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LORAZEPAM TABLETS

Active substance(s): LORAZEPAM

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PATIENT INFORMATION LEAFLET

Lorazium Tablets 1 and 2.5 mg
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE
PRESCRIBED COURSE OF LORAZIUM.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST.
What is in Lorazium tablets?
The active ingredient of Lorazium is lorazepam BP.
Lorazium 1 mg tablets contain 1.0 mg lorazepam BP and are
white tablets.
Lorazium 2.5 mg tablets contain 2.5 mg lorazepam BP and
are pink capsule-shaped tablets marked LOR 2.5 and scored.
Lorazium tablets also contain the ingredients microcrystalline
cellulose, lactose, talc, sodium starch glycollate, and
magnesium stearate. Lorazium 2.5mg tablets in addition
contain the colour E127.
Both strengths of Lorazium tablets are available in containers
of 100 and 500 and in blister-packs of 28 tablets.
Lorazium belongs to a group of medicines, the
benzodiazepines, that slow down the nervous system and are
known as Central Nervous System (CNS) depressants.
The name and address of the Product Licence holder of
Lorazium tablets is
Chelonia Healthcare Limited,
11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus
The name and address of the manufacturer of Lorazium
tablets is
DDSA Pharmaceuticals Ltd.,
Chatfield Road, off York Road, London SW11 3SE.
Why have you been prescribed Lorazium?
Lorazium is used for the short-term relief (2-4 weeks only) of
nervousness or tension which is disabling or which can cause
unacceptable distress, either on its own or together with
trouble in falling asleep or in sleeping known as insomnia.
Lorazium is also used for premedication for dental and
surgical procedures.
Before taking this medicine
Before taking this medicine tell your doctor if you have ever
had unusual or allergic reactions to Lorazium (Lorazepam) or
other benzodiazepines. Also tell your doctor or pharmacist if
you are allergic to any other substances, such as foods,
preservatives or dyes.

The presence of other medical problems may affect the use
of this medicine. Make sure, therefore, to tell your doctor if
you have any other medical problems, particularly if you
suffer from depression.
This medicine will add to the effects of alcohol and other
medicines that slow down the Central Nervous Systems
(CNS), possibly causing drowsiness. Some examples of CNS
depressants are antihistamines (medicines for hayfever and
other allergies), sedatives, tranquillisers, sleeping medicines,
pain relieving medicines, barbiturates, medicines for seizures,
muscle relaxants, anaesthetics (including some dental
anaesthetics).
Tell your doctor if you suffer from Myasthesia Gravis; severe
breathing problems; the sleep apnoea problem; liver disease.
How and when to use Lorazium
Take this medicine by mouth and only in the doses prescribed
by your doctor. Do not take more of it and do not take it more
often or for a longer time than your doctor ordered.
When your doctor decides that treatment should be stopped,
then Lorazium will be withdrawn gradually; even then
symptoms such as headache, muscle pain, extreme anxiety,
tension, restlessness, confusion and irritability, depression,
nervousness, insomnia, sweating and diarrhoea may occur.
If you feel this medicine is not working as well after you have
taken it for a short time (1-2 weeks) do not increase the dose,
instead check with your doctor.
If you miss a dose, skip the missed dose and go back to
your regular dosing schedule. Do not double the dose.
Adults dosage:
Your doctor will prescribe a suitable dose for your condition.
Children:
Not recommended for Children.
Overdose
If you think you may have taken an overdose of this medicine,
and particularly if you have also taken other Central Nervous
System depressants (including alcohol) you should obtain
emergency help at once. Tell the doctor in charge, or the
nurse or pharmacist, that you are taking this medicine and
also tell them whether you have taken other medicines or
alcohol. Take any remaining tablets in their original container
with you so they may be identified.
With overdose you will become drowsy, mentally confused,
lethargic and experience loss of balance, muscle weakness,
lowered blood pressure and rarely coma and very rarely
death.

What side effects can Lorazium have?
When Lorazium has been combined during treatment with
CNS depressants, sedative effects of these are likely to be
intensified.
Along with its needed effects, the medicine may cause some
unwanted effects, which may persist into the next day.
Common amongst these include drowsiness, sedation,
fatigue, headache, unsteadiness and difficulty with balance
when walking.
Other adverse effects are rare and include drowsiness,
sedation, blurring of vision, aggressive outbursts of anger,
excitement and confusion may be experienced.
Other rare effects include: lowering of blood pressure,
stomach upset, skin rashes, headache, dizziness, inability to
pass urine, changes in sexual desire, different types of
anaemia, yellowing of the skin and whites of eyeballs
(jaundice).
If the above occur check with your doctor at once, as he may
wish to discontinue using the drug.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist.
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.
Driving and using machines
Lorazium can affect your ability to drive and use machines as
it may make you sleepy or dizzy. Please remember that
alcohol may intensify these effects and should be avoided
during treatment.
Do not drive or use machines 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:
- Lorazium 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.
Use in pregnancy
Do not take this medicine if you are pregnant, might
become pregnant, or are breast-feeding. If your doctor
has decided that you should receive this medicine during
late pregnancy or during labour, your baby might have a
low body temperature, floppiness, and breathing and
feeding difficulties. If this medicine is taken regularly in
late pregnancy, your baby may develop withdrawal
symptoms.

Storing your medicine
Keep out of the sight and reach of children.
Keep your medicine in a dry place, below 25ºC in a wellclosed container.
If your doctor tells you to stop the treatment, return any
remaining tablets to the pharmacist. Only keep the medicine if
the doctor tells you to.
On the label you will find the words "Expiry Date" followed by
numbers indicating the month and year. This is the date when
the medicine is no longer fit for use. Do not use the medicine
after this date, but return it to your doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist who have
access to additional information.
Lorazium Tablets 1 mg Product Licence PL 33414/0056
Lorazium Tablets 2.5 mg Product Licence PL 33414/0057
This leaflet was revised in July 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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