Oxibate sodium Sala 500 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Oxibato sódico Sala 500 mg/ml oral solution EFG

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Oxibato sódico Sala is and what it is used for
2. What you need to know before taking Oxibato sódico Sala
3. How to take Oxibato sódico Sala
4. Possible side effects
5. How to store Oxibato sódico Sala
6. Contents of the pack and other information

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1. What Oxibato Sódico Sala is and what it is used for

Oxibato sódico Sala contains the active substance sodium oxybate. Oxibato sódico Sala acts by consolidating nighttime sleep, although its exact mechanism of action is unknown.

Oxibato sódico Sala 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 sudden sleep attacks during periods when a person is normally awake, as well as cataplexy, sleep paralysis, hallucinations, and insomnia. Cataplexy is the sudden onset of muscle weakness or paralysis without loss of consciousness, occurring in response to a sudden emotional reaction such as anger, fear, joy, laughter, or surprise.

2. What you need to know before taking Oxibato sódico Sala

Do not take Oxibato sódico Sala

• if you are allergic to sodium oxybate or to any of the other components of this medicine (listed in section 6);
• if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder);
• if you suffer from severe depression;
• if you are receiving treatment with opioid or barbiturate medicines.

Warnings and precautions

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

• if you have respiratory or lung problems (and especially if you are obese), as Oxibato sódico Sala may potentially cause difficulty breathing;
• 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 (hypertension), or liver or kidney problems, as your dose may need to be adjusted;
• if you have previously used drugs or abused medications;
• if you suffer from epilepsy, as the use of Oxibato sódico Sala is not recommended in this condition;
• if you have porphyria (a rare metabolic disorder).

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

If, while taking Oxibato sódico Sala, you experience nocturnal urine loss and incontinence (both urinary and fecal), confusion, hallucinations, sleepwalking episodes, or abnormal thinking, you must inform your doctor immediately. Although these effects are uncommon, when they occur, they are generally mild to moderate in nature.

In elderly patients, your doctor will carefully monitor your progress to ensure this medicine produces the desired effects.

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

Your doctor will ask you whether you have used any drugs before starting and while taking this medicine.

Children and adolescents

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

Oxibato sódico Sala must 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 the doctor is adjusting the dose, which may take several weeks, parents/caregivers must carefully monitor the child's breathing during the first 2 hours after taking sodium oxybate to assess for any breathing abnormalities; for example, brief interruptions in breathing during sleep, noisy breathing, or bluish discoloration of the lips and face. If any breathing abnormalities are observed, medical help must be sought and the doctor informed as soon as possible. If any abnormality is observed after the first dose, the second dose must not be administered. If no abnormalities are observed, the second dose may be given. The second dose must not be administered earlier than 2.5 hours or later than 4 hours after the first dose.

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

Taking Oxibato sódico Sala with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, Oxibato sódico Sala must not be used together with medicines that induce sleep or medicines 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):

You should also inform your doctor or pharmacist if you are taking any of the following types of medicines:

• medicines that increase central nervous system activity;
• antidepressants;
• medicines that may be metabolized similarly by the body (e.g., valproate, phenytoin, or ethosuximide, 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 interactions may occur.

Taking Oxibato sódico Sala with food, drinks, and alcohol

Do not drink alcohol while taking this medicine, as its effects may be increased.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Very few women have taken sodium oxybate during pregnancy, and some of them experienced spontaneous abortions. The risk of taking Oxibato sódico Sala during pregnancy is unknown; therefore, its use is not recommended in pregnant women or women trying to become pregnant.

Patients taking Oxibato sódico Sala must discontinue breastfeeding, as Oxibato sódico Sala passes into breast milk.

Changes in sleep patterns have been observed in infants exposed through breast milk.

Driving and using machines

Oxibato sódico Sala may affect your ability to drive or operate machinery. Do not drive, operate heavy machinery, or perform any activity that could be dangerous or require mental alertness for at least 6 hours after taking Oxibato sódico Sala. When you first start taking Oxibato sódico Sala and until you know whether it causes drowsiness the following day, take special care when driving, operating heavy machinery, or performing any other activity that could be dangerous or require full mental alertness.

For pediatric patients, physicians, parents, and caregivers are advised that the waiting time before engaging in activities requiring mental alertness, motor coordination, or activities involving physical risk may exceed 6 hours, depending on individual sensitivity.

Oxibato sódico Sala contains sodium

This medicine contains 182.24 mg of sodium (the main component of table/cooking salt) per gram. This corresponds 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 advised to follow a low-salt (sodium) diet.

3. How to take Oxibato sódico Sala

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is important that you only use the syringe provided in the package when preparing doses of Oxibato sódico Sala.

Adults: taking Oxibato sódico Sala alone

• For adults, the recommended initial dose is 4.5 g per day, divided into two separate doses of 2.25 g each.

• 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 each.

• Take Oxibato sódico Sala orally twice each night:

• Take the first dose at bedtime and the second dose 2½ 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 consistently 2 or 3 hours after meals.

• Prepare both doses before going to bed.

• Take the doses within 24 hours of preparation.

Adolescents and children aged 7 years and older weighing 15 kg or more: taking Oxibato sódico Sala alone

For children aged 7 years and older weighing 15 kg or more, the doctor will calculate the appropriate dose based on body weight.

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

Adults: taking Oxibato sódico Sala with valproate

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

• For adults, the recommended initial dose of Oxibato sódico Sala when used in combination with valproate is 3.6 g per day, divided into two separate doses of 1.8 g each.
• Take the first dose at bedtime and the second dose 2½ to 4 hours later.

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

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

Liver or kidney problems

If you have kidney problems, you should follow dietary recommendations to reduce sodium (salt) intake. If you have liver problems, the initial dose should be reduced by 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 assist you, the Oxibato sódico Sala package contains 1 medicine vial, a graduated syringe, and two dosing cups with child-resistant safety caps.

Step 1

• Remove the vial cap by pressing down and unscrewing counterclockwise (to the left).
• After removing the cap, place the vial upright on a table.

While keeping the vial upright, insert the press-in adapter into the neck of the vial. This only needs to be done the first time the vial is opened. The adapter can remain in place for subsequent uses.

Step 2

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

Figure 1

• While holding the vial and syringe in one hand, turn the vial upside down and withdraw the prescribed dose using the other hand by pulling the plunger. NOTE: The medicine will not flow into the syringe unless you keep the vial inverted (see Figure 2).

Figure 2

Step 3

• Place the vial upright. Remove the syringe from the center of the vial opening.
• Empty the medicine from the syringe into one of the provided dosing cups by pushing the plunger (See Figure 3). Repeat this step for the second dosing cup.
• Then add approximately 60 ml of water to each dosing cup (60 ml is about 4 tablespoons).

Figure 3

Step 4

• Place the caps on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into child-resistant position (caution: since the dosing cup cap is reversible, only after hearing the click sound can you be sure the cap is securely closed in child-resistant mode). (See Figure 4).
• Rinse the syringe with water.

Figure 4

Just before going to sleep:

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

Parents or caregivers of adolescents and children aged 7 years and older 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, no sooner than 2.5 hours and no later than 4 hours after your first dose.

Then:

• Remove the cap from the first dosing cup by pressing down on the child-resistant safety cap and turning it counterclockwise (to the left).

• Take the first dose while sitting up in bed, cap the cup, and then lie down immediately. In the case of children who sleep more than 8 hours but less than 12 hours, the first dose may be administered after the child has slept for 1 to 2 hours.

• When you wake up or wake the child 2½ to 4 hours later, remove the cap from the second dosing cup. While sitting up in bed, take the second dose just before lying down again to continue sleeping. Cap the second cup.

If you think the effect of Oxibato sódico Sala is too strong or too weak, inform your doctor or pharmacist.

If you take more Oxibato sódico Sala than you should

Symptoms of Oxibato sódico Sala overdose may include agitation, confusion, impaired mobility, breathing difficulties, blurred vision, excessive sweating, headache, vomiting, reduced consciousness which may lead to coma and epileptic seizures, excessive thirst, muscle cramps, and weakness. If you take more of this medicine than you should, or take it by accident, seek immediate emergency medical help. You must bring the medicine carton with you, even if it is empty.

If you forget to take Oxibato sódico Sala

If you forget to take the first dose, take it as soon as you remember and continue with the previously described procedure. 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 make up for missed doses.

If you are unsure whether you have taken Oxibato sódico Sala

If in doubt about whether a dose has been administered, do not re-administer the dose to reduce the risk of overdose.

If you stop taking Oxibato sódico Sala

You should continue taking Oxibato sódico Sala for as long as your doctor continues to prescribe it. If treatment is interrupted, cataplexy attacks may return and you may experience insomnia, headache, anxiety, dizziness, sleep disorders, drowsiness, hallucinations, and abnormal thinking.

If you stop treatment with this medicine for more than 14 days, you must consult your doctor, as treatment must be restarted at a lower dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Adults: most frequently observed adverse effects in clinical studies (occurring in 10% to 20% of patients):

• dizziness
• nausea
• headache

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

Children and adolescents: most frequently observed adverse effects in a clinical study:

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

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

Adverse effects in adults and children are the same. If you experience any of these adverse 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, drowsiness, nightmares, sleepwalking, bedwetting, excessive daytime sleepiness, difficulty falling asleep during the night,
• feeling drunk, tremors, confusion or disorientation, blurred vision, balance disorder, falls, sensation of "dizziness" (vertigo),
• awareness of your heartbeat, increased blood pressure, shortness of breath,
• vomiting, stomach pain, diarrhea,
• anorexia, decreased appetite, weight loss,
• weakness, fatigue, sedation,
• sweating,
• depression,
• muscle cramps, swelling,
• joint pain, back pain,
• attention disturbance, altered sensation especially to touch, abnormal sensation of touch, abnormal taste,
• anxiety, nervousness,
• urinary incontinence,
• snoring, nasal congestion,
• rash,
• breast enlargement, inflammation of 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, suicide attempt,
• difficulty falling asleep, restless legs,
• memory impairment,
• myoclonus (involuntary muscle contractions),
• involuntary defecation,
• hypersensitivity.

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

• seizure,
• decreased depth or frequency of breathing, brief cessation of breathing during sleep,
• urticaria (hives),
• suicidal thoughts, delirium, thoughts of committing violent acts (including harming other people),
• irritability, aggression,
• euphoric mood,
• panic attack,
• mania/bipolar disorder,
• dry mouth, dehydration,
• facial swelling (angioedema),
• bruxism (teeth grinding and jaw clenching),
• pollakiuria/urinary urgency (increased need to urinate),
• tinnitus (noise in the ears, such as ringing or buzzing),
• sleep-related eating disorder,
• increased appetite,
• loss of consciousness,
• dyskinesia (e.g., abnormal, uncontrolled movements of limbs),
• dandruff,
• increased sex drive,
• nocturia (excessive urination at night),
• sensation of suffocation.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxibato sódico Sala

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle after (EXP). The expiry date is the last day of the month indicated.

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

Once the Oxibato sódico Sala bottle has been opened, any unused content remaining after 90 days from opening must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxibato Sódico Sala

-The active substance is sodium oxybate. Each ml contains 500 mg of sodium oxybate.

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

Appearance of the product and contents of the pack

Oxibato Sódico Sala is supplied as a 200 ml amber plastic bottle containing 180 ml of oral solution, closed with a child-resistant cap. Each pack contains one bottle, a press-in bottle adapter (PIBA), a graduated plastic syringe, and two dosing cups with child-resistant caps.

Oxibato Sódico Sala is a clear, colorless solution.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofré, S.A.

Gran Capitan 10,

08970 Sant Joan Despí (Barcelona)

Spain

Your doctor should have provided you with a package of information for Oxibato Sódico Sala, which includes a leaflet on how to take the medicine, a patient information sheet with Frequently Asked Questions, and a patient alert card.

You may request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Laboratorio Reig Jofré, S.A.

Gran Capitan 10,

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent revision of this package leaflet: June 2025

Other sources of information

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