Natriumoxibat Reig Jofre
This medicine helps adults, adolescents, and children over 7 years old who have narcolepsy with cataplexy by improving night-time sleep.
Form
oraaliliuos
Strength
500 mg/ml
Active Ingredient
Sodium oxybate
Manufacturer
Laboratorio Reig Jofré S.A.
How to Use
Dosage
The usual starting dose for adults is 4.5 grams per day, taken as two separate 2.25 gram doses. Your doctor may gradually increase the dose up to a maximum of 9 grams per day, given as two separate 4.5 gram doses.
Method
Take two doses orally every night. Take the first dose when you go to bed, and the second dose 2.5 to 4 hours later. You might need an alarm to wake up for the second dose. Take the medicine 2-3 hours after eating, as food can reduce its absorption. Prepare both doses before bed and take them within 24 hours of preparation.
Important
The maximum daily dose is 9 grams, given as two separate 4.5 gram doses.
Possible Side Effects
COMMON
- •Dizziness
- •Nausea
- •Headache
- •Sleep problems (including insomnia, abnormal dreams, sleep paralysis, sleepiness, nightmares, sleepwalking, bedwetting, daytime sleepiness, difficulty falling asleep in the middle of the night)
- •Feeling drunk, tremors, confusion or disorientation, blurred vision, balance problems, dizzy spells (vertigo)
- •Heart palpitations, high 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
- •Difficulty concentrating, disturbed touch sensitivity, abnormal sensations, taste disturbance
- •Anxiety, nervousness
- •Urinary incontinence
- •Snoring, stuffy nose
- •Rash
- •Sinusitis, inflammation of the nose and throat
- •Feeling mentally unwell (loss of contact with reality)
- •Suicidal thoughts (in children and adolescents)
RARE
- •Psychosis (a mental disorder involving hallucinations, confused speech, or disorganized and agitated behavior)
- •Paranoia, abnormal thoughts, hallucinations, agitation, attempted suicide
- •Difficulty falling asleep, restless legs (a feeling of numbness and tingling in the legs)
- •Forgetfulness
- •Involuntary movements (involuntary muscle contractions)
- •Fecal incontinence (involuntary bowel movements)
- •Hypersensitivity
- •Seizures
- •Shallow or slowed breathing, short pauses in breathing during sleep
- •Hives
- •Suicidal thoughts, delusions, thoughts of harming others (including violence)
- •Irritability, aggressiveness
- •Euphoric mood, elation
- •Panic attacks
- •Mania / bipolar disorder
- •Dry mouth, dehydration
- •Facial swelling (angioedema)
- •Bruxism (teeth grinding and jaw clenching)
- •Frequent urination / urgent need to urinate
- •Ringing or humming in the ears (tinnitus)
- •Sleep-related eating disorder
- •Loss of consciousness
- •Involuntary movements (e.g., abnormal, uncontrolled limb movements)
- •Dandruff
- •Increased sexual desire
- •Nocturia (excessive nighttime urination)
- •Feeling of choking
Important Warnings
- Do not take this medicine if you are allergic to sodium oxybate or any other ingredient in this medicine.
- Do not take this medicine if you have a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency.
- Do not take this medicine if you have severe depression.
- Do not take this medicine if you are taking opioid pain medicines or barbiturates.
- Tell your doctor if you have breathing or lung problems (especially if you are overweight), as this medicine can cause breathing difficulties.
Show 11 more warnings
- Tell your doctor if you have or have had depression, suicidal thoughts, anxiety, psychosis (a mental disorder that can include hallucinations, confused speech, confused behavior, and agitation), or bipolar disorder.
- Tell your doctor if you have heart failure, high blood pressure, or liver or kidney problems, as your dose may need to be adjusted.
- Tell your doctor if you have a history of drug abuse.
- Tell your doctor if you have epilepsy, as this medicine is not recommended for people with epilepsy.
- Tell your doctor if you have porphyria (a rare metabolic disease).
- Do not drink alcohol while taking this medicine, as alcohol may increase its effects.
- Do not breastfeed while taking this medicine, as it is known to pass into breast milk and can cause changes in sleep patterns in infants.
- Avoid driving, operating heavy machinery, or performing tasks that require full attention for at least 6 hours after taking this medicine.
- Do not use this medicine at the same time as sleeping pills or medicines that depress the central nervous system.
- If you are taking valproate with this medicine, your doctor will adjust your dose.
- If you have kidney problems, consider a low-salt diet. If you have liver problems, the starting dose will be halved, and your doctor may gradually increase it.