PACKAGE LEAFLET: INFORMATION FOR THE USER
Zopiklon Mylan 5 mg Film-Coated Tablets
Zopiclone
Read all of this leaflet carefully before you start to take 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 Zopiklon Mylan is and what it is used for
2.
Before you take Zopiklon Mylan
3.
How to take Zopiklon Mylan
4.
Possible side effects
5.
How to store Zopiklon Mylan
6.
Further information
1.
WHAT ZOPIKLON MYLAN IS AND WHAT IT IS USED FOR
Zopiklon Mylan tablets are sleeping pills (hypnotics) which work by acting on the brain to cause
sleepiness.
Zopiklon Mylan may be used in adults for the short term treatment of sleeping difficulties which are
severe, disabling or causing great distress.
2.
BEFORE YOU TAKE ZOPIKLON MYLAN
Do not take Zopiklon Mylan if you :
 are allergic (hypersensitive) to zopiclone or any of the other ingredients of this medicine.
 suffer from a disease of the muscles causing drooping eyelids, double vision, difficulty speaking
and swallowing and sometimes muscle weakness in the arms and legs (myasthenia gravis)
 have severe liver problems
 suffer from irregular breathing while asleep (sleep apnoea syndrome)
 are under the age of 18
Take special care with Zopiklon Mylan
You should tell your doctor before taking Zopiklon Mylan if you:
 are elderly or at risk of becoming confused. .
 suffer from liver problems
 have a history of breathing problems. Taking zopiclone will reduce the force of your breathing
 suffer from or have a history of depression, anxiety or psychotic illness. Zopiclone may cause
the symptoms to reappear or worsen
 have or ever had a history of alcohol or drug abuse.
 have an intolerance to some sugars or suffer from a rare hereditary disease such as galactose
intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Other considerations for when taking Zopiklon Mylan are:
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 Tolerance – If after a few weeks you notice that the tablets are not working as well as they did
when you first started taking them, you should see your doctor, as an adjustment of your
dosage may be required.
 Dependence – when taking this type of medicine there is a risk that you may develop some
dependence. This risk increases with the time for which you have been taking zopiclone and
your dosage. There is also a greater risk in those patients who have history of alcohol or drug
abuse.
 Withdrawal – when you stop taking zopiclone treatment should be gradually withdrawn. For a
time after stopping taking the tablets you may find that your symptoms of difficulty sleeping
reoccur. This may be accompanied by other reactions such as nervousness, headaches, muscle
pain, tension, confusion, restlessness and irritability.
Children and adolescents
Zopiklon Mylan should not be given to children and adolescents under the age of 18 years. The safety
and efficacy of zopiclone in children and adolescents aged less than 18 years have not been
established.
Taking 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, or the following:
 Medicines used to treat certain mental and emotional conditions (antipsychotics).
 Other sleeping pills (sedatives)
 Medicines used to treat depression (antidepressants)
 Antibiotics such as Erythromycin and Clarithromycin.
 Medicines used to treat fungal infections such as itraconazole and ketoconazole.
 Medicine used to treat HIV infections.
 Medicines that increase liver function, such as rifampicin, phenobarbital, phenytoin and St
Johns wort. Ask your doctor or pharmacist which medicines have this affect.
 Medicines used to treat epilepsy such as Carbamazepine.
Taking Zopiklon Mylan with food and drink


You should not drink alcohol while being treated with this medicine, because this may
increase the sedative effects of zopiclone. This may persist to the following morning and
affect your ability to drive.
Take special care with grapefruit juice as this may increase the effects of your medicine.
Please check with your doctor or pharmacist.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant. Zopiclone should not be taken
during pregnancy.
Breast Feeding
Do not breast-feed your baby, as small amounts of zopiclone can pass into breast milk.
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Driving and using machines
Do not drive or operate machinery if you feel dizzy or drowsy, or you have eyesight problems while
taking this medicine. Zopiclone may make you feel drowsy, cause loss of concentration or muscle
weakness.
Important information about some of the ingredients of Zopiklon Mylan
This medicine contains lactose. If you doctor has told you that you have intolerance to some sugars,
such as lactose, contact your doctor before taking this medicine.
3.
HOW TO TAKE ZOPIKLON MYLAN
Always take Zopiklon Mylan exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The tablet should be taken with a glass of liquid, immediately before going to bed. You should take
the tablet when standing or sitting upright, and not when lying down.
The usual dose is:
Adults – 1 tablet (5mg) immediately before going to bed. This dose should not be exceeded unless
advised by your doctor.
How long should you take Zopiklon Mylan for
The duration of treatment with Zopiklon Mylan should be as short as possible. Generally treatment
should last from between a few days to up to two weeks. Treatment should not exceed 4 weeks,
including a period of tapering off.
If you take more Zopiklon Mylan than you should
Contact your doctor or nearest hospital emergency department immediately, do not go
unaccompanied to seek medical help. If an overdose has been taken you may become increasingly
drowsy very quickly. Take the container and any remaining tablets with you. Symptoms of overdose
can range from extreme drowsiness to coma. These symptoms can be magnified when combined with
alcohol.
If you forget to take Zopiklon Mylan
If you forget to take a dose immediately before going to bed but remember during the night only take
the missed dose if you are still able to have 7-8 hours uninterrupted sleep. If this is not possible, take
the next dose before bed time the following night. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Zopiklon Mylan
Treatment of zopiclone should be gradually withdrawn, otherwise your original symptoms that
zopiclone was used to treat will return with a higher intensity (rebound insomnia). Other such
withdrawal symptoms could include anxiety, restlessness and mood changes. These will however
disappear with time.
If you have become physically dependent on zopiclone, sudden withdrawal of treatment could lead to
symptoms such as headaches, tension, muscle pain, confusion, anxiety, abnormally increased sweating
from hands, feet, armpits and groin, restlessness and irritability, hallucinations, increased heart rate or
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abnormal heart beat, nightmares, personality disturbances, or the feeling that the world around you is
not real (derealisation). In very rare cases seizures have been reported.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Zopiklon Mylan can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Zopiklon Mylan and tell your doctor immediately or go to
your nearest hospital emergency department:
 Serious allergic reaction causing difficulty breathing or dizziness (anaphylaxis)
 Serious allergic reaction which causes swelling of the face or the throat (angioedema)
 Serious skin reactions
Other side effects may include:
Common (affecting more than 1 in 100 patients):
 Dry mouth
 Bitter after taste
 Drowsiness
Uncommon (affecting fewer than 1 in 100 patients)
 Anxiety
 Nightmares
 Feeling sick
 Headache
 Dizziness
Rare (affecting fewer than 1 in 1,000 patients)
 Loss of memory (amnesia)
 Difficulty concentrating
 Confusion
 Agitation
 Irritability
 Aggressiveness
 Hallucinations
 Rash
 Raised liver enzyme levels in the blood
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
5.
HOW TO STORE ZOPIKLON MYLAN
Keep out of the reach and sight of children.
Do not use Zopiklon Mylan after the expiry date which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
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Zopiklon Mylan should be stored below 25ºC.
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 Zopiklon Mylan contains
The active substance is zopiclone
The other ingredients are lactose anhydrous, calcium hydrogen phosphate anhydrous, maize starch,
povidone, magnesium stearate and hypromellose. The printing ink contains titanium dioxide (E171)
and macrogol.
What Zopiklon Mylan looks like and contents of the pack
Your medicine comes as a white film coated tablet, round tablet. The tablets are marked ‘Z05’ on one
side and G on the other.
Zopiklon Mylan is also available in blisters of 10, 30 and 100 tablets and in unit dose blisters of 100x1
tablets.
Zopiklon Mylan is also available in packs of 100, 250 and 500 tablets in a polypropylene container.
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Tel: +46 8 555 22 750
Fax: +46 8 555 22 751
Mail: inform@mylan.se
Manufacturer
<[To be completed nationally]>
This medicinal product is authorised in the Member States of the EEA under the following
names:
Finland – Zopiklon Mylan 5 mg tabletti, kalvopaallysteinen
Iceland – Zopiklon Mylan 5 mg filmuhúðaðar töflur
Sweden - Zopiklon Mylan 5 mg filmdragerad tablett
This leaflet was last revised in 6 November 2015
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