Lormetazepam Tablets 1mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lormetazepam 0.5 mg and 1 mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Lormetazepam is and what it is used for
2. What you need to know before you take Lormetazepam
3. How to take Lormetazepam
4. Possible side effects
5. How to store Lormetazepam
6. Contents of the pack and other information
1. WHAT LORMETAZEPAM IS AND WHAT IT IS USED FOR
Lormetazepam belongs to a group of medicines called benzodiazepines. It is not clear exactly how this medicine works, but it is thought that it increases the actions of a naturally occurring substance called GABA, in the brain. This means that after you take Lormetazepam you should feel tired and fall asleep.
Lormetazepam is used for short-term treatment (up to 4 weeks) to help with sleeping difficulties which are severe and significantly affecting your normal daily life or causing you distress.
Before treatment with Lormetazepam, your doctor should determine the underlying cause of your sleeping difficulties.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORMETAZEPAM Do not take Lormetazepam:
- if you are allergic (hypersensitive) to lormetazepam, other benzodiazepines or any of the other ingredients of Lormetazepam Tablets
- if you have severe breathing problems or lung disease
- if your breathing sometimes stops when you are asleep(sleep apnoea syndrome)
- if you suffer from a condition which causes muscle weakness and tiredness (myasthenia gravis)
- if you have taken an excessive amount of alcohol or other drugs (e.g. sleeping tablets, painkillers or drugs used to treat psychiatric illness)
Warnings and precautions
Talk to your doctor or pharmacist before taking Lormetazepam:
- If you have long term lung disease (respiratory insufficiency). You may need a lower dose than other patients as Lormetazepam can interfere with your breathing.
- If you have severely reduced liver function (hepatic insufficiency). Special care is needed because drugs such as Lormetazepam can increase symptoms such as loss of memory, loss of consciousness, personality changes and difficulty with concentration (possible symptoms of encephalopathy).
- If you have severe kidney problems. You may need to be observed more closely while taking Lormetazepam.
Lormetazepam should be used for as short a period as possible.
You may find that Lormetazepam becomes less effective after you have taken it for a few weeks (tolerance).
Taking Lormetazepam can lead to you becoming dependent on the drug (physical or psychological dependence). This is more likely with higher doses or if you take Lormetazepam for a long time. It is also more likely if you have a history of alcohol or drug abuse. Lormetazepam must be used extremely carefully if you have a history of alcohol or drug abuse.
If you have become dependent on Lormetazepam and you then suddenly stop taking it you will suffer withdrawal symptoms. These may include:
• extreme anxiety
• tension
• restlessness
• confusion
• irritability
• headaches
• muscle pain
In severe cases you may :
• feel out of touch with reality
• feel strange in familiar surroundings
• have hallucinations
• have numbness and tingling of your arms and legs
• become over-sensitive to light, noise, sound and physical contact
• have epileptic seizures.
It is possible with some drugs of this type that withdrawal symptoms may start between one dose and the next. This is very unlikely to happen with Lormetazepam.
However, if you have taken a similar drug before starting Lormetazepam, you may develop these withdrawal symptoms when you start taking Lormetazepam.
When you stop taking Lormetazepam, you may find it difficult to sleep for some time
(rebound insomnia). Tell your doctor if this happens.
You are less likely to suffer from withdrawal symptoms or rebound insomnia if you reduce the dose of Lormetazepam gradually.
Lormetazepam may cause a short term loss of memory (anterograde amnesia). This occurs most often in the first few hours after taking the tablets. Make sure that you will be able to sleep without interruption for at least 7-8 hours in order to reduce this risk.
Stop taking the tablets and see your doctor if you have reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses or inappropriate abnormal behaviour (psychiatric and paradoxical reactions). These reactions are more likely to occur in children, in the elderly and in patients with dementia (organic brain syndrome).
Lormetazepam is not recommended as the main treatment for psychotic illness.
Lormetazepam should not be used alone to treat sleep disorders associated with depression.
Tell your doctor if you are suffering from depression. Depression may be unmasked during use of drugs like Lormetazepam. This may lead to suicidal tendencies.
Children and adolescents:
Lormetazepam should not be given to patients younger than eighteen years unless it is essential. Your doctor will carefully assess the need for treatment in younger patients. If there is a need to take Lormetazepam it must be taken for the shortest possible time.
Elderly patients:
You are more likely to fall while taking these tablets, especially if you are an older patient. This is because of some of the side effects of Lormetazepam, such as loss of coordination, muscle weakness, dizziness, sleepiness and tiredness.
Elderly patients may need a lower dose of Lormetazepam.
For further information, see Section 3‘How to take Lormetazepam’.
Other medicines and Lormetazepam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular you should tell your doctor if you are taking the following:
- other sedatives, other drugs which make you sleep, these are drugs such as benzodiazepines (e.g. diazepam and alprazolam) and barbiturates (e.g. mephobarbital and pentobarbital sodium)
- general anaesthetics, tell your doctor if you need to have an operation
- strong pain killers e.g. morphine
- monoamine oxidase inhibitors e.g. phenelzine, used to treat mental illness
- antidepressants e.g. dothiepin
- drugs used to treat psychosis
- medicines used for epilepsy,
- medicines used to treat allergies (antihistamines), some of which may cause sleepiness (sedation).
These may enhance the effect of Lormetazepam and your dosage may need to be adjusted.
If certain kinds of painkillers (narcotic analgesics) are taken with Lormetazepam, it may affect your mood. This may increase the risk of you becoming dependent.
You should tell your doctor if you take medicines to reduce your blood pressure (betablocking agents, e.g atenolol), medicines to treat heart failure and/or heart rhythm (cardiac glycosides e.g. digoxin), medicines to treat severe heart or breathing conditions (methylxantines ,e.g aminophylline), oral contraceptives and antibiotics concomitantly with lormetazepam, as co-administration can cause side effects.
Taking Lormetazepam with food and drink
Do not drink alcohol whilst taking Lormetazepam. Alcohol can increase the sedative effects of Lormetazepam and should therefore be avoided.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you take this medicine in the late stages of pregnancy or during labour and delivery , your baby when born might have a lower body temperature, weak muscles, low blood temperature, breathing and feeding difficulties.
Regular use during pregnancy may also lead to dependence and/or withdrawal symptoms in the new born baby.
Breast-feeding
Do not take this medicine if you are breast-feeding, since the drug may pass into breast milk. Tell your doctor if you are breastfeeding.
Driving and using machines
Lormetazepam may make you sleepy during the day or affect your concentration and ability to perform skilled tasks. These effects are worse if you have not had sufficient sleep. You should not operate or drive machinery if you are affected in this way and do not drink alcohol, as this will make the effects worse.
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:
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.
Important information about some of the ingredients of Lormetazepam
Lormetazepam contains lactose. If you have been told by your doctor that you have intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
3. HOW TO TAKE LORMETAZEPAM
Always take Lormetazepam exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Take Lormetazepam for as short a period as possible. Usually this will vary from a few days up to two weeks with a maximum of four weeks. This includes the period during which the dose is gradually reduced.
In certain cases treatment may be continued for longer. This should only happen after your doctor has examined your situation.
Do not take tablets for longer or more often than your doctor has advised. This reduces the risk of becoming dependant on Lormetazepam or suffering unpleasant side-effects when you stop taking them (See ‘If you stop taking Lormetazepam’ section).
If you have been taking Lormetazepam for a long time your dose may have to be reduced gradually over a longer period before you stop completely.
The usual adult dose is 0.5 mg to 1.5 mg before you go to bed at night.
Elderly:
The lowest adult dose is preferable for elderly patients Children:
Lormetazepam should not be given to patients younger than eighteen years unless it is essential. Your doctor will carefully assess the need for treatment in younger patients. If there is a need to take Lormetazepam it must be taken for the shortest possible time.
For patiens with mild to moderate difficulties in breathing or patients with liver impairment a dose reduction should be considered.
If you take more Lormetazepam than you should
Contact your doctor or nearest hospital emergency department at once. Take the container and any remaining tablets with you.
Taking too much Lormetazepam does not usually present a threat to life. However, if you have also taken other drugs or alcohol, you may have difficulty in breathing. In rare cases this has led to coma and in very rare cases, death.
If you have taken too much Lormetazepam, you may feel drowsy or tired. You may also have problems with your coordination (ataxic symptoms) and vision.
Higher doses may cause deep sleep or unconsciousness, problems with breathing and low blood pressure.
If you have milder symptoms your doctor may decide to let you sleep them off while someone is taking care of you. If larger amounts have been taken, it may be necessary to make you vomit or give other treatment.
A drug called flumazenil may be useful to reverse the effects of overdose.
If you forget to take Lormetazepam
Do not take a double dose to make up for a forgotten tablet; just take your next tablet when it is due.
If you stop taking Lormetazepam
After you have finished your prescribed treatment, your doctor will decide if you need further treatment.
The number of Lormetazepam 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 risks of unpleasant side effects when you stop taking them. Your doctor will tell you how to do this.
On stopping Lormetazepam suddenly you may experience side-effects such as feeling anxious, depressed or tense, sleeplessness, headaches and sweating. If you suffer from any of these symptoms, you should ask your doctor for advice immediately.
Some patients have also experienced ringing in the ears (tinnitus), twitching, tingling or numbness in arms and legs, convulsions, stomach and muscle cramps, vomiting, feeling confused, unreal or detached. These symptoms are associated with a condition that is sometimes caused when stopping this type of medicine and others like it. If you suffer from any of these symptoms, you should ask your doctor for advice immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lormetazepam can cause side effects, although not everybody gets them.
At the beginning of the treatment, feeling drowsy during the day, emotional disorder, depressed mood, confusion, fatigue, headache, dizziness, muscular weakness, loss of coordination or double vision may occur; these reactions usually disappear after several doses.
If you experience any of the following side effects, you should contact your doctor immediately:
- Symptoms of an allergy (hypersensitivity): swelling of face, lips, tongue, throat, hands or feet, difficulty breathing or swallowing (angioedema).
Depression may be unmasked during the use of lormetazepam. This may lead to suicidal attempts and self-harm. Please contact your doctor immediately if you any of these symptoms.
Other side effects you may experience:
Very common: may affect more than 1 in 10 people:
- headache
Common: may affect up to 1 in 10 people
- anxiety
- loss of sex drive
- feeling dizzy
- feeling drowsy during the day
- reduced attention
- loss of memory
- changes in eyesight and speech
- taste disturbance
- reduced thought process
- feeling sick and being sick
- fast heart rate
- stomach pain, constipation, dry mouth
- itching
- difficulty passing urinereduced vitality (asthenia)
- sweating
Not known: frequency cannot be estimated from the available data
- acute psychosis, hallucination, delusion
- emotional disorders, abnormal behaviour
- depressed mood
- confusional state
- Depressed level of consciousness
- anger, aggression
- restlessness, irritability
- nightmare
- withdrawal syndrome
- dependence
- fatigue
- fall
- lack of co-ordination (especially affects elderly)
- muscular weakness
- red skin, rash
You may become dependent on Lormetazepam or similar drugs (physical or psychological dependence).
If you have become dependent and you suddenly stop taking Lormetazepam, you may have withdrawal symptoms. These include extreme anxiety, tension, restlessness, confusion, irritability, headaches, and/or muscle pain. In severe cases you may feel out of touch with reality, feel strange in familiar surroundings or have hallucinations, numbness or tingling of your hands and feet. You may also become very sensitive to light, noise and physical contact or have epileptic seizures.
When you stop taking your tablets, you may suffer from increased difficulty in sleeping for some time (rebound insomnia). Tell your doctor if this happens.
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses and inappropriate abnormal behaviour can occur with Lormetazepam (psychiatric or ‘paradoxical reactions’). You should stop taking Lormetazepam and contact your doctor if this happens.
These tablets may induce a temporary loss of memory (anterograde amnesia).
See Section 2: Warning and precautions for more information on these side effects.
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 LORMETAZEPAM
Keep out of the sight and reach of children.
Do not use Lormetazepam after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store in a dry place below 25°C.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. FURTHER INFORMATION What Lormetazepam contains
- The active substance is lormetazepam. Each tablet contains either 0.5 mg or 1 mg of lormetazepam.
- The other ingredients are lactose (anhydrous), dibasic calcium phosphate anhydrous, crospovidone, purified talc and magnesium stearate.
What Lormetazepam looks like and contents of the pack
Lormetazepam tablets are round and white.
0.5 mg tablets are marked LT breakline 0.5 on one side with “G” on the reverse 1 mg tablets are marked LT breakline 1 on one side with “G” on the reverse
Lormetazepam is available in containers of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Potters Bar Hertfordshire EN6 1TL
Manufacturer
Generics [UK] Ltd Potters Bar Hertfordshire EN6 1TL
This leaflet was last revised in 12/2015.