Leaflet: information for the user

Anartex®300 mg/ml oral solution

Sodium oxibate

Read this leaflet carefully before starting to take this medicine, as 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 only for you, and you must not give it to other people 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 Anartex is and what it is used for

2. What you need to know before starting to take Anartex

3. How to take Anartex

4. Possible side effects

5. Storage of Anartex

6. Contents of the pack and additional information

Anartex contains the active ingredient oxibato of sodium. Anartex acts by consolidating nocturnal sleep, although its exact mechanism of action is unknown.

Anartex 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 sleep attacks during hours when normally awake, as well as cataplexy, sleep paralysis, hallucinations, and insomnia. Cataplexy is a 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 takeAnartex

- if you are allergic to sodium oxibate or any of the other components 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 Anartex.

- if you have respiratory or pulmonary problems (and especially if you are obese), as Anartex 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 medications;

- if you have epilepsy, as Anartex 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 Anartex.

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

Anartex 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 Anartex and while taking this medication.

Children and adolescents

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

Anartex 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 during the 2 hours after the sodium oxibate intake to evaluate if there are any breathing anomalies; for example, interruptions in breathing during short periods while sleeping, noisy breathing, and a blue color on the lips and face. If breathing anomalies are observed, seek medical assistance and inform your doctor as soon as possible. If any anomalies are observed after the first dose, do not administer the second dose. If no anomalies 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 ofAnartexwith other medications

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

In particular, Anartex 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):

Also, inform your doctor or pharmacist if you are using any of the following types of medications:

* medications that increase the activity of the central nervous system and antidepressants

* medications that can be metabolized similarly 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 Anartex will need to be adjusted (see section 3) as it may cause interactions.

Use ofAnartexwith alcohol

Do not drink alcohol while taking Anartex, 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 oxibate during pregnancy, and some of them experienced spontaneous abortions. The risk of taking Anartex during pregnancy is unknown, so it is not recommended for use in pregnant women or women trying to become pregnant.

Patients taking Anartex should discontinue breastfeeding, as Anartex passes into breast milk. Changes in sleep have been observed in infants exposed to mothers taking Anartex.

Driving and operating machinery

Anartex 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 full mental alertness for at least 6 hours after taking Anartex. When starting Anartex 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 full mental alertness.

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

Anartex contains sodium

This medication 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 (Anartex) or more per day for an extended 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 as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is essential to use only the syringe and dosing cups provided in the box during the preparation of Anartex doses. The Anartex syringe has two distinct measurement units: grams (g) and milliliters (ml).

Adults: Anartex 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 Anartexby mouth 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 you wake up to take the second dose.
  • Food reduces the amount of Anartexthat your body absorbs. Therefore, it is best to take Anartexat 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 older weighing 15 kg or more: Anartex only

For children aged 7 years or older 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: Anartex with valproate

If you are taking valproate along with Anartex, your doctor will adjust your Anartex dose.

• For adults, the recommended initial dose of Anartex when used with valproate is 3.6 g per 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 older weighing 15 kg or more: Anartex with valproate

If you are taking valproate along with Anartex, your doctor will adjust your Anartex dose.

Liver or kidney problems

• If you have kidney problems, you should follow dietary recommendations to reduce sodium intake (salt).

• If you have liver problems, the initial dose should be reduced to half. Your doctor may gradually increase your dose.

Anartex dilution instructions

There are other oral solutions of sodium oxibate, but each has a different administration method. Read carefully the administration instructions for this medication and ask your pharmacist if you have any doubts.

The following instructions explain how to prepare Anartex. Read the instructions carefully and follow them step by step.

To help you, the Anartexpackage contains 1 bottle of medication, a graduated syringe in grams (g) and milliliters (ml), an adapter, and two dosing cups of approximately 60 ml capacity with child-resistant caps.

Anartexcontains 300 mg of sodium oxibate per ml of solution. A dose of 4.5 g of sodium oxibate corresponds to 15 ml of solution.The syringe provided for administering the medication, which is included in the package, is graduated in grams(1.5g, 2.25g, 3.0g, 3.75g, 4.5g) and in milliliters (5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml)with horizontal marks every 0.25 grams (or what is the same, every 1.25 ml). The dosing cups do not have graduation marks. The following table includes the volume of Anartex solution and grams of sodium oxibate it contains. You should refer to the first column of the table (“Amount in grams of Anartex”) when preparing your dose with the graduated syringe in grams, as this is how your doctor will prescribe it:

Each measured dose ofAnartexmust be dispensed into the dosing cup and diluted with 60 ml of water before taking. The 60 ml are approximately the volume of the dosing cup provided in the package, which corresponds to approximately 4 tablespoons.

1. Remove the cap from the bottle by pressing down and unscrewing it in the opposite direction to the clock hands (to the left). After removing the cap, place the bottle upright on a table. Holding the bottle upright, insert the adapter into the neck of the bottle by pressing it firmly (See Figure 1).

2. Next, insert the tip of the graduated syringe into the center of the opening of the bottle and press firmly (See Figure 2).

3. 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 hold the bottle upright (See Figure 3).

4. After preparing the dose, place the bottle upright and remove the syringe from the center of the opening of the bottle. Empty the medication from the syringe into one of the dosing cups provided, pushing the plunger (See Figure 4). Repeat this step for the second dosing cup. Then add approximately 60 ml of water to each dosing cup (60 ml are approximately 4 tablespoons).

5. Place the caps on the dosing cups and turn each cap in the direction of the clock hands (to the right) until you feel the click and close it in the child-resistant position (See Figure 5). Clear the syringe with water.

6. 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 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, not before 2.5 hoursand not later than 4 hours after your first dose.

Then

• Remove the cap from the first dosing cup by pressing on the child-resistant cap and turning it in the opposite direction to the clock hands (to the left).
• Drink the first dose while sitting in bed, cap the cup, and then go to bed immediately. In the case of children who sleep more than 8 hours but less than 12, the first dose may be administered after the child has slept for 1 to 2 hours.

7. When you wake up or wake the child between 2.5 and 4 hours later, remove the cap from the second dosing cup. Sit in bed and drink the second dose just before going back to sleep. Cap the second cup.

If you consider that the effect of Anartexis too intense or too weak, inform your doctor or pharmacist.

If you take moreAnartexthan you should

The symptoms of Anartex overdosemay include agitation, confusion, altered mobility, respiratory difficulty, blurred vision, excessive sweating, headache, vomiting, decreased consciousness that may lead to coma, seizures, excessive thirst, muscle cramps, and weakness. If you take more Anartex than you should, or take it by accident, seek immediate medical help. You should bring the empty medication package 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 forgot to takeAnartex

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 Anartex 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 Anartex

In case of doubt about administering a dose, do not administer the dose again to reduce the risk of overdose.

If you interrupt treatment withAnartex

You should continue taking Anartexwhile 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 Anartex for more than 14 days, you should consult your doctor as you should start treatment with Anartexfrom a lower dose.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. These are often of mild to moderate intensity.

Adults: more frequent side effects observed in clinical studies(which occur in 10% to 20% of patients):

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

Children and adolescents: more frequent side effects observed in a clinical study:

?dizziness (5.8%)

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, daytime somnolence, nightmares, sleepwalking, excessive daytime sleepiness, 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
• anorexia, decreased appetite, weight loss
• weakness, fatigue, sedation
• sweating
• depression
• muscle cramps, swelling
• joint pain, back pain
• alteration of attention, alteration of essential sensitivity, 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
• memory loss
• myoclonia (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/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 effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect 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 effects, you can contribute to providing more information on the safety of this medication.

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 Anartex bottle is opened, any unused content should be discarded after 40 days following its opening.

Medications should not be thrown down the 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.

Once finished, dispose of the container, including syringes, adapter, and dosing vials.

Composition ofAnartex

- The active principle is sodium oxibate. Each ml contains 300 mg of sodium oxibate.

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

Appearance of the product and contents of the packaging

Anartexis presented in an amber-colored plastic bottle of 300 ml that contains 300 ml of oral solution, closed with a child-resistant cap. Each package contains a bottle, a adapter, a plastic syringe graduated in grams (1.5g, 2.25g, 3.0g, 3.75g, 4.5g) and in milliliters (5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml) with horizontal marks every 0.25 grams (or the same, every 1.25 ml) and two dosing cups with child-resistant caps.The dosing cups do not contain graduation marks.

Anartexis a clear, colorless and particle-free solution.

Holder of the marketing authorization

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6th floor 08039 - Barcelona

Spain

Responsible for manufacturing

Medichem S.A.

Narcís Monturiol, 41 A

08970 Sant Joan Despí

Barcelona. Spain

or

Laboratorios Salvat, S.A.

Gall, 30-36

08950 Esplugues de Llobregat (Barcelona)

Spain

Last review date of this leaflet: October 2021

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/.