Skip to Content

ZIMOVANE 7.5MG FILM-COATED TABLETS

Active substance: ZOPICLONE

View full screen / Print PDF » Download PDF ⇩
Transcript
Version N°
COMPIÈGNE

6

créé le
par
modifié le
par

04/12/2014
E Wasczczyk
28/01/2015
E Wasczczyk

Laboratoires
Pays

N° version Logo/Name
N° version Country Ex.
Nom du produit Zimovane
N° plan Dimensionnel
Référence article R774050
N° plan positionnement
3,75 mg & 7,5 mg Dimensions
Dosage
Taille mini caractères
cprs
Quantité
Type Article

Sanofi
Grande-Bretagne

Couleur
Nbre/Réf.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Zimovane 7.5 mg
film-coated tablets

Zimovane LS 3.75 mg
film-coated tablets
zopiclone

Notice triple

1

Read all of this leaflet carefully
before you start taking this medicine
• 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. 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
pharmacist.

In this leaflet:
1. What Zimovane is and what it is
used for
2. Before you take Zimovane
3. How to take Zimovane
4. Possible side effects
5. How to store Zimovane
6. Further information

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
• Severe or upsetting sleep problems
that 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.
-1-

Code sécurité
R774050
Numéro de Pages
1 / 6

Bleu Reflex Blue U

1. What Zimovane is and
what it is used for

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

NA
CRGB - V1 - 05/2012
1-606251a
606251-1a
150 x 210 mm
10 pts

R774050

Ask your doctor for advice if you are
unsure.
2. Before you take Zimovane
Do not take this medicine and
tell your doctor if:
You are allergic (hypersensitive) to
zopiclone or any of the other
ingredients of Zimovane (listed in
Section 6 below)
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 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.

Version N°
COMPIÈGNE

6

créé le
par
modifié le
par

04/12/2014
E Wasczczyk
28/01/2015
E Wasczczyk

Laboratoires
Pays

Sanofi
Grande-Bretagne

N° version Logo/Name
N° version Country Ex.
Nom du produit Zimovane
N° plan Dimensionnel
Référence article R774050
N° plan positionnement
3,75 mg & 7,5 mg Dimensions
Dosage
Taille mini caractères
cprs
Quantité
Type Article

Couleur
Nbre/Réf.

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

Notice triple

1

Bleu Reflex Blue U

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.

Taking other medicines
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:
• Medicines for mental problems
(antipsychotics)
-2-

NA
CRGB - V1 - 05/2012
1-606251a
606251-1a
150 x 210 mm
10 pts

Code sécurité
R774050
Numéro de Pages
2 / 6

• Medicines for depression
• Medicines for epilepsy (anticonvulsants)
• Medicines used in surgery
(anaesthetics)
• Medicines to calm or reduce anxiety
or for sleep problems (hypnotics)
• 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 Zimovane. To make
this less likely, your doctor may decide
to lower your dose of Zimovane:
• 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
Zimovane work less well:
• Some medicines for epilepsy such as
carbamazepine, phenobarbital or
phenytoin

Version N°
COMPIÈGNE

6

créé le
par
modifié le
par

04/12/2014
E Wasczczyk
28/01/2015
E Wasczczyk

Laboratoires
Pays

Sanofi
Grande-Bretagne

N° version Logo/Name
N° version Country Ex.
Nom du produit Zimovane
N° plan Dimensionnel
Référence article R774050
N° plan positionnement
3,75 mg & 7,5 mg Dimensions
Dosage
Taille mini caractères
cprs
Quantité
Type Article

Couleur
Nbre/Réf.

• Rifampicin (an antibiotic) - for
infections
• St John’s Wort (a herbal medicine) for mood swings and depression
Taking Zimovane with food and drink
• Do not drink alcohol while you are
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 and breast-feeding
• Talk to your doctor before taking
this medicine if you are pregnant,
might become pregnant, or think
you may be pregnant
• Do not take Zimovane 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
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

Notice triple

1

Code sécurité
R774050
Numéro de Pages
3 / 6

Bleu Reflex Blue U

Ask your doctor or pharmacist for
advice before taking any medicine if
you are pregnant or breast-feeding.
Driving and using machines
On the day after taking Zimovane, do
not drive or use machinery or tools if
you feel sleepy, dizzy or confused.
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 Zimovane
Zimovane 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.
• Wheat starch. People with wheat
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-

NA
CRGB - V1 - 05/2012
1-606251a
606251-1a
150 x 210 mm
10 pts

R774050

3. How to take Zimovane
Treatment should be as short as
possible and should not exceed four
weeks including period of tapering
off
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
• Do not crush or chew your tablets
• Take just before bedtime
• The usual length of treatment is 2
days 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.

Version N°
COMPIÈGNE

6

créé le
par
modifié le
par

04/12/2014
E Wasczczyk
28/01/2015
E Wasczczyk

Laboratoires
Pays

Sanofi
Grande-Bretagne

N° version Logo/Name
N° version Country Ex.
Nom du produit Zimovane
N° plan Dimensionnel
Référence article R774050
N° plan positionnement
3,75 mg & 7,5 mg Dimensions
Dosage
Taille mini caractères
cprs
Quantité
Type Article

Couleur
Nbre/Réf.

Notice triple

1

Bleu Reflex Blue U

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.

• 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)

Blood Tests
• Zimovane 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 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.
Taking too much Zimovane can be
very dangerous. The following effects
may happen:

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.

-4-

NA
CRGB - V1 - 05/2012
1-606251a
606251-1a
150 x 210 mm
10 pts

Code sécurité
R774050
Numéro de Pages
4 / 6

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:
• Feeling anxious, shaky, irritable,
agitated, confused or having panic
attacks
• Sweating
• Headache
• Faster heartbeat or uneven heartbeat
(palpitations)
• A lower level of awareness and
problems with focusing or
concentrating
• Nightmares, seeing or hearing things
that are not real (hallucinations)
• Being more sensitive to light, noise
and touch than normal
• Relaxed grip on reality
• Numbness and tingling in your
hands and feet
• Aching muscles
• Stomach problems
In rare cases fits (seizures) may also
occur.

Version N°
COMPIÈGNE

6

créé le
par
modifié le
par

04/12/2014
E Wasczczyk
28/01/2015
E Wasczczyk

Laboratoires
Pays

Sanofi
Grande-Bretagne

N° version Logo/Name
N° version Country Ex.
Nom du produit Zimovane
N° plan Dimensionnel
Référence article R774050
N° plan positionnement
3,75 mg & 7,5 mg Dimensions
Dosage
Taille mini caractères
cprs
Quantité
Type Article

Couleur
Nbre/Réf.

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:
• You have an allergic reaction. The
signs may include: a rash,
swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
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)
• Poor memory since taking Zimovane
(amnesia). By having 7-8 hours of
uninterrupted sleep after taking
Zimovane, this is less likely to cause
you a problem.
• Seeing or hearing things that are not
real (hallucinations)
• Falling, especially in the elderly
Not known (frequency cannot be
estimated from available data)
• Thinking things that are not true
(delusions)
• Feeling low or sad (depressed mood)

Notice triple

1

NA
CRGB - V1 - 05/2012
1-606251a
606251-1a
150 x 210 mm
10 pts

Numéro de Pages
5 / 6

Bleu Reflex Blue U

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)
• A mild bitter or metallic taste in
your mouth or a dry mouth
• Feeling drowsy or sleepy
• Dry mouth
Uncommon (affects 1 to 10 users in
1,000)
• Feeling sick (nausea) or being sick
(vomiting)
• Feeling dizzy or sleepy
• 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
• Difficulty breathing or being short of
breath
Not known (frequency cannot be
estimated from available data)
• Feeling restless or angry
• Feeling light headed or having
problems with your coordination
-5-

Code sécurité
R774050








Double vision
Moving unsteadily or staggering
Muscular weakness
Indigestion
Becoming dependent on Zimovane
Slower breathing (respiratory
depression)
• Unusual skin sensations such as
numbness, tingling, pricking, burning
or creeping on the skin
(paraesthesia)
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

Version N°
COMPIÈGNE

6

créé le
par
modifié le
par

04/12/2014
E Wasczczyk
28/01/2015
E Wasczczyk

Laboratoires
Pays

Sanofi
Grande-Bretagne

N° version Logo/Name
N° version Country Ex.
Nom du produit Zimovane
N° plan Dimensionnel
Référence article R774050
N° plan positionnement
3,75 mg & 7,5 mg Dimensions
Dosage
Taille mini caractères
cprs
Quantité
Type Article

Couleur
Nbre/Réf.

By reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store Zimovane
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.
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. Further information
What Zimovane and Zimovane LS
contain
• Each tablet of Zimovane contains
7.5 mg of the active substance
zopiclone
• Each tablet of Zimovane LS contains
3.75 mg of the active substance
zopiclone

Notice triple

1

NA
CRGB - V1 - 05/2012
1-606251a
606251-1a
150 x 210 mm
10 pts

Code sécurité
R774050
Numéro de Pages
6 / 6

Bleu Reflex Blue U

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, 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
01/2015.
© sanofi, 1993 - 2015

-6-

R774050

Expand view ⇕

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.

Hide