Soloxikam

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 the patient.

• 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 only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 an active substance called midazolam.
Midazolam belongs to a group of medicines known as benzodiazepines.
Soloxelam is used to stop acute, prolonged seizures in infants from the age of 3 months, children, adolescents, and adults.
In infants aged from 3 months up to but not including 6 months, this medicine should only be used in a hospital setting where patient monitoring and resuscitation equipment are 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 Soloxelam must not be given

• 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 disease 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 treatment with Soloxelam, consult a doctor or pharmacist if the patient has:

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

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

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

This medicine may cause patients to forget events occurring after administration. Patients should be closely monitored after receiving the medicine.
Avoid administering Soloxelam 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, as there is insufficient information available for 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.

Interaction of Soloxelam with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take. If in doubt whether another medicine being taken by the patient may affect the use of Soloxelam, consult a doctor or pharmacist.
This is extremely important because concomitant use of multiple medicines may enhance or reduce their effects.
The effect of Soloxelam may be enhanced by medicines such as:

• anticonvulsants (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;
• certain 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). Concomitant use of St. John’s wort 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 should be avoided during treatment with Soloxelam.

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

Pregnancy
If the patient to be given this medicine is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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. Babies born to mothers who received this medicine during labour may have a 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 discontinuation of breast-feeding may not be necessary. The doctor will decide whether the patient can 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 a vehicle, cycling or operating machinery.
After administration of this medicine, patients should 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 administered according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Dosage
The doctor will prescribe the appropriate dose of Soloxelam for the patient, primarily based on the
patient's age. Different doses are indicated by different colors 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 marked by color:

The dose consists of the entire contents of one oral syringe. Do not administer more than one dose.
Infants aged 3 months 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. Only move the patient if there is a risk of injury, 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 lap.
Check that the medicine dose is correct for the patient and appropriate for their 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. Do NOT attach a needle to the syringe.

Step 1

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

Step 2

Remove the clear 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 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 physician or qualified medical personnel. If in doubt, seek immediate medical help if:

• the seizure does not stop within 10 minutes;
• it is not possible to empty the syringe or if part of its contents has spilled;
• the patient begins to breathe more slowly or stops breathing, i.e., breathing becomes slow and shallow, or the patient’s lips turn blue;
• symptoms of 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, fatigue, or feeling of exhaustion;
  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 or feeling faint);
  o coma.

Keep the syringe to show it to emergency medical personnel or the doctor.
Do not administer a dose larger than that prescribed to the patient by the doctor.

If the patient vomits

• Do not give the patient another dose of Soloxelam.
• 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 everybody gets them.

Serious side effects

Contact a doctor immediately 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 causing difficulty in swallowing or breathing, or pale skin, weak and rapid pulse, or feeling faint. This 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 (wheals), itching.

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

• agitation, anxiety, 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 movements);
• reduced alertness;
• headache;
• dizziness;
• difficulty with muscular 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 (constriction of the vocal cords causing breathing difficulties and loud breathing);
• constipation;
• dry mouth;
• fatigue;
• hiccup.

Reporting of side effects

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of 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 marketing authorization holder.
Reporting side effects helps to 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 the abbreviation 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 must not be disposed of via the wastewater system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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 violet color.
10 mg - pack marked with orange color.

Soloxelam is a clear solution for oral use.
The medicine is supplied in an orange-filled oral syringe, without a needle, with a plunger and cap.
Each oral syringe is individually packed in a protective plastic tube.
Soloxelam is available in cardboard boxes containing 2 or 4 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.
Szamocka 8 Street
01-748 Warsaw
email: [email protected]

Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo, 7
Poligono Industrial Miralcampo
19200 Azuqueca de Henares
Guadalajara
Spain

This medicinal product is authorised 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 medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl.