Sodium oxybate Accord

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodio oxibato Accord 500 mg/ml oral solution

Sodium oxybate
Equivalent medicine
Please read all of this leaflet carefully before you start using 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Sodio oxibato Accord is and what it is used for

Sodio oxibato Accord contains the active substance sodium oxybate. Sodio oxibato Accord
acts by stabilizing nighttime sleep, although its exact mechanism of action is
unknown.
Sodio oxibato Accord is used to treat narcolepsy with cataplexy in adults.
Narcolepsy is a sleep disorder that may include sudden sleep attacks during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations, and poor-quality sleep. Cataplexy is the sudden onset of muscle weakness or paralysis without loss of consciousness, triggered by sudden emotional reactions such as anger, fear, joy, laughter, or surprise.

2. What you need to know before taking Sodio oxibato Accord

Do not take Sodio oxibato Accord

• 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 have major depression;
• if you are being treated with opioid or barbiturate medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sodio oxibato Accord:

• if you have breathing or lung problems (and particularly if you are obese), as Sodio oxibato Accord may cause breathing difficulties;
• if you have or have previously had depression;
• if you have heart failure, high blood pressure, or liver or kidney problems, as your dose may need to be adjusted;
• if you have previously abused medicines;
• if you have epilepsy, as the use of Sodio oxibato Accord is not recommended in this condition;
• if you have porphyria (an uncommon metabolic disorder).

If any of these apply to you, tell your doctor before taking Sodio oxibato Accord.
If, while taking Sodio oxibato Accord, you experience bedwetting and incontinence (both urinary and faecal), confusion, hallucinations, sleepwalking episodes, or abnormal thoughts, you must inform your doctor immediately. Although these effects are not common, if they occur, they are usually mild to moderate in severity.
If you are elderly, your doctor will closely monitor your condition to assess whether Sodio oxibato Accord is producing the desired effects.
Sodio oxibato Accord has a well-known potential for abuse. Cases of dependence have occurred following illicit use of sodium oxybate.
Before you start taking this medicine and during treatment, your doctor will ask whether you have ever abused medicines.

Children and adolescents
Do not give this medicine to children or adolescents.

Other medicines and Sodio oxibato Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, Sodio oxibato Accord must not be taken 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 related to the brain and spinal cord).
Also inform your doctor or pharmacist if you are taking any of the following types of medicines:

• medicines that increase central nervous system activity and antidepressants
• medicines that may be metabolised 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 Sodio oxibato Accord will need to be adjusted, as this may lead to interactions (see section 3).

Sodio oxibato Accord with food, drinks and alcohol
You must not drink alcohol while taking Sodio oxibato Accord, as its effects may be increased.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Very few women have taken Sodio oxibato Accord during pregnancy, and some of them experienced spontaneous abortions. The risk associated with taking Sodio oxibato Accord during pregnancy is not known; therefore, the use of Sodio oxibato Accord is not recommended in pregnant women or in women planning a pregnancy.
Patients taking Sodio oxibato Accord must not breastfeed, as it is known that Sodio oxibato Accord passes into breast milk. Changes in sleep patterns have been observed in infants breastfed by exposed mothers.

Driving and using machines
Sodio oxibato Accord will affect your ability to drive or operate tools or machinery. Do not drive, operate tools or machinery, or perform any activity that is dangerous or requires mental alertness for at least 6 hours after taking Sodio oxibato Accord. When taking Sodio oxibato Accord for the first time, and until you have determined whether this medicine causes you to feel drowsy the following day, exercise extreme caution when driving, operating complex machinery, or performing any other activity that may be dangerous or require full attention.

Sodio oxibato Accord contains sodium
You should monitor your salt intake, as Sodio oxibato Accord contains sodium (which is present in table salt) that may affect you if you have previously had high blood pressure, heart or kidney problems. If you take two doses of 2.25 g of sodium oxybate each night, you will consume 0.82 g of sodium; if you take two doses of 4.5 g of sodium oxybate each night, you will consume 1.6 g of sodium. You should moderate your salt intake.

3. How to take Sodio oxibato Accord

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 4.5 g/day, divided into two equal doses of 2.25 g per dose. Your doctor may gradually increase your dose up to a maximum of 9 g/day, administered in two equally divided doses of 4.5 g each.
Take Sodio oxibato Accord orally twice each night. Take the first dose at bedtime and the second dose 2.5 to 4 hours later. You may need to set an alarm to ensure you wake up to take the second dose. Food reduces the amount of Sodio oxibato Accord absorbed by the body. Therefore, it is best to take Sodio oxibato Accord at the same time, 2 to 3 hours after a meal. Prepare both doses before going to bed. Take the doses within 24 hours of preparation.
If you are taking valproate together with Sodio oxibato Accord, your doctor will adjust the dose of Sodio oxibato Accord. The recommended starting dose of Sodio oxibato Accord when used with valproate is 3.6 g/day, administered in two equally divided doses of 1.8 g. Take the first dose at bedtime and the second dose 2.5 to 4 hours later.
If you have kidney problems, a diet low in sodium should be considered.
If you have liver problems, the starting dose should be halved. Your doctor may gradually increase the dose.

Instructions for diluting Sodio oxibato Accord
The following instructions explain how to prepare Sodio oxibato Accord. Please read the instructions carefully and follow them step by step.
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To assist you, the Sodio oxibato Accord package contains a medicine bottle, a dosing syringe, an adapter, and two dosing cups with child-resistant closure caps.

1. Remove the bottle cap by pushing down while turning it counterclockwise (to the left). After removing the cap, place the bottle upright on a flat surface. Insert the adapter firmly into the neck of the bottle. This step is only necessary the first time the bottle is opened. The adapter can then remain on the bottle for all subsequent uses.
2. Next, insert the tip of the dosing syringe into the central opening of the bottle and press down firmly (Figure 1).

Figure 1

3. Holding the bottle and syringe with one hand, turn the bottle upside down and draw the prescribed dose into the syringe by pulling the plunger with the other hand. NOTE: The medicine will not flow into the syringe if the bottle is not held upside down. (Figure 2).

Figure 2

4. Place the bottle upright. Remove the syringe from the central opening of the bottle. Transfer the medicine from the syringe into one of the provided dosing cups by pushing the plunger (Figure 3). Repeat this procedure for the second dosing cup. Then add approximately 60 ml of water to each dosing cup (60 ml corresponds to about 4 tablespoons).

Figure 3
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5. Place the provided caps on the dosing cups and turn each cap clockwise (to the right) until you hear a click and it locks into the child-resistant safety position (Figure 4). Rinse the syringe with water.

Figure 4

6. Just before going to sleep, place the second dose next to your bed. You may need to set an alarm to wake up and take the second dose, no sooner than 2.5 hours and no later than 4 hours after the first dose. Remove the cap from the first dosing cup by pressing down on the child-resistant closure cap and turning the cap counterclockwise (to the left). Sit up in bed, drink the entire first dose, close the cup, and lie down immediately.
7. When you wake up, 2.5 to 4 hours later, remove the cap from the second dosing cup. While sitting in bed, drink the entire second dose immediately before lying down again to continue sleeping. Close the second cup afterwards.

If you feel that the effect of Sodio oxibato Accord is too strong or too weak, consult your doctor or pharmacist.
If you take more Sodio oxibato Accord than you should
Symptoms of overdose with Sodio oxibato Accord may include agitation, confusion, difficulty moving, breathing difficulties, blurred vision, excessive sweating, headache, vomiting, decreased level of consciousness leading to coma and epileptic seizures, excessive thirst, muscle cramps, and weakness.
If you take more Sodio oxibato Accord than prescribed, or take it accidentally, seek immediate emergency medical help. You must bring the medicine bottle with its label, even if it is empty.
If you forget to take Sodio oxibato Accord
If you forget to take the first dose, take it as soon as you remember, then continue as previously described. If you forget to take the second dose, skip it and do not take Sodio oxibato Accord again until the next night. Do not take a double dose to make up for the missed dose.
If you stop taking Sodio oxibato Accord
You should continue taking Sodio oxibato Accord for the entire duration prescribed by your doctor. If treatment is stopped, you may experience a return of cataplexy attacks and may develop insomnia, headache, anxiety, dizziness, sleep disturbances, drowsiness, hallucinations, and abnormal thoughts.
If you stop treatment with Sodio oxibato Accord for more than 14 consecutive days, you must consult your doctor, as you will need to restart Sodio oxibato Accord at a reduced dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. These are generally mild to moderate. If you experience any of the following 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 disorders including insomnia, blurred vision, sensation of heartbeat, vomiting, stomach pain, diarrhoea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, fatigue, feeling drunk, sleep paralysis, somnolence, tremor, confusion/disorientation, nightmares, sleepwalking, bedwetting, sweating, depression, muscle cramps, swelling, falls, joint pain, back pain, excessive daytime sleepiness, balance disorders, attention disturbances, reduced sensitivity especially to touch, abnormal tactile sensation, sensation of "pins and needles" (a part of the body, usually a foot or hand, starts to tingle and becomes numb or "goes to sleep"), sedation, taste disturbances, anxiety, difficulty falling asleep in the middle of the night, restlessness, sensation of spinning (vertigo), urinary incontinence, breathing difficulties, snoring, nasal congestion, skin rash, sinusitis, inflammation of the nose and throat, increased blood pressure.
Uncommon (may affect up to 1 in 100 people):
Psychosis (a mental disorder which may include hallucinations, disorganized or incoherent speech, and agitated behaviour), paranoia, abnormal thoughts, hallucinations, agitation, suicide attempt, difficulty falling asleep, restless legs, memory loss, myoclonus (involuntary muscle contractions), involuntary loss of faeces, hypersensitivity.
Not known (frequency cannot be estimated from the available data):
Seizures, decreased depth or frequency of breathing, urticaria, suicidal thoughts, brief interruption of breathing during sleep, euphoria, dry mouth, facial swelling (angioedema), dehydration, panic attacks, mania / bipolar disorder, delirium, bruxism (teeth grinding and jaw clenching), pollakiuria/urinary urgency (increased need to urinate), nocturia (repeated need to urinate during the night), tinnitus (noise in the ears such as ringing or buzzing), sleep-related eating disorder, loss of consciousness, increased appetite, irritability, aggression, dyskinesia (e.g. abnormal, uncontrolled movements of limbs) and thoughts of committing violent acts (including harming others), dandruff and increased sexual desire.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sodio oxibato Accord

Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date stated on the bottle after (Exp.). The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
After dilution in the dosing cups, the preparation must be used within 24 hours.
After opening the Sodio oxibato Accord bottle, any unused content remaining after 40 days from opening must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Sodio oxibato Accord contains

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

Description of the appearance of Sodio oxibato Accord and package contents
Sodio oxibato Accord is supplied in an amber PET (polyethylene terephthalate) bottle of 200 ml
containing 180 ml of oral solution, closed with a white polyethylene screw cap with child-resistant closure.
Each package also contains a dosing syringe made of polypropylene and polyethylene, an adapter made of polyethylene, and two dosing cups made of polypropylene with polyethylene caps with child-resistant closure.
The syringe is graduated in g (grams); therefore, it must be used only for Sodio oxibato Accord.
Sodio oxibato Accord is a liquid solution ranging from clear to colourless.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50, Pabianice - place of import,
95-200 Poland
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
LABORATORIO REIG JOFRE S.A.
Gran Capitan, 10, 08970 Sant Joan Despí,
Barcelona - Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
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