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ZOPICLONE 3.75 MG TABLETS

Active substance(s): ZOPICLONE / ZOPICLONE

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Version: V001/22/06/17/PL20117/0268-0269
Supersedes: None

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zopiclone
3.75 mg Tablets
7.5 mg 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. 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.
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
The name of your medicine is either Zopiclone 3.75 mg Tablets
or Zopiclone 7.5 mg Tablets. For easy reference both will be
called zopiclone in this leaflet. Zopiclone tablets 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.
Zopiclone 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.
Zopiclone can be used for both temporary and longer lasting
sleep problems. However, zopiclone 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.
2. What you need to know before you use Zopiclone
Do not use Zopiclone and tell your doctor if:
You are allergic (hypersensitive) to zopiclone or any of the
other ingredients of Zopiclone tablets (listed in Section 6
below). The 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
zopiclone 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 zopiclone.
Warnings and precautions
Take special care with Zopiclone
Check with your doctor or pharmacist before taking your
medicine if:
- You have any liver problems (see also ‘Do not take this
medicine and tell your doctor if:’ in the section above).
Your doctor may need to give you a lower dose of zopiclone.
- You have any kidney problems. Your doctor may need to give
you a lower dose of zopiclone.
- You suffer from mild breathing problems, your doctor will
decide if you should receive zopiclone (see also ‘Do not take
this medicine and tell your doctor if:’ in the 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 zopiclone or other similar medicines
for more than four weeks.
- You do not feel you will ever be able to stop taking zopiclone
or other medicines used to treat sleep problems.
Before taking zopiclone, 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 zopiclone.
Other medicines and Zopiclone
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 zopiclone can affect the way some other
medicines work. Also, some medicines can affect the way
zopiclone works.
Tell your doctor if you are taking any of the following medicines.
Zopiclone 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.
The following medicines can increase the chance of you getting
side effects when taken with zopiclone. To make this less likely,
your doctor may decide to lower your dose of zopiclone.
- 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 zopiclone 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.
Taking Zopiclone with food, drink and alcohol
- 
Do not drink alcohol while you are taking zopiclone. Alcohol
can increase the effects of zopiclone and make you sleep very
deeply so that you do not breathe properly or have difficulty
waking.
Pregnancy, breast-feeding and fertility
- Talk to your doctor before taking this medicine if you are
pregnant, might become pregnant, or think you may be
pregnant.
- Do not take zopiclone 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 zopiclone. This is because
small amounts may pass into mother’s milk. If you are breastfeeding 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.
Driving and using machines
Like other medicines used for sleep problems, zopiclone can
cause slowing of your normal brain function (central nervous
system depression). The risk of psychomotor impairment
including driving ability is increased if:
• You take zopiclone within 12 hours of performing activities that
require mental alertness
• You take higher than the recommended dose of zopiclone
• You take zopiclone while already taking another central
nervous system depressant or another medicine that
increases levels of zopiclone in your blood, or while drinking
alcohol.
Do not engage in hazardous activities requiring complete mental
alertness such as driving or operating a machinery after taking
zopiclone 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.
Important information about some of the ingredients of
Zopiclone
Zopiclone tablet 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.
3. How to take Zopiclone
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 zopiclone 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 in a single intake and do not take
again during the same night.
- The usual length of treatment is 2 days to 3 weeks.

Version: V001/22/06/17/PL20117/0268-0269
Supersedes: None

Adults
The usual dose is zopiclone 7.5 mg just before bedtime.
Elderly
The usual starting dose is one zopiclone tablet (3.75 mg) just
before bedtime. Your doctor may decide to increase your dose
to one zopiclone tablet (7.5 mg) if needed.
Use in 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.
Patients with liver, respiratory or kidney problems
The usual starting dose is one zopiclone tablet (3.75 mg) just
before bedtime.
Blood Tests
• Zopiclone 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.
If you take more Zopiclone than you should
If you take more zopiclone 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 zopiclone can be very dangerous.
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
Zopiclone 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 stop taking Zopiclone
Keep taking zopiclone until your doctor tells you to stop. Do not
stop taking zopiclone 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 zopiclone 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.
4. Possible side effects
Like all medicines, zopiclone can cause side effects, although
not everybody gets them.
Stop taking Zopiclone 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 zopiclone (amnesia). By having
7-8 hours of uninterrupted sleep after taking zopiclone, 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).
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.
- Double vision.
- Moving unsteadily or staggering.
- Muscular weakness.
- Indigestion.
- Becoming dependent on zopiclone.
- Slower breathing (respiratory depression).
- Unusual skin sensations such as numbness, tingling, pricking,
burning or creeping on the skin (paraesthesia).
- Mental problems such as poor memory.
- Difficulty paying attention.
- Disrupted normal speech.
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 Zopiclone
Keep this medicine in a safe place where children cannot see or
reach it.
Do not use zopiclone 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 30°C. 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. Contents of the pack and other information
What Zopiclone contains
The active substance is zopiclone.
The other ingredients (excipients) are lactose monohydrate,
calcium hydrogen phosphate dihydrate, maize starch, starch
pregelatinized, magnesium stearate, hypromellose, titanium
dioxide, macrogol 400, purified water.
What Zopiclone looks like and contents of the pack
Zopiclone 3.75 mg Tablets: White to off white, round, biconvex
film-coated tablets with diameter of 5.95 mm to 6.25 mm.
Zopiclone 7.5 mg Tablets: White to off white, oval, biconvex filmcoated tablet with breakline on one side, with dimensions,
length: 9.95 mm to 10.25 mm, width: 4.95 mm to 5.25 mm.
Clear white PVC – aluminium blisters of 7, 10, 14, 28 and 30
tablets are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Morningside Healthcare Ltd
115, Narborough Road, Leicester, LE3 0PA, UK
Manufacturer:
Morningside Pharmaceuticals Ltd
5, Pavilion Way, Loughborough, LE11 5GW, UK
This leaflet was last revised in september 2016.

M0269LAMUKNA-S-001

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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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