Zopitin 7.5 mg coated tablets

Package leaflet: Information for the patient

Zopitin 7.5 mg film-coated tablets
Zopiclone
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If any of the side effects worsens, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Zopitin is and what it is used for
2. What you need to know 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 Zopitin is and what it is used for

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

2. Important information before using Zopitin

When not to use Zopitin:

• if the patient is allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a severe form of muscle weakness (myasthenia gravis);
• if the patient has a severe form of sleep apnoea syndrome;
• if the patient has severe respiratory insufficiency;
• if the patient has severe hepatic insufficiency.

Warnings and precautions
Before taking Zopitin, consult a doctor or pharmacist.
With prolonged use of Zopitin, the effectiveness of the medicine decreases and dependence may occur. Therefore, the medicine should be used for as short a time as possible (usually a few days) and not longer than 4 weeks.
If prolonged treatment is necessary, do not stop the treatment suddenly, as this may cause insomnia, headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability.
When long-term therapy is required, the medicine should be gradually discontinued. Zopitin may cause transient memory loss. To reduce the risk of memory loss, the patient should ensure that the tablet is taken immediately before going to bed and that an uninterrupted sleep of 7 to 8 hours is guaranteed.
In some patients, the effect of Zopitin may be stronger. The recommended dose for elderly patients or weakened patients, patients with liver or kidney disorders, or respiratory insufficiency is 3.75 mg (half a tablet).
Use in children
This product is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Zopitin
Inform your doctor about all medicines you are currently taking, including those available without a prescription. The sleep-inducing effect of Zopitin is particularly enhanced by the following medicines:

• other sedatives;
• hypnotics, antipsychotics, antidepressants, or antiepileptics;
• strong analgesics;
• antihistamines.

The mode of action and safety of Zopitin may be altered when taken concomitantly with other medicines. Therefore, inform your doctor before starting Zopitin 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).

Concomitant use of Zopitin and opioids (strong analgesics, medicines used in substitution treatment, 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 no other treatment options are available.
However, if your doctor prescribes Zopitin together with opioids, the doctor should limit the dose and duration of concomitant treatment.
Inform your doctor about all opioids you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned signs and symptoms. If such symptoms occur, contact your doctor immediately.
Zopitin with food, drink, and alcohol
Zopitin tablets should be taken with an adequate amount of water. The medicine may also be taken with food. Alcohol should not be consumed while taking Zopitin, as alcohol enhances the central nervous system depressant effects of the medicine and impairs its function.
Pregnancy and breastfeeding
Before taking any medicine, consult a doctor or pharmacist.
Zopitin should not be used during pregnancy or while breastfeeding.
Driving and operating machinery
Zopitin impairs the ability to drive and perform tasks requiring precision. Driving should be avoided for at least 8 hours after taking zopiclone.

3. How to use Zopitin 7.5 mg film-coated tablets

Zopitin must always be used as directed by the physician. If the patient has any doubts
regarding its use, they should consult a doctor or pharmacist.
The dosage and duration of treatment are determined individually. The recommended dose for adult
patients is 1 tablet taken just before going to bed, and the longest recommended duration of
therapy is four weeks.
However, the physician may decide on a different duration of therapy and dosage adjusted to
individual needs, which may differ from 1 tablet taken before sleep. The medicine should be used
exactly as prescribed by the doctor. Do not change the dose independently.
The tablet may be divided into two equal parts.

Use in children
Zopitin must not be used in children.

Taking more than the recommended dose of Zopitin
In case of overdose or poisoning, seek immediate medical advice or go to the hospital emergency
department.
To reduce absorption of zopiclone, activated charcoal may be administered.
For additional information regarding the use of this medicine, consult a doctor or
pharmacist.

Missed dose of Zopitin
Do not take a double dose to make up for a missed dose.
Zopitin should be used only when necessary, i.e. to initiate sleep. If the patient forgets to take
zopiclone before going to bed and is unable to fall asleep, they may then take a tablet. However,
ensure that sleep can last between 7 and 8 hours. Otherwise, the medicine should not be used.

Discontinuation of Zopitin
When using the 7.5 mg dose, gradual discontinuation of Zopitin is recommended. On the following
evening, only half a tablet should be taken. If the dose being used is less than 7.5 mg, it is unlikely
that abrupt discontinuation will cause difficulty in falling asleep.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Zopitin may cause adverse reactions, although not everyone experiences them.

Common (occur in more than 1 in 100 patients):
bitter or metallic taste in the mouth, dry mouth, fatigue the following morning after taking the medicine.

Uncommon (occur in less than 1 in 100 patients):
nightmares, restlessness, headache, dizziness, nausea, vomiting, indigestion, fatigue.

Rare (occur in less than 1 in 1,000 patients):
generalized allergic reactions, rash, itching, memory loss, hallucinations, irritability, aggression, disorientation, depression, decreased libido, worsening of insomnia, and falls (mainly in elderly patients).

Very rare (occur in less than 1 in 10,000 patients):
anaphylactic reactions, facial swelling, swelling of lips, throat or tongue (angioedema), mild to moderate increase in aminotransferase and/or alkaline phosphatase activity.

Not known (frequency cannot be estimated from available data):
anxiety, hallucinations, anger, behavioural disturbances (may occur with amnesia), somnambulism, dependence and withdrawal symptoms, ataxia, double vision, muscle weakness.

Adverse reactions are dose-dependent and usually occur at the beginning of treatment, subsiding as the dose is reduced. Continuous use of the medicine may lead to dependence and reduced effectiveness.

If any adverse reactions occur, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not mentioned in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zopitin 7.5 mg film-coated tablets

• Keep this medicine out of the sight and reach of children.
• Do not store above 25 °C.
• Do not use this medicine after the expiry date stated on the carton following EXP. The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. These measures 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.
• Other ingredients are: core of the tablet: microcrystalline cellulose, pregelatinized maize starch, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, magnesium stearate; coating of the tablet: 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
A light blue, capsule-shaped coated tablet, convex with a groove, 10.0 mm long and 5.0 mm wide.
Contents of the pack:
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