Apozolpin

Package leaflet: information for the patient

ApoZolpin, 10 mg, coated tablets
Zolpidemi tartras
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What ApoZolpin is and what it is used for
2. What you need to know before taking ApoZolpin
3. How to take ApoZolpin
4. Possible side effects
5. How to store ApoZolpin
6. Contents of the pack and other information

1. What ApoZolpin is and what it is used for

Zolpidem belongs to a group of medicines called benzodiazepine-like drugs.
ApoZolpin is a sleeping tablet which causes drowsiness by acting on the brain. It is used for the short-term treatment of insomnia in adults, only when the disorder is severe, significantly impairs normal functioning, or causes extreme distress to the patient.

2. Important information before using ApoZolpin

Do not use 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 apnoea syndrome (the patient stops breathing for brief periods 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 treatment with ApoZolpin, consult a doctor or pharmacist if:

• the patient is elderly or has a tendency to bone fractures. If the patient gets up at night, extreme caution should be taken. ApoZolpin may cause reduced muscle tone. This, together with its sedative effect, increases the risk of falls and consequently hip fractures;
• the patient has any kidney or liver function disorders;
• the patient has previously had respiratory disorders. During treatment with ApoZolpin, breathing may become shallower;
• the patient has previously had psychiatric disorders, anxiety, or psychotic disorders. Zolpidem may unmask or worsen symptoms of illness;
• the patient has symptoms of depression or has previously had depression;
• 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 (symptoms of physical or psychological compulsion to take the medicine), and this risk increases with dose and duration of treatment;
• the risk of suicide and suicidal attempts may be increased in patients treated with benzodiazepines or sleep medicines, including zolpidem. If the patient has thoughts of self-harm or suicide, contact a doctor or go to hospital immediately;
• in patients with long QT syndrome (a heart conduction disorder, a type of arrhythmia).

Before using this medicine:

• the cause of sleep disturbances should be clarified;
• underlying diseases should be treated.

If treatment of sleep disturbances is ineffective after 7–14 days, this may indicate a psychological or physical illness that should be investigated.
Zolpidem should not be used in patients with severe liver function disorders, as due to liver failure, accumulation of toxic substances in the body may cause brain dysfunction (encephalopathy).
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Other notes

• Tolerance – if after a few weeks of treatment the patient notices that the medicine is not as effective as when treatment was started, they should contact their doctor.
• Dependence – when taking this type of medicine, there is a risk of dependence, which increases with dose and duration of treatment. The risk is higher in patients who have previously had psychiatric disorders, drug addiction, alcohol abuse, or drug dependence. However, dependence may also occur at doses usually used in treatment or in the absence of known risk factors such as past alcohol or drug abuse.
• Discontinuation – treatment should be discontinued gradually. Abruptly stopping therapy may lead to a transient withdrawal syndrome with a recurrence of symptoms more intense than those that prompted the use of ApoZolpin. This may be accompanied by other symptoms such as mood changes, anxiety, and restlessness.
• Memory loss – ApoZolpin may cause memory loss. To reduce the risk of memory loss, ensure the patient has 8 hours of uninterrupted sleep.
• Psychological reactions and "paradoxical" reactions – ApoZolpin may cause undesirable behaviours such as anxiety, agitation, irritability, aggression, delusions (false beliefs), anger outbursts, nightmares, hallucinations, psychosis (hallucinations; the patient sees, hears, or feels things that are not real), inappropriate behaviour, and worsening of insomnia.
• Sleepwalking and related behaviours – ApoZolpin may cause people to perform activities during sleep that they do not remember upon waking. This includes sleepwalking, driving while asleep, preparing and eating food, making phone calls, or engaging in sexual activity. Alcohol and certain medicines used to treat depression, anxiety, or taking ApoZolpin at doses exceeding the maximum recommended dose may increase the risk of these adverse effects.
• The risks and benefits of using zolpidem should be carefully considered in patients with long QT syndrome (a heart conduction disorder, a type of arrhythmia).
• Like other sleep or (and) sedative medicines, zolpidem has a depressant effect on the central nervous system. Psychomotor disturbances the following day (see also "Driving and operating machinery") – the risk of psychomotor disturbances, including impaired ability to drive, may be increased the day after taking ApoZolpin (as with other sleep medicines) if:
  • the medicine is taken less than 8 hours before performing activities requiring alertness;
• a higher than recommended dose is taken;
• zolpidem is taken together with other medicines that depress the central nervous system or other medicines that increase zolpidem blood levels, or when consuming alcohol or illicit substances. Zolpidem may cause drowsiness and reduced awareness, which may lead to falls and consequently serious injuries.

The prescribed dose of medicine should be taken immediately before bedtime. Do not take another dose during the same night.
ApoZolpin and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
ApoZolpin may affect the action of other medicines and (or) the occurrence of adverse effects.

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

When zolpidem is used together with some of the following medicines, drowsiness and next-day psychomotor disturbances, including impaired ability to drive, may be intensified:

• Medicines used to treat certain psychiatric disorders (antipsychotics).
• Medicines used to treat sleep problems (sleep medicines).
• 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 (opioid analgesics), such as codeine, morphine. The feeling of euphoria may increase, thereby increasing the risk of physical or psychological dependence.
• Medicines used to treat epilepsy, such as phenytoin and carbamazepine.
• Medicines used in anaesthesia. If the patient is to undergo surgery under general anaesthesia, inform the doctor about all medicines being taken.
• Medicines used to treat hay fever, rashes, or other allergies, which may cause drowsiness (sedating antihistamines).
• Muscle relaxants; muscle-relaxing effects 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 liver enzyme activity.

No significant interactions have been observed when zolpidem is administered concomitantly with warfarin (to reduce blood clotting), digoxin (for heart failure treatment), or ranitidine (for stomach problems).
Concomitant use of ApoZolpin and opioids (strong painkillers, replacement therapy medicines, 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 other treatment options are not possible.
However, if a doctor has prescribed ApoZolpin together with opioids, the dose and duration of concomitant treatment should be limited.
Inform your doctor about all opioid medicines being taken and strictly follow the doctor's instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. If such symptoms occur, contact a doctor.
When zolpidem is used concomitantly with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, the patient may see things that are not real (visual hallucinations).
Concomitant use of zolpidem with fluvoxamine or ciprofloxacin is not recommended.
ApoZolpin with food, drink, and alcohol
Do not consume alcohol while taking ApoZolpin, as it may intensify the sedative effect of the medicine.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Using zolpidem during pregnancy may be harmful to the unborn child.
In some studies, an increased risk of cleft lip and palate ("hare lip") has been observed.
After administration of zolpidem in the second and (or) third trimester of pregnancy, reduced fetal movements and changes in fetal heart rate may occur.
ApoZolpin should not be used during pregnancy, especially during the first three months. If ApoZolpin is used for important medical reasons late in pregnancy or during delivery, the newborn may experience: low body temperature, floppy infant syndrome, feeding difficulties, breathing problems, and withdrawal symptoms such as motor restlessness and tremors after birth due to physical dependence. In such cases, newborns must be closely monitored in the postnatal period.
Breastfeeding should not be performed during treatment, as zolpidem passes into human milk in small amounts.
Driving and operating machinery
ApoZolpin has a major effect on the ability to drive and operate machinery, such as "falling asleep at the wheel". The patient should be aware that the day after taking ApoZolpin (as with other sleep medicines):

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

To minimize the risk of the events listed above, it is recommended to maintain at least an 8-hour interval between taking zolpidem and driving, operating machinery, or working at heights.
Do not consume alcohol or psychoactive substances while taking ApoZolpin, as this may worsen the effects listed above.
ApoZolpin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.
ApoZolpin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 10 mg tablet, meaning the medicine is considered "sodium-free".

3. How to take ApoZolpin

Always take this medicine exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
ApoZolpin is a medicine taken by mouth.
Since ApoZolpin works very quickly, it should be taken immediately before going to bed or while lying down.
Adults
The recommended dose of ApoZolpin is 10 mg once every 24 hours. Your doctor may prescribe a lower dose for some patients.
ApoZolpin should be taken:

• as a single dose,
• immediately before sleep. The patient must ensure a period of at least 8 hours between taking the medicine and performing any activities requiring increased concentration. Do not exceed the dose of 10 mg per 24 hours.

Elderly patients (over 65 years of age) or debilitated patients
The usual dose is 5 mg. Do not exceed the prescribed dose.
Patients with impaired liver function
The usual initial dose is 5 mg. Your doctor may decide to increase the dose to 10 mg if this is safe. ApoZolpin should not be used in cases of severe liver impairment. Particular caution is required in elderly patients with impaired liver function.
Patients with a history of respiratory disorders (chronic respiratory insufficiency)
A lower dose is recommended.
Use in children and adolescents
ApoZolpin is not intended for use in individuals under 18 years of age.
Duration of treatment
The treatment duration 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 gradual discontinuation period according to your individual needs. In certain situations, treatment with ApoZolpin may be necessary for longer than four weeks.
Taking more than the recommended dose of ApoZolpin
If a patient (or anyone else) takes a large number of tablets at once, or if there is suspicion that a child has swallowed a tablet, contact the nearest hospital emergency department or a doctor immediately. Bring the medicine packaging and any remaining tablets with you. Ensure that you go there accompanied by another person. In case of overdose, the patient may become very sleepy very quickly, which with high doses of the medicine may lead to coma or even death. If zolpidem is taken together with other medicines acting on the central nervous system (including alcohol), this may result in serious consequences, which may also be fatal. In moderate cases, symptoms include: drowsiness, confusion and feeling of fatigue, exhaustion (lethargy). In more severe cases, symptoms may include lack of motor coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension), respiratory depression, disturbances of consciousness up to coma, and more serious symptoms, including death.
Missed dose of ApoZolpin
If the patient does not take the dose immediately before going to bed but remembers during the night, the missed dose may be taken only if at least 8 hours of uninterrupted sleep are still assured. If this is not possible, the next dose should be taken before going to bed the following night. Do not take a double dose to make up for a missed dose.
If in doubt about the use of this medicine, consult your doctor or pharmacist.
Stopping ApoZolpin
Treatment should be discontinued gradually, because the symptoms for which the patient was treated may return more severely than before (rebound insomnia). Anxiety, restlessness and mood changes may also occur. These symptoms resolve over time.
If the patient becomes physically dependent on ApoZolpin, abrupt discontinuation of treatment may lead to adverse effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability and drowsiness. In severe cases, other symptoms may occur, such as hypersensitivity to light, noise and touch, perception that sounds are louder than usual, painful sensitivity to acoustic stimuli, hallucinations, numbness and tingling in the limbs, loss of sense of reality (feeling that the surrounding environment is unreal), depersonalization (feeling of loss of self-identity), or seizures (sudden twisting movements or tremors).
Such symptoms may also occur between doses, especially if the dose is high.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions of zolpidem, particularly those affecting the central nervous system, are dose-dependent and are less pronounced if the medicine is taken immediately before going to sleep. These adverse reactions are more likely in elderly patients.
If any of the following symptoms occur, stop taking ApoZolpin and contact your doctor immediately 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 adverse reactions are severe, but their frequency is unknown (cannot be estimated from available data). The patient requires immediate medical attention.
Inform your doctor or pharmacist if any of the following adverse reactions occur or worsen:

Common (may occur in up to 1 in 10 people):

• upper or lower respiratory tract infections
• hallucinations, agitation, nightmares
• drowsiness, headache, dizziness, increased insomnia, amnesia (which may be associated with inappropriate behaviors)
• sensation of spinning
• next-day drowsiness, blunted emotions, reduced alertness, disorientation, double vision
• diarrhoea, nausea, vomiting
• skin reactions
• fatigue
• back pain
• abdominal pain

The risk of amnesia is higher at higher doses. Ensuring you have 8 hours of uninterrupted sleep reduces the risk of amnesia.

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

• unexplained itching or tingling (paresthesia)
• joint pain, muscle pain, muscle cramps, neck pain
• involuntary trembling (tremor)
• speech disorders
• difficulty concentrating
• loss of appetite
• blurred vision
• skin rash, itching
• excessive sweating
• double vision
• euphoric mood
• muscle weakness
• confusion, irritability
• worsening insomnia
• coordination disturbances
• increased activity of certain liver enzymes (detected by your doctor during blood tests)

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

• decreased or increased libido
• liver damage (hepatocellular, cholestatic or mixed)
• reduced level of consciousness
• narrowed vision
• urticaria
• changes in gait
• falls, particularly in elderly patients
• paradoxical reactions (anxiety, agitation, irritability, aggression, delusions (false beliefs), rage, nightmares, hallucinations, psychosis, inappropriate behavior and other undesirable behavioral changes). These are more likely if the patient is elderly.

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

• delusions (false beliefs)
• 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
• psychological dependence: occurs when the patient believes they cannot sleep without taking ApoZolpin.

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

• various types of liver damage
• breathing difficulties
• motor restlessness, aggression, rage, psychosis (hallucinations involving seeing, hearing or feeling things that are not there), inappropriate behavior
• depression (feeling of sadness)
• sleepwalking
• need to take increasingly higher doses of the medicine to achieve the same effect

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store ApoZolpin
Keep the medicine out of the 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 stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What ApoZolpin contains

• The active substance is zolpidem tartrate. Each coated tablet contains 10 mg of the active substance.
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.
  Coating: hypromellose (5cPs), polyethylene glycol 400, titanium dioxide (E 171).

What ApoZolpin looks like and contents of the pack
Coated tablet.
White or almost white, oval, biconvex coated tablets, embossed with the letter "E" on one side and the number "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 blister packs and HDPE bottles.
Blister packs: 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw, Poland

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 authorised 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