Nasen Odt

Leaflet attached to the packaging: information for the user

NASEN ODT, 5 mg, orally disintegrating tablets

Zolpidem tartrate

You should carefully read the contents of the leaflet before taking 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.
• If you have 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 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

NASEN is available in the form of orally disintegrating tablets and contains the active substance zolpidem.
Zolpidem belongs to a group of sedative and hypnotic medicines.
NASEN is used for the short-term treatment of insomnia in adults when insomnia causes the patient disabling weakness or severe suffering.
The medicine facilitates falling asleep, reduces the number of nocturnal awakenings, prolongs the duration of sleep, and improves its quality.
Before starting treatment with NASEN, you should discuss it with your doctor.
In each case, it is necessary to determine, if possible, the causes of insomnia and, if possible, eliminate the factors causing it before the doctor recommends taking a sedative or hypnotic medicine.
Persistence of insomnia after 7-14 days of treatment may indicate the existence of primary mental or physical disorders that require diagnosis and evaluation by a doctor at regular intervals.
Do not take it for a long time. Treatment should last as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important information before taking NASEN

Do not take NASEN if:

• you are allergic to zolpidem or any of the other ingredients of this medicine (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 and/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 medicine if any of the above points apply to you. If in doubt, consult your doctor or pharmacist before taking zolpidem.

Warnings and precautions

Before starting treatment with NASEN, you should discuss it with your doctor or pharmacist if:

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

Dependence
Taking NASEN may lead to abuse of the medicine and/or the development of psychological or physical dependence.
The risk of dependence is greater when NASEN is taken for longer than 4 weeks and in patients with mental disorders and/or a history of alcohol, substance, or drug abuse.
Suicidal thoughts, suicide attempts, suicide, and depression
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedative and hypnotic medicines, including this one. However, it has not been established whether this is caused by taking the medicine or other factors.
If you have suicidal thoughts, you should contact your doctor as soon as possible for medical advice.
Severe injuries
The medicine may cause drowsiness and impaired consciousness, which can lead to falls and consequently to severe injuries.
Psychomotor disorders the next day (see also Driving and using machines)
NASEN has a sedative effect on the central nervous system. The risk of psychomotor disorders, including impaired driving ability, may be increased if:

• you take the medicine less than 8 hours before activities that require increased mental alertness;
• you take a higher dose than recommended;
• you take zolpidem while being treated 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 psychoactive substances.

You should take a single dose of NASEN directly before bedtime.
Do not take another dose on the same night.
Amnesia
Sedative and hypnotic medicines can cause anterograde amnesia. It usually occurs a few hours after taking the medicine. To reduce the risk, the patient should have the opportunity for uninterrupted sleep lasting 8 hours.
Other psychological reactions and "paradoxical" reactions
The use of sedative and hypnotic medicines, such as zolpidem, may be accompanied by other psychological reactions and paradoxical reactions, such as: anxiety, increased insomnia, agitation, irritability, aggression, delusions, outbursts of anger, nightmares, hallucinations, inappropriate behavior, and other behavioral disorders.
In such cases, treatment should be discontinued. The occurrence of such reactions is more likely in the elderly.
Somnambulism and similar behaviors
NASEN may cause sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or having sex, 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 the above behaviors occur in the patient, treatment with NASEN should be discontinued immediately and the doctor should be consulted, as such behaviors during sleep can pose a serious risk of injury to the patient or their environment.
Consuming alcohol or taking other medicines that cause drowsiness at the same time as NASEN 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 sedative and hypnotic treatment recur in an intensified form.
These symptoms may be accompanied by other reactions, such as mood changes, anxiety, and fear.
The patient should be informed about the possibility of rebound insomnia and the need to take appropriate measures to minimize the possibility of anxiety and other symptoms if they occur during withdrawal from the medicine.
In the case of short-acting sedative and hypnotic medicines, withdrawal syndrome may occur between doses.

NASEN and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take. This includes medicines bought without a prescription, including herbal medicines. This is important because zolpidem may affect the action of some other medicines, and some medicines may affect the action of zolpidem.
Medicines with a sedative effect on the central nervous system:
When taking zolpidem with some medicines, drowsiness and psychomotor disorders the next day, including impaired driving ability, may be intensified. These medicines include:

• Medicines used to treat certain mental health disorders (antipsychotic medicines).
• Medicines used to treat depression, such as sertraline.
• Medicines used to treat moderate to severe pain (opioid analgesics).
• Medicines used to treat epilepsy.
• Medicines used in anesthesia.
• Sedative medicines, anxiolytics, or medicines used to treat sleep problems (hypnotic medicines).
• Medicines used to treat hay fever, rash, or other allergies that may cause drowsiness in the patient (sedating antihistamines), such as chlorpheniramine or promethazine.

When taking zolpidem with antidepressant medicines, 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 medicine) used to treat mood swings and depression.
Concomitant use with opioids
Concomitant use of NASEN and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be fatal. Therefore, concomitant use of these medicines should only be considered when other treatment methods are not possible.
However, if the doctor prescribes NASEN together with opioids, the dose and duration of concomitant use should be limited by the doctor.
You should inform your doctor about all opioid medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform your friends and family to be aware of the above signs and symptoms. If these symptoms occur, you should contact your doctor.
The following medicines may increase the risk of side effects when taken with zolpidem. To reduce this probability, the doctor may decide to reduce the dose of zolpidem:

• Some medicines used to treat fungal infections, such as ketoconazole.

The following medicines may weaken the effect of zolpidem:

• Rifampicin (an antibiotic) - for infections.

Taking NASEN with alcohol

Concomitant consumption of alcohol with zolpidem is not recommended.
It may cause an intensification of the sedative effect of zolpidem and lead to very deep sleep, making it difficult to breathe or wake up properly.

Taking NASEN with food and drink

The medicine should be taken 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, you should consult your doctor before taking this medicine.
Pregnancy
NASEN is not recommended during pregnancy.
A large amount of data has not shown evidence of developmental disorders after benzodiazepines. However, the medicine 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 in the second and/or third trimester of pregnancy.
If the patient takes NASEN in late pregnancy or during delivery, her baby may show muscle weakness, low body temperature, feeding difficulties, and breathing problems (respiratory depression).
If the patient regularly takes NASEN in late pregnancy, the baby may develop physical dependence and may experience withdrawal symptoms, such as agitation or convulsions. In such a case, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Do not take NASEN while breastfeeding, as a small amount of the medicine passes into breast milk.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

• you feel drowsy, sleepy, have dizziness, or are disoriented;
• you need more time to make quick decisions (slowed reflexes);
• you see things blurry or double;
• you are 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 machines, or working at heights.
Do not consume alcohol or psychoactive substances while taking NASEN, as this may intensify the above effects.

NASEN contains excipients - lactose monohydrate, aspartame, and sodium.

NASEN contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains 2.5 mg of aspartame in each 5 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 medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

NASEN contains sulfites

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take NASEN

This medicine should be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

The medicine should be taken orally.

The recommended dose of NASEN is 10 mg (2 tablets) per day (24 hours).
Some patients may be prescribed a lower dose by their doctor. NASEN should be taken:

• in 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.
As with all hypnotic medicines, long-term use of NASEN is not recommended. The recommended treatment duration should not exceed 4 weeks.
Adults:
The recommended dose of NASEN is 10 mg (2 tablets) per day, directly before bedtime.
Some patients may be prescribed a lower dose by their doctor.
Elderly patients:
The recommended initial dose for elderly patients is 5 mg of NASEN (1 tablet), directly before bedtime. If necessary, the doctor may increase the dose to 2 tablets of 5 mg of NASEN (or 1 tablet of 10 mg of NASEN).
Children and adolescents:
NASEN should not be taken by children and adolescents under 18 years old.
Patients with liver function disorders:
The recommended initial dose for patients with liver function disorders is 5 mg of NASEN (1 tablet), directly before bedtime.
Zolpidem should not be taken by patients with severe liver failure.
Blood test:

• Zolpidem may affect the change in liver enzyme activity during a blood test.
• Before performing a blood test, you should inform your doctor that you are taking zolpidem.

Taking a higher dose of NASEN than recommended

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

• feeling drowsy, disoriented, deeply asleep, up to the possibility of falling into a coma.

Missing a dose of NASEN

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

Stopping treatment with NASEN

You should continue taking NASEN until your doctor recommends stopping treatment.
Do not stop taking NASEN abruptly, but if this happens, you should inform your doctor. The doctor will inform you about how to end treatment by gradually reducing the dose.
If you stop taking zolpidem abruptly, sleep problems may return, and a "withdrawal effect" may occur. If this happens, some of the effects listed below may occur.
You should immediately consult your doctor if you experience any of the following symptoms:

• feeling anxious, trembling, irritable, agitated, or disoriented;
• headache;
• muscle weakness or flaccidity;
• impaired consciousness, problems with concentration or 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 doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking zolpidem and immediately consult your doctor or go to the hospital if:

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

You should tell your doctor or pharmacist as soon as possible if you experience any of the following side effects:
Common(may affect up to 1 in 10 people):

• Cognitive disorders, such as anterograde amnesia (amnesia may be associated with unusual behavior). It is more likely to occur within a few hours of taking the medicine. If you sleep 7-8 hours after taking zolpidem, the risk of problems will be lower;

Driving during sleep and other sleep-related behaviors
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 some medicines used to treat depression or anxiety may increase the risk of this serious side effect.

• Sleep problems that worsen after taking the medicine;
• Seeing or hearing things that are not real (hallucinations).

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

• Blurred vision or double vision.

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

• Impaired consciousness;
• Gait disturbances, falls (especially in the elderly);
• Visual disturbances.

You should tell your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:
Common(may affect up to 1 in 10 people):

• Diarrhea;
• Nausea, vomiting;
• Abdominal 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 section: Driving during sleep and other sleep-related behaviors);
• Attention disorders (concentration);
• Speech disorders;
• Changes in liver enzyme activity - visible in blood test results;
• Changes in appetite;
• Muscle pain, muscle spasms, 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 manifests as 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 disorders; Most psychological side effects are associated with paradoxical reactions.
• Tolerance to the medicine (need to take a higher dose to fall asleep).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration 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 the medicine.

5. How to store NASEN

The medicine should be stored in a place that is invisible and inaccessible to children.
There are no special recommendations for the storage temperature of the medicine.
Store in the original packaging to protect from light and moisture.
Do not use this medicine 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.
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 pack and other information

What NASEN contains

• The active substance of NASEN is zolpidem tartrate. Each tablet contains 5 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, among others, natural flavoring substances, maltodextrins, triethyl citrate (E 1505), ammoniacal caramel (E 150d)), magnesium stearate.

What NASEN looks like and contents of the pack

NASEN is a white to off-white orally disintegrating tablet, round, flat, with beveled edges, with the inscription "5" on one side and smooth on the other, with a blackcurrant flavor.
The pack contains 30 orally 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 (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