Leaflet: information for the user

Oxibate Sodium Normon 500 mg/ml oral solution EFG

oxibate sodium

Read 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 doubts, 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 Oxibate Sodium Normon and what it is used for

2. What you need to know before starting to take Oxibate Sodium Normon

3. How to take Oxibate Sodium Normon

4. Possible side effects

5. Storage of Oxibate Sodium Normon

6. Contents of the pack and additional information

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

Sodium Oxibate 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 attacks of sleep during hours when 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, in response to a sudden emotional reaction such as anger, fear, joy, laughter, or surprise.

Do not take Normon Sodium Oxibate

• if you are allergic to sodium oxibate 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 have severe depression;
• if you are receiving treatment with opioid or barbiturate medicines.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Sodium Oxibate Normon.

• if you have respiratory or pulmonary problems (and especially if you are obese), as Sodium Oxibate Normon 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, high blood pressure, liver or kidney problems, your doctor may need to adjust your dose;
• if you have previously consumed drugs or abused medicines;
• if you have epilepsy, as Sodium Oxibate Normon 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 Oxibate Normon.

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

Sodium Oxibate Normon has a well-known potential for abuse. Cases of dependence have been reported after illicit use of sodium oxibate.

Your doctor will ask if you have consumed any drugs before starting to take Sodium Oxibate Normon and while taking this medicine.

Children and Adolescents

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

Sodium Oxibate Normon 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 should carefully monitor the child's breathing during the 2 hours after ingesting sodium oxibate 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.

Use of Sodium Oxibate with Other Medicines

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

In particular, Sodium Oxibate Normon should not be used with sleep-inducing medicines 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 using any of the following types of medicines:

• medicines that increase the activity of the nervous system
• antidepressants
• medicines 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 Oxibate Normon will need to be adjusted (see section 3) as it may cause interactions.

Taking Sodium Oxibate with Food, Drinks, and Alcohol

You should not drink alcohol while taking Sodium Oxibate Normon, 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 medicine.

Very few women have taken Sodium Oxibate Normon during pregnancy, and some of them experienced spontaneous abortions. The risk of taking Sodium Oxibate Normon during pregnancy is unknown, so it is not recommended for use in pregnant women or women trying to become pregnant.

Women taking Sodium Oxibate Normon should stop breastfeeding, as Sodium Oxibate Normon passes into breast milk. Changes in sleep have been observed in infants of mothers exposed to Sodium Oxibate Normon.

Driving and Operating Machines

Sodium Oxibate Normon may affect you if you drive or operate machines. Do not drive, operate heavy machinery, or perform any activity that may be hazardous or require mental alertness for at least 6 hours after ingesting Sodium Oxibate Normon. When you start taking Sodium Oxibate Normon 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 pose a physical risk may be more than 6 hours, depending on individual sensitivity.

Sodium Oxibate Contains Sodium

This medicine 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 Oxibate Normon or more per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

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

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 Normon. The Oxibato de sodio Normon syringe has a measurement scale in grams, you will see which one has the exact mark for your dose.

Adults: take Oxibato de sodio Normon only

• For adults, the recommended initial dose is 4.5 g/day, divided into two separate doses of 2.25 g.
• Your doctor may gradually increase your dose up to a maximum of 9 g/day divided into two separate doses of 4.5 g.
• Take Oxibato de sodio Normon 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 that you wake up to take the second dose.
• Food reduces the amount of Oxibato de sodio Normon that your body absorbs. Therefore, it is best to take Oxibato de sodio Normon at a set 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 or more weighing 15 kg or more: take Oxibato de sodio Normon only

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

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

Adults: take Oxibato de sodio Normon with valproate

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

• For adults, the recommended initial dose of Oxibato de sodio Normon when used with valproate is 3.6 g/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 de sodio Normon with valproate

If you are taking valproate along with Oxibato de sodio Normon, your doctor will adjust your Oxibato de sodio Normon 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 to 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 help you, the Oxibato de sodio Normon packaging contains 1 bottle of medication, 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.
• While holding 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.

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

Step 2

• While holding the bottle and syringe in one hand, prepare 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 upright (See Figure 2).

Step 3

• 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.
• Add approximately 60 ml of water to each dosing vial (60 ml is approximately 4 tablespoons).

Step 4

• Place 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).
• Flush the syringe with water.

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 that 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. In the case of children who sleep for 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. While sitting in bed, drink the second dose just before going back to bed to continue sleeping. Cap the second vial.

If you consider that the effect of Oxibato de sodio Normon is too intense or too weak, inform your doctor or pharmacist.

If you take more Oxibato de sodio Normon than you should

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

The symptoms of Oxibato de sodio Normon 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 Normon than you should, or take it by accident, seek immediate medical emergency assistance. You should bring the medication packaging with you, even if it is empty.

If you forgot to take Oxibato de sodio Normon

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 de sodio Normon 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 Normon

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 Normon

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

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

If you have any other questions about the use of 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, sensation 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 may include hallucinations, incoherent speech, or disorganized and agitated behavior)
• paranoia, abnormal thinking, hallucinations, agitation, suicidal attempt,
• difficulty falling asleep, restless legs,
• amnesia (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 tinkling 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 adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, 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 infusion sets, the preparation should be used within 24 hours thereafter.

Once the bottle of Sodium Oxibate Normon is opened, any unused content should be discarded after 40 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 Normon Sodium Oxibate

• The active principle is sodium oxibate. Each ml contains 500 mg of sodium oxibate.
• The other components are maleic acid, sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging

Normon Sodium Oxibate is presented in an amber-colored 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-Inducing Bottle Adapter), a plastic graduated syringe (graduated from 0.25 to 0.25 grams with horizontal markings presenting the doses of 1.5g, 2.25g, 3.0g, 3.75g, and 4.5g) and two dosing cups with child-resistant caps.

Normon Sodium Oxibate is a clear and colorless solution.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos- Madrid (SPAIN)

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

Last review date of this leaflet: November 2021

Other sources of information

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