Apozolpin

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
ApoZolpin (Zolpidem Aurovitas 10 mg), 10 mg, coated tablets
Zolpidemi tartras
ApoZolpin and Zolpidem Aurovitas 10 mg are different brand names of the same medicine.
Please read this leaflet carefully 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 side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 condition 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 impairment;
• 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 has a tendency 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 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 suicide attempts may be increased in patients treated with benzodiazepines or sleep 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 medical conditions 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 impairment, 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.
• Discontinuation – treatment should be discontinued gradually. Abruptly stopping therapy may lead to a transient syndrome with a rebound 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.
• 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" effects – ApoZolpin may cause undesirable behaviours such as restlessness, 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 other 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 day after taking ApoZolpin

the risk of psychomotor disturbances, including impaired ability to drive, may
be increased 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 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 medicine should be taken immediately before bedtime. Do not take a second
dose during the same night.
ApoZolpin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 (sleeping pills).
• 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 (narcotic 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, medicines used in substitution therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use should only be considered if other treatment options are not possible.
However, if your doctor has prescribed ApoZolpin together with opioids, they should limit the dose and duration of concomitant treatment.
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 or 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 ("harelip") 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 carefully monitored in the postnatal period.
Breastfeeding should be avoided during treatment, 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 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 minimise the risk of the above-mentioned events, 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 above-mentioned effects.
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
The 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 you are unsure,
you should consult your doctor or pharmacist.
ApoZolpin is an oral medicine.
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 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 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 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 period, including gradual discontinuation, is four weeks. Your doctor will determine the appropriate tapering period according to the individual needs of the patient. In certain circumstances, treatment with ApoZolpin may be necessary 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. Take 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 at high doses may rapidly progress to coma or even death. If zolpidem is taken together with other medicines acting on the central nervous system (including alcohol), the consequences may be serious and potentially fatal. In moderate cases, symptoms may include drowsiness, confusion, fatigue, and lethargy. In 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 miss a dose of ApoZolpin
If you do not take your dose immediately before going to bed but remember during the night, you may take the missed dose only if you can still ensure an uninterrupted 8-hour sleep period. If this is not possible, take the next dose before going to bed the following night. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Stopping ApoZolpin
Treatment should be discontinued gradually, as 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 will resolve over time.
If you become physically dependent on ApoZolpin, abruptly stopping 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 of sounds as 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 (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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse 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 adverse effects are more likely in elderly patients.
If any of the following symptoms occur, stop taking ApoZolpin immediately and contact your doctor or go to the nearest hospital emergency department:

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

These adverse 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 adverse effects 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 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 at higher doses. If you ensure you have 8 hours of uninterrupted sleep, the risk of amnesia decreases.

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

• unexplained itching or tingling (paraesthesia)
• joint pain, muscle pain, muscle cramps, neck pain
• involuntary 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 occur in up to 1 in 1000 people):

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

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, mania, psychosis (hallucinations involving seeing, hearing or feeling things that are not present), inappropriate behaviour
• depression (feeling of sadness)
• sleepwalking
• need to take increasingly higher doses of the medicine to achieve the same effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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.
Reporting adverse effects helps to provide more information on the safety of the 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 packaging. 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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.
• Other components are:
  Tablet core: monohydrate lactose, microcrystalline cellulose (PH-101), sodium carboxymethyl starch (type A), magnesium stearate.
  Coating: hypromellose (5 cPs), 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 mark "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 contained in cardboard boxes.
Blister packs: 10, 20, 30, 50, 60 and 100 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish Marketing Authorisation Number (country of export): 723427.2
Parallel Import Authorisation Number: 150/21
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