Apodream

Package leaflet: Information for the user

ApoDream, 7.5 mg, coated tablets
Zopiclonum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• 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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What ApoDream is and what it is used for
2. Before you take 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 medicines called hypnotics. It acts on the brain to help induce sleep.
In adults:
Zopiclone, the active substance in ApoDream, is used to treat sleep disorders such as:

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

Zopiclone can be used to treat both short-term and longer-lasting sleep problems. However, zopiclone should not be used daily for prolonged periods, nor for the treatment of depression. If you are unsure, you should consult your doctor for advice.

2. Information before using ApoDream

When not to use 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, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;

• if the patient suffers from one of the following conditions:

  • severe muscle weakness known as myasthenia gravis (an autoimmune disease),
  • severe respiratory insufficiency (a condition in which gas exchange in the lungs is insufficient to meet the body's needs),
  • sleep apnoea syndrome (a sleep disorder characterized by breathing interruptions during sleep),
  • severe liver problems;

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

If in any doubt, consult a doctor or pharmacist before taking ApoDream.

Warnings and precautions

Before starting treatment with ApoDream, discuss this with your doctor or pharmacist if:

• The patient has liver problems (see also “When not to use 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 difficulties. The doctor will decide whether the patient should receive zopiclone (see also “When not to use 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 similar medicines for more than four weeks.
• The patient does not believe they would be able to stop taking zopiclone or other sleep medicines.

Before taking zopiclone, ensure that the patient can allow at least 7 to 8 hours of uninterrupted sleep, which will reduce the risk of certain adverse effects (see section 4).

If unsure whether any of the above points apply, speak to a doctor or pharmacist before starting zopiclone.

This medicine does not treat depression. If the patient also has depression, the doctor will recommend appropriate treatment. If depression is left untreated, it may worsen or increase the risk of suicide.

Other considerations

Tolerance

If after a few weeks the patient notices that the tablets are no longer working as well as they did initially, they should see a doctor.

Dependence

The use of benzodiazepines and substances similar to benzodiazepines may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer treatment duration. This risk is also higher in patients with a history of alcohol or drug abuse and/or in individuals with marked personality disorders.

Suicide

The risk of suicide and suicide attempts may be increased in patients treated with benzodiazepines or sleep medicines, including zopiclone. If the patient ever experiences thoughts of self-harm or suicide, they should contact a doctor immediately or go to hospital.

Stopping treatment

Treatment should be discontinued gradually. When stopping treatment, a temporary state may occur in which the symptoms that led to zopiclone treatment may return or worsen. These 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), particularly a few hours after taking the medicine. To reduce this risk, the patient should ensure they can allow 7–8 hours of uninterrupted sleep.

ApoDream and other medicines

Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines purchased without a prescription, including herbal remedies. ApoDream may affect the action of other medicines, and some medicines may affect the action of ApoDream.

Inform the doctor if the patient is taking any of the following medicines.

The following medicines may enhance the effect of ApoDream:

• medicines for mental health problems (antipsychotics),
• medicines used in epilepsy (anticonvulsants),
• medicines that calm or reduce anxiety or sleep problems (hypnotics),
• medicines for depression,
• certain medicines used to treat moderate to severe pain (opioid analgesics), such as codeine, methadone, morphine, oxycodone, pethidine, or tramadol,
• medicines used in surgery (anaesthetics),
• medicines for hay fever, rashes, or other allergies that may cause drowsiness (sedating antihistamines), such as chlorphenamine or promethazine.

The following medicines may increase the risk of adverse effects when used with ApoDream. To reduce this risk, the doctor may decide to reduce the dose of zopiclone:

• certain antibiotics, such as clarithromycin or erythromycin,
• certain antifungal medicines, such as ketoconazole and itraconazole,
• ritonavir – a protease inhibitor (used in the treatment of AIDS).

The following medicines may reduce the effect of ApoDream:

• certain medicines used in epilepsy, such as carbamazepine, phenobarbital, and phenytoin,
• rifampicin (an antibiotic) – used in infections,
• products containing St. John’s wort (a herb used in the treatment of depression and mood disorders).

Concomitant use of ApoDream and opioids (strong painkillers, medicines used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use of these medicines should only be considered if other treatment options are not possible.

If the doctor prescribes ApoDream together with opioids, they should limit the dose and duration of concomitant use.

Inform the doctor about all opioid medicines the patient is taking and strictly follow dosing instructions. It may be helpful to inform friends or family about the risks so they are aware of the symptoms listed. If these symptoms occur, contact a doctor.

ApoDream with food, drink, and alcohol

While taking ApoDream, do not drink alcohol. Alcohol may enhance the effect of zopiclone, causing the patient to fall into a very deep sleep, breathe improperly, or have difficulty waking up.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Do not take ApoDream during the last 3 months of pregnancy or during childbirth, as it may be harmful to the baby.

Do not breastfeed while taking ApoDream, as small amounts of the medicine may pass into breast milk. If the patient is breastfeeding or planning to breastfeed, she should talk to a doctor or pharmacist before taking any medicine.

Driving and operating machinery

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

• ApoDream was taken within 12 hours before performing tasks requiring concentration,
• a higher dose of ApoDream than recommended was taken,
• ApoDream was taken together with another medicine that depresses the central nervous system, another medicine that increases zopiclone blood levels, or alcohol was consumed.

Do not perform dangerous tasks requiring full alertness, such as driving or operating machinery, after taking ApoDream, especially within 12 hours of taking the medicine.

More information about possible adverse effects that may affect driving is provided in section 4 of this leaflet.

ApoDream contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.

ApoDream contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 7.5 mg coated tablet, i.e. is essentially “sodium-free”.

3. How to take ApoDream

Treatment should be as short as possible and should not exceed four weeks,
including the tapering-off period.
This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
contact the doctor or pharmacist.

How to take the medicine

• Take the medicine orally.
• Swallow the tablet with water.
• Do not crush or chew the tablets.
• Take one dose just before bedtime and do not take another dose during the same night.
• Treatment usually lasts from 2 days to 3 weeks.

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

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

Patients with impaired liver, respiratory or kidney function
The usual initial dose is one 3.75 mg zopiclone tablet taken just before bedtime.

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

Blood tests

• Zopiclone tablets may alter liver enzyme levels shown in blood tests. This may indicate impaired liver function.
• If a patient is scheduled for blood tests, it is important to inform the doctor about taking zopiclone.

Taking more ApoDream than prescribed
If a patient has taken too many tablets, they should contact their doctor or the nearest hospital emergency department immediately for advice. The medicine packaging should be taken along. This will allow the doctor to identify which medicine has been taken.
Overdosing on zopiclone can be very dangerous.
The following effects may occur:

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

If a dose of ApoDream is missed
Zopiclone should only be taken before bedtime. If a patient forgets to take the tablet before bedtime, they should not take it at any other time, otherwise they may experience daytime drowsiness, dizziness and disorientation. A double dose must not be taken to make up for a missed dose.

Stopping ApoDream treatment
Continue taking zopiclone until the doctor advises stopping treatment. Do not stop taking zopiclone suddenly, but inform the doctor if the patient wishes to discontinue treatment. The doctor will gradually reduce the dose to stop treatment slowly.
If zopiclone is stopped suddenly, sleep problems and adverse effects may occur. If this happens, the patient may experience some of the following symptoms. In such cases, contact the doctor immediately:

• feelings of anxiety, uneasiness, irritability, nervousness, disorientation or panic attacks,
• sweating,
• headache,
• faster heartbeat or irregular heartbeat (palpitations),
• reduced level of consciousness and difficulty concentrating or focusing,
• nightmares, seeing or hearing things that are not real (hallucinations),
• increased sensitivity to light, noise and touch,
• feeling detached from reality,
• numbness and tingling in hands and feet,
• muscle pain,
• stomach problems.

In rare cases, seizures (convulsions) may also occur.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking ApoDream and contact a doctor or go immediately to hospital if:
The patient experiences an allergic reaction. Symptoms may include: rash, difficulty swallowing
or breathing, swelling of the lips, face, throat or tongue.
You should contact a doctor as soon as possible if any of the following symptoms occur:
Rare (may affect 1 in 1,000 people)

• Memory impairment after taking zopiclone (amnesia). This problem is less likely if you have had 7–8 hours of uninterrupted sleep after taking zopiclone,
• Seeing or hearing things that are not real (hallucinations),
• Falls, especially in elderly patients.

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

• Thinking about things that are not true (delusions),
• Feelings of sadness or low mood (depressive mood).

You should inform your doctor or pharmacist if any of the following adverse effects
worsen or persist for more than a few days:
Common (may affect 1 in 10 people)

• Mildly bitter or metallic taste in the mouth,
• Drowsiness or somnolence,
• Dry mouth.

Uncommon (may affect 1 in 100 people)

• Nausea or vomiting,
• Dizziness,
• Headache,
• Nightmares,
• Feeling of physical or mental fatigue,
• Agitation.

Rare (may affect 1 in 1,000 people)

• Confusion,
• Itchy, lumpy rash (urticaria),
• Irritability or aggression,
• Decreased sexual drive,
• Breathing difficulties or shortness of breath.

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

• Feelings of anxiety or anger,
• Feeling of emptiness in the head or coordination problems,
• Double vision,
• Problems with movement or dizziness,
• Muscle weakness,
• Indigestion,
• Dependence on zopiclone,
• Slowed breathing (respiratory depression),
• Unusual skin sensations such as numbness, tingling, pricking, burning or crawling on the skin (paraesthesiae),
• Psychological problems such as poor memory, difficulty maintaining attention, or speech disturbances.

Sleepwalking and other unusual behaviours
After taking a sleeping medicine, patients have reported performing various activities while asleep, with no memory of these events the following day. These include driving and sleepwalking (walking during sleep). Alcohol and certain antidepressants or anti-anxiety medicines may increase the likelihood of such events.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine ApoDream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What ApoDream contains

• The active substance is zopiclone. Each coated tablet contains 7.5 mg of zopiclone.
• Other ingredients:
  Core: Lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch gelatinised, povidone (K-30), sodium carboxymethyl starch (type A), magnesium stearate.
  Coating: Hypromellose (6 cps), polyethylene glycol 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, embossed with the mark “Z” and “2” separated by a division line on one side and a division line on the other side. The tablet can be divided into equal doses.
ApoDream 7.5 mg, coated tablets, is available in blisters and in HDPE bottles, packed 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 dispensing).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 authorised in the European Economic Area countries under the following names:
Belgium: Zopiclone AB 7.5 mg filmomhulde tabletten
Germany: Zopiclon PUREN 3.75 mg/7.5 mg Filmtabletten
France: Zopiclone Arrow Lab 3.75 mg comprimé pelliculé
Zopiclone Arrow Lab 7.5 mg comprimé pelliculé sécable
Netherlands: Zopiclon Aurobindo 3.75 mg/7.5 mg, filmomhulde tabletten
Poland: ApoDream