Soloxelam is available in cardboard boxes containing 2 or 4 pre-filled oral syringes (each containing the same dose).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]
Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo, 7
Poligono Industrial Miralcampo
19200 Azuqueca de Henares
Guadalajara
Spain
This medicine is authorised for marketing in the European Economic Area countries under the following names:
Sweden: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg munhålelösning
Finland: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg liuos suuonteloon
Germany: Midazolam Desitin 2.5 mg, 5 mg, 7.5 mg, 10 mg Lösung zur Anwendung in der Mundhöhle
Norway: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg munnvann, oppløsning
Netherlands: Midazolam Xiromed 2.5 mg, 5 mg, 7.5 mg, 10 mg oplossing voor oromucosaal gebruik
Denmark: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg mundhulevæske, opløsning
Iceland: Midazolam Medical Valley 2.5 mg, 5 mg, 7.5 mg, 10 mg munnholslausn
France: Midazolam Exeltis 2.5 mg, 5 mg, 7.5 mg, 10 mg solution buccale
Ireland: Midazolam Rowa 2.5 mg, 5 mg, 7.5 mg, 10 mg oromucosal solution
Romania: Midazolam Desitin 2.5 mg, 5 mg, 7.5 mg, 10 mg soluție bucofaringiană
Spain: Oroxelam 2.5 mg, 5 mg, 7.5 mg, 10 mg solución bucal
Poland: Soloxelam
Italy: Oroxelam
Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl.