ZOLPEDUAR 5 mg Сублингвальная Таблетка

Содержание инструкции

1. Zolpeduar 5 mg sublingual tablets, 10 mg sublingual tablets
   1. What is Zolpeduar and what is it used for
   2. What you need to know before you take Zolpeduar
   3. How to take Zolpeduar
   4. Possible side effects
   5. How to store Zolpeduar
   6. Contents of the pack and other information

Zolpeduar 5 mg sublingual tablets, 10 mg sublingual tablets

Zolpidem tartrate

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Zolpeduar and what is it used for

Zolpeduar tablets are sleeping pills (hypnotics) that act on the brain
causing drowsiness. They can be used in adults for the short-term treatment of
severe insomnia, disabling or causing significant distress. Insomnia is the difficulty of
falling asleep or sleeping properly.

2. What you need to know before you take Zolpeduar

Do not take Zolpeduar if:

• you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, swelling of the face, lips, throat or tongue;
• you have severe liver problems;
• you suffer from sleep apnea (a condition in which you stop breathing for very short periods while you sleep);
• you suffer from severe muscle weakness (myasthenia gravis);
• you have acute and severe breathing problems.
• if you have previously experienced episodes of sleepwalking or other unusual behaviors while sleeping such as driving, eating, making phone calls or having sexual intercourse, etc.) while not fully awake, after taking Zolpeduar or other medicines containing zolpidem.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zolpeduar if:

• you are elderly or frail. If you get up at night, be careful. Zolpeduar may relax your muscles. This effect and the sedative effect increase the risk of falling and, consequently, of hip fracture;
• you have any kidney or liver problems;
• you have a history of respiratory problems. While taking Zolpeduar your breathing may become weaker;
• you have a history of mental illness, anxiety or psychotic illness. Zolpidem may reveal or worsen the symptoms;
• you have or have had heart problems or a condition called prolonged QT syndrome;
• you suffer from or have a history of depression (feeling sad) or have suicidal thoughts;
• you have, or have ever had, a history of alcoholism or drug addiction or a tendency to use them. In these patients, the risk of dependence on Zolpeduar (physical or mental effects produced by a compulsion to continue taking the medicine) increases even with the dosage and duration of treatment.

Children and adolescents
Zolpeduar should not be used in children and adolescents under 18 years of age.

Psychomotor impairment the next day (see also “Driving and using machines”)
The day after taking Zolpeduar, the risk of psychomotor impairment, including impairment of the ability to drive, may increase if you:

• take this medicine less than 8 hours before performing activities that require mental alertness;
• take a higher dose than recommended;
• take zolpidem while already taking other medicines with a depressant effect on the central nervous system or other medicines that increase the levels of zolpidem in the blood, or while drinking alcohol, or while taking illicit substances. Take the single dose immediately at bedtime. Do not take another dose during the same night.

Other considerations

• Tolerance: if after a few weeks you notice that the tablets are not working as when you started treatment for the first time, consult your doctor.
• Dependence: when you take this type of medicine, there is a risk of abuse and dependence, which increases with the dose and duration of treatment. The risk is greater if

you have a history of psychiatric disorders or drug, alcohol, or substance abuse.
However, dependence can also develop at normally used doses for
treatment or if you do not show risk factors, such as a history of alcohol or
drug abuse.

• Discontinuation: treatment should be discontinued gradually. When you stop taking the medicine, you may experience a short-term syndrome, in which the symptoms that prompted you to take treatment with Zolpeduar reappear in an increased form. It may be accompanied by other reactions, including mood changes, anxiety and restlessness.
• Amnesia: Zolpeduar can cause memory loss. To reduce the risk, make sure you can sleep uninterruptedly for 8 hours.
• Psychiatric and “paradoxical” reactions: Zolpeduar can cause undesirable behavioral effects such as restlessness, agitation, irritability, aggression, delirium (false beliefs), anger, nightmares, hallucinations, psychosis (hallucinations; when you see, hear or perceive things that do not exist), inappropriate behavior and increased insomnia.
• Zolpeduar can induce sleepwalking and other unusual behaviors associated with sleep and while not fully awake (such as driving, eating, making phone calls or having sexual intercourse, for example). You may not remember doing something during the night the next morning. If any of the above cases occur, stop treatment with Zolpeduar immediately and contact your doctor as these sleep behaviors could put you and others at serious risk of injury.
• Alcohol and certain medicines used to treat depression or anxiety, or the use of Zolpeduar at doses exceeding the maximum recommended dose, can increase the risk of these side effects.
• Risk of falls and serious injuries - Zolpeduar can cause drowsiness and a reduced level of consciousness, which can increase the risk of falls and consequently serious injuries (see also section 4 “Possible side effects”).

Other medicines and Zolpeduar
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. Zolpeduar can affect the effect and/or side effects of other medicines. If you are about to undergo general anesthesia, tell the doctor about the medicines you are taking.
When zolpidem is taken with the following medicines, increased effects of
drowsiness and psychomotor impairment the next day, including
impairment of the ability to drive, are possible.

• medicines for some mental health problems (antipsychotics)
• medicines for sleep problems (hypnotics)
• medicines to calm or reduce anxiety
• medicines for depression
• medicines for moderate to severe pain (narcotic analgesics)
• medicines for epilepsy
• medicines used for anesthesia
• medicines for hay fever, skin rashes (rash) or other allergies that can cause drowsiness (sedating antihistamines)
• muscle relaxants
• medicines that inhibit liver enzymes. Ask your doctor or pharmacist which medicines have this effect (e.g., ketoconazole, a medicine used to treat fungal infections).

While you take zolpidem with antidepressants, including bupropion, desipramine,
fluoxetine, sertraline and venlafaxine, you may see things that do not exist (hallucinations).
The concomitant use of Zolpeduar and opioids (strong painkillers, medicines for addiction therapy and some medicines for cough) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For
this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Zolpeduar together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and follow
your doctor's dosage recommendations carefully. It may be helpful to inform friends or
family to pay attention to the signs and symptoms listed above. Contact your doctor if
you experience these symptoms.
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
Zolpeduar can cause an increase in the effect of muscle relaxant medicines.
Therefore, the risk of falling may be increased, especially in elderly patients and at a
higher dosage.
Rifampicin (a medicine used to treat tuberculosis), carbamazepine (a
medicine used for example for epilepsy), phenytoin (a medicine used for example for
epilepsy) and St. John's wort [(hypericum perforatum) a traditional herbal medicine],
can cause a reduction in the effect of Zolpeduar. Therefore, concomitant use is not
recommended.

Zolpeduar with food, beverages and alcohol
During treatment with Zolpeduar, you should not consume alcohol, as it can increase
the sedative effect.

Grapefruit juice can affect the effect of this medicine, talk to your doctor for
further information.

Pregnancy and breastfeeding
Pregnancy
Zolpeduar should not be taken during pregnancy. If you are pregnant, suspect or
are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.
If Zolpeduar is used during pregnancy there is a risk that the baby will be
harmed. Some studies have shown that the risk of cleft lip and palate (sometimes called “harelip”) may increase in the newborn. Decreased fetal movement and fetal heart rate variability can occur after taking zolpidem
during the second and/or third trimester of pregnancy.
If this medicine is taken at the end of pregnancy or during labor, the baby may
present with muscle weakness, lowered body temperature, difficulty
feeding and breathing (breathing problems).
If this medicine is taken regularly in the late stages of pregnancy, the
baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn must be carefully
monitored in the period immediately after birth.
Breastfeeding
Do not breastfeed your baby, as zolpidem can pass into breast milk.

Driving and using machines
Zolpeduar impairs the ability to drive vehicles and use machines, for example with
the risk of "falling asleep at the wheel".
The day after taking Zolpeduar (as with other hypnotic medicines), you should be aware of the fact that:

• you may feel drowsy, sleepy, dizzy or confused;
• it may take longer to make decisions;
• vision may be blurred or double;
• you may feel less alert. A period of at least 8 hours is recommended between taking zolpidem and driving vehicles, using machines and working at height, to minimize the effects listed above.

Do not drink alcohol or take other psychoactive substances while taking Zolpeduar, as the
effects listed above may be potentiated.

Zolpeduar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially “sodium-free”.

3. How to take Zolpeduar

Always take this medicine exactly as your doctor has told you. If
you have any doubts, ask your doctor or pharmacist.
The tablet should be placed under the tongue and allowed to dissolve. Because the tablet
acts quickly, take Zolpeduar immediately before going to bed or when you are in bed. Do not
take Zolpeduar during or immediately after a meal.

Adults:
The recommended dose every 24 hours is 10 mg of Zolpeduar. A lower dose may be
prescribed to certain patients. Zolpeduar should be taken:

• with a single dose,
• just before going to bed. Make sure you have at least 8 hours after taking this medicine before performing activities that require your attention. Do not exceed 10 mg every 24 hours.

Elderly patients (over 65 years) or debilitated patients:The recommended dose is 5 mg. The dose
recommended should not be exceeded.

Patients with liver problems:The usual starting dose is 5 mg. The doctor may decide
to increase it to 10 mg if he/she deems it appropriate.
Do not take Zolpeduar if you have severe liver problems.

Patients with respiratory problems:a lower dose is recommended for patients with
respiratory problems.

Use in children and adolescents:Zolpeduar should not be used in children and
adolescents under 18 years of age.
If after a few weeks you notice that the tablets are not working as when you started the
treatment for the first time, consult your doctor as a dosage adjustment may be necessary.

Duration of treatment
The duration of administration should be as short as possible. The maximum treatment period, including the gradual discontinuation process, is four weeks.
Your doctor will choose the most appropriate gradual discontinuation regimen for you, based on your
individual needs.
In some situations, you may need to take Zolpeduar for a period longer
than 4 weeks. If this is the case, your doctor will need to re-evaluate your condition and the
treatment, as the risk of abuse and dependence increases with the duration of treatment.

If you take more Zolpeduar than you should
In the event that you (or another person) ingest a large number of tablets together, or
if you think a child has ingested any tablets, contact your doctor or the nearest emergency room immediately. Bring the package and any remaining tablets
with you. Do not seek medical help on your own.
The following symptoms may occur:

• Feeling of weakness, drowsiness, possible risk of falling into a coma and other disorders leading to death.

If you forget to take Zolpeduar
If you forget to take a dose just before going to bed, but remember during the
night, take the forgotten dose only if you can still have 8 hours of uninterrupted sleep. If
this is not possible, take the next dose the following night, before going to bed. Do not
take a double dose to make up for a forgotten dose. If you are concerned, ask
your pharmacist or doctor for advice.

If you stop taking Zolpeduar
Treatment should be discontinued gradually, otherwise the treated symptoms may
return with greater intensity than before (return of insomnia). Anxiety, restlessness and changes in mood may also
occur. These effects will disappear over time.
If you have become physically dependent on Zolpeduar, sudden discontinuation of
treatment will cause undesirable effects such as headache, muscle pain, anxiety,
tension, restlessness, confusion, irritability and insomnia. In severe cases, other effects may manifest, such as
hypersensitivity to light, noise and physical contact, unusually acute hearing and painful sensitivity to sound, hallucinations, numbness and tingling of the
extremities, derealization (perception of the world around you as if it were not real),
depersonalization (perception of detachment of your mind from your body) or seizures
(violent convulsion or tremor). These symptoms may also occur between doses
and doses, especially if the dose is high.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following effects, stop taking Zolpeduar and immediately inform
your doctor or go to the nearest emergency room:

• allergic reactions such as skin rash or itching, accompanied by swelling of the face, lips, throat or tongue and difficulty breathing or swallowing (angioedema).

These side effects are serious, but the frequency is unknown (cannot be
defined based on available data). You need medical attention.
Tell your doctor or pharmacist if you notice the appearance or worsening of any of the
following side effects:

Common side effects(may affect up to 1 in 10 people):

• respiratory infections
• hallucinations, agitation, nightmares, blunted emotions, depression (sadness)
• drowsiness, headache, dizziness, increased insomnia, cognitive disorders such as amnesia (which may be associated with inappropriate behaviour), daytime sleepiness
• feeling of dizziness
• double vision
• diarrhoea, nausea, vomiting, abdominal pain
• skin reactions
• fatigue
• back pain

The risk of amnesia is higher at higher doses. If you are sure you can sleep
uninterruptedly for 8 hours, the risk of amnesia is reduced.

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

• confusion, irritability, restlessness, aggression
• disturbances in coordination, tingling or numbness, tremors, muscle weakness, muscle pain, muscle spasm, joint pain, neck pain
• blurred vision
• skin rashes, itching, excessive sweating
• loss of appetite
• sleepwalking (see section 2 ‘Other considerations - sleepwalking and other associated behaviours’)
• reduced attention
• speech disorders
• euphoric mood
• increased levels of certain liver enzymes (which would be detected by your doctor during a blood test)

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

• urticaria
• changes in sexual desire (libido)
• reduced level of consciousness
• alterations in gait
• falls, especially in elderly patients
• vision disorders
• liver damage
• paradoxical reactions (restlessness, agitation, irritability, aggression, delusions (false beliefs), anger, nightmares, hallucinations, psychosis, inappropriate behaviour and other adverse behavioural effects). These effects are more likely to occur if you are elderly.

Very rare side effects(may affect up to 1 in 10,000 people)

• decreased respiratory function (respiratory depression)

Not known(frequency cannot be estimated from available data)

• delusions (false beliefs), anger, psychosis (hallucinations; when you see, hear or feel things that do not exist), inappropriate behaviour
• physical dependence: use (even at therapeutic doses) can lead to physical dependence, abrupt discontinuation of treatment can cause withdrawal effects and recurrence of problems
• psychological dependence: this occurs when you think you cannot sleep without taking Zolpeduar
• need to take increasingly higher doses of a medicine to achieve the same effect

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Zolpeduar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zolpeduar contains
The active ingredient is zolpidem tartrate.
Zolpeduar 5 mg:
Each sublingual tablet contains 5 mg of zolpidem tartrate.
Zolpeduar 10 mg:
Each sublingual tablet contains 10 mg of zolpidem tartrate.
The other ingredients are mannitol (E421), silicified microcrystalline cellulose (a mixture of
microcrystalline cellulose and anhydrous colloidal silica), anhydrous colloidal silica, croscarmellose
sodium, sodium saccharin, magnesium stearate.

Description of the appearance of Zolpeduar and contents of the pack
Zolpeduar 5 mg:
The medicine is presented as white, round, flat tablets with bevelled edges, approximately 7.5 mm in
diameter and with a “V” imprinted on one side.
Zolpeduar 10 mg:
The medicine is presented as white, round, flat tablets with bevelled edges, approximately 7.5 mm in
diameter and with an “X” imprinted on one side.
The medicine is available in blister packs of 10, 14, 20, 28, 30, 60, 100 and 150 sublingual
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Italia S.r.l.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer
Mylan Hungary Kft.
Mylan utca 1
2900 Komárom
Hungary

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Austria, Bulgaria, Denmark, Finland, France, Hungary, Iceland, Ireland, Netherlands,
Portugal, Romania, Slovenia, Spain, Sweden, Northern Ireland: Edluar
Belgium, Italy, Luxembourg: Zolpeduar