PACKAGE LEAFLET
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What ZOPITIN is and what it is used for
2. Before you use ZOPITIN
3. How to use ZOPITIN
4. Possible side effects
5. How to store ZOPITIN
6. Further information
1. WHAT ZOPITIN IS AND WHAT IT IS USED FOR
The active ingredient in ZOPITIN is zopiclone which is a hypnotic medicine affecting via central nervous system. The drug fortifies falling in sleep and continuation of sleep. The sedative effect of the drug begins in 15 - 20 minutes.
ZOPITIN is indicated only for short-term treatment of insomnia.
2. BEFORE YOU USE ZOPITIN
Do not use ZOPITIN
- if you are hypersensitive (allergic) to zopiclone or any of the other ingredients of ZOPITIN.
- if you have severe muscle weakness (myasthenia gravis).
- if you have severe sleep apnoea.
- if you have severe depression of respiration.
- if you have severe liver insufficiency.
Take special care with ZOPITIN
ZOPITIN should not be taken together with alcohol, since alcohol increases ZOPITIN's depressing effect of the central nervous system and impairing function.
Long-term use of ZOPITIN decreases efficacy of the drug and induces drug-dependence. Therefore the duration of treatment should be as short as possible (normally few days) and should not exceed 4 weeks.
A long-term treatment should not be stopped abruptly since it may cause sleeplessness, headache, muscle pain, anxiety, tension, restlessness, confusion and irritability. A long-term treatment should be discontinuated gradually. ZOPITIN may cause reversible amnesia. To reduce the risk of amnesia You should ensure to take the tablet only just before going to bed, and ensure to be able to have an uninterrupted sleep of 7 - 8 hours.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially following drugs strengths ZOPITIN's sedative effect:
- other sedative agent
- hypnotic, antipsychotic, antidepressive, or antiepileptic products
- strong analgesics
- antihistamines
The effect and safety of ZOPITIN may be altered if used concomitantly with other medicines. Your doctor should know if you are using any of these medicines before prescribing ZOPITIN:
- some antifungal drugs (eg. ketoconazol and itraconazol)
- some antibiotics (eg. erythromycin and clarithromycin)
- some antiviral drugs (eg. ritonavir)
- some antidepressive drugs (eg. nefazodone).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
ZOPITIN should not be used during pregnancy and lactation.
Driving and using machines
ZOPITIN weakens the ability to drive and perform tasks that need precision. You should avoid driving at least 8 hours after an administration of zopiclone.
Special groups
Effect of ZOPITIN may be stronger in certain people. A dose of 3,75 mg (half a tablet) is recommended for elderly or debilitated patients, for patients with impaired liver or renal function or with respiratory insufficiency. The product is not recommended for children or adolescents with age under 18 years.
3. HOW TO USE ZOPITIN
The dose and duration of treatment are individual. The usual dose for adult is 1 tablet just before going to bed and the longest recommended duration of treatment is 4 weeks.
However your doctor has ordered duration of treatment and dosage just for you, which may be different than 1 tablet just before going to bed. Follow carefully the doctor`s instructions. You should not change your dosage by yourself.
ZOPITIN should not be given to children.
Taking ZOPITIN with food and drink
ZOPITIN is recommended to be taken with plenty of water (at least 2 dl). It can also be taken with food. Do NOT drink alcohol when using zopiclone.
If you take more ZOPITIN than you should
In case of overdosage contact your doctor, hospital emergency room or Poison Information Center (tel. 09-471 977) immediately. Activated charcoal can be taken as a first aid to inhibit absorption of zopiclone.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If You stop taking ZOPITIN
Discontinuation of ZOPITIN use is recommended to be carried out gradually, if the dose is 7.5 mg. Take only half a tablet on the next evening. If the dose is less than 7.5 mg, stopping the medication abruptly is not likely to cause any harm in falling sleep.
If You forget to use ZOPITIN
In principal, ZOPITIN should be used only if necessary; that is, to fall asleep. If You forget to take zopiclone before going bed, and can not fall asleep, You may take the tablet then. However, ensure that You can sleep 7 to 8 hours. Otherwise, don't take the drug.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ZOPITIN can cause side effects, although not everybody gets them.
Adverse effects have been reported in clinical studies with zopiclone in following frequencies:
Very common (>1/10) or common ( >1/100):
Bitter or metallic taste in the mouth, dry mouth, tiredness on the following morning.
Uncommon (>1/1000 but <1/100): headache, dizziness, nausea, vomiting, dyspepsia.
Rare (>1/10 000 but <1/1000) and very rare (<1/10 000):
Generalised allergic reactions, rash, itch, amnesia, nightmares, hallucinations, irritability, aggressiveness, confusion, depression, impaired libido and worsening of insomnia.
The adverse effects are dose-dependent and occur usually at the beginning of a treatment and decrease when the dose is reduced. A continuous use induces addiction and weakens the efficacy of the drug.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ZOPITIN
- Keep out of the reach and sight of children.
- Do not store above 25°C.
- Do not use the tablets after the expiry date that is stated on the carton.
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 to protect the environment.
6. FURTHER INFORMATION
What ZOPITIN contains
- The active substance is zopiclone. One film-coated tablet contains 7,5 mg of zopiclone.
- The other ingredients are:
Core: pregelatinised starch, calcium hydrogen phosphate dehydrate, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous silica.
Coating: macrogol 4000, polyvinyl alcohol, talk, indigo carmine (E132) and titanium dioxide (E171).
What ZOPITIN looks like and contents of the pack:
What ZOPITIN looks like:
Light blue, capsule shaped, convex, scored, film-coated tablet with a length of 10.0 mm and width of 5.0 mm.
Contents of the pack:
10, 20, 30, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Tel: +358 (3) 615 600
Fax: +358 (3) 618 3130
This leaflet was last approved on 30.10.2007
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