Sodium oxybate Kalceks

Package leaflet: Information for the user

Sodium oxybate Kalceks 500 mg/ml oral solution

Generic medicine
Please read all of this leaflet carefully before you start taking 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, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sodio oxibato Kalceks contains the active substance sodium oxybate. This medicine works by stabilizing nighttime sleep, although its exact mechanism of action is unknown.
This medicine 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 Kalceks

Do not take Sodio oxibato Kalceks

• if you are allergic to sodium oxybate or to 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 Kalceks:

• if you have respiratory or lung problems (and especially if you are obese), as this medicine 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 sodium oxybate 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 Kalceks.
If, while taking this medicine, you experience bedwetting or incontinence (either urinary or fecal), confusion, hallucinations, sleepwalking episodes, or abnormal thoughts, you must inform your doctor immediately. Although these side 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 check whether this medicine is having the desired effect.
Sodium oxybate has a well-known potential for abuse. Cases of dependence have occurred following illicit use of sodium oxybate. Before starting and during treatment with this medicine, your doctor will ask you whether you have ever abused medicines.

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

Other medicines and Sodio oxibato Kalceks
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, Sodio oxibato Kalceks 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 metabolized similarly by the body (e.g. valproate, phenytoin or ethosuximide used to treat seizures)
• topiramate used to treat epilepsy

If you are taking valproate, your daily dose of Sodio oxibato Kalceks will need to be adjusted, as it may lead to interactions (see section 3).

Sodio oxibato Kalceks with food and alcohol
You must not drink alcohol while taking this medicine, as its effects may be increased. Food reduces the amount of sodium oxybate absorbed by the body (see section 3).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Very few women have taken sodium oxybate occasionally during pregnancy, and a few of these experienced spontaneous abortions. The risk of taking sodium oxybate during pregnancy is not known, and therefore the use of this medicine is not recommended in pregnant women or in women planning pregnancy.
Patients taking sodium oxybate must not breastfeed, as it is known that sodium oxybate passes into breast milk. Changes in sleep patterns have been observed in infants breastfed by exposed mothers.

Driving and using machines
Sodio oxibato Kalceks affects the 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 this medicine. When you first take sodium oxybate, take extreme caution when driving, operating heavy vehicles, or performing any other activity that may be dangerous or require full mental alertness, until you have determined whether this medicinal product causes you drowsiness the following day.

Sodio oxibato Kalceks contains sodium
This medicine contains 0.41 g of sodium (a main component of cooking salt/table salt) in each 2.25 g dose. This corresponds to 20% of the maximum daily recommended sodium intake for an adult.
Talk to your doctor or pharmacist if you need Sodio oxibato Kalceks on a daily basis for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take Sodio oxibato Kalceks

Take this medicine exactly as directed 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 equal doses of 4.5 g per dose.

Take Sodio oxibato Kalceks 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 sodium oxybate absorbed by the body. Therefore, it is best to take this medicine at the same time each day, 2 to 3 hours after a meal. Prepare both doses before going to bed. Use the doses within 24 hours of preparation.

If you are taking valproate together with Sodio oxibato Kalceks, your doctor will adjust the dose of sodium oxybate accordingly.

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 thereafter.

Instructions for diluting Sodio oxibato Kalceks
The following instructions explain how to prepare this medicine. Read the instructions carefully and follow them step by step.

To assist you, the Sodio oxibato Kalceks package contains a medicine bottle, a dosing pipette, and two dosing cups with child-resistant closure caps.

1. Remove the bottle cap by pressing down while turning the cap counterclockwise (to the left). After removing the cap, place the bottle upright on a flat surface. While holding the bottle upright, insert the press-in adapter into the neck of the bottle. This step is only required 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 pipette into the central opening of the bottle and firmly push it down (Figure 1). Make sure the dosing pipette is securely attached.

Figure 1

3. To fill the pipette, turn the bottle upside down. While holding the pipette in place, gently pull the plunger down to draw the medicine to the prescribed dose (see Figure 2).

Figure 2

4. Return the bottle to its upright position. Remove the pipette from the central opening of the bottle. Transfer the medicine from the pipette into one of the provided dosing cups by pressing 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

5. Place the provided caps onto 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 pipette with water.

Figure 4

6. Just before going to sleep, place the second dose near 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 then lie down immediately.
7. When you wake up, 2.5 to 4 hours later, remove the cap from the second dosing cup. While sitting up in bed, drink the entire second dose immediately before lying down again to continue sleeping. Close the second cup afterward.

For each subsequent preparation of this medicine, follow steps 2 to 7.
Keep the entire package until the end of treatment.

If you feel that the effect of Sodio oxibato Kalceks is too strong or too weak, consult your doctor or pharmacist.

If you take more Sodio oxibato Kalceks than you should
Symptoms of sodium oxybate overdose may include agitation, confusion, movement disturbances, difficulty breathing, blurred vision, excessive sweating, headache, vomiting, decreased level of consciousness leading to coma and seizures, excessive thirst, muscle cramps, and weakness. If you take more sodium oxybate 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 Kalceks
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 this medicine again until the next night. Do not take a double dose to make up for the missed dose.

If you stop taking Sodio oxibato Kalceks
You must continue taking this medicine for as long as your doctor has instructed. If treatment is stopped, you may experience a return of cataplectic attacks and develop insomnia, headache, anxiety, dizziness, sleep disturbances, drowsiness, hallucinations, and abnormal thoughts. If you stop treatment with Sodio oxibato Kalceks for more than 14 consecutive days, you must consult your doctor, as you will need to restart this medicine at a reduced dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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, awareness 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 disorders, reduced sensitivity especially to touch, abnormal tactile sensation, sensation of "pins and needles" (a part of the body, usually a foot or a hand, starts to tingle and becomes numb or "goes to sleep"), sedation, taste alteration, anxiety, difficulty falling asleep in the middle of the night, restlessness, sensation of spinning (vertigo), urinary incontinence, shortness of breath, 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 that 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 faecal incontinence, 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 (increased 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 limb movements) 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Sodio oxibato Kalceks

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after (Exp.). The expiry date refers to the last day of that month.
After dilution in the dosing syringes, the preparation must be used within 24 hours.
After opening the Sodio oxibato Kalceks bottle, any unused content remaining more than 90 days after opening must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sodio oxibato Kalceks contains

• The active substance is sodium oxybate. Each ml of solution contains 500 mg of sodium oxybate.
• The other excipients are malic acid (for pH adjustment), sodium hydroxide (for pH adjustment) and purified water.

Description of the appearance of Sodio oxibato Kalceks and contents of the pack
Sodio oxibato Kalceks is a solution ranging from colourless to yellowish and from clear to slightly opalescent.
180 ml of solution in an amber plastic bottle of 200 ml closed with a child-resistant closure cap.
Each pack contains one bottle, a press-in adapter for the bottle, a graduated dosing pipette (graduated for dosing from 1.5 g to 4.5 g) and two dosing cups with child-resistant screw caps.
Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Estonia Sodium oxybate Kalceks
Austria Natriumoxybat Kalceks 500 mg/ml Lösung zum Einnehmen
Belgium Oxybate Kalceks 500 mg/ml, drink
Oxybate Kalceks 500 mg/ml, oral solution
Oxybate Kalceks 500 mg/ml, Lösung zum Einnehmen
Czech Republic Sodium oxybate Kalceks
Denmark Natriumoxybat Kalceks
Germany Natriumoxybat Ethypharm 500 mg/ml Lösung zum Einnehmen
Spain Oxibato de sodio Kalceks 500 mg/ml solución oral EFG
Finland Natriumoksibaatti Kalceks
France OXYBATE DE SODIUM KALCEKS 500 mg/mL, solution buvable
Ireland Sodium oxybate 500 mg/ml oral solution
Italy Sodio oxibato Kalceks 500 mg/ml soluzione orale
Lithuania Sodium oxybate Kalceks 500 mg/ml geriamasis tirpalas
Latvia Nartex 500 mg/ml šķīdums iekšķīgai lietošanai
Netherlands Natriumoxybaat Kalceks 500 mg/ml drink
Norway Natriumoksybat Kalceks
Sweden Natriumoxibat Kalceks
Slovenia Natrijev oksibat Kalceks 500 mg/ml peroralna raztopina
Slovakia Sodium oxybate Kalceks 500 mg/ml perorálny roztok