Lormetazepam 1mg Tablets
Package Leaflet: Information for the user
Lormetazepam 1mg 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 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 symptoms 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.
- The name of this medicine is Lormetazepam 1mg tablets but it will be referred to as Lormetazepam throughout the remainder of this leaflet.
- This product is also available in other strengths.
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 is a medicine in the hypnotic group which promotes sleep: it normalises the time necessary to fall asleep and its total duration, while reducing sleep disruption.
It is indicated for:
- Short-term treatment of insomnia.
Lormetazepam belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORMETAZEPAM
Do not take Lormetazepam
- if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Lormetazepam (listed in section 6).
- if you suffer from myasthenia gravis (a disease characterised by the appearance of an abnormal degree of muscle weakness),
- if you have severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease),
- if you suffer from sleep apnoea syndrome (a condition characterised by short episodes of stopping breathing which appear during sleep),
- in the case of acute intoxication with alcohol, hypnotics, analgesics or drugs which act on the central nervous system (neuroleptics, antidepressants, lithium).
- If you suffer from severe hepatic insufficiency.
- If you are pregnant or breast-feeding (see also “Pregnancy, breastfeeding and fertility)
Warnings and precautions
Talk to your doctor or pharmacist before taking Lormetazepam:
- if you have chronic respiratory insufficiency, as you must take a lower dose than usual,
- if you have severe renal insufficiency,
- Lormetazepam should not be used as first line treatment of psychotic disease or as sole treatment for anxiety or sleep disorders associated with depression.
Tolerance
- Some loss of efficacy with regard to the hypnotic effects may develop after repeated use for a few weeks.
- Tolerance for other Central Nervous System (CNS) depressants will be diminished in the presence of Lormetazepam, these substances should either be avoided or taken in reduced dosage.
Dependence
- Lormetazepam may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. Abrupt termination of treatment may be accompanied by withdrawal symptoms such as headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating and the occurrence of "rebound" phenomena (temporary reappearance of symptoms which led to starting treatment). These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed.
Always take Lormetazepam exactly as your doctor has told you, in order to avoid the onset of these symptoms as far as possible.
Rebound insomnia and anxiety
- You may have a rebound episode (temporary reappearance of symptoms which led to starting treatment). This episode may be accompanied by other reactions such as mood changes, anxiety or sleep disorders and restlessness. The likelihood of a withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore it is recommended that the dose is decreased bit by bit until it is finally withdrawn. Follow the recommendations for use and instructions for administration of Lormetazepam exactly as your doctor has told you, in order to avoid the appearance of these symptoms as far as possible.
Amnesia
- Lormetazepam may induce anterograde amnesia, that is, difficulty in remembering recent events. To reduce this risk, you should ensure that you will be able to have uninterrupted sleep for 7-8 hours (see section “4. Possible side effects”).
Psychiatric and paradoxical reactions
- Lormetazepam may cause restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects. These reactions are more common in children and the elderly, as well as in patients with organic brain syndrome (physical disorders which cause decreased mental function). Your doctor will discontinue treatment with Lormetazepam should these reactions appear.
- Depression prior to treatment with Lormetazepam may be unmasked during Lormetazepam treatment. There is a risk of suicide in these patients (see section “4. Possible side effects”).
Other warnings
- Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematologic and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary
- Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.
- Abuse of benzodiazepines has been reported.
- Caution should be used in the treatment of patients with narrow-angle glaucoma.
Use in children and adolescents
Lormetazepam should not be administered to patients under 18 years of age for the treatment of insomnia without careful assessment of the need for it by the doctor. The duration of treatment should also be as short as possible. For more information on use in patients under 18 years of age, see section “3. How to take Lormetazepam”.
Use in elderly patients
Elderly patients should receive a lower dose than usual. Your doctor will recommend the most appropriate dose. (See section “3. How to take Lormetazepam”).
Using Lormetazepam with other medicines
Please tell your doctor or pharmacist about any other medicines you are taking, have recently taken or may need to take.
Enhancement of the effect of Lormetazepam may occur when administered concomitantly with the following medicines:
- Anti-psychotics (neuroleptics, medicines used in the treatment of psychiatric disorders)
- Hypnotics (medicines that improve the onset of sleep and its duration)
- Anxiolytics/sedatives (medicines used for the treatment of anxiety)
- Antidepressants (medicines used for the treatment of depression)
- Narcotic analgesics (certain medicines which reduce pain). These medicines may also cause an increased sense of euphoria, which may increase psychological dependence.
- Anti-epileptics (medicines used in the treatment of epilepsy)
- Anaesthetics (medicines generally used in surgical procedures to reduce pain and/or consciousness)
- Sedative antihistamines (medicines used mainly for the treatment of allergic symptoms)
- Calcium antagonists (medicines used for the treatment of cardiovascular diseases)
- Oral contraceptives (medicines used to prevent pregnancy)
- Certain antibiotics (medicines used for the treatment of certain infections)
- Levo-dopa and its combinations (medicine for the treatment of Parkinson's disease)
- Theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including Lormetazepam
- Clozapine should cause enhanced sedative effects, increased salivation and ataxia
Tell your doctor if you are taking other medicines.
Using Lormetazepam with food, drink and alcohol
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. The sedative effect may be enhanced when the product is used in combination with alcohol, so the use of alcoholic beverages should be avoided. This should be particularly considered as it affects the ability to drive and use machinery (see section “Driving and using machines").
Pregnancy, breast-feeding and fertility
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.
Ask your doctor or pharmacist for advice before taking any medicine.
As a general precaution, you should not use Lormetazepam during pregnancy, labour or breast-feeding.
If, for strict medical reasons, the medicine is administered during the third trimester of pregnancy, or at high doses during labour, effects on the newborn, such as hypothermia, hypotonia and moderate respiratory depression may appear.
Infants born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence and develop a withdrawal syndrome in the postnatal period.
Since benzodiazepines pass into breast milk, their use is contraindicated in breast-feeding mothers.
Driving and using machines
Lormetazepam is a medicine that causes sleep. Do not drive or use machinery if you feel drowsy and if you notice that your attention and ability to react are reduced. Pay special attention at the start of treatment or if the dose is increased.
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.
Lormetazepam contains lactose.
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
3) HOW TO TAKE LORMETAZEPAM
Always take Lormetazepam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Remember to take your medicine.
Your doctor will tell you the duration of your treatment with Lormetazepam. Do not stop treatment earlier as it may not have the desired effect.
Treatment should be as short as possible. Generally, it varies from a few days to two weeks with a maximum period of four weeks, including the gradual dose reduction period.
The tablets should be taken with a small amount of liquid before going to bed.
Adults
The recommended dose is 1mg of Lormetazepam as a single dose.
In cases of severe or persistent insomnia, and always according to the doctor's opinion, the dose can be increased to 2mg.
Elderly patients
The recommended dose is 0.5mg of Lormetazepam per day as a single dose.
In the elderly, benzodiazepines may be associated with an increased risk of falling as they can cause muscle weakness, dizziness, drowsiness and fatigue. Therefore, your doctor will tell you the dose that best suits your condition.
Talk to your doctor or pharmacist if your think that the effect of Lormetazepam is too strong or too weak.
There are other forms of Lormetazepam in case Lormetazepam tablets do not comply with the prescribed dose.
If you take more Lormetazepam than you should
Overdose is not life-threatening unless combined with other centrally-acting depressants (including alcohol). In the case of overdose, it should be taken into account that the patient may have taken multiple agents. Overdose of benzodiazepines generally appears as varying degrees of central nervous system depression ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion and lethargy; in more serious cases, ataxia (impaired coordination of movements), hypotonia (decrease in muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma and very rarely death may occur.
In the event of overdose or accidental intake, please consult your doctor or pharmacist immediately, indicating the medicine and the amount taken.
If you go to a health care centre, remember to take this package leaflet with you.
If you forget to take Lormetazepam
Do not take a double dose to make up for a forgotten dose.
If you stop taking Lormetazepam
Your doctor will tell you the duration of treatment with Lormetazepam. Do not stop treatment early; otherwise it may not have the desired effect. When stopping treatment, the symptoms that led you to take the medicine may recur; restlessness, anxiety, insomnia, headache and sweating may occur, so your doctor will explain clearly how to decrease the dose gradually.
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Lormetazepam can cause side effects, although not everybody gets them.
If the dose is not adapted to the individual conditions of each patient, side effects may appear due to excessive sedation and muscle relaxation.
Very common side effects (may affect more than 1 in every 10 patients)
- Headache
Common side effects (may affect between 1 and 10 in every 100 patients)
- Quincke's oedema (inflammatory disease that affects the skin and subcutaneous tissue and submucosa)
- Anxiety, reduced libido (sexual desire)
- Dizziness, sedation, drowsiness (sleepiness), attention disorder, amnesia, disturbed vision, speech disorder, abnormal sense of taste, slowed thinking.
- Tachycardia (accelerated heart beat)
- Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
- Pruritus (itching).
- Urination disorder.
- Asthenia (lack of energy), sweating.
For more information on the following points, see section “Warnings and precautions”.
Dependence
Use of Lormetazepam (even at therapeutic doses) may lead to the development of physical dependence; discontinuation of the therapy may result in the development of withdrawal or rebound phenomena (see section “Warnings and precautions”). Psychological dependence may occur. Cases of abuse of have been reported.
Psychiatric disorders
- Rebound insomnia (after discontinuing treatment, the same symptoms for which it was started appear) (see section “Warnings and precautions”).
- Psychiatric and paradoxical reactions: Reactions such as restlessness, agitation, irritability, aggressiveness, delusion (false ideas that are believed to be true and which are impossible to prove), rages, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate behaviour and other behavioural disorders may occur when using benzodiazepines or benzodiazepine-like agents. These reactions may be severe and are more likely to occur in children and the elderly (see section “Warnings and precautions”).
- Depression: The use of benzodiazepines may unmask pre-existing depression. Suicide may be precipitated in such patients.
Nervous system disorders
- Amnesia: Anterograde amnesia (difficulty in remembering recent events) may occur when using therapeutic doses; the risk being greater at higher doses. Amnestic effects may be associated with inappropriate behaviour (see section “Warnings and precautions”).
Various system organ disorders
The following side effects have been reported with the use of Lormetazepam: drowsiness during the day, emotional numbness, emotional disorder, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movements) and double vision. These effects occur predominantly at the start of treatment and usually disappear with repeated administration. Jaundice (yellowing of the mucosa and skin) and adverse skin reactions such as urticaria, pruritus or rash have been reported occasionally.
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 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 LORMETAZEPAM
• Keep out of the sight and reach of children.
• Lormetazepam does not require any special storage conditions.
• Do not use Lormetazepam after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
• If your tablets become discoloured or show any sign of deterioration, return them 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) CONTENTS OF THE PACK AND OTHER INFORMATION What Lormetazepam contains
The active substance is lormetazepam. Each tablet contains 1mg of lormetazepam.
Other ingredients are lactose monohydrate, croscarmellose sodium, magnesium stearate, maize starch and povidone K-25.
What the product looks like and contents of the pack
Lormetazepam 1mg tablets are round white tablets scored on one side and come in boxes containing blister strips with 30 tablets.
Manufactured by Kern Pharma, S.L.,
Pollgono Ind. Colon II, C/ Venus 72,
08228 Terrassa (Barcelona), Spain
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0564
pom!
Leaflet dated 13th July 2015 Leaflet coded XXXXXXXXXX