Apozolpin

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ApoZolpin (Zolpidem tartrate Aurobindo)

10 mg, coated tablets
Zolpidem tartrate
ApoZolpin and Zolpidem tartrate Aurobindo are different trade names for the same medicine.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any further doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed for 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 any of the side effects worsen or if any side effects not mentioned in the leaflet occur, the patient should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is ApoZolpin and what is it used for
• 2. Important information before taking ApoZolpin
• 3. How to take ApoZolpin
• 4. Possible side effects
• 5. How to store ApoZolpin
• 6. Package contents and other information

1. What is ApoZolpin and what is it used for

Zolpidem belongs to a group of medicines called benzodiazepine-like medicines.
ApoZolpin is a sleeping pill that, by affecting the brain, causes drowsiness. It is used for the short-term treatment of insomnia in adults, only when the disorder is severe, disrupts normal functioning, or causes extreme suffering in the patient.

2. Important information before taking ApoZolpin

Do not take ApoZolpin:

• if the patient is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6);
• if allergic reactions 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 (the patient stops breathing for a very short time during sleep);
• if the patient has muscle weakness (myasthenia gravis);
• if the patient has acute and severe respiratory disorders;
• if the patient is under 18 years of age.

Warnings and precautions

Before starting ApoZolpin, the patient should discuss it with their doctor or pharmacist if:

• the patient is elderly or has a tendency to fractures. If the patient gets up at night, they should be very careful. ApoZolpin may cause decreased muscle tone. This and the sedative effect increase the risk of falls and, consequently, fractures;
• the patient has any kidney or liver function disorders;
• the patient has a history of respiratory disorders. During ApoZolpin treatment, breathing may become shallower;
• the patient has a history of mental illnesses, anxiety, or psychotic disorders. Zolpidem may reveal or worsen symptoms of the disease;
• the patient has symptoms of depression or has had depression in the past;
• the patient has or has had a tendency to abuse alcohol or drugs. In these patients, there is an increased risk of dependence on ApoZolpin (physical or psychological compulsion to take the medicine) and it increases with the dose and duration of treatment;
• the risk of suicide and suicide attempts may be increased in patients treated with benzodiazepines or sleeping pills, including zolpidem. If the patient has thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately;
• in patients with long QT syndrome (a heart conduction disorder, a type of arrhythmia).

Before taking this medicine

• the cause of sleep disorders should be explained,
• underlying diseases should be treated.

If the treatment of sleep disorders is not effective after 7-14 days, it may indicate a mental or physical illness that needs to be examined.
Zolpidem should not be taken by patients with severe liver function disorders, as liver failure may cause the accumulation of toxic substances in the body, leading to brain function disorders (encephalopathy).

Children and adolescents

ApoZolpin should not be taken by children and adolescents under 18 years of age.

Other notes

• Tolerance (habituation) - if the patient notices that the medicine is not working as effectively as when they started therapy, they should contact their doctor.
• Dependence - when taking this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. The increased risk occurs in patients who have had mental disorders, drug addiction, alcohol abuse, or drug dependence in the past. However, dependence can also occur at doses usually used in treatment or if no risk factors are present, such as alcohol or drug abuse in the past.
• Withdrawal - treatment should be discontinued gradually. As a result of stopping therapy, a transient syndrome may occur, with a recurrence of symptoms more severe than those that were the reason for taking ApoZolpin. This may be accompanied by other symptoms, such as mood changes, anxiety, and restlessness. These symptoms will subside over time.
• Amnesia - ApoZolpin may cause amnesia. To reduce the risk of amnesia, the patient should ensure they have 8 hours of uninterrupted sleep.
• Psychological reactions and "paradoxical" - ApoZolpin may cause undesirable behaviors such as anxiety, agitation, irritability, aggression, delusions (false beliefs), anger, nightmares, hallucinations, psychosis (hallucinations; the patient sees, hears, or feels things that do not exist), inappropriate behavior, and increased insomnia.
• Sleepwalking and other related behaviors - ApoZolpin may cause people to do things while sleeping that they do not remember when they wake up. This includes sleepwalking, driving while asleep, preparing and eating food, making phone calls, or having sex. Alcohol and some medicines used to treat depression, anxiety, or taking ApoZolpin in doses exceeding the maximum recommended dose may increase the risk of these side effects.
• Risk and benefits associated with zolpidem should be carefully considered if the patient has long QT syndrome (a heart conduction disorder, a type of arrhythmia).

Similarly to other sleeping pills and/or sedatives, zolpidem has a depressive effect on the central nervous system. Psychomotor disorders occurring the next day (see also "Driving and operating machinery") - the next day after taking ApoZolpin, the risk of psychomotor disorders, including impaired driving ability, may be increased if:

• the medicine is taken for less than 8 hours before performing activities that require increased alertness;
• a higher dose than recommended is taken;
• zolpidem is taken while using other medicines that act on the central nervous system or other medicines that increase the concentration of zolpidem in the blood or while drinking alcohol or taking illegal substances. Zolpidem may cause drowsiness and reduced awareness, leading to falls and potentially serious injuries.

The prescribed dose of the medicine should be taken directly before bedtime. Do not take another dose during the same night.

ApoZolpin 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.
ApoZolpin may affect the action of other medicines and/or increase the risk of side effects.

• Rifampicin, a medicine used to treat tuberculosis, may reduce the effect of ApoZolpin.

When zolpidem is taken with some of the following medicines, drowsiness and psychomotor disorders the next day, including impaired driving ability, may be increased:

• Medicines used to treat certain mental disorders (antipsychotic medicines).
• Medicines used to treat sleep disorders (sleeping pills).
• Sedatives or anxiolytics.
• Medicines used to treat depression, including St. John's Wort (a herbal medicine used to treat depression).
• Medicines used to treat moderate to severe pain (narcotic analgesics), such as codeine, morphine. The feeling of euphoria may increase, which in turn increases the chance of physical or psychological dependence.
• Medicines used to treat epilepsy, such as phenytoin and carbamazepine.
• Medicines used for anesthesia. If the patient is to have surgery under general anesthesia, they should tell their doctor what medicines they are taking.
• Medicines used to treat hay fever, rash, or other allergies, may cause drowsiness in the patient (sedating antihistamines).
• Muscle relaxants; the muscle relaxant effect may increase the risk of falls, especially in elderly patients.
• Medicines that inhibit liver enzymes. The patient should ask their doctor or pharmacist which medicines have this effect (e.g., ketoconazole, a medicine used to treat fungal infections).
• Grapefruit juice may also inhibit the activity of liver enzymes.

No significant interactions have been observed when zolpidem is administered in combination with warfarin (to reduce blood clotting), digoxin (in the treatment of heart failure), or ranitidine (in case of stomach problems).
Concomitant use of ApoZolpin and opioids (strong painkillers, drugs used in substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor has prescribed ApoZolpin together with opioids, they should limit the dose and duration of concomitant treatment.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow their doctor's instructions. It may be helpful to inform friends or relatives so that they are aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.
When zolpidem is taken with antidepressant medicines, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not there (visual hallucinations).
It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

ApoZolpin with food, drink, and alcohol

Alcohol should not be consumed while taking ApoZolpin, as it may increase the sedative effect of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Taking zolpidem during pregnancy may be harmful to the fetus.
In some studies, an increased risk of cleft lip and palate ("harelip") has been observed.
After administration of zolpidem in the second and/or third trimester of pregnancy, decreased fetal movement and changes in fetal heart rate may occur.
ApoZolpin should not be taken during pregnancy, especially during the first three months of pregnancy. If, for important medical reasons, ApoZolpin is taken in late pregnancy or during childbirth, the baby may experience: low body temperature, floppy baby syndrome, difficulty breastfeeding, breathing problems, and may exhibit withdrawal symptoms, such as restlessness, shaking after birth due to physical dependence. In such cases, newborns must be closely monitored in the postpartum period.
Breastfeeding should not be done while taking the medicine, as zolpidem passes into human milk in small amounts.

Driving and operating machinery

ApoZolpin has a major impact on the ability to drive and operate machinery, such as "falling asleep at the wheel". The patient should be aware that the next day after taking ApoZolpin (like other sleeping pills):

• they may feel drowsy, sleepy, dizzy, or disoriented,
• they may need more time to make quick decisions,
• they may see double or blurred vision,
• they may be less alert.

To minimize the risk of the above events, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, and working at heights.
Alcohol or psychoactive substances should not be consumed while taking ApoZolpin, as this may increase the above effects.

ApoZolpin contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

ApoZolpin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 10 mg tablet, which means the medicine is considered "sodium-free".

3. How to take ApoZolpin

The medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
ApoZolpin is taken orally.
Since ApoZolpin acts very quickly, it should be taken directly before bedtime or while lying down.

Adults

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

• in a single dose,
• directly before bedtime. The patient must maintain a period of at least 8 hours between taking the medicine and starting activities that require increased alertness. Do not exceed the dose of 10 mg per 24 hours.

Elderly patients (over 65 years) or weakened patients

The usual dose is 5 mg. The prescribed dose should not be exceeded.

Patients with liver function disorders

The usual initial dose is 5 mg. The doctor may decide to increase the dose to 10 mg if it is safe. ApoZolpin should not be taken in case of severe liver function disorders. Special caution should be exercised in elderly patients with liver function disorders.
Patients with a history of respiratory disorders(chronic respiratory failure)
A lower dose is recommended.

Use in children and adolescents

ApoZolpin is not intended for persons under 18 years of age.

Duration of treatment

The treatment period should be as short as possible. It usually ranges from a few days to two weeks.
The maximum treatment period, including gradual discontinuation, is four weeks.
The doctor will determine the appropriate treatment period for the patient, according to their individual needs. In some cases, it may be necessary to take ApoZolpin for longer than 4 weeks.

Taking a higher dose of ApoZolpin than recommended

If the patient (or someone else) has taken a large number of tablets at once, or if it is suspected that a child has swallowed a tablet of the medicine, they should immediately contact the nearest hospital emergency department or doctor. They should take the medicine packaging and any remaining tablets with them. They should go there accompanied by another person. If an overdose has occurred, the patient may become very sleepy, which can lead to coma or even death after large doses of the medicine. If zolpidem is taken with other medicines that act on the central nervous system (including alcohol), it may have serious consequences, which can also be fatal. In moderate cases, symptoms include: drowsiness, confusion, and fatigue (drowsiness). In severe cases, symptoms may include: lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, and more severe symptoms, including death.

Missing a dose of ApoZolpin

If the patient does not take a dose of the medicine directly before bedtime, but remembers during the night, they may take the missed dose of the medicine only if they still have 8 hours of uninterrupted sleep ahead. If this is not possible, they should take the next dose of the medicine before bedtime the following night. They should not take a double dose to make up for the missed dose.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

Stopping ApoZolpin treatment

Treatment should be discontinued gradually, as the symptoms for which the patient was being treated may return more severely than before (rebound insomnia). It may also cause anxiety, restlessness, and mood changes. These symptoms will subside over time.
If the patient becomes physically dependent on ApoZolpin, sudden discontinuation of treatment will lead to the occurrence of side effects, such as headaches, muscle pain, anxiety, tension, restlessness, confusion, and drowsiness. In severe cases, other symptoms may occur, such as hypersensitivity to light, noise, and touch, a feeling that sounds are louder than usual, and painful hypersensitivity to acoustic stimuli, hallucinations, numbness, and tingling in the limbs, loss of sense of reality (feeling that the surroundings are unreal), depersonalization (feeling of loss of one's own identity), or seizures (sudden, convulsive movements or shaking). Such symptoms may also occur between doses, especially if the dose is high.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoZolpin can cause side effects, although not everybody gets them.
The side effects of zolpidem, especially with regard to some effects on the central nervous system, depend on the dose and are less severe if the medicine is taken directly before bedtime or going to sleep. These side effects are more likely to occur in elderly patients.
If any of the following symptoms occur, the patient should stop taking ApoZolpin and immediately contact their doctor or go to the nearest hospital emergency department:

• allergic reactions, such as rash or itching of the skin, accompanied by swelling of the face, lips, throat, or tongue, and difficulty breathing or swallowing (angioedema).

These side effects are severe, but their frequency is not known (it cannot be estimated from the available data). The patient needs medical attention.
The patient should tell their doctor or pharmacist if they experience or worsen any of the following side effects:
Common(may occur in up to 1 in 10 people):

• infections of the upper or lower respiratory tract;
• hallucinations, agitation, nightmares;
• drowsiness, headaches, dizziness, increased insomnia, amnesia (which may be related to inappropriate behavior);

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

• itching or tingling without reason (paresthesia);
• joint pain, muscle pain, muscle cramps, and neck pain;
• involuntary trembling (tremor);
• speech disorders;
• concentration disorders;
• appetite disorders;
• blurred vision;
• skin rash, itching;
• excessive sweating;
• double vision;
• euphoric mood;
• muscle weakness;
• confusion (disorientation), irritability;
• worsening insomnia;
• coordination disorders;
• increased activity of some liver enzymes (which will be detected by the doctor during a blood test).

Rare(may occur in up to 1 in 1,000 people):

• decreased or increased libido;
• liver damage (hepatocellular, cholestatic, or mixed);
• decreased level of consciousness;
• impaired vision;
• hives;
• changes in gait;
• falls, especially in elderly patients;
• paradoxical reactions (anxiety, agitation, irritability, aggression, delusions (false beliefs), anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other undesirable changes in behavior). These are more likely to occur in elderly patients.

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

• delusions (false beliefs);
• physical dependence: taking (even at therapeutic doses) may lead to physical dependence, and sudden discontinuation of treatment may cause withdrawal symptoms and a recurrence of problems;
• psychological dependence: this occurs when the patient thinks they cannot sleep without taking ApoZolpin.

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

• various types of liver damage;
• breathing difficulties;
• restlessness, aggression, rage, psychosis (hallucinations, when the patient sees, hears, or feels things that do not exist), inappropriate behavior;
• depression (feeling of sadness);
• sleepwalking;
• need to take increasingly larger doses of the medicine to achieve the same effect.

Reporting side effects

If any 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, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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, more information can be gathered on the safety of the medicine.

5. How to store ApoZolpin

The medicine should be stored in a place that is out of sight and reach of 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 month stated.
There are no special precautions for storage.
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. Package contents and other information

What ApoZolpin contains

• The active substance of the medicine is zolpidem tartrate. Each coated tablet of the medicine contains 10 mg of the active substance.
• The other ingredients of the medicine are: Tablet core: lactose monohydrate, microcrystalline cellulose (PH-101), sodium carboxymethylcellulose (type A), magnesium stearate. Coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What ApoZolpin looks like and what the package contains

Coated tablet.
White or almost white, oval, biconvex coated tablets, with the inscription "E" on one side and the inscription "80" with a dividing line between "8" and "0" on the other side. The tablet can be divided into equal doses.
ApoZolpin is available in blisters: 10, 20, 30, 50, 60, or 100 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

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

Aurobindo Pharma B.V., Baarnsche Dijk 1, 3741 LN Baarn, Netherlands

Manufacturer:

APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, BBG 3000, Birzebbugia, Malta
Generis Farmaceutica, S.A., Rua Joao de Deus, n° 19, 2700-487, Venda Nova, Amadora, Portugal

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 121165

Parallel import authorization number: 107/24

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

Czech Republic: Zolpidem Aurovitas
Germany: Zolpidem PUREN 10 mg Filmtabletten
Poland: ApoZolpin
Spain: Zolpidem Aurovitas 10 mg comprimidos recubiertos con película EFG
Netherlands: Zolpidemtartraat Aurobindo 10 mg, filmomhulde tabletten

Date of leaflet approval: 13.03.2024

[Information about the trademark]