Sodium oxibate Accord

Package Leaflet: Information for the User

Sodium oxybate Accord, 500 mg/ml, oral solution

Sodium hydroxybutyrate

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Sodium oxybate Accord is and what it is used for
• 2. Important information before taking Sodium oxybate Accord
• 3. How to take Sodium oxybate Accord
• 4. Possible side effects
• 5. How to store Sodium oxybate Accord
• 6. Contents of the pack and other information

1. What Sodium oxybate Accord is and what it is used for

Sodium oxybate Accord contains the active substance sodium oxybate. Sodium oxybate Accord works by improving nighttime sleep, although the exact mechanism of action is not known.
Sodium oxybate Accord is used in adults to treat narcolepsy with cataplexy.
Narcolepsy is a sleep disorder that can cause excessive daytime sleepiness, cataplexy, hallucinations, and sleep paralysis. Cataplexy is a sudden weakness or paralysis of the muscles that can be triggered by strong emotions such as anger, fear, joy, laughter, or surprise.

2. Important information before taking Sodium oxybate Accord

When not to take Sodium oxybate Accord

Warnings and precautions

Before taking Sodium oxybate Accord, discuss with your doctor or pharmacist:

If any of these conditions apply to you, tell your doctor before starting treatment.
While taking Sodium oxybate Accord, tell your doctor immediately if you experience:
bedwetting and loss of bladder or bowel control, confusion, hallucinations, sleepwalking, or abnormal thinking. Although these symptoms do not occur often, if they do, they are usually mild to moderate.
In elderly patients, the doctor will monitor you closely to see if the treatment is working.
Sodium oxybate Accord has known addictive potential. Cases of addiction have occurred with illegal use of sodium oxybate.
Your doctor will ask if you have ever abused drugs before taking Sodium oxybate Accord and while taking this medicine.

Children and adolescents

Do not give this medicine to children and adolescents.

Sodium oxybate Accord with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and any medicines you plan to take.
In particular, Sodium oxybate Accord should not be taken with sleeping pills or medicines that reduce activity of the central nervous system (the central nervous system consists of the brain and spinal cord).
Also, tell your doctor or pharmacist if you are taking any of the following types of medicines:

• medicines that increase nervous system activity and antidepressants
• medicines that may be processed in the same way by the body (e.g., valproic acid, phenytoin, or ethosuximide used to treat seizures)
• topiramate (used to treat epilepsy)

Taking Sodium oxybate Accord with food, drink, and alcohol

Do not drink alcohol while taking Sodium oxybate Accord, as the effects of the medicine may be increased.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Only a few women have taken Sodium oxybate Accord during pregnancy, and some had a miscarriage. The risk of taking Sodium oxybate Accord during pregnancy is not known, so it is not recommended to take Sodium oxybate Accord during pregnancy or in women trying to conceive.
Women taking Sodium oxybate Accord must stop breastfeeding, as Sodium oxybate Accord passes into breast milk. In newborns breastfed by mothers taking Sodium oxybate Accord, changes in sleep patterns have been observed.

Driving and using machines

Sodium oxybate Accord can affect your ability to drive and use machines. Do not drive, operate heavy machinery, or perform hazardous activities that require attention for at least 6 hours after taking Sodium oxybate Accord. When taking Sodium oxybate Accord for the first time, be extra careful when driving, operating heavy machinery, or performing any activities that may be hazardous or require full attention until you know if the medicine causes drowsiness the next day.

Sodium oxybate Accord contains sodium

It is recommended to control your salt intake, as Sodium oxybate Accord contains sodium (a component of common salt), which may be important if you have had problems with high blood pressure, heart, or kidney disease in the past. If you take two doses of 2.25 g of sodium oxybate per night, you will take 0.82 g of sodium, and if you take two doses of 4.5 g of sodium oxybate, you will take 1.6 g of sodium. Your salt intake may need to be adjusted.

3. How to take Sodium oxybate Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended starting dose is 4.5 g per day, taken in two equal doses of 2.25 g per dose. Your doctor may gradually increase the dose to a maximum dose of 9 g per day, taken as two equal doses of 4.5 g per dose.
Sodium oxybate Accord should be taken orally twice each night. The first dose should be taken immediately before bedtime, and the second dose 2.5 to 4 hours later. You may need to set an alarm to wake up and take the second dose. Food reduces the amount of Sodium oxybate Accord absorbed by the body, so it is best to take the medicine at set times: 2-3 hours after a meal. Both doses should be prepared before going to bed and taken within 24 hours of preparation.
If you have kidney problems, you may need to make changes to your diet to reduce your sodium intake.
If you have liver problems, you should reduce the starting dose by half. Your doctor may gradually increase the dose.
How to dilute Sodium oxybate Accord
The following describes how to prepare Sodium oxybate Accord. Read it carefully and follow the instructions step by step.

• 1. Remove the cap from the bottle by pushing it down and twisting it counterclockwise (to the left). After removing the cap, place the bottle upright on a table. There is a protective foil on top of the bottle that must be removed before first use. Holding the bottle upright, place the included adapter on the neck of the bottle. This should only be done when opening the bottle for the first time. The adapter can then be left on the bottle for subsequent uses.

Then, insert the tip of the dosing syringe into the visible hole in the center of the bottle opening and push the syringe firmly (see Figure 1).

Figure 1

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

Figure 2

• 4. Place the bottle in an upright position and remove the syringe from the bottle opening. Pressing the plunger, inject the medicine from the syringe into one of the included dosing cups (see Figure 3). Repeat this step for the second dosing cup. Then, add approximately 60 ml of water (about 4 tablespoons) to each dosing cup.

Figure 3

• 5. Place the included child-resistant caps on both dosing cups and twist them clockwise (to the right) until you hear a click, indicating the cap is child-resistant. Rinse the syringe with water.

Figure 4

• 6. Just before going to bed, move the dosing cup with the second dose near your bed. To ensure the second dose is taken no earlier than 2.5 hours and no later than 4 hours after the first dose, you may need to set an alarm. Remove the cap from the first dosing cup by pressing the child-resistant feature and twisting the cap counterclockwise (to the left). Take the first dose in its entirety while sitting in bed, replace the cap, and immediately lie down.
• 7. After waking up 2.5 to 4 hours later, remove the cap from the second dosing cup. Take the second dose in its entirety while sitting in bed, just before lying down again to continue sleeping. Replace the cap on the second dosing cup.

If you feel that the effect of Sodium oxybate Accord is too strong or too weak, talk to your doctor or pharmacist.

Taking more Sodium oxybate Accord than prescribed

Symptoms of overdose with Sodium oxybate Accord may include: restlessness, disorientation, abnormal behavior, breathing difficulties, blurred vision, increased sweating, headache, vomiting, abnormal thinking leading to coma and seizures, excessive thirst, muscle cramps, and weakness. If you take more Sodium oxybate Accord than prescribed by your doctor or accidentally take the medicine, seek immediate medical attention. Take the labeled bottle with you, even if it is empty.

Missing a dose of Sodium oxybate Accord

If you miss the first dose, take it as soon as possible and then continue as before. If you miss the second dose, skip it and do not take the medicine until the next evening. Do not take a double dose to make up for a missed dose.

Stopping Sodium oxybate Accord treatment

Take Sodium oxybate Accord for as long as your doctor recommends. After stopping the medicine, cataplexy attacks may return, and you may experience: insomnia, headache, anxiety, dizziness, sleep disturbances, drowsiness, hallucinations, and abnormal thinking.
If you stop taking Sodium oxybate Accord for more than 14 consecutive days, consult your doctor, as you may need to restart the medicine at a lower dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sodium oxybate Accord can cause side effects, although not everybody gets them.
These are usually mild or moderate. If you experience any of the following side effects, tell 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 disturbances, including insomnia, blurred vision, palpitations, vomiting, abdominal pain, diarrhea, loss of appetite, weight loss, weakness, vivid dreams, fatigue, feeling drunk, sleep paralysis, drowsiness, tremors, confusion/disorientation, nightmares, sleepwalking, bedwetting, excessive sweating, depression, painful muscle spasms, swelling, falls, joint pain, back pain, excessive daytime sleepiness, balance disturbances, attention disturbances, reduced sensitivity, particularly to touch, abnormal sensations of touch, sedation, taste disturbances, anxiety, difficulty falling asleep in the middle of the night, nervousness, feeling of spinning (dizziness), urinary incontinence, shortness of breath, snoring, nasal congestion, sinusitis, pharyngitis, high blood pressure.

Uncommon (may affect up to 1 in 100 people):

psychosis (a mental illness that can include hallucinations, disorganized speech, and agitation), paranoia, thought disturbances, hallucinations, agitation, suicidal attempts, difficulty falling asleep, restless legs syndrome, poor memory, myoclonus (involuntary muscle contractions), fecal incontinence, hypersensitivity.

Frequency not known (cannot be estimated from the available data):

seizures, decreased depth or rate of breathing, hives, suicidal thoughts, short pauses in breathing during sleep, euphoria, dry mouth, facial swelling (angioedema), dehydration, panic attack, mania/bipolar disorder, delusions, bruxism (grinding teeth and clenching jaw), frequent urination (increased need to urinate), nocturia (excessive urination at night), tinnitus (ringing or other sounds in the ears), sleep-related eating disorders, loss of consciousness, increased appetite, irritability, aggression, dyskinesia (abnormal, uncontrolled movements of the limbs) and thoughts of committing acts of violence (including harming others), seborrhea, and increased sexual drive.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [[email protected]](mailto:[email protected])
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sodium oxybate Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle after “EXP”. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
After dilution in the dosing cups, the product should be used within 24 hours.
After 40 days from first opening the bottle of Sodium oxybate Accord, discard any remaining contents.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sodium oxybate Accord contains

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

What Sodium oxybate Accord looks like and contents of the pack

Sodium oxybate Accord is packaged in 200 ml amber-colored plastic bottles containing 180 ml of oral solution, closed with a child-resistant cap. Under the cap, there is a protective foil on top of the bottle. Each carton contains one bottle, a push-in adapter for the bottle, a plastic dosing syringe, and two dosing cups with child-resistant caps. Sodium oxybate Accord is a clear to slightly opalescent solution.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw

Manufacturer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50, 95-200 Pabianice
Poland
Laboratoris Fundació DaU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Laboratorio Reig Jofre S.A.
Gran Capitán, 10, 08970 Sant Joan Despí,
Spain
Your doctor should provide you with a set of informational materials about the medicine, including a booklet on how to take the medicine, an informational leaflet - Frequently Asked Questions, and a Warning Card for the patient.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: