Zolpigen

Patient Information Leaflet

Warning! Keep this 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 brand names for the same medicine.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

1. What Zolpigen is and what it is 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 pack and other information

1. What Zolpigen is and what it is used for

Zolpigen contains zolpidem, an active substance belonging to the group of hypnotic medicines.
Zolpigen tablets are sleeping tablets that induce sleepiness by acting on the brain.
This medicine may be used for the short-term treatment of insomnia in adults when the insomnia is severe,
impairs normal functioning, or causes marked distress. Insomnia means difficulty falling asleep or staying asleep properly.

2. Important information before using Zolpigen

When not to use Zolpigen

• if the patient is allergic to zolpidem hemitartrate 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 apnoea syndrome (characterized by brief breathing interruptions during sleep),
• if the patient has severe muscle weakness (myasthenia gravis),
• if the patient has acute and/or severe respiratory disorders,
• if the patient previously experienced sleep disorders after taking zolpidem hemitartrate.

Warnings and precautions
Before starting treatment with Zolpigen, discuss the following with your doctor:

• if the patient is elderly or frail. The patient must be cautious when getting up at night.

Zolpigen may cause muscle relaxation and drowsiness, increasing the risk of falls and consequently the risk of hip fracture,

• if the patient has liver or kidney function disorders,
• if the patient previously experienced breathing problems. During treatment with Zolpigen, breathing may become weaker,
• if the patient previously had a psychiatric disorder, anxiety, or psychosis, as Zolpigen may unmask or worsen symptoms of these conditions,
• if the patient currently has or previously had depression (feeling of sadness),
• if the patient currently has or has ever had a psychiatric disorder, or a history of alcohol or drug abuse. The risk of dependence on Zolpigen (physical or psychological symptoms due to a perceived compulsion to continue taking the medicine) is increased in such patients. This risk increases with higher doses and prolonged use.

Children and adolescents
Zolpigen must not be used in children and adolescents under 18 years of age.
Other issues

• General – before administering the medicine, the doctor will assess the patient's sleep problems to ensure they are not caused by an underlying illness. If the medicine does not help the patient after 7–14 days, consult a doctor, as another condition may be responsible and needs to be diagnosed.
• Tolerance – if after several weeks the patient notices that the medicine is no longer as effective as at the beginning of treatment, contact the doctor. A dose adjustment may be necessary.
• Dependence – there is a risk of dependence when using this type of medicine, which increases with dose and duration of treatment. The risk is higher in patients with psychiatric disorders and in those currently or previously abusing alcohol or drugs.
• Discontinuation – the medicine should be discontinued gradually. After stopping the medicine, a short-term withdrawal syndrome may occur, in which the symptoms requiring treatment with Zolpigen return in an intensified form. This may be accompanied by other reactions such as mood changes, anxiety, and motor restlessness.
• Amnesia – Zolpigen may cause memory loss. To reduce the risk of this occurring, the patient should ensure they will have the opportunity for uninterrupted sleep lasting 8 hours.
• Psychiatric and "paradoxical" reactions – Zolpigen may cause undesirable behavioural changes such as motor restlessness, excitement, irritability, aggression, delusions (false beliefs), rage outbursts, nightmares, hallucinations (when the patient sees, hears, or feels things that are not actually present), psychosis (when the patient loses contact with reality, cannot think or judge clearly), inappropriate behaviour, and worsening of insomnia.
• Sleepwalking and similar behaviours – Zolpigen may cause patients to perform various activities during sleep, which they do not remember upon waking. These activities may include: sleepwalking, driving while asleep, preparing and eating meals, making phone calls, or engaging in sexual activity. These sleep disorders may occur after taking Zolpigen. If any of these behaviours occur, treatment with Zolpigen must be stopped immediately and the patient should contact their doctor, as such sleep behaviours may pose a serious risk of injury to the patient or their surroundings. Alcohol, certain medicines used to treat depression or anxiety disorders, or using Zolpigen at doses higher than the maximum recommended dose may increase the risk of these symptoms.
• Suicide – an increased number of suicides and suicide attempts have been reported in patients with or without depression treated with zolpidem. However, a causal relationship between these events and zolpidem use has not been established.
• Heart rhythm disorders (QT prolongation syndrome) – if the patient has a heart condition called QT prolongation, detectable by ECG, the doctor will consider whether this medicine is appropriate.
• Next-day psychomotor disturbances (see also "Driving and operating machinery") – the risk of next-day psychomotor disturbances, including impaired ability to drive, may be increased the day after taking Zolpigen if:
• the medicine was taken less than 8 hours before activities requiring full mental alertness,
• a higher than recommended dose was taken,
• zolpidem was taken during treatment with other central nervous system depressants or other medicines that increase zolpidem blood levels, while consuming alcohol, or while using illicit substances.

A single dose should be taken immediately before bedtime. Do not take another dose the same night.
Zolpigen and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use, including those obtained without a prescription. Zolpigen may affect the action and/or side effects of other medicines. If surgery under general anaesthesia is planned, inform the doctor about all medicines being taken.
When zolpidem is taken together with certain medicines, drowsiness and next-day psychomotor disturbances, including impaired driving ability, may be intensified. These medicines include:

• medicines used to treat certain mental health disorders (antipsychotics),
• medicines used to treat sleep problems (hypnotics),
• sedatives or anxiolytics,
• antidepressants,
• medicines used to treat moderate to severe pain (opioid analgesics),
• antiepileptic medicines,
• anaesthetics,
• medicines used to treat hay fever, rashes, or other allergies, which may cause drowsiness (sedating antihistamines).

When taking zolpidem together with antidepressants such as bupropion, desipramine, fluoxetine, sertraline, or venlafaxine, the patient may see unreal things (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine, ciprofloxacin, or St. John's wort (an herbal medicine used for mood disorders 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 depression), coma, and may be fatal. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available.
However, if the doctor prescribes Zolpigen together with opioids, the dose and duration of concomitant use should be limited by the doctor.
Inform the doctor about all opioid medicines the patient is taking and strictly follow dosing instructions. It may be helpful to inform friends and family members so they are aware of the above-mentioned signs and symptoms. If these symptoms occur, contact the doctor immediately.
The following medicines may increase the risk of adverse effects when used together with Zolpigen. To reduce this risk, 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
Do not consume alcohol while taking Zolpigen, as it may intensify the sedative effect of the medicine.
Pregnancy and breastfeeding
Do not use Zolpigen during pregnancy, especially during the first three months of pregnancy. If the patient receives Zolpigen for urgent medical reasons towards the end of pregnancy or during delivery, the newborn may experience low body temperature, muscle weakness, feeding and breathing difficulties, and withdrawal symptoms due to physical dependence.
Some studies have shown an increased risk of cleft lip and palate (so-called "hare lip") in newborns.
Use of zolpidem during the second and/or third trimester of pregnancy may reduce fetal movements and alter fetal heart rhythm.
Do not breastfeed, as small amounts of zolpidem may pass into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
Zolpigen has a major effect on the ability to drive and operate machinery and may cause events such as falling asleep at the wheel. The day after taking Zolpigen (as with other hypnotics), the patient may experience:

• drowsiness, sleepiness, dizziness, or disorientation,
• slower reaction time (impaired reflexes),
• blurred or double vision,
• reduced alertness.

To minimize the risk of these events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, or working at heights.
Do not consume alcohol or psychoactive substances while taking Zolpigen, as this may worsen the effects mentioned above.
Zolpigen contains monohydrate lactose
If your doctor has ever mentioned that you have an intolerance to certain sugars, such as lactose, consult your doctor before starting treatment with this medicine.

3. How to use Zolpigen

This medicine should always be used exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
This medicine acts rapidly, therefore the tablet should be swallowed whole with liquid, immediately before
going to bed or after lying down. After taking this medicine, ensure at least 8 hours of sleep.
The tablet may be divided into equal doses.
Adults: The recommended dose of Zolpigen is 10 mg per 24 hours. Your doctor may prescribe a lower dose for some patients. Zolpigen should be taken:

• as a single dose
• immediately before sleep.

Patients must allow at least 8 hours between taking the medicine and performing any activities requiring concentration.
Do not exceed the dose of 10 mg per 24 hours.
Elderly patients (over 65 years of age) or weakened patients: The recommended dose is 5 mg.
Patients with impaired liver function: The initial recommended dose is 5 mg. Your doctor may
increase the dose to 10 mg if deemed safe.
The maximum dose of 10 mg must not be exceeded in any patient.
Use in children and adolescents
Zolpigen must not be used in patients under 18 years of age.
If a patient notices that the medicine no longer works as well as it did at the beginning of treatment, they should consult their doctor, as a dose adjustment 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 duration of treatment, including the tapering-off period, is 4 weeks.
Your doctor will determine the tapering schedule based on the individual needs of the patient.
In certain situations, treatment may need to continue for longer than 4 weeks.
The risk of dependence increases with the duration of treatment (see section 2 "Other problems").
Taking more than the recommended dose of Zolpigen
If a patient (or anyone else) swallows a large number of tablets at once, or if there is suspicion that a child has swallowed any tablets, immediately seek medical help from a doctor or go to the nearest hospital emergency department. Bring the medicine packaging and any remaining tablets with you. Do not go for medical help alone. In cases of overdose, drowsiness may rapidly worsen, and large doses may lead to coma or even death.
Missed dose of Zolpigen
If a patient forgets to take the medicine before going to bed but remembers during the night, the missed dose may 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 bed the following night. Do not take this medicine at another time of day, as it may cause drowsiness, dizziness, or confusion. Do not take a double dose to make up for a missed dose. If in doubt, consult your pharmacist or doctor.
Stopping Zolpigen
Zolpigen should be taken until your doctor advises you to stop. Do not discontinue treatment abruptly; instead, inform your doctor of your intention to stop. The medicine should be tapered off gradually. Otherwise, the sleep disturbances for which the medicine was prescribed may return with greater intensity (rebound insomnia). Other symptoms such as anxiety, restlessness, and mood changes may also occur. These symptoms resolve after some time.
If physical dependence on Zolpigen has developed, abrupt discontinuation may lead to adverse effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, additional symptoms may occur, such as hypersensitivity to light, noise, and touch, abnormal auditory acuity, painful sensitivity to sounds, hallucinations, tingling and numbness in the limbs, feelings of unreality (the sensation that the surrounding world is not real), depersonalization (the sensation that the mind is separating from the body), or seizures (convulsions or tremors). These symptoms may also be experienced between doses, especially if high doses are used.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking the medicine and contact your doctor or go to the nearest hospital emergency
department if:

• the patient has 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 problems (amnesia) or unusual behaviour while taking Zolpigen (see section 2 "Other problems"). The risk of these effects may be higher within a few hours after taking the medicine. If the patient ensures 8 hours of sleep after taking the tablet, the risk of memory problems is reduced.
• sleep problems, which may worsen after taking this medicine
• seeing or hearing things that are not real (hallucinations)
• excessive drowsiness or tiredness, 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 believes they will not be able to sleep without taking Zolpigen
• breathing difficulties.

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

• physical dependence: prolonged use (even at therapeutic doses) may lead to physical dependence; abruptly stopping treatment may cause withdrawal symptoms and recurrence of problems
• loss of contact with reality (psychoses).

These side effects are serious. If any of them occur, the patient may require medical help.
If any of the following side effects occur or worsen, tell your doctor or pharmacist:
Common (may occur in less than 1 in 10 people):

• restlessness, nightmares
• headache, dizziness
• depression (feeling of sadness)
• diarrhoea, nausea or vomiting, abdominal pain
• back pain
• fatigue
• nose and throat infections.

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

• irritability, confusion, anxiety, aggression
• muscle weakness
• tremor
• sleepwalking and sleep disorders (see section 2 "Warnings and precautions")
• unnatural state of cheerfulness and self-confidence (euphoric mood)
• speech disorders
• rash, itching
• excessive sweating
• increased liver enzyme activity (detected during blood tests).

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

• paradoxical reactions (motor restlessness, stimulation, irritability, aggression, delusions - false beliefs, rage attacks, nightmares, hallucinations, psychoses, inappropriate behaviour and other undesirable changes in behaviour). Elderly patients are more susceptible to such symptoms
• decreased libido
• urticaria.

Very rare (may occur in less than 1 in 10,000 people):

• false beliefs (delusions).

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

• blurred vision
• loss of appetite
• anger
• behavioural disturbances.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Zolpigen

Keep out of the 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 stated month.
Store below 25°C in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Zolpigen contains
The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
Other components of the medicine are: monohydrate lactose (see section 2, "Zolpigen contains monohydrate lactose"), microcrystalline cellulose, pregelatinized maize starch, magnesium stearate.
Tablet coating Opadry YS-1R-7003: titanium dioxide (E 171), hypromellose 3 cPs, hypromellose 5 cPs, polyethylene glycol 400, polysorbate 80 (E 433).

What Zolpigen looks like and contents of the pack
The medicine is in the form of white or almost white, capsule-shaped coated tablets marked as follows: "ZM" with a dividing line and "10" on one side and "G" on the other.
The tablet can be divided into equal doses.
The pack contains 10 or 20 coated tablets.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Mylan Pharmaceuticals Ltd
Damastown Industrial Park
Mulhuddart
Dublin 15
Dublin
Ireland

Manufacturer:
Mylan B.V
Krijgsman 20, Amstelveen, 1186 DM, Netherlands
Mc Dermott 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation number in the Netherlands, country of export: RVG 28486
Parallel Import Authorisation number: 345/18

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Czech Republic: Zolpidem Mylan 10 mg potahované tablety
Hungary: Somnogen 10 mg filmtabletta
Poland: Zolpigen
Portugal: Zolpidem Mylan
Slovakia: Zolpidem Mylan 10 mg