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LORAZEPAM 2.5 MG TABLETS

Active substance(s): LORAZEPAM / LORAZEPAM / LORAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lorazepam 1 mg Tablets
Lorazepam 2.5 mg Tablets
Lorazepam

Aged 6 - 12 years:
Before surgery or dental procedures: The
recommended dose is between 0.5mg to 1mg,
depending upon the weight of the child
(0.05mg/Kg body weight dose should not be
exceeded), taken at least one to tow hours
before the operation.

Common (may affect up to 1 in 10 people):
Confusion, depression, unmasking of
!
depression.
Poor muscle control.
!
Muscle weakness, loss of strength.
!
Lack of energy.
!
Spinning feeling.
!
Dizziness.
!

Aged 13 - 18 years of age:
Before surgery or dental procedures: The
recommended dose is between 1mg to 4mg,
taken one to two hours before the operation.

Uncommon (may affect up to 1 in 100
Read all of this leaflet carefully before you
If you take your whole dose in the evening, it
people):
start taking this medicine because it
should not be taken until four hours after food;
Feeling sick.
!
contains important information for you.
otherwise you may feel hungover the next day.
Changes in sex drive, impotence,
!
!
Keep this leaflet. You may need to read it
The Lorazepam 1mg Tablets can be broken to
decreased orgasm.
again.
Grapefruit juice and drinks containing caffeine
give two equal doses. Each half tablet contains
!
If you have any further questions, ask your
should be avoided as they can affect the way
0.5mg lorazepam.
Rare (may affect up to 1 in 1,000 people):
doctor or pharmacist.
that Lorazepam works.
Sleeping difficulties, numbed emotions,
!
!
This medicine has been prescribed for you
The Lorazepam 2.5mg Tablets can be broken
appetite changes.
only. Do not pass it on to others. It may
Pregnancy and breast-feeding
to give two equal doses. Each half tablet
Reduced alertness.
!
harm them, even if their signs of illness are
Pregnancy
contains 1.25mg lorazepam.
Low blood pressure.
!
the same as yours.
Ask your doctor or pharmacist for advice before
Problems with vision including double vision
!
!
If you get any side effects, talk to your
taking any medicine.
Your doctor may adjust the dose to suit you,
or blurred vision.
doctor or pharmacist. This includes any
Lorazepam should not be used during
depending on how you respond, and how well
Constipation.
!
possible side effects not listed in this leaflet.
pregnancy. If you are pregnant, think you may
you tolerate the tablets. Your doctor can explain
Headache.
!
See section 4.
be pregnant or are planning to have a baby ask
more. Always follow the instructions of the
Allergic skin reactions such as reddening,
!
your doctor or pharmacist for advice before
doctor.
rash.
What is in this leaflet
taking this medicine. Benzodiazepines,
Loss of short term memory.
!
1. What Lorazepam is and what it is used for
including, Lorazepam may cause damage to
If you take more Lorazepam than you
Changes in the amount of saliva in the
!
2. What you need to know before you take
the unborn baby if taken during early
should
mouth.
Lorazepam
pregnancy. If you take Lorazepam during late
If anyone has taken an overdose of Lorazepam
Changes in liver function - your doctor will
!
3. How to take Lorazepam
pregnancy or during labour, your baby, when
Tablets (that is more than the doctor has
check for this.
4. Possible side effects
born, may be less active than other babies,
prescribed), seek medical help immediately,
Lowered breathing rate, breath shortness,
!
5. How to store Lorazepam
have soft and limp muscles, a low body
either by calling your doctor, or going to the
temporarily stopping breathing, including
6. Contents of the pack and other information
temperature, and / or a low blood pressure,
nearest casualty department. Always take the
while asleep, worsening of asthma, difficulty
have breathing or feeding difficulties for a while,
labelled medicine container with you, even if
in speaking and slurred speech.
1. What Lorazepam is and what it is used
and be floppy. Your baby might not be able to
there are no tablets left. Do not drive yourself Difficulty controlling urges and impulses to
!
for
respond to cold properly for a while. If you take
get a friend or neighbour to take you, or call an
speak, act or show emotions, a feeling of
Lorazepam regularly in late pregnancy, your
ambulance.
well-being for no reason.
The name of your medicine is Lorazepam 1mg
baby may develop withdrawal symptoms after
or 2.5mg Tablets, called Lorazepam in the rest
birth.
If you forget to take Lorazepam
Very rare (may affect up to 1 in 10,000
of the leaflet. Lorazepam is a member of a
Do not take a double dose to make up for a
people):
group of medicines called benzodiazepines. It
Breast-feeding
forgotten tablet.
Low levels of red blood cells, white blood
!
can help to relieve anxiety. Lorazepam is
Lorazepam may pass into the breast milk.
If you forget to take a tablet for anxiety, you
cells, and platelets, resulting in unexplained
prescribed as short-term therapy for anxiety (2Therefore it should not be taken while breastshould take it as soon as you remember if it is
bruising or bleeding, pale skin,
4 weeks), or sleeping difficulties due to anxiety.
feeding, unless the expected benefit outweighs
less than 3 hours since your usual time. If more
weakness/breathlessness, and/or frequent
It may also be used as a sedative before
the potential risk for the baby. Your baby may
than 3 hours has passed from when you
infections.
surgery or operative dental treatment.
otherwise suffer from sedation and difficulties in
usually take your tablet, just take your next
Hypersensitivity including anaphylaxis
!
suckling. In this case, monitoring of the baby is
tablet when it is due.
(allergic reactions).
Lorazepam is not to be used for longer than 4
recommended.
Low blood sodium levels, concentrated
!
weeks, to treat mild or moderate anxiety in
If you forget to take a tablet for sleeping
(very dark) urine.
adults or for anxiety/insomnia in children.
Driving and using machines
problems, only take it if you will be able to sleep
Trembling or shaking.
!
Do not drive, operate machinery, or perform
for 7 to 8 hours afterwards.
Unconsciousness.
!
2. What you need to know before you take
any task requiring concentration while taking
Very low body temperature.
!
Lorazepam
Lorazepam. Lorazepam may make you sleepy
While taking Lorazepam
or dizzy during the day, and affect your
Lorazepam may affect your concentration and
Not known (frequency cannot be estimated
Do not take Lorazepam
concentration. This may be worse if you have
make you feel sleepy during the day.
from the available data):
!
If you are allergic to lorazepam,
not had enough sleep at night. This may affect
Some elderly patients may feel dizzy after
Hair loss.
!
benzodiazepines or any of the other
your performance at skilled tasks such as
taking Lorazepam, and may be in danger of
Muscle spasms, difficulty opening the
!
ingredients of this medicine (listed in section
driving machinery or operating machinery by
falling.
mouth fully, tendency to stick the tongue out
6).
affecting your vision or muscle function. You
You may get tolerant to Lorazepam. The
of the mouth, and abnormal changes in
!
If you have severe breathing or chest
should not take part in any other activities
beneficial effects may be less apparent after
body posture, difficulty concentrating, fits.
problems.
where this could put yourself or others at risk.
several weeks of use.
!
Sexual arousal.
!
If you have very tired or very weak muscles,
If you are prescribed Lorazepam for more than
!
Nightmares.
a condition called myasthenia gravis.
The medicine can affect your ability to drive as
4 weeks, your doctor may want to take blood
!
Violent anger, personality changes.
!
If you have serious liver problems.
it may make you sleepy or dizzy.
samples occassionally to check your blood and
!
Anxiety, excitability, hostility, rage, seeing or
!
If you suffer from breathing problems when
!
Do not drive while taking this medicine until
liver. Lorazepam may occassionally affect liver
hearing things that are not there - these are
you are asleep, a condition called sleep
you know how it affects you.
function or your blood.
more likely to occur in children and the
apnoea.
!
It is an offence to drive if this medicine
Dependence on Lorazepam may occur after
elderly.
!
If you are planning a pregnancy or are
affects your ability to drive.
prolonged treatment. Lorazepam is usually
!
Memory loss or forgetfulness.
pregnant.
!
However, you would not be committing an
prescribed for short treatment course, from a
!
Balance disorder.
If you are breast-feeding, as Lorazepam
!
offence if:
few days to four weeks, including a dose
!
Becoming dependent on Lorazepam.
may pass into breast milk (see Pregnancy
 The medicine has been prescribed to
reduction at the end of treatment. This lessens
!
Insomnia.
and breast-feeding below).
treat a medical or dental problem and,
the chances of becoming dependent upon
If you suffer from obsessional states like
!
 You have taken it according to the
Lorazepam, or suffering unpleasant effects
Reporting of side effects
unwanted thoughts or images or ideas.
instructions given by the prescriber or in
when you stop taking it. See the next section
If you get any side effects, talk to your doctor or
If any of the above apply to you, do not take
the information provided with the
for more details.
pharmacist. This includes any possible side
Lorazepam and go back to your doctor.
medicine and,
effects not listed in this leaflet. You can also
 It was not affecting your ability to drive
If you stop taking Lorazepam
report side effects directly via the Yellow Card
If you have been only prescribed Lorazepam
safely.
After you have finished your prescribed
Scheme at: www.mhra.gov.uk/yellowcard.
for depression or anxiety with depression and
Talk to your doctor or pharmacist if you are not
treatment with Lorazepam , your doctor will
By reporting side effects you can help provide
no other medications, please consult with your
sure whether it is safe for you to drive while
decide whether you need further treatment.
more information on the safety of this
doctor whether other medications should also
taking this medicine.
medicine.
be prescribed.
The number of Lorazepam tablets, and how
Lorazepam contains lactose
often you take them, should always be reduced
5. How to store Lorazepam
Warnings and precautions
Lorazepam contain lactose as lactose
slowly before you stop taking them altogether.
Talk to your doctor before taking Lorazepam if
monohydrate. If you have been told by your
This lets your body get used to being without
Keep this medicine out of the sight and reach of
any of the following apply to you:
doctor that you have an intolerance to some
lorazepam, and lessens the chances of
children.
If you abuse or have in the past abused
!
sugars, contact your doctor before taking this
unpleasant effects when you stop taking them.
drugs or alcohol.
medicinal product.
Your doctor will tell you how to do this.
Store below 25oC. Store in the original
If you have a personality disorder; it may
!
container to protect from light.
mean you have a greater chance of
3. How to take Lorazepam
When you stop taking Lorazepam you may
becoming dependent upon Lorazepam.
experience withdrawal symptoms such as
Do not use this medicine after the expiry date
!
If you have any kidney or liver problems.
Always take this medicine exactly as your
headache, muscle pain, anxiety, sleep
which is stated on the carton and the blister
!
If you have suffered from depression
doctor or pharmacist has told you. Check with
disorders, tension, depression, restlessness,
after EXP. The expiry date refers to the last day
before, as it might come back during
your doctor or pharmacist if you are not sure.
dizziness, feeling sick, diarrhoea, appetite loss,
of that month.
Lorazepam treatment.
confusion, irritability, agitation, shaking,
!
If you are suffering from depression, as
Lorazepam Tablets should be swallowed with a
stomach and / or muscle pain, changes in heart
Return any unused tablets to your pharmacist.
Lorazepam may increase any suicidal
glass of water.
beat, short term memory loss, high body
Only keep them if your doctor tells you to.
feelings or thoughts you may have.
A large bed time dose may cause sleepiness or
temperature, and sweating. Your original
!
If you suffer from breathing problems.
dizziness the next day ('hangover effect'),
difficulty sleeping may come back. If any of
Do not throw away any medicines via
!
If you are suffering from difficulty in coparticularly if you have insufficient sleep,
these signs occur, they usually do not last long.
wastewater or household waste. Ask your
ordination, or you are taking a lot of
around 7-8 hours is needed (please see
If you do suffer from any of these signs, ask
pharmacist how to throw away medicines you
medicines that affect the brain.
'Driving and using machines' section)
your doctor for advice.
no longer use. These measures will help
!
If you suffer from raised eye pressure, an
protect the environment.
eye condition called glaucoma.
If you have been given Lorazepam for anxiety
Do not stop taking Lorazepam suddenly. You
!
If you are elderly, as you may be more likely
or sleeping problems, treatment will usually last
might have more serious withdrawal signs,
6. Contents of the pack and other
to fall.
from a few days to 4 weeks, and will usually
such as loss of sense of reality, feeling unreal
information
!
If you have low blood pressure.
include a gradual reduction in dose at the end
or detached from life, not able to feel emotion.
of treatment.
Some patients have had numbness or tingling
What Lorazepam contains
Other medicines and Lorazepam
of the arms or legs, ringing in the ears, seeing
The active substance is lorazepam, either 1
!
Tell your doctor or pharmacist if you are taking,
Adults (over the age of 18 years):
or hearing things that are not there, fits, and
mg or 2.5 mg in a tablet.
have recently taken or might take any other
Anxiety: The recommended starting dose is
being extra sensitive to touch, sound, and light,
The
other ingredients are: lactose
!
medicines, including medicines obtained
0.5mg, taken 2 or 3 times a day, which may be
uncontrolled or overactive movements,
monohydrate;
povidone (K30);
without a prescription. Other medicines may
increase up to 2.5mg per day (maintenance
twitching, shaking, feeling sick, being sick,
crospovidone,
type A; maize starch;
affect the way Lorazepam works. Lorazepam
dose). The daily dose can be divided in 2 or 3
stomach upsets or stomach pain, loss of
microcrystalline
cellulose; sodium starch
may also affect the way other medicines work.
separate doses taken during the day, or it can
appetite, agitation, abnormally fast heartbeats,
glycolate; magnesium stearate and
Especially:
be taken as a single dose in the evening, four
panic attacks, dizziness or feeling that you are
polacrillin potassium.
!
Any other sedative (e.g. barbiturates or
hours after food and 30 minutes before going to
about to fall, memory loss, hallucinations,
antihistamines) or anti-anxiety medicines.
bed. Your doctor will tell you how often to take
feeling stiff and unable to move easily, feeling
What Lorazepam looks like and contents of
!
Antidepressants.
your tablets.
very warm, convulsions (sudden uncontrolled
the pack
!
Anaesthetics.
The maximum daily dose of 2.5mg should not
shaking or jerking of the body).
Lorazepam 1 mg: white, round, flat, bevelled,
!
Strong pain killers, such as tramadol,
be exceeded.
scored tablets, inscribed 1.0.
codeine, morphine, methadone.
Patients taking anti-depressants and patients
Lorazepam 2.5 mg: white, round, flat, bevelled,
!
Medicines for epilepsy, such as
Insomnia caused by anxiety: The
with seizure disorders may be more likely to
scored tablets.
phenobarbital or sodium valproate.
recommended starting dose is 1 mg before
experience convulsions.
!
Antihistamine medicines for allergies.
going to sleep, which may be increased to 1mg
Blister packs containing 10, 14, 15, 20, 28, 30,
!
Medicines for mood or mental disorders,
to 2mg before going to sleep.
If you have any of these signs, immediately ask
50, 60, 90, 100 or (only available to pharmacies
such as chlorpromazine, clozapine,
your doctor for advice.
or hospitals) 500 tablets are available.
haloperidol, loxapine.
Before surgery or dental operations: The
Not all pack sizes may be marketed.
!
Medicine for cataplexy (e.g. sodium
recommended dose is between 2mg to 4mg,
If you have any further questions on the use of
oxybate).
taken one to two hours prior to the operation.
this medicine, ask your doctor or pharmacist.
Marketing Authorisation Holder
!
Medicine for treating HIV.
Morningside Healthcare Limited
!
Medicine to treat delusions or
Elderly or weak patients and patients with
4. Possible side effects
115 Narborough Road
hallucinations.
kidney problems:
Leicester
!
Medicine to help with indigestion (e.g.
Elderly patients and patients with kidney
Like all medicines, this medicine can cause
LE3 0PA
cisapride or omeprazole).
problems may be given lower doses. The
side effects, although not everybody gets them.
UK
!
A medicine to control nausea and vomiting
starting dose is usually half of the
induced by chemotherapy called nabilone.
recommended normal adult dose. Your doctor
Immediately contact your doctor if you
Manufacturers
!
Medicines for addiction treatment (e.g.
will see how you respond to the medicine and
develop any of the following signs:
Farmaceutisch Analytisch Laboratorium Duiven
lofexidine and disulfram).
alter the dose if needed.
!
Sudden, severe allergic reaction, causing
B.V (FAL Duiven B.V)
!
TB drugs such as isoniazid.
difficulty in breathing, dizziness.
Dijkgraaf, 6921,
!
Antibiotics such as erthromycin.
Patients with liver problems:
!
Serious allergic reaction with swelling of
RK Duiven,
!
Medicines to treat high blood pressure.
Patients with severe liver problem should not
face, lips, and throat.
The Netherlands.
!
Medicines for Parkinson's disease e.g.
take Lorazepam.
!
Yellowing of the skin and the whites of the
levodopa.
Patients with moderate to mild liver problems
eyes.
Medochemie Ltd, Factory A - Z,
!
Oestrogen-containing contraceptives.
may be given lower doses. The starting dose is
!
Breathing difficulties.
Ayios Athanassios,
!
Medicines which affect liver enzymes (e.g.
usually half of the recommended normal adult
!
Thoughts of harming, or killing yourself.
Industrial Street,
cimetidine, esomeprazole, rifampicin,
dose. Your doctor will see how you respond to
!
Changes in your mental state such as:
Limassol, Cyprus.
itraconazole).
the medicine and alter the dose if needed.
restlessness, agitation, irritability,
!
Medicines for asthma, such as theophylline
aggressiveness, hallucinations, unusual
This leaflet was last revised in May 2017.
or aminophylline.
Children and adolescents:
behaviour and beliefs.
!
Medicines for relaxing your muscles (e.g.
Lorazepam should not be used in children and
baclofen and tizanidine).
adolescents under 18 years of age, except for
Tell your doctor or pharmacist if you get any
!
A medicine for gout called probenecid.
the following treatments.
of the following side effects:
The dose of these drugs may need to be
reduced before you can take Lorazepam.
Lorazepam with food, drink and alcohol
Do not drink any alcohol while taking
Lorazepam.

Aged less than 6 years:
Children under the age of six should not be
treated with Lorazepam.

Very common (may affect more than 1 in 10
people):
Drowsiness, sedation.
!
Tiredness.
!

Expand Transcript

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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