Dobroson

Package leaflet: information for the patient

DOBROSON
(Zopiclone)
7.5 mg, film-coated tablets
Read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Dobroson is and what it is 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 Dobroson is and what it is used for

Zopiclone belongs to a group of medicines called cyclopyrrolones. The medicine has effects similar to benzodiazepines. Benzodiazepines and benzodiazepine-like substances should be used only in cases of severe disorders causing significant patient distress.
Zopiclone, the active substance in Dobroson, has sedative-hypnotic properties (sleeping tablets). The medicine causes drowsiness and is therefore used in the short-term treatment of insomnia.

2. Important information before using 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 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 relative to the body's needs),
  • sleep apnoea syndrome (sleep disorders characterised by breathing interruptions during sleep),
  • severe hepatic insufficiency.
• in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Dobroson, discuss it with your doctor or pharmacist.
General information
Before starting treatment with Dobroson:

• the cause of insomnia should be identified,
• any underlying illness should be treated.

Inform your doctor if the patient currently has or has previously had any of the following conditions or diseases, especially:

• chronic respiratory insufficiency (caused by breathing or heart problems). In such cases, the doctor will reduce the dose of the medicine due to the risk of respiratory depression,
• liver function disorders; in such cases, the doctor will reduce the dose of the medicine,
• psychosis (severe mental disorders characterised by personality disturbances and loss of contact with reality),
• depression,
• anxiety associated with depression,
• alcohol or drug abuse.

Your doctor will decide whether the patient should use Dobroson. During treatment, the doctor should closely monitor the patient.
Dependence and withdrawal symptoms:
The use of benzodiazepines and other substances similar to benzodiazepines may lead to physical and psychological dependence on these medicines. The risk of dependence increases if the dose used is high and the duration of treatment is long. The risk is also higher in patients who have previously abused alcohol or drugs and/or in patients with marked personality disorders.
If physical dependence occurs, abruptly stopping treatment may lead to withdrawal symptoms (see section 3 – How to use Dobroson).
Rebound insomnia
After stopping treatment with benzodiazepines or substances similar to benzodiazepines, a transient syndrome called "rebound insomnia" may occur. Insomnia may then return in a more severe form. Other possible symptoms include mood changes, anxiety, and restlessness. The risk of withdrawal or rebound symptoms is greater if treatment is stopped abruptly. Therefore, your doctor will recommend gradually reducing the dose of Dobroson.
Tolerance
The effect of some benzodiazepines and substances similar to benzodiazepines may diminish when the medicine is taken again after several weeks. This phenomenon is known as tolerance. Inform your doctor if the patient feels the medicine is no longer effective after re-starting treatment.
Short-term memory loss (anterograde amnesia)
Benzodiazepines and substances similar to benzodiazepines may cause short-term memory loss (anterograde amnesia). This usually occurs within a few hours after taking the medicine. To reduce the risk of this adverse effect, ensure that sleep remains uninterrupted for 7 to 8 hours after taking the medicine.
Psychological and paradoxical reactions
When using benzodiazepines and substances similar to benzodiazepines, the following reactions may occur:

• anxiety,
• agitation,
• irritability,
• aggression,
• false beliefs (delusions),
• rage attacks,
• nightmares,
• seeing, hearing or feeling things that do not exist (hallucinations),
• severe mental disorders characterised by personality disturbances and loss of contact with reality (psychoses),
• inappropriate behaviour,
• other behavioural disturbances. The risk of such symptoms is higher in children and elderly patients. If any of the above symptoms occur, stop treatment with Dobroson immediately. Consult your doctor for advice.

Sleepwalking and related behaviours
In patients taking zopiclone who were not fully awake, sleepwalking and other associated behaviours have been reported, such as sleep-driving, preparing and eating food, making phone calls, with amnesia regarding these events.
The risk of such behaviours is increased if:

• the patient consumes alcohol or other medicines (such as opioid painkillers, antipsychotics, hypnotics or anxiolytics/sedatives) during zopiclone treatment,
• zopiclone is used at doses exceeding the maximum recommended dose.

If such behaviours occur, inform your doctor immediately. The doctor may consider discontinuing zopiclone treatment.
Risk of falls
Due to the muscle-relaxant effect of zopiclone, there is a risk of falls, especially in elderly patients who get up during the night.

Dobroson 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.
The following medicines may enhance the effect of Dobroson:

• antipsychotics/neuroleptics (used to treat psychosis),
• hypnotics (used to treat insomnia),
• anxiolytics (used to treat anxiety),
• sedatives/tranquillisers (medicines that induce calmness and reduce anxiety),
• antidepressants (used to treat depression),
• opioid painkillers, such as morphine and morphine-like drugs (used to treat pain); these medicines may additionally cause excessive feelings of well-being (euphoria), which may lead to dependence. Concurrent use of Dobroson 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, concurrent use should only be considered when no other treatment options are available. If your doctor has prescribed Dobroson together with opioids, the dose and duration of concurrent treatment should be minimised. Inform your doctor about all opioid medicines you are taking and strictly follow dosing instructions. It may be helpful to inform family members or friends so they are aware of the above-mentioned symptoms. If such symptoms occur, contact your doctor immediately.
• anticonvulsants/antiepileptics (used to prevent epileptic seizures),
• anaesthetics (used to relieve pain, e.g. during surgery),
• sedating antihistamines (used to treat allergic reactions).

Concurrent use of Dobroson and muscle relaxants may enhance the muscle-relaxant effect.
The following medicines may enhance the effect of Dobroson, so a reduced dose of Dobroson may be necessary:

• macrolide antibiotics (used to treat bacterial infections), e.g. 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),
• St John's wort preparations (herbal remedy used to treat depression and anxiety).

Dobroson, food, drink, and alcohol
Do not consume alcoholic beverages during treatment with Dobroson. Alcohol may enhance the effect of this medicine, especially impairing the ability to drive or operate machinery.
Avoid drinking grapefruit juice during treatment. Grapefruit may enhance the effect of Dobroson.

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 her doctor or pharmacist before using this medicine.
The safety of using zopiclone during pregnancy or breastfeeding has not yet been established.
Pregnancy
Dobroson should not be used if the patient is pregnant. If zopiclone was used during the last three months of pregnancy or during delivery, the newborn may experience certain symptoms such as low body temperature (hypothermia), low blood pressure (hypotension), reduced muscle tone (hypotonia), slow or shallow breathing (respiratory depression), and reduced sucking reflex (floppy infant syndrome).
Withdrawal symptoms may occur in the newborn. This has been observed in infants whose mothers used zopiclone for a prolonged period during the last months of pregnancy.
Your doctor will prescribe Dobroson only after careful assessment of the risks and benefits of treatment.
Breastfeeding
Dobroson should not be used if a woman is breastfeeding, as zopiclone passes into breast milk.

Driving and operating machinery
The patient should not drive or operate machinery until treatment is completed or until it is established that the medicine does not impair the patient's psychomotor performance.
Dobroson may cause adverse effects that may affect the ability to drive or operate machinery, such as:

• drowsiness (sedation),
• memory loss (amnesia),
• concentration difficulties,
• impaired muscle function.

The risk of these effects is increased when alcohol is consumed simultaneously or if sleep duration is insufficient. These symptoms may persist into the following day.

Dobroson contains lactose (milk sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Dobroson

This medicine should always be used exactly as instructed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose of Dobroson:

Adults
The recommended dose is 7.5 mg of zopiclone. This dose should not be exceeded.

Use in children
Dobroson must not be used in patients under 18 years of age.

Elderly patients, patients with impaired liver or kidney function, or with chronic respiratory insufficiency (a condition in which gas exchange in the lungs is insufficient to meet the body's needs)
Treatment should be initiated at a dose of 3.75 mg of zopiclone.

Maximum dose of the medicine
The daily dose must not exceed 7.5 mg (1 coated tablet of Dobroson).

Tablets may be divided as follows:

• Place the tablet on a flat surface,
• Press with the left and right thumbs or index fingers on both sides of the dividing groove. The tablet can be split into equal doses.

Dobroson should be taken immediately before bedtime. Ensure uninterrupted sleep for 7 to 8 hours. Swallow the tablet with a glass of water.

Duration of treatment
Treatment with Dobroson should be as short as possible. The treatment period usually lasts from several days to 2 weeks. Your doctor will explain how to gradually reduce the dose at the end of treatment (during discontinuation). This approach reduces the risk of withdrawal symptoms or rebound effects (see section 2 "Warnings and precautions").

Dobroson should not be used for longer than 4 weeks, including the tapering period. If symptoms do not improve within this time, consult your doctor for advice.

Taking more than the recommended dose of Dobroson
If an excessive number of tablets has been taken, contact your doctor or the nearest hospital emergency department immediately.

Overdose of Dobroson, especially when taken together with other medicines that depress the central nervous system or with alcohol, may be life-threatening.

Overdose of benzodiazepines and benzodiazepine-like substances usually causes depression of the central nervous system, with increasing symptoms of drowsiness, progressing to coma. The most common symptoms include dizziness, lack of energy (lethargy), and difficulty in coordinating muscle movements (ataxia).

Missed dose of Dobroson
If the patient realizes they have forgotten to take the medicine but can still sleep for 7 to 8 hours, they should take the dose immediately. If the available time for sleep is shorter, the missed dose should be skipped, and the next dose should not be taken until the following day, before bedtime. Never take a double dose to make up for a missed tablet.

Stopping Dobroson treatment
Abruptly stopping treatment may cause withdrawal symptoms or rebound effects. Withdrawal symptoms may include:

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

In severe cases, the following withdrawal symptoms may occur:

• altered perception of the world, feeling strange and unreal (derealization),
• loss of sense of self-identity, followed by feelings of unreality and detachment (depersonalization),
• increased sensitivity to sound (auditory hyperesthesia),
• numbness and tingling in hands and feet,
• increased sensitivity to light, noise, or touch,
• seeing, hearing, or feeling things that are not there (hallucinations),
• seizures.

The risk of such symptoms is higher if the medicine has been used at high doses and for a prolonged period. Therefore, your doctor will advise you on how to gradually reduce the dose.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The most commonly reported adverse effect of zopiclone is a bitter or metallic taste.
The following adverse effects have been observed in patients treated with zopiclone.

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

• Bitter or metallic taste (taste disturbances).

Common (may affect up to 1 in 10 people)

• Drowsiness the following day,
• Reduced alertness,
• Headache,
• Dizziness,
• Gastrointestinal problems, including nausea and vomiting.

Uncommon (may affect more than 1 in 1,000 people)

• Slight or moderate increase in the activity of certain liver enzymes (serum aminotransferases or alkaline phosphatase),
• Memory loss (amnesia),
• Coordination disturbances,
• Difficulty in muscle coordination (ataxia), usually occurring at the beginning of treatment and usually resolving during continued use,
• Mild dizziness,
• Double vision, usually occurring at the beginning of treatment and usually resolving during continued use,
• Dry mouth,
• Skin reactions, including urticaria,
• Muscle weakness,
• Risk of falls, particularly in elderly patients (see also section “Warnings and precautions”),
• Feeling of fatigue,
• Blunted sensation,
• Disorientation,
• Depression,
• So-called paradoxical reactions, such as:
  • Anxiety,
  • Stimulation,
  • Irritability,
  • Aggression,
  • False beliefs (delusions),
  • Rage attacks,
  • Nightmares,
  • Seeing, hearing or feeling things that are not there (hallucinations),
  • Severe psychiatric disturbances characterized by personality disorders and loss of contact with reality (psychoses),
  • Inappropriate behaviours and other behavioural disturbances.

Rare (may affect more than 1 in 10,000 people)

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

Not known ( frequency cannot be estimated from the available data):

• Physical and psychological dependence,
• Somnambulism (sleepwalking and other related behaviours; see also section 2 “Warnings and precautions”).

Even when taken according to instructions, (transient) memory loss may occur, sometimes accompanied by inappropriate behaviour. The risk of this is higher when higher doses are used.
Depression that previously existed may become apparent during treatment with Dobroson.
Treatment with Dobroson may lead to physical and psychological dependence, and discontinuation of treatment may result in withdrawal reactions or rebound insomnia. See also section 2 “Warnings and precautions”.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 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 Dobroson

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack following the words
"Expiry date". The expiry date refers to the last day of the stated month.
Do not store above 25 °C.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What Dobroson contains

• The active substance in this medicine is zopiclone. Each coated tablet contains 7.5 mg of zopiclone.
• The other ingredients are:
  • monohydrate lactose,
  • calcium hydrogen phosphate dihydrate,
  • maize 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 an imprint "ZOC 7.5" on one side and score lines on both sides.
Dobroson is available in cardboard packs containing 20 tablets (2 blisters PVC/PVDC/Aluminium, containing 10 tablets each), 30 tablets (3 blisters PVC/PVDC/Aluminium, containing 10 tablets each), 60 tablets (6 blisters PVC/PVDC/Aluminium, containing 10 tablets each), or in HDPE bottles containing 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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, The Netherlands
Synthon Hispania, s.l., C/Castelló, 1 Poligono Las Salinas, 08830 Sant Boi de Llobregat, Barcelona, Spain

This medicinal product is authorised 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