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ZIMOVANE 7.5MG FILM-COATED TABLETS

Active substance(s): ZOPICLONE

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COMPIÈGNE

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Nom du produit
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Zimovane
R775350
3.75 mg & 7.5 mg
cprs

Sanofi
Grande-Bretagne

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Zimovane 7.5 mg

film-coated tablets

Zimovane LS 3.75 mg
film-coated tablets
zopiclone

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Read all of this leaflet carefully before
you start taking this medicine
•  eep this leaflet. You may need to read
K
it again.
•  f you have any further questions, ask
I
your doctor or pharmacist.
•  his medicine has been prescribed for
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you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
•  f any of the side effects gets serious, or
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if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.


What is in this leaflet
1. What Zimovane is and what it is used for
2.  hat you need to know before you take
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Zimovane
3. How to take Zimovane
4. Possible side effects
5. How to store Zimovane
6.  ontents of the pack and other information
C

The name of your medicine is Zimovane
tablets or Zimovane LS tablets (both
called Zimovane in this leaflet). Zimovane
contains a medicine called zopiclone. This
belongs to a group of medicines called
hypnotics. It works by acting on your brain
to help you sleep.
Zimovane is used to treat sleep problems
in adults such as:
• Difficulty falling asleep
• Waking in the middle of the night
• Waking too early
•  evere or upsetting sleep problems that
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are caused by your mood or mental
health problems
Zimovane can be used for both temporary
and longer lasting sleep problems.
However, Zimovane is not meant to be
used every day for long periods of time or
to treat depression.
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1.  hat Zimovane is and what it
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is used for

Is this leaflet hard
to see or read?
Phone 08453727101
for help

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Ask your doctor for advice if you are
unsure.
2.  hat you need to know before you
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take Zimovane
Do not take Zimovane
  ou are allergic (hypersensitive)
Y
to zopiclone or any of the other
ingredients of Zimovane (listed in
Section 6 below)
 igns of an allergic reaction include:
S
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
  ou have a problem that causes severe
Y
muscle weakness (myasthenia gravis)
  our lungs do not work properly
Y
(respiratory failure)
  ou have a problem where you stop
Y
breathing for short periods at night
(sleep apnoea)
  ou have severe liver problems
Y
  ou are under the age of 18.?The safety
Y
and efficacy of Zimovane 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 Zimovane.

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Zimovane
R775350
3.75 mg & 7.5 mg
cprs

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Warnings and precautions
Talk to your doctor or
pharmacist before taking
Zimovane
▲  ou have any liver problems (see also
Y
‘Do not take this medicine and tell your
doctor if:’ section above). Your doctor
may need to give you a lower dose of
Zimovane
▲  ou have any kidney problems. Your
Y
doctor may need to give you a lower
dose of Zimovane
▲  ou suffer from mild breathing
Y
problems, your doctor will decide if
you should receive Zimovane (see also
‘Do not take this medicine and tell your
doctor if:’ section above).
▲  ou have a history of alcohol or drug
Y
abuse
▲  ou have been told by a doctor that
Y
you have a personality disorder
▲  ou have recently taken Zimovane or
Y
other similar medicines for more than
four weeks
▲  ou do not feel you will ever be able
Y
to stop taking Zimovane or other
medicines used to treat sleep problems


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Before taking Zimovane, 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 Zimovane.

Other medicines and Zimovane
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
Zimovane can affect the way some other
medicines work. Also some medicines can
affect the way Zimovane works.
Tell your doctor if you are taking any of
the following medicines.
Zimovane may increase the effect of the
following medicines:
•  edicines for mental problems
M
(antipsychotics)
• Medicines for depression
• Medicines for epilepsy (anticonvulsants)
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•  edicines used in surgery
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(anaesthetics)
•  edicines to calm or reduce anxiety or
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for sleep problems (hypnotics)
•  edicines for hay fever, rashes or other
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allergies that can make you sleepy
(sedative antihistamines) such as
chlorphenamine or promethazine
•  ome medicines for moderate to
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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 Zimovane. To make this less
likely, your doctor may decide to lower
your dose of Zimovane:
•  ome antibiotics such as clarithromycin
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or erythromycin
•  ome medicines for fungal infections
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such as ketaconazole and itraconazole
•  itonavir (a protease inhibitor) - for
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HIV infections
The following medicines can make
Zimovane work less well:
•  ome medicines for epilepsy such
S
as carbamazepine, phenobarbital or
phenytoin

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•  ifampicin (an antibiotic) - for infections
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•  t John’s Wort (a herbal medicine) - for
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mood swings and depression
Taking Zimovane with food and drink
•  o not drink alcohol while you are
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taking Zimovane. Alcohol can increase the
effects of Zimovane and make you sleep
very deeply so that you do not breathe
properly or have difficulty waking.
Pregnancy, breast-feeding and fertility
•  alk to your doctor before taking this
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medicine if you are pregnant, might
become pregnant, or think you may be
pregnant
•  o not take Zimovane during the
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last 3 months of pregnancy or during
labour because it may be harmful to
your baby
•  o not breast-feed if you are taking
D
Zimovane. This is because small
amounts may pass into mother’s milk.
If you are breast-feeding 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.


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Driving and using machines
Like other medicines used for sleep
problems, Zimovane can cause slowing
of your normal brain function (central
nervous system depression). The risk
of psychomotor impairment including
driving ability, is increased if:
•  ou take Zimovane within 12 hours
Y
of performing activities that require
mental alertness
•  ou take higher than the recommended
Y
dose of Zimovane
•  ou take Zimovane while already
Y
taking another central nervous system
depressant or another medicine that
increases levels of Zimovane in your
blood, or while drinking alcohol.
Do not engage in hazardous activities
requiring complete mental alertness such
as driving or operating machinery after
taking Zimovane, 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.

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Important information about some of
the ingredients of Zimovane
Zimovane contains:
•  actose. This is a type of sugar. If
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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.
•  heat starch. People with wheat
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allergy should not take this medicine.
Wheat allergy is not the same as Coeliac
disease. Zimovane can be taken by
people with Coeliac disease.
3. How to take Zimovane
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 Zimovane exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablet with a drink of water

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Zimovane
R775350
3.75 mg & 7.5 mg
cprs

Sanofi
Grande-Bretagne

• Do not crush or chew your tablets
•  ake just before bedtime in a single
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intake and do not take again during the
same night
•  he usual length of treatment is 2 days
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to 3 weeks
Adults
The usual dose is one Zimovane tablet
(7.5 mg) just before bedtime.
Elderly
The usual starting dose is one Zimovane
LS tablet (3.75 mg) just before bedtime.
Your doctor may decide to increase your
dose to one Zimovane tablet (7.5 mg) if
needed.
Use in children and adolescents
Zimovane should not be used in children
and adolescents less than 18 years.
The safety and efficacy of Zimovane in
children and adolescents aged less than
18 years have not been established.
Patients with liver, respiratory or
kidney problems
The usual starting dose is one Zimovane
LS tablet (3.75 mg) just before bedtime.



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Blood Tests
•  imovane can change the levels of liver
Z
enzymes shown up in blood tests. This
can mean that your liver is not working
properly
• I
  f you are going to have a blood test, it
is important to tell your doctor that you
are taking Zimovane

If you forget to take Zimovane
Zimovane must only be taken at bedtime.
If you forget to take your tablet at
bedtime, then you should not take it at
any other time, otherwise you may feel
drowsy, dizzy and confused during the day.
Do not take a double dose to make up for
a forgotten tablet.

If you take more Zimovane than you
should
If you take more Zimovane than you
should, tell a doctor or go to a hospital
casualty department straight away. Take
the medicine pack with you. This is so the
doctor knows what you have taken.

If you stop taking Zimovane
Keep taking Zimovane until your doctor
tells you to stop. Do not stop taking
Zimovane suddenly, but tell your doctor if
you want to stop. Your doctor will need to
lower your dose and stop your tablets over
a period of time.

Taking too much Zimovane can be very
dangerous. The following effects may
happen:
•  eeling drowsy, confused, sleeping
F
deeply and possibly falling in to a coma
• Floppy muscles (hypotonia)
•  eeling dizzy, light headed or faint.
F
These effects are due to low blood
pressure
•  alling over or losing your balance
F
(ataxia)
•  hallow breathing or difficulty
S
breathing (respiratory depression)

If you stop taking Zimovane suddenly,
your sleep problems may come back and
you may get a ‘withdrawal effect’. If this
happens you may get some of the effects
listed below.
See a doctor straight away if you get any of
the following effects:
•  eeling anxious, shaky, irritable,
F
agitated, confused or having panic
attacks
• Sweating
• Headache

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Zimovane
R775350
3.75 mg & 7.5 mg
cprs

Sanofi
Grande-Bretagne

•  aster heartbeat or uneven heartbeat
F
(palpitations)
•  lower level of awareness
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and problems with focusing or
concentrating
•  ightmares, seeing or hearing things
N
that are not real (hallucinations)
•  eing more sensitive to light, noise and
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touch than normal
• Relaxed grip on reality
•  umbness and tingling in your hands
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and feet
• Aching muscles
• Stomach problems
In rare cases fits (seizures) may also occur.
4. Possible side effects
Like all medicines, Zimovane can cause
side effects, although not everybody gets
them.
Stop taking Zimovane and see a doctor
or go to a hospital straight away if:
•  ou have an allergic reaction. The signs
Y
may include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue



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Tell your doctor as soon as possible
if you have any of the following side
effects:
Rare (affects 1 to 10 users in 10,000)
•  oor memory since taking Zimovane
P
(amnesia). By having 7-8 hours of
uninterrupted sleep after taking
Zimovane, this is less likely to cause
you a problem.
•  eeing or hearing things that are not
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real (hallucinations)
• §Falling, especially in the elderly
Not known (frequency cannot be
estimated from available data)
•  hinking things that are not true
T
(delusions)
• Feeling low or sad (depressed mood)
Tell your doctor or pharmacist if any of
the following side effects get serious or
lasts longer than a few days:
Common (affects 1 to 10 users in 100)
•  mild bitter or metallic taste in your
A
mouth or a dry mouth
•  eeling drowsy or sleepy
F
•  ry mouth
D
Uncommon (affects 1 to 10 users in 1,000)
•  eeling sick (nausea) or being sick
F
(vomiting)
• Feeling dizzy or sleepy
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• Headache
• Nightmares
• Feeling physically or mentally tired
• Agitation
Rare (affects 1 to 10 users in 10,000)
• Feeling confused
• Itchy, lumpy rash (urticaria)
• Feeling irritable or aggressive
• Reduced sex drive
•  ifficulty breathing or being short of
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breath
Not known (frequency cannot be
estimated from available data)
• Feeling restless or angry
•  eeling light headed or having
F
problems with your coordination
• Double vision
• Moving unsteadily or staggering
• Muscular weakness
• Indigestion
• Becoming dependent on Zimovane
• Slower breathing (respiratory
depression)
•  nusual skin sensations such as
U
numbness, tingling, pricking, burning
or creeping on the skin (paraesthesia)
•  ental problems such as poor memory
M
•  ifficulty paying attention
D
•  isrupted normal speech
D

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Nom du produit
Référence article
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Zimovane
R775350
3.75 mg & 7.5 mg
cprs

02/07/2015
E Wasczczyk

Laboratoires
Pays

Type Article

Sanofi
Grande-Bretagne

Sleep-Driving and other strange
behaviour
There have been some reports of people
doing things while asleep that they do not
remember when waking up after taking a
sleep medicine.
This includes sleep-driving and sleep
walking. Alcohol and some medicines for
depression or anxiety can increase the
chance that this serious effect will happen.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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.
5. How to store Imovane
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Zimovane 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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150 x 210 mm
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Store below 30ºC. Keep the blister in the
outer carton in order to protect from light
and moisture.
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.  ontents of the pack and other
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information
What Zimovane and Zimovane LS
contain
•  ach tablet of Zimovane contains 7.5
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mg of the active substance zopiclone
•  ach tablet of Zimovane LS contains
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3.75 mg of the active substance zopiclone
Other ingredients are lactose
monohydrate, calcium hydrogen
phosphate dihydrate, wheat starch,
sodium starch glycollate, magnesium
stearate, hypromellose, titanium dioxide
and macrogol 6000.
What Zimovane looks like and contents
of the pack
Zimovane is a white, elliptical (oval),
biconvex shaped film-coated tablet with
a score line on one side contained within
PVC/aluminium foil blisters containing 56,
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Code sécurité
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R775350

28, 14, 7 or 3 tablets, and in a starter pack
containing 3 tablets.
Zimovane LS is a white, round, biconvex
shaped film-coated tablet within PVC/
aluminium foil blisters containing 112, 56,
28, 14, 10, 7 or 3 tablets, and in a starter
pack containing 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford,
Surrey, GU1 4YS
Tel: 08453727101
email:
uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie,
56, route de Choisy-au-Bac,
60205 Compiegne,
France.
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in June 2015
© sanofi, 1993 - 2015

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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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