LORAZEPAM TABLETS 2.5MG

Active substance: LORAZEPAM

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LORAZEPAM SECOND VERSION:LORAZEPAM 2ND VERSION

5/9/13

2:51 PM

Page 1

Patient Information Leaflet

LORAZEPAM 1MG & 2.5MG TABLETS

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 or nurse. This includes any possible
side effects not listed in this leaflet.
• This medicine should be used for as short a time as
possible and should not be used for more than four
weeks. If used for too long without a break, there
is a risk of becoming dependent or of having
problems when you stop taking it.
In this leaflet:
1. What Lorazepam is and what is it used for?
2. What you need to know before you take
Lorazepam
3. How to take Lorazepam Tablets
4. Possible side effects
5. How to store Lorazepam Tablets
6. Contents of the pack and other information

1. What Lorazepam is and what is it used for
• Lorazepam belongs to a group of medicines called

benzodiazepines.

• Lorazepam tablets are used as a short-term therapy

for severe anxiety or sleeping difficulties due to
anxiety.
• It may also be used as a sedative before general
surgery or pre-operative dental treatment.
• When taking this medicine there is a risk of
dependence (a need to keep taking the medicine)
the risk increases with the dose and length of
treatment period. The risk is greater if you have
ever had a history of alcohol or drug abuse.

2. What you need to know before you take
Lorazepam
DO NOT take Lorazepam if you:

• are allergic to benzodiazepines or any of the

other ingredients of this medicine (listed in
section 6)
• have severe breathing or chest problems
• have ‘myasthenia gravis’ (very weak or tired
muscles)
• have serious liver problems
• suffer from ‘sleep apnoea’ (breathing problems
when you are asleep)
• are pregnant or trying to become pregnant
• are breast feeding
• are taking antipsychotics, antidepressants,
hypnotics, sedative or antihistamines as these
medicines may interact with Lorazepam.
Warnings and precautions
Talk to your doctor or pharmacist before taking
these tablets if you:
• have kidney or liver problems
• are suffering from psychiatric illness or a
personality disorder
• abuse or have in the past abused drugs or alcohol
• have suffered or are suffering from depression as
it could re-occur during treatment with
Lorazepam and if you have suicidal feelings,
these may increase
• suffer from an eye problem called glaucoma
• are taking any other medicine, including those
which have not been prescribed by a doctor, as
they may affect the way Lorazepam works
• suffer from a condition called ‘porphyria’
(inherited metabolic disorder).

Taking other medicines
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, especially if you are already taking:
• sedative drugs (e.g. barbiturates)
• analgesics, anti-anxiety drugs, anti-depressants
• strong painkillers (e.g. methadone)
• sodium oxybate (used to treat narcolepsy)
• zidovudine (used in HIV treatment)
• antiepileptic drugs (e.g. phenobarbital or
valproate)
• antihistamines(eg. cimetidine)
• drugs to treat delusions or hallucinations (eg.
clozapine)
• muscle relaxants (eg. baclofen or tizanidine)
• cisapride, omeprazole, esomeprazole (drugs to
help treat indigestion)
• drugs to treat high blood pressure, antacids
• drugs to treat parkinson’s disease (eg.levodopa)
• antifungal drugs such as ketoconazole
• antibiotics (eg. erythromycin, rifampicin,
isoniazid)
• drugs for addiction treatment (e.g. lofexidine,
disulfram)
• oestrogen- containing contraceptives
• drugs for asthma (theophylline/ aminophylline).
The dose of these drugs may need to be reduced
before you can take Lorazepam.
Using Lorazepam with food, drink and alcohol
• Drinks containing caffeine and grapefruit juice
should be avoided while taking these tablets.
• No alcohol should be consumed during treatment
with benzodiazepines. Talk to a pharmacist or
your doctor before taking this medicine if you are
taking alcohol (see driving information).
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or
breast feeding, think you may be pregnant or are
planning to have a baby. If your doctor has
decided that you should receive this medicine
during late pregnancy or during labour, your
baby, when born, may be less active than other
babies, have a low body temperature, be floppy,
or have breathing and feeding difficulties for a
while. If this medicine is taken regularly in late
pregnancy, your baby may develop withdrawal
symptoms after birth.
Driving and using machines
Lorazepam can cause sedation, impaired
concentration, blurred vision, drowsiness, or
amnesia which may adversely affect ability to
perform skilled tasks such as driving or operating
machinery.
You should avoid alcohol while you are taking
lorazepam, since this may make you very drowsy
and seriously affect your ability to drive or use
machines.
Lorazepam tablet contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Lorazepam

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
Dosage-The dosage of Lorazepam should be
adjusted according to the needs of the patient and the
minimum dose to control symptoms should be used.
• Adults (and children over 13 years of age)
Anxiety: 1 to 4mg daily in divided doses. Your
doctor will tell you how often to take your tablets.
Sleeping Problems: 1 to 2mg before going to
sleep.

LORAZEPAM SECOND VERSION:LORAZEPAM 2ND VERSION

Before Surgery: 2 to 3mg the night before your
operation and 2 to 4mg 1 or 2 hours before your
operation.
• Children (between 5 and 13 years of age)
Before Surgery: The dose is usually between 0.5
and 2.5mg at 0.05mg/kg to the nearest 0.5mg
according to weight, not less than 1 hour before
your child’s operation.
Lorazepam is not recommended for the treatment
of anxiety or sleeping problems in children. Nor is
it recommended for children below 5 years of age.
• Elderly or patients with liver or kidney problems
Older patients may be given lower doses. They
may respond to half the usual adult dose or less.
How to take
• Swallow the tablet with water.
Duration of use
• Lorazepam should be used as a short-term
therapy for the treatment of severe anxiety or
insomnia. Treatment should not normally be
continued beyond 4 weeks.
• Treatment should if possible be intermittent; the
lowest dose to control symptoms should be used.
• Long term chronic use is not recommended.
• Treatment should always be reduced gradually.
If you take more Lorazepam than you should
If you or anyone else has taken too many tablets,
contact your doctor or hospital immediately.
Bring any remaining tablets with you to show the
doctor.
If you forget to take Lorazepam
If you forget to take your medicine for anxiety,
you should take it as soon as you remember if it
is less than 3 hours since your usual time. If more
than 3 hours have passed, then just continue
taking your next dose; do not try to catch up by
doubling up the dosage.
If you stop taking Lorazepam
If you stop taking the tablets suddenly you may
experience depression, nervousness, difficulty in
sleeping, irritability, sweating, upset stomach, or
the symptoms you are being treated for can come
back worse than before.
You may also experience mood changes, anxiety,
restlessness and changes in sleep patterns. These
effects may occur even after taking low doses for
a short period of time.
If you stop taking these tablets suddenly after
being treated with high doses, you may
experience confusion, hallucinations, shaking,
faster heartbeat or fits (see section 4).
Withdrawal may also cause unusual behaviour
including aggressive outbursts, excitement or
depression with suicidal thoughts or actions.
This medicine should not be stopped suddenly;
keep taking it until your doctor tells you how to
reduce the dose slowly.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following serious
side effects, tell your doctor immediately:
• severe allergic reactions like difficulty in
breathing, swelling of the lips, mouth, tongue,
throat, hands, feet and /or severe faintness or
dizziness, sensitivity to light
• restlessness, agitation, irritability,
aggressiveness, violent anger, sleeping
difficulties, nightmares, hallucinations,
personality changes, abnormal behaviour with
suicidal tendency
• unexplained bleeding and/or bruising; increased
risk of infections like frequent sore throats, mouth
ulcers, weakness and pale skin
• yellowing of the skin, eye, nose, and mouth, pale

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coloured stools and dark coloured urine.
Other side effects:
• Very common (may affect more than 1 in
10people): daytime drowsiness, sedative effect.
• Common (may affect up to 1 in 10 people):
dizziness, muscle weakness, fatigue, poor muscle
control.
• Rare (may affect up to 1 in 1,000 people):
nausea, confusion, depression, numbed emotions,
change in appetite, stomach upset, headache,
reduced alertness, problems with vision, memory
loss or forgetfulness, ringing, buzzing, loss of
sensation, changes in sex drive, impotence, skin
problems.
• Very rare (may affect up to 1 in 10,000 people):
tremor, reduction in blood cells and decrease in
body temperature.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. Also you can help to make
sure that medicines remain as safe as possible by
reporting any unwanted side effects via the internet
at www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

5. How to store Lorazepam

Keep all medicines out of the sight and reach of
children.
• Do not use this medicine after the expiry date
stated on the pack after Exp. The expiry date
refers to the last day of that month.
• Store below 25˚C. Protect from moisture and
light. Store 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 protect the environment.

6. Contents of the pack and other information

What Lorazepam Tablets contain
Lorazepam 1 mg: The active substance is 1mg
of Lorazepam. The other ingredients are lactose,
colloidal silicon dioxide, starch, sodium starch
glycollate, magnesium stearate, and aluminium
lake patent blue V (E131).
Lorazepam 2.5mg: The active substance is
2.5mg of Lorazepam. The other ingredients are
lactose, starch, colloidal silicon dioxide, sodium
starch glycollate, magnesium stearate, and
aluminium lake quinoline yellow (E104).
See end of section 2 for further information on
lactose
What Lorazepam Tablet looks like and contents
of the pack
Lorazepam 1 mg: Pale blue, oblong shaped
tablets with bevelled edge, embossed “L/1” on
one face and “PV” on the other face.
Lorazepam 2.5mg: Yellow oblong tablets with
bevelled edge, embossed “L/2.5” on one face and
“PV” on the other face
Pack sizes of Lorazepam 1mg & 2.5mg are “14,
28, 30, 50, 56, 100, 250, 500 & 1000” tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or
audio format or additional copies, please contact the
licence holder at the address (or telephone, fax)
above.
PL 04556/0019, PL 04556/0020 POM
This leaflet was last revised: May 2013
Reference: 0019200513 / 01

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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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