LORAZEPAM TABLETS 2.5MG

Active substance: LORAZEPAM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Lorazepam Tablets 1 mg and 2.5 mg

SZ00000LT000

(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 Tablets are and what they are
used for
2. Before you take Lorazepam Tablets
3. How to take Lorazepam Tablets
4. Possible side effects
5. How to store Lorazepam Tablets
6. Further Information

1

What Lorazepam Tablets are and what
they are used for

Lorazepam Tablets contain lorazepam as the active
ingredient. This belongs to a group of medicines
known as benzodiazepines, which have sedative and
muscle relaxing properties.
Lorazepam Tablets are used for the short term
treatment of anxiety, which may or may not be
associated with sleeping problems and is severe,
disabling, or causing unacceptable distress.
Lorazepam Tablets are also used as a sedative and
pre-medication before investigative or surgical
procedures, such as dental surgery.

2

Before you take Lorazepam Tablets

DO NOT take Lorazepam Tablets if you have:
• an allergy (hypersensitivity) to lorazepam or any of
the other ingredients in the tablets (see Section 6:
Further information)
• myasthenia gravis (extreme tiredness and
weakness of selected muscles, symptoms of which
may include drooping of the upper eyelid, double
vision or speech difficulties)
• difficulties in breathing
• sleep apnoea syndrome (when you stop breathing
while asleep)
• severe liver damage.

Take special care with Lorazepam Tablets if you:
• are suffering with depression, or anxiety associated
with depression, and are not taking any other medication
• have an alcohol or drugs problem, or a history of
this. If so, you have a greater chance of becoming
dependant on lorazepam.
• have a history of a personality disorder
• have kidney problems
• suffer with muscular weakness.
• you are going to have an operation which requires
an anaesthetic, tell the hospital or surgery that you
are taking Lorazepam Tablets in advance.
Lorazepam Tablets are not recommended for the
treatment of mild anxiety.

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.
In particular, please tell your doctor if you are taking
any of the following:
• antidepressants e.g. lithium, citalopram
• medicines to treat severe mental illnesses e.g.
amisulpride, olanzapine
• medicines to help you sleep e.g. temazepam, zolpidem
• medicines to treat anxiety e.g. diazepam
• narcotic analgesics (strong painkillers) e.g.
morphine, fentanyl, oxycodone
• anti-epileptic medicines e.g. phenytoin, carbamazepine
• antihistamines (for allergies and hayfever) that
cause drowsiness e.g. chlorphenamine, ketotifen
• an antibiotic called Rifampicin.

Taking Lorazepam Tablets with food and drink
Do not drink alcohol while taking Lorazepam Tablets.
It can interfere with the usual effect of the medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.

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 may
have a low body temperature, floppiness and
breathing difficulties. If this medicine is taken regularly
in late pregnancy, your baby may develop withdrawal
symptoms. Discuss any concerns with your doctor.
Lorazepam is found in breast milk. Therefore, do not
take lorazepam whilst breast-feeding.
Driving and using machines
These tablets may cause drowsiness, loss of
concentration (especially if you have not had enough
sleep), and loss of muscle function, which may
adversely affect your ability to drive and use
machines. Do not drive or operate machines whilst
taking Lorazepam Tablets if you notice these effects.

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 Lorazepam Tablets
This medicine 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 Tablets

Always take Lorazepam Tablets exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Usually the course of treatment with lorazepam will be
as short as possible. If you are being treated for
severe anxiety and phobia or severe and disabling
insomnia you will be reassessed regularly by your
doctor and treatment should not continue for more
than 2 to 4 weeks. This includes a tapering off period.
Lorazepam Tablets should be swallowed with water.

Continued on the next page >>

Adults
For severe anxiety and phobia:
1 mg to 4 mg per day, in divided doses.

For severe and disabling insomnia:
1 mg to 2 mg before bed-time.
For premedication:
2 mg to 3 mg the night before the operation, 2 mg to
4 mg, 1 to 2 hours before the operation.

Children aged 5 to 13 years
For premedication: 0.5 mg to 2.5 mg (at 0.05 mg per
kilogram of the childʼs body
weight, to the nearest 0.5 mg),
not less than 1 hour before the
operation.
Dentistry:

1 mg to 2.5 mg, 1½ to 2 hours
before dental treatment. For
dental surgery, dosage as for
premedication.

Elderly patients may be given a lower dose.

Patients with liver or kidney disease or with
breathing difficulties may be given a lower dose.
If you have the impression that the effect of
Lorazepam Tablets is too strong or too weak, talk to
your doctor or pharmacist.

If you take more Lorazepam Tablets than you should
If you may have taken more Lorazepam Tablets than
you should, tell your doctor or pharmacist. If you have
accidentally taken one extra dose, this is unlikely to be
a cause for concern. However, if you or someone else
may have taken more than one extra dose or a large
overdose, contact your doctor or local hospital
accident and emergency department immediately.
If you forget to take Lorazepam Tablets
Do not take a double dose to make up for forgotten
individual doses. Do not worry if you have forgotten to
take your medicine. Wait until the next dose is due
and carry on as normal. If you are concerned, consult
your doctor or pharmacist.
If you stop taking Lorazepam Tablets
DO NOT stop taking the tablets until the doctor has
told you to. It is possible that your body has become
dependant on lorazepam.
If you wish to stop taking these tablets before the end
of the course, discuss this with your doctor.
Lorazepam Tablets need to be withdrawn gradually to
allow your body to get used to being without
lorazepam and reduce the risk of unpleasant side
effects (see the information on “Dependence” under
Section 4: Possible side effects).

4

Possible side effects

Like all medicines, lorazepam can cause side effects,
although not everybody gets them.

At the start of treatment, you may notice the following:
• tiredness, reduced alertness, feeling drowsy during
the day
• numbed emotions
• confusion, dizziness
• loss of coordination, weak muscles
• headache
• nausea and vomiting, changes in saliva
• slurring of speech or difficulty in speaking
• tremors
• visual disturbances (e.g. double vision).
These effects usually disappear after you have been
taking lorazepam for a while.

Occasionally, the following effects have been reported:
• stomach upsets
• changes in sex drive
• blood disorders (e.g. unexplained bruising, pale
skin)
• jaundice (yellowing of the skin or whites of the eyes)
• skin reactions.
You may feel depressed after taking Lorazepam
Tablets.
Memory loss
Lorazepam may cause memory loss. To reduce the
risk of this happening, make sure you get 7-8 hours of
uninterrupted sleep.

Dependence
The use of lorazepam may lead to dependence. If you
stop taking it suddenly you may get withdrawal
symptoms or rebound phenomena.
Withdrawal symptoms include:
• headaches
• muscle pain
• extreme anxiety, tension
• restlessness, irritability
• confusion.
In severe cases the following may occur:
• a state of feeling unreal or strangely altered
• abnormally sensitive hearing
• numbness and tingling in the fingers and toes
• hypersensitivity to light, noise and physical contact
• hallucinations
• fits.

Rebound phenomena occur when the symptoms that
led to treatment with lorazepam temporarily return in a
more severe form when treatment is stopped. This
may be accompanied by mood changes, anxiety or
sleep disturbances and restlessness. If you are
concerned about this, discuss it with your doctor.
Behavioural effects
The following effects have been reported with
benzodiazepines such as lorazepam:
• restlessness, irritability
• agitation
• aggressiveness, rages
• delusion, hallucinations
• nightmares
• mental disorders
• inappropriate behaviour or other unwanted
behavioural effects.

These effects may be severe and are more likely to
occur in children and the elderly. Tell your doctor
immediately if you experience any of these effects, as
your doctor may want you to stop taking your
medicine.
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 Tablets

Keep out of the reach and sight of children.
Do not use Lorazepam Tablets after the expiry date
which is stated on the carton after EXP. 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 Tablets contain
The active substance is lorazepam. Each tablet
contains 1 mg or 2.5 mg.
The other ingredients are lactose, microcrystalline
cellulose, talc, sodium starch glycollate and indigo
carmine lake (E132) colouring (see Section 2: Further
information about some of the ingredients of
Lorazepam Tablets).

What Lorazepam Tablets look like and contents of
the pack
Lorazepam 1 mg tablets are pale blue capsule shaped
tablets and Lorazepam 2.5 mg tablets are yellow
capsule shaped tablets.
The 1mg tablets are available in Securitainer packs of
28, 100, 500 and 1,000 tablets, and blister packs of 30
or 100 tablets.
The 2.5mg tablets are available in Securitainer packs
of 28, 100 and 500 tablets, and blister packs of 30 or
100 tablets.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Leaflet prepared: 08/2014

SZ00000LT000

Expand view ⇕

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.

Hide
(web3)