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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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to receive email notifications whenever new articles are published. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. To view content sources and attributions, please refer to our editorial policy. We comply with the HONcode standard for trustworthy health information - verify here. You may need to read it again. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. This includes any possible side effects not listed in this leaflet. 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 is indicated for: 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. 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. Tolerance - Some loss of efficacy with regard to the hypnotic effects may develop after repeated use for a few weeks. 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. 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. 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 facts. This occurs most commonly in the first few hours after taking the medicine. Therefore, to reduce this risk, you should ensure that you will be able to get hours of uninterrupted sleep see section 4. 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. Lormetazepam must not be used as a single-dose treatment for sleep abnormalities associated with depression. Other warnings - Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. This is particularly important in elderly patients. Caution should be used in the treatment of patients with narrow-angle glaucoma Children and adolescents Lormetazepam must not be administered to patients under 18 years of age to treat insomnia without a careful assessment by the doctor of the need for the treatment. In addition, treatment duration must be as short as possible see section 3. Use in elderly people Elderly patients should receive a lower dose than the usual dose since they are more susceptible to the effects of the medicine. Your doctor will recommend the most appropriate dose for you see section 3. 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: With these medicines, an increased feeling of euphoria may also occur. This may increase psychic dependence. Tell your doctor if you are taking other medicines. Using lormetazepam with food, drink and alcohol During treatment with lormetazepam, avoid alcoholic beverages. 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. Pregnancy 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. 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. Breast-feeding 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. It is an offence to drive if this medicine affects your ability to drive. However, you would not be committing an offence if: If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine. 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. Elderly patients The recommended dose is 0. 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. For patients with mild to moderate difficulties in breathing or patients with liver impairment a dose reduction should be considered. Talk to your doctor or pharmacist if you 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. 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. At the start of treatment, the following may occur: All these effects occur predominantly at the start of treatment and usually disappear with repeated administration. The most serious adverse reactions observed in patients treated with Lormetazepam are angioedema swelling completed suicide and attempted suicide, generally associated with masking of pre-existing depression. The most commonly observed adverse reactions in patients treated with Lormetazepam are headache, sedation and anxiety. When Lormetazepam is used, reactions such as jumpiness, agitation, irritability, aggressiveness, delirium false ideas that are believed to be true and that are impossible to prove , fits of rage, nightmares, hallucinations false perceptions of the senses , psychosis a type of mental disorder , inappropriate abnormal behaviour or other behavioural abnormalities may occur. The use of benzodiazepines may mask pre-existing depression. Suicides may be triggered in these patients. Lormetazepam must be used with caution in patients with depression. Nervous system disorders - Amnesia: Lormetazepam may cause anterograde amnesia difficulty remembering recent facts. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly via the Yellow card Scheme at: By reporting side effects you can help provide more information on the safety of this medicine. How to store lormetazepam Keep this medicine 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. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment. Contents of the pack and other information What lormetazepam contains - The active substance is lormetazepam. Each tablet contains either 0. The other ingredients are: What the product looks like and contents of the pack Lormetazepam 0. The tablets are round and white. Ver01 — Updated in line with National phase comments-approved Ver addition of 14pack size and name change in France-approved Veraddition of mandatory driving statement and PV wording approved27 March Ver 04 Renewal Ver 05 PSUSA Lormetazepam 1 mg tablets come in boxes containing blister strips with 14, 30 or tablets. The tablets are round, white and scored on one side. The score is used to divide the tablet into equal halves. Not all pack sizes may be marketed. Marketing authorisation holder and manufacturer Marketing authorisation holder: Latest Drug Information Updates. 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