ZIMOVANE 7.5MG FILM-COATED TABLETS

Active substance: ZOPICLONE

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• 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.

Read all of this leaflet carefully before
you start taking this medicine

Is this leaflet hard
to see or read?
Phone 01483
505515 for help

film-coated tablets
zopiclone

Zimovane LS 3.75 mg

film-coated tablets

Zimovane 7.5 mg

PACKAGE LEAFLET:
INFORMATION FOR THE USER

-1-

R769460

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
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

1. What Zimovane is and what
it is used for

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

In this leaflet:

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
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.

Do not take this medicine and
tell your doctor if:

2. Before you take Zimovane

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. Ask your doctor for advice if
you are unsure.

L

L

L
L

L

L

‘Do not take this medicine and tell your
doctor if:’ section above). Your doctor
may need to give you a lower dose of
Zimovane
You have any kidney problems. Your
doctor may need to give you a lower
dose of Zimovane
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).
You have a history of alcohol or drug abuse
You have been told by a doctor that you
have a personality disorder
You have recently taken Zimovane or other
similar medicines for more than four weeks
You do not feel you will ever be able to
stop taking Zimovane or other medicines
used to treat sleep problems

L You have any liver problems (see also

Take special care with
Zimovane
Check with your doctor or pharmacist
before taking your medicine if:

-2-

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

Taking other medicines

If you are not sure if any of the above
applies to you, talk to your doctor or
pharmacist before taking Zimovane.

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).

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

the following medicines.
Zimovane may increase the effect of the
following medicines:
• Medicines for mental problems (antipsychotics)
• 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

• 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,

Pregnancy and breast-feeding

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.

Taking Zimovane with food and drink
• Do not drink alcohol while you are

The following medicines can make Zimovane
work less well:
• Some medicines for epilepsy such as
carbamazepine, phenobarbital or
phenytoin
• Rifampicin (an antibiotic) - for infections
• St John’s Wort (a herbal medicine) - for
mood swings and depression

infections

-3-

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.

Important information about some of
the ingredients of Zimovane

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.

Driving and using machines

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.

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

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.

Elderly

The usual dose is one Zimovane tablet
(7.5 mg) just before bedtime.

Adults







Taking this medicine

Always take Zimovane exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.

3. How to take Zimovane
Treatment should be as short as
possible and should not exceed four
weeks including period of tapering off

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:
• Feeling drowsy, confused, sleeping deeply
and possibly falling in to a coma

If you take more Zimovane than you
should

• 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

Blood Tests

The usual starting dose is one Zimovane LS
tablet (3.75 mg) just before bedtime.

Patients with liver, respiratory or
kidney problems

Zimovane should not be used in children
and adolescents under 18 years of age.

Children and adolescents

-4-

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.
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.

If you stop taking 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 forget to take Zimovane

• 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)

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.

4. Possible side effects

• A mild bitter or metallic taste in your
mouth or a dry mouth

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)

• 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.
Not known (frequency cannot be
estimated from available data)
• Believing, seeing or hearing things that
are not real (delusion or hallucinations)
• Feeling low or sad (depressed mood)

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)

• You have an allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue

Stop taking Zimovane and see a doctor
or go to a hospital straight away if:

Like all medicines, Zimovane can cause side
effects, although not everybody gets them.

Reporting of side effects

-5-

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.

Sleep-Driving and other strange behaviour

• Feeling sick (nausea) or being sick
(vomiting)
• Feeling dizzy or sleepy
• Headache
• Nightmares
• Feeling physically or mentally tired
Rare (affects 1 to 10 users in 10,000)
• Feeling confused
• Itchy, lumpy rash (urticaria)
• Feeling irritable or aggressive
• Reduced sex drive
Not known (frequency cannot be estimated
from available data)
• Feeling restless or angry
• Feeling light headed or having problems
with your coordination
• Double vision
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.

5. How to store Zimovane

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.

Uncommon (affects 1 to 10 users in 1,000)

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.

What Zimovane looks like and contents
of the pack

• 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
Other ingredients are lactose monohydrate,
calcium hydrogen phosphate dihydrate,
wheat starch, sodium starch glycollate,
magnesium stearate, hypromellose, titanium
dioxide and macrogol 6000.

What Zimovane and Zimovane LS
contain

6. Further information

-6-

© sanofi, 1993 - 2013

This leaflet was last revised in
06/2013.

R769460

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.

Manufacturer
Sanofi Winthrop Industrie,
56, route de Choisy-au-Bac,
60205 Compiegne,
France.

Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford,
Surrey, GU1 4YS
Tel: 01483 505515
Fax: 01483 535432
email:
uk-medicalinformation@sanofi.com

Marketing Authorisation Holder and
Manufacturer

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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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