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ZOPICLONE 7.5 MG FILM COATED TABLETS

Active substance(s): ZOPICLONE

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TEVA UK Ref:

231-30-85167-ZA LEA ZOPICLONE A/S TAB TUK

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5

How to store Zopiclone

Keep this medicine out of the sight and
reach of children.
Do not store above 25° C.
Do not use this medicine after the expiry
date which is stated on the outer
packaging after EXP.
The expiry date refers to the last day of
that month.
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 to protect the environment.

6

Contents of the pack and other
information

What Zopiclone tablets contain:
• The active substance is zopiclone.
• The other ingredients are lactose
monohydrate, calcium hydrogen
phosphate dihydrate, maize starch,
sodium carmellose, magnesium
stearate, titanium dioxide (E171) and
hypromellose. The 3.75 mg tablets also
contain red and yellow iron oxide (E172).
What Zopiclone tablets look like and
contents of the pack:
• Zopiclone 3.75 mg Film-Coated Tablets
are orange, round, biconvex film-coated
tablets. They are embossed with ‘ZOC
3.75’.
• Zopiclone 7.5 mg Film-Coated Tablets
are white, round, biconvex, scored,
film-coated tablets. They are embossed
with ‘ZOC 7.5’ on one side and division
mark on both sides.
• Zopiclone Film-Coated Tablets are
available in pack sizes of 10, 14, 20, 28,
30, 50, 56, and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG,
England.
This leaflet was last revised: December
2015
PL 00289/0413-0414

85167-ZA
320 x 323

10 December 2015

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ZOPICLONE 3.75 mg AND 7.5 mg
FILM-COATED TABLETS
Zopiclone

Package leaflet: Information for the user

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, pharmacist or nurse.
• 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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
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

Zopiclone belongs to a group of
medicines called hypnotics. These are
medicines which help you sleep.
Zopiclone is used in adults for the
short-term treatment of severe sleeping
difficulties, which are causing you
extreme distress.

2

What you need to know before
you take Zopiclone

Do not take Zopiclone:
• if you are allergic to zopiclone or any of
the other ingredients of this medicine
(listed in section 6).
• if you are allergic to any other sleeping
tablets or tablets taken for anxiety
• if you have myasthenia gravis (a muscle
disease where the muscles become
weak and tire easily)
• if you have severe breathing difficulties,
including difficulty in breathing or
stopping of breathing for very short
periods when asleep (sleep apnoea)
• if you have severe liver problems. In
patients with severe liver problems
encephalopathy (a brain disorder) may
develop
• if you are under the age of 18
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Zopiclone
General
Before treatment with Zopiclone
• the cause of the sleep disturbances
should be clarified
• underlying diseases should be treated.
• General information about effects
observed after use of benzodiazepines
and benzodiazepine-like agents (such as
Zopiclone-PCH 3.75 mg) or other
hypnotics which the prescribing doctor
should consider is described in the
following:
• When taking this medicine there is a
risk of dependence (a need to keep
taking the medicine). This may be

physical dependence, where the body
becomes used to the presence of the
medicine and stopping treatment
causes withdrawal symptoms and/or
mental dependence, where you develop
a craving for the medicine. The risk is
greater if you have ever had a history of
alcohol or drug abuse, or suffer from a
personality disorder.
• When stopping this medicine you may
experience withdrawal effects (rebound
insomnia) (see section 3, If you stop
taking Zopiclone). Withdrawal effects
may also occur between doses,
especially if you are taking a high dose
of Zopiclone. It may be accompanied by
other reactions: mood changes, sleep
disturbances, anxiety and restlessness.
• It is important that you are aware of the
possibility of such symptoms in order to
minimize your anxiety.
• Behavioural effects may occur while
taking Zopiclone.
During the use of benzodiazepines and
benzodiazepine-like substances, the
following psychiatric and paradoxical
reactions may occur: restlessness,
agitation, irritability, aggression, having
false beliefs that persist even with
having evidence that the belief is not
true (delusions), outbursts of rage,
nightmares, seeing, hearing or feeling
things that are not real (hallucinations),
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. Ask your doctor
for advice.
Sleep walking (somnambulism) 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.
• 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 gradually.
• The effect of some benzodiazepines or
benzodiazepine-like substances may
decrease after repeated use for a few
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Pharma code 539

During treatment with zopiclone,
pre-existing depression can be unmasked.
The use of zopiclone can lead to physical
or psychological dependence, so that
stopping treatment can result in
withdrawal reactions or the recurrence of
insomnia. Consult also the section: 'Take
special care with zopiclone.
If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

2

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everybody gets them. Side effects are most
common at the beginning of treatment,
during the first hour after taking your
tablet.
If the following happens, stop taking the
tablets and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty
in breathing; skin rash or hives).
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.
The following side effects have been
observed in patients treated with zopiclone:
Very common (may affect more than 1 in
10 people)
• a bitter taste or metallic after-taste is the
most common adverse reaction of
zopiclone.
Common (may affect up to 1 in 10 people):
• drowsiness during the following day
• reduced alertness
• headache
• dizziness
• stomach upsets (including feeling or
being sick).
Rare (may affect up to 1 in 1,000 people):
• numbed emotions
• confusion
• depressed mood
• paradoxal reactions such as
restlessness, agitation, irritability,
aggression, having false beliefs that
persist even with having evidence that
the belief is not true (delusions),
outburst of rage, nightmares, seeing,
hearing or feeling things that are not
real (hallucinations), a severe mental
disorder in which contact with reality is
lost or highly distorted (psychosis),
inappropriate behaviour or any other
changes in behaviour and sleep walking
(see section 2 “Take special care with
Zopiclone”).
• amnesia (loss of memory)
• loss of co-ordination
• difficulty in controlling movements
(predominantly at the beginning of
treatment; generally disappears after
repeated administration)
• risk of fall (especially in the elderly)
• light-headedness
• problems with sight (double vision)
• skin rashes including hives (urticaria)
• muscle weakness
• tiredness
• dry mouth
• dyspepsia
• slight to moderate changes in liver
function tests
Very rare (may affect up to 1 in 10,000
people):
• changes in sex drive
• swelling of the limbs and face, serious
skin reactions (Stevens-Johnson
syndrome, toxic epidermal
necrolysis/Lyell’s syndrome and
erythema multiforme)
Not known (frequency cannot be
estimated from the available data)
• physical and mental dependence
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.

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weeks. This process is called tolerance.
Please ask your doctor, if you have the
feeling that the effect of Zopiclone
decreases after repeat use for a few
weeks.
• 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.
Special patient groups
Benzodiazepines and benzodiazepine-like
agents (such as Zopiclon-ratiopharm 7.5 mg)
should be administered with care in
• Older people and debilitated patients
They should receive a lower dose (see
3. “How to use Zopiclon-ratiopharm
7.5 mg”). Zopiclon-ratiopharm 7.5 mg
has a muscle-relaxant effect. For this
reason, especially elderly patients are
at risk of falling and consequently of
hip joint fractures when getting out of
bed at night.
• Patients with chronic dyspnoea
It is proven that benzodiazepines can
impair breathing. It should be
considered as well that anxiety or
inner restlessness has been described
as signs of dyspnoea.
• Patients with alcohol and drug abuse
in their medical history
Extreme caution is required. These
patients should carefully be supervised
during treatment with
Zopiclon-ratiopharm 7.5 mg, as they
are at risk of habituation and
psychological dependence.
Talk to your doctor before taking
Zopiclone if you:
• are elderly or frail. Due to the muscle
relaxing effect of Zopiclone, there is a
danger of falls, particularly for the
elderly when getting up at night
• have a history of alcohol or drug abuse
• have psychiatric problems or mental
illness (including personality disorders),
depression or anxiety (as thoughts of
suicide may occur)
• have breathing difficulties
• have mild or moderate liver problems.
You are at risk of brain damage
(encephalopathy).
• have kidney problems.
If you are elderly, you are more likely to
experience certain of the side effects.
Children and adolescents
Zopiclone should not be used in children
and adolescents less than 18 years. The
safety and efficacy of zopiclone in children
and adolescents aged less than 18 years
have not been established.
Other medicines and Zopiclone
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Talk to your doctor if you are taking any
of the following:
• muscle relaxants e.g. baclofen, as their
muscle relaxing effect may be increased
• medicines which may increase the effect
of Zopiclone, such as:
• other hypnotics e.g. nitrazepam, used
as short-term treatments to help you
to sleep
• anxiolytics or sedatives e.g. diazepam,

used to alleviate anxiety
• antidepressants e.g. amitriptyline,
fluoxetine, and those known as
monoamine oxidase inhibitors (MAOIs)
e.g. phenelzine
• antipsychotic drugs also known as
neuroleptics or tranquillisers e.g.
chlorpromazine, used to treat mental
illness
• strong (narcotic) painkillers e.g.
codeine, morphine
• drugs to treat epilepsy e.g.
carbamazepine, phenytoin
• anaesthetics
• sedative antihistamines e.g.
alimemazine, chlorphenamine, used to
treat allergies and allergic reactions
and which also cause drowsiness
• Medicines which may reduce the effect
of Zopiclone, such as:
• erythromycin (an antibiotic)
• 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).
• Medicines which may reduce the effect
of Zopiclone, such as:
• 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).
Tell the hospital or dentist you are taking
Zopiclone if you are to have an operation
or treatment requiring an anaesthetic.
Zopiclone with food, drink and alcohol
• DO NOT drink alcohol whilst taking
these tablets as the sedative effect of
Zopiclone may be increased.
You should not take the tablets with
grapefruit juice, as this will change and
intensify the effect of Zopiclone- in an
unforeseeable way.
Pregnancy and breast-feeding
• 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.
• Zopiclone is not recommended if you
are pregnant or planning to become
pregnant. Ask your doctor for advice
before taking this medicine. It should
not be taken during pregnancy,
especially not in the first trimester
because no sufficient data is available
to evaluate safe administration of
Zopiclon-ratiopharm 7.5 mg during
pregnancy and the lactation period.
Although Zopiclon-ratiopharm 7.5 mg
did not show any malformations or any
effect damaging the embryo in animal
studies, the safety during human
pregnancy has not been verified.
If your doctor has decided that you
should take Zopiclone during the last
three months of pregnancy or during
labour, your baby may have a low body
temperature, breathing problems,
decreased muscle tone, and suckling
reflex (“floppy infant syndrome”). If
Zopiclone has been taken for a

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prolonged period during the last
months of pregnancy, your baby may
suffer withdrawal symptoms.
Breast-feeding
• You should not take Zopiclone if you are
breast-feeding. Zopiclone is excreted in
breast milk.
Driving and using machines
• Rarely, Zopiclone can cause you to feel
sleepy during the day. It can also cause
reduced alertness, confusion, tiredness,
headache, dizziness, muscle weakness,
double vision, loss of memory, difficulty
concentrating, loss of coordination, and
clumsiness.
• If Zopiclone is taken with alcohol effects
of sleepiness, loss of memory, difficulty
concentrating and difficulty
co-ordinating movements will be
increased
• If you are affected in any way by these
effects, DO NOT drive or operate
machinery.
Zopiclone contains lactose
• Zopiclon PCH 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

child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause drowsiness,
confusion and lethargy. In more serious
cases, overdose may cause loss of
co-ordination, muscle weakness, low blood
pressure (feeling dizzy and faint), breathing
problems, reduced ability of red blood cells
to carry oxygen (methaeglobinemia), which
can be accompanied with the bluish tinge
of the skin and mucous membranes, you
may also complain of headache, fatigue,
shortness of breath or lack of energy, rarely
coma and very rarely death. The effects of an
overdose may be more severe if the tablets
have been taken with alcohol or other
medicines such as antidepressants or
sedatives.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know
which tablets were consumed.
If you forget to take Zopiclone
If you forget to take a dose immediately
before bed but remember during the night,
only take the missed dose if you are still
able to have 7 -8 hours of uninterrupted
sleep. If this is not the case, restart
immediately before the next night. Do not
take a double dose to make up for a
forgotten dose.
If you stop taking Zopiclone
DO NOT stop taking your tablets without
talking to your doctor first, even if you
feel better.
DO NOT stop taking your tablets
suddenly. When your doctor decides to
stop your tablets, the dose will be
reduced gradually over a period of time.
Stopping Zopiclone may lead to
“re-bound insomnia”.This means the
symptoms that required you to take your
tablets in the first place may reappear and
be more severe for a short time. These
symptoms may also be accompanied by
mood changes, sleeping difficulties,
anxiety and restlessness. Therefore, the
dose of these tablets must always be
reduced gradually.
Taking Zopiclone may lead to dependence.
If dependence has developed, stopping
your treatment abruptly will cause
withdrawal effects. These may consist of
headache, muscular pain, extreme anxiety,
feelings of tension, restlessness, confusion,
sleeping difficulties and irritability.
In severe cases the following symptoms
may occur:
• a feeling of detachment from your
surroundings
• a feeling of things being unreal
• sounds seeming to be louder than usual
and which can sometimes be painful if
the sound is loud
• numbness and tingling in the fingers
and toes
• sensitivity to light, noise and physical
contact
• seeing, hearing or feeling things that
are not real (hallucinations)
• fits.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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 tablets should be swallowed
preferably with a drink of water
immediately before going to bed. DO NOT
break, crush, chew, or suck the tablet.
The recommended dose is:
• Adults
One 7.5 mg tablet (or two 3.75 mg
tablets) a day. DO NOT take more than
one 7.5 mg tablet (or two 3.75 mg
tablets) a day.
• Children and adolescents under the age
of 18 years
Zopiclone should not be used in
children and adolescents under the age
of 18 years
• The older people and patients with
breathing difficulties, kidney or liver
problems
A starting dose of one 3.75 mg tablet (or
half a 7.5 mg tablet) is recommended,
which may be increased if necessary by
your doctor.
Method of use
The only suitable time for taking the
tablet is immediately before going to
sleep. The best way of taking a (whole or
half) tablet is to place it on the back of the
tongue and swallow it with a large amount
of water (half a glass, for example).
Duration of the treatment
Treatment with Zopiclone usually lasts
from a few days to two weeks, up to a
maximum of four weeks. In certain cases
treatment may last longer than four
weeks, but only if your doctor believes
this to be necessary. Your treatment with
Zopiclone should be for as short a time
and as low a dose as possible to reduce
the risk of dependence occurring.
If you take more Zopiclone than you should
4 Possible side effects
If you (or someone else) swallow a lot of
Like all medicines, this medicine can
the tablets all together, or if you think a
cause side effects, although not

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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