Zolpigen

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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.
• If you have 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, pharmacist, or nurse. 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. Contents of the packaging 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 sleepiness as a result of their action 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 liver function disorders,
• if the patient has sleep apnea syndrome (characterized by short pauses in breathing during sleep),
• if the patient has severe muscle weakness (myasthenia),
• if the patient has severe respiratory disorders.

Warnings and precautions

Before starting to take Zolpigen, you should discuss it with your doctor:

• if the patient is elderly or weakened. The patient should be careful when getting up at night. Zolpigen may relax muscles and have a sedative effect, 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 had breathing disorders in the past. During treatment with Zolpigen, breathing may become weaker,
• if the patient has had a 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 compulsion to continue taking the medicine) is increased in such persons. This risk is increased when taking higher doses and when taking the medicine for a longer period.

Children and adolescents

Zolpigen should not be taken by 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 that 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 the cause of the problems and needs to be diagnosed.
• Tolerance (habituation) - if after a few weeks the patient notices that the medicine no longer works as well as at the beginning of treatment, they should consult a doctor. A dose change may be necessary.
• Dependence - when taking this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. The risk is greater in people with mental illness and in people 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, which consists of the symptoms that required treatment with Zolpigen returning in an exacerbated form. Other reactions, such as mood changes, anxiety, and restlessness, may accompany this.
• Amnesia - Zolpigen may cause memory loss. To reduce the risk of its occurrence, the patient should ensure that they will have the opportunity for uninterrupted sleep lasting 8 hours.
• Psychological reactions and "paradoxical" - 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 do not actually exist), psychoses (when the patient loses contact with reality, is unable to think clearly, and evaluate), inappropriate behavior, and exacerbation of 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 sleeping, preparing and consuming meals, making phone calls, or having sexual intercourse. Alcohol and some medicines used to treat depression or anxiety disorders, or 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 called QT interval prolongation, 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:

psychomotor disorders, including impaired ability to drive a vehicle,
may be increased if:

• the patient took the medicine less than 8 hours before activities that require increased mental alertness;
• the patient took a higher dose than recommended;
• the patient took 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 while taking prohibited substances.

The medicine should be taken as a single dose, directly before sleep. A second 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 purchased 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, sleepiness and psychomotor disorders the next day, including impaired ability to drive a vehicle, may be increased. 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 (narcotic analgesics),
• medicines used to treat epilepsy,
• medicines used in anesthesia,
• medicines used to treat hay fever, rashes, 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).
It is not recommended to take zolpidem with fluvoxamine, ciprofloxacin, and St. John's wort (a herbal medicine), used in mood swings and depression.

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 sleepiness, 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 so that they are aware of the above signs and symptoms. In case of their occurrence, medical help should be sought.
The following medicines may increase the risk of side effectswhen used with Zolpigen. To reduce this probability, the doctor may decide to reduce the dose of Zolpigen:

• certain antifungal medicines, e.g., ketoconazole.

The following medicines may weaken the effect of Zolpigen:

• rifampicin, an antibiotic used to treat infections.

Zolpigen and alcohol

During treatment with Zolpigen, the patient should not consume alcohol, as it may increase the sedative effect of the medicine.

Pregnancy and breastfeeding

Zolpigen should not be taken during pregnancy, especially in the first three months of pregnancy. If, for urgent medical reasons, a pregnant woman receives Zolpigen 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.
Breastfeeding should not be done, as small amounts of zolpidem may pass into breast milk.
If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.

Driving and operating machinery

Zolpigen has a major impact on the ability to drive vehicles 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 (slowed reflexes),
• the patient may see things blurry or double,
• the patient may be less alert.

To minimize the risk of these events, it is recommended to 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 increase the above-mentioned 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 contact their doctor.

3. How to take Zolpigen

This medicine should always be taken according to the doctor's recommendation. In case of doubts, the patient should consult a 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 per 24 hours. Some patients may be prescribed a lower dose by their doctor. Zolpigen should be taken:

• in a single dose,
• directly before sleep.

The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased concentration.
The dose should not exceed 10 mg per 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 taken by patients under 18 years of age.
If the patient notices that the medicine no longer works as well as at the beginning of treatment, they should consult a 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 of the medicine, is 4 weeks.
The doctor will determine the scheme of gradual withdrawal of the medicine based on the individual needs of the patient.
In some cases, it may be necessary to take the medicine for a period longer than 4 weeks.
The risk of dependence increases with the duration of treatment (see section 2 "Other problems").

Use of a higher than recommended dose of Zolpigen

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 packaging of the medicine and any remaining tablets with them. The patient should not go to the doctor alone. If an overdose occurs, sleepiness 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 it in the middle of the night, the missed dose can be taken only if it is possible to 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 medicine should not be taken at a different time of day, as it may cause drowsiness, dizziness, or confusion in the patient. A double dose should not be taken to make up for a missed dose. In case of doubts, the patient should consult a pharmacist or doctor.

Stopping treatment with Zolpigen

Zolpigen should be taken as long as the doctor does not recommend stopping it. The patient should not stop treatment abruptly but should inform their doctor about their desire to stop taking the medicine. Treatment should be discontinued gradually; otherwise, sleep disorders, for which the medicine is taken, may return in an even more severe form (rebound insomnia). The following may also occur: anxiety, restlessness, and mood changes. These symptoms will subside after some 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 may also occur, such as hypersensitivity to light, noise, and touch, abnormal hearing, and sensitivity to 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). Such symptoms may also be experienced during periods between doses, especially when taking high doses.
In case of any further doubts related to the use of the medicine, the patient should consult a 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 a doctor or go to the emergency room of the nearest hospital if:

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

If any of the following symptoms occur, the patient should inform their doctor as soon as possible:

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 memory loss is lower.
• sleep problems, which may worsen after taking this medicine
• seeing or hearing things that are not real (hallucinations)
• increased sleepiness 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 1,000 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 discontinuation of 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 less than 1 in 10 people):

• restlessness, 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 less than 1 in 100 people):

• irritability, confusion, restlessness, aggression
• muscle weakness
• tremors
• somnambulism (sleepwalking)
• abnormal state of cheerfulness and confidence (euphoric mood)
• attention disorders
• speech disorders
• rash, itching
• excessive sweating
• increased activity of liver enzymes (detected by blood tests).

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

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

Very rare(may occur in less than 1 in 10,000 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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
Phone: +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

The medicine should be stored in a place that is invisible and inaccessible to children.
The medicine should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated 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. Contents of the packaging 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.
Tablet coating Opadry YS-1R-7003: titanium dioxide (E 171), hypromellose 3cP, hypromellose 5cP, macrogol 400, polysorbate 80 (E 433).

What Zolpigen looks like and what the packaging contains

Zolpigen has the form of white or almost white coated tablets in the shape of capsules, 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 the medicine contains 10 or 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

Manufacturers:

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen, 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 28486

Parallel import authorization number: 317/16

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Zolpidem Mylan 10 mg coated tablets
Hungary: Somnogen 10 mg film-coated tablets
Poland: Zolpigen
Portugal: Zolpidem Mylan
Slovakia: Zolpidem Mylan 10 mg
Date of leaflet approval: 20.07.2022
[information about the trademark]