PACKAGE LEAFLET: INFORMATION FOR THE USER

ZOLPIDEM DOC Generici 10 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because
it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people,
even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

What ZOLPIDEM DOC Generici is and what it is used for
What you need to know before taking ZOLPIDEM DOC Generici
How to take ZOLPIDEM DOC Generici
Possible side effects
How to store ZOLPIDEM DOC Generici
Contents of the pack and other information

1. WHAT ZOLPIDEM DOC Generici IS AND WHAT IT IS USED FOR

ZOLPIDEM DOC Generici is a hypnotic medicine belonging to the group of drugs known as
benzodiazepine-like agents. It is used for the short-term treatment of sleep disorders in adults.
ZOLPIDEM DOC Generici is indicated only in cases of severe, disabling insomnia or insomnia causing marked distress.
Do not use for long-term treatments. The duration of treatment should be as short as possible, since the risk of dependence increases with longer treatment duration.
However, not all sleep disorders require treatment with medication. Sleep disorders secondary to a physical or mental illness may be managed by specifically addressing the underlying condition.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ZOLPIDEM DOC Generici

Do not take ZOLPIDEM DOC Generici

If you are allergic to zolpidem or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from severe muscle weakness ( myasthenia gravis ).
If your breathing stops for short periods during sleep ( sleep apnoea syndrome ).
If you suffer from severe respiratory insufficiency (in which the lungs cannot take in enough oxygen) ( respiratory failure ).
If you have severe liver damage ( hepatic failure ).
Children and adolescents under 18 years of age must not take zolpidem.
As a long-term treatment. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.
If after taking ZOLPIDEM DOC Generici or other medicines containing zolpidem you have ever experienced sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls, or having sexual intercourse, etc.) while not fully awake.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZOLPIDEM DOC Generici.

If you are elderly or debilitated . You should take a reduced dose (see section 3 How to take ZOLPIDEM DOC Generici). Zolpidem has a muscle-relaxant effect; therefore, especially in elderly patients who get up during the night, there is a risk of falls and consequent hip fractures.
If you have reduced kidney function . Your body may take longer to eliminate zolpidem. Although dose adjustment is not required, caution is nevertheless necessary. Contact your doctor.
If you suffer from chronic respiratory problems (long-lasting). Your condition may worsen.
If you have a history of alcohol or drug abuse . You must be closely monitored by your doctor during treatment with zolpidem, as you are at risk of tolerance and psychological dependence.
If you suffer from severe liver disease . You must not take zolpidem, as you risk brain damage (encephalopathy). Contact your doctor.
If you suffer from delirium (psychosis), depression or anxiety associated with depression. Zolpidem must not be the only medicine you take.

Next-day psychomotor impairment (see also Driving and use of machines)
The day after taking ZOLPIDEM DOC Generici, the risk of
psychomotor impairment, including impaired ability to drive, may
increase if:

you take this medicine less than 8 hours before performing activities requiring mental alertness
you take a higher dose than recommended
you take zolpidem while already taking other medicines with central nervous system depressant effects or other medicines that increase zolpidem levels in the blood, or while drinking alcohol, or while taking illicit substances. Take the single dose just before going to bed. Do not take another dose during the same night.

In general
Before taking zolpidem:

the cause of insomnia should be clarified.
any underlying diseases causing your symptoms should be treated.

Lack of success in treating insomnia after 7–14 days may indicate the presence of a psychiatric or physical disorder, which should be evaluated. Contact your doctor.
Tolerance
Repeated use of hypnotics for a few weeks may lead to loss of effectiveness (tolerance).
Dependence
Physical and psychological dependence may develop.
The risk of dependence increases with dose and duration of treatment and is greater when zolpidem is used for more than 4 weeks. The risk of abuse and dependence is higher in patients with a history of mental illness and/or alcohol, drug, or medicine abuse. Inform your doctor if you have or have ever had a mental illness or if you abuse or have abused alcohol, drugs, or medicines, or if you are or have been dependent on them.
Withdrawal
If physical dependence has developed, abruptly stopping treatment will be accompanied by withdrawal symptoms such as headache, muscle pain, anxiety and unusual tension, restlessness, confusion, and irritability. In severe cases, loss of reality, personality disturbances, hearing problems (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures may occur. Therefore, it is recommended to discontinue treatment gradually by tapering the dose. Zolpidem may cause withdrawal symptoms even between doses.
Rebound insomnia
When treatment is stopped, temporary withdrawal symptoms may occur and the symptoms that led to treatment with ZOLPIDEM DOC Generici may reappear in an intensified form. Associated reactions include mood changes, anxiety, and restlessness. Since the risk of withdrawal or discontinuation symptoms is greater after abrupt interruption of treatment, it is recommended to stop treatment gradually by reducing the dose.
When ZOLPIDEM DOC Generici is taken according to the recommended dose, duration of use, precautions, and warnings, the occurrence of withdrawal or discontinuation symptoms at the end of treatment is minimal.
Depression
Like other hypnotic or tranquilizing medicines, ZOLPIDEM DOC Generici should be used with caution in patients with symptoms of depression or anxiety associated with depression. In some circumstances, depressive symptoms may worsen if the underlying condition is not adequately treated with appropriate medicines (antidepressants). This may increase the risk of suicide in these patients. A previously unrecognized depression may emerge during treatment with ZOLPIDEM DOC Generici. Some studies show an increased incidence of suicide or attempted suicide in patients taking certain hypnotics or sedatives, including ZOLPIDEM DOC Generici.
However, it has not been established whether this is due to the treatment with the medicine or whether other causes may be involved.
Inform your doctor immediately if you have suicidal thoughts (thoughts of harming yourself or killing yourself) or suicidal behaviour.
Memory impairment (amnesia)
Zolpidem may cause memory loss (amnesia). This usually occurs several hours after taking zolpidem. To reduce the risk, ensure you can have 8 hours of uninterrupted sleep (see section 4 Possible side effects).
Psychiatric reactions and “paradoxical” effects
It is known that during treatment, restlessness, agitation, irritability, aggression, delirium (psychosis), rage, nightmares, hallucinations, sleepwalking, inappropriate behaviour, worsening of insomnia, and other behavioural side effects may occur.
If this occurs, you must stop taking ZOLPIDEM DOC Generici and contact your doctor.
These reactions are more likely to occur in elderly patients.
Sleepwalking and other associated behaviours such as “sleep-driving”, preparing and eating food, making phone calls, or having sexual intercourse, without memory of the event, have been reported in patients who had taken zolpidem and were not fully awake.
The risk of such behaviours may increase if you take ZOLPIDEM DOC Generici with alcohol or other medicines that slow down the central nervous system, or if you exceed the maximum recommended dose. If you experience any of these behaviours, inform your doctor immediately. Your doctor may advise you to stop treatment.
The use of zolpidem has been associated with an increased risk of falls. Falls may be caused by side effects such as coordination problems, muscle weakness, dizziness, drowsiness, and fatigue. The risk of falls is higher in elderly patients and when a higher than recommended dose is used.
Impaired respiratory and liver function
Patients with chronically impaired respiratory function or liver function disorders should be treated with caution, and your doctor may prescribe a lower dose of ZOLPIDEM DOC Generici (see also section 3).
Cardiac conduction disorders
Patients with certain congenital cardiac conduction disorders (long QT syndrome) should be treated with caution. Your doctor will carefully evaluate the benefits versus risks before starting treatment with ZOLPIDEM DOC Generici.
Children and adolescents
Children and adolescents under 18 years of age must not take ZOLPIDEM DOC Generici.
Other medicines and ZOLPIDEM DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may be affected by zolpidem and, in turn, may influence the effect of zolpidem.
Your insomnia may worsen if you take zolpidem together with the following medicines.
When taking zolpidem with the following medicines, there may be an increased risk of effects such as drowsiness and next-day psychomotor impairment, including impaired ability to drive.

Medicines for the treatment of mental illnesses (lithium, neuroleptics/antipsychotics, e.g. chlorpromazine or clozapine)
Medicines for treating depression ( antidepressants , e.g. amitriptyline, sertraline, and clomipramide)
Products containing St. John’s Wort (a herbal remedy used in the treatment of depression and anxiety)
Medicines for sleep problems (hypnotics, e.g. nitrazepam and temazepam)
Medicines to calm or reduce anxiety (tranquillisers, anxiolytics, sedatives, muscle relaxants), e.g. diazepam and oxazepam
Medicines for moderate to severe pain (narcotic analgesics), e.g. codeine and morphine. An increased feeling of well-being (euphoria) may occur, which could lead to increased psychological dependence
Muscle relaxants such as baclofen
Medicines for epilepsy (antiepileptics), e.g. phenytoin, valproic acid, carbamazepine, and phenobarbital
Medicines used for anaesthesia (e.g. halothane or isoflurane)
Medicines for hay fever, skin rashes, other allergies, or the common cold that cause drowsiness (sedating antihistamines), e.g. chlorphenamine
Medicines for treating various fungal infections such as itraconazole and ketoconazole. Taking ketoconazole with ZOLPIDEM DOC Generici may increase the sedative effect
Clarithromycin and erythromycin
Ritonavir (an antiretroviral medicine used to treat HIV and AIDS)

While taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.
Medicines that strongly increase the activity of certain liver enzymes may reduce the effects of zolpidem, e.g. rifampicin (an antibacterial used, for example, in the treatment of tuberculosis).
Medicines that increase the activity of certain liver enzymes (particularly the CYP3A4 isoenzyme of cytochrome P450) may weaken the effect of ZOLPIDEM DOC Generici (e.g. rifampicin, carbamazepine, phenytoin, St. John’s Wort). Concomitant use of zolpidem with St. John’s Wort is not recommended.
Concomitant use of ZOLPIDEM DOC Generici and opioids (strong painkillers, medicines for addiction therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes ZOLPIDEM DOC Generici together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
ZOLPIDEM DOC Generici with food, drinks, and alcohol
Do not drink any alcohol during treatment, as it may increase the sedative effect of zolpidem.
This affects your ability to drive and use machinery.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your pharmacist before taking this medicine.
Zolpidem must not be taken during pregnancy or breastfeeding, especially during the first trimester of pregnancy, as there are insufficient data to establish the safety of zolpidem during pregnancy and breastfeeding.
If used during pregnancy, there is a risk that the baby may be affected. Some studies have shown an increased risk of cleft lip and palate (also known as “hare lip”) in the newborn. After taking ZOLPIDEM DOC Generici during the second and/or third trimester of pregnancy, reduced fetal movement and variability in heart rate may occur. If ZOLPIDEM DOC Generici is taken at the end of pregnancy or during labour, your baby may experience muscle weakness, lowered body temperature, feeding difficulties, and breathing problems (respiratory depression). If this medicine is taken regularly in the late stages of pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn must be closely monitored during the postnatal period.
Since zolpidem passes into breast milk in small amounts, it must not be taken during breastfeeding.
Driving and use of machines
Do not drive or operate tools or machinery. Your ability to concentrate and react may be reduced during treatment with zolpidem. You may feel drowsy or have difficulty remembering things. This is more likely if you have slept too little.
ZOLPIDEM DOC Generici impairs your ability to drive vehicles and use machinery, for example, with the risk of “falling asleep at the wheel”.
The day after taking ZOLPIDEM DOC Generici (as with other hypnotic medicines), you should be aware that:

you may feel drowsy, sleepy, dizzy, or confused
you may take longer to make decisions
your vision may be blurred or double
you may feel less alert

An interval of at least 8 hours is recommended between taking zolpidem and driving, operating machinery, or working at heights, to minimize the previously listed effects.
Do not drink alcohol or take other psychoactive substances while taking ZOLPIDEM DOC Generici, as the effects listed above may be intensified.
ZOLPIDEM DOC Generici contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE ZOLPIDEM DOC Generici

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
The recommended dose every 24 hours is 10 mg of ZOLPIDEM DOC Generici. A lower dose may be prescribed for certain patients. ZOLPIDEM DOC Generici should be taken:

as a single dose
immediately before going to bed. Make sure you have at least 8 hours available after taking this medicine before engaging in any activities requiring full alertness.

The product should be taken with liquid just before going to sleep. Ensure you are able to sleep uninterrupted for 8 hours.
Elderly patients, debilitated patients, or patients with hepatic impairment
At the beginning of treatment, a reduced daily dose of 5 mg (half a 10 mg tablet) is recommended. Your doctor may increase your dose to 10 mg if the effect is insufficient and the medicine is well tolerated.
Maximum dose
The daily dose of 10 mg must not be exceeded.
Children and adolescents
ZOLPIDEM DOC Generici must not be used in children and adolescents under 18 years of age due to lack of data supporting its use in this patient group.
Duration of treatment
After repeated administration over several weeks, the sleep-promoting effect (hypnotic action) may diminish.
Treatment duration should be as short as possible. It may range from a few days to two weeks and should in any case not exceed four weeks.
In certain situations, longer-term use of ZOLPIDEM DOC Generici may be required.
Your doctor will inform you when and how to discontinue treatment.
If you take more ZOLPIDEM DOC Generici than you should
Contact your doctor immediately. Take this leaflet and any remaining tablets with you.
In cases of overdose with zolpidem, taken alone or in combination with other medicines that depress the Central Nervous System (including alcohol), the following symptoms have been reported:

decreased level of consciousness up to coma
severe disturbances that may lead to death

Consult your doctor in case of excessive dosing. In case of massive ingestion, treatment must be carried out in a hospital setting. If poisoning is recent, gastric lavage may be performed. An antidote exists—specifically flumazenil—which must be used with caution.

If you forget to take ZOLPIDEM DOC Generici
Do not take a double dose to make up for the missed dose. Take one tablet only if you are able to sleep for 8 hours; if this is not possible, do not take the tablet until you go to sleep the following night.
If you stop taking ZOLPIDEM DOC Generici
Do not stop treatment with this medicine abruptly. Since the risk of withdrawal symptoms is higher when treatment is stopped suddenly, your doctor will advise you to gradually reduce the dose before completely stopping treatment.
If treatment is stopped abruptly, a temporary worsening of your sleep (rebound phenomena) may occur. This may be accompanied by mood changes, anxiety, and restlessness.
It may also be associated with other reactions including mood changes, anxiety, and restlessness.
Withdrawal symptoms may include headache or muscle pain, extreme anxiety and nervous tension, restlessness, confusion, irritability, and sleep disturbances. In severe cases, there may be loss of perception of reality (derealization), clouding of self-awareness (depersonalization), abnormal sensitivity to sound (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or seizures (epileptic fits).
It is important that you are aware of the possible occurrence of these symptoms in order to minimize anxiety.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
These adverse effects appear to be related to individual sensitivity and seem to occur more frequently in the hours following administration if you do not go to bed or do not fall asleep immediately.
These adverse effects occur more frequently in elderly patients.

The adverse effects are:
Common: may affect up to 1 in 10 people

seeing or hearing non-existent things (hallucinations),
agitation,
nightmares,
daytime drowsiness,
emotional blunting,
reduced alertness,
fatigue,
headache,
dizziness,
difficulty remembering things, which may be associated with inappropriate behavior, ataxia (loss of muscular coordination),
worsening of insomnia,
sensation of spinning with loss of balance (vertigo),
diarrhea,
malaise,
vomiting,
stomach ache,
fatigue,
upper and lower respiratory tract infections,
back pain,
reduced ability to see (visual impairment)

Uncommon: may affect up to 1 in 100 people

confusion, irritability, double vision, blurred vision, appetite disturbances, sleepwalking or other inappropriate behaviors during sleep, such as driving, eating, making phone calls, or having sexual intercourse while not fully awake (see section “Warnings and precautions”),
euphoric mood,
sensory disturbances such as tingling or numbness (paraesthesia),
tremors,
attention deficit,
speech disorders,
joint pain,
muscle pain,
muscle cramps,
neck pain

Rare: may affect up to 1 in 1,000 people

clouding of consciousness,
liver damage (hepatocellular, cholestatic, or mixed) (see also section 2 “What you need to know before taking ZOLPIDEM DOC Generici” and section 3).

Very rare: may affect up to 1 in 10,000 people

impaired breathing (respiratory depression)

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

restlessness,
aggression,
illusions, anger, mental disorders (psychosis),
sleepwalking, inappropriate behavior, and other adverse events of behavioral type,
memory loss (amnesia), which may be associated with inappropriate behavior (see section 2). These reactions are more frequent in the elderly.
Pre-existing depression may be unmasked during treatment with ZOLPIDEM DOC Generici or other hypnotics.
Long-term use of ZOLPIDEM DOC Generici may lead to physical or psychological dependence. If you abruptly stop taking ZOLPIDEM DOC Generici, you may experience withdrawal symptoms (see section 2). Cases of misuse have been reported in individuals with a history of drug abuse.
Reduced sexual desire (libido),
skin rash, urticaria, itching, excessive sweating,
muscle weakness,
abnormal walking posture (gait disturbance), drug tolerance, falls (mainly in elderly patients and when zolpidem tartrate is not taken as prescribed),
increased liver enzymes,
sudden swelling of lips, neck, eyes, tongue, or throat.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ZOLPIDEM DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle,
and blister after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What ZOLPIDEM DOC Generici contains

The active substance is zolpidem tartrate 10 mg.
The other components are: microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium stearate (E470b), hypromellose (E464), hydroxypropyl cellulose (E463), polyethylene glycol 8000 and titanium dioxide (E171).

Description of the appearance of ZOLPIDEM DOC Generici and the pack contents
ZOLPIDEM DOC Generici
The ZOLPIDEM DOC Generici film-coated tablet is white and oval-shaped. The tablet has a break line on one side, with the刻ings “1” and “0” on the left and right side of the break line, respectively. On the other side of the tablet, the刻ing “APO” appears. The tablet can be divided into two equal parts.
ZOLPIDEM DOC Generici is available in:

Carton boxes containing 7, 10, 20, 28, 30 or 50 tablets in blisters (PVC/Aluminum)
HDPE bottles with polypropylene screw cap and LDPE liner containing 30 or 100 tablets. The bottle containing 100 tablets is intended exclusively for hospital use and its sale to the public is prohibited.

Not all pack sizes may be marketed.
Marketing Authorization Holder:
DOC Generici Srl, Via Turati 40, 20121 Milan, Italy
Responsible producer for batch release:
Lamp San Prospero S.p.A.
Via della Pace 25/A
41030 San Prospero S/S Modena
Italy
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000,
Malta
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
BE: Zolpitop 10 mg film-coated tablets
IT: ZOLPIDEM DOC Generici 10 mg film-coated tablets
LUX: Zolpitop 5 mg / 10 mg film-coated tablets
NL: Zolpidemtartraat Auro 5 mg & 10 mg, filmomhulde tabletten
CZ: Apo-Zolpidem
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Zolpidem Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER