Zolpigen

Leaflet attached to 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.
Zolpigen tablets are sleeping pills that cause drowsiness by acting on the brain.
This medicine may be used for short-term treatment of insomnia in adults, if it is severe,
interferes with normal 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 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 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, 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 cause drowsiness, which increases the risk of falls and thus the risk of hip fracture,

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 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 people. 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 make sure 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 using this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. The risk is higher 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 involves the recurrence of symptoms that required treatment with Zolpigen in an intensified form. This may be accompanied by other reactions, such as mood changes, anxiety and restlessness.
• 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 and "paradoxical" reactions - Zolpigen may cause undesirable changes in behavior, such as restlessness, excitement, irritation, 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 sleeping, preparing and consuming meals, making phone calls or having sex. These sleep disorders may occur after taking Zolpigen. If any of the above behaviors occur in the 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, 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 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 feels drowsy, sleepy, has dizziness or is disoriented
• the patient needs more time to make quick decisions (impaired reflex)
• the patient may see blurry or double vision
• the patient may be less alert.

You should take a single dose directly before sleep. You should not take another dose
that same night.

Zolpigen and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking,
or have recently taken, as well as any medicines you plan to take, including those bought without a prescription. Zolpigen may affect the action and/or side effects of other medicines. If a general anesthetic is planned, you should tell your doctor about all the medicines you are taking.
When taking zolpidem with certain medicines, drowsiness and psychomotor disorders the next day, including impaired driving ability, may be increased. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics)
• medicines used to treat sleep problems (sleeping pills)
• calming or anti-anxiety medicines
• medicines used to treat depression
• medicines used to treat moderate to severe pain (narcotic painkillers)
• medicines used to treat epilepsy
• medicines used in anesthesia
• medicines used to treat colds, allergies 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 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.
You should inform your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform your friends and family to be aware of the above signs and symptoms. In case of their occurrence, you should consult a doctor.
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, such as ketoconazole.

The following medicines may weaken the effect of Zolpigen:

• rifampicin, an antibiotic used to treat infections.

Zolpigen and alcohol

You should not drink alcohol while taking Zolpigen, as it may increase 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, for urgent medical reasons, a patient takes Zolpigen at the end of pregnancy or during childbirth, the baby 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.
You should notbreastfeed, as small amounts of zolpidem may pass into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, you should consult your 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 reflex)
• the patient may see blurry or double vision
• the patient may be less alert.

To minimize the risk of the above events, it is recommended to maintain an interval of at least 8 hours between taking zolpidem and driving, operating machinery or working at heights.
You should not drink alcohol or take psychoactive substances while taking Zolpigen, as this may increase the above effects.

Zolpigen contains lactose monohydrate

If your doctor has ever mentioned intolerance to some sugars, such as lactose, before starting treatment with this medicine, you should consult your doctor.

3. How to take Zolpigen

This medicine should always be taken according to the doctor's recommendation. In case of doubts, you should consult a doctor or pharmacist.
The medicine works immediately, so you should swallow the tablet whole with a drink of water, just before going to sleep or after lying down. After taking this medicine, you 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. Your doctor may prescribe a lower dose. 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.
You should not exceed the dose of 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.
You should not exceed the maximum dose of 10 mg 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 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 discontinuation of the medicine, is 4 weeks.
The doctor will determine the schedule for gradual discontinuation of the medicine based on the individual needs of the patient.
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").

Using a higher than recommended dose of Zolpigen

If the patient (or anyone else) swallows a large number of tablets at once, or if there is a suspicion 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. They 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, they should take the next dose before going to sleep the next evening. They should not take this medicine at any other time of day, as it may cause drowsiness, dizziness or confusion. They should not take a double dose to make up for the missed dose. In case of doubts, they should consult a pharmacist or doctor.

Stopping treatment with Zolpigen

Zolpigen should be used until the doctor recommends stopping it. You should not stop treatment abruptly, but you should inform your doctor about your desire to stop taking the medicine. Treatment should be discontinued gradually, otherwise the sleep disorders for which the medicine is used may recur 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 discontinuation of the medicine may lead to side effects such as headaches, muscle pain, anxiety, tension, restlessness, confusion, irritation and insomnia. In severe cases, other symptoms may also occur, 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 epileptic seizures (convulsions or trembling). 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, you should consult a 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 the medicine and consult a doctor or go to the emergency room of the nearest hospital if:

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

If any of the following symptoms occur, you should inform your 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 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 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, you should inform your doctor:

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, irritation, aggression, delusions - false beliefs, outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior and other undesirable changes in behavior). Elderly people are more prone to these symptoms
• decreased libido
• hives.

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

• false beliefs (delusions).

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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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, you can help gather more information on the safety of this 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 stated.
Store in a temperature below 25°C, in the original packaging.
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. 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-7003contains: titanium dioxide (E 171), hypromellose 3cPs, hypromellose 5cPs, macrogol 400, polysorbate 80 (E 433).

What Zolpigen looks like and what the package 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 Zolpigen contains 10 or 20 coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

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

Mylan Pharmaceuticals Ltd
Damastown Industrial Park
Mulhuddart
Dublin 15
Dublin
Ireland

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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number, the country of export:RVG 28486
Parallel import authorization number:345/18

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: 06.12.2023