APODREAM 7.5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. ApoDream, 7.5 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 ApoDream is and what it is used for
4. Important information before taking ApoDream
   1. When not to take ApoDream:
   2. Warnings and precautions
   3. Other notes
   4. Dependence
   5. Addiction
   6. Suicide
   7. Stopping treatment
   8. Short-term memory loss (Anterograde amnesia)
   9. ApoDream and other medicines
   10. ApoDream with food, drink, and alcohol
   11. Pregnancy, breastfeeding, and fertility
   12. Driving and using machines
   13. ApoDream contains lactose
   14. ApoDream contains sodium
5. How to take ApoDream
   1. Treatment should be as short as possible and should not exceed 4 weeks, including the period of dose reduction.
   2. How to take the medicine
   3. Adults
   4. Elderly
   5. Patients with liver, respiratory, or kidney problems
   6. Use in children and adolescents
   7. Blood tests
   8. Taking a higher dose of ApoDream than recommended
   9. Missing a dose of ApoDream
   10. Stopping treatment with ApoDream
6. Possible side effects
   1. The patient should stop taking ApoDream and contact their doctor or go to the hospital immediately if:
   2. The patient should contact their doctor as soon as possible if they experience any of the following symptoms:
   3. The patient should inform their doctor or pharmacist if any of the following side effects get worse or last more than a few days:
   4. Driving "asleep" and other strange behavior
   5. Reporting side effects
7. How to store ApoDream
8. Contents of the pack and other information
   1. What ApoDream contains
   2. What ApoDream looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 03/2023

Leaflet attached to the packaging: information for the user

ApoDream, 7.5 mg, coated tablets

Zopiclone

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.
• If you have any doubts, consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What ApoDream is and what it is used for

ApoDream is available as coated tablets and contains the active substance zopiclone. This medicine belongs to a group of sleeping medicines. It works by affecting the brain, making it easier to fall asleep.
In adults:
Zopiclone, the active substance in ApoDream, is used to treat sleep problems, such as:

• difficulty falling asleep,
• waking up in the middle of the night,
• waking up too early in the morning,
• severe or unpleasant sleep problems caused by mood or mental health issues.

Zopiclone can be used to treat both short-term and longer-term sleep problems. However, zopiclone should not be used every day for a long time, nor should it be used to treat depression. If the patient is unsure, they should consult a doctor for advice.

2. Important information before taking ApoDream

When not to take ApoDream:

• if the patient is allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue;
• if the patient has one of the following diseases: severe muscle weakness called myasthenia gravis(an autoimmune disease),

o
severe respiratory failure (a condition in which gas exchange in the lungs is insufficient to meet the body's needs),
o
sleep apnea syndrome (a sleep disorder characterized by pauses in breathing during sleep),
o
severe liver problems;

• the patient is a child or adolescent under 18 years of age. The safety and efficacy of zopiclone in children and adolescents under 18 years of age have not been established.

In case of doubts, before taking ApoDream, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take ApoDream, the patient should discuss it with their doctor or pharmacist if:

• The patient has liver problems (see also "When not to take ApoDream" above). The doctor may recommend a lower dose of zopiclone.
• The patient has any kidney problems. The doctor may recommend a lower dose of zopiclone.
• The patient has mild breathing problems. The doctor will decide whether the patient should receive zopiclone (see also "When not to take ApoDream" above).
• The patient has a history of alcohol or drug abuse.
• The doctor has informed the patient that they have a personality disorder.
• The patient has recently taken zopiclone or other similar medicines for more than four weeks.
• The patient does not think they can ever stop taking zopiclone or other sleep medicines.

Before taking zopiclone, the patient should make sure they can have at least 7 to 8 hours of uninterrupted sleep, which will reduce the risk of certain side effects (see section 4).
In case of uncertainty about any of the above points, before starting to take zopiclone, the patient should talk to their doctor or pharmacist.
This medicine does not treat depression. If the patient also has depression, the doctor will prescribe appropriate treatment. If depression is not treated, it may worsen or increase the risk of suicide.

Other notes

Dependence

If after a few weeks the patient notices that the tablets are not working as well as they did at first, they should go to their doctor.

Addiction

Taking benzodiazepines and benzodiazepine-like substances can lead to physical and psychological dependence on these substances. The risk of dependence increases with higher doses and longer treatment periods. This risk is also higher in patients with a history of alcohol or drug abuse and (or) with marked personality disorders.

Suicide

The risk of suicide and attempted suicide may be increased in patients treated with benzodiazepines or sleep medicines, including zopiclone. If the patient has ever had thoughts of harming themselves or killing themselves, they should contact their doctor or go to the hospital immediately.

Stopping treatment

Treatment should be stopped gradually. When stopping treatment, a transient state may occur, in which the symptoms that led to the treatment with zopiclone worsen. This may be accompanied by other reactions, including mood changes, anxiety, and restlessness.

Short-term memory loss (Anterograde amnesia)

Zopiclone may cause short-term memory loss (anterograde amnesia). This usually occurs a few hours after taking the medicine. To reduce this risk, the patient should make sure they can have 7-8 hours of uninterrupted sleep.

ApoDream and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those bought without a prescription, including herbal medicines. ApoDream may affect the way other medicines work. Some medicines may also affect the way ApoDream works.
The patient should inform their doctor about taking any of the following medicines.
The following medicines may increase the effect of ApoDream:

• medicines for mental problems (antipsychotics),
• medicines used in epilepsy (anticonvulsants),
• medicines that calm or reduce anxiety or sleep problems (sleeping medicines),
• medicines for depression,
• certain medicines used to treat moderate to severe pain (opioid painkillers), such as codeine, methadone, morphine, oxycodone, pethidine, or tramadol,
• medicines used in surgery (anesthetics),
• medicines for colds, rashes, or other allergies that can cause drowsiness (sedating antihistamines), such as chlorphenamine or promethazine.

The following medicines may increase the risk of side effects when taking ApoDream. To reduce the risk, the doctor may decide to reduce the dose of zopiclone:

• certain antibiotics, such as clarithromycin or erythromycin,
• certain medicines used to treat fungal infections, such as ketoconazole and itraconazole,
• ritonavir - a protease inhibitor (used to treat AIDS).

The following medicines may reduce the effect of ApoDream:

• certain medicines used in epilepsy, such as carbamazepine, phenobarbital, and phenytoin.
• rifampicin (an antibiotic) - in case of infections.
• products containing St. John's Wort (a herb used to treat depression and mood disorders).

Taking ApoDream and opioids (strong painkillers, medicines used to treat addiction, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, taking these medicines together should only be considered if other treatment options are not possible.
If the doctor prescribes ApoDream with opioids, they should limit the dose and duration of concurrent use.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage instructions. It may be helpful to inform friends or family about the risk, so they are aware of the symptoms. If these symptoms occur, the patient should contact their doctor.

ApoDream with food, drink, and alcohol

While taking ApoDream, the patient should not drink alcohol. Alcohol may increase the effect of zopiclone and cause the patient to fall into a deep sleep, and they may not breathe properly or have problems waking up.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
ApoDream should not be taken during the last 3 months of pregnancy or during childbirth, as it may harm the baby.
The patient should not breastfeed if they are taking ApoDream. This is because small amounts of the medicine may pass into breast milk. If the patient is breastfeeding or plans to breastfeed, they should talk to their doctor or pharmacist before taking any medicine.

Driving and using machines

Like other sleep medicines, ApoDream may cause slowing of normal brain function (central nervous system depression). The risk of psychomotor disturbances, including the ability to drive, increases if:

• ApoDream is taken within 12 hours before performing activities that require attention,
• a higher dose of ApoDream is taken than recommended,
• ApoDream is taken with another medicine that depresses the central nervous system, another medicine that increases the concentration of zopiclone in the blood, or while drinking alcohol.

The patient should not perform hazardous activities that require full alertness, such as driving or operating machinery, after taking ApoDream, especially within 12 hours of taking the medicine.
For more information on possible side effects that may affect driving, see section 4 of this leaflet.

ApoDream contains lactose

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

ApoDream contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 7.5 mg coated tablet, which is essentially "sodium-free".

3. How to take ApoDream

Treatment should be as short as possible and should not exceed 4 weeks, including the period of dose reduction.

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

How to take the medicine

• The medicine should be taken orally.
• The tablet should be swallowed with water.
• The tablets should not be crushed or chewed.
• The patient should take one dose just before bedtime and not take it again during the same night.
• Treatment usually lasts from 2 days to 3 weeks.

Adults

The recommended initial dose is 7.5 mg of zopiclone just before bedtime (two 3.75 mg tablets or one 7.5 mg tablet). This dose should not be exceeded.

Elderly

The usual initial dose is one 3.75 mg zopiclone tablet just before bedtime. If necessary, the doctor may decide to increase the dose to one 7.5 mg zopiclone tablet.

Patients with liver, respiratory, or kidney problems

The usual initial dose is one 3.75 mg zopiclone tablet just before bedtime.

Use in children and adolescents

Zopiclone should not be used in children and adolescents under 18 years of age. The safety and efficacy of zopiclone in children and adolescents under 18 years of age have not been established.

Blood tests

• Zopiclone tablets may change liver enzyme levels in blood tests. This may mean that the liver is not working properly.
• If the patient is going to have a blood test, it is important to inform their doctor that they are taking zopiclone.

Taking a higher dose of ApoDream than recommended

If the patient has taken too many tablets, they should contact their doctor or the nearest hospital immediately for advice. They should take the medicine packaging with them. This will help the doctor know what medicine has been taken.
Overdose of zopiclone can be very dangerous.
The following effects may occur:

• drowsiness, disorientation, deep sleep, and coma,
• muscle weakness (hypotonia),
• dizziness, "empty head" or fainting. These effects are caused by low blood pressure,
• falling or loss of balance (ataxia),
• shallow breathing or breathing difficulties (respiratory depression).

Missing a dose of ApoDream

Zopiclone can only be taken before bedtime. If the patient forgets to take a tablet before bedtime, they should not take it at any other time, or they may feel drowsy, dizzy, and disoriented during the day. They should not take a double dose to make up for a forgotten dose.

Stopping treatment with ApoDream

The patient should continue taking zopiclone until their doctor advises them to stop. They should not stop taking zopiclone suddenly but should inform their doctor if they want to stop treatment. The doctor will gradually reduce the dose to slowly stop treatment.
If zopiclone is stopped suddenly, sleep problems and side effects may occur. If this happens, the patient may experience some of the following symptoms. They should contact their doctor immediately:

• feeling anxious, unsteady, irritable, agitated, disoriented, or having panic attacks,
• sweating,
• headache,
• fast or irregular heartbeat (palpitations),
• lowered level of consciousness and problems with concentration or attention,
• nightmares, seeing or hearing things that are not real (hallucinations),
• increased sensitivity to light, noise, and touch,
• feeling disconnected from reality,
• numbness and tingling in hands and feet,
• aching muscles,
• stomach problems.

In rare cases, seizures (fits) may also occur.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoDream can cause side effects, although not everybody gets them.

The patient should stop taking ApoDream and contact their doctor or go to the hospital immediately if:

The patient has an allergic reaction. Symptoms may include: rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue.

The patient should contact their doctor as soon as possible if they experience any of the following symptoms:

Rare(may affect up to 1 in 1,000 people)

• memory loss after taking zopiclone (amnesia). After 7-8 hours of uninterrupted sleep after taking zopiclone, the likelihood of this problem is lower,
• seeing or hearing things that are not real (hallucinations),
• falling, especially in older people.

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

• thinking about things that are not real (delusions),
• feeling depressed or sad (depressive mood).

The patient should inform their doctor or pharmacist if any of the following side effects get worse or last more than a few days:

Common(may affect up to 1 in 10 people)

• mildly bitter or metallic taste in the mouth,
• feeling drowsy or sleepy,
• feeling dry in the mouth.

Uncommon(may affect up to 1 in 100 people)

• nausea (feeling sick) or vomiting,
• dizziness,
• headache,
• nightmares,
• feeling physically or mentally tired,
• restlessness.

Rare(may affect up to 1 in 1,000 people)

• feeling confused,
• itchy, lumpy rash (hives),
• irritability or aggression,
• reduced sex drive,
• breathing difficulties or shortness of breath.

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

• feeling restless or angry,
• feeling "empty head" or problems with coordination,
• double vision,
• problems with movement or balance,
• muscle weakness,
• indigestion,
• dependence on zopiclone,
• slower breathing (respiratory depression),
• abnormal skin sensations, such as numbness, tingling, prickling, burning, or crawling under the skin (paresthesia),
• mental problems, such as poor memory, difficulty concentrating, or speech disturbances.

Driving "asleep" and other strange behavior

After taking a sleep medicine, there have been reports of performing various activities while asleep, which the patient does not remember after waking up the next day. This includes driving and sleepwalking. Alcohol and some medicines for depression or anxiety may increase the likelihood of such events.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ApoDream

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister, bottle, and carton after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ApoDream contains

• The active substance is zopiclone. One coated tablet contains 7.5 mg of zopiclone.
• The other ingredients are: Core: lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, povidone (K-30), sodium carboxymethylcellulose (type A), magnesium stearate. Coating: hypromellose (6 cps), macrogol 6000, titanium dioxide (E 171).

What ApoDream looks like and contents of the pack

Coated tablet.
White, round (7.6 mm in diameter), biconvex, coated tablets, with "Z" and "2" engraved on one side, separated by a score line, and a score line on the other side. The tablet can be divided into equal doses.
ApoDream, 7.5 mg, coated tablets are available in blisters and HDPE bottles, in a cardboard box.

Pack sizes:

Blisters:5, 10, 14, 20, 28, 30, 50, 60, and 90 coated tablets.
HDPE bottle:500 coated tablets (only for dose dispensing).
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebuggia, BBG 3000
Malta
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
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:

Belgium:
Zopiclone AB 7,5 mg film-coated tablets
Germany:
Zopiclon PUREN 3,75 mg/7,5 mg film-coated tablets
France:
Zopiclone Arrow Lab 3,75 mg film-coated tablet
Zopiclone Arrow Lab 7,5 mg film-coated tablet, scored
Netherlands:
Zopiclon Aurobindo 3,75 mg/7,5 mg film-coated tablets
Poland:
ApoDream

Date of last revision of the leaflet: 03/2023