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ZOLPIDEM 10MG FILM COATED TABLETS

Active substance(s): ZOLPIDEM TARTRATE

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(zolpidem tartrate)

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
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 side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Zolpidem is and what it is used for
2. What you need to know before you take
Zolpidem
3. How to take Zolpidem
4. Possible side effects
5. How to store Zolpidem
6. Contents of the pack and other information.
1. What Zolpidem is and what it is used for
Zolpidem contains zolpidem, which belongs to
a group of medicines called hypnotics. Zolpidem
Tablets are sleeping pills, which work by acting
on the brain to cause sleepiness.
This medicine may be used in adults for shortterm treatment of insomnia which is severe,
disabling or causing great distress. Insomnia is a
difficulty in falling asleep or sleeping properly.
2. What you need to know before you take
Zolpidem
Do not take Zolpidem if you
• are allergic to zolpidem tartrate or any of the
other ingredients of this medicine (listed in
section 6). An allergic reaction may include a
rash, itching, difficulty breathing or swelling of
the face, lips, throat or tongue.
• have severe liver problems
• suffer from sleep apnoea (a condition where
you stop breathing for very short periods
whilst sleeping)
• suffer from severe muscle weakness
(myasthenia gravis)
• have acute and/or severe breathing problems
• are under 18 years of age.

TBC

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Warnings and precautions
Talk to your doctor before taking this medicine
if you:
• are elderly or frail. If you get up at night, take
care. Zolpidem may relax your muscles. This
increases your risk of falling and consequently
of hip fractures.
• have any kidney or liver problems.
• have a history of breathing problems. Whilst
taking Zolpidem your breathing may become
less forceful
• have a history of mental illness, anxiety or
psychotic illness. Zolpidem may unmask or
worsen symptoms
• suffer from or have a history of depression
(feeling sad)
• have, or have ever had a history of, or
tendency towards alcohol or drug abuse.
The risk of dependence on Zolpidem (physical
or mental effects produced by a compulsion
to keep taking the medicine) increases in
these patients, and with dose and length
of treatment.
Other considerations
• Tolerance – if, after a few weeks, you notice
that your tablets are not working as well as
they did when you first started treatment, you
should see your doctor. Adjustment of your
dosage may be required.
• Dependence - when taking this type of
medicine there is a risk of dependence, which
increases with dose and length of treatment.
The risk is greater if you have a history of
alcohol or drug abuse.
• Withdrawal - treatment should be withdrawn
gradually. A short-lived syndrome may occur
on withdrawal, where the symptoms that
led to your treatment with Zolpidem recur in
an enhanced form. It may be accompanied
by other reactions including mood changes,
anxiety and restlessness.
• Amnesia - Zolpidem can cause memory loss.
To reduce this risk you should ensure that you
are able to have 8 hours of uninterrupted sleep.
• Psychiatric and 'paradoxical' reactions Zolpidem can cause behavioural side effects
such as restlessness, agitation, irritability,
aggressiveness, delusions (false beliefs), rages,
nightmares, hallucinations (seeing, hearing or
feeling things that are not there), psychoses
(losing contact with reality, unable to think and
judge clearly), inappropriate behaviour and
increased insomnia.
• Sleep walking and other associated behaviours
- Zolpidem can cause people to do things
whilst asleep that they do not remember when
they wake up. This includes sleep walking,
sleep driving, preparing and eating food,
making phone calls or having sex. Alcohol and
some medicines used to treat depression or
anxiety or the use of Zolpidem at doses larger
than the maximum recommended dose can
increase the risk of these side effects.

Other medicines and Zolpidem
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription. Zolpidem may influence the effect
and/or side effects of other medicines. If you are
to have an operation under general anaesthetic,
tell the doctor which medicines you use.
While taking zolpidem with the following
medicines, drowsiness and next-day
psychomotor impairment effects, including
impaired driving ability, may be increased.
• Medicines for some mental health problems
(antipsychotics)
• Medicines for sleep problems (hypnotics)
• Medicines to calm or reduce anxiety
• Medicines used to relax muscles
• Medicines for depression
• Medicines for moderate to severe pain
(narcotic analgesics)
• Medicines for epilepsy
• Medicines used for anaesthesia
• Medicines for hay fever, rashes or other
allergies that can make you sleepy (sedatives
antihistamines).
While taking zolpidem with antidepressants
including bupropion, desipramine, fluoxetine,
sertraline and venlafaxine, you may see things
that are not real (hallucinations).
It is not recommended to take zolpidem with
fluvoxamine or ciprofloxacin.
The following medicines may increase the
sedating effect of Zolpidem:
• medicines which inhibit liver enzymes. Ask
your doctor or pharmacist which medicines
have this effect (e.g. ketoconazole, a medicine
used to treat fungal infections).
Rifampicin, a medicine used to treat
tuberculosis, may cause a decrease in the effect
of Zolpidem.
Zolpidem with alcohol
Alcohol should not be consumed when taking
Zolpidem, as the sedating effect may be increased.
Pregnancy and breast-feeding
Zolpidem should not be taken during
pregnancy, especially in the first three months.
If for urgent medical reasons, you take Zolpidem
during late pregnancy or during labour, your
baby might suffer from low body temperature,
floppy muscle, and breathing difficulties, and
may show withdrawal symptoms after birth
because of physical dependence.
Do not breast-feed your baby, as small amounts
of zolpidem can pass into breast milk.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Driving and using machines
Zolpidem has major influence on the ability to
drive and use machines such as 'sleep driving'.
On the day after taking Zolpidem (as other
hypnotic medicines), you should be aware that:
• You may feel drowsy, sleepy, dizzy or confused
• Your quick decision-making may be longer
• Your vision may be blurred or double
• You may be less alert.
A period of at least 8 hours is recommended
between taking zolpidem and driving, using
machinery and working at heights to minimise
the above listed effects.
Do not drink alcohol or take other psychoactive
substances while you are taking Zolpidem, as it
can increase the above listed effects.
Zolpidem contains lactose
If your doctor has told you that you have an
intolerance to some sugars, such as lactose,
contact your doctor before taking this medicine.
3. How to take Zolpidem
Always take Zolpidem exactly as your doctor has
told you. Check with your doctor or pharmacist
if you are not sure.
The tablets act rapidly and should be swallowed
whole with liquid immediately before going
to bed, or in bed. Make sure you have at least
8 hours of sleep after taking this medicine.
The tablets can be divided into equal doses.
Adults: The recommended dose per 24 hours
is 10 mg of Zolpidem. A lower dose may be
prescribed to some patients. Zolpidem should
be taken:
• as a single intake
• just before bedtime.

TBC

Zolpidem 10 mg
Film-coated Tablets

• Falls and injury - Zolpidem can cause you to
feel drowsy or have lower levels of awareness,
which may lead to falling and possible injury.
• Next-day psychomotor impairment (see also
'Driving and using machines') - The day after
taking Zolpidem, the risk of psychomotor
impairment, including impaired driving ability,
may be increased if:
• You take this medicine less than 8 hours
before performing activities that require
your alertness
• You take a higher dose than the
recommended dose
• You take zolpidem while you are already
taking another central nervous system
depressant or another medicine that increase
zolpidem in your blood, or while drinking
alcohol, or while taking illicit substances.
Take the single intake immediately at bedtime.
Do not take another dose during the same night.

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Package leaflet: Information for the patient

Make sure you have a period of at least 8 hours
after taking this medicine before performing
activities that require your alertness.
Do not exceed 10 mg per 24 hours.
Elderly (over 65 years) or debilitated patients:
The recommended dose is 5 mg.
Patients with liver problems: The
recommended starting dose is 5 mg. Your doctor
may decide to increase this to 10 mg if it is safe
to do so.
The maximum dose of 10 mg must not be
exceeded in any patients.
Use in children and adolescents: Zolpidem
should not be taken by patients under 18 years
of age.
If you notice that the tablets are not working as
well as they did when first starting treatment,
you should go and see your doctor as an
adjustment to your dosage may be required.
Duration of treatment
The duration of administration should be as
short as possible. This usually varies from a few
days to two weeks. The maximum treatment
period, including the stepwise withdrawal
process, is four weeks.
Your doctor will choose a stepwise withdrawal
regime for you based on your individual needs.
In certain situations you may be required to
take Zolpidem for longer than 4 weeks.
If you take more Zolpidem than you should
If you (or someone else) swallow a lot of the
tablets at the same time, or if you think a child
has swallowed any of the tablets, contact
your doctor or nearest hospital emergency
department immediately. Take the container
and any remaining tablets with you. Do not
go unaccompanied to seek medical help. If
an overdose has been taken you may become
increasingly drowsy very quickly, with high
doses possibly leading to a coma or even death.
If you forget to take Zolpidem
If you forget to take a dose immediately before
going to bed but remember during the night,
only take the missed dose if you are still able to
have 8 hours of uninterrupted sleep. If this is not
possible, take the next dose before bed time the
next night. You should not take this medicine
at another time of the day because it may make
you feel drowsy, dizzy or confused. Do not take
a double dose to make up for a forgotten dose.
If you are worried ask your pharmacist or doctor
for advice.
If you stop taking Zolpidem
Keep taking your medicine until your doctor tells
you to stop. Do not stop taking your medicine
suddenly, but tell your doctor if you want to
stop. Treatment should be withdrawn gradually,
otherwise the sleep problems you are treated for
may return more intensely than before (rebound
insomnia). Also anxiety, restlessness and mood
changes may occur. These effects will disappear
in time.
If you have become physically dependent to
Zolpidem, sudden withdrawal of treatment
will lead to side effects such as headaches,
muscle pain, anxiety, tension, restlessness,
confusion, irritability and sleeplessness. In
severe cases other effects may appear, such
as hypersensitivity to light, noise and physical
contact, abnormally acute hearing and
painful sensitivity to sound, hallucinations,
numbness and tingling of the extremities,
derealisation (feeling the world around you is
not real), depersonalisation (feeling your mind
is becoming separated from your body) or
epileptic seizures (violent fitting or shaking).
These symptoms may also be experienced
between doses, especially if the dose is high.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen, stop taking
Zolpidem and tell your doctor immediately
or go to your nearest hospital emergency
department:
Common (may affect up to 1 in 10 people):
• amnesia (which may be associated with
inappropriate behaviours (see section 2,
'Other considerations').
Not known (frequency cannot be estimated
from the available data):
• allergic reactions such as skin rash, itching,
swelling of the face, lips, throat or tongue,
difficulty breathing or swallowing
• physical dependence: use (even at therapeutic
dosages) may lead to physical dependence;
sudden discontinuation of treatment may
result in withdrawal effects and recurrence
of problems
• psychological dependence: this is when you
think that you cannot ever sleep without
taking Zolpidem
• feeling very sleepy or tired, unable to
concentrate or carry out normal activities
• difficulty breathing
• psychosis (losing contact with reality, unable to
think and judge clearly).

The risk of amnesia is higher at higher doses.
If you make sure that you can have 8 hours
of uninterrupted sleep the risk of amnesia
is reduced.
Tell your doctor or pharmacist if any of the
following side effects occur or worsen:
Common (may affect up to 1 in 10 people):
• hallucinations, agitation, nightmares
• drowsiness, headache, dizziness, increased
insomnia
• 'spinning' sensation
• drowsiness the following day, numbed
emotions, reduced alertness
• diarrhoea, nausea, vomiting
• skin reactions
• back pain
• fatigue
• abdominal pain
• infections in the nose or throat.
Uncommon (may affect up to 1 in 100 people):
• irritability, confusion
• co-ordination disturbances
• double vision.
Rare (may affect up to 1 in 1,000 people):
• paradoxical reactions (restlessness, agitation,
irritability, aggressiveness, delusions (false
beliefs), rage, nightmares, hallucinations,
psychoses, inappropriate behaviour and other
adverse behavioural effects). These are more
likely to occur if you are elderly.
Not known (frequency cannot be estimated
from the available data):
• restlessness, aggression, delusion (false
beliefs), rages, inappropriate behaviour.
• depression (feeling sad)
• decreased libido
• sleep walking
• increased levels of some liver enzymes (which
would be detected by your doctor during a
blood test)
• skin rash, itching, hives
• excessive sweating
• muscle weakness
• changes in the way you walk
• the need to take increasingly higher doses of a
medicine to gain the same effect
• falls, particularly in the elderly.
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 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 Zolpidem
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the label after 'EXP'. The expiry
date refers to the last day of that month.
Do not store above 25°C. Keep your medicine in
the original package.
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 to
protect the environment.
6. Contents of the pack and other information
What Zolpidem contains
The active substance is zolpidem tartrate. Each
tablet contains 10 mg of zolpidem tartrate.
The other ingredients are lactose monohydrate
(see section 2, 'Zolpidem contains lactose'),
microcrystalline cellulose, pregelatinised
maize starch, magnesium stearate. The coating
includes hypromellose, titanium dioxide (E171),
polysorbate 80 (E433), macrogol 400.
What Zolpidem looks like and contents of
the pack
Your medicine comes as a white to off-white
capsule shaped film-coated tablet, marked 'ZM
breakline 10' on one side and 'G' on the other.
The tablets can be divided into equal doses.
Zolpidem Tablets are available in blister packs or
in plastic containers containing 4, 7, 10, 14, 20,
28, 30, 50, 100 or 250 film-coated tablets. Not
all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer(s)
Generics [UK] Limited, Station Close, Potters Bar,
Herts EN6 1TL, United Kingdom
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary
Orifice Medical AB, Aktergatan 2, 271 53 Ystad,
Sverige

These side effects are serious. You may need
medical attention.

This leaflet was last revised in March 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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