Sodium oxybate Zentiva 500 mg/ml oral solution EFG

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sodium oxybate Zentiva 500 mg/ml oral solution EFG

sodium oxybate

Read the entire 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 may 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 the leaflet

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

1. What Oxibato de sodio Zentiva is and what it is used for

This medicine contains the active substance sodium oxybate. Sodium oxybate acts by consolidating night-time sleep, although its exact mechanism of action is unknown.

Oxibato de sodio is used to treat narcolepsy with cataplexy in adults, adolescents, and children from 7 years of age.

Narcolepsy is a sleep disorder that may include sudden sleep attacks during hours 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, triggered by a sudden emotional reaction such as anger, fear, joy, laughter, or surprise.

2. What you need to know before taking Oxibato de sodio Zentiva

Do not take sodium oxybate

• if you are allergic to sodium oxybate or to any of the other ingredients 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 Oxibato de sodio Zentiva.

• if you have breathing or lung problems (and especially if you are obese), as sodium oxybate may cause difficulty in 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, your dose may need to be adjusted;
• if you have previously abused medicines;
• if you have epilepsy, as the use of sodium oxybate 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 de sodio Zentiva.

If, while taking sodium oxybate, you experience nocturnal enuresis and incontinence (both urinary and fecal), confusion, hallucinations, sleepwalking episodes, or abnormal thinking, you must inform your doctor immediately. Although these side effects are uncommon, when they occur, they are generally mild to moderate in severity.

In elderly patients, your doctor will closely monitor your progress to ensure that sodium oxybate is producing the desired effects.

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

Your doctor will ask you about any drug use before you start taking sodium oxybate and while you are taking this medicine.

Children and adolescents

Oxibato de sodio Zentiva may be taken by adolescents and children aged 7 years and older when they weigh more than 15 kg.

Oxibato de sodio Zentiva 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 a bluish coloration 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 abnormalities are 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 had or are experiencing unpleasant feelings, especially if you feel very sad or have lost interest in life, it is important that you inform your doctor or caregiver.

Other medicines and Oxibato de sodio Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, Oxibato de sodio Zentiva 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 de sodio Zentiva will need to be adjusted (see section 3), as interactions with valproate may occur.

Taking Oxibato de sodio Zentiva with food, drinks, and alcohol

You must not drink alcohol while taking sodium oxybate, as its effects may be increased.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may 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 sodium oxybate during pregnancy is unknown; therefore, its use is not recommended 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 patterns have been observed in infants of exposed mothers.

Driving and using machines

Sodium oxybate may affect your ability to drive or use machines. 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 sodium oxybate. When you first start taking sodium oxybate, and until you know whether it causes daytime drowsiness, 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, doctors, parents, and caregivers are advised that the waiting time before performing activities requiring mental alertness, motor coordination, or activities that may pose physical risk may exceed 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 your salt intake, as it may affect you if you previously had hypertension, heart, or kidney disorders. If you take two nightly doses of 2.25 g of sodium oxybate each, you will be ingesting 0.82 g of sodium; if you take two nightly doses of 4.5 g of sodium oxybate each, you will be ingesting 1.6 g of sodium. Consult your doctor, as you may need to moderate your salt intake.

This medicine contains 0.41 g of sodium (main component of table/cooking salt) per 2.25 g dose. This corresponds to 20% of the maximum recommended daily sodium intake for an adult.

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

3. How to take Oxibate de Sodio Zentiva

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

It is important that you use only the syringe provided in the package when preparing doses of Oxibate de Sodio Zentiva. The sodium oxybate syringe has two different measurement scales: one scale may be more suitable 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 containing sodium oxybate, but each may have a different method of administration. Read carefully how to use this medicine and consult your doctor or pharmacist if you are unsure.

Adults: taking Oxibate de Sodio Zentiva alone

• 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 sodium oxybate 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 sodium oxybate absorbed by your body. Therefore, it is best to take sodium oxybate consistently 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 and older weighing 15 kg or more: taking Oxibate de Sodio Zentiva alone

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

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

Adults: taking Oxibate de Sodio Zentiva with valproate

If you are taking valproate together with sodium oxybate, your doctor will adjust your sodium oxybate dose.

• For adults, the recommended initial dose of this medicine when used together with valproate is 3.6 g per day, administered in two separate doses of 1.8 g.
• 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 Oxibate de Sodio Zentiva with valproate

If you are taking valproate together with sodium oxybate, your doctor will adjust your sodium oxybate dose.

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 Oxibate de Sodio Zentiva

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

To assist you, the sodium oxybate package contains 1 medicine bottle, a graduated syringe (with two different scales), an adapter, and two dosing cups with child-resistant safety caps.

1. Remove the cap from the bottle by pressing down and unscrewing counterclockwise (to the left). After removing the cap, place the bottle upright on a table. The plastic seal must be removed from the mouth of the bottle before first use. While keeping the bottle upright, press the adapter firmly into the neck of the bottle. This should only be done the first time the bottle is opened. The adapter can remain attached to the bottle for subsequent uses.

2. Push the plunger of the syringe fully to the bottom of the syringe barrel (toward the tip). Then insert the tip of the graduated syringe into the center of the bottle opening and press firmly (See Figure 1).

Figure 1

1. While holding the bottle and syringe with one hand, turn the bottle upside down and with the other hand pull the plunger to withdraw the prescribed dose (following the 0.20 g or 0.25 g graduations on the syringe barrel). NOTE: The medicine 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 bottle 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 approximately 4 tablespoons).

Figure 3

1. Place the caps on the dosing cups and turn each cap clockwise (to the right) until you hear a click, securing them in child-resistant position. (See Figure 4). Rinse the syringe with water.

Figure 4

1. Just before going to sleep:
   • Adult patients should place their second dose near their bed just before going to sleep.
   • 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).
• Sit up in bed, drink the first dose, cap the cup, and then lie down immediately.
• For 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.

1. When you wake up or wake the child 2.5 to 4 hours later, remove the cap from the second dosing cup. While sitting up in bed, drink the second dose just before lying down again to continue sleeping. Cap the second cup.

If you think the effect of sodium oxybate is too strong or too weak, tell your doctor or pharmacist.

If you take more sodium oxybate than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take sodium oxybate

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 sodium oxybate 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 sodium oxybate

If you are uncertain about whether a dose was administered, do not re-administer the dose to reduce the risk of overdose.

If you stop treatment with sodium oxybate

You should continue taking sodium oxybate 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 disturbances, drowsiness, hallucinations, and abnormal thinking.

If you stop treatment with sodium oxybate for more than 14 days, you must consult your doctor, as you will need to restart treatment with sodium oxybate 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 may cause adverse effects, although not everyone experiences 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%)
• feeling mentally unwell (loss of touch with reality) (1%)

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

The 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 returning to sleep in the middle of 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, sensory disturbance especially to touch, abnormal touch sensation, abnormal taste
• anxiety, restlessness
• urinary incontinence
• snoring, nasal congestion
• rash
• inflammation of sinuses, inflammation of nose and throat

Uncommon: may affect up to 1 in 100 people

• Psychosis (a mental disorder that may cause hallucinations, incoherent speech, or disorganized or agitated behavior)
• paranoia, abnormal thinking, hallucinations, agitation, suicide attempt
• difficulty falling asleep, restless legs
• memory impairment
• myoclonus (involuntary muscle contractions)
• fecal incontinence
• hypersensitivity

Frequency not known: cannot be estimated from the 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 (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

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 Sodium Oxybate Zentiva

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

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

This medicine does not require any special storage conditions.

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

Once the sodium oxybate vial has been opened, any unused content remaining after 45 days from opening must be discarded.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxibato de sodio Zentiva

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 to adjust pH.

Appearance of the product and contents of the pack

Sodium oxybate is presented in an amber-colored PET bottle of 200 ml containing 180 ml of oral solution, closed with an external white transparent plastic screw cap with child-resistant closure made of HDPE/polypropylene, and a white expanded polyethylene sealing disc.

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

A comma is used as the decimal separator on the syringe graduations.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

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

For further information about this medicinal product, please contact 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 provided you with a patient information pack for Oxibato de sodio Zentiva, which includes a leaflet on how to take the medicine, a patient information sheet with Frequently Asked Questions, and a patient alert card.

This medicinal product is authorized in the EEA Member States under the following names:

Netherlands: Natriumoxybaat Aristo 500mg/ml drank
Germany: Natriumoxybat Aristo 500mg/ml Lösung zum Einnehmen
Spain: Oxibato de sodio Zentiva 500mg/ml solución oral EFG
Italy: Sodio Oxibato Aristo
United Kingdom: Sodium Oxybate 500mg/ml Oral Solution

Date of the most recent review of this leaflet: April 2021

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