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LORMETAZEPAM 0.5 MG TABLETS

Active substance(s): LORMETAZEPAM

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ARTWORK INFORMATION:
PRODUCT:

Lormetazepam 0.5 mg & 1 mg Tablets

LICENCE:

PL 17507/0131-132

APPROVED FOR
SUBMISSION:

ITEM / SIZE: Generic package leaflet / 148 mm (w) x 250 mm (h) [flat]
ID CODE:

A1000223/3

APPROVED BY
HEALTH AUTHORITY:

ITERATION: Version 1; 18/02/2016
INK:

Black

PATIENT INFORMATION LEAFLET

LORMETAZEPAM 0.5 MG & 1 MG TABLETS

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 become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What is LORMETAZEPAM and what is it used for?
2. Before you take LORMETAZEPAM 0.5 mg or 1 mg Tablets
3. How to take LORMETAZEPAM 0.5 mg or 1 mg Tablets
4. Possible side effects
5. Storing LORMETAZEPAM 0.5 mg or 1 mg Tablets
6. Further information
1. What is LORMETAZEPAM and what is
it used for?
The name of this medicine is Lormetazepam 0.5 mg or 1 mg
Tablets. Lormetazepam is one of a group of medicines called
benzodiazepines.
Lormetazepam is prescribed as a short-term therapy to help
with sleeping difficulties which are significantly affecting
normal daily life.

2. Before you take LORMETAZEPAM 0.5 mg
or 1 mg Tablets

Do not take LORMETAZEPAM if you:
• have severe breathing or chest problems
• have an allergic reaction to benzodiazepines or any of
the ingredients in Lormetazepam Tablets (see list under
Section 6). An allergic reaction can be a rash, itchiness or
shortness of breath
• have myasthenia gravis (very weak or tired muscles)
• have serious liver problems
• have sleep apnoea (breathing problems when you are asleep)
• are breastfeeding.
Special Precautions
Check with your doctor or pharmacist before taking your
medicine if any of the following applies to you:
• You are pregnant, or trying to become pregnant (see below).
• You abuse or have in the past abused drugs or alcohol.
• You have a personality disorder. If so, you have a greater
chance of becoming dependent on lormetazepam.
• You have any kidney or liver problems.
• You have suffered from depression before, since it could
re-occur during treatment with lormetazepam.
• You are suffering from depression, since lormetazepam may
increase any suicidal feelings which you may have.
• You are suffering from an eye problem called glaucoma.
• You suffer from breathing problems.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
The beneficial effect of Lormetazepam Tablets may be less
apparent after several weeks of use.
If you are given lormetazepam for more than 4 weeks, your
doctor might want to take blood samples occasionally to
check your blood and liver, since drugs like lormetazepam
have occasionally affected liver function.
Lormetazepam Tablets are usually prescribed for short
courses of treatment, lasting from a few days to 2 weeks.
You should not usually take Lormetazepam Tablets for longer
than 4 weeks including a dose reduction at the end. This
reduces the risk of becoming dependent on Lormetazepam
Tablets, or suffering unpleasant effects when you stop taking
it. (See “Stopping your medicine”, at the end of section 3).
LORMETAZEPAM and 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. Taking some medicines
together can be harmful.

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines as the dose of these drugs may
need to be reduced before you take lormetazepam:
• Sedatives
• Anti-anxiety drugs
• Antidepressants
• Strong pain-killers (e.g. methadone)
• Drugs for epilepsy
• Anaesthetics
• Antihistamines
• Drugs for mood or mental disorders (e.g. chlorpromazine)
• Medicines that help with breathing e.g. theophylline and
aminophylline
• Drugs that inhibit certain liver enzymes e.g ketoconazole or
ritonavir
If you are unsure of the types of medicines you are taking, ask
your doctor or pharmacist.
Taking LORMETAZEPAM with food and drink
You should avoid alcohol while you are taking Lormetazepam
Tablets, since this may make you very drowsy and seriously
affect your ability to drive or use machines.
Pregnancy and breast feeding
Lormetazepam may cause damage to the foetus if taken during
early pregnancy. Therefore, do not take this medicine if you
are pregnant or might become pregnant without consulting
your doctor. 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 also. If
this medicine is taken regularly in late pregnancy, your baby
may develop withdrawal symptoms after birth.
Lormetazepam should not be used during breast feeding.
Driving and using machines
Lormetazepam 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.
• 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:
o The medicine has been prescribed to treat a medical or
dental problem and
o You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
o 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.
Lormetazepam Tablets contain lactose
This product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, please
contact your doctor before taking this medicinal product.

3. How to take LORMETAZEPAM 0.5 mg
or 1 mg Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you.You should check with them if you
are not sure. Lormetazepam Tablets should be taken orally.
Adults:
The recommended adult dose of Lormetazepam Tablets is
0.5 mg to 1.5 mg.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 Tablets. 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.
For patients with mild to moderate difficulties in breathing or
patients with liver impairment a dose reduction should be
considered.
Elderly:
The dose for elderly patients will be reduced to either half
the adult dose or less.
Children:
This product should not be taken by children.
If you take more LORMETAZEPAM than you
should:
Taking too much lormetazepam can result in symptoms
including drowsiness, confusion, problems with co-ordination,
balance and speech, decreased muscle tone, shallow or slow
breathing or even coma.
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:
If you forget to take a dose, don’t worry, just take your next
tablet when it is due. Never take a double dose of tablets to
make up for a forgotten dose.
Stopping your medicine:
• After you have finished your prescribed treatment with
Lormetazepam Tablets, your doctor will decide whether or
not you need further treatment.
• The number of Lormetazepam Tablets and how often you
take them should always be reduced slowly before you stop
taking them altogether. 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, 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 a loss of the sense of
reality, feeling unreal or detached from life, and unable to feel
emotion. Some have experienced numbness or tingling of the
arms or legs, seeing and hearing things that are not real
(hallucinations), spinning feeling (vertigo), loss of appetite,
agitation, poor short term memory, severe confusion
(delirium), vomiting, tinnitus (ringing sounds in your ears),
abnormal twitching and convulsions (hyper-relexia), abnormal
movement and behaviour (catatonia), and hypersensitivity to
light, sound and touch. If you suffer from any of these
symptoms, ask your doctor for advice immediately.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, lormetazepam can have side effects,
although not everybody gets them.
Occasionally you may have unwanted effects while taking
Lormetazepam Tablets. 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.
(These effects are more likely to occur in children and elderly
patients):
A1000223/3

• Restlessness, agitation, irritability, aggressiveness, violent
anger, nightmares, hallucinations, personality changes,
abnormal behaviour or false beliefs.
• Signs and symptoms of blood count changes e.g. any
unexplained bruising or bleeding, sudden fever, sore throat,
tiredness, mouth sores.
• Abnormal liver function and the signs and symptoms
associated with jaundice e.g. yellowing of the whites of the
eyes and skin, abdominal pain, vomiting.
• Tremor, slurred speech, poor muscle control, slowing of
movement or thought processes.
• Collapse, difficulty breathing or any kind of skin rash or
itching of the skin. These may be signs of an allergic reaction.
You should tell your doctor if any of the following symptoms
are severe, last more than a few days or become troublesome:
Very common (may affect more than 1 in 10 people)
Daytime drowsiness, dizziness.
Common (may affect up to 1 in 10 people)
Fatigue, muscle weakness, abnormal physical weakness or lack
of energy.
Rare (may affect up to 1 in 1000 people)
Sleep problems, confusion, depression, numbed emotions,
changes in appetite, changes in sex drive, sexual problems,
difficulty controlling urges and impulses to speak, act or show
emotions, an intense feeling of excitement and happiness,
problems with vision, stomach upsets, nausea, headaches,
reduced alertness, memory loss or forgetfulness, difficulty in
passing stools, salivation changes, a drop in blood pressure,
feeling cold.
If you notice any side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.
Reporting of 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 (Website: www.mhra.gov.uk/yellowcard). By reporting
side effects, you can help provide more information on the
safety of this medicine.

5. Storing LORMETAZEPAM 0.5 mg or 1 mg
Tablets
Keep all medicines out of the sight and reach of children.
Do not use Lormetazepam Tablets after the expiry date on
the carton and blister. The expiry date refers to the last day
of that month.
Keep the tablets in the carton, in their blister pack, in order
to protect from light.
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 contains:
Each tablet contains either 0.5 mg or 1 mg of lormetazepam
as the active ingredient.
The tablets also contain lactose monohydrate, microcrystalline
cellulose, sodium starch glycolate, talc and magnesium stearate.
What LORMETAZEPAM looks like and contents
of the pack:
Lormetazepam 0.5 mg tablets are round white tablets with
the marking `LMT 0.5’ on one side and plain on the other.
Lormetazepam 1 mg tablets are round white tablets with the
marking `LMT 1’ on one side and plain on the other.
Lormetazepam tablets are available in boxes of 30 tablets.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL, UK
Manufacturer:
Tiofarma, Benjamin Franklinstraat 9,
3261 LW Oud-Beijereland, Netherlands
This leaflet was last revised in February 2016.

For information in large print, on tape,
on CD or in Braille, phone 01895 627 420.

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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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