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LORMETAZEPAM 1MG TABLETS

Active substance(s): LORMETAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LORMETAZEPAM 1MG TABLETS
Lormetazepam Tablets are available in strengths of
0.5mg & 1mg.

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 get serious, or if you notice any
side-effects not listed in this leaflet, please tell your
doctor or pharmacist.

What is in this leaflet:
1.

2.
3.
4.
5.
6.

What Lormetazepam 1mg Tablets are and what they are
used for
Before you take Lormetazepam 1mg Tablets
How to take Lormetazepam 1mg Tablets
Possible side-effects
How to store Lormetazepam 1mg Tablets
Further information

1. What Lormetazepam 1mg Tablets are and
what they are used for
The name of your medicine is Lormetazepam 1mg Tablets.
Lormetazepam is a member of a group of medicines called
benzodiazepines. Lormetazepam is used for short-term
therapy to help with sleeping difficulties which are
significantly affecting your normal daily life.

2. Before you take Lormetazepam 1mg
Tablets
Do not take Lormetazepam 1mg Tablets:









if you have severe breathing or chest problems
if you are allergic to benzodiazepines or any of the other
ingredients in Lormetazepam 1mg Tablets (see list
under ‘What Lormetazepam 1mg Tablets contain’)
if you have myasthenia gravis (very weak or tired
muscles)
if you have serious liver problems
if you suffer from sleep apnoea (breathing problems
when you are asleep)
if you are breast-feeding, since the drug may pass into
breast milk.

Take special care with Lormetazepam 1mg Tablets:











if you are pregnant, or trying to become pregnant (see
below)
if you abuse or have in the past abused drugs or alcohol
if you have a personality disorder. If so, you have a
greater chance of becoming dependent on
Lormetazepam 1mg Tablets
if you have any kidney or liver problems
if you are suffering from depression, since
Lormetazepam 1mg Tablets may increase any suicidal
feelings which you may have
if you have suffered from depression before, since it
could re-occur during treatment with Lormetazepam
1mg Tablets
if you suffer from breathing problems
if you are suffering from an eye problem called
glaucoma.

Taking other medicines

Tell your doctor or pharmacist that you are taking
Lormetazepam 1mg Tablets before taking any other medicine
or if you enter hospital for treatment, or if you are taking any
other medicines, including those which have not been
prescribed by a doctor, since they may affect the way
Lormetazepam 1mg Tablets work.
Lormetazepam 1mg Tablets may also affect the way other
drugs work. In particular, you should tell your doctor if you
are taking any other sedative, anti-anxiety drugs, antidepressants, anti-hypertensives, strong pain killers (e.g.
methadone), drugs for epilepsy, drugs to help breathing,
drugs which stop liver enzymes working, anaesthetics,
antihistamines or drugs for mood or mental disorders (e.g.
chlorpromazine). The dose of these drugs may need to be
reduced before you can take Lormetazepam 1mg Tablets.

Pregnancy and breast-feeding
Pregnancy

Do not take this medicine if you are pregnant, or might
become pregnant, without consulting your doctor.
Benzodiazepines, including Lormetazepam 1mg Tablets, may
cause damage to the foetus if taken during early pregnancy.
If you take 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 or feeding difficulties for a while. Your baby’s
response to the cold might be temporarily impaired. If this
medicine is taken regularly in late pregnancy, your baby may
develop withdrawal symptoms after birth.

Breast-feeding

Do not take this medicine if you are breast-feeding, since the
drug may pass into breast milk and may cause the baby to be
less active and unable to suckle.

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Driving and using machines

Lormetazepam 1mg Tablets may make you feel dizzy or
sleepy during the day, or may affect your concentration. This
may affect your performance at skilled tasks such as driving
and operating machinery.
You should avoid alcohol while you are taking Lormetazepam
1mg Tablets, since this may make you very drowsy and
seriously affect your ability to drive or use machines.
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 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 Lormetazepam 1mg Tablets

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 Lormetazepam 1mg Tablets
Always take Lormetazepam 1mg Tablets exactly as
your doctor has told you. The label on your medicine
should also tell you. You should check with your doctor
or pharmacist if you are not sure.
The usual adult dose of Lormetazepam 1mg Tablets is 0.5mg
to 1.5mg. For patients with mild to moderate difficulties in
breathing or patients with liver impairment a dose reduction
should be considered. You should swallow your tablets with
water just before you go to bed at night. Make sure you can
have 7 or 8 hours of uninterrupted sleep before taking
Lormetazepam 1mg Tablets.
Elderly: Elderly patients may respond to half the usual adult
dose or less. The label on your medicine will tell you how
many tablets to take and how often. If it does not, or you are
not sure, ask your doctor or pharmacist.
Treatment usually lasts from a few days to 2 weeks. It should
not usually last longer than 4 weeks including a dose
reduction at the end. This reduces the risk of becoming
dependant on Lormetazepam 1mg Tablets, or suffering
unpleasant side-effects when you stop taking them (See ‘If
you stop taking Lormetazepam 1mg Tablets’ section).

The beneficial effect of Lormetazepam 1mg Tablets may be
less apparent after several weeks of use. If you are given
Lormetazepam 1mg Tablets for more than 4 weeks, your
doctor might want to take blood samples occasionally to
check your blood and liver, since drugs like Lormetazepam
1mg Tablets have occasionally affected liver function.

If you take more Lormetazepam 1mg Tablets than
you should

Do not take more tablets than stated on the label of your
medicine. If you take too many tablets you should seek
medical attention immediately, either by calling your doctor,
or going to the nearest casualty department. Always take the
labelled medicine container with you, even if there are no
tablets left.

If you forget to take Lormetazepam 1mg Tablets

If you forget to take a dose, don’t worry, just take your next
tablet when it is due. Do not take a double dose to make
up for a forgotten tablet.

If you stop taking Lormetazepam 1mg Tablets

After you have finished your prescribed treatment with
Lormetazepam 1mg Tablets, your doctor will decide if
you need further treatment.

The number of Lormetazepam 1mg Tablets and how
often you take them should always be reduced slowly
before stopping them. This allows your body to get used
to being without your tablets, and reduces the risk of
unpleasant effects when you stop taking them. Your
doctor will tell you how to do this.

On stopping Lormetazepam 1mg Tablets, you may
experience symptoms such as headaches, muscle pain,
anxiety, tension, depression, restlessness, sweating,
confusion or irritability. Your original sleeplessness may
also return. If you suffer from any of these symptoms,
ask your doctor for advice.

Do not stop taking your tablets suddenly. This could lead
to more serious symptoms such as loss of the sense of
reality, feeling unreal or detached from life and unable
to feel emotion. Some patients have also experienced
numbness or tingling of the arms or legs, tinnitus
(ringing sounds in the ears), oversensitivity to light,
sound and touch, uncontrolled or overactive
movements, twitching, shaking, feeling sick, being sick,
stomach upsets or stomach pain, loss of appetite,
agitation, abnormally fast heartbeats, panic attacks,
dizziness or feeling that you are about to fall, memory
loss, hallucinations, feeling stiff and unable to move
easily, feeling very warm, convulsions (sudden
uncontrolled shaking or jerking of the body).

Patients taking anti-depressants and patients with
seizure disorders may be more likely to experience
convulsions.
If you suffer from any of these symptoms, ask your doctor for
advice immediately.


4. Possible side-effects

5. How to store Lormetazepam 1mg Tablets

Like all medicines, Lormetazepam 1mg Tablets can cause
side-effects, although not everybody gets them. These are
usually not serious and do not last long.





If you experience any of the following more rare unwanted
effects, you should tell your doctor immediately:
Confusion, depression, numbed emotions, difficulty
controlling urges and impulses to speak, act or show
emotions, a feeling of well-being for no reason, allergic
reaction, changes in appetite, sleep problems, changes in sex
drive, sexual problems, headaches, reduced alertness, speech
problems, memory loss or forgetfulness, problems with
vision, worsening of sleep apnoea, difficulty breathing, feeling
sick, stomach upsets, changes in the amount of saliva in the
mouth, yellowing of the skin and eyes, skin problems such as
a rash, dependence to Lormetazepam 1mg Tablets, suicidal
thoughts or plans, hypersensitivity including anaphylaxis,
twitching or shaking, feeling worried or stressed, slow
thoughts, coma, feeling very cold, worsening of original
sleeplessness and related symptoms such as: restlessness,
agitation, irritability, aggressiveness, loss of the sense of
reality, intense anger, nightmares, hallucinations and
inappropriate behaviour.
Other rare unwanted effects include blood or liver function
changes, or low blood pressure.
However, you should tell your doctor if any of the following
symptoms are severe or become troublesome:
Daytime drowsiness, feeling calm and sleepy, dizziness,
muscle weakness, poor muscle control and unsteady
movements, general weakness, feeling tired.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.





Store in a cool dry place.
Keep out of the sight and reach of children.
Don’t take the tablets after the ‘expiry date’ shown on
the carton and blister label. The expiry date refers to the
last date of the month.
Return any unused tablets to your pharmacist. Only
keep them if your doctor tells you to.
If your tablets become discoloured or show any other
signs of deterioration, take them back to your
pharmacist.
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 Lormetazepam 1mg Tablets contain
Each tablet contains 1mg of lormetazepam.

Lormetazepam 1mg Tablets also contain lactose,
maize starch, polyvinylpyrrolidone and magnesium stearate.

What Lormetazepam 1mg Tablets look like and
contents of the pack

The tablets are round, white tablets, scored on one side with
L and 1 embossed on either side of the score line and plain on
the reverse.
The tablets are available in blister packs of 30. However, your
doctor may prescribe a different number of tablets for you.

Manufacturer

Manufactured by:
Meda Pharma GmbH & Co. KG, Benzstrasse 1,
61352 Bad Homburg, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 04423/0602

POM

Leaflet revision & issue date (ref): 24.05.16

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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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