Leaflet: information for the patient

Sodium oxibateZentiva500 mg/ml oral solution EFG

sodium oxibate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

1. What is Sodium oxibate Zentiva and what it is used for

2. What you need to know before starting to take Sodium oxibate Zentiva

3. How to take Sodium oxibate Zentiva

4. Possible side effects

5. Storage of Sodium oxibate Zentiva

6. Contents of the pack and additional information

This medicine contains the active ingredient sodium oxibate. Sodium oxibate acts by consolidating nocturnal sleep, although its exact mechanism of action is unknown.

Sodium oxibate 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 the sudden appearance of muscle weakness or paralysis without loss of consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter, or surprise.

Do not take sodium oxybate

• if you are allergic to sodium oxybate or any of the other ingredients 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 Sodium Oxybate Zentiva.

• if you have respiratory or pulmonary problems (and especially if you are obese), as sodium oxybate may cause breathing difficulties;
• 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, hypertension (high blood pressure), liver or kidney problems, your doctor may need to adjust your dose;
• if you have previously abused medications;
• if you have epilepsy, as sodium oxybate 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 Sodium Oxybate Zentiva.

If you experience nocturnal enuresis and incontinence (both urinary and fecal), confusion, hallucinations, sleepwalking episodes, or abnormal thinking while taking sodium oxybate, you must 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 sodium oxybate produces the desired effects.

Sodium oxybate 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 sodium oxybate and while you are taking this medication.

Children and adolescents

Sodium Oxybate Zentiva can be taken by adolescents and children aged 7 years or older who weigh more than 15 kg.

Sodium Oxybate Zentiva 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 for 2 hours after the sodium oxybate intake to evaluate if there are any breathing abnormalities; for example, interruptions in breathing while sleeping, noisy breathing, and a blue color on the lips and face. If breathing abnormalities are observed, seek medical assistance and inform your doctor as soon as possible. If any abnormalities are observed after the first dose, do not administer the second dose. If no abnormalities 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.

Other medications and Sodium Oxybate Zentiva

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

In particular, Sodium Oxybate Zentiva 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):

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

• 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 epilepsy)
• topiramate (used to treat epilepsy)

If you are taking valproate, your daily dose of Sodium Oxybate Zentiva will need to be adjusted (see section 3) as it may cause interactions with valproate.

Taking Sodium Oxybate Zentiva with food, drinks, and alcohol

You should not drink alcohol while taking sodium oxybate, 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 sodium oxybate during pregnancy is unknown, so it is not recommended for use in pregnant women or women trying to become pregnant.

Patients taking sodium oxybate should stop 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

Sodium oxybate 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 mental alertness for at least 6 hours after taking sodium oxybate. When you start taking sodium oxybate for the first time and until you know if it causes drowsiness the next day, be especially careful when driving, operating heavy machinery, or performing any other activity that may be hazardous or require complete mental alertness.

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

Sodium oxybate contains sodium

Since sodium oxybate contains sodium (which is found in table salt), you need to monitor the amount of salt you ingest, as it may affect you if you previously had hypertension, heart problems, or kidney problems. If you take 2 doses of 2.25 g of sodium oxybate each night, you will be ingesting 0.82 g of sodium, or if you take 2 doses of 4.5 g of sodium oxybate each night, you will be ingesting 1.6 g of sodium. Ask your doctor for advice, as you may need to moderate your salt intake.

This medication contains 0.41 g of sodium (the main component of table salt/for cooking) in each 2.25 g dose. This is equivalent to 20% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need this medication daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

Follow exactly the administration instructions of this medication 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 the doses of Oxibato de Sodio Zentiva. The oxibato de sodio syringe has two different measurement scales: one scale may be more useful for you than the other, depending on the dose prescribed by your doctor. When looking at each scale, you will see which one has the exact mark for your dose. There are other oral solutions with oxibato de sodio, but each one may have a different administration method. Read carefully how to use this medication and consult your doctor or pharmacist if you are unsure.

Adults: take Oxibato de sodio Zentiva 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 orally twice a night:
• • Take the first dose when going to bed 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.
  • Foods reduce the amount of oxibato de sodio absorbed by your body. Therefore, it is best to take oxibato de sodio 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 de sodio Zentiva 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 de sodio Zentiva with valproate

If you are taking valproate along with oxibato de sodio, your doctor will adjust the dose of oxibato de sodio.

• For adults, the recommended initial dose of this medication, when used with valproate, is 3.6 g per day, administered in two separate doses of 1.8 g.
• Take the first dose when going to bed and the second dose 2½ to 4 hours later.

Adolescents and children aged 7 years or more weighing 15 kg or more: take Oxibato de sodio Zentiva with valproate

If you are taking valproate along with oxibato de sodio, your doctor will adjust the dose of oxibato de sodio.

Liver or kidney problems

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

Instructions for diluting Oxibato de sodio Zentiva

The following instructions explain how to prepare oxibato de sodio. Read the instructions carefully and follow them step by step. Do not allow children to prepare oxibato de sodio.

To help you, the oxibato de sodio packaging contains 1 bottle of medication, a graduated syringe (with two different scales), a adapter, and two dosing vials with child-resistant caps.

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. The plastic seal must be removed from the bottle mouth before using it for the first time. Holding the bottle upright, insert the adapter into the neck of the bottle by pressure. This should only be done the first time the bottle is opened. The adapter can be left in the bottle for subsequent uses.

1. Push the plunger of the syringe to the bottom of the syringe barrel (towards the tip) to remove excess air. Then, insert the tip of the graduated syringe into the center of the opening of the bottle and press firmly (See Figure 1).

Figure 1

1. While holding the bottle and syringe with one hand, turn the bottle and extract the prescribed dose (following the 0.20 g or 0.25 g graduations on the syringe body) with the other hand by pulling the plunger. NOTE: The medication will not flow into the syringe unless you keep the bottle upright (See Figure 2).

Figure 2

1. Place the bottle upright. Remove the syringe from the center of the opening of the bottle. 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. Then, add approximately 60 ml of water to each dosing vial (60 ml is approximately 4 tablespoons).

Figure 3

1. Put the caps on the dosing vials and turn each cap clockwise (to the right) until you feel the click and close it in the child-resistant position (See Figure 4). Clear the syringe with water.

Figure 4

1. Just before going to bed:
   • Adult patients should place their second dose near their bed just before going to 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:

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

If you consider the effect of oxibato de sodio too intense or too weak, inform your doctor or pharmacist.

If you take more oxibato de sodio than you should

The symptoms of oxibato de sodio 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 oxibato de sodio than you should, or take it by accident, seek immediate medical help. You should bring the empty medication box with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take oxibato de sodio

If you forget 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 de sodio 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 de sodio

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 de sodio

You should continue taking oxibato de sodio 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, somnolence, hallucinations, and abnormal thinking.

If you interrupt treatment with oxibato de sodio for more than 14 days, you should consult your doctor as you should start treatment with oxibato de sodio from a lower dose.

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

Like all medicines, this medicine may 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, feeling of "dizziness" (vertigo)
• feeling the heartbeat, increased blood pressure, shortness of breath
• vomiting, stomach pain, diarrhea
• loss of appetite, decreased appetite, weight loss
• weakness, fatigue, sedation
• sweating
• depression
• muscle cramps, swelling
• joint pain, back pain
• alteration of attention, alteration of sensitivity 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 can cause hallucinations, incoherent speech, or disorganized or agitated behavior)
• paranoia, abnormal thinking, hallucinations, agitation, suicidal attempt
• difficulty falling asleep, restless legs
• memory loss
• myoclonias (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
• facial swelling (angioedema)
• bruxism (bruxism and clenched jaw)
• polyuria/urinary urgency (increased need to urinate)
• tinnitus (ringing in the ears, such as ringing or buzzing)
• sleep-related eating disorders
• increased appetite
• loss of consciousness
• discinesia (e.g., abnormal and uncontrolled movements of the limbs)
• dandruff
• increased libido
• nocturia (excessive nighttime urination)
• feeling of suffocation

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

This medication does not require special storage conditions.

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

Once the sodium oxibate bottle is opened, any unused content should be discarded after 45 days following its opening.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Sodium Oxibate Zentiva Composition

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

The other components are purified water, maleic acid, and sodium hydroxide to adjust the pH.

Product Appearance and Packaging Content

Sodium oxibate is presented in a 200 ml amber glass bottle containing 180 ml of oral solution and closed with an external thread plastic white transparent cap and a child-resistant closure, composed of HDPE/polpropylene, with a white expanded polyethylene seal.

Each package contains a bottle, a graduated measuring device (a transparent polypropylene syringe with a white PE piston) of 4.5 g capacity with graduations of 0.25 g, a transparent LDPE syringe adapter, two 90 ml capacity polypropylene dosing cups, and two child-resistant HDPE white caps.

A comma is used as a decimal separator in the syringe graduation.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Responsible Manufacturer

Labomed Pharmaceutical Company S.A.

84 Ioannou Metaxa street,

Koropi, Attica 19441,

Greece

or

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

Berlin-13435 Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

This medication is authorized in the EEA member states with the following names:

NetherlandsNatriumoxybaat Aristo 500mg/ml drank

GermanyNatriumoxybat Aristo 500mg/ml Lösung zum Einnehmen

SpainOxibato de sodio Zentiva 500mg/ml solución oral EFG

ItalySodio Oxibato Aristo

United KingdomSodium Oxybate 500mg/ml Oral Solution

Last review date of this leaflet:April 2021

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