Xyrem oral solution

Xyrem 500mg/ml oral solution tie orala (sodium oxybate / Oxibat de sodiu)

WHAT XYREM IS AND WHAT IT IS USED FOR

Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown.

Xyrem is used to treat narcolepsy with cataplexy in adult patients. Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep. Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.

BEFORE YOU TAKE XYREM

Do not take Xyrem:

• if you are allergic (hypersensitive) to sodium oxybate or any of the other ingredients of Xyrem
• if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder)
• if you are being treated with opioids or barbiturate agents

Take special care with Xyrem:

• if you have breathing or lung problems
• if you have or have previously had depressive illness
• if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your dose may need to be adjusted
• if you are taking other CNS depressants or alcohol
• if you have previously had experience with drug abuse
• if you suffer from epilepsy the use of Xyrem is not recommended
• if you have porphyria (an uncommon metabolic disorder)

If any of these apply to you, tell your doctor before you take Xyrem.

While you are taking Xyrem, if you experience bed wetting and incontinence (both urine and faeces), confusion, hallucinations, episodes of sleepwalking or abnormal thinking you should tell your doctor straight away. Whilst these effects are uncommon, if they do occur they are usually mild-to-moderate in nature.

If you are elderly, your doctor will monitor your condition carefully to check whether Xyrem is having the desired effects.

Xyrem should not be taken by children.

When you discontinue taking Xyrem you need to follow your doctor’s instructions as it may result in side effects e.g. headache, lack of sleep, mood changes and hallucinations.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Xyrem with food and drink

You must not drink alcohol while taking Xyrem, as its effects can be increased. Xyrem is to be taken at a set time well after a meal (two – three hours) as food decreases the amount of Xyrem that is absorbed by your body. Xyrem should be diluted only with water.

You need to monitor the amount of salt you take as Xyrem contains sodium (which is found in table salt) which may affect you if you have had blood pressure, heart or kidney problems in the past. If you take two 2.25 g doses of sodium oxybate each night you will take 0.82g of sodium, or if you take two 4.5g doses of sodium oxybate each night you will take in 1.6g sodium. You may need to moderate your intake of salt.

Pregnancy and breast-feeding

The effects of Xyrem in pregnant women are not known, and so the use of

Xyrem in pregnant women is not recommended. Tell your doctor if you are pregnant or are planning to become pregnant. Xyrem is not recommended during pregnancy unless on the advice of your doctor.

It is not known whether Xyrem passes into breast milk. Patients taking Xyrem should stop breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Xyrem will affect you if you drive or operate tools or machines. Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Xyrem. When you first start taking Xyrem, until you know whether it makes you sleepy the next day, use extreme care while driving a car, operating heavy machinery or doing anything else that could be dangerous or needs you to be fully mentally alert.

HOW TO TAKE XYREM

Always take Xyrem exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual starting dose is 4.5g/day, given as two equally divided doses of 2.25g/dose.

Your doctor may gradually increase your dose up to a maximum of 9g/day given as two equally divided doses of 4.5g/dose.

Take Xyrem orally two times each night. Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later. You may need to set an alarm clock to make sure you wake up to take the second dose. Food decreases the amount of Xyrem that is absorbed by your body. Therefore, it is best to take Xyrem at set times well after a meal (two-three hours). Prepare both doses before bedtime.

If you stop taking Xyrem for more than 14 consecutive days you should consult your doctor as you should restart taking Xyrem at a reduced dose.

Instructions on how to dilute Xyrem

The following instructions explain how to prepare Xyrem. Please read the instructions carefully and follow them step by step.

To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.

1. The bottle will contain a tamper-evident seal that will need to be removed before using the bottle for the first time.

Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left). After removing the cap, set the bottle upright on a table-top. While holding the bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the bottle. This needs only to be done the first time that the bottle is opened. The adaptor can then be left in the bottle for all subsequent uses.

2. Next, insert the tip of the measuring syringe into the centre opening of the bottle and press down firmly.

3. While holding the bottle and syringe with one hand, draw up the prescribed dose with the other hand by pulling on the plunger. NOTE: Medicine will not flow into the syringe unless you keep the bottle in its upright position.

4. Remove the syringe from the centre opening of the bottle. Empty the medicine from the syringe into one of the dosing cups provided by pushing on the plunger (See Figure 3). Repeat this step for the second dosing cup. Then add about 60 ml of water to each dosing cup (60 mis is about 4 tablespoons).

5. Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 4). Rinse out the syringe with water.

6.  Just before going to sleep, place your second dose near your bed. You may need to set an alarm so you wake up to take your 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 anticlockwise (to the left). Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away.

7.  When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.

If you have the impression that the effect of Xyrem is too strong or too weak, talk to your doctor or pharmacist.

If you take more Xyrem than you should

Symptoms of Xyrem overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures. If you take more Xyrem than you were told to take, or take it by accident, get emergency medical help right away. You should take the labelled medicine bottle with you, even if it is empty.

If you forget to take Xyrem

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 dose and do not take Xyrem again until the next night. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Xyrem

You should continue to take Xyrem for as long as instructed by your Doctor. You may find that your cataplexy attacks return if your medicine is stopped and you may experience insomnia, headache, anxiety, dizziness, sleeping problems, sleepiness, hallucination and abnormal thinking.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Xyrem can have side effects. These are usually mild to moderate. If you experience any of these, tell your doctor straight away. Sodium oxybate has a well known abuse potential. No cases of abuse are known among individuals treated for narcolepsy. However cases of dependency have occurred after the illicit use of sodium oxybate.

Very common side effects include:

Nausea, dizziness, headache.

Common side effects include:

Sleeping problems including insomnia, blurred vision, vomiting, stomach pains, diarrhoea, anorexia, weakness, abnormal dreams, tiredness, feeling drunk, sleep paralysis, sleepiness, trembling, confusion/disorientation, nightmares, sleep walking, bed wetting, sweating, depression, muscle cramps, swelling, fall, joint pain, cataplexy, balance disorder, disturbance in attention, disturbed sensitivity particularly to touch, abnormal touch sensation, sedation, anxiety, difficulty in falling asleep in the middle of the night, nervousness, urinary incontinence, shortness of breath, snoring

Uncommon side effects include:

Psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behaviour), paranoia, abnormal thinking, hallucination, agitation, suicide attempt, difficulty in falling asleep, restless legs, weight loss, forgetfulness, myoclonus (involuntary contractions of muscles), involuntary passage of faeces, rash, increased blood pressure

Side effects with unknown frequency include:

Convulsion, decreased breathing depth or rate, hives, hypersensitivity, suicidal thoughts

If any of these affect you severely, tell your doctor.

If you are concerned about any side effect, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE XYREM

Keep out of the reach and sight of children.

Do not use Xyrem after the expiry date stated on the bottle. The expiry date refers to the last day of that month.

Store in the original container.

Do not store Xyrem solutions diluted with water for more than 24 hours.

Once you open a bottle of Xyrem, any contents that you have not used within 40 days of opening should be disposed of.

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.

FURTHER INFORMATION

What Xyrem contains

The active substance is sodium oxybate.

The other ingredients are purified water, malic acid and sodium hydroxide. Xyrem is supplied as an oral solution in a 180 ml tamper-evident amber plastic bottle. Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.

What Xyrem looks like and contents of the pack

Xyrem is a clear to slightly opalescent solution.

The amber plastic bottle contains 180 ml of oral solution.