NASEN 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. NASEN, 10 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Nasen and what is it used for
4. Important information before taking Nasen
   1. When not to take Nasen:
   2. Warnings and precautions
   3. Psychomotor disorders the next day (see also Driving and using machines)
   4. Nasen and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Nasen contains lactose monohydrate and sodium
5. How to take Nasen
   1. Taking a higher dose of Nasen than recommended
   2. Missing a dose of Nasen
6. Possible side effects
   1. Reporting side effects
7. How to store Nasen
8. Contents of the pack and other information
   1. What Nasen contains
   2. What Nasen looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

NASEN, 10 mg, coated tablets

Zolpidem tartrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Nasen and what is it used for

The active substance of the medicine is zolpidem, a short-acting hypnotic from the imidazopyridine group.
Zolpidem shortens the time to fall asleep and reduces the number of awakenings, prolongs sleep and improves
its quality.
Nasen is indicated for use:

• in the short-term treatment of insomnia. Nasen should only be used to treat insomnia that disrupts normal functioning or is extremely bothersome to the patient.

2. Important information before taking Nasen

When not to take Nasen:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has sleep apnea syndrome;
• if the patient has myasthenia gravis (excessive muscle fatigue after exertion);
• if the patient has severe liver failure;
• if the patient has severe respiratory failure. The medicine should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to take Nasen, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Nasen in patients:

• with liver failure;
• over 65 years of age or weakened. In these patients, the initial dose should be reduced and the dose should be individually adjusted according to the patient's condition. In elderly patients, the risk of side effects is increased, especially orientation and motor coordination disorders

and increased risk of falls and hip fractures due to the muscle relaxant effect;

• with symptoms of depression, as suicidal tendencies may occur in this group of patients;
• abusing alcohol and/or drugs;
• with mental illnesses and patients after detoxification treatments for overdose, e.g. narcotics;
• with respiratory disorders, as it may exacerbate respiratory failure.

The medicine should be discontinued in case of paradoxical reactions (states of psychomotor excitement, insomnia, irritability, delusions, nightmares, hallucinations, psychosis, behavioral changes).
Long-term use of the medicine may lead to gradual weakening of its effect due to tolerance. Long-term use of high doses of hypnotics may lead to physical and psychological dependence. The risk of dependence increases with the increase in dose and duration of treatment, as well as in patients abusing alcohol and/or drugs.
The duration of treatment should be limited to a minimum. The maximum treatment duration should not exceed 4 weeks, including the period of withdrawal from the medicine.
Sudden withdrawal of the medicine after long-term use of high doses may cause the occurrence of withdrawal syndrome symptoms, such as: insomnia; headaches; muscle pain; increased anxiety and tension; psychomotor excitement; confusion and irritability. In severe cases, the following may occur: depersonalization (feeling of personality change); derealization (change in perception of reality); hyperacusis (increased sensitivity to sound stimuli); numbness and tingling of limbs; increased sensitivity to light, noise, and touch; hallucinations or seizures.
The medicine may cause anterograde amnesia, especially in the absence of 7-8 hours of sleep after taking the medicine.
There are no data on the safety and efficacy of the medicine in children and adolescents under 18 years of age.

Psychomotor disorders the next day (see also Driving and using machines)

The next day after taking Nasen, the risk of psychomotor performance disorders, including impaired ability to drive vehicles, may be increased if:

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

The patient should take a single dose directly before sleep.
The patient should not take another dose on the same night.

Nasen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Alcohol enhances the sedative effect of zolpidem and increases the risk of paradoxical reactions (psychomotor excitement, aggression, irritability).
Medicines that inhibit or induce the activity of the cytochrome P450 system (e.g. erythromycin) may enhance or weaken the effect of zolpidem; rifampicin weakens the effect of the medicine.
When taking zolpidem with certain medicines, the risk of sedation and psychomotor disorders the next day, including impaired ability to drive vehicles, may increase. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics);
• medicines used to treat sleep disorders (hypnotics);
• 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 colds, allergic reactions, or other allergies that may cause drowsiness in the patient (sedating antihistamines).

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may experience visual hallucinations.
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Zolpidem, like other hypnotics, should not be used during pregnancy, especially in the first trimester. In newborns whose mothers have taken benzodiazepines or similar-acting medicines for a long time, withdrawal syndrome or physical dependence may occur.
In the case of justified use of the medicine in the late pregnancy or during delivery, it may cause hypothermia, hypotonia, and respiratory failure in the child.
Zolpidem has been shown to pass into breast milk in small amounts. The use of the medicine during breastfeeding is not recommended.

Driving and using machines

The patient should not drive vehicles or operate machines for 7-8 hours after taking zolpidem, due to the risk of drowsiness.
The ability to drive vehicles and operate machines may be impaired due to amnesia, sedative effects, and muscle relaxant effects, as well as coordination disorders.
Nasen has a major impact on the ability to drive vehicles and operate machines, and may cause events such as "falling asleep at the wheel". The next day after taking Nasen (like other hypnotics), it may happen that:

• the patient feels drowsy, sleepy, has dizziness, or is disoriented;
• the patient needs more time to make quick decisions (impaired reflexes);
• the patient may see blurred or double vision;
• the patient may be less alert.

In order to minimize the risk of the above events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving a vehicle, operating machines, or working at heights.
The patient should not consume alcohol or psychoactive substances while taking Nasen, as this may enhance the above effects.

Nasen contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Nasen

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Nasen is 10 mg per 24 hours. The doctor may prescribe a lower dose for some patients. Nasen should be taken:

• in a single dose;
• directly before sleep.

The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration.
The patient should not exceed the dose of 10 mg per 24 hours.
Elderly patients (over 65 years of age) and weakened patients who may be particularly sensitive to the effect of the medicine: treatment should be started with a dose of 5 mg (half a tablet). The patient should not exceed the dose of 10 mg (1 tablet) before sleep.
Patients with liver failure: 5 mg (half a tablet) directly before sleep.
In adults (under 65 years of age), it is possible to increase the dose of the medicine if the patient's condition is good and the medicine is well tolerated.
The treatment duration is from a few days to 2 weeks, up to a maximum of 4 weeks.

Taking a higher dose of Nasen than recommended

Overdose of zolpidem may cause disorders of consciousness of varying severity (drowsiness, coma). No permanent consequences of overdose have been observed after 40-fold exceeding the recommended dose.
Life-threatening situations may arise from mixed poisoning with zolpidem and alcohol or zolpidem and other central nervous system depressants. The treatment includes: inducing vomiting (within one hour of taking the medicine) or gastric lavage if the patient is unconscious, and administration of activated charcoal. Any overdose requires medical intervention. The patient's cardiovascular and respiratory function should be monitored, and symptomatic and supportive treatment should be initiated. In case of overdose, flumazenil can be administered intravenously, but administration of flumazenil may cause neurological symptoms, such as seizures.
Zolpidem is not removed by hemodialysis.

Missing a dose of Nasen

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cardiac disorders:palpitations, rarely arrhythmia (heart rhythm disorder)
Blood and lymphatic system disorders:changes in blood count, e.g. leukopenia (decrease in white blood cell count), agranulocytosis (significant decrease or absence of granulocytes)
Nervous system disorders:dizziness, feeling of fainting, headache, drowsiness, anterograde amnesia (memory disorders), apathy (decreased sensitivity to emotional and physical stimuli), emotional lability (emotional instability), sleep disorders, change in taste, ataxia (coordination disorders), unsteady gait
Psychiatric disorders:nightmares, nocturnal anxiety
Eye disorders:vision disorders
Respiratory, thoracic, and mediastinal disorders:cough, asthma
Gastrointestinal disorders:diarrhea, nausea, vomiting, bloating
Musculoskeletal and connective tissue disorders:muscle cramps, arthritis
Endocrine disorders:menstrual disorders
Reproductive system and breast disorders:decreased libido (decreased sexual desire)
Metabolic and nutritional disorders:change in appetite, increased thirst, change in body weight
Immune system disorders:hypersensitivity reactions, such as rash, urticaria

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nasen

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and blister or container after the "EXP" label. The expiry date refers to the last day of the month.
The medicine should be stored in its original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nasen contains

• The active substance of the medicine is zolpidem tartrate. One coated tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, hypromellose, magnesium stearate, sodium carboxymethyl cellulose (type A). Coating: lactose monohydrate, hypromellose, macrogol (6000), titanium dioxide (E 171).

What Nasen looks like and contents of the pack

The tablets are white to light cream-colored, oblong, biconvex, with a dividing line on one side. The tablet can be divided into equal doses.
The pack contains 10, 20, or 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
Email: [email protected]

Date of last revision of the leaflet: