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ZOPICLONE 7.5 MG TABLETS

Active substance(s): ZOPICLONE

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PATIENT INFORMATION LEAFLET

ZOPICLONE 7.5mg TABLETS
Read this leaflet carefully BEFORE you start taking Zopiclone Tablets because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• 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 of the side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1. What Zopiclone Tablets are and what they are used for
2. What you need to know before you take Zopiclone Tablets
3. How to take Zopiclone Tablets
4. Possible side effects
5. How to store Zopiclone Tablets
6. Contents of the pack and other information

1.

WHAT ZOPICLONE TABLETS ARE
AND WHAT THEY ARE USED FOR

Zopiclone is one of a group of medicines called
hypnotics (sleeping tablets). These tablets can
be used for both temporary and longer lasting
sleep problems (insomnia). It should help you to
sleep, without leaving you drowsy the next day.
However, Zopiclone is not meant to be used
every day for long periods of time. If you need
any further information on your condition, please
ask your doctor.

2.

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ZOPICLONE TABLETS

Do not take Zopiclone:
• If you are allergic to Zopiclone or any
of the other ingredients of this medicine
(listed in section 6). Signs of an allergic
reaction include: a rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Zopiclone if you:
• suffer from myasthenia gravis (a condition
where the muscles easily tire and become
weak)
• have any breathing problems, especially
during sleep (sleep apnoea)
• suffer from respiratory failure (your lungs do
not work properly)
• have severe liver problems
• are under 18 years of age
Please tell your doctor before taking this
medicine if you:
• have a personality disorder
• have ever been, or are currently being
treated for drug or alcohol abuse
• have any kidney or liver problems - your
doctor may need to give you a lower dose
• feel you will not be able to stop taking
zopiclone or any medication used to treat
your sleep problems
• are elderly as there may be a greater risk of
side effects
Children and adolescents
Do not give this medication to children or
adolescents under 18 years of age as the safety
has not yet been established in this group.
Other medicines and Zopiclone
Please inform your doctor or pharmacist if you
are taking, or have recently taken, any other
medicines including medicines obtained without
a prescription. If you are taking any other
medicines, these medicines may change the
way Zopiclone Tablets work.
Example:
• another treatment to help you sleep, to calm
or reduce anxiety (hypnotics)
• treatment for schizophrenia and psychotic
disorders (antipsychotics)
• treatment for depression
• treatment for epilepsy such as
carbamazepine, phenobarbital or phenytoin
• strong pain killers such as codeine,
morphine, methadone, oxycodone, pethidine,
tramadol or diamorphine
• sedative antihistamines (to treat allergies,
skin irritation or vomiting) such as
chlorpheniramine or promethazine
• rifampicin, clarithromycin or erythromycin
(antibiotics to treat infections)
• some medicines for fungal infections such as
ketoconazole and itraconazole
• St. John’s Wort (a herbal medicine) for mood
swings and depression
• ritonavir (a protease inhibitor) for HIV
infections
• medicines used in surgery (anaesthetics)
If you have to go to a doctor, dentist or hospital,
for any reason, tell them that you are taking
Zopiclone Tablets.
Zopiclone with alcohol
Do not drink alcohol while you are taking this
medicine. 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 and breast-feeding
Tell your doctor or pharmacist if you are
pregnant or think you might be pregnant or if
you are breast-feeding. Do not take this
medicine during the last 3 months of pregnancy
or during labour because it may be harmful to
your baby. If taken in late pregnancy, the baby
may have low body temperature or breathing
difficulties and show withdrawal symptoms after
birth because of physical dependence.
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
preforming 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 the levels of
Zopiclone in your blood, or while drinking
alcohol.
On the day after taking Zopiclone 7.5mg
Tablets, 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.
Zopiclone contains Lactose
This medicine contains 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 TABLETS

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure. The number of
tablets you need to take will depend on your
condition.
Zopiclone Tablets should be swallowed whole
without sucking, chewing or crushing, with a
small glass of water before you go to bed.
The recommended dose is:
Adults
The usual adult dose is one Zopiclone Tablet
(7.5mg) per day.
Elderly
The usual starting dose is 3.75mg (½ a tablet).
Patients with liver or kidney problems
The usual starting dose is 3.75mg (½ a tablet).
Patients with Respiratory Insufficiency
A reduced dosage is recommended
Use in Children and adolescents
Zopiclone Tablets are NOT recommended for
children.
Your treatment will usually be for less than 4
weeks, and the doctor may reduce your dose
near the end of your course. If you take
Zopiclone longer than this, the medicine may
not work as well, you may become dependent
and you may have withdrawal symptoms when
you stop.
If you have the impression that the effect of
Zopiclone Tablets is too strong or too weak talk
to your doctor or pharmacist.
If you take more of this medicine than you
should
If you have taken more Zopiclone Tablets than
you should, or a child swallows any tablets, go
to your nearest casualty department
immediately. Take the medicine pack with you
so the doctor knows what you have taken.
Taking too much Zopiclone can be very
dangerous. The symptoms of overdose include
feeling drowsy, shallow breathing or difficulties
breathing and difficulty in controlling
movements.
Pharmacode
CP.ZOP.7-5T.V3P2

location

If you forget to take your medicine
Zopiclone must only be taken before going to
bed. If you forget to take a dose just take the
next tablet at the usual time. DO NOT take two
doses at the same time.
If you stop taking this medicine
It is important to continue taking the tablets for
as long as your doctor tells you to. You should
not stop taking your tablets suddenly without
advice from your doctor. Do not change the
dose of your medicine unless you have spoken
with your doctor.
Your doctor will need to lower your dose before
stopping your treatment to help prevent any
withdrawal effects and to help prevent return of
your sleep problems (rebound insomnia).
Stopping treatment with Zopiclone Tablets is
unlikely to be associated with withdrawal effects
when duration of treatment is limited to 4 weeks.
Withdrawal symptoms
Some patients may experience withdrawal
symptoms when they stop taking this medicine.
See a doctor immediately if you get any of the
following symptoms:
• Headaches
• Muscle pain
• Sweating
• Stomach problems
• Relaxed grip on reality
• Faster or uneven heartbeat
• Numbness and tingling sensation in hands
and feet
• Increased sensitivity to light, noise and
physical contact
• Feeling of watching yourself
(Depersonalization)
• A lower level of awareness and problems with
focusing or concentrating
• Nightmares, seeing or hearing things that are
not real (hallucinations)
• Feeling anxious, shaky, irritable, agitated,
confused or having panic attacks
• Epileptic Seizures
• Rare cases of abuse have been reported

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience the following rare, but very
serious side effects, stop taking Zopiclone
tablets and tell your doctor immediately or
contact the casualty department at your
nearest hospital:
An allergic reaction: skin rash, swelling of the
face, lips, tongue or throat or difficulty breathing
or swallowing or light headedness, lack of
co-ordination, delusions (thinking things that are
not true), depression (feeling low or sad), and
respiratory depression (slower breathing)
including these signs and symptoms.
Tell your doctor or pharmacist if any of the
following side effects occur or worsen:
The following side effects have been
reported:
Common (may affect up to 1 in 10 people)
• Mild bitter taste or metallic taste in the mouth
• Dry mouth
• Sleepiness
Uncommon (may affect up to 1 in 100 people)
• Headache
• Nightmares
• Stomach discomfort
• Drowsiness
• Nausea (feeling sick)
• Vomiting (being sick)
• Dizziness
• Tiredness
• Agitation

• Becoming dependent
• Sleepwalking
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 sleepwalking.
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 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, Website:
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
TABLETS

KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not use this medicine after the expiry date
printed on the blister and carton. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original
package.
Do not keep the tablets if your doctor decides to
stop treatment.
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 protect the
environment.

6.

CONTENTS OF PACK AND OTHER
INFORMATION

What your medicine contains
The active ingredient is zopiclone. Each tablet
contains 7.5mg of zopiclone.
The inactive ingredients are calcium hydrogen
phosphate dihydrate, lactose monohydrate,
maize starch, sodium starch, glycollate type A,
magnesium stearate, hydroxypropylmethylcellulose, propylene glycol, titanium dioxide and
talc.
Pharmacode
location

What your medicine looks
like and contents of the pack
Zopiclone 7.5mg Tablets are white coloured,
circular, film-coated tablets with a score line on
one side.
The tablets are available in a pack size of 28.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray,
Co. Roscommon, Ireland.
Telephone: 00 353 (0) 9066 61109
Fax: 00 353 (0) 9066 61921
For any information about this medicine, please
contact Athlone Laboratories on the contact
details above.
Manufacturer responsible for batch release
Kent Pharmaceuticals Limited, Crowbridge
Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
Distributor
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
PL 30464/0127
POM
This leaflet was revised in May 2016.

Rare (may affect up to 1 in 1,000 people)
• Poor memory since taking Zopiclone
• Confusion
• Libido disorder
• Hallucinations - seeing or hearing things that
are not real
• Mood changes such as irritability or
aggressiveness
• Fall, especially the elderly
Very Rare (may affect up to 1 in 10,000 people)
• Change in blood tests (increase of liver
enzymes in the blood)
Not known (frequency cannot be estimated
from the available data)
• Restlessness
• Anger
• Muscle Weakness
• Loss of co-ordination
• Loss of memory
• Double vision
• Unusual skin sensations such as numbness,
burning, tingling or prickling (paraesthesia)
• Difficulty concentrating or paying attention
• Disrupted normal speech
• Indigestion

CP.ZOP.7-5T.V3P2

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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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