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Zopiklon är indicerat för kortvarig behandling av sömnlöshet som kännetecknas av svårigheter att somna, frekventa nattliga uppvakningar och / eller tidiga morgonväckningar. Eftersom sömnstörningar kan vara det presenterande symtomet på en fysisk och / eller psykisk störning, ska patienten noggrant utvärderas innan farmakologisk behandling påbörjas. Sömnlöshet som fortsätter efter 7 till 10 dagars behandling kan indikera förekomsten av en primär psykiatrisk och / eller medicinsk sjukdom.



Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or
– 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
What is in this leaflet
1. What Zopiclone is and what it is used for
2. What you need to know before you take Zopiclone
3. How to take Zopiclone
4. Possible side effects
5. How to store Zopiclone
6. Contents of the pack and other information
1. What Zopiclone is and what it is used for
The name of your medicine is either Zopiclone 3.75 mg Tablets
or Zopiclone 7.5 mg Tablets. For easy reference both will be
called zopiclone in this leaflet. Zopiclone tablets contains a
medicine called zopiclone. This belongs to a group of medicines
called hypnotics. It works by acting on your brain to help you
Zopiclone is used to treat sleep problems in adults such as:
• Difficulty falling asleep,
• Waking in the middle of the night,
• Waking too early,
• Severe or upsetting sleep problems that are caused by your
mood or mental health problems.
Zopiclone can be used for both temporary and longer lasting
sleep problems. However, zopiclone is not meant to be used
every day for long periods of time or to treat depression.
Ask your doctor for advice if you are unsure.
2. What you need to know before you use Zopiclone
Do not use Zopiclone and tell your doctor if:
You are allergic (hypersensitive) to zopiclone or any of the
other ingredients of Zopiclone tablets (listed in Section 6
below). The signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your lips, face,
throat or tongue.
– You have a problem that causes severe muscle weakness
(myasthenia gravis).
– Your lungs do not work properly (respiratory failure).
– You have a problem where you stop breathing for short
periods at night (sleep apnoea).
– You have severe liver problems.
– You are under the age of 18. The safety and efficacy of
zopiclone in children and adolescents aged less than 18 years
have not been established.
Do not take this medicine if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before
taking zopiclone.
Warnings and precautions
Take special care with Zopiclone
Check with your doctor or pharmacist before taking your
medicine if:
– You have any liver problems (see also ‘Do not take this
medicine and tell your doctor if:’ in the section above).
Your doctor may need to give you a lower dose of zopiclone.
– You have any kidney problems. Your doctor may need to give
you a lower dose of zopiclone.
– You suffer from mild breathing problems, your doctor will
decide if you should receive zopiclone (see also ‘Do not take
this medicine and tell your doctor if:’ in the section above).
– You have a history of alcohol or drug abuse.
– You have been told by a doctor that you have a personality
– You have recently taken zopiclone or other similar medicines
for more than four weeks.
– You do not feel you will ever be able to stop taking zopiclone
or other medicines used to treat sleep problems.
Before taking zopiclone, it is important to make sure that you
can have at least 7 to 8 hours of uninterrupted sleep to help
reduce the risk of some side effects (see section 4 – Possible
side effects).
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking zopiclone.
Other medicines and Zopiclone
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you
buy without a prescription, including herbal medicines.

This is because zopiclone can affect the way some other
medicines work. Also, some medicines can affect the way
zopiclone works.
Tell your doctor if you are taking any of the following medicines.
Zopiclone may increase the effect of the following medicines: – Medicines for mental problems (antipsychotics).
– Medicines for depression.
– Medicines for epilepsy (anticonvulsants).
– Medicines used in surgery (anaesthetics).
– Medicines to calm or reduce anxiety or for sleep problems
– Medicines for hay fever, rashes or other allergies that
can make you sleepy (sedative antihistamines) such as
chlorphenamine or promethazine.
– Some medicines for moderate to severe pain (narcotic
analgesics) such as codeine, methadone, morphine,
oxycodone, pethidine or tramadol.
The following medicines can increase the chance of you getting
side effects when taken with zopiclone. To make this less likely,
your doctor may decide to lower your dose of zopiclone.
– Some antibiotics such as clarithromycin or erythromycin.
– Some medicines for fungal infections such as ketaconazole
and itraconazole.
– Ritonavir (a protease inhibitor) – for HIV infections.
The following medicines can make zopiclone work less well:
– Some medicines for epilepsy such as carbamazepine,
phenobarbital or phenytoin.
– Rifampicin (an antibiotic) – for infections.
– St John’s Wort (a herbal medicine) – for mood swings and
Taking Zopiclone with food, drink and alcohol

Do not drink alcohol while you are taking zopiclone. Alcohol
can increase the effects of zopiclone and make you sleep very
deeply so that you do not breathe properly or have difficulty
Pregnancy, breast-feeding and fertility
– Talk to your doctor before taking this medicine if you are
pregnant, might become pregnant, or think you may be
– Do not take zopiclone during the last 3 months of pregnancy
or during labour because it may be harmful to your baby.
– Do not breast-feed if you are taking zopiclone. This is because
small amounts may pass into mother’s milk. If you are breastfeeding or planning to breast-feed, talk to your doctor or
pharmacist before taking any medicine.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Driving and using machines
Like other medicines used for sleep problems, zopiclone can
cause slowing of your normal brain function (central nervous
system depression). The risk of psychomotor impairment
including driving ability is increased if:
• You take zopiclone within 12 hours of performing activities that
require mental alertness
• You take higher than the recommended dose of zopiclone
• You take zopiclone while already taking another central
nervous system depressant or another medicine that
increases levels of zopiclone in your blood, or while drinking
Do not engage in hazardous activities requiring complete mental
alertness such as driving or operating a machinery after taking
zopiclone and in particular during the 12 hours after taking your
medicine. For more information about possible side effects
which could affect your driving see section 4 of this leaflet.
Important information about some of the ingredients of
Zopiclone tablet contains:-
Lactose. This is a type of sugar. If you have been told by
your doctor that you cannot tolerate some sugars (have an
intolerance to some sugars), talk to your doctor before taking
this medicine.
3. How to take Zopiclone
Treatment should be as short as possible and should not
exceed four weeks including period of tapering off.
Your doctor will give you the lowest effective dose.
Always take zopiclone exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
Taking this medicine
– Take this medicine by mouth.
– Swallow the tablet with a drink of water.
– Do not crush or chew your tablets.
– Take just before bedtime in a single intake and do not take
again during the same night.
– The usual length of treatment is 2 days to 3 weeks.

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