500 mg / ml oral solution
sodium oxybate
What Sodium Oxibate Reig Jofre is and what it is used for
Sodium oxybate Reig Jofre contains the active substance sodium oxybate. It works by strengthening the night’s sleep, but the exact mechanism of action is unknown.
Sodium oxybate Reig Jofre is used to treat narcolepsy with cataplexy in adults.
Narcolepsy is a sleep disorder that can include sleep attacks during the normally awake part of the day, as well as cataplexy , sleep paralysis, hallucinations, and poor sleep. Cataplexy is an attack of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter, or surprise.
Sodium oxidate contained in Sodium oxidate Reig Jofre may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sodium Oxibate Reig Jofre
Do not use Sodium Oxibate Reig Jofre
- 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 suffer from severe depression,
- if you are being treated with medicines containing opioids or barbiturates.
Warnings and cautions
Talk to your doctor or pharmacist before taking Sodium Oxibate Reig Jofre:
- if you have breathing or lung problems (and especially if you are overweight), as Sodium oxibate Reig Jofre may cause difficulty breathing,
- if you have or have had a depressive illness before,
- if you have heart failure , hypertension (high blood pressure ), liver or kidney problems, as your dose may need to be adjusted,
- if you have used drugs in the past,
- if you have epilepsy because the use of Sodium Oxibate Reig Jofre is not recommended in this condition,
- if you have porphyria (an unusual metabolic disease).
If any of these apply to you, tell your doctor before taking Sodium Oxibate Reig Jofre.
While taking Sodium Oxibate Reig Jofre, tell your doctor immediately if you experience bedwetting and incontinence (both urine and feces), feel confused, have hallucinations, fall asleep or have abnormal thoughts. These effects are unusual, but if they do occur, they are usually mild to moderate in nature.
If you are older, your doctor will closely monitor your condition to check if Sodium Oxibate Reig Jofre has the desired effects.
There is a well-known risk of misuse of sodium oxybate Reig Jofre. There are cases of addiction after the illegal use of sodium oxybate.
Your doctor will ask you if you have abused drugs before you start taking Sodium Oxibate Reig Jofre and while you are taking this medicine.
Children and young people
Do not give this medicine to children and adolescents.
Other medicines and Sodium oxybate Reig Jofre
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, Sodium oxybate Reig Jofre should not be taken with sleeping pills or medicines that reduce the activity of the central nervous system (the central nervous system is the part of the body that deals with the brain and spinal cord).
Also, tell your doctor or pharmacist if you are taking any of the following medicines:
- drugs that increase the activity of the central nervous system and drugs for depression
- drugs that can be similarly converted in the body (eg valproate , phenytoin or ethosuximide used to treat seizures)
- topiramate (used to treat epilepsy)
- if you are taking valproate your daily dose of Sodium Oxibate Reig Jofre will need to be adjusted (see section 3) as this may lead to interactions
Sodium oxybate Reig Jofre with food, drink and alcohol
You must not drink alcohol while taking Sodium Oxibate Reig Jofre, as its effects may be amplified.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
There are very few women who have taken Sodium Oxibate Reig Jofre at any time during pregnancy and a few of these have had miscarriages. The risk of taking Sodium Oxibate Reig Jofre during pregnancy is unknown and therefore the use of Sodium Oxibate Reig Jofre by pregnant women or women planning to become pregnant is not recommended.
Patients taking Sodium Oxibate Reig Jofre should not breastfeed because it is known that Sodium Oxibate Reig Jofre passes into breast milk. Changes in sleep patterns have been observed in breast-fed infants whose mothers have been exposed to sodium oxybate.
Driving and using machines
Sodium oxybate Reig Jofre will affect you if you drive or use tools or machines. Do not drive, use heavy machinery, or perform any activity that is dangerous or requires you to be mentally alert for at least six hours after taking this medicine. From the time you start taking Sodium Oxibate Reig Jofre until you know if it makes you sleepy the next day, you should be extremely careful when driving, using heavy machinery, or doing anything else that may be dangerous or require your full mental attention.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
Sodium oxybate Reig Jofre contains sodium
You need to control your salt intake because Sodium oxidate Reig Jofre contains sodium (found in table salt) which can affect you if you have previously had high blood pressure, heart or kidney problems. If you take two doses of 2.25 g sodium oxybate every night, you will get 0.82 g of sodium, and if you take two doses of 4.5 g of sodium oxybate every night, you will get 1.6 g of sodium. You may need to reduce your salt intake.
How to use Sodium Oxibate Reig Jofre
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose is 4.5 g / day, which is given as two equally divided doses
of 2.25 g / dose each. Your doctor may gradually increase the dose one up to a maximum of 9 g / day given as two equally divided doses of 4.5 g / dose each.
Take Sodium Oxibate Reig Jofre by mouth twice every night. Take the first dose one when you go to bed and the second dose one 2.5 to 4 hours later. You may need to set an alarm clock for you to wake up and take the second dose. Food reduces the amount of sodium oxybate Reig Jofre absorbed by the body. It is, therefore, best if you take Sodium Oxibate Reig Jofre at certain times two to three hours after a meal. Prepare both doses before going to bed. Take the doses within 48 hours after reconstitution.
Your doctor will adjust the dose of Sodium Oxibate Reig Jofre if you are taking valproate with Sodium Oxibate Reig Jofre. The recommended starting dose of Sodium Oxibate Reig Jofre for concomitant treatment with valproate is 3.6 g / day, given as two equal doses of 1.8 g. Take the first dose one at bedtime and the second dose 2.5 to 4 hours later.
If you have kidney problems, you should consider reducing your salt intake.
If you have liver problems, the starting dose should be halved. Your doctor will gradually increase your dose.
Instructions for dilution of sodium oxybate Reig Jofre
The following instructions explain how to prepare Sodium Oxibate Reig Jofre. Read the instructions carefully and follow them step by step.
To help you, the Sodium Oxibate Reig Jofre carton contains 1 bottle of medicine, a bottle adapter, a measuring syringe, and two dosing cups with a child-resistant lid.
- Remove the bottle cap by pushing down and turning the cap counterclockwise (to the left). After removing the lid, place the bottle upright on a table top. Hold the bottle in an upright position and at the same time push the bottle adapter into the neck of the bottle. This only needs to be done the first time the bottle is opened. The adapter can then remain in the bottle for all later use.
- Then insert the tip of the measuring syringe into the center opening of the bottle and press firmly downwards (see figure 1).Figure 1
- While holding the bottle and syringe with one hand, turn them upside down and then pull up the prescribed dose with the other hand by pulling on the plunger. NOTE: Medicines will not flow into the syringe unless the bottle is held upside down (see Figure 2).Figure 2
- Turn the bottle upright. Remove the syringe from the center opening of the bottle. Empty the drug from the syringe into one of the provided dosing cups by pushing down the plunger (see Figure 3). Repeat this step with the other dosing cup. Then add about 60 ml of water to each dosing cup (60 ml is about four tablespoons).Figure 3
- Attach the supplied caps to the dosing cups and turn each cap clockwise (to the right) until it clicks and locks in the child-resistant position (see figure 4). Rinse the syringe with water.Figure 4
- Just before going to bed, place your second dose next to your bed. You may need to set an alarm clock so that you wake up to take the second dose no earlier than 2.5 hours and no later than 4 hours after your first dose . Remove the cap from the first dosing cup by pressing down on the child-resistant locking tab and turning the cap counterclockwise (to the left). Drink the entire first dose one while sitting in bed, put the lid back on the cup, and then lie down immediately.
- When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup. Drink the entire second dose one while sitting in bed and immediately before going to bed to continue sleeping. Put the lid back on the other cup.
If you have the impression that the sodium oxidate Reig Jofre is too strong or too weak, talk to your doctor or pharmacist.
If you use more Sodium Oxibate Reig Jofre than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms of sodium oxybate Reig Jofre overdose include agitation, confusion, reduced mobility, decreased breathing, blurred vision, heavy sweating, headache, vomiting, decreased level of consciousness leading to coma and seizures. If you take or happen to get more Sodium Oxibate Reig Jofre than you have been told to take, seek immediate medical attention. You should take the labeled medicine bottle with you, even if it is empty.
If you forget to use Sodium Oxibate Reig Jofre
If you forget to take the first dose, take it as soon as you remember, and then continue as before. If you miss the second dose, skip that one dose and do not take Sodium Oxibate Reig Jofre again until the next night. Do not take a double dose to compensate for the missed dose .
If you stop using Sodium Oxibate Reig Jofre
You should continue to take Sodium Oxibate Reig Jofre for as long as your doctor prescribes it. You may find that your cataplexy attacks come back if you stop your medication and you may experience insomnia, headaches, anxiety, dizziness, sleep problems, drowsiness, hallucinations, and abnormal thoughts.
If you do not take Sodium Oxibate Reig Jofre for more than 14 consecutive days, you should contact your doctor as you should resume the use of Sodium Oxibate Reig Jofre with a reduced dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These are usually mild to moderate. If you get any of these side effects, talk to your doctor immediately.
Very common (may affect more than 1 user in 10):
Nausea, dizziness, headache
Common (may affect up to 1 in 10 users):
Sleep problems include insomnia, blurred vision, palpitations, vomiting, abdominal pain, diarrhea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, fatigue, feelings of intoxication, sleep paralysis, drowsiness, tremors, confusion/disorientation, nightmares, nightmares, nightmares, nightmares. depression, muscle cramps, swelling, fall accident, joint pain, back pain, excessive daytime sleepiness, balance disorders, lack of attention, disturbed sensitivity especially to touch, abnormal sensations, drowsiness, abnormal taste, anxiety, difficulty falling asleep at night, nervousness, feeling of rotation ( dizziness), urinary incontinence, shortness of breath, snoring, nasal congestion, rash, sinusitis, inflammation of the nose and throat, high blood pressure.
Uncommon (may affect up to 1 in 100 people):
Psychosis (a mental illness that can include hallucinations, incoherent speech or disorganized and upset behavior), paranoia, abnormal thoughts, hallucinations, upset, suicide attempts, difficulty falling asleep, restless legs, a form of numbness and stinging sensation in legs), forgetfulness, myoclonus (involuntary muscle contractions), involuntary emptying of the bowel, hypersensitivity.
No known frequency (can not be calculated from the available data):
Seizures decreased depth or frequency of breathing, hives, suicidal ideation, shortness of breath during sleep, agitation, dry mouth, swelling of the face ( angioedema ), dehydration, panic attacks, mania / bipolar disorder, delusions, bruxism (gnashing of teeth) urination/urination, nocturia (excessive urination at night) tinnitus (ringing or ringing in the ears), sleep-related eating disorder, unconsciousness, increased appetite, irritability, aggression, dyskinesia (eg abnormal, uncontrolled movements of the arms and legs) and thoughts of to commit acts of violence (including harming others), dandruff and increased sexual desire.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly to
The Medical Products Agency
Box 26
751 03 Uppsala
By reporting side effects, you can help increase the safety of medicines.
How to store Sodium oxybate Reig Jofre
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 expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
After dilution in dosing cups, the diluted medicine should be used within 48 hours.
Once you have opened a bottle of Sodium Oxibate Reig Jofre, all contents that you have not used within 40 days of the opening should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- 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 the medicine looks like and contents of the pack
Sodium oxybate Reig Jofre is supplied in a 200 ml amber plastic bottle containing a 180 ml oral solution and closed with a child-resistant cap. Each package contains a bottle, a push-in bottle adapter, a plastic measuring syringe, and two dosing cups with child-resistant lids.
Sodium oxybate Reig Jofre is a clear and colorless solution.
Marketing Authorization Holder and Manufacturer
Laboratory Reig Jofré, SA
Gran Capitan 10;
08970 Sant Joan Despí (Barcelona)
Spain