Noxizol

Leaflet attached to the packaging: information for the user

Noxizol, 10 mg, coated tablets

Zolpidem tartrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Noxizol and what is it used for
• 2. Important information before using Noxizol
• 3. How to use Noxizol
• 4. Possible side effects
• 5. How to store Noxizol
• 6. Contents of the packaging and other information

1. What is Noxizol and what is it used for

Noxizol is a sleeping medicine that works by affecting the brain, causing drowsiness. The tablets can be used for a short period in the treatment of insomnia that is severe and disrupts normal functioning or leads to extreme exhaustion.

2. Important information before using Noxizol

When not to use Noxizol

• if the patient is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• if the patient has severe liver function disorders
• if the patient has breathing difficulties during sleep (sleep apnea syndrome)
• if the patient has muscle weakness (myasthenia gravis)
• if the patient has severe respiratory failure
• if the patient has ever experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls or having sex, etc.) without full awakening after taking Noxizol or other medicines containing zolpidem
• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to use Noxizol, you should discuss it with your doctor or pharmacist if:

• the patient is elderly or has a tendency to fractures. If the patient gets up at night, they should be made aware of the increased risk of falls and consequently hip fractures due to the muscle relaxant effect of this medicine

if the patient has any kidney or liver function disorders

• if the patient has a history of respiratory disorders. While taking Noxizol, breathing may become shallower
• if the patient has a history of mental illnesses, anxiety or psychotic disorders. Noxizol may reveal or exacerbate symptoms of the disease
• if the patient has symptoms of depression or has had depression in the past
• if the patient has or has had a tendency to abuse alcohol or drugs. In these patients, there is an increased risk of dependence on Noxizol (symptoms of physical or psychological compulsion to take the medicine) and it increases with the dose and duration of treatment.

Psychomotor disorders the next day (see also "Driving and operating machinery")
The next day after taking Noxizol, the risk of psychomotor disorders, including impaired driving ability, may be increased if:

• the patient took the medicine less than 8 hours before activities that require increased mental alertness
• the patient took a higher dose than recommended
• the patient took zolpidem during treatment with other medicines that have a sedative effect on the central nervous system or other medicines that increase the concentration of zolpidem in the blood, while consuming alcohol or taking prohibited substances.

Sleepwalking and other related behaviors
In patients who took zolpidem and were not fully awake, sleepwalking or other related behaviors have been reported, which are unusual during sleep, such as driving, preparing and eating meals, making phone calls or having sex, without remembering the event. The risk of such events may increase if the patient takes Noxizol with alcohol or other medicines that slow down the activity of the central nervous system or if the patient exceeds the maximum recommended dose. If such an event occurs, the doctor should be informed immediately, as such behaviors during sleep can put the patient and others at serious risk of injury. The doctor may recommend stopping the treatment.
Noxizol should be taken as a single dose directly before bedtime.
A second dose should not be taken on the same night.
Other notes

• Tolerance - if after a few weeks of treatment the patient notices that the medicine is not working as effectively as when they started therapy, they should consult a doctor, as it may be necessary to change the dosage.
• Dependence - when taking this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. The increased risk occurs in patients who abuse alcohol and/or drugs currently or in the past.
• Withdrawal - treatment should be discontinued gradually. As a result of stopping therapy, a transient syndrome may occur, which consists of a return of symptoms that are more severe than those that were the reason for using Noxizol. It may be accompanied by other symptoms, such as mood changes, anxiety, and restlessness.
• Amnesia - Noxizol may cause amnesia. To reduce the risk, it should be ensured that the patient has 7-8 hours of uninterrupted sleep.
• Psychological reactions and "paradoxical" - Noxizol may cause undesirable behaviors such as anxiety, agitation, irritability, aggression, delusions (false beliefs), outbursts of anger, nightmares, hallucinations, psychosis, sleepwalking, inadequate behavior, increased insomnia, and other behavioral disorders.

Noxizol and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Noxizol may change the effect of other medicines and/or other medicines may change the effect of Noxizol. If you go to see another doctor or go to the hospital, especially if surgery under general anesthesia is planned, you should inform the doctor about the medicines you are taking.
When taking zolpidem with certain medicines, drowsiness and psychomotor disorders the next day, including impaired driving ability, may be increased. These medicines include:

• Medicines used to treat certain mental health disorders (antipsychotics)
• Medicines used to treat sleep problems (sleeping pills)
• Sedatives or anxiolytics
• Medicines used to treat depression
• Medicines used to treat moderate to severe pain (narcotic analgesics)
• Medicines used to treat epilepsy
• Medicines used in anesthesia
• Medicines used to treat hay fever, rashes, or other allergies (sedating antihistamines). These medicines may cause drowsiness in the patient,
• Liver enzyme inhibitors. You should ask your doctor or pharmacist which medicines have this effect.

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not there (visual hallucinations).
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
The effect of the following medicines may be increased by taking Noxizol:

• Muscle relaxants.

The effect of Noxizol may be reduced by taking the following medicines:

• Medicines used to treat tuberculosis (rifampicin).

Taking Noxizol with opioid medicines (strong painkillers, replacement therapy, and some cold medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to these risks, such treatment should only be considered in patients for whom other types of treatment are not possible. However, if the doctor prescribes Noxizol with opioids, the dose and duration of such concurrent treatment should be limited by the attending physician.
You should tell your doctor about all opioid medicines you are taking and strictly follow the dosage recommended by your doctor. It may be helpful to inform friends and relatives about the possibility of the above-mentioned signs and symptoms. If they occur, you should contact your doctor.

Noxizol with alcohol

You should not drink alcohol while taking Noxizol, as it may increase the sedative effect of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
You should not use Noxizol during pregnancy, especially during the first three months of pregnancy. If for important medical reasons Noxizol is used in late pregnancy or during childbirth, the baby may experience withdrawal symptoms after birth due to physical dependence.
Noxizol passes into breast milk in small amounts, so breastfeeding women should not use this medicine.

Driving and operating machinery

Noxizol has a major impact on the ability to drive and operate machinery, such as "falling asleep at the wheel". The next day after taking Noxizol (like other sleeping medicines), it may happen that:

• the patient feels drowsy, sleepy, has dizziness or is disoriented,
• the patient needs more time to make quick decisions,
• the patient may see blurry or double vision,
• the patient may be less alert. To minimize the risk of the above events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, and working at heights. You should not drink alcohol or psychoactive substances while taking Noxizol, as it may increase the above-mentioned effects.

Noxizol contains lactose

If you have been informed that you do not tolerate some sugars, before using Noxizol, which contains lactose, you should inform your doctor.

Noxizol contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means that the medicine is considered "sodium-free".

3. How to use Noxizol

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.
The tablets should be taken with a liquid, directly before going to bed.

Recommended dose:

Adults
The recommended dose of Noxizol is 10 mg per 24 hours. Some patients may be prescribed a lower dose by their doctor. Noxizol should be taken:

• as a single dose,
• directly before bedtime. The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration. Do not exceed the dose of 10 mg per 24 hours.

Elderly or weakened patients
In elderly or weakened patients, the recommended dose is 1/2 tablet of Noxizol (which corresponds to 5 mg of zolpidem tartrate per day).
This dose may be increased by the doctor to 1 tablet of Noxizol (which corresponds to 10 mg of zolpidem tartrate per day), if the effect of the medicine is too weak and it is well tolerated.
Patients with liver function disorders
The recommended dose in patients with liver function disorders is 1/2 tablet of Noxizol (which corresponds to 5 mg of zolpidem tartrate per day). This dose may be increased by the doctor to 1 tablet of Noxizol (which corresponds to 10 mg of zolpidem tartrate per day), if the effect of the medicine is too weak and it is well tolerated.
Maximum dose
The maximum daily dose should not exceed 1 tablet of Noxizol (which corresponds to 10 mg of zolpidem tartrate per day).
How long to use Noxizol
The duration of treatment should be as short as possible. It usually should last for a few days to two weeks and should not exceed 4 weeks in total, including the period of gradual withdrawal of the medicine.
The doctor will choose a withdrawal schedule based on the individual needs of the patient.
Sometimes there is a need for longer use of the medicine than the maximum recommended duration of treatment. The attending physician will decide on this after re-evaluating the patient's condition.
Use in children and adolescents
Noxizol should not be used in children and adolescents under 18 years of age.

Using a higher than recommended dose of Noxizol

If you (or someone else) have taken a large amount of tablets at once, or if you suspect that a child has swallowed a tablet of Noxizol, you should immediately contact the nearest emergency department or doctor, going there with someone else. If there has been an overdose, the patient may become very sleepy, which may lead to a coma after large doses of the medicine.

Missing a dose of Noxizol

If you do not take a dose of Noxizol directly before going to bed, but remember during the night, you can take the missed dose of the medicine only if you still have 7-8 hours of uninterrupted sleep ahead. If this is not possible, you should take the next dose of the medicine before going to bed the next night. Do nottake a double dose to make up for the missed dose.
In case of doubts about using the medicine, you should consult your doctor or pharmacist.

Stopping the use of Noxizol

• Treatment should be discontinued gradually, as the symptoms for which the patient was being treated may return more severely than before (rebound insomnia), and may also be accompanied by anxiety, restlessness, and mood changes. These symptoms will subside over time.
• If the patient becomes physically dependent on Noxizol, sudden discontinuation of treatment will lead to the occurrence of side effects, such as headaches, muscle pain, anxiety, tension, restlessness, and drowsiness. In severe cases, other symptoms may occur, such as hypersensitivity to light, noise, and touch, a feeling that sounds are louder than usual, and painful hypersensitivity to acoustic stimuli, hallucinations, numbness, and tingling in the limbs, loss of sense of reality (feeling that the surroundings are unreal), depersonalization (feeling of loss of one's own identity), or seizures (sudden, convulsive movements or trembling). Such symptoms may also occur between doses, especially if the dose is large.

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4. Possible side effects

Like all medicines, Noxizol can cause side effects, although not everybody gets them.

You should stop using Noxizol and contact your doctor or go to the nearest hospital immediately if:

The patient experiences an allergic reaction. Symptoms include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

You should contact your doctor as soon as possible if the following side effects occur:

Common (may affect up to 1 in 10 people):

• Memory impairment during Noxizol use (amnesia) and strange behavior during this time. The occurrence of such a state is more likely in the patient within a few hours of taking this medicine. Ensuring 7-8 hours of sleep after taking Noxizol reduces the likelihood of this disorder
• Worsening sleep problems after taking this medicine
• Seeing or hearing things that are not there (hallucinations).

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

• Visual disturbances or double vision.
• Sleepwalking or other related behaviors, which are unusual during sleep, such as driving, preparing and eating meals, making phone calls, or having sex (see section 2 "Warnings and precautions").

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

• Decreased level of consciousness
• Falls, especially in elderly patients.

You should tell your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

Common (may affect up to 1 in 10 people):

• Diarrhea
• Nausea or vomiting
• Abdominal pain
• Respiratory tract infections
• Headache
• Feeling tired or agitated
• Nightmares.

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

• Feeling confused or irritable.

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

• Itching of the skin or skin rash
• Excessive sweating
• Slow breathing (respiratory depression)
• Muscle weakness
• Coordination disorders (ataxia)
• Abuse
• Feeling anxious, aggressive, angry, or behaving unusually
• Depression
• Thinking about things that are not true (delusions)
• Changes in sexual drive
• Changes in liver enzyme activity - observed in blood tests
• Changes in gait
• Weaker than usual effect of Noxizol.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
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 Noxizol

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Noxizol contains

• The active substance of the medicine (the ingredient that makes the medicine work) is zolpidem tartrate. Each coated tablet of Noxizol contains 10 mg of the active substance.
• The other ingredients of the medicine are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose Type A, hypromellose, magnesium stearate. Coating (Opadry Y-1-700 White): hypromellose, titanium dioxide (E 171), macrogol 400.

What Noxizol looks like and what the pack contains

• Noxizol, 10 mg, coated tablets are white, oval, biconvex tablets with a dividing line on both sides. One side has the inscription "ZIM 10" embossed.
• The coated tablets are packaged in blisters placed in a cardboard box.
• Pack sizes: 10, 20, and 60 coated tablets.

Marketing authorization holder and manufacturer

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Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer:

Merckle GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

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

Denmark and Norway
Zolpidem Actavis
Finland
Stella 5mg 10mg tablets
United Kingdom
Zolpidem Tartrate
Poland
Noxizol
Date of last revision of the leaflet:May 2024
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