Senzop

SENZOP, 7.5 mg, coated tablets

(Zopiclone)

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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Senzop and what is it used for

Senzop is a hypnotic drug from the cyclopyrrolone derivative group, acting similarly to benzodiazepines.
Senzop facilitates falling asleep, reduces the number of nocturnal awakenings, prolongs sleep duration, and improves both sleep quality and post-awakening well-being. Like other hypnotic zopiclone drugs, it shortens stage I sleep (drowsiness), prolongs stage II (light sleep), but unlike these drugs, it also prolongs stages III and IV (deep sleep).

Indications for use

Short-term treatment of insomnia in adults - transient, short-term, or chronic (including difficulty falling asleep, fragmented sleep, early morning awakening).

2. Important information before taking Senzop

When not to take Senzop:

• if the patient is hypersensitive to the active substance (zopiclone) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has myasthenia gravis;
• if the patient has severe sleep apnea syndrome;
• if the patient has respiratory failure;
• if the patient has severe liver failure.

Warnings and precautions

Before starting treatment with Senzop, discuss it with your doctor, pharmacist, or nurse.
Caution should be exercised when administering the medicine to patients:

• of advanced age;
• with mental disorders;
• who have abused drugs in the past or present;
• with liver or kidney failure;
• with acute respiratory failure. In each such case, the doctor will recommend appropriate dosing - see section 3 (How to take Senzop).

Since the hypnotic effect of Senzop occurs quickly (within 15 to 20 minutes), the dose should be taken shortly before bedtime. Senzop should not be used as the only treatment for patients with psychosis or severe depression. In these patients, as well as in all patients with insomnia, the underlying disease and factors should be treated first.
In patients taking Senzop, psychic and paradoxical reactions have been observed - see section 4 (Possible side effects).

Tolerance

The effectiveness of benzodiazepines and benzodiazepine-like drugs may decrease during continuous treatment lasting several weeks. However, the use of Senzop for a period not exceeding 4 weeks did not lead to the development of tolerance.

Dependence

The risk of dependence cannot be excluded. It increases with the dose and duration of therapy. The risk of dependence should be considered in patients who have abused alcohol and/or drugs in the past. If dependence develops, the doctor will recommend gradual discontinuation of Senzop therapy to avoid withdrawal symptoms.
Withdrawal symptoms include: headache, muscle pain, severe anxiety, tension, restlessness, confusion (disorientation), and irritability. In severe cases, the following symptoms may occur: derealization (feeling of strangeness), depersonalization (loss of identity), hyperacusis, paresthesia of limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures.
If the treatment period was a maximum of 4 weeks, the occurrence of withdrawal symptoms when stopping treatment is unlikely, but patients may benefit from gradual withdrawal from therapy.
During regular use of benzodiazepines and similar short-acting drugs, withdrawal symptoms may occur between doses, especially when the drug doses were high.

Rebound insomnia

This is a transient event, consisting of the occurrence of symptoms that led to the initiation of benzodiazepine or benzodiazepine-like drug treatment. It returns in an intensified form after discontinuation of treatment.
Other symptoms may also occur: mood changes, restlessness, and agitation. Since the risk of withdrawal symptoms and rebound insomnia is higher after prolonged treatment or sudden discontinuation of the drug, it is recommended to gradually reduce the dose.

Amnesia

Anterograde amnesia (memory loss) may occur. To reduce the risk of amnesia, patients should take the tablets only before going to bed and ensure uninterrupted sleep for 7-8 hours.

Somnambulism and similar behaviors

In patients who took zopiclone and did not wake up completely, the following disorders may occur: sleepwalking and related behavioral disorders, such as driving while asleep, preparing and eating food, making phone calls while asleep with no memory of the actions performed.
Drinking alcohol or taking drugs with a central nervous system depressant effect in combination with zopiclone increases the risk of such behaviors, as does the use of zopiclone in doses exceeding the maximum recommended dose. In patients reporting such behaviors, it is recommended to discontinue zopiclone.

Children and adolescents

The safe and effective dose of the medicine has not been established in children and adolescents under 18 years of age.

Senzop and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
The following medicines may increase the sedative effect of Senzop on the central nervous system (CNS):

• other hypnotic drugs;
• antipsychotic drugs;
• anxiolytic drugs;
• antidepressant drugs;
• antiepileptic drugs;
• antihistamine drugs (used in allergies) with a sedative effect;
• narcotic analgesic drugs, including opioids and morphine derivatives (used as analgesics, antitussives, and for the treatment of withdrawal symptoms).

Drugs that accelerate gastric emptying may affect the absorption of Senzop.
Drugs such as ketoconazole, erythromycin, clarithromycin, itraconazole, ritonavir, and nefazodone, which inhibit the metabolism of zopiclone in the body, may enhance its effect.
Erythromycin accelerates the absorption of zopiclone and may enhance its sedative effect.
The concentration of zopiclone in the blood may be reduced when taking drugs such as:

• rifampicin;
• carbamazepine, phenobarbital, phenytoin (antiepileptic drugs);
• St. John's Wort (Hypericum perforatum). In such a situation, the doctor may increase the dose of Senzop.

Concomitant use of Senzop and opioids (strong analgesics, drugs used in substitution therapy, and some antitussive drugs) increases the risk of sedation, respiratory difficulties (respiratory failure), coma, and can be life-threatening. For this reason, concomitant use of these drugs can only be considered when other treatment options are not possible.
If, however, the doctor prescribes Senzop with opioids, the dose and duration of concomitant treatment should be limited.
You should inform your doctor about all opioids you are taking and strictly follow their instructions.
It may be helpful to inform friends or relatives about the above symptoms. If such symptoms occur, you should contact your doctor.

Senzop with food, drink, and alcohol

You should avoid drinking alcohol while taking Senzop. Alcohol enhances the sedative effect of zopiclone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Senzop during pregnancy and breastfeeding.
If you suspect you are pregnant or plan to become pregnant, you should contact your doctor to stop taking Senzop.

Driving and using machines

Due to its sedative effect, Senzop affects the ability to drive and use machines. You should avoid driving and performing tasks that require special concentration for at least 8 hours after taking the medicine.
Senzop contains lactose monohydrate.If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Senzop.

3. How to take Senzop

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine shortly before bedtime.
The recommended dose is 7.5 mg, taken orally before bedtime. Do not exceed this dose.
In elderly patients and in patients with liver dysfunction or chronic respiratory failure, treatment should be started with a dose of 3.75 mg (½ tablet). The dose can be increased to 7.5 mg (1 tablet) only if necessary and if the patient tolerates the medicine well.
Although renal impairment does not lead to accumulation of zopiclone in the body, it is recommended to start treatment with a dose of 3.75 mg (½ tablet) per day in such cases as well.
The dividing line on the tablet makes it easier to divide it into equal doses.

Use in children and adolescents

The safe and effective dose of the medicine has not been established in children and adolescents under 18 years of age.
Method of administration: swallow the tablets whole, with a small amount of liquid. Take in the evening, immediately before bedtime.
Duration of treatment:

• transient insomnia: 2 to 5 days;
• short-term insomnia: 2 to 3 weeks.

Overdose of Senzop

Overdose is characterized by central nervous system depression: sedation, dizziness, confusion, lethargy, decreased blood pressure, respiratory disorders, coma, ataxia (loss of coordination), and loss of consciousness, depending on the dose. Overdose is usually not life-threatening unless it occurs in combination with other central nervous system depressants (including alcohol).
Other risk factors, such as underlying disease or poor general condition of the patient, may contribute to the severity of symptoms. Very rarely, they can lead to death.
Treatment of overdose involves administration of activated charcoal as soon as possible. Particular attention should be paid to the patient's respiratory and cardiovascular function. Flumazenil can be given as an antidote. Hemodialysis is not effective in treating zopiclone overdose. Gastric lavage may be useful only if performed immediately after zopiclone ingestion.

Missed dose of Senzop

Do not take a double dose to make up for a forgotten dose.

Stopping Senzop treatment

Especially after long-term use or sudden discontinuation of zopiclone, withdrawal symptoms and rebound insomnia may occur. For this reason, it is recommended to gradually reduce the dose.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects associated with zopiclone are: bitter taste, dry mouth, and morning fatigue after the dose taken.

Side effects may occur with the following frequency:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

Gastrointestinal disorders:
common: bitter or metallic taste in the mouth, dry mouth;
uncommon: nausea, vomiting, indigestion.
General disorders and administration site conditions:
common: next-day fatigue;
uncommon: headache, dizziness;
rare: generalized allergic reactions;
very rare: angioedema.
Psychiatric disorders:
rare: withdrawal symptoms, rebound insomnia or worsening of insomnia, worsening of depression;
very rare: anterograde amnesia, nightmares, hallucinations, and behavioral disorders such as irritability, aggression, confusion, or depression, sexual disorders, psychic and paradoxical reactions, psychotic symptoms, and irrational behavior possibly related to amnesia.
Skin and subcutaneous tissue disorders:
rare: rash, itching;
very rare: anaphylactic reactions.
Investigations:
very rare: slight or moderate increase in transaminase and/or alkaline phosphatase activity.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Aleje 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, you can help provide more information on the safety of this medicine.

5. How to store Senzop

Store in a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Senzop contains

• The active substance is zopiclone. One coated tablet contains 7.5 mg of zopiclone.
• The other ingredients are: calcium hydrogen phosphate dihydrate, lactose monohydrate, maize starch, sodium carboxymethyl starch (type A), magnesium stearate. The coating contains: hypromellose, propylene glycol, talc, titanium dioxide (E 171).

What Senzop looks like and contents of the pack

Senzop is a white, round, biconvex coated tablet.
One side of the tablet has a score line that allows it to be divided into equal doses.
The pack contains 20 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Pharmaceutical Company Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Date of last revision of the leaflet: