Dobroson

Package Leaflet: Information for the Patient

DOBROSON

(Zopiclone)
7.5 mg, coated tablets

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of 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 those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Dobroson and what is it used for

Zopiclone belongs to a group of medicines called cyclopyrrolones. The medicine has properties similar to benzodiazepines. Benzodiazepines and substances similar to benzodiazepines should only be used in cases of severe disorders that cause significant exhaustion of the patient. Zopiclone, the active substance of Dobroson, has a sedative effect (sleeping tablets). The medicine causes drowsiness and is used for short-term treatment of insomnia.

2. Important information before taking Dobroson

When not to take Dobroson:

• if the patient is allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6).
• if the patient has any of the following diseases:
• severe muscle weakness called myasthenia (an autoimmune disease),
• severe respiratory failure (a condition in which gas exchange in the lungs is insufficient for the body's needs),
• sleep apnea syndrome (sleep disorders characterized by pauses in breathing during sleep),
• severe liver failure.
• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to take Dobroson, the patient should discuss it with their doctor or pharmacist. General information: before starting treatment with Dobroson:

• the cause of insomnia should be determined,
• the underlying disease should be treated.

The patient should inform their doctor if they have or have had any of the following conditions or diseases, especially:

• chronic respiratory failure (caused by breathing or heart problems). In this case, the doctor will reduce the dose of the medicine due to the risk of respiratory depression,
• liver function disorders; in this case, the doctor will reduce the dose of the medicine,
• psychoses (severe mental disorders, characterized by personality disorders and loss of contact with reality),
• depression,
• anxiety associated with depression,
• alcohol or drug abuse.

The doctor will decide whether the patient should take Dobroson. During treatment, the doctor should carefully monitor the patient. Dependence and withdrawal symptoms: the use of benzodiazepines and other substances similar to benzodiazepines may cause physical and psychological dependence on these medicines. The risk of dependence increases if the dose of the medicine is high and the treatment is long. Additionally, it is higher in patients who have abused alcohol or drugs in the past and (or) in patients with significant personality disorders. If physical dependence occurs, sudden cessation of treatment may cause withdrawal symptoms (see section 3 - How to take Dobroson). Rebound insomnia: after stopping treatment with benzodiazepines or substances similar to benzodiazepines, a transient syndrome may occur, which is called rebound insomnia. Insomnia may then return in a more severe form. Other symptoms that may occur include mood changes, anxiety, and restlessness. The risk of withdrawal symptoms or rebound is higher if treatment is stopped abruptly. Therefore, the doctor will advise the patient to gradually reduce the dose of Dobroson. Tolerance: the effect of some benzodiazepines and substances similar to benzodiazepines may weaken when the medicine is reused after a few weeks. This phenomenon is called tolerance. The patient should inform their doctor if they feel that the effect of the medicine is too weak after reusing it. Anterograde amnesia (retrograde amnesia): benzodiazepines and substances similar to benzodiazepines may cause anterograde amnesia (retrograde amnesia). This occurs especially within a few hours of taking the medicine. To reduce the risk of this side effect, the patient should ensure that they have uninterrupted sleep for 7 to 8 hours after taking the medicine. Psychiatric and paradoxical reactions: during the use of benzodiazepines and substances similar to benzodiazepines, the following reactions may occur:

• anxiety,
• agitation,
• irritability,
• aggression,
• delusions,
• fits of rage,
• nightmares,
• seeing, hearing, or feeling things that do not exist (hallucinations),
• severe mental disorders, characterized by personality disorders and loss of contact with reality (psychoses),
• inappropriate behavior,
• other behavioral disorders. The risk of such symptoms is higher in children and elderly patients. If the patient experiences any of the above symptoms, they should stop taking Dobroson and consult their doctor.

Somnambulism (sleepwalking) and related behaviors: in patients taking zopiclone who were not fully awake, sleepwalking and other related behaviors have been reported, such as driving a car while asleep, preparing and eating food, making phone calls, with amnesia for these events. The risk of such behaviors is increased if:

• the patient consumes alcohol or other medicines (such as opioid painkillers, antipsychotics, sleeping pills, or anxiolytic/sedative medicines) during treatment with zopiclone,
• zopiclone is used in doses exceeding the maximum recommended dose.

If such behaviors occur, the patient should immediately inform their doctor. The doctor may consider stopping treatment with zopiclone. Risk of falls: due to the muscle relaxant effect of zopiclone, there is a risk of falls, especially in elderly patients who get up at night.

Dobroson and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The following medicines may enhance the effect of Dobroson:

• antipsychotic/neuroleptic medicines (used to treat psychoses),
• sleeping pills (used to treat insomnia),
• anxiolytic medicines (used to treat anxiety),
• sedative/tranquilizer medicines (medicines that induce a feeling of calm and reduce anxiety),
• antidepressant medicines (used to treat depression),
• opioid painkillers, such as morphine and morphine-like medicines (used to treat pain); these medicines may also cause excessive happiness (euphoria) and may lead to dependence. Concomitant use of Dobroson and opioids (strong painkillers, substitution 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. If the doctor prescribes Dobroson in combination with opioids, they should limit the dose and duration of concomitant treatment. 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 relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.
• antiepileptic/anticonvulsant medicines (used to prevent epileptic seizures),
• anesthetic medicines (used to prevent pain, e.g., during surgery),
• antihistamine medicines with a sedative effect (used to treat allergic reactions).

Concomitant use of Dobroson and muscle relaxant medicines may enhance the muscle relaxant effect. The following medicines may enhance the effect of Dobroson, and it may be necessary to reduce the dose of concomitantly taken Dobroson:

• macrolide antibiotics (used to treat bacterial infections), such as erythromycin,
• azole antifungals (used to treat fungal infections),
• HIV protease inhibitors (used to treat AIDS).

The following medicines may reduce the effect of Dobroson:

• phenobarbital and phenytoin (used to treat seizures),
• carbamazepine (used to treat seizures and mood disorders),
• rifampicin (an antibiotic),
• preparations containing St. John's Wort (a herb used to treat depression and anxiety).

Dobroson with food, drink, and alcohol

During treatment with Dobroson, the patient should not consume alcoholic beverages. Alcohol may enhance the effect of this medicine, especially impairing the ability to drive vehicles or operate machinery. During treatment, the patient should avoid drinking grapefruit juice. Grapefruit may enhance the effect of Dobroson.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The safety of zopiclone during pregnancy or breastfeeding has not been established. Pregnancy: Dobroson should not be taken during pregnancy. If the patient took zopiclone during the last three months of pregnancy or during childbirth, the newborn may experience certain symptoms, such as low body temperature (hypothermia), low blood pressure (hypotension), low muscle tone (hypotonia), slow or shallow breathing (respiratory depression), and reduced sucking reflex in the child (floppy infant syndrome). The newborn may experience withdrawal symptoms. This has been observed in children of mothers who took zopiclone for a long time during the last months of pregnancy. The doctor will prescribe Dobroson only after careful assessment of the risks and benefits of taking the medicine. Breastfeeding: Dobroson should not be taken during breastfeeding, as zopiclone passes into breast milk.

Driving and using machines

The patient should not drive vehicles or operate machinery until treatment is completed or until it is established that the medicine does not impair their physical and mental abilities. Dobroson may cause side effects that may affect the ability to drive vehicles or operate machinery, such as:

• drowsiness,
• memory loss,
• concentration disorders,
• muscle function disorders.

The risk of these symptoms increases if alcohol is consumed or if the patient does not get enough sleep. These symptoms may occur in the patient even the next day.

Dobroson contains lactose

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

Dobroson contains sodium

Each tablet contains less than 1 mmol of sodium (23 mg), which means the medicine is considered "sodium-free".

3. How to take Dobroson

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose of Dobroson is: Adults: the recommended dose is 7.5 mg of zopiclone. This dose should not be exceeded. Use in children: Dobroson should not be taken by patients under 18 years of age. Elderly patients, including those with liver or kidney function disorders, or chronic respiratory failure (a condition in which gas exchange in the lungs is insufficient for the body's needs): treatment should be started with a dose of 3.75 mg of zopiclone. Maximum dose: the daily dose should not exceed 7.5 mg (1 coated tablet of Dobroson). Tablets can be divided as follows:

• place the tablet on a table,
• press the tablet on both sides of the dividing line with the left and right thumbs or index fingers. The tablet can be divided into equal doses.

Dobroson should be taken immediately before bedtime. The patient should ensure uninterrupted sleep for 7 to 8 hours. The tablet should be swallowed with a glass of water.

Duration of treatment

Treatment with Dobroson should be as short as possible. The treatment period usually lasts from a few days to 2 weeks. The doctor will explain to the patient how to gradually reduce the dose of the medicine at the end of treatment (during withdrawal of the medicine). This approach reduces the risk of withdrawal symptoms or rebound (see section 2 "Warnings and precautions"). Dobroson should not be taken for more than 4 weeks, including the period of dose reduction. If the symptoms of the disease do not disappear within this time, the patient should consult their doctor.

Overdose of Dobroson

In case of taking too many tablets, the patient should immediately contact their doctor or the emergency department of the nearest hospital. Overdose of Dobroson during concomitant use with certain other medicines may be life-threatening. This applies to medicines that have a depressant effect on the central nervous system and alcohol. Overdose of benzodiazepines and substances similar to benzodiazepines usually causes depression of the central nervous system with increasing symptoms of drowsiness, up to coma. The most common symptoms are dizziness, lack of energy (lethargy), and coordination disorders (ataxia).

Missed dose of Dobroson

If the patient realizes they have forgotten to take the medicine, but they can still sleep for 7 to 8 hours, they should take the medicine immediately. If the time they can sleep is shorter, they should skip this dose and not take the next dose until the next day, before bedtime. The patient should never take a double dose to make up for a missed tablet.

Stopping treatment with Dobroson

Sudden cessation of treatment may cause withdrawal symptoms or rebound. Withdrawal symptoms may include:

• headaches,
• muscle pain,
• severe anxiety,
• tension,
• restlessness,
• disorientation,
• irritability.

In severe cases, the following withdrawal symptoms may occur:

• change in the way the world is perceived, which seems strange and unreal (derealization),
• loss of identity and feeling of unreality and strangeness (depersonalization),
• increased sensitivity to sound (hyperacusis),
• numbness and tingling of hands and feet,
• increased sensitivity to light, noise, or touch,
• seeing, hearing, or feeling things that do not exist (hallucinations),
• seizures.

The risk of such symptoms is higher if the medicine is used in high doses and for a long time. Therefore, the doctor will advise the patient on how to gradually reduce the dose of the medicine. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dobroson can cause side effects, although not everybody gets them. The most common side effect of zopiclone is a bitter or metallic taste. The following side effects have been observed in patients treated with zopiclone.

Very common (may affect more than 1 in 10 people)

• bitter or metallic taste (taste disorders).

Common (may affect up to 1 in 10 people)

• drowsiness the next day,
• reduced alertness,
• headache,
• dizziness,
• gastrointestinal problems, including nausea (nausea) and vomiting.

Uncommon (may affect up to 1 in 100 people)

• mild or moderate increase in the activity of certain liver enzymes (aminotransferases in serum or alkaline phosphatase),
• memory loss (amnesia),
• coordination disorders,
• difficulty in coordinating muscle movements (ataxia), usually occurring at the beginning of treatment and usually disappearing during continued use of the medicine,
• mild dizziness,
• double vision, usually occurring at the beginning of treatment and usually disappearing during continued use of the medicine,
• dry mouth,
• skin reactions, including urticaria,
• muscle weakness,
• risk of falls, especially in elderly patients (see also section "Warnings and precautions")
• feeling of fatigue,
• numbness,
• disorientation,
• depression,
• so-called paradoxical reactions, such as:
• anxiety,
• agitation,
• irritability,
• aggression,
• delusions,
• fits of rage,
• nightmares,
• seeing, hearing, or feeling things that do not exist (hallucinations),
• severe mental disorders, characterized by personality disorders and loss of contact with reality (psychoses),
• inappropriate behavior,
• other behavioral disorders.

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

• swelling of the face, lips, or tongue associated with difficulty swallowing or breathing (angioedema),
• severe allergic reactions (anaphylactic reactions),
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome, erythema multiforme),
• change in libido.

Unknown (frequency cannot be estimated from the available data):

• physical and psychological dependence,
• somnambulism (sleepwalking and other related behaviors; see also section 2 "Warnings and precautions").

Even if the medicine is taken by the patient according to the instructions, anterograde amnesia (retrograde amnesia) may occur, sometimes accompanied by inappropriate behavior. The risk of its occurrence is higher when using high doses. During treatment with Dobroson, depression that existed before may become apparent. Taking Dobroson may cause physical and psychological dependence, and stopping treatment may cause withdrawal symptoms or rebound. The patient should also read section 2 "Warnings and precautions".

Reporting side effects

If the patient experiences any side effects, including those not listed in this 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 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dobroson

The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack after the term "Expiry date". The expiry date refers to the last day of the month stated. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dobroson contains

• The active substance of Dobroson is zopiclone. Each coated tablet contains 7.5 mg of zopiclone.
• The other ingredients of the medicine are:
• calcium hydrogen phosphate dihydrate,
• corn starch,
• sodium carmellose,
• magnesium stearate,
• titanium dioxide (E171),
• hypromellose.

What Dobroson looks like and contents of the pack

Dobroson coated tablets are white, round, biconvex, with the inscription "ZOC 7,5" on one side and a dividing line on both sides. Dobroson is available in cardboard boxes containing 20 tablets (2 PVC/PVDC/Aluminum blisters, each containing 10 tablets), 30 tablets (3 PVC/PVDC/Aluminum blisters, each containing 10 tablets), or 60 tablets (6 PVC/PVDC/Aluminum blisters, each containing 10 tablets). Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany, Centrafarm Services B.V., Nieuwe Donk 9, 4879, AC Etten-Leur, Netherlands, Synthon Hispania, s.l., C/Castelló, 1 Poligono Las Salinas, 08830 Sant Boi de Llobregat, Barcelona, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AT: Somnal® 7,5 mg – Filmtabletten, BE: Zopiclone EG 7,5mg filmomhulde tabletten, DE: Zopiclon STADA 7,5 mg Filmtabletten, DK: Zopiclon Stada, ES: Zopicalma 7.5 mg comprimidos recubiertos, FR: Zopiclone EG 7,5 mg, comprimé pelliculé sécable, IT: Zopiclone EG® 7,5 mg Compresse Rivestite con Film, LU: Zopiclone EG, NL: Zopiclone CF 7,5 mg, tabletten, PL: Dobroson, SE: Zopiclon Stada, Date of last revision of the leaflet:09.06.2021