Noxizol

Patient Information Leaflet

Noxizol, 10 mg, film-coated tablets
Zolpidem tartrate
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Noxizol is and what it is used for

Noxizol is used for the short-term treatment of insomnia in patients over 18 years of age when insomnia causes significant distress or is particularly burdensome.
Noxizol has hypnotic, sedative, muscle relaxant, and anticonvulsant properties.
Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

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)
• if the patient has irregular breathing during sleep with breathing pauses (sleep apnoea)
• if the patient has severe liver function impairment
• if the patient has muscle weakness ( myasthenia gravis )
• if the patient has acute and/or severe breathing problems (respiratory failure)
• for long-term treatment. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• if the patient has ever experienced sleepwalking or other unusual sleep-related behaviours (such as driving a car, eating, making phone calls or having sexual intercourse, etc.) without fully waking up after taking Noxizol or other medicines containing zolpidem.

Noxizol must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Before starting treatment with Noxizol, discuss with your doctor or pharmacist if:

• the patient has ever had psychiatric disorders, or has abused or been dependent on alcohol or illegal substances.

Treatment with sleeping tablets should be short-term. If insomnia persists after 1-2 weeks of treatment, this may indicate underlying psychological or physical causes of insomnia, which the patient should discuss with their doctor.
The patient should ensure an uninterrupted 8-hour sleep period after taking sleeping tablets. If the patient wakes up earlier, they may experience memory loss and disorientation.
Noxizol may cause drowsiness or impaired consciousness, which may lead to falls and serious injuries.
Taking zolpidem may lead to abuse or physical and psychological dependence. The risk of dependence is higher when zolpidem is taken for more than 4 weeks and in individuals with a history of psychiatric illness and/or alcohol or drug abuse. Inform your doctor if the patient has a history of psychiatric illness or has abused or been dependent on alcohol, illegal substances or medicines.
The effect of Noxizol may decrease if the patient takes it repeatedly for several weeks.
The dose should be gradually reduced, as abruptly stopping treatment may increase the risk of rebound insomnia. A transient condition may occur in which the symptoms that led to treatment with Noxizol return in an intensified form. This may be accompanied by other reactions such as mood changes, anxiety and restlessness. The doctor will provide further information on this.
Clinical studies indicate an increased risk of suicidal thoughts, suicide attempts and suicide in individuals taking certain sedative and hypnotic medicines, such as Noxizol.
However, it has not been established whether this is caused by taking the medicine or whether other factors may be involved.
If the patient experiences suicidal thoughts, they should contact their doctor as soon as possible for medical advice.
The doctor should carefully consider the benefit-risk ratio of treating the patient with Noxizol in patients with congenital long QT syndrome (a heart rhythm disorder with rapid, irregular heartbeat).
Next-day psychomotor disturbances (see also "Driving and operating machinery")
Like other sedative/hypnotic medicines, zolpidem may depress the central nervous system. The risk of next-day psychomotor impairment, including impaired ability to drive, may be increased after taking Noxizol if:

• the patient takes the medicine less than 8 hours before activities requiring mental alertness
• the patient takes a higher than recommended dose
• the patient takes zolpidem together with other medicines that depress the central nervous system or other medicines that increase zolpidem blood levels, or while consuming alcohol or using illicit substances.

A single dose should be taken immediately before going to bed.
Do not take another dose the same night.
Sleepwalking and other related behaviours
In patients taking zolpidem who were not fully awake, sleepwalking or other unusual sleep-related behaviours have been reported, such as driving, preparing and eating food, making phone calls or having sexual intercourse, without remembering the event. The risk of such events may increase if the patient takes Noxizol with alcohol or other medicines that depress the central nervous system, or if the patient exceeds the maximum recommended dose.
If such an event occurs, inform the doctor immediately, as these sleep-related behaviours may expose the patient and others to serious risk of injury. The doctor may recommend discontinuing treatment.
Concomitant use of Noxizol and alcohol or other sedative medicines may increase the risk of abnormal sleep behaviours.
Special patient groups
Before taking Noxizol, inform your doctor or pharmacist if:
When zolpidem is taken together with antidepressants, including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, the patient may see things that are not real (visual hallucinations).
Co-administration of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
Concomitant use of Noxizol and strong painkillers may increase psychological dependence on this medicine.
Concomitant use of Noxizol with opioid medicines (strong painkillers, substitution therapy medicines and some cold medicines) increases the risk of drowsiness, breathing difficulties with bluish discoloration of lips and nails (respiratory depression), coma and life-threatening effects. Due to these risks, such combined treatment should only be considered in patients for whom alternative treatments are not possible. However, if the doctor prescribes Noxizol together with opioids, the dose and duration of such concomitant treatment should be strictly limited by the prescribing doctor.
Inform your doctor about all opioid medicines the patient is taking and strictly follow the prescribed dosage. It may be helpful to inform friends and family about the possibility of the above-mentioned signs and symptoms. If they occur, contact the doctor immediately.
Concomitant use of rifampicin and St. John’s wort with Noxizol may reduce zolpidem blood levels.
Noxizol and alcohol
Do not consume alcohol while taking Noxizol, as it may enhance the sedative effect of the medicine.
Drinking alcohol while taking Noxizol may cause sleepwalking and other similar abnormal sleep behaviours that the patient will not remember upon waking.
Pregnancy and breastfeeding
Pregnancy
Noxizol should not be taken during pregnancy.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
The medicine taken during pregnancy may affect the unborn child. Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns. Reduced fetal movement and variable fetal heart rate may occur if the mother takes Noxizol during the second and/or third trimester of pregnancy.
If the patient takes Noxizol late in pregnancy or during delivery, her baby may experience muscle weakness, low body temperature, feeding difficulties and breathing problems (respiratory depression).
If the patient regularly takes Noxizol late in pregnancy, the baby may develop physical dependence and withdrawal symptoms such as agitation or seizures may occur. In such cases, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Noxizol passes into breast milk in small amounts; therefore, breastfeeding women should not use this medicine.
Driving and operating machinery
Noxizol has a major effect on the ability to drive and operate machinery, such as "falling asleep at the wheel". The day after taking Noxizol (as with other hypnotic medicines), the patient may:

• feel drowsy, sleepy, dizzy or confused
• need more time to make quick decisions
• experience blurred or double vision
• be less alert
  To minimise the risk of these events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery or working at heights. Do not consume alcohol or psychoactive substances while taking Noxizol, as this may worsen the effects mentioned above.

The effects and side effects of Noxizol are described in other sections of the leaflet. For further information, please read the entire leaflet.
If you have any doubts, contact your doctor or pharmacist.
Noxizol contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Noxizol contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per coated tablet, which means the medicine is considered "sodium-free".

3. How to use Noxizol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Noxizol tablets should be taken with liquid, immediately before going to bed.

Recommended dose:
Adults
The recommended dose of Noxizol is 10 mg once daily. Some patients may be prescribed a lower dose by their doctor. Noxizol should be taken:

• as a single dose,
• immediately before bedtime. The patient must ensure a period of at least 8 hours between taking the medicine and performing any activities requiring increased concentration. Do not exceed the dose of 10 mg per 24 hours.

Elderly patients or debilitated patients
For elderly or debilitated patients, the recommended dose is / tablet of Noxizol (corresponding to 5 mg of zolpidem tartrate per day), as these patients may be particularly sensitive to the adverse effects of zolpidem.
This dose may be increased by the doctor to 1 tablet of Noxizol (corresponding to 10 mg of zolpidem tartrate per day) if the effect of the medicine is too weak and it is well tolerated.

Patients with hepatic impairment
The recommended dose for patients with impaired liver function is / tablet of Noxizol (corresponding to 5 mg of zolpidem tartrate per day). This dose may be increased by the doctor to 1 tablet of Noxizol (corresponding to 10 mg of zolpidem tartrate per day) if the effect of the medicine is too weak and it is well tolerated.
Particular caution is required in elderly patients with impaired liver function.

Maximum dose
The maximum daily dose must not exceed 1 tablet of Noxizol (corresponding 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 lasts from several days to two weeks and should not exceed 4 weeks, including the period of gradual withdrawal.
The doctor will determine the withdrawal schedule based on the individual needs of the patient.
Sometimes prolonged use of the medicine may be necessary beyond the maximum recommended treatment duration. The treating doctor will decide on this after re-evaluating the patient's condition.

Use in children and adolescents
Noxizol must not be used in children and adolescents under 18 years of age.

Taking more Noxizol than prescribed
If a patient (or anyone else) takes a large number of tablets at once, or if there is suspicion that a child has swallowed a tablet, seek immediate medical help at the nearest hospital emergency department or contact a doctor, accompanied by another person. In case of overdose, the patient may become very sleepy very quickly, and with high doses of the medicine, this may likely lead to coma.

Missed dose of Noxizol
If the patient does not take the dose immediately before going to bed but remembers during the night, the missed dose may be taken only if the patient can still ensure 7–8 hours of uninterrupted sleep. If this is not possible, the next dose should be taken before going to bed the following night. Do not take a double dose to make up for a missed dose.
If in doubt about how to use the medicine, consult your doctor or pharmacist.

Stopping Noxizol treatment

• Treatment should be discontinued gradually, because the symptoms for which the patient was treated may return more intensely than before (rebound insomnia), and anxiety, restlessness, and mood changes may also occur. These symptoms resolve over time.
• If the patient becomes physically dependent on Noxizol, abrupt discontinuation of treatment may lead to adverse effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, and drowsiness. In severe cases, other symptoms may occur, such as hypersensitivity to light, noise, and touch, perception that sounds are louder than usual, painful sensitivity to acoustic stimuli, hallucinations, numbness and tingling in the limbs, loss of sense of reality (feeling that the surrounding environment is unreal), depersonalization (sense of loss of self-identity), or seizures (violent twisting movements or tremors). These symptoms may also occur between doses, especially if the dose is high.

The doctor will inform the patient how to gradually discontinue treatment.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects are likely to be less severe if the medicine is taken immediately before going to bed.
The higher the dose of the medicine, the greater the risk of adverse effects. Adverse effects are most commonly observed in elderly patients.

Serious adverse effects
Stop taking Noxizol and contact your doctor or go to the nearest hospital immediately if:
Very rare: may affect up to 1 in 10,000 patients

• Breathing difficulties, bluish discoloration of the lips and nails (respiratory depression).
  Unknown: frequency cannot be estimated from available data
• Rash (urticaria) and swelling (angioedema). If the patient develops swelling of the face, lips, and tongue, it may be life-threatening.

Other adverse effects
Common (may affect up to 1 in 10 people)

• Hallucinations. These may be serious. Contact your doctor or the emergency department.
• Agitation
• Nightmares
• Depression. In some people, this may develop into a serious adverse effect. Talk to your doctor.
• Drowsiness
• Headache
• Dizziness
• Worsening of insomnia
• Memory loss. In some people, this may develop into a serious adverse effect. Talk to your doctor.
• Drowsiness the following day
• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• Back pain
• Infections of the upper and lower respiratory tract
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Confusion
• Irritability
• Threatening, potentially aggressive behaviour. In some people, this may develop into a serious adverse effect. Contact your doctor.
• Sleepwalking or other related behaviours that are unusual during sleep, such as driving a car, preparing and eating meals, making phone calls, or engaging in sexual activity (see section 2 "Warnings and precautions")
• Extreme feelings of happiness
• Sensations such as numbness, tingling, and pricking
• Tremor
• Reduced alertness
• Speech disorders
• Double vision. This may be serious. Contact your doctor or the emergency department.
• Blurred vision
• Rashes
• Itching
• Increased sweating
• Joint pain, muscle pain, muscle cramps, neck pain, muscle weakness
• Restlessness
• Increased liver enzyme activity (Noxizol may cause adverse effects that the patient may not notice. These are changes in certain laboratory tests, such as blood tests performed to check liver function, which return to normal after treatment is discontinued.)
• Loss of appetite

Rare (may affect up to 1 in 1,000 patients)

• Disorders of sexual drive
• Disorders of consciousness
• Visual disturbances
• Liver function disorders
• Gait disturbances
• Falls (mainly in elderly patients and when zolpidem is not taken according to the recommended dose)
• Urticaria

Unknown (frequency cannot be estimated from available data)

• The following psychological reactions may occur (may be serious): False beliefs, anger, altered sense of reality, abnormal behaviour, misuse, dependence, withdrawal symptoms, reduced effect of the medicine. Contact your doctor.
• Delirium (sudden and severe change in a person's mental state causing confusion or disorientation).
• Inability to coordinate muscle movements

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Noxizol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the medicine container after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Noxizol contains

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

What Noxizol looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland
Manufacturer:
Merckle GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
For further information about this medicine, please contact
the Marketing Authorisation Holder's representative:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
This medicine is authorised for sale in the European Economic Area countries under the following names:
Denmark and Norway Zolpidem Actavis
Finland Stella 5 mg 10 mg tabletti
Poland Noxizol