Sodium oxybate Normon 500 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxibato de sodio Normon 500 mg/ml oral solution EFG

sodium oxybate

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

• Keep this leaflet. 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. Do not pass it on to others, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Oxibato de sodio Normon 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 times 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 starting to take Oxibato de sodio Normon

Do not take Oxibato de sodio Normon

• if you are allergic to sodium oxybate or 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

Consult your doctor or pharmacist before starting to take Oxibato de sodio Normon.

• if you have respiratory or lung problems (and especially if you are obese), since Oxibato de sodio Normon may 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, hypertension (high blood pressure), or liver or kidney problems, as your dose may need to be adjusted;
• if you have previously used drugs or abused medications;
• if you have epilepsy, as the use of Oxibato de sodio Normon 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 Normon.

If, while taking Oxibato de sodio Normon, 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, if they occur, they are generally mild to moderate in severity.

In elderly patients, your doctor will closely monitor your progress to ensure that Oxibato de sodio Normon is producing the desired effects.

Oxibato de sodio Normon 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 Oxibato de sodio Normon and while taking this medication.

Children and adolescents

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

Oxibato de sodio Normon 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 assistance must be sought and the doctor informed as soon as possible. If abnormalities occur 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 currently experiencing unpleasant feelings, especially if you feel very sad or have lost interest in life, it is important to inform your doctor or caregiver.

Use of Sodium Oxybate with Other Medicines

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

In particular, Sodium Oxybate Normon must not be used together with medicines that induce sleep and 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 in the treatment of epileptic seizures)
• topiramate (used for the treatment of epilepsy)

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

Taking Sodium Oxybate with food, drinks, and alcohol

You should not drink alcohol while taking Sodium Oxybate Normon, as its effects may be increased.

Pregnancy and lactation

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 Oxibato de sodio Normon during pregnancy, and some of them experienced spontaneous abortions. The risk of taking Oxibato de sodio Normon during pregnancy is unknown; therefore, its use is not recommended in pregnant women or in women attempting to become pregnant.

Patients taking Oxibato de sodio Normon must discontinue breastfeeding, as Oxibato de sodio Normon passes into breast milk. Changes in sleep patterns have been observed in infants exposed through breastfeeding.

Driving and Use of Machinery

Oxibato de sodio Normon may affect you if you drive or operate machinery. Do not drive, operate heavy machinery, or engage in any activity that could be dangerous or require mental alertness for at least 6 hours after taking Oxibato de sodio Normon. When starting treatment with Oxibato de sodio for the first time and until you know whether it causes drowsiness the following day, exercise special caution when driving, operating heavy machinery, or performing any other activity that could be hazardous or require full mental alertness.

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

Sodium oxybate contains sodium

This medicine contains 182.24 mg of sodium (the main component of table/cooking salt) in each 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 Normon or more per day for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

This is also relevant for children, in whom the maximum daily intake is considered proportional to that of adults and based on energy requirements.

3. How to take Oxibato de sodio Normon

Follow exactly the instructions for use of this medicine 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 de sodio Normon. The Oxibato de sodio Normon syringe has a measurement scale in grams; you will see the mark corresponding exactly to your prescribed dose.

Adults: taking Oxibato de sodio Normon alone

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

• Take Oxibato de sodio Normon orally twice each night.

• Take the first dose at bedtime 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 de sodio Normon absorbed by your body. Therefore, it is best to take Oxibato de sodio Normon consistently at the same time, 2–3 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 Oxibato de sodio Normon 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 to you.

Adults: taking Oxibato de sodio Normon with valproate

If you are taking valproate together with Oxibato de sodio Normon, your doctor will adjust your dose of Oxibato de sodio Normon.

• For adults, the recommended initial dose of Oxibato de sodio Normon when used concomitantly with valproate is 3.6 g/day, divided into two separate doses of 1.8 g each.
• Take the first dose at bedtime and the second dose 2.5 to 4 hours later.

Adolescents and children aged 7 years and older weighing 15 kg or more: taking Oxibato de sodio Normon with valproate

If you are taking valproate together with Oxibato de sodio Normon, your doctor will adjust your dose of Oxibato de sodio Normon.

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 de sodio Normon

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

To assist you, the Oxibato de sodio Normon 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 in an upright position, insert the push-fit adapter into the neck of the vial. This should only be done the first time the vial is opened. The adapter can remain in place for subsequent uses.

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

Step 2

• Holding the vial and syringe in one hand, draw up the prescribed dose with the other hand by pulling the plunger. NOTE: The medicine will not flow into the syringe unless you keep the vial in an upright position (See Figure 2).

Step 3

• 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 approximately 4 tablespoons).

Step 4

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

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 the child's 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).

• While sitting up in bed, drink the first dose, 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 1 to 2 hours after the child has fallen asleep.

• 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 dosing cup.

If you think the effect of Oxibato de sodio Normon is too strong or too weak, tell your doctor or pharmacist.

If you take more Oxibato de sodio Normon than you should

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

Symptoms of overdose with Oxibato de sodio Normon may include agitation, confusion, altered mobility, difficulty breathing, blurred vision, excessive sweating, headache, vomiting, decreased consciousness that may lead to coma and epileptic seizures, excessive thirst, muscle cramps, and weakness. If you take more Oxibato de sodio Normon than prescribed, or take it by accident, seek emergency medical help immediately. You must bring the medicine package with you, even if it is empty.

If you forget to take Oxibato de sodio Normon

If you forget to take the first dose, take it as soon as you remember, and then continue with the previously described procedure. If you miss the second dose, skip that dose and do not take Oxibato de sodio Normon 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 de sodio Normon

If you are uncertain whether a dose has been administered, do not administer another dose, in order to reduce the risk of overdose.

If you interrupt treatment with Oxibato de sodio Normon

You should continue taking Oxibato de sodio Normon for as long as your doctor continues to prescribe it. If you stop taking the medication, cataplexy attacks may return and you may experience insomnia, headache, anxiety, dizziness, sleep disorders, somnolence, hallucinations, and abnormal thinking.

If you interrupt treatment with Oxibato de sodio Normon for more than 14 days, you must consult your doctor, as you will need to restart treatment with Oxibato de sodio Normon 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 produce 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, contact 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, contact 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, somnolence, 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 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 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,
• amnesia (memory loss),
• myoclonus (involuntary muscle contractions),
• fecal incontinence,
• 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 other people)
• irritability, aggressiveness
• 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 reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if these are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Oxybate Normon

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 bottles, the preparation must be used within 24 hours.

Once the Sodium Oxybate Normon bottle has been opened, any unused content remaining after 40 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 containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxibato de sodio Normon

• The active substance is sodium oxybate. Each ml contains 500 mg of sodium oxybate.
• The other components are malic acid, sodium hydroxide and purified water.

Appearance of the product and contents of the container

Oxibato de sodio Normon is supplied in a 200 ml amber-colored 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 (graduated in 0.25 gram increments with horizontal markings indicating doses of 1.5 g, 2.25 g, 3.0 g, 3.75 g, and 4.5 g), and two dosing cups with child-resistant caps.

Oxibato de sodio Normon is a clear, colorless solution.

Marketing Authorization Holder and Manufacturing Responsible

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos- Madrid (SPAIN)

Your doctor should have provided you with an information package for Sodium Oxybate Normon, which includes a leaflet on how to take the medicine, a patient information sheet with Frequently Asked Questions, and a patient alert card.

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

Other sources of information

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