LORAZEPAM 2.5 MG TABLETS

Active substance: LORAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lorazepam 1 mg tablets
Lorazepam 2.5 mg tablets
Lorazepam
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.
In this leaflet:
1. What Lorazepam is and what it is used for
2. Before you take Lorazepam
3. How to take Lorazepam
4. Possible side effects
5. How to store Lorazepam
6. Further information
1. WHAT LORAZEPAM IS AND WHAT IT IS
USED FOR
The name of your medicine is Lorazepam,
called lorazepam or lorazepam tablets in the
rest of the leaflet. The tablets contain
lorazepam.
The active ingredient is lorazepam, which is a
type of medicine called a benzodiazepine. It
relieves anxiety and it is used for short periods
to relieve anxiety that is severe, disabling, or
causing you extreme distress, and to treat
difficulties sleeping that are caused by anxiety.
It may also be used as a sedative shortly
before a dental or surgical operation.
2. BEFORE YOU TAKE LORAZEPAM
Do not take Lorazepam
! if you are allergic (hypersensitive) to
lorazepam, or to any other benzodiazepine,
or any of the other ingredients of
Lorazepam tablets, see section 6.
! you have severe breathing or chest
problems
! you have very tired or very weak muscles, a
condition called myasthenia gravis
! you have serious liver problems
! you suffer from breathing problems when
you are asleep, a condition called sleep
apnoea
! you have a history of persistently abusing
alcohol and / or drugs
! you are breast feeding, as lorazepam may
pass into breast milk (see Pregnancy and
breast feeding below)
If any of the above apply to you, do not take
lorazepam and go back to your doctor.
Take special care with Lorazepam
! you are pregnant, or trying to become
pregnant (see Pregnancy and breast
feeding)
! you have a personality disorder; it may
mean you have a greater chance of
becoming dependent upon lorazepam
! you have any kidney or liver problems
! you have suffered from depression before,
as it might come back during lorazepam
treatment
! you are suffering from depression as
lorazepam may increase any suicidal
feelings or thoughts you may have
! you suffer from breathing problems
! you are suffering from difficulty in coordination, or you are taking a lot of
medicines that affect the brain
! you suffer from raised eye pressure, an eye
condition called glaucoma
! you are elderly, as you may be more likely
to fall
Although lorazepam may still be suitable for
you, you should discuss any of the points
above that apply to you with your doctor or
pharmacist. Do this before taking lorazepam.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription. Other medicines may
affect the way lorazepam works. Lorazepam
may also affect the way other medicines work.
Tell your doctor if you are taking:
Any other sedative or anti-anxiety
medicines
! Antidepressants
! Strong pain killers, such as tramadol,
codeine, morphine, methadone
! Medicines for epilepsy, such as sodium
valproate
! Antihistamine medicines for allergies
! Medicines for mood or mental disorders,
such as chlorpromazine, clozapine,
haloperidol, loxapine
! Medicines for asthma, such as theophylline
or aminophylline
! Medicines for relaxing your muscles
! A medicine for gout called probenecid
! A medicine called scopalamine that may be
used for gut problems or before an
operation

!

Taking Lorazepam with food and drink
Do not drink any alcohol while taking
lorazepam.
If you take your whole dose in the evening, it
should not be taken until four hours after food;
otherwise you may feel hungover the next day.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Lorazepam should not be used during
pregnancy. If you are pregnant or might
become pregnant do not take this medicine
without talking to your doctor first. Lorazepam
may cause damage to the unborn baby if taken
during pregnancy. If you take lorazepam during
late pregnancy or during labour, your baby,
when born, may be less active than other
babies, have soft and limp muscles, a low body
temperature, and / or a low blood pressure,
have breathing or feeding difficulties for a while,
and be floppy. Your baby might not be able to
respond to cold properly for a while. If you take
lorazepam regularly in late pregnancy, your
baby may develop withdrawal symptoms after
birth.
Lorazepam may pass into the breast milk.
Therefore it should not be taken while breast
feeding, unless the expected benefit outweighs
the potential risk for the baby. Your baby may
otherwise suffer from sedation and difficulties in
suckling. In this case, monitoring of the baby is
recommended.
Driving and using machines
Do not drive, operate machinery, or perform
any task requiring concentration while taking
lorazepam. Lorazepam may make you sleepy
or dizzy during the day, and affect your
concentration. This may be worse if you have
not had enough sleep at night.
This 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 Lorazepam
These tablets contain lactose monohydrate. If
you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.
3. HOW TO TAKE LORAZEPAM TABLETS
Always take Lorazepam exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Lorazepam tablets should be swallowed with a
glass of water.
A large bed time dose may cause sleepiness or
dizziness the next day ('hangover effect'),
particularly if you have insufficient sleep,
around 7-8 hours is needed (please see
'Driving and using machines' section).
If you have been given lorazepam for anxiety or
sleeping problems, treatment will usually last
from a few days to 4 weeks, and will usually
include a gradual reduction in dose at the end
of treatment.
Adults (over the age of 18 years):
Anxiety: The usual starting dose is 0.5 mg,
taken 2 or 3 times a day, which may be
increase up to 2.5 mg per day (maintenance
dose). The daily dose can be divided in 2 or 3
separate doses taken during the day, or it can
be taken as a single dose in the evening, four
hours after food and 30 minutes before going
to bed. Your doctor will tell you how often to
take your tablets.
The maximum daily dose of 2.5 mg should not
be exceeded.
Insomnia caused by anxiety: The usual starting
dose is 1 mg before going to sleep, which may
be increased to 1 mg to 2 mg before going to
sleep.
Before surgery or dental operations: The usual
dose is between 2 mg to 4 mg, taken one to
two hours prior to the operation.
Older patients, and patients with kidney or liver
problems may be given lower doses, about the
usual starting dose is half the normal adult
dose. Your doctor will see how you respond to
the medicine and alter the dose if needed.

Children and adolescents:
Lorazepam should not be used in children and
adolescents under 18 years of age, except for
the following treatments.
Aged 6 years or less:
Children under the age of six should not be
treated with Lorazepam.
Aged 6-12 years:
Before surgery or dental procedures: The usual
dose is between 0.5 mg to 1 mg, depending
upon the weight of the child (0.05 mg / Kg body
weight dose should not be exceeded), taken at
least one hour before the operation.
Aged 13 - 18 years of age:
Before surgery or dental procedures: The usual
dose is between 1 to 4 mg, taken one to two
hours before the operation.
The lorazepam 1 mg tablets can be broken to
give two equal doses. Each half tablet contains
0.5 mg lorazepam.
The lorazepam 2.5 mg tablets can be broken to
give two equal doses. Each half tablet contains
1.25 mg lorazepam.
Your doctor may adjust the dose to suit you,
depending on how you respond, and how well
you tolerate the tablets. Your doctor can explain
more. Always follow the instructions of the
doctor.
If you take more Lorazepam than you
should
You must seek medical help immediately, either
by calling your doctor, or going to the nearest
hospital casualty department. Do not drive
yourself - get a friend or neighbour to take you,
or call an ambulance. Always take the medicine
container with you, even if it is empty. The
doctor will then know what it is you have taken.
Signs of mild overdose include drowsiness,
mental confusion, and lethargy; in more serious
cases, difficulty speaking, slurred speech,
clumsiness or unsteadiness, low muscle tone,
dizziness, and loss of balance and
co-ordination may occur.
If you forget to take Lorazepam
Do not take a double dose to make up for a
forgotten dose.
If you are being treated for anxiety, and it is
less than 3 hours since you forgot the dose,
you should take it as soon as you remember
and carry on as normal. If it is more than 3
hours, do not worry, simply take the next tablet
when it is due.
If you are being treated for sleeping problems,
only take the tablet if you have sufficient
sleeping time.
While taking Lorazepam
Lorazepam tablets may affect your
concentration and make you feel sleepy during
the day.
Some elderly patients may feel dizzy after
taking lorazepam, and may be in danger of
falling.
You may get tolerant to lorazepam. The
beneficial effects may be less apparent after
several weeks of use.
If you are prescribed lorazepam for more than 4
weeks, your doctor may want to take blood
samples occassionally to check your blood and
liver. Lorazepam may occassionally affect liver
function or your blood.
Dependence on lorazepam may occur after
prolonged treatment. Lorazepam tablets are
usually prescribed for short treatment course,
from a few days to four weeks, including a dose
reduction at the end of treatment. This lessens
the chances of becoming dependent upon
lorazepam, or suffering unpleasant effects
when you stop taking it. See the next section
for more details.
If you stop taking Lorazepam
After you have finished your prescribed
treatment with lorazepam, your doctor will
decide whether you need further treatment.
The number of lorazepam tablets, and how
often you take them, should always be reduced
slowly before you stop taking them altogether.
This lets your body get used to being without
lorazepam, and lessens the chances of
unpleasant effects when you stop taking them.
Your doctor will tell you how to do this.
When you stop taking lorazepam you may
experience withdrawal symptoms such as
headache, muscle pain, anxiety, sleep
disorders, tension, depression, restlessness,
dizziness, feeling sick, diarrhoea, appetite loss,
confusion, irritability, agitation, shaking,
stomach and / or muscle pain, changes in heart
beat, short term memory loss, high body
temperature, and sweating. Your original
difficulty sleeping may come back. If any of
these signs occur, they usually do not last long.
If you do suffer from any of these signs, ask
your doctor for advice.
Do not stop taking lorazepam suddenly. You
might have more serious withdrawal signs,
such as loss of sense of reality, feeling unreal
or detached from life, not able to feel emotion.
Some patients have had numbness or tingling
of the arms or legs, being sick, ringing in the
ears, twitches, seeing or hearing things that are
not there, fits, and being extra sensitive to
touch, sound, and light. If you have any of
these signs, immediately ask your doctor for
advice.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, lorazepam can cause side
effects, although not everybody gets them.
Immediately contact your doctor if you
develop any of the following signs:
! Sudden, severe allergic reaction, causing
difficulty in breathing, dizziness
! Serious allergic reaction with swelling of
face, lips, and throat
! Yellowing of the skin and the whites of the
eyes
! Breathing difficulties
! Thoughts of harming, or killing yourself
! Changes in your mental state such as:
restlessness, agitation, irritability,
aggressiveness, hallucinations, unusual
behaviour and beliefs.
Tell your doctor or pharmacist if you get any
of the following side effects:
Very common-affects more than 1 user in 10 :
Drowsiness, sedation
Tiredness

!
!

Common-affects 1 to 10 users in 100 :
Confusion, depression, unmasking of
depression
Poor muscle control, dizziness
Muscle weakness, loss of strength
Lack of energy

!
!
!
!

Uncommon-affects 1 to 10 users in 1,000:
! Feeling sick
! Changes in sex drive, impotence,
decreased orgasm
The following side effects have been reported
with lorazepam, but the frequency cannot be
estimated from the available data:
! Low levels of red blood cells, white blood
cells, and platelets, resulting in unexplained
bruising or bleeding, pale skin, weakness /
breathlessness, and / or frequent infections
! Allergic skin reactions such as reddening,
rash; hair loss
! Low blood sodium levels, concentrated
(very dark) urine
! Very low body temperature
! Loss of short term memory
! Muscle spasms, difficulty opening the
mouth fully, tendency to stick the tongue out
of the mouth, slurred speech, and abnormal
changes in body posture, difficulty
concentrating, dizziness, spinning feeling,
headache, shaking, fits, unconsciousness
! Blurred vision, double vision
! Low blood pressure
! Sexual arousal
! Anxiety, agitation, excitability, hostility,
aggression, rage, sleep disturbances,
seeing or hearing things that are not therethese are more likely to occur in children
and the elderly
! Lowered breathing rate, breath shortness,
temporarily stopping breathing, including
while asleep, worsening of asthma, difficulty
in speaking and slurred speech
! Constipation
! Changes in liver function-your doctor will
check for this
! Changes in your blood-your doctor will
check for this
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.
5. HOW TO STORE LORAZEPAM
Store below 25oC. Store in the original
container to protect from light.
Keep out of the reach and sight of children.
Do not use Lorazepam after the expiry date
which is stated on the carton after EXP; it is
also stated on the blister. The expiry date refers
to the last day of that month.
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 Lorazepam contains
! The active substance is lorazepam, either 1
mg or 2.5 mg in a tablet
! The other ingredients are: lactose
monohydrate, povidone (K30),
crospovidone, type A, maize starch,
microcrystalline cellulose, sodium starch
glycollate, Magnesium stearate and
polacrillin potassium.
What Lorazepam looks like and contents of
the pack
Lorazepam 1 mg: white, round, flat, bevelled,
scored tablets, inscribed 1.0
Lorazepam 2.5 mg: white, round, flat, bevelled,
scored tablets
Blister packs containing 10, 14, 15, 20, 28, 30,
50, 60, 90, 100 or (only available to pharmacies
or hospitals) 500 tablets are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Limited
115 Narborough Road, Leicester, LE3 0PA, UK
Manufacturers
Farmaceutisch Analytisch Laboratorium Duiven
B.V (FAL Duiven B.V)
Dijkgraaf, 6921, RK Duiven, The Netherlands.
Medochemie Ltd, Factory A-Z, Ayios
Athanassios, Industrial Street, Limassol,
Cyprus.
This leaflet was last revised in April 2014

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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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