Download Package leaflet: Information for the user Zopiclon CF 7.5 mg film

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Package leaflet: Information for the user
Zopiclon CF 7.5 mg film coated tablets
Zopiclone
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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Zopiclon CF is and what it is used for
2. What you need to know before you take Zopiclon CF
3. How to take Zopiclon CF
4. Possible side effects
5. How to store Zopiclon CF
6. Contents of the pack and other information
1. What Zopiclon CF is and what it is used for
Zopiclone belongs to a class of medicines called cyclopyrrolones. It has similar properties as
benzodiazepines. You should use benzodiazepines or benzodiazepine-like substances only
if you suffer from severe sleep disorders which cause you extreme distress.
Zopiclone, the active substance in Zopiclon CF, is a sedative-hypnotic drug (sleeping pill). It
induces sleep and is thus used in the short-term treatment of sleeplessness.
2. What you need to know before you take Zopiclon CF
DO NOT take Zopiclon CF
if you are allergic to zopiclone or to any of the other ingredients of this medicine (listed in
section 6)
 if you suffer from any of the following diseases:
– a serious muscle-weakness called myasthenia gravis (an autoimmune disease)
– severe respiratory insufficiency (a condition in which the gas exchange in the lungs
is insufficient to meet the body’s needs)
– sleep apnoea syndrome (a sleep disorder characterized by pauses in breathing
during sleep)
– severe liver impairment
 if you are a child or adolescent under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclon CF.
General
Before treatment with Zopiclon CF
–
the cause of the sleep disturbances should be clarified
–
underlying diseases should be treated.
Please tell your doctor if you have or have had any medical conditions or illnesses, especially
any of the following:
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chronic respiratory insufficiency (caused by breathing or heart problems). Your doctor will
reduce the dose due to the risk of respiratory depression.
 impaired liver function. Your doctor will reduce the dose.
 psychoses (severe mental disorders characterized by disturbance of personality and loss
of contact with reality)
 depression
 anxiety linked with depression
 alcohol or drug abuse.
Your doctor will decide whether you should take Zopiclon CF or not. They will also monitor
you closely during the treatment.
Dependence and withdrawal symptoms
The use of benzodiazepines and benzodiazepine-like substances can lead to physical and
psychological dependence on these agents. The risk of dependence increases the higher the
dose and the longer the period of treatment. This risk is also higher in patients with a history
of alcohol or drug abuse and/or those who have marked personality disorders.
If physical dependence occurs, stopping the treatment suddenly may lead to withdrawal
symptoms (see section 3. “How to take Zopiclon CF”).
Sleeplessness (Rebound insomnia)
After stopping the treatment with a benzodiazepine or a benzodiazepine-like substance, a
temporary syndrome called rebound insomnia may occur. Sleeplessness (insomnia) may
return in a more severe form. Other symptoms may be mood changes, anxiety and
restlessness. The risk of withdrawal or rebound symptoms is higher if you stop the treatment
suddenly. Therefore, your doctor will advise you to reduce your dose of Zopiclon CF
gradually.
Tolerance
The effect of some benzodiazepines or benzodiazepine-like substances may decrease after
repeated use for a few weeks. This process is called tolerance. Please ask your doctor, if
you have the feeling that the effect of Zopilcon CF decreases after repeat use for a few
weeks.
Short-term memory loss (Anterograde amnesia)
Benzodiazepines and benzodiazepine-like substances may cause a short-term memory loss
(anterograde amnesia). This occurs particularly a few hours after taking the medicine. In
order to reduce this risk, make sure you will be able to have an uninterrupted sleep of 7-8
hours.
Psychiatric and “paradoxical” reactions
During the use of benzodiazepines and benzodiazepine-like substances, the following
reactions may occur:
 restlessness
 agitation
 irritability
 aggression
 false beliefs (delusions)
 outbursts of rage
 nightmares
 seeing, hearing or feeling things that don’t really exist (hallucination)
 severe mental disorders characterized by disturbance of personality and loss of contact
with reality (psychoses)
 unsuitable behaviour
 other behavioural disturbances.
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The risk of these reactions is higher in elderly patients. If you feel any of the symptoms listed
above, you should stop taking Zopiclon CF. Ask your doctor for advice.
Sleepwalking (somnambulism) and associated behaviours
Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating
food, or making phone calls, with memory loss (amnesia) for the event, have been reported
in patients who have taken zopiclone and were not fully awake.
The risk of such behaviours is increased
 if alcohol or certain other medicines (such as narcotic analgesics, antipsychotic agents,
hypnotics or anxiolytics/sedatives) are used during treatment with zopiclone
 if zopiclone is used at doses exceeding the maximum recommended dose.
If you develop such behaviours, please inform your doctor immediately. Your doctor may
discontinue the treatment with zopiclone.
Risk of falling
Due to the muscle relaxant effect of zopiclone there is a risk of falling, especially in the
elderly in case they get up during the night.
Other medicines and Zopiclon CF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The following medicines may increase the effect of Zopiclon CF:
 antipsychotics/neuroleptics (used to treat psychoses)
 hypnotics (used to treat sleeplessness)
 anxiolytics (used to treat anxiety)
 sedatives/tranquilizers (used to induce calmness and reduce anxiety)
 antidepressants (used to treat depression)
 narcotic analgesics/painkillers of the opioid class, such as morphine and morphine-like
substances (used to relieve pain). They may additionally cause an abnormal feeling of
happiness (euphoria). This may promote psychological dependence.
 antiepileptics/anticonvulsants (used to prevent epileptic seizures)
 anaesthetics (used to block pain sensation, for example during surgeries)
 calming antihistamines (used to treat allergic reactions).
The combination of Zopiclon CF with muscle relaxants may enhance the muscle relaxing
effect.
The following medicines may increase the effect of Zopiclon CF. Therefore a reduction in the
amount of Zopiclon CF you take may be required.
 antibiotics of the macrolide class (used to treat bacterial infections), e.g. erythromycin
 antimycotics of the azole group (used to treat fungal infections)
 HIV protease inhibitors (used to treat AIDS).
The following medicines may reduce the effect of Zopiclon CF:
 phenobarbital and phenytoin (used to treat seizures)
 carbamazepine (used to treat seizures and mood disorders)
 rifampicin (antibiotic)
 products containing St. John's wort (herb used to treat depression and anxiety).
Zopiclon CF with food, drink and alcohol
You should not drink alcoholic beverages while you are on treatment with zopiclone. Alcohol
may increase the effect of the medicine. This may particularly affect your ability to drive or
operate machines.
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Avoid drinking grapefruit juice during the treatment. Grapefruit may enhance the effect of
zopiclone.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of zopiclone during pregnancy and breast-feeding has not been established yet.
Pregnancy
You should not take Zopiclon CF if you are pregnant. If zopiclone is used during the last
three months of pregnancy or during labour, some effects on the newborn child may arise.
These include low body temperature (hypothermia), and low blood pressure (hypotension),
decreased muscle tone (hypotonia), very slow or shallow breathing (respiratory depression)
and decreased suckling reflex (“floppy infant syndrome”).
Withdrawal symptoms may occur in newborns. This has been observed in children of
mothers who have used zopiclone for long periods during the last months of pregnancy.
Your doctor will prescribe you Zopiclon CF only after weighings the risks against the benefits.
Breast-feeding
You should not take Zopiclon CF if you are breast-feeding. Zopiclone is excreted in breast
milk.
Driving and using machines
You should not drive or operate machines until the treatment has finished or it has been
established that your performance is not impaired.
Zopiclon CF may cause side effects which affect your ability to drive and use machines.
These are, for example:
 feeling numb (sedation)
 loss of memory (amnesia)
 impaired concentration
 impaired muscle function.
The risk of these effects increases with alcohol intake and is even higher when the sleep
duration is insufficient. The symptoms may affect you also in the next morning.
Zopiclon CF contains milk sugar (lactose).
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
3. How to take Zopiclon CF
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is...
Adults
The recommended dose is 7.5 mg zopiclone. This dose should not be exceeded.
Children
You must not take Zopiclon CF if you are under 18 years of age.
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Elderly, also patients with impaired liver or kidney function or chronic respiratory insufficiency
(a condition in which the gas exchange in the lungs is insufficient to meet the body’s needs)
You should start the treatment at a dosage of 3.75 mg zopiclone.
Maximum dose
A daily dose of 1 film-coated tablet of Zopiclon CF should not be exceeded.
You can break the tablet as follows:
 lay the tablet on a desk
 take the left and right thumb or forefinger and press on both sides of the scoring line.
The tablet can be divided into equal doses.
Take Zopiclon CF just before going to bed. Make sure you will be able to have an
uninterrupted sleep of 7-8 hours. Swallow the tablet with liquid (e.g. 1 glass of water),
however not with grapefruit juice.
Duration of the treatment
Your treatment with Zopiclon CF should be as short as possible. In general, it should last
between a few days to 2 weeks. Your doctor will explain to you how to reduce the dose of
Zopiclon CF gradually at the end of the treatment (tapering off). This measure lowers the risk
of withdrawal or rebound symptoms (see section 2. Warnings and precautions).
You should not take Zopiclon CF for longer than 4 weeks including the tapering off phase.
Ask your doctor for advice if your symptoms don’t improve within this period.
If you take more Zopiclon CF than you should
If you have taken too many tablets, contact your doctor or nearest hospital casualty
department immediately for advice.
Zopiclone overdosage together with certain agents might be life-threatening. These agents
are drugs which have a suppressive effect on the central nervous system, including alcohol.
Overdosage of benzodiazepines or benzodiazepines-like substances usually causes
depression of the central nervous system which ranges from drowsiness to coma. The most
frequent symptoms are dizziness, lack of energy (lethargy) and difficulty coordinating muscle
movements (ataxia).
If you forget to take Zopiclon CF
If you still have time to sleep for 7 to 8 hours, you should take the dose immediately.
If there is less time, ignore the forgotten dose and do not take another dose until the
following day before going to sleep. Never take a double dose, that is worse than skipping a
dose.
If you stop taking Zopiclon CF
Stopping the treatment suddenly may lead to withdrawal or rebound symptoms. Withdrawal
symptoms may include:
 headaches
 muscle pain
 extreme anxiety
 tension
 restlessness
 confusion
 irritability.
In severe cases, the following withdrawal symptoms may occur:
an alteration in the perception of the world so that it seems strange or unreal
(derealisation)
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loss of your own personal identity followed by feelings of unreality and strangeness
(depersonalization)
oversensitivity to sound (hyperacusis)
numbness and tingling of the arms and legs
hypersensitivity to light, noise or physical contact
seeing, hearing or feeling things that don’t really exist (hallucinations )
epileptic seizures.
The risk to develop such symptoms increases the higher the dose and the longer the period
of treatment. Therefore, your doctor will advise you how to reduce the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A bitter taste or metallic after taste is the most common adverse reaction of zopiclone.
The following side effects have been observed in patients treated with zopiclone.
Very common (may affect more than 1 in 10 people):
 a bitter or metallic taste (dysgeusia).
Common (may affect up to 1 in 10 people):
sleepiness during the following day
reduced alertness
headache
dizziness
gastrointestinal problems, including feeling sick (nausea) and vomiting.
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Rare (may affect up to 1 in 1,000 people):
slight to moderate increases of certain liver enzymes (serum transaminases and/or
alkaline phosphatase)
 loss of memory (amnesia)
 incoordination
 difficulty coordinating muscle movements (ataxia), which occurs mainly at the beginning
of the treatment and generally disappears after repeated use.
 light headedness
 double vision, which occurs mainly at the beginning of the treatment and generally
disappears after repeated use.
 dry mouth
 skin reactions, including hives (urticaria).
 muscle weakness
 risk of falling, especially in the elderly (see also section 2: Warnings and precautions)
 tiredness
 dulling of sensitivity
 confusion
 depression
 so called paradoxical reactions such as
– restlessness
– agitation
– irritability
– aggression
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false beliefs (delusions)
outbursts of rage
nightmares
seeing, hearing or feeling things that don’t really exist (hallucinations)
severe mental disorders characterized by disturbance of personality and loss of
contact with reality (psychoses)
inappropriate behaviour and other behavioural disturbances.
Very rare (may affect up to 1 in 10,000 people):
 swelling of the face, lips or tongue with difficulty swallowing or breathing (angiooedema)
 serious allergic reactions (anaphylactic reactions)
 Serious skin reactions (Stevens-Johnson syndrome, Toxic epidermal necrolysis/Lyell’s
syndrome, erythema multiforme).
 change in sexual desire (decreased libido).
Not known (frequency cannot be estimated from available data):
physical and psychological dependence
somnambulism (sleepwalking and associated behaviour; see also section 2: Warnings
and precautions).
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Even when taken normally as prescribed, (short-term) memory loss can occur, sometimes
associated with inappropriate behaviour. The risk of this increases at higher doses.
During treatment with Zpiclon CF pre-existing depression can be unmasked.
The use of Zopiclon CF can lead to physical or psychological dependence, so that stopping
treatment can result in withdrawal reactions or the recurrence of insomnia. Consult also
section 2: Warnings and precautions.
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 {to be completed
nationally: 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 Zopiclon
Keep this medicne out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the blister after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Zopiclon CF contains
The active substance is zopiclone.
Each Zopiclon CF 7.5 mg tablet contains 7.5 mg of zopiclone.
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The other ingredients are:
 lactose monohydrate
 calcium hydrogen phosphate dihydrate
 maize starch
 croscarmellose sodium
 magnesium stearate
 titanium dioxide (E171)
 hypromellose.
What Zopiclon CF tablets looks like and contents of the pack
Zopiclon CF 7.5 mg tablets are white, round biconvex film-coated tablets, embossed with
“ZOC 7,5” on one side and scored on both sides.
Zopiclon CF is available in packs containing 5, 10, 14, 18, 20, 28, 30, 50, 56, 60, 90, 100,
150, 200, 250, 300, 400, 500 or 1000 tablets in PVC/PVDC/Al blisters.
Not all packaging sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
This medicine is authorised in the Member States of the EEA under the following
names:
AT:
Somnal® 7,5 mg – Filmtabletten
BE:
Zopiclone EG 7,5mg omhulde tabletten
DE:
Zopistad 7,5 mg
DK:
Zopiclon Stada
ES:
Zopicalma 7.5 mg comprimidos recubiertos
FR:
Zopiclone EG 7,5 mg, comprimé pelliculé sécable
IT:
Zopiclone EG® 7,5 mg Compresse Rivestite con Film
LU:
Zopiclone EG
NL:
Zopiclone CF 7,5 mg, tabletten
PL:
Dobroson
SE:
Zopiclon Stada
This leaflet was last revised in October 2013.