NASEN 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. NASEN ODT, 10 mg, Oral Disintegrating Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What NASEN ODT is and What it is Used For
4. Important Information Before Taking NASEN ODT
   1. Do Not Take NASEN ODT if:
   2. Warnings and Precautions
   3. NASEN ODT and Other Medications
   4. Taking NASEN ODT with Alcohol
   5. Taking NASEN ODT with Food and Drink
   6. Pregnancy and Breastfeeding
   7. Driving and Operating Machinery
   8. NASEN ODT Contains the Following Excipients
   9. NASEN ODT Contains Sulfites
5. How to Take NASEN ODT
   1. Take the Medication Orally.
   2. Taking a Higher Dose of NASEN ODT than Recommended
   3. Missing a Dose of NASEN ODT
   4. Stopping Treatment with NASEN ODT
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store NASEN ODT
8. Package Contents and Other Information
   1. What NASEN ODT Contains
   2. What NASEN ODT Looks Like and Contents of the Package
   3. Marketing Authorization Holder and Importer
   4. Importer

Package Leaflet: Information for the User

NASEN ODT, 10 mg, Oral Disintegrating Tablets

Zolpidem Tartrate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition only. Do not pass it on to others. It may harm them, 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.

Package Leaflet Contents

• 1. What NASEN ODT is and what it is used for
• 2. Important Information Before Taking NASEN ODT
• 3. How to Take NASEN ODT
• 4. Possible Side Effects
• 5. How to Store NASEN ODT
• 6. Package Contents and Other Information

1. What NASEN ODT is and What it is Used For

NASEN ODT is available as oral disintegrating tablets and contains the active substance zolpidem.
Zolpidem belongs to a group of sedative and hypnotic medications.
NASEN ODT is used for the short-term treatment of insomnia in adults when insomnia causes the patient significant distress or impairment in social, occupational, and other areas of functioning.
The medication facilitates falling asleep, reduces the number of nocturnal awakenings, prolongs sleep duration, and improves sleep quality.
Before starting treatment with NASEN ODT, discuss it with your doctor.
In all cases, the underlying causes of insomnia should be identified and, if possible, eliminated before the doctor recommends taking a hypnotic medication.
Persistent insomnia after 7-14 days of treatment may indicate the presence of underlying psychological or physical disorders that require diagnosis and evaluation by a doctor at regular intervals.
Do not take it for a long time. Treatment should be as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important Information Before Taking NASEN ODT

Do Not Take NASEN ODT if:

• you are allergic to zolpidem or any of the other ingredients of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, swallowing or breathing problems, swelling of the face, lips, throat, or tongue.
• you have sleep apnea syndrome,
• you have myasthenia gravis (a disease characterized by muscle weakness),
• you have acute or severe respiratory failure,
• you have severe liver failure,
• you have a mental illness (psychosis),
• you are under 18 years old. Do not take this medication if any of the above points apply to you. If in doubt, consult your doctor or pharmacist before taking zolpidem.

Warnings and Precautions

Before taking NASEN ODT, discuss it with your doctor or pharmacist if:

• you have a history of alcohol or substance abuse,
• you have breathing problems,
• you have liver problems,
• you have depression or have had other mental illnesses in the past,
• you have recently taken zolpidem or other similar medications for more than 4 weeks.

Dependence
Taking NASEN ODT may lead to abuse and/or the development of psychological or physical dependence.
The risk of dependence is higher when NASEN ODT is taken for longer than 4 weeks and in patients with a history of mental disorders and/or alcohol or substance abuse.
Suicidal Thoughts, Suicide Attempts, and Depression
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and depression in patients taking certain sedative and hypnotic medications, including this medication. However, it has not been established whether this is caused by the medication or other factors.
If you experience suicidal thoughts, you should contact your doctor as soon as possible for medical advice.
Severe Injuries
The medication may cause drowsiness and impaired consciousness, which can lead to falls and consequently to severe injuries.
Next-Day Psychomotor Impairment (see also Driving and Operating Machinery)
NASEN ODT has a central nervous system depressant effect. The risk of impaired psychomotor function, including impaired driving ability, may be increased if:

• the patient takes the medication less than 8 hours before activities that require increased alertness;
• the patient takes a higher dose than recommended;
• the patient takes zolpidem while being treated with other central nervous system depressants or medications that increase zolpidem blood levels, while consuming alcohol, or while taking illicit substances.

Take a single dose of NASEN ODT directly before bedtime.
Do not take another dose on the same night.
Amnesia
Sedative and hypnotic medications can cause anterograde amnesia. It usually occurs a few hours after taking the medication. To minimize the risk, the patient should have the opportunity for uninterrupted sleep lasting 8 hours.
Other Psychiatric Reactions and "Paradoxical" Reactions
The use of sedative and hypnotic medications, such as zolpidem, may be associated with other psychiatric reactions and paradoxical reactions, such as: anxiety, increased insomnia, agitation, aggression, hallucinations, rage, and other behavioral disturbances.
In such cases, treatment should be discontinued. The occurrence of such reactions is more likely in the elderly.
Somnambulism and Similar Behaviors
NASEN ODT may cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, phone calls, or sexual activity, etc.) when the patient has not fully woken up. The next morning, the patient may not remember the activities performed during the night. If any of these behaviors occur, treatment with NASEN ODT should be discontinued immediately and the patient should consult a doctor, as these behaviors during sleep can pose a serious risk of injury to the patient or their environment.
Consuming alcohol or taking other medications that cause drowsiness at the same time as NASEN ODT may increase the risk of such behaviors during sleep, as well as taking zolpidem in doses exceeding the maximum recommended dose.
Rebound Insomnia (Rebound Insomnia)
After stopping hypnotic treatment, a transient syndrome may occur, in which the symptoms that led to the initiation of hypnotic treatment recur in an intensified form.
These symptoms may be accompanied by other reactions, such as mood changes, anxiety, and restlessness.
The patient should be informed about the possibility of rebound insomnia and the need to take appropriate measures to minimize the risk of anxiety and other symptoms if they occur during withdrawal from the medication.
In the case of short-acting sedative and hypnotic medications, withdrawal syndrome may occur between doses.

NASEN ODT and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. This includes medications purchased without a prescription, including herbal remedies. This is important because zolpidem may affect the action of some other medications, and some medications may affect the action of zolpidem.
Central Nervous System Depressants:
When taking zolpidem with certain medications, drowsiness and next-day psychomotor impairment, including impaired driving ability, may be increased. These medications include:

• Medications used to treat certain mental health disorders (antipsychotics).
• Medications used to treat depression, such as sertraline.
• Medications used to treat moderate to severe pain (opioid analgesics).
• Medications used to treat epilepsy.
• Medications used for anesthesia.
• Sedative, anxiolytic, or hypnotic medications.
• Medications used to treat allergies, which may cause drowsiness in the patient (sedating antihistamines), such as chlorpheniramine or promethazine.

When taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not real (visual hallucinations).
It is not recommended to take zolpidem with fluvoxamine, ciprofloxacin, or St. John's Wort (a herbal remedy) used to treat mood swings and depression.
Concomitant Use with Opioids
Concomitant use of NASEN ODT and opioids (strong painkillers, substitution therapy medications, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be fatal. Therefore, concomitant use of these medications should only be considered when other treatment options are not possible.
However, if the doctor prescribes NASEN ODT with opioids, the dose and duration of concomitant use should be limited by the doctor.
Inform your doctor about all opioid medications you are taking and strictly follow the dosage instructions. It may be helpful to inform your friends and family to be aware of the above signs and symptoms. If these symptoms occur, contact your doctor.

• Certain medications used to treat fungal infections, such as ketoconazole.

The following medications may reduce the effect of zolpidem:

• Rifampicin (an antibiotic) - for infections.

Taking NASEN ODT with Alcohol

It is not recommended to consume alcohol while taking zolpidem.
There may be an increase in the sedative effect of zolpidem, causing very deep sleep, making it difficult to breathe or wake up properly.

Taking NASEN ODT with Food and Drink

Take the medication directly before bedtime or after lying down.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medication.
Pregnancy
NASEN ODT is not recommended during pregnancy.
A large amount of data did not show evidence of malformations after benzodiazepines. However, the medication taken during pregnancy may affect the baby, as some studies have shown an increased risk of cleft lip and palate in newborns compared to the general population.
Cleft lip and palate (sometimes called "hare lip") is a congenital deformity caused by the incomplete fusion of the palate and upper lip.
There may be decreased fetal movement and variable fetal heart rate if the mother takes NASEN ODT in the second and/or third trimester of pregnancy.
If a patient takes NASEN ODT in late pregnancy or during childbirth, her baby may show muscle weakness, low body temperature, feeding difficulties, and breathing difficulties (respiratory depression).
If a patient regularly takes NASEN ODT in late pregnancy, her baby may develop physical dependence, and withdrawal symptoms may occur, such as agitation or convulsions. In such a case, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Do not take NASEN ODT while breastfeeding, as a small amount of the medication passes into breast milk.
If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medication.

Driving and Operating Machinery

After taking NASEN ODT, do not drive vehicles, operate machinery, or use tools if you feel drowsy, dizzy, or disoriented. NASEN ODT has a major impact on driving ability and operating machinery, and may cause events such as "falling asleep at the wheel". After waking up after taking NASEN ODT (like other hypnotic medications), it may happen that:

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

To minimize 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 NASEN ODT, as this may increase the above-mentioned effects.

NASEN ODT Contains the Following Excipients

NASEN ODT contains lactose. If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medication.
The medication contains 5 mg of aspartame in each 10 mg tablet. Aspartame is a source of phenylalanine.
It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

NASEN ODT Contains Sulfites

The medication may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to Take NASEN ODT

Take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Take the Medication Orally.

The recommended dose of NASEN ODT is 10 mg (1 tablet) per day (24 hours).
Some patients may be prescribed a lower dose by their doctor. NASEN ODT should be taken:

• as a single dose,
• directly before bedtime.

The patient must maintain a period of at least 8 hours between taking the medication and engaging in activities that require increased concentration.
Do not exceed the dose of 10 mg per 24 hours.
As with all hypnotic medications, it is not recommended to take NASEN ODT for a long time. The recommended treatment duration should not exceed 4 weeks.
Adults:
The recommended dose of NASEN ODT is 10 mg (1 tablet) per day, directly before bedtime.
Some patients may be prescribed a lower dose by their doctor.
Elderly Patients:
For elderly patients, the recommended initial dose is 5 mg of NASEN ODT (1 tablet of 5 mg), directly before bedtime. If necessary, the doctor may increase the dose to 1 tablet of 10 mg of NASEN ODT (or 2 tablets of 5 mg of NASEN ODT).
Children and Adolescents:
Do not take NASEN ODT in children and adolescents under 18 years of age.
Patients with Liver Impairment:
For patients with liver impairment, the recommended initial dose is 5 mg of NASEN ODT (1 tablet of 5 mg), directly before bedtime.
Zolpidem should not be taken by patients with severe liver impairment.
Blood Tests:

• Zolpidem may affect liver enzyme activity in blood tests.
• Before undergoing a blood test, inform your doctor that you are taking zolpidem.

Taking a Higher Dose of NASEN ODT than Recommended

If you take more than the recommended dose, contact your doctor or go to the emergency department immediately.
Taking a higher dose of zolpidem can be very dangerous. The following side effects may occur:

• drowsiness, disorientation, deep sleep, or even coma.

Missing a Dose of NASEN ODT

NASEN ODT should be taken directly before bedtime.
Take the medication the next day at the usual time.
Do not take two doses of the medication at the same time to make up for a missed dose.

Stopping Treatment with NASEN ODT

Continue taking NASEN ODT until your doctor tells you to stop.
Do not stop taking NASEN ODT abruptly, but if this happens, inform your doctor. The doctor will inform you about how to stop treatment by gradually reducing the dose.
If zolpidem treatment is stopped abruptly, sleep problems may return, and a "withdrawal effect" may occur. If this happens, some of the following effects may occur.
Consult your doctor immediately if you experience any of the following symptoms:

• feeling anxious, trembling, irritable, agitated, or disoriented;
• headache;
• muscle weakness or fatigue;
• impaired consciousness, difficulty concentrating or paying attention;
• nightmares, hallucinations;
• increased sensitivity to light, noise, and touch;
• impaired contact with reality;
• numbness, tingling, prickling, or burning sensation on the skin;
• muscle pain;
• changes in behavior;
• seizures.

If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, NASEN ODT can cause side effects, although not everybody gets them.
Stop taking zolpidem and contact your doctor or go to the hospital immediately if:

• you have an allergic reaction. These symptoms may include: itchy, lumpy rash, or hives, swelling of the hands, feet, ankles, face, lips, tongue, or throat, which may cause difficulty swallowing or breathing.
• you have liver damage due to the toxic effect of the medication, which may be manifested by yellowing of the skin or eyes, stomach pain, or a feeling of bloating, severe itching, pale or bloody stools, extreme weakness, nausea, or loss of appetite.

Tell your doctor or pharmacist if you experience any of the following side effects:

• frequent (may affect up to 1 in 10 people):

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

• cognitive disorders, such as anterograde amnesia (amnesia may be associated with unusual behavior). This is more likely to occur within a few hours of taking the medication. If the patient sleeps for 7-8 hours after taking zolpidem, the risk of problems will be lower;

Driving and Other Activities During Sleep
In patients taking zolpidem, the following complex behaviors during sleep may occur: sleep driving, sleepwalking, preparing and eating food, and having sex during sleep with no memory of the activities performed.
Alcohol and certain medications used to treat depression or anxiety may increase the risk of this serious side effect.

• sleep problems that worsen after taking the medication;
• seeing or hearing things that are not real (hallucinations).

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

• blurred or double vision.

Rare(may affect up to 1 in 1,000 people):

• impaired consciousness;
• gait disturbances, falls (especially in the elderly);
• vision disturbances.

Tell your doctor or pharmacist if any of the following side effects get worse or persist for more than a few days:

• diarrhea;
• nausea, vomiting;
• stomach pain;
• upper and lower respiratory tract infections;
• headache;
• feeling tired or agitated;
• nightmares;
• depression;
• dizziness;
• drowsiness;
• back pain.

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

• rash, itching;
• excessive sweating;
• feeling anxious, aggressive, confused, or irritable;
• feeling excessively happy/confident, euphoria;
• paresthesia (numbness, tingling, prickling, or burning sensation on the skin);
• tremors;
• sleepwalking or other unusual behaviors during sleep, somnambulism (see Driving and Other Activities During Sleep);
• attention disturbances (concentration);
• speech disturbances;
• changes in liver enzyme activity - visible in blood test results;
• appetite disturbances;
• muscle pain, muscle cramps, muscle weakness.

Rare(may affect up to 1 in 1,000 people):

• itchy, lumpy rash (hives);
• libido disorders (sex drive);
• cholestasis (a disease characterized by the blockage of bile removal from the liver), which is manifested by jaundice, rash, fever, and darker urine.

Very Rare(may affect up to 1 in 10,000 people):

• delusions;
• breathing difficulties (respiratory depression);
• dependence on zolpidem.

Frequency Not Known(frequency cannot be estimated from the available data):

• anger or behavioral disturbances; Most psychiatric side effects are associated with paradoxical reactions.
• tolerance to the medication (need to take a higher dose to fall asleep).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 medication.

5. How to Store NASEN ODT

Keep the medication out of sight and reach of children.
There are no special storage temperature requirements for the medication.
Store in the original packaging to protect from light and moisture.
Do not use this medication after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What NASEN ODT Contains

• The active substance of NASEN ODT is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: potassium polyacrylate, mannitol (E 421), lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, aspartame (E 951), blackcurrant flavor (contains natural flavoring substances, maltodextrin, triethyl citrate (E 1505), glycerol triacetate (E 1518), ammonio methacrylate copolymer), magnesium stearate.

What NASEN ODT Looks Like and Contents of the Package

NASEN ODT is a white to off-white oral disintegrating tablet, round, flat, with beveled edges, with the inscription "10" on one side and smooth on the other, with a blackcurrant flavor.
The package contains 30 oral disintegrating tablets, packaged in aluminum/aluminum blisters in a carton box.

Marketing Authorization Holder and Importer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
Email: [email protected]

Importer

Inpharmasci
Zone Industrielle N 2, 1 Rue Nungesser,
Prouvy, 59121, France
Date of Last Revision of the Leaflet:March 2025