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LOPRAZOLAM 1MG TABLETS

Active substance(s): LOPRAZOLAM / LOPRAZOLAM MESILATE / LOPRAZOLAM MESYLATE / LOPRAZOLAM / LOPRAZOLAM MESILATE / LOPRAZOLAM MESYLATE

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Loprazolam 1mg Tablets
(Loprazolam mesylate)
Your medicine is known by the above name, but will be referred to as
Loprazolam throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
 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.
 Your doctor may have given you this medicine before from another
company. It may have looked slightly different. However, either brand
will have the same effect.
In this leaflet:
1) What loprazolam is and what it is used for
2) Before you take loprazolam
3) How to take loprazolam
4) Possible side effects
5) How to store loprazolam
6) Further information

1) What loprazolam is and what it is used for
Loprazolam contains a medicine called loprazolam mesylate.
This belongs to a group of medicines called hypnotics.
It works by acting on your brain to help you sleep.
Loprazolam is used to treat sleep problems such as:
 Difficulty falling asleep
 Waking often during the night
Loprazolam is used for short term sleep problems.
Loprazolam is not meant to be used every day for long periods of time. Ask
your doctor for advice if you are unsure.

2) Before you take loprazolam
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to loprazolam mesylate or any of the
other ingredients of this medicine (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 are allergic (hypersensitive) to other benzodiazepines such as
nitrazepam or temazepam
 You have a problem that causes severe muscle weakness
(myasthenia gravis)
 Your lungs do not work properly
 You have heart problems
 You suffer from depression, anxiety or mental problems including
phobias and obsessive disorders
 You have ever been addicted to alcohol
 You have a problem where you stop breathing for short periods at
night (sleep apnoea)
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 loprazolam.
Take special care and check with your doctor or pharmacist before
taking loprazolam if:
 You have any liver problems
 You have any kidney problems
 You have a history of drug abuse
 You have been told by your doctor that you have had or are likely to
have a stroke
 You have been told by a doctor that you have a personality disorder
 You have recently taken loprazolam or other similar medicines for
more than four weeks
 You do not feel you will ever be able to stop taking loprazolam or other
medicines used to treat sleep problems
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before taking loprazolam.

Taking other medicines
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 loprazolam can
affect the way some other medicines work. Also some medicines can
affect the way loprazolam works.
Tell your doctor if you are taking any of the following:
 Medicines to treat stomach problems such as cisapride
 Medicines which relax muscles (neuromuscular depressants). These
are often used during operations or in Intensive Care Units.
 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
Taking loprazolam with food and drink
 Do not drink alcohol while you are taking loprazolam.
 Alcohol can increase the effects of loprazolam and make you sleep
very deeply so that you do not breathe properly or have difficulty
waking.
Pregnancy and breast-feeding
 Talk to your doctor before taking this medicine if you are pregnant,
might become pregnant, or think you may be pregnant.
 Do not take loprazolam if you are in the last 3 months of pregnancy or
during labour because it may be harmful to your baby. However, in
some cases your doctor may feel it is absolutely necessary for you to
take this medicine during this time. Taking it during this time means
your baby may be born with breathing difficulties, limp or weak
muscles, a low body temperature (hypothermia) and may have
withdrawal symptoms.
 Do not take loprazolam if you are breast-feeding or planning to breastfeed. This is because small amounts may pass into mother’s milk.
Ask your doctor or pharmacist for advice before taking any medicine if you
are pregnant or breast-feeding.
Driving and using machines
This medicine may cause drowsiness, lack of concentration, muscle
weakness and memory loss. If this happens do not drive or use any tools
or machines.
The medicine can affect your ability to drive as it may make you sleepy or
dizzy.
 Do not drive while taking this medicine until you know how it affects you.
 It is an offence to drive if this medicine affects your ability to drive.
 However, you would not be committing an offence if:
 The medicine has been prescribed to treat a medical or dental
problem and
 You have taken it according to the instructions given by the
prescriber or in the information 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.
Important information about some of the ingredients of loprazolam
Lactose: This is a type of sugar. If you have been told by your doctor that
you cannot tolerate some sugars, talk to your doctor before having this
medicine.

3) How to take loprazolam
Always take loprazolam exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Taking this medicine
 Swallow the tablet whole with a drink of water
 Take just before bedtime
 You should not normally take loprazolam for more than 4 weeks.
Adults
The usual dose is one tablet (1mg) just before bedtime.
This dose may be increased by your doctor to one and a half tablets or 2
tablets (2mg).
Elderly or frail people
The starting dose is half a 1mg tablet just before bedtime. This dose may
be increased by your doctor to one whole tablet.
Children
Do not give this medicine to children.
If you take more loprazolam than you should
If you take more loprazolam 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.
If you forget to take loprazolam
Loprazolam 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 loprazolam
Keep taking loprazolam until your doctor tells you to stop.
Do not stop taking loprazolam 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 loprazolam 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, irritable, confused or restless
 Changes in your behaviour
 Depression (low mood)
 Sleep problems
 Headaches

4) Possible side effects
Like all medicines, loprazolam can cause side effects, although not
everybody gets them.
Stop taking loprazolam and see a doctor or go to a hospital straight
away if:
 You get swelling of the hands, feet, ankles, face, lips or throat which
may cause difficulty in swallowing or breathing. You could also notice
an itchy, lumpy rash (hives) or nettle rash (urticaria).
This may mean you are having an allergic reaction to loprazolam
tablets.
Tell your doctor straightaway if you have any of the following side
effects:
 Poor memory since taking loprazolam (amnesia)
 Thoughts of harming or killing yourself, depression (low mood)
 Limp or weak muscles
 Behavioural changes. This might include angry outbursts or feeling
very excited
 Liver problems that may cause the eyes or skin to go yellow (jaundice)

Tell your doctor or pharmacist if any of the following side effects get
serious or lasts longer than a few days:
 Skin rash
 Difficulty passing water (urine)
 Feeling unsteady or clumsy
 Feeling sick (nausea), stomach problems
 If you have recently suffered a bereavement you may find it more
difficult to cope
 Feeling dizzy, sleepy or confused
 Headache
 Problems with your eyesight such as blurred vision
 Changes in your sex drive
 Feeling dizzy, light headed or faint. These effects are due to low blood
pressure
 You get infections or bruise more easily than usual.
This could be because of a blood problem (such as agranulocytosis,
neutropenia or thrombocytopenia)
 Speech problems.
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 loprazolam







Keep out of the sight and reach of children
Do not store above 25°C. Store in a dry place.
Store in the original package and protect from light.
Do not use loprazolam after the expiry date which is printed on the
carton and blister label. The expiry date refers to the last day of that
month.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
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) Further information
What loprazolam 1mg Tablets contain
Each tablet contains 1.245mg of the active ingredient loprazolam mesylate
equivalent to 1mg of loprazolam.
The other ingredients are lactose monohydrate, magnesium stearate,
aerosil 200, maize starch, povidone and microcrystalline cellulose.
What loprazolam looks like and contents of the pack
Loprazolam 1mg Tablets are pale yellow, biconvex with a break line on
one side and plain on the other side.
Loprazolam 1mg Tablets are available in blister packs of 30 Tablets.
PL 10383/1865

POM

Who makes and repackages your medicine?
Your medicine is manufactured by: Teofarma SRL, Via F LLI Cervi No.8, I-27010 Valle Salimbene (PV) Italy. Procured from within the EU by
Necessity Supplies Ltd., Northolt, UB5 5QS and repackaged by the
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 14.09.2015

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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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