Zolpigen

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

ZolpiGen(Zolpidem tartrate Mylan)

10 mg, coated tablets

Zolpidem tartrate
ZolpiGen and Zolpidem tartrate Mylan are different trade names for the same medicine.

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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 ZolpiGen and what is it used for
• 2. Important information before taking ZolpiGen
• 3. How to take ZolpiGen
• 4. Possible side effects
• 5. How to store ZolpiGen
• 6. Package contents and other information

1. What is ZolpiGen and what is it used for

ZolpiGen contains zolpidem, an active substance belonging to the group of sedative medicines.
The tablets of ZolpiGen are sleeping pills that cause drowsiness as a result of their effect on the brain.
This medicine may be used for short-term treatment of insomnia in adults, if it is severe,
prevents proper functioning or is very troublesome. Insomnia means problems with
falling asleep or proper sleep.

2. Important information before taking ZolpiGen

When not to take ZolpiGen:

• if the patient is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue,
• if the patient has severe liver function disorders,
• if the patient has sleep apnea syndrome (characterized by short breaks in breathing during sleep),
• if the patient has severe muscle weakness (myasthenia),
• if the patient has acute and/or severe respiratory disorders.
• if the patient has experienced sleep disorders after taking zolpidem tartrate in the past

Warnings and precautions

Before starting treatment with ZolpiGen, the patient should discuss the following with their doctor:

• if the patient is elderly or weakened. The patient should be careful when getting up at night. ZolpiGen may relax the muscles and cause drowsiness, which increases the risk of falls and thus the risk of hip fractures,
• if the patient has liver or kidney function disorders,
• if the patient has experienced respiratory disorders in the past. During treatment with ZolpiGen, breathing may become weaker,
• if the patient has experienced mental illness, anxiety or psychosis in the past, as ZolpiGen may reveal or exacerbate the symptoms of these diseases,
• if the patient currently has or has had depression (feeling of sadness) in the past,
• if the patient currently has or has had a mental illness, a tendency to abuse alcohol or drugs in the past. The risk of dependence on ZolpiGen (physical or psychological symptoms caused by the feeling of needing to take the medicine constantly) increases in such patients. This risk increases with higher doses and longer treatment.

Children and adolescents

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

Other problems

• General - before administering the medicine, the doctor will assess the patient's sleep problems to ensure they are not caused by a disease. If the medicine does not help the patient after 7-14 days, they should consult a doctor, as something else may be causing the problems and needs to be diagnosed.
• Tolerance (addiction) - if after a few weeks the patient notices that the medicine is no longer working as well as at the beginning of treatment, they should consult a doctor. A dose change may be necessary.
• Dependence - there is a risk of dependence when taking this type of medicine, which increases with the dose and duration of treatment. The risk is higher in patients with mental illness and in patients who currently or in the past have abused alcohol or drugs.
• Withdrawal - the medicine should be discontinued gradually. After discontinuing the medicine, a short-term withdrawal syndrome may occur, characterized by the recurrence of symptoms that required treatment with ZolpiGen, in an exacerbated form. This may be accompanied by other reactions, such as mood changes, anxiety and restlessness.
• Amnesia - ZolpiGen may cause memory loss. To minimize the risk of its occurrence, the patient should ensure that they will have the opportunity for uninterrupted sleep lasting 8 hours.
• Psychological and "paradoxical" reactions - ZolpiGen may cause undesirable changes in behavior, such as restlessness, excitement, irritability, aggression, delusions (false beliefs), outbursts of anger, nightmares, hallucinations (when the patient sees, hears or feels things that are not really there), psychosis (when the patient loses contact with reality, is unable to think clearly and evaluate), inappropriate behavior and increased insomnia.
• Sleepwalking and similar behaviors - ZolpiGen may cause patients to perform various activities during sleep, which they do not remember after waking up. These activities may include: sleepwalking, driving while asleep, preparing and consuming meals, making phone calls or having sexual intercourse. These sleep disorders may occur after taking ZolpiGen. If any of the above behaviors occur in a patient, they should immediately stop treatment with ZolpiGen and consult a doctor, as such behaviors during sleep may pose a serious risk of injury to the patient or their environment. Alcohol and certain medicines used to treat depression or anxiety, as well as taking ZolpiGen in doses higher than the maximum recommended dose, may increase the risk of these symptoms.
• Suicide - there have been reports of an increased number of suicides and attempted suicides in patients with depression or without depression, treated with zolpidem. However, the relationship between these events and the use of zolpidem has not been established
• Heart rhythm disorders (prolonged QT interval) - if the patient has a heart disorder known as prolonged QT interval, which can be detected by an ECG, the doctor will consider whether this medicine is suitable for the patient.
• Psychomotor disorders the next day (see also "Driving and operating machinery") - the next day after taking ZolpiGen (like other sleeping pills), it may happen that:

the patient's psychomotor performance is impaired, including the ability to drive a vehicle, if:

• the patient took the medicine less than 8 hours before activities that require increased alertness
• the patient took a higher dose than recommended
• the patient took zolpidem during treatment 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 prohibited substances. A single dose should be taken directly before sleep. Another dose should not be taken on the same night.

ZolpiGen 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, including those bought without a prescription. ZolpiGen may affect the action and/or side effects of other medicines. If surgery under general anesthesia is planned, the patient should tell their doctor about all medicines they are taking.
When taking zolpidem with certain medicines, drowsiness and psychomotor disorders the next day, including impaired ability to drive a vehicle, may be exacerbated. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics)
• medicines used to treat sleep problems (sleeping pills)
• medicines that have a sedative or anxiolytic effect
• medicines used to treat depression
• medicines used to treat moderate to severe pain (opioid analgesics)
• medicines used to treat epilepsy
• medicines used in anesthesia
• medicines used to treat hay fever, skin rash 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 see things that are not real (visual hallucinations).
Taking zolpidem with fluvoxamine, ciprofloxacin and St. John's wort (a herbal medicine used in mood swings and depression) is not recommended.

Risk associated with concomitant use with opioids

Concomitant use of ZolpiGen 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. Due to this, concomitant use of these medicines should only be considered when other treatment methods are not possible.
However, when the doctor prescribes ZolpiGen together with opioids, the dose and duration of concomitant use should be limited by the doctor.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage instructions. It may be helpful to inform friends and family members to be aware of the above signs and symptoms. In case of their occurrence, the patient should contact their doctor.
The following medicines may increase the risk of side effectswhen used with ZolpiGen. To minimize this risk, the doctor may decide to reduce the dose of ZolpiGen:

• certain antifungal medicines, such as ketoconazole

The following medicines may weaken the effect of ZolpiGen:

• rifampicin, an antibiotic used to treat infections

ZolpiGen and alcohol

The patient should not consume alcohol while taking ZolpiGen, as it may enhance the sedative effect of the medicine.

Pregnancy and breastfeeding

ZolpiGen should not be used during pregnancy, especially in the first three months of pregnancy. If a patient is given ZolpiGen for urgent medical reasons at the end of pregnancy or during childbirth, the newborn may experience hypothermia, muscle weakness, feeding difficulties and breathing difficulties, as well as withdrawal symptoms due to physical dependence.
Some studies have shown an increased risk of cleft lip and palate in newborns (so-called "hare lip").
Taking zolpidem in the second and/or third trimester of pregnancy may reduce the active movements of the fetus and change the fetal heart rate.
The patient should notbreastfeed, as small amounts of zolpidem may pass into breast milk.
If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.

Driving and operating machinery

ZolpiGen has a major impact on the ability to drive and operate machinery, and may cause events such as falling asleep at the wheel. The next day after taking ZolpiGen (like other sleeping pills), 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 double or blurred vision
• the patient may be less alert

To minimize the risk of the above events, the patient should maintain an interval of at least 8 hours between taking zolpidem and driving a vehicle, operating machinery or working at heights.
The patient should not consume alcohol or psychoactive substances while taking ZolpiGen, as this may exacerbate the above effects.

ZolpiGen contains lactose monohydrate

If the doctor has ever mentioned intolerance to certain sugars, such as lactose, before starting treatment with this medicine, the patient should consult their doctor.

3. How to take ZolpiGen

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine works immediately, so the tablet should be swallowed whole with a liquid, just before going to sleep or after lying down. After taking this medicine, the patient should ensure at least 8 hours of sleep.
The tablet can be divided into equal doses.
Adults:The recommended dose of ZolpiGen is 10 mg every 24 hours. The doctor may prescribe a lower dose for some patients. ZolpiGen should be taken:

• in a single dose
• directly before sleep

The patient must maintain an interval of at least 8 hours between taking the medicine and engaging in activities that require increased concentration.
The dose should not exceed 10 mg every 24 hours.
Elderly or weakened patients (over 65 years old):The recommended dose is 5 mg.
Patients with liver function disorders:The recommended initial dose is 5 mg. The doctor may increase the dose to 10 mg if they consider it safe.
The maximum dose of 10 mg should not be exceeded in any patient.

Use in children and adolescents:

ZolpiGen should not be used in patients under 18 years of age.
If the patient notices that the medicine is no longer working as well as at the beginning of treatment, they should consult their doctor, as a dose change may be necessary.

Duration of treatment

The treatment period should be as short as possible. It usually ranges from a few days to 2 weeks.
The maximum treatment duration, including the period of gradual withdrawal, is 4 weeks.
The doctor will determine the schedule for gradual withdrawal of the medicine based on the patient's individual needs.
In some cases, it may be necessary to use the medicine for a period longer than 4 weeks.
The risk of dependence increases with the duration of treatment (see section 2 "Other problems").

Taking a higher dose of ZolpiGen than recommended

If the patient (or anyone else) swallows a large number of tablets at once or if it is suspected that a child has swallowed any tablets, they should immediatelyconsult a doctor or go to the emergency room of the nearest hospital. They should take the medicine packaging and any remaining tablets with them. The patient should not go to the doctor alone. If an overdose occurs, drowsiness may increase rapidly, and high doses may lead to coma or even death.

Missing a dose of ZolpiGen

If the patient forgets to take a dose of the medicine before going to sleep, but remembers during the night, they can take the missed dose only if they can ensure 8 hours of uninterrupted sleep after taking the tablet. If this is not possible, the next dose should be taken before going to sleep the next evening. The patient should not take this medicine at any other time of day, as it may cause drowsiness, dizziness or disorientation. The patient should not take a double dose to make up for the missed dose. In case of doubts, the patient should consult their pharmacist or doctor.

Stopping treatment with ZolpiGen

ZolpiGen should be taken for as long as the doctor recommends. The patient should not stop treatment abruptly, but should inform their doctor about their intention to stop taking the medicine. The treatment should be discontinued gradually, otherwise the sleep disorders for which the medicine is taken may recur in an exacerbated form (rebound insomnia). The patient may also experience anxiety, restlessness and mood changes. These symptoms will subside over time.
If physical dependence on ZolpiGen occurs, sudden withdrawal of the medicine may lead to side effects such as headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability and insomnia. In severe cases, other symptoms such as hypersensitivity to light, noise and touch, abnormal hearing and pain associated with sounds, hallucinations, tingling and numbness of limbs, feeling of unreality (feeling that the world around is not real), depersonalization (feeling that the mind is separating from the body) or seizures (convulsions or tremors) may occur. Such symptoms may also occur during periods between doses, especially when high doses are used.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ZolpiGen can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and consult their doctor or go to the emergency room of the nearest hospital if:

• they experience an allergic reaction. Symptoms may include a skin rash, itching, swelling of the face, lips, throat or tongue, difficulty breathing or swallowing

The patient should inform their doctor as soon as possible if they experience any of the following symptoms:

Common(may occur in up to 1 in 10 people):

• memory disorders (amnesia) or strange behavior while taking ZolpiGen (see section 2 "Other problems"). The risk of these symptoms may be higher within a few hours of taking the medicine. If the patient has 8 hours of sleep after taking the tablet, the risk of amnesia is lower.
• sleep problems, which may worsen after taking this medicine
• seeing or hearing things that are not real (hallucinations)
• increased drowsiness or fatigue, problems with concentration or daily activities.

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

• double vision

Rare(may occur in up to 1 in 1000 people):

• liver damage, which may include symptoms such as severe abdominal pain, nausea, vomiting, loss of appetite and yellowing of the skin and eyes
• falls (especially in elderly patients)

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

• psychological dependence: the patient thinks they will not fall asleep if they do not take ZolpiGen
• breathing difficulties

Frequency not known(the frequency of occurrence cannot be determined based on available data):

• physical dependence: taking the medicine (even in therapeutic doses) may lead to physical dependence, and sudden withdrawal of the treatment may cause withdrawal symptoms and recurrence of problems
• loss of contact with reality (psychosis)

These side effects are serious. If they occur, the patient may need medical attention.

If any of the following side effects occur or worsen, the patient should tell their doctor or pharmacist:

Common(may occur in up to 1 in 10 people):

• agitation, nightmares
• headache, dizziness
• depression (feeling of sadness)
• diarrhea, nausea or vomiting, abdominal pain
• back pain
• fatigue
• infections of the nose and throat

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

• irritability, confusion, restlessness, aggression
• muscle weakness
• tremors
• sleepwalking (and sleep disorders, see section 2 "Warnings and precautions")
• abnormal state of cheerfulness and confidence (euphoric mood)
• speech disorders
• rash, itching
• excessive sweating
• increased liver enzyme activity (detected by blood tests)

Rare(may occur in up to 1 in 1000 people):

• "paradoxical" reactions (restlessness, excitement, irritability, aggression, delusions - false beliefs, outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior and other undesirable changes in behavior). Elderly patients are more prone to these symptoms
• decreased libido
• hives

Very rare(may occur in up to 1 in 1000 people):

• delusions (false beliefs)

Frequency not known(the frequency of occurrence cannot be determined based on available data):

• blurred vision
• loss of appetite
• anger
• behavioral disorders

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ZolpiGen

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C in the 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. Package contents and other information

What ZolpiGen contains

The active substance of ZolpiGen is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
Other ingredients of the medicine are: lactose monohydrate (see section 2, "ZolpiGen contains lactose monohydrate"), microcrystalline cellulose, maize starch, magnesium stearate.
The tablet coating Opadry YS-1R-7003: titanium dioxide (E 171), hypromellose 3cP, hypromellose 5cP, macrogol 400, polysorbate 80.

What ZolpiGen looks like and what the package contains

ZolpiGen is a white or almost white, coated tablet in the shape of a capsule, marked as follows: "ZM with a dividing line 10" on one side and "G" on the other side.
The tablet can be divided into equal doses.
The packaging of ZolpiGen contains 20 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
Netherlands

Manufacturer

Mylan B.V
Krijgsman 20
Amstelveen, 1186 DM
Netherlands
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Netherlands, the country of export: RVG 28486
Parallel import authorization number: 308/19
Date of leaflet approval: 31.03.2023
[Information about the trademark]