EDLUAR 10 MG SUBLINGUAL TABLETS

Active substance: ZOLPIDEM TARTRATE

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Package leaflet: Information for the patient

Edluar 5 mg sublingual tablets
Edluar 10 mg sublingual tablets
®

®

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.
 o not pass it on to others. It may harm them, even if their signs of illness are the same
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as yours.
–  f you get any side effects talk to your doctor or pharmacist. This includes any possible
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side effects not listed in this leaflet.
What is in this leaflet:
1. What Edluar® is and what it is used for
2. What you need to know before you take Edluar®
3. How to take Edluar®
4. Possible side effects
5. How to store Edluar®
6. Contents of the pack and other information
1. What Edluar® is and what it is used for
Edluar® Tablets are sleeping pills (hypnotics) which work by acting on the brain to cause
sleepiness. It may be used for short-term 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 Edluar®
Do not take Edluar® 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
–  uffer from sleep apnoea (a condition where you stop breathing for very short periods
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whilst sleeping)
– suffer from severe muscle weakness (myasthenia gravis)
– have acute and severe breathing problems
– are under the age of 18 years

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Warnings and precautions
Talk to your doctor or pharmacist before taking Edluar® if you:
–  elderly or frail. If you get up at night, take care. Edluar® may relax your muscles.
are
This and the sedative effect increases your risk of falling and consequently of hip
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­ ractures.
– have any kidney or liver problems.
–  ave a history of breathing problems. Whilst taking Edluar® your breathing may
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become less forceful.
–  a history of mental illness, anxiety or psychotic illness. Zolpidem may unmask or
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worsen symptoms.
– suffer from or have a history of depression (feeling sad).
–  ave, or have ever had a history of, or tendency towards alcohol or drug abuse. The risk
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of dependence on Edluar® (physical or mental effects produced by a compulsion to keep
taking the medicine) increases in these patients, and with dose and length of treatment.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age.
Next-day psychomotor impairment (see also Driving and using machines)
The day after taking Edluar, the risk of psychomotor impairment, including impaired driving
ability may be increased if:
–  ou take this medicine less than 8 hours before performing activities that require your
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alertness
–  ou take a higher dose than the recommended dose
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–  ou take zolpidem while you are already taking other central nervous system depresY
sants or other medicines 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 night.
Other considerations
–  abituation – if, after a few weeks, you notice that your tablets are not working as well
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as they did when you first started treatment, you should see your doctor. Adjustment of
your dosage may be required.
–  ependence – when taking this type of medicine there is a risk of dependence, which
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increases with dose and length of treatment. The risk is greater if you have a history
of drug dependence, alcohol, substance or drug abuse. However, dependence may also
occur at doses normally used for treatment or if you do not show risk factors such as a
history of alcohol or drug abuse.
– 
Withdrawal – treatment should be withdrawn gradually. A short-lived syndrome may
occur on withdrawal, whereby the symptoms that led to your treatment with Edluar®
recur in an enhanced form. It may be accompanied by other reactions including mood
changes, anxiety and restlessness.
–  mnesia – Edluar® can cause memory loss. To reduce this risk you should ensure that
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you are able to have 7-8 hours uninterrupted sleep.
–  sychiatric and “paradoxical” reactions – Edluar® can cause behavioural side effects
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such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs),

rages, nightmares, hallucinations, psychoses (hallucinations; when you see, hear or feel
things that are not there), inappropriate behaviour and increased insomnia.
–  leep walking and other associated behaviours – Edluar® can cause people to do things
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whilst asleep that they do not remember when they wake up. This includes sleep ­ alking,
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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 Edluar® at doses
exceeding the maximum recommended dose can increase the risk of these side effects.
Other medicines and Edluar®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Edluar® 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.
–  edicines for some mental health problems (antipsychotics)
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–  edicines for sleep problems (hypnotics)
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–  edicines to calm or reduce anxiety
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–  edicines for depression
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–  edicines for moderate to severe pain (narcotic analgesics)
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–  edicines for epilepsy
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–  edicines used for anaesthesia
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–  edicines for hay fever, rashes or other allergies that can make you sleepy (sedative
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antihistamines)
–  uscle relaxants
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–  edicines which inhibit liver enzymes. Ask your doctor or pharmacist which medicines
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have this effect (e.g. ketoconazole, a medicine used to treat fungal infections).
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–  hile 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.
Edluar® may cause an increase in the effect of muscle relaxant medicines. Rifampicin,
a medicine used to treat tuberculosis, may cause a decrease in the effect of Edluar®.
Edluar® with alcohol
Alcohol should not be consumed when taking Edluar®, as the sedating effect may be
increased.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Edluar® should not be taken during pregnancy, especially in the first three months. If for urgent
medical reasons, you take Edluar® 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.

Driving and using machines
Edluar has major influence on the ability to drive and use machines such as ‘sleep driving’.
On the day after taking Edluar (as other hypnotic medicines), you should be aware that:
–  ou may feel drowsy, sleepy, dizzy or confused
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–  our quick-decision-making may be longer
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–  our vision may be blurred or double
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–  ou may be less alert
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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 Edluar, as
it can increase the above listed effects.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
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– o not drive while taking this medicine until you know how it affects you.
–  is an offence to drive if this medicine affects your ability to drive.
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– owever, you would not be committing an offence if:
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– The medicine has been prescribed to treat a medical or dental problem and
–  ou have taken it according to the instructions given by the prescriber or in the inforY
mation provided with the medicine and
– It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive
while taking this medicine.
3. How to take Edluar®
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The tablet should be put under the tongue and should be kept there until dissolved. As the
tablet acts rapidly take Edluar® immediately before going to bed, or in bed. Do not take
Edluar® with or shortly after a meal.
Adults: The recommended dose per 24 hours is 10 mg of Edluar. A lower dose may be
prescribed to some patients. Edluar should be taken:
–  s a single intake,
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– ust before bedtime
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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.

Use in children and adolescents:
Edluar® is not intended for people under 18 years of age.
If after a few weeks 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 Edluar® for
longer than 4 weeks.
If you take more Edluar® 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 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 probably leading to a coma or even death.
If you forget to take Edluar®
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. Do not take a ­ ouble dose to
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make up for a forgotten dose. If you are worried ask your pharmacist or doctor for advice.
If you stop taking Edluar®
Treatment should be withdrawn gradually, otherwise the symptoms 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 Edluar®, 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 hyper­
sensitivity 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.

Elderly (over 65 years) or debilitated patients: The recommended dose is 5 mg. The
recommended dose should not be exceeded.
Patients with liver problems:
The usual starting dose is 5 mg. Your doctor may decide to increase this to 10 mg if it is safe
to do so. Do not take Edluar® if you have severe liver problems.

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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Edluar® and seek urgent medical advice immediately:
–  allergic reactions such as skin rash or itching, accompanied by swelling of the
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face, lips, throat or tongue and difficulty breathing or swallowing (angioedema)
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
–  rowsiness, headache, dizziness, increased insomnia, amnesia (which may be associated
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with inappropriate behaviours)
– ‚spinning‘ sensation
–  rowsiness the following day, numbed emotions, reduced alertness, confusion, double
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vision
– diarrhoea, nausea, vomiting
– skin reactions
– fatigue
– abdominal pain
The risk of amnesia is higher at higher doses. If you make sure that you can have 8 hours
uninterrupted sleep the risk of amnesia is reduced.
Uncommon (may affect up to 1 in 100 people):
– irritability
– muscle weakness, co-ordination disturbances
Rare (may affect up to 1 in 1,000 people):
– decreased libido
–  aradoxical reactions (restlessness, agitation, irritability, aggressiveness, delusions
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(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)
– depressed level of consciousness
–  estlessness, aggression, delusion (false beliefs), rages, psychosis (hallucinations; when
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you see, hear or feel things that are not there), inappropriate behaviour
– depression (feeling sad)
–  hysical dependence: use (even at therapeutic dosages) may lead to physical ­ ependence,
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sudden discontinuation of treatment may result in withdrawal effects and recurrence of
problems.
–  sychological dependence: this is when you think that you cannot ever sleep without
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taking Edluar®
– Sleep walking
–  ncreased levels of some liver enzymes (which would be detected by your doctor during
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a blood test)
– skin rash, itching, hives

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excessive sweating
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, 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 Edluar®
Keep this medicine 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.

Marketing Authorisation Holder
Meda Pharmaceuticals Ltd.
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
United Kingdom
Manufacturer
Recipharm Stockholm AB
Lagervägen 7
13650 Jordbro
Sweden
This leaflet was last revised in September 2014.

This medicinal product does not require any special storage conditions.
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 the pack and other information
What Edluar® contains
The active substance is zolpidem tartrate.
Edluar® 5 mg:
Each sublingual tablet contains 5 mg zolpidem tartrate.
Edluar® 10 mg:
Each sublingual tablet contains 10 mg zolpidem tartrate.
The other ingredients are mannitol (E421), silicafied microcrystalline cellulose (mixture
of microcrystalline cellulose and silica colloidal anhydrous), silica colloidal anhydrous,
croscarmellose sodium, saccharin sodium, magnesium stearate.
What Edluar® looks like and contents of the pack
Edluar® 5 mg:
Your medicine comes as white, round, flat-faced, bevel-edged tablets approximately 7.5 mm
in diameter with V debossed on one side.
Edluar® 10 mg:
Your medicine comes as white, round, flat-faced, bevel-edged tablets approximately 7.5 mm
in diameter with X debossed on one side.
The medicine is available in blister packs containing 10, 14, 20, 28, 30, 60, 100 and
150 sublingual tablets.
Not all pack sizes may be marketed.

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Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85    
· Fax: -87    
· E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG
PRODUCT:



COLOURS USED:
Black

EDLUAR – 5 mg + 10 mg

Sublingualtabletten
MEDA-NO.: 56UK1946130-02
MFS-NO.:
797439
LAETUS-CODE:

XX
COUNTRY:

United Kingdom UK

LANGUAGE: English
PACK SIZE:

592,6 x 203 mm

CORRECTION: 1.

FONT SIZE:

9,0 pt / 10,5 pt

DATE:

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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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