Package Insert: Information for the User

Oxibate Sodium 500 mg/ml Oral Solution

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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Sodium oxybate contains the active ingredient sodium oxybate. Sodium oxybate acts by consolidating nighttime sleep, although its exact mechanism of action is unknown.

Sodium oxybate is used to treat narcolepsy with cataplexy in adults, adolescents, and children aged 7 years and older.

Narcolepsy is a sleep disorder that may include attacks of sleep during hours when normally awake, as well as cataplexy, sleep paralysis, hallucinations, and insomnia. Cataplexy is a sudden appearance of muscle weakness or paralysis without loss of consciousness, in response to a sudden emotional reaction such as rage, fear, joy, laughter, or surprise.

Do not take Oxibato sódico Sala

- if you are allergic to sodium oxybate or any of the other components of this medication (listed in section 6);

- if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder);

- if you have a severe depression;

- if you are receiving treatment with opioid or barbiturate medications.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Oxibato sódico Sala.

- if you have respiratory or pulmonary problems (and especially if you are obese), as Oxibato sódico Sala may cause breathing difficulty;

- if you have or have had depression, suicidal thoughts, anxiety, psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behavior) or bipolar disorder;

- if you have heart failure, high blood pressure, liver or kidney problems, your doctor may need to adjust your dose;

- if you have previously consumed drugs or abused medications;

- if you have epilepsy, as Oxibato sódico Sala is not recommended for use in this condition;

- if you have porphyria (a rare metabolic disorder).

If you have any of these problems, inform your doctor before taking Oxibato sódico Sala.

If you experience nocturnal enuresis and incontinence (both urinary and fecal), confusion, hallucinations, sleepwalking episodes, or abnormal thinking while taking Oxibato sódico Sala, inform your doctor immediately. Although these effects are rare, they are usually mild to moderate in nature.

In elderly patients, your doctor will closely monitor your progress to check if this medication produces the desired effects.

Oxibato sódico Sala has a well-known potential for abuse. Cases of dependence have been reported after illicit use of sodium oxybate.

Your doctor will ask if you have consumed any drugs before starting to take this medication and while taking this medication.

Children and adolescents

Oxibato sódico Sala can be taken by adolescents and children aged 7 years or older who weigh more than 15 kg.

Oxibato sódico Sala should not be taken by children under 7 years of age or who weigh less than 15 kg.

If you are a child or adolescent, your doctor will monitor your body weight regularly.

While your doctor is adjusting the dose, which may take several weeks, parents/caregivers must carefully monitor the child's breathing during the 2 hours after the sodium oxybate intake to evaluate if there are any breathing anomalies; for example, interruptions in breathing during short periods while sleeping, noisy breathing, and a blue color on the lips and face. If breathing anomalies are observed, seek medical assistance and inform your doctor as soon as possible. If any anomalies are observed after the first dose, do not administer the second dose. If no anomalies are observed, the second dose can be administered. The second dose should not be administered before 2.5 hours or after 4 hours after the administration of the first dose.

If you have had or are experiencing unpleasant sensations, especially if you feel very sad or have lost interest in life, it is essential to inform your doctor or caregiver.

Use of Oxibato sódico Sala with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In particular, Oxibato sódico Sala should not be used with sleep-inducing medications and medications that reduce the activity of the Central Nervous System (the Central Nervous System is the part of the body composed of the brain and spinal cord):

• medications that increase the activity of the nervous system
• antidepressants
• medications that can be metabolized in a similar way by the body (e.g., valproate, phenytoin, or ethosuximide, which are used to treat epileptic seizures)
• topiramate (used to treat epilepsy)

If you are taking valproate, your daily dose of Oxibato sódico Sala will need to be adjusted (see section 3) as it may cause interactions.

Taking Oxibato sódico Sala with food, drinks, and alcohol

You should not drink alcohol while taking this medication, as its effects may be increased.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. There have been very few women who have taken sodium oxybate during pregnancy, and some of them experienced spontaneous abortions. The risk of taking Oxibato sódico Sala during pregnancy is unknown, so it is not recommended for use in pregnant women or women trying to become pregnant.

Patients taking Oxibato sódico Sala should discontinue breastfeeding, as sodium oxybate passes into breast milk.

Changes in sleep have been observed in infants of mothers exposed to sodium oxybate.

Driving and operating machinery

Oxibato sódico Sala may affect you if you drive or operate machinery. Do not drive, do not operate heavy machinery, or perform any activity that may be hazardous or require full mental alertness for at least 6 hours after taking Oxibato sódico Sala. When you start taking Oxibato sódico Sala for the first time and until you know if it causes drowsiness the next day, be extra careful when driving, operating heavy machinery, or performing any other activity that may be hazardous or require full mental alertness.

In pediatric patients, doctors, parents, or caregivers are warned that the waiting time for activities requiring full mental alertness, motor coordination, or activities that may have a physical risk may be more than 6 hours, depending on individual sensitivity.

Oxibato sódico Sala contains sodium

This medication contains 182.24 mg of sodium (main component of table salt/for cooking) in each gram. This is equivalent to 9.11% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 2 g of sodium oxybate or more per day for a prolonged period, especially if you have been recommended a low-sodium diet.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is essential to use only the syringe included in the box during the preparation of Oxibato sódico Sala doses.

Adults: take Oxibato sódico Sala only

• For adults, the recommended initial dose is 4.5 g per day, divided into two separate doses of 2.25 g.
• Your doctor may gradually increase your dose up to a maximum of 9 g per day, divided into two separate doses of 4.5 g.
• Take Oxibato sódico Sala orally twice a night:

- Take the first dose when going to bed and the second dose 2.5 to 4 hours later. You may need an alarm clock to ensure you wake up to take the second dose.

- Food reduces the amount of Oxibato sódico Sala absorbed by your body. Therefore, it is best to take Oxibato sódico Sala at a set time 2 or 3 hours after meals.

- Prepare both doses before going to bed.

- Take the doses within 24 hours after preparation.

Adolescents and children aged 7 years or more weighing 15 kg or more: take Oxibato sódico Sala only

Your doctor will calculate the appropriate dose based on your weight.

Your doctor will calculate the appropriate dose for you. Do not exceed the dose prescribed.

Adults: take Oxibato sódico Sala with valproate

If you are taking valproate along with Oxibato sódico Sala, your doctor will adjust your Oxibato sódico Sala dose.

• For adults, the recommended initial dose of Oxibato sódico Sala when used with valproate is 3.6 g per day, divided into two separate doses of 1.8 g.
• Take the first dose when going to bed and the second dose 2.5 to 4 hours later.

Adolescents and children aged 7 years or more weighing 15 kg or more: take Oxibato sódico Sala with valproate

If you are taking valproate along with Oxibato sódico Sala, your doctor will adjust your Oxibato sódico Sala dose.

Liver or kidney problems

If you have kidney problems, you should follow dietary recommendations to reduce sodium intake (salt). If you have liver problems, the initial dose should be reduced to half. Your doctor may gradually increase your dose.

Instructions for diluting Oxibato sódico Sala

The following instructions explain how to prepare Oxibato sódico Sala. Read the instructions carefully and follow them step by step. Do not allow children to prepare Oxibato sódico Sala.

To help you, the Oxibato sódico Sala packaging contains 1 medication bottle, a graduated syringe, and two dosing vials with child-resistant safety caps.

Step 1

• Remove the cap from the bottle by pressing down and unscrewing it in a counterclockwise direction (to the left).
• After removing the cap, place the bottle upright on a table.

Keeping the bottle upright, insert the pressure adapter into the neck of the bottle. This should only be done the first time the bottle is opened. The adapter can be left in the bottle for subsequent uses.

Step 2

• Next, insert the tip of the graduated syringe into the center of the bottle opening and press firmly (See Figure 1).

Figure 1

• Keeping the bottle and syringe in one hand, turn the bottle upside down and extract the prescribed dose with the other hand by pulling the plunger. NOTE: The medication will not flow into the syringe unless you keep the bottle in an inverted position (see Figure 2).

Figure 2

Step 3

• Place the bottle upright. Remove the syringe from the center of the bottle opening.
• Empty the medication from the syringe into one of the dosing vials provided by pushing the plunger (See Figure 3). Repeat this step for the second dosing vial.
• Add approximately 60 ml of water to each dosing vial (60 ml is approximately 4 tablespoons).

Figure 3

Step 4

• Place the dosing vial caps and turn each cap clockwise (to the right) until you feel the click and close it in the child-resistant position (See Figure 4).
• Flush the syringe with water.

Figure 4

Just before going to bed:

• Adult patients should place their second dose near their bed.

Parents or caregivers of adolescents and children aged 7 years or more should not leave the second dose near the child's bed or within their reach.

• You may need an alarm clock to ensure you wake up to take your second dose, not before 2.5 hours and not later than 4 hours after your first dose.

Next:

• Remove the cap from the first dosing vial by pressing on the child-resistant safety cap and turning it counterclockwise (to the left).
• Drink the first dose while sitting in bed, cap the vial, and then go to bed immediately. For children who sleep more than 8 hours but less than 12, the first dose can be administered after the child has slept for 1 to 2 hours.

• When you wake up or wake the child between 2.5 and 4 hours later, remove the cap from the second dosing vial. Sit in bed and drink the second dose just before going back to bed to continue sleeping. Cap the second vial.

If you consider the effect of Oxibato sódico Sala to be too intense or too weak, inform your doctor or pharmacist.

If you take more Oxibato sódico Sala than you should

The symptoms of Oxibato sódico Sala overdose may include agitation, confusion, altered mobility, difficulty breathing, blurred vision, excessive sweating, headache, vomiting, decreased consciousness that may lead to coma, and seizure crisis, excessive thirst, muscle cramps, and weakness. If you take more of this medication than you should, or take it by accident, seek immediate emergency medical help. You should carry the medication box with you, even if it is empty.

If you forgot to take Oxibato sódico Sala

If you forgot to take the first dose, take it as soon as you remember and continue with the procedure described above. If you miss the second dose, skip that dose and do not take Oxibato sódico Sala again until the next night. Do not take a double dose to compensate for the missed doses.

If you are unsure if you have taken Oxibato sódico Sala

In case of doubt about administering a dose, do not re-administer the dose to reduce the risk of overdose.

If you interrupt treatment with Oxibato sódico Sala

You should continue taking Oxibato sódico Sala as long as your doctor prescribes it. If you interrupt the medication, seizures may recur, and you may experience insomnia, headache, anxiety, dizziness, sleep disorders, drowsiness, hallucinations, and abnormal thinking.

If you interrupt treatment with this medication for more than 14 days, you should consult your doctor as you should restart treatment with a lower dose.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These are often of mild to moderate intensity.

Adults: most common side effects observed in clinical studies(which occur in 10% to 20% of patients):

• dizziness
• nausea
• headache

If you experience any of these side effects,inform your doctor immediately.Children and adolescents: most common side effects observed in a clinical study:

• bedwetting (18.3%)
• nausea (12.5%)
• vomiting (8.7%)
• weight loss (8.7%)
• loss of appetite (6.7%)
• headache (5.8%)
• dizziness (5.8%)
• suicidal thoughts (1%)
• feeling mentally unwell (loss of contact with reality) (1%)

If you experience any of these side effects,inform your doctor immediately.

The side effects in adults and children are the same. If you experience any of these side effects,

inform your doctor immediately:

Very common (may affect more than 1 in 10 people):

• nausea,
• dizziness,
• headache.

Common (may affect up to 1 in 10 people):

• sleep problems such as insomnia, abnormal dreams, sleep paralysis, somnolence, nightmares, sleepwalking, excessive daytime somnolence, difficulty falling asleep in the middle of the night,
• feeling drunk, tremors, confusion or disorientation, blurred vision, balance disorder, falls, sensation of“dizziness”(vertigo),
• feeling the heartbeat, increased blood pressure, shortness of breath
• vomiting, stomach pain, diarrhea
• anorexia, loss of appetite, weight loss
• weakness, fatigue, sedation
• sweating
• depression
• muscle cramps, swelling
• joint pain, back pain
• attention disorder, sensory disorder especially to touch, abnormal sensation of touch, abnormal taste
• anxiety, nervousness
• urinary incontinence
• snoring, nasal congestion
• hives
• inflammation of the breasts, inflammation of the nose and throat

Uncommon (may affect up to 1 in 100 people):

• psychosis (a mental disorder that may include hallucinations, incoherent speech or
• disorganized and agitated behavior)
• paranoia, abnormal thinking, hallucinations, agitation, suicidal attempt
• difficulty falling asleep, restless legs
• memory loss
• myoclonia (involuntary muscle contractions)
• involuntary bowel movements
• hypersensitivity

Frequency not known (cannot be estimated from available data):

• seizure
• decreased depth or frequency of breathing, brief cessation of breathing during sleep
• urticaria
• suicidal thoughts, delirium, thoughts of committing violent acts (including harming others)
• irritability, aggression
• euphoric mood
• panic attack
• mania/bipolar disorder
• dry mouth, dehydration
• swelling of the face (angioedema)
• bruxism (bruxism and clenched jaw)
• polyuria/urgency (increased need to urinate)
• acoustic neuroma (ringing in the ears, such as tinnitus or buzzing)
• sleep-related eating disorder
• increased appetite
• loss of consciousness
• discinesia (e.g., abnormal and uncontrolled movements of the limbs)
• dandruff
• increased libido
• nocturia (excessive nighttime urination)
• sensation of choking

If you experience any of these side effects,inform your doctor immediately.

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlythrough the Spanish System for the Vigilance of Medicines for Human Use:https://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 bottle after (CAD). The expiration date is the last day of the month indicated.

After dilution in the dosing vials, the preparation should be used within 24 hours thereafter.

Once the Sodium Oxibate Solution bottle is opened, any unused content should be discarded after 90 days of its opening.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Oxibato sódico Sala

-The active ingredient is oxibate of sodium. Each ml contains 500 mg of oxibate sodium.

-The other components are purified water, maleic acid and sodium hydroxide.

Appearance of the product and contents of the packaging

Oxibato sódico Sala is presented in an amber plastic bottle of 200 ml containing 180 ml of oral solution, closed with a child-resistant cap. Each package contains a bottle, a PIBA (Pressure-Indicating Bottle Adapter), a plastic graduated syringe and two dosing cups with child-resistant caps.

Oxibato sódico Sala is a clear and colorless solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Reig Jofré, S.A.

Gran Capitan 10,

08970 Sant Joan Despí (Barcelona)

Spain

Your doctor should have given you a package of information about Oxibato sódico Sala, which includes a leaflet on how to take the medication, a patient information leaflet with Frequently Asked Questions and a patient alert card.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorio Reig Jofré, S.A.

Gran Capitan 10,

08970 Sant Joan Despí (Barcelona)

Spain

This prospectus has been approved in: October 2023

Other sources of information

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