Jubilant Pharmaceuticals nv
Zopiclone Jubilant 7,5 mg film-coated tablets
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April 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zopiclone Jubilant 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 Zopiclone Jubilant is and what it is used for
2. What you need to know before you take Zopiclone Jubilant
3. How to take Zopiclone Jubilant
4. Possible side effects
5. How to store Zopiclone Jubilant
6. Contents of the pack and other information
1. What Zopiclone Jubilant is and what it is used for
Zopiclone Jubilant is a sedative-hypnotic drug with zopiclone as active substance. Zopiclone
Jubilant induces sleep and helps you to relax.
Zopiclone Jubilant is used in adults for the short-term treatment of sleeplessness which causes
you extreme distress. The treatment can take a few days to 2 weeks and usually does not take
longer than 4 weeks.
2. What you need to know before you take Zopiclone Jubilant
DO NOT take Zopiclone Jubilant
 if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in
section 6. “Further information” at the end of this leaflet)
 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.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone Jubilant.
General
Before treatment with Zopiclone Jubilant
–
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:
 Zopiclone Jubilant should not be used in children and adolescent under the age of 18. The
safety and efficacy in children and adolescents aged less than 18 years have not been
established.

chronic respiratory insufficiency (caused by breathing or heart problems). Your doctor
will reduce the dose due to the risk of respiratory depression.
 impaired liver or kidney 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
 history of alcohol or drug abuse.
 you have recentely taken Zopiclone Jubilant or other similar medicines for more than four
weeks.
 you do not fee you will ever be able to stop taking Zopiclone Jubilant or other medicines
used to treat sleep problems.
Your doctor will decide whether you should take Zopiclone Jubilant 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 such as: headache, muscle pain, extreme anxiety, tension, restlessness, confusion
and irritability. In severe cases following symptoms may occur: an alteration in the perception
of the world so that it seems strange or unreal (derealisation), loss of your own personal
identity followed by feelings of unreality and strangeness (depersonalization), oversensitivity
to sound (hyperacusis), numbness and tingling of arms and legs, hypersensitivity to light,
noise or physical contact, seeing, hearing or feeling things that don’t really exist
(hallucinations) and epileptic seizures.
Sleeplessness (Rebound insomnia)
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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 Zopiclone Jubilant 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 Jubilant 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.
The risk of these reactions is higher in elderly patients. If you feel any of the symptoms listed
above, you should stop taking Zopiclone Jubilant. 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) of 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.
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Risk of fall
Due to the muscle relaxing effect of zopiclone, there is a risk of fall, especially in the elderly
when they get up during the night.
Other medicines and Zopiclone Jubilant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines, herbal remedies, health foods or supplements that you
have obtained without a prescription.
The following medicines may increase the effect of Zopiclone:
 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)
 grapefruit juice
 alcohol
The following medicines can increase the chance of you getting side effects when taken with
Zopiclone Jubilant. To make this less likely, your doctor may decide to lower your dose of
Zopiclone Jubilant:
 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 combination of Zopiclone Jubilant with muscle relaxants may enhance the muscle
relaxing effect.
The following medicines may reduce the effect of Zopiclone:
 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).
Taking Zopiclone Jubilant with food and drink
 Do not drink alcohol while you are taking Zopiclone Jubilant. Alcohol can increase the
effects of Zopiclone Jubilant and make you sleep very deeply so that you do not breathe
properly or have difficulty waking.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
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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.
Pregnancy
The use of Zopiclone Jubilant is not recommended during pregnancy.
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.
Breast-feeding
You should not take Zopiclone Jubilant if you are breast-feeding. Zopiclone is excreted in
breast milk in a small amount.
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.
Zopiclone Jubilant 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 (7-8 hours). The symptoms may affect you also in the next morning.
Zopiclone Jubilant 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 Zopiclone Jubilant
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is:
Use in adults
The recommended dose is 7,5 mg zopiclone. This dose should not be exceeded.
Use in children and adolescents
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Zopiclone Jubilant should not be used in children and adolescents less than 18 years. The
safety and efficacy of Zopiclone Jubilant in children and adolescents aged less than 18 years
have not been established.
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 Zopiclone Jubilant 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.
Take Zopiclone Jubilant 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.
Please talk to your doctor if you think that the effect of Zopiclone Jubilant is too weak or too
strong.
Duration of the treatment
Your treatment with Zopiclone Jubilant 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
Zopiclone Jubilant gradually at the end of the treatment (tapering off). This measure lowers
the risk of withdrawal or rebound symptoms (see section 2. “Take special care with
Zopiclon”).
You should not take Zopiclone Jubilant for longer than 4 weeks including the tapering off
phase. Ask your doctor for advice if your symptoms don’t improve within this period.
Blood tests
 Zopiclone Jubilant can change the levels of liver enzymes shown up in blood tests. This
can mean that your liver is not working properly.
 If you are going to have a blood test, it is important to tell your doctor that you are taking
Zopiclone Jubilant.
If you take more Zopiclone Jubilant 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.
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Overdosage of benzodiazepines or benzodiazipines-like substances usually causes depression
of the central nervous system which ranges from drowsiness to coma. The following effects
may happen:
 Feeling drowsy, confused, sleeping deeply and possibly falling in to a coma.
 Floppy muscles (hypotonia).
 Feeling dizzy, light headed or faint. These effects are due to low blood pressure.
 Falling over or losing your balance (ataxia).
 Shallow breathing or difficulty breathing (respiratory depression).
If you forget to take Zopiclone Jubilant
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.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Zopiclone Jubilant
Stopping the treatment suddenly may lead to withdrawal or rebound symptoms. See section 2.
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.
The most commonly reported adverse effects are: sleeplessness during the day, a bitter taste, a
dry mouth and a reduced alertness. These affect 1 to 10 users in 100.
Coordination problems or double vision occurs in 1 to 10 users in 10,000, especially at the
beginning of the treatment. These symptoms usually disappear spontaneously so that the
treatment doesn’t need to be stopped.
Stop using Zopiclone Jubilant and contact your doctor immediately if you develop one or more
of following symptoms:
 swelling of the face, lips or tongue
 difficulty breathing
 sudden high fever
 joint pain
 blistering of the skin
These symptoms can be signs of severe allergic reactions which can be life-threathening.
Other severe adverse effects which rarely occur are:
 loss of memory (amnesia) (sometimes in combination with inappropriate behaviour)
 risk of fall (particularly in the elderly)
The risk for memory loss is greater when high doses are used.
The following side effects have been observed in patients treated with zopiclone.
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Uncommon (1 to 10 users in 1,000)
 nightmares
 agitation
 headache
 dizziness
 gastro-intestinal problems, including feeling sick (nausea) and vomiting
 tiredness.
Rare (1 to 10 users in 10,000):
 slight to moderate increases of certain liver enzymes (serumtransaminases and/or alkaline
phosphatase)
 allergic reactions including itching and skin reactions
 dulling of sensitivity
 confusion
 depression
 restlessness
 irritability
 aggression
 false beliefs (delusions)
 outbursts of rage
 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 behavioral disturbances.
 change in sexual desire (decreased libido).
 sleepwalking
 physical and psychological dependence
 dreaming more frequently
 difficulties in concentrating
 dyspepsia
 withdrawal symptoms like:
o anxiety
o tremor
o palpitations
o tension
o loss of feeling who and where you are
o oversensitivity to sound
o numb feeling and tingling in arms and legs
o hypersensitivity to light, noise and physical contact
o hearing or feeling things that don’t really exist
o epileptic seizures
Very rare (less than 1 user in 10,000):
 skin rash with irregular red spots (erythema multiforme)
 seizures
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During treatment with Zopiclon Jubilant pre-existing depression can be unmasked.
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 [To be completed nationally]. By reporting side effects you can help
provide more information on the safety of this medicine.
If you get any side effects, talk to your doctor or pharmacist. This includes any side
effects not listed in this leaflet.
5. How to store Zopiclone Jubilant
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton 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 Zopiclone Jubilant contains
The active substance is zopiclone.
Each Zopiclone Jubilant 7,5 mg tablet contains 7,5 mg of zopiclone.
The other ingredients are:
 calcium hydrogen phosphate dihydrate
 lactose monohydrate
 maize starch
 sodium starch glycolate
 magnesium stearate (E470b)
 hypromellose (E464)
 propylene glycol (E1520)
 titanium dioxide (E171)
 talc (E553B)
What Zopiclone Jubilant tablets look like and contents of the pack
- Zopiclone Jubilant 7,5 mg tablets are white, round, biconvex film-coated tablets, scored
Jubilant Pharmaceuticals nv
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April 2016
on one side and divisible.
The tablet can be divided in equal doses.
Zopiclone Jubilant is available in packs containing 10, 20, 28, 30 or 100 film-coated
tablets in PVC/PVDC/Al blisters.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
This medicinal product is authorized in the Member States of the EEA under following
names:
Denmark
Germany
Sweden
The Netherlands
United kingdom
Zopiclon “Jubilant”
Zopiclon Jubilant 7,5 mg Filmtabletten
Zopiclone Jubilant 7.5 mg Filmdragerade Tabletter
Zopiclone 7,5 mg filmomhulde tabletten
Zopiclone 7.5 mg film-coated tablets
This leaflet was last revised in April 2016.