Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Zolpigen (Zolpidemtartrate Mylan)
10 mg, coated tablets
Zolpidem tartrate
Zolpigen and Zolpidemtartrate Mylan are different brand names for the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Zolpigen is and what it is used for
Important information before taking Zolpigen
How to take Zolpigen
Possible side effects
How to store Zolpigen
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 condition is severe,
impairs normal functioning, or causes marked distress. Insomnia means difficulties with falling asleep or maintaining normal sleep.

2. Important information before using Zolpigen

When not to use Zolpigen

if the patient is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6.). Allergic reaction may include 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 apnoea syndrome (characterised by brief interruptions in breathing during sleep),
if the patient has severe muscle weakness (myasthenia),
if the patient has severe respiratory depression.

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 sedation, increasing the risk of falls and consequently the risk of hip fracture,
if the patient has impaired liver or kidney function,
if the patient has previously had breathing problems. During treatment with Zolpigen, breathing may become weaker,
if the patient has previously had a psychiatric disorder, anxiety or psychosis, as Zolpigen may unmask or worsen symptoms of these conditions,
if the patient currently has or has previously had depression (feeling of low mood),
if the patient currently has or has ever had a psychiatric disorder, tendency to alcohol or drug abuse. The risk of dependence on Zolpigen (physical or psychological symptoms caused by a compulsive need 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 problems

General - before administering the medicine, the doctor should 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 a few weeks the patient notices that the medicine is no longer as effective as at the beginning of treatment, the patient should consult a 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.
Withdrawal - the medicine should be discontinued gradually. After stopping the medicine, a transient withdrawal syndrome may occur, in which the symptoms requiring treatment with Zolpigen reappear 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, agitation, irritability, aggression, delusions (false beliefs), rage outbursts, nightmares, hallucinations (when the patient sees, hears or feels things that are not real), psychosis (when the patient loses contact with reality, is unable to 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. Alcohol and 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, the relationship between these events and zolpidem use has not been established.
Cardiac rhythm disorders (prolonged QT interval syndrome) - if the patient has a heart condition called QT prolongation, detectable by ECG, the doctor will consider whether this medicine is appropriate for the patient.
Next-day psychomotor impairment (see also "Driving and operating machinery") - the risk of next-day psychomotor impairment, including impaired ability to drive, may be increased if:
- the patient took the medicine less than 8 hours before activities requiring increased mental alertness;
- the patient took a dose higher than the recommended dose;
- the patient took zolpidem while being treated 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those purchased 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 with certain medicines, drowsiness and next-day psychomotor impairment, including impaired driving ability, may be intensified. These medicines include:

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

When zolpidem is taken with antidepressants such as bupropion, desipramine, fluoxetine, sertraline and venlafaxine, the patient may experience unreal sensations (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine, ciprofloxacin and St. John's wort (a herbal medicine used for mood swings and depression) is not recommended.
Risk associated with concomitant use with opioids
Concomitant use of Zolpigen and opioids (strong painkillers, medicines used in substitution therapy 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 other treatment options are not possible.
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. Contact the doctor if these symptoms occur.
The following medicines may increase the risk of adverse effects when used concomitantly 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 reduce the effect of Zolpigen:

rifampicin, an antibiotic used to treat infections.

Zolpigen and alcohol
Do not consume alcohol during treatment with 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 for urgent medical reasons the patient receives Zolpigen towards the end of pregnancy or during delivery, the newborn may experience hypothermia, muscle weakness, feeding difficulties, breathing problems and withdrawal symptoms due to physical dependence.
Some studies have shown an increased risk of cleft lip and palate (so-called "harelip") in newborns.
Use of zolpidem during the second and/or third trimester of pregnancy may reduce foetal movements and alter foetal 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 plans to become pregnant, she should consult a doctor before using this medicine.
Driving and operating machinery
Zolpigen has a major influence 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), it may happen that:

the patient feels drowsy, sleepy, dizzy or disoriented,
the patient needs more time to make quick decisions (impaired reflexes),
the patient may have blurred or double vision,
the patient may be less alert.

To minimise the risk of these events, it is recommended to allow 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 intensify the effects mentioned above.
Zolpigen contains monohydrate lactose
If the doctor has previously mentioned intolerance to certain sugars such as lactose, consult the doctor before starting treatment with this medicine.

3. How to use Zolpigen

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The medicine acts rapidly, so 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 uninterrupted sleep.
The tablet may be divided into equal doses.

Adults: The recommended dose of Zolpigen is 10 mg every 24 hours. Some patients may be prescribed a lower dose by their doctor. Zolpigen should be taken:

as a single dose,
immediately before bedtime.

The patient must allow at least an 8-hour interval between taking the medicine and engaging in activities requiring increased concentration.
Do not exceed the dose of 10 mg every 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. The 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 the patient notices that the medicine no longer works as well as it did at the beginning of treatment, they should contact their doctor, as a dose adjustment may be necessary.

Duration of treatment
The treatment period should be as short as possible. It usually lasts from a few days to 2 weeks.
The maximum duration of treatment, including the tapering-off period, is 4 weeks.
The 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 the patient (or anyone else) swallows a large number of tablets at once, or if there is suspicion that a child has swallowed any tablets, seek medical help immediately by contacting a doctor or going to the nearest hospital emergency department. Bring the medicine packaging and any remaining tablets with you. Do not travel alone to seek medical help. In cases of overdose, drowsiness may rapidly worsen, and large doses may lead to coma or even death.

Missed dose of Zolpigen
If the patient forgets to take the dose before going to bed but remembers in the middle of 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 at the usual time the following evening. This medicine must not be taken at any other 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 a pharmacist or doctor.

Stopping Zolpigen treatment
Zolpigen should be taken until the doctor advises stopping. Do not stop treatment suddenly. The patient should inform their doctor of their intention to discontinue the medicine. Treatment should be tapered off gradually; otherwise, the sleep disturbances for which the medicine was prescribed may return with greater intensity (rebound insomnia). Other symptoms may also occur, such as anxiety, restlessness, and mood changes. 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, including hypersensitivity to light, noise, and touch, abnormal auditory perception, 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 of the mind separating from the body), or seizures (convulsions or tremors). These symptoms may also occur between doses, especially when high doses are used.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Treatment should be discontinued and a doctor should be contacted or the nearest hospital emergency
department visited immediately 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, the doctor should be informed 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 lower.
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 (jaundice)
falls (especially in elderly patients).

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

psychological dependence: the patient feels unable to sleep without taking Zolpiden
breathing difficulties.

Frequency unknown (frequency cannot be estimated from available data):

physical dependence: use (even at therapeutic doses) may lead to physical dependence; abrupt discontinuation of treatment may result in withdrawal symptoms and recurrence of problems
loss of touch with reality (psychosis).

These adverse effects are serious and may require medical attention.
If any of the following adverse effects occur or worsen, inform your doctor or pharmacist:
Common (may occur in less than 1 in 10 people):

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

Uncommon (may occur in less than 1 in 100 people):

irritability, confusion, anxiety, aggression
muscle weakness
tremor
sleepwalking
unnatural state of euphoria and self-confidence (euphoric mood)
attention disturbances
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, psychosis, inappropriate behaviour and other undesirable behavioural changes). Elderly patients are more susceptible to such reactions
decreased libido
urticaria (hives).

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

false beliefs (delusions).

Frequency unknown (frequency cannot be estimated from available data):

blurred vision
loss of appetite
anger
behavioural disturbances.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Zolpigen

Keep the medicine 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. This will help 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 ingredients are: lactose monohydrate (see section 2 "Zolpigen contains lactose monohydrate"), microcrystalline cellulose, pregelatinized starch, corn starch, magnesium stearate.
Tablet coating Opadry YS-1R-7003: titanium dioxide (E 171), hypromellose 3 cP, hypromellose 5 cP, 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, film-coated tablets, marked on one side with "ZM" with a central break line and "10", and on the other side with "G".
The tablet can be divided into equal doses.
Packaging contains 10 or 20 film-coated tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands

Manufacturers:
Mylan B.V.
Krijgsman 20
1186 DM Amstelveen, The 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

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

Marketing Authorisation Number in the Netherlands, country of export: RVG 28486
Parallel Import Authorisation Number: 317/16

This medicinal product is authorised 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