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DORMAGEN TABLETS 1MG

Active substance(s): LORMETAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dormagen Tablets 0.5mg and 1mg
(Lormetazepam)
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. What Dormagen Tablets are and what they are used for
2. Before you take Dormagen Tablets
3. How to take Dormagen Tablets
4. Possible side-effects
5. How to store Dormagen Tablets
6. Further information

1. WHAT DORMAGEN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Dormagen 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 DORMAGEN TABLETS
Do not take Dormagen Tablets:
• if you have severe breathing or chest problems
• if you are allergic to benzodiazepines or any of the other ingredients in Dormagen Tablets (see list
under ’What Dormagen 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 Dormagen 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
• if you have any kidney or liver problems
• if you are suffering from depression, since lormetazepam 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
• 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 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 Dormagen Tablets work.
Dormagen 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, anti-depressants, 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.
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, 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.
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.
You should avoid alcohol while you are taking lormetazepam, 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 Dormagen 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 DORMAGEN TABLETS
Always take Dormagen 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 Dormagen 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 Dormagen 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 Dormagen
Tablets, or suffering unpleasant side-effects when you stop taking them (See ‘If you stop taking
Dormagen Tablets’ section).
The beneficial effect of Dormagen 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.
Please read the back of this leaflet.

* Trademark

25070603

If you take more Dormagen 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 Dormagen 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 Dormagen Tablets
- After you have finished your prescribed treatment with lormetazepam, your doctor will decide if
you need further treatment.
- The number of Dormagen 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, 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
Like all medicines, Dormagen 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 Dormagen 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.

5. HOW TO STORE DORMAGEN TABLETS
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take Dormagen Tablets after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Dormagen Tablets should be kept in a cool, dry place. Return any unused tablets to your
pharmacist. Only keep them if your doctor tells you to. 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 Dormagen Tablets contain
The active substance in 0.5mg and 1mg tablets is lormetazepam.
The other ingredients are lactose, maize starch, polyvinylpyrrolidone and magnesium stearate.
What Dormagen Tablets look like and contents of the pack
Dormagen Tablets are round, white tablets, plain on one side, and with either ‘GP036’ (0.5mg
tablets) or with ‘GP037’ (1mg tablets) on the other.
Each pack contains 30 tablets.
POM

PL 17225/0012
Dormagen Tablets 0.5mg
PL 17225/0013
Dormagen Tablets 1mg
Marketing Authorisation Holder
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany.
This leaflet was last revised in February 2016

* Trademark
25070603

MHRA Header Box
Product
Title

Dormagen Tablets 0.5mg/1mg Lormetazepam Colours used
(Haupt)

Fonts used

Component

Leaflet

Helvetica 55 Roman

Pack Size

30's

IG code

25070603

Dimensions

148 x 420mm

Proof No.

03

Black

Helvetica 75 Bold

Date

15/01/2016

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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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