Zopitin 7,5 mg tabletki povlekane

Package Leaflet: Information for the Patient

Zopitin 7.5 mg Coated Tablets

Zopiclone

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you. 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 or any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Zopitin and what is it used for

The active substance of Zopitin is zopiclone, which is a hypnotic acting on the central nervous system. The medicine facilitates falling asleep and continuing sleep. The hypnotic effect of the medicine occurs within 15-20 minutes.
Zopitin is indicated only for the short-term treatment of insomnia.

2. Important information before taking Zopitin

When not to take Zopitin:

• if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6).
• if you have severe muscle weakness (myasthenia gravis);
• if you have severe sleep apnea syndrome;
• if you have severe respiratory failure;
• if you have severe liver failure.

Warnings and precautions

Before taking the medicine, consult your doctor or pharmacist.
In case of long-term use of Zopitin, the efficacy of the medicine decreases and dependence may occur. Therefore, the medicine should be used for as short a period as possible (usually a few days) and not longer than 4 weeks.
In case of long-term use, do not stop treatment abruptly, as this may cause insomnia, headache, muscle pain, anxiety, tension, restlessness, and irritability.
In case of long-term therapy, the medicine should be gradually discontinued. Zopitin may cause transient memory loss. To reduce the risk of memory loss, the patient should ensure that they take the tablet directly before going to bed and have uninterrupted sleep lasting from 7 to 8 hours.
In some patients, the effect of Zopitin may be stronger. The recommended dose for elderly or weakened patients, patients with liver or kidney disorders or respiratory failure is 3.75 mg (half a tablet).

Use in children

The product is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zopitin

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription. The hypnotic effect of Zopitin is enhanced by:

• other sedatives;
• sleeping pills, antipsychotics, antidepressants, or antiepileptics;
• strong painkillers;
• antihistamines.

The way Zopitin works and its safety may change if it is taken with other medicines. Therefore, before prescribing the medicine, tell your doctor if you are taking any of the following medicines:

• certain antifungal medicines (ketoconazole, itraconazole);
• certain antibiotics (e.g., erythromycin, clarithromycin);
• certain antiviral medicines (e.g., ritonavir);
• certain antidepressants (e.g., nefazodone).

Taking Zopitin and opioids (strong painkillers, substitution therapy, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Zopitin with opioids, your doctor should limit the dose and duration of concurrent treatment.
Tell your doctor about all the opioid medicines you are taking and follow your doctor's instructions for dosing. It may be helpful to inform friends or relatives to be aware of the above signs and symptoms. If such symptoms occur, contact your doctor.

Zopitin with food, drink, and alcohol

Zopitin tablets should be taken with a sufficient amount of water. The medicine can also be taken with food. Do not drink alcohol while taking Zopitin, as alcohol increases the inhibitory effect of the medicine on the central nervous system and impairs its function.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.
Zopitin should not be taken during pregnancy or breastfeeding.

Driving and using machines

Zopitin impairs the ability to drive and perform tasks that require precision.
Avoid driving for at least 8 hours after taking zopiclone.

3. How to take Zopitin 7.5 mg Coated Tablets

Zopitin should always be taken exactly as directed by your doctor. If you have any doubts about taking the medicine, consult your doctor or pharmacist.
Dosage and treatment duration are determined individually. The recommended dose for adults is 1 tablet taken just before bedtime, and the maximum recommended treatment duration is 4 weeks.
However, your doctor may decide on a different, individually tailored treatment duration and dose, which may be different from 1 tablet before bedtime. Take the medicine exactly as directed by your doctor. Do not change the dose yourself.
The tablet can be divided into 2 equal parts.

Use in children

Zopitin should not be taken by children.

Overdose of Zopitin

In case of overdose or poisoning, seek medical attention immediately.
To reduce zopiclone absorption, activated charcoal can be given.
For more information on taking the medicine, consult your doctor or pharmacist.

Missing a dose of Zopitin

Do not take a double dose to make up for a missed dose.
Zopitin should only be taken when necessary, i.e., to fall asleep. If you forgot to take zopiclone before going to bed and cannot fall asleep, you can take a tablet then. However, make sure you can sleep for 7 to 8 hours. Otherwise, do not take the medicine.

Stopping Zopitin treatment

In case of a 7.5 mg dose, it is recommended to gradually discontinue Zopitin. The next evening, take only half a tablet. If the dose of the medicine is less than 7.5 mg, it is unlikely that abrupt cessation of the medicine will cause difficulties in falling asleep.
If you have any questions about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zopitin can cause side effects, although not everybody gets them.
Frequent(occurring in more than 1 in 100 patients):
bitter or metallic taste in the mouth, dry mouth, next-morning fatigue after taking the medicine.
Infrequent(occurring in less than 1 in 100 patients):
nightmares, restlessness, headache, dizziness, nausea, vomiting, indigestion, fatigue.
Rare(occurring in less than 1 in 1,000 patients):
allergic reactions, rash, itching, memory loss, hallucinations, irritability, aggression, disorientation, depression, sexual dysfunction, worsening of insomnia, and falls (mainly in elderly patients).
Very rare(occurring in less than 1 in 10,000 patients):
anaphylactic reactions, facial, lip, throat, or tongue swelling (angioedema), mild to moderate increase in transaminase and (or) alkaline phosphatase activity.
Unknown(frequency cannot be estimated from the available data):
restlessness, hallucinations, anger, behavioral disorders (may occur with amnesia), sleepwalking, dependence, and withdrawal symptoms, ataxia, double vision, muscle weakness.
Side effects are dose-dependent and usually occur at the beginning of treatment and disappear with dose reduction. Continuous use of the medicine leads to dependence and reduced efficacy of the medicine.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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, you can help provide more information on the safety of this medicine.

5. How to store Zopitin 7.5 mg Coated Tablets

• Keep the medicine out of the sight and reach of children.
• Do not store above 25°C.
• 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. This will help protect the environment.

6. Contents of the pack and other information

What Zopitin contains

• The active substance is zopiclone. One coated tablet contains 7.5 mg of zopiclone.
• The other ingredients are: tablet core: microcrystalline cellulose, maize starch, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, magnesium stearate; tablet coating: polyvinyl alcohol, titanium dioxide (E 171), talc, indigo carmine (E 132), macrogol 4000.

What Zopitin looks like and contents of the pack

What Zopitin looks like
Zopitin is a light blue, capsule-shaped, biconvex coated tablet with a score line, 10.0 mm long and 5.0 mm wide.
Pack sizes: 10, 20, 30, 90, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Vitabalans Oy, Varastokatu 8, FI-13500 Hämeenlinna, Finland
Date of last revision of the leaflet: 5.10.2023.