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.

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:

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 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. 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.

GENUS PHARMACEUTICALS 25070602

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G E N/DGN/PI L/285_02 22/09/2014

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 1 mg 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 1 mg

Marketing Authorisation Holder

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturer

Haupt Pharma Munster GmbH, Schleebruggenkamp 15, 48159 Munster, Germany. This leaflet was last approved in December 2014

25070602    GENUS PHARMACEUTICALS

GEN/DGN/PIL/285_02

22/09/2014