Nasen odt

Package leaflet: Information for the user

NASEN ODT, 10 mg, orodispersible tablets
Zolpidem tartrate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it 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.

Contents of the leaflet

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

1. What N is and what it is used for

N is available as orodispersible tablets and contains the active substance zolpidem.
Zolpidem belongs to a group of medicines called hypnotics and sedatives.
N is used for the short-term treatment of insomnia in adults when insomnia causes significant distress or impairment in daily functioning.
The medicine helps to fall asleep, reduces the number of nocturnal awakenings, prolongs sleep duration, and improves sleep quality.
Before starting treatment with N, you should discuss it with your doctor.
In each case, the underlying causes of insomnia should be evaluated and, if possible, eliminated before your doctor prescribes a hypnotic medicine.
Persistent insomnia after 7–14 days of treatment may indicate the presence of underlying psychological or physical disorders requiring diagnosis and medical evaluation at regular intervals.
Do not use for prolonged periods. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

2. Important information before using Nasen ODT

Do not use Nasen ODT 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, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• you have sleep apnoea syndrome,
• you have myasthenia gravis (a disease characterised by muscle weakness),
• you have acute and/or severe respiratory insufficiency,
• you have severe hepatic insufficiency,
• you have a mental illness (psychosis),
• you are under 18 years of age.

Do not take this medicine if any of the above apply to you. If in doubt, speak to your doctor or pharmacist before taking zolpidem.

Warnings and precautions
Before taking Nasen ODT, talk to your doctor or pharmacist if:

• you have previously abused alcohol or psychoactive substances,
• you have breathing problems,
• you have liver problems,
• you have depression or have previously had another mental illness,
• you have recently taken zolpidem or other similar medicines for more than 4 weeks.

Dependence
Taking Nasen ODT may lead to drug abuse and/or the development of psychological or physical dependence.
The risk of dependence is higher when Nasen ODT is used for longer than 4 weeks and in patients with mental disorders and/or a history of alcohol, illicit 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 medicine. However, it is not known whether this is due to the medicine or whether other causes exist.
If you have suicidal thoughts, you should contact your doctor as soon as possible to obtain medical advice.

Severe injuries
This medicine may cause drowsiness and impaired consciousness, which may lead to falls and consequently to severe injuries.

Next-day psychomotor impairments (see also Driving and operating machinery)
Nasen ODT has a central nervous system depressant effect. The risk of psychomotor impairment, including impaired ability to drive, may be increased if:

• you take the medicine less than 8 hours before activities requiring full alertness;
• you take a dose higher than the recommended dose;
• you take zolpidem while being treated with other medicines that depress the central nervous system or other medicines that increase the blood concentration of zolpidem, while consuming alcohol or while taking illicit substances.

A single dose of Nasen ODT should be taken immediately before going to bed.
Do not take another dose during the same night.

Amnesia
Sedative and hypnotic medicines may cause anterograde amnesia. This most commonly occurs several hours after taking the medicine. To reduce the risk, you should ensure you have the opportunity to sleep uninterrupted for 8 hours.

Other psychiatric reactions and "paradoxical" reactions
Treatment with sedative and hypnotic medicines such as zolpidem may be associated with other psychiatric and paradoxical reactions such as: anxiety, worsened insomnia, agitation, irritability, aggression, hallucinations, rage attacks, nightmares, delusions, inappropriate behaviour and other behavioural disturbances.
In such cases, treatment should be discontinued. These reactions are more likely to occur in elderly patients.

Sleepwalking and similar behaviours
Nasen ODT may cause sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or having sexual intercourse) while not being fully awake. In the morning, the patient may not remember these activities. If any of these behaviours occur, treatment with Nasen ODT should be stopped immediately and you should contact your doctor, as such sleep-related behaviours may pose a serious risk of injury to the patient or others.
Consuming alcohol or taking other medicines that cause drowsiness together with Nasen ODT may increase the risk of such sleep-related behaviours, as may using zolpidem at doses exceeding the maximum recommended dose.

Rebound insomnia (insomnia rebound)
After stopping hypnotic treatment, a transient syndrome may occur in which the symptoms that led to the initiation of sedative and hypnotic treatment return in an intensified form. These symptoms may be accompanied by other reactions such as mood changes, anxiety and restlessness.
You should be informed about the possibility of rebound insomnia and the need to take appropriate measures to minimise the risk of anxiety and other symptoms if they occur during discontinuation of the medicine.
With short-acting sedative and hypnotic medicines, withdrawal symptoms may occur between consecutive doses.

Nasen ODT and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained 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 central nervous system depressant effects:
When zolpidem is taken with certain medicines, drowsiness and next-day psychomotor impairments, including impaired ability to drive, may be intensified. These medicines include:

• Medicines used to treat certain mental disorders (antipsychotics).
• 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 anaesthesia.
• Sedatives, anxiolytics or medicines used to treat sleep problems (hypnotics).
• Medicines used to treat hay fever, rashes or other allergies, which may cause drowsiness (sedating antihistamines), such as chlorpheniramine or promethazine.

When taking zolpidem together with antidepressants such as bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (visual hallucinations).

Concomitant use of zolpidem with fluvoxamine, ciprofloxacin or St John's wort (a herbal medicine) used in the treatment of mood disorders and depression is not recommended.

Concomitant use with opioids
Concomitant use of Nasen ODT and opioids (strong painkillers, medicines used in substitution therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be fatal. Therefore, concomitant use of these medicines should only be considered if other treatment options are not possible.
However, if your doctor prescribes Nasen ODT together with opioids, the dose and duration of concomitant use should be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow dosing instructions. It may be helpful to inform your friends and family so they are aware of the signs and symptoms listed above. If these symptoms occur, contact your doctor immediately.

The following medicines may increase the risk of adverse effects when taken with zolpidem. To reduce this risk, your doctor may decide to reduce the dose of zolpidem:

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

The following medicines may reduce the effect of zolpidem:

• Rifampicin (an antibiotic) – for infections.

Taking Nasen ODT with alcohol
Concomitant use of alcohol with zolpidem is not recommended.
The sedative effect of zolpidem may be intensified, leading to very deep sleep, which may impair normal breathing or make waking up difficult.

Taking Nasen ODT with food and drink
Take the medicine immediately before going to bed or after lying down.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, you should consult your doctor before taking this medicine.

Pregnancy
Nasen ODT is not recommended during pregnancy.
Large amounts of data have not shown evidence of developmental abnormalities with benzodiazepines. However, use of this medicine during pregnancy may affect the unborn child, 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 malformation caused by incomplete fusion of the palate and upper lip.
Reduced fetal movement and variable fetal heart rate may occur if the mother takes Nasen ODT during the second and/or third trimester of pregnancy.
If you take Nasen ODT late in pregnancy or during delivery, your baby may show muscle weakness, low body temperature, feeding difficulties and breathing problems (respiratory depression).
If you regularly take Nasen ODT late in pregnancy, your baby may develop physical dependence and withdrawal symptoms such as agitation or seizures may occur after birth. In such cases, the newborn should be closely monitored after delivery.

Breastfeeding
Do not take Nasen ODT during breastfeeding, as small amounts of the medicine pass into breast milk.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery
Do not drive, operate machinery or tools if you feel drowsy, dizzy or disoriented after taking Nasen ODT. Nasen ODT has a major influence on the ability to drive and operate machinery and may cause events such as "falling asleep at the wheel". After waking up following administration of Nasen ODT (as with other hypnotic medicines), you may experience:

• feeling sleepy, drowsy, dizzy or disoriented;
• needing more time to make quick decisions (impaired reflexes);
• blurred or double vision;
• reduced alertness.

To minimise the risk of these events, it is recommended to allow at least 8 hours 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 intensify the effects listed above.

Nasen ODT contains excipients – lactose monohydrate, aspartame and sodium.
Nasen ODT contains lactose. If you have been previously diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.
The medicine contains 5 mg of aspartame per 10 mg tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Nasen ODT contains sulphites
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Nasen ODT

This medicine should be used as directed by the doctor. If in doubt, consult a
doctor or pharmacist.
The medicine should be taken orally.
The recommended dose of Nasen ODT is 10 mg (1 tablet) per day (24 hours).
The doctor may prescribe a lower dose for some patients. Nasen ODT should be taken:

• as a single dose,
• immediately before bedtime.

The patient must allow a period of at least 8 hours between taking the medicine and engaging in
activities requiring increased concentration.
The dose of 10 mg within 24 hours must not be exceeded.
As with all sleeping medicines, prolonged use of Nasen ODT is not recommended. The recommended duration of treatment with this medicine should not exceed 4 weeks.
Adults:
The recommended dose of Nasen ODT is 10 mg (1 tablet) per day, taken immediately before bedtime.
The doctor may prescribe a lower dose for some patients.
Elderly patients:
In elderly patients, the recommended initial dose is 5 mg of Nasen ODT (1 tablet of
Nasen ODT 5 mg), taken immediately before bedtime. If necessary, the doctor may increase the dose
to 1 tablet of 10 mg Nasen ODT (or 2 tablets of 5 mg Nasen ODT).
Children and adolescents:
Nasen ODT must not be used in children and adolescents under 18 years of age.
Patients with liver function disorders:
In patients with impaired liver function, the recommended initial dose is 5 mg of
Nasen ODT (1 tablet of Nasen ODT 5 mg), taken immediately before bedtime.
Zolpidem must not be used in patients with severe liver impairment.
Blood tests:

• Zolpidem may affect liver enzyme activity during blood testing.
• Before undergoing a blood test, inform the doctor that you are taking zolpidem.

Taking a higher than recommended dose of Nasen ODT
If a dose higher than recommended is taken, seek medical advice immediately or go to a hospital emergency department.
Taking an excessive dose of zolpidem may be very dangerous. The following adverse effects may occur:

• Drowsiness, disorientation, deep sleep, up to possible coma.

Missing a dose of Nasen ODT
Nasen ODT should be taken immediately before bedtime.
Take the medicine the next day at the usual time.
Do not take two doses at the same time to make up for a missed dose.
Stopping Nasen ODT treatment
Continue taking Nasen ODT until the doctor advises stopping treatment.
Do not stop taking Nasen ODT suddenly, but if this occurs, inform the
doctor. The doctor will advise the patient on how to discontinue treatment gradually by tapering the dose.
If Nasen ODT is stopped abruptly, sleep problems may return and a "withdrawal effect" may occur. If this happens, one or more of the following effects may occur.
Contact a doctor immediately if any of the following symptoms occur:

• Feelings of anxiety, tremors, irritability, restlessness, or disorientation;
• Headache;
• Muscle weakness or floppiness;
• Disturbances in consciousness, difficulty concentrating or focusing;
• Nightmares, hallucinations;
• Increased sensitivity to light, noise, and touch;
• Impaired contact with reality;
• Numbness, tingling in hands and feet;
• Muscle pain;
• Changes in behavior;
• Seizures.

If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking zolpidem and contact your doctor immediately or go to
hospital if:

• The patient has an allergic reaction. Symptoms may include itchy, lumpy rash or hives, swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty swallowing or breathing.
• The patient has liver damage due to toxic effects of the medicine, which may manifest as skin or eye discolouration, abdominal (stomach) pain or feeling of bloating, severe itching, pale or bloody stools, extreme weakness, nausea or loss of appetite.

You should inform your doctor as soon as possible if the patient experiences any of the following
adverse effects:
Common (may occur in less than 1 in 10 people):

• Cognitive disturbances, such as anterograde amnesia (memory loss may be associated with unusual behaviour). This is more likely to occur within a few hours after taking this medicine. If the patient sleeps for 7-8 hours after taking zolpidem, the risk of problems will be lower;

Sleep-driving and other complex sleep-related behaviours
In patients taking zolpidem, the following complex sleep-related behaviours may occur:
driving while asleep, walking while asleep, preparing and eating food, or engaging in sexual activity while asleep, with no memory of these activities.
Alcohol and certain medicines used to treat depression or anxiety may increase the risk of this serious adverse effect.

• Worsening of sleep problems after taking this medicine;
• Seeing or hearing things that are not real (hallucinations).

Uncommon (may occur in less than 1 in 100 people):

• Blurred vision or double vision.

Rare (may occur in less than 1 in 1,000 people):

• Disturbances of consciousness;
• Gait disturbances, falls (especially in elderly people);
• Visual disturbances.

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

• Diarrhoea;
• Nausea, vomiting;
• Abdominal pain;
• Infections of upper and lower respiratory tract;
• Headache;
• Feeling of tiredness or overstimulation;
• Nightmares;
• Depression;
• Dizziness;
• Drowsiness;
• Back pain.

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

• Rash, itching;
• Excessive sweating;
• Feelings of restlessness, aggression, confusion or irritability;
• Feeling of excessive happiness/self-confidence, euphoria;
• Paresthesia (numbness, tingling, pricking, burning sensation on the skin);
• Tremor;
• Sleepwalking or other unusual behaviours during sleep, somnambulism (see section: Sleep-driving and other complex sleep-related behaviours);
• Attention disturbances (concentration);
• Speech disorders;
• Changes in liver enzyme activity – visible in blood test results;
• Appetite disturbances;
• Muscle pain, muscle cramps, muscle weakness.

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

• Itchy, lumpy rash (urticaria);
• Libido disturbances (sexual drive);
• Cholestasis (a condition involving blockage of bile excretion from the liver), which manifests as jaundice, rash, fever and darkening of urine.

Very rare (may occur in up to 1 in 10,000 people):

• Delusions;
• Breathing difficulties (respiratory depression);
• Dependence on zolpidem.

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

• Anger or behavioural disturbances; Most psychiatric adverse effects are related to paradoxical reactions.
• Tolerance to the medicine (need to take higher doses to fall asleep).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
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 provide more information on the safety of the medicine.

5. How to store the medicine N

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this 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 and carton after "EXP". The expiry date refers to the last day of the stated month.
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 packaging and other information

What the medicine N contains

• The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
• The other ingredients are: potassium polyacrylate, mannitol (E 421), monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, aspartame (E 951), blackcurrant flavour (containing, among others, natural flavouring substances, maltodextrins, glyceryl triacetate (E 1518), ethyl citrate (E 1505), ammonium sulfite caramel (E 150d)), magnesium stearate.

What the medicine N looks like and contents of the pack
The medicine is in the form of white to off-white orodispersible tablets, round, flat with bevelled edges, embossed with the number "10" on one side and smooth on the other, with a blackcurrant odour.
The pack contains 30 orodispersible tablets packed in aluminium/aluminium blisters within a cardboard carton.

Marketing Authorisation Holder and Importer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]

Importer
Inpharmasci
Zone Industrielle N 2, 1 Rue Nungesser,
Prouvy, 59121, France