Apozolpin

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the adverse effects worsen or if any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What ApoZolpin is and what it is used for
2. Important information 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 medicines.
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, interferes with 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 short 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, discuss with your doctor or pharmacist if:

• the patient is elderly or prone to bone fractures. If the patient gets up at night, they should be very careful. 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 the illness;
• 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 (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 suicide attempts may be increased in patients treated with benzodiazepines or hypnotic medicines, including zolpidem. If the patient has thoughts of self-harm or suicide, they should 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 information

• 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 risk factors such as previous alcohol or drug abuse.
• Withdrawal – 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 led to the use of ApoZolpin. This may be accompanied by other symptoms such as mood changes, anxiety, and restlessness.
• Amnesia – ApoZolpin may cause memory loss. To reduce the risk of amnesia, ensure the patient has 8 hours of uninterrupted sleep.
• Psychological and "paradoxical" reactions – ApoZolpin may cause undesirable behaviours such as restlessness, excitement, irritability, aggression, delusions (false beliefs), anger, nightmares, hallucinations, psychosis (hallucinations; the patient sees, hears, or feels non-existent things), 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 antidepressants, anxiolytics, or doses of ApoZolpin 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 hypnotic and (or) sedative medicines, zolpidem has a depressant effect on the central nervous system. Psychomotor disturbances the following day (see also "Driving and operating machinery") – the day after taking ApoZolpin (as with other hypnotic medicines), the risk of psychomotor disturbances, including impaired ability to drive, may be increased if:
  • the medicine is taken less than 8 hours before performing tasks requiring alertness;
  • a higher than recommended dose is taken;
  • zolpidem is taken together with other central nervous system depressants or other medicines that increase zolpidem blood levels, or with alcohol or illicit substances. Zolpidem may cause drowsiness and reduced awareness, which may lead to falls and consequently serious injuries.

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

• 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 (hypnotics).
• Sedatives or anxiolytics.
• Medicines used to treat depression, including St. John's wort (an herbal medicine used to treat depression).
• Medicines used to treat moderate to severe pain (opioid analgesics), such as codeine, morphine. Feelings 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 relaxation 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), 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 if no other treatment options are available.
However, if your doctor prescribes ApoZolpin together with opioids, the dose and duration of concomitant treatment should be limited.
Inform your doctor about all opioid medicines you are taking 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 your 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.
Use of 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 of pregnancy. If ApoZolpin is used for important medical reasons in late 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 with this medicine, as zolpidem passes into human milk in small amounts.
Driving and operating machinery
ApoZolpin has a major influence 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 hypnotic 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 monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.
ApoZolpin contains sodium
This medicine contains less than 1 mmol 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 an oral medicine.
Because 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 bedtime. 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 within 24 hours.

Elderly patients (over 65 years of age) or weakened patients
The usual dose is 5 mg. Do not exceed the prescribed dose.
Patients with impaired liver function
The usual starting dose is 5 mg. Your doctor may decide to increase the dose to 10 mg if it is safe.
ApoZolpin should not be used in cases of severe impairment of liver function. Particular caution is
required in elderly patients with impaired liver function.
Patients with a history of respiratory disorders (chronic respiratory insufficiency)
A reduced 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 duration, including gradual discontinuation, is four weeks.
Your doctor will determine the appropriate period for gradually stopping treatment according to
the individual needs of the patient. In certain situations, it may be necessary to use ApoZolpin for
longer than four weeks.
Taking more ApoZolpin than recommended
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
accompanied by another person. If an overdose occurs, the patient may become very drowsy, which
with large doses of the medicine may rapidly lead to coma or even death. If zolpidem is taken with
other medicines acting on the central nervous system (including alcohol), serious consequences may
occur, which may also be fatal. In moderate cases, symptoms include drowsiness, confusion, and
feelings of fatigue or 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.
If you forget to take 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 can still be
ensured. 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 you have any doubts about how to use the medicine, consult your doctor or pharmacist.
Stopping ApoZolpin
Treatment should be discontinued gradually, because the symptoms for which the patient was being
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
hypersensitivity to acoustic stimuli, hallucinations, numbness and tingling in the limbs, loss of
reality perception (feeling that the surrounding environment is unreal), depersonalization (sense
of loss of self-identity), or seizures (sudden movements with twisting or trembling). These
symptoms may also occur between doses, especially if the dose is high.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects 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 side effects are more likely to occur 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, accompanied by swelling of the face, lips, throat or tongue, and difficulty breathing or swallowing (angioedema).

These side effects are serious, 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 side effects occur or worsen:
Common (may affect 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 abnormal behaviour);

• 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 with higher doses. If you ensure you can have 8 hours of uninterrupted sleep, the risk of amnesia decreases.
Uncommon (may affect up to 1 in 100 people):

• unexplained itching or tingling (paraesthesia);
• joint pain, muscle pain, muscle cramps, neck pain;
• involuntary tremor (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 (which will be detected by your doctor during blood tests).

Rare (may affect up to 1 in 1000 people):

• decreased or increased libido;
• liver damage (hepatocellular, cholestatic or mixed);
• reduced level of consciousness;
• narrowed vision;
• urticaria;
• changes in walking pattern;
• falls, especially in elderly patients;
• paradoxical reactions (anxiety, restlessness, agitation, irritability, aggression, delusions (false beliefs), rage, nightmares, hallucinations, psychosis, abnormal behaviour and other undesirable behavioural changes). These are more likely if the patient is elderly.

Very rare (may affect 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 feels unable to 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), abnormal behaviour;

• depression (feeling of sadness);

• sleepwalking;

• need to take increasingly higher doses of the medicine to achieve the same effect.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store ApoZolpin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
No special storage conditions required.
Medicines should not be disposed of via wastewater 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 (PH-101), sodium carboxymethyl starch (type A), magnesium stearate. Coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What ApoZolpin looks like and contents of the pack
Coated tablet.
White or almost white, oval, biconvex coated tablets, with the imprint "E" on one side and the imprint "80" with a score line between "8" and "0" on the other side. The tablet can be divided into equal doses.
ApoZolpin is available in blister packs containing 10, 20, 30, 50, 60 or 100 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in the Netherlands, country of export:
Aurobindo Pharma B.V., Baarnsche Dijk 1, 3741 LN Baarn, the 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, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Netherlands, country of export: RVG 121165
Parallel Import Authorisation number: 107/24
This medicinal product is authorised in the European Economic Area countries 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