APOZOLPIN 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. ApoZolpin, 10 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is ApoZolpin and what is it used for
4. Important information before taking ApoZolpin
   1. Do not take ApoZolpin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Other notes
   5. ApoZolpin and other medicines
   6. ApoZolpin with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and operating machinery
   9. ApoZolpin contains lactose
   10. ApoZolpin contains sodium
5. How to take ApoZolpin
   1. Adults
   2. Elderly patients (over 65 years old) or weakened patients
   3. Patients with liver function disorders
   4. Use in children and adolescents
   5. Duration of treatment
   6. Taking a higher dose of ApoZolpin than recommended
   7. Missing a dose of ApoZolpin
   8. Stopping ApoZolpin treatment
6. Possible side effects
   1. Reporting side effects
7. How to store ApoZolpin
8. Package contents and other information
   1. What ApoZolpin contains
   2. What ApoZolpin looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. APL Swift Services (Malta) Limited
   7. Generis Farmaceutica, S.A.
   8. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   9. Date of last revision of the leaflet: 07/2022

Leaflet attached to the packaging: patient information

ApoZolpin, 10 mg, coated tablets

Zolpidem tartrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, tell your doctor or pharmacist.

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 sleepiness. 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 you are 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 you have severe liver function disorders;
• if you have sleep apnea syndrome (you stop breathing for a very short time during sleep);
• if you have muscle weakness (myasthenia gravis);
• if you have acute and severe respiratory disorders;
• if you are under 18 years old.

Warnings and precautions

Before starting ApoZolpin, discuss with your doctor or pharmacist if:

• you are an elderly person or have a tendency to bone fractures. If you get up at night, you should be very careful. ApoZolpin may cause decreased muscle tone. This and the sedative effect increase the risk of falls and, consequently, hip fractures;
• you have any kidney or liver function disorders;
• you have had breathing disorders in the past. While taking ApoZolpin, breathing may become shallower;
• you have had mental illnesses, anxiety, or psychotic disorders in the past. Zolpidem may reveal or worsen symptoms of the disease;
• you have symptoms of depression or have had depression in the past;
• you have or have 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 you have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately;
• if you have a 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 old.

Other notes

• Tolerance (habituation) - if after a few weeks of treatment 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 normally 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, which involves the return of symptoms that were more severe than those that led to the use of ApoZolpin. These symptoms 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, ensure that the patient has 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 other undesirable changes in behavior. These are more likely to occur in elderly patients.
• 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.
• The risk and benefits of using zolpidem should be carefully considered if the patient has a long QT syndrome (a heart conduction disorder, a type of arrhythmia).
• Like 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 have a sedative effect 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, which can lead to falls and, consequently, serious injuries.

Take the prescribed dose of the medicine directly before bedtime. Do not take another dose during the same night.

ApoZolpin and other medicines

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

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

When zolpidem is used 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 (antipsychotics).
• 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 you are going to have surgery under general anesthesia, tell your doctor what medicines you 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. Ask your 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 your doctor has prescribed ApoZolpin with opioids, they should limit the dose and duration of concomitant treatment.
Tell your doctor about all opioid medicines you are taking and strictly follow your 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, contact your doctor.
When zolpidem is used with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not there (visual hallucinations).

ApoZolpin with food, drink, and alcohol

Do not drink alcohol while taking ApoZolpin, as it may increase the sedative effect of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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, tremors after birth due to physical dependence. In such cases, newborns must be closely monitored in the postpartum period.
Do not breastfeed while taking ApoZolpin, 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.
Do not drink alcohol or psychoactive substances while taking ApoZolpin, as this may increase the above effects.

ApoZolpin contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your 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. Your doctor may prescribe a lower dose for some patients.
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 old) or weakened patients

The usual dose is 5 mg. Do not exceed the prescribed dose.

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 cases of severe liver function disorders. Special caution is required 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 old.

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.
Your doctor will determine the appropriate treatment period for you, according to your individual needs. In some cases, it may be necessary to take ApoZolpin for more than 4 weeks.

Taking a higher dose of ApoZolpin than recommended

If you (or someone else) have taken a large number of tablets at once, or if you suspect that a child has swallowed a tablet, contact the nearest hospital emergency department or your doctor immediately. Take the medicine package and any remaining tablets with you. It is recommended to go there with someone else. If an overdose occurs, 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, lethargy (drowsiness). In more severe cases, symptoms may include: lack of coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, cases of impaired consciousness up to coma, and more severe symptoms, including death.

Missing a dose of ApoZolpin

If you do not take a dose of the medicine directly before bedtime, but remember during the night, you can take the missed dose of the medicine only if you still have 8 hours of uninterrupted sleep. If this is not possible, take the next dose of the medicine before bedtime the next night. Do not take a double dose to make up for the missed dose.
In case of doubts about taking the medicine, consult your 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 you become physically dependent on ApoZolpin, sudden discontinuation of treatment will lead to side effects, such as headaches, muscle pain, anxiety, tension, restlessness, confusion, and drowsiness. In severe cases, other symptoms may occur, such as increased sensitivity to light, noise, and touch, a feeling that sounds are louder than usual, and painful sensitivity 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 tremors). These symptoms may also occur between doses, especially if the dose is high.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoZolpin can cause side effects, although not everybody gets them.
Zolpidem's side effects, especially those related to 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 you experience any of the following symptoms, stop taking ApoZolpin and contact your doctor or go to the nearest hospital emergency department immediately:

• 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 (cannot be estimated from available data). You need medical attention.
Tell your doctor or pharmacist if you experience or worsen any of the following side effects:
Common(may affect 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)
• a feeling of "spinning"
• drowsiness the next day, subdued emotions, decreased alertness, disorientation, double vision,
• diarrhea, nausea, vomiting
• skin reactions
• fatigue
• back pain
• abdominal pain.

The risk of amnesia is higher at higher doses. If you ensure that you can have 8 hours of uninterrupted sleep, the risk of amnesia is reduced.
Uncommon(may affect up to 1 in 100 people):

• itching or tingling without reason (paresthesia)
• joint pain, muscle pain, muscle cramps, and neck pain
• involuntary trembling (tremors)
• 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 your doctor during a blood test).

Rare(may affect 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 affect 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 return of problems
• psychological dependence: occurs when the patient thinks they cannot sleep without taking ApoZolpin.

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

• various types of liver damage
• breathing difficulties
• restlessness, aggression, rage, psychosis (hallucinations, when you see, hear, or feel 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 you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store ApoZolpin

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, or bottle after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. 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 ApoZolpin contains

• The active substance of the medicine is zolpidem tartrate. Each coated tablet contains 10 mg of the active substance.
• The other ingredients of the medicine are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate. Coating: hypromellose (5cPs), 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 and HDPE bottles.
Blisters: 7, 8, 10, 14, 15, 20, 28, 30, 50, 56, 60, and 100 coated tablets.
HDPE bottles: 30, 100, 250, and 500 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000, Malta

Generis Farmaceutica, S.A.

Rua João de Deus, 19
2700-487, Amadora, Portugal

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 film-coated tablets
Poland:
ApoZolpin
Spain:
Zolpidem Aurovitas 10 mg film-coated tablets EFG
Netherlands:
Zolpidem tartrate Aurobindo 10 mg, film-coated tablets

Date of last revision of the leaflet: 07/2022