LORAMET 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

LORAMET 2 mg tablets

Lormetazepam

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Loramet and what is it used for
2. What you need to know before you take Loramet
3. How to take Loramet
4. Possible side effects
5. Storing Loramet
6. Package contents and further information

1. What is Loramet and what is it used for

Loramet contains lormetazepam, which belongs to a group of medicines called benzodiazepines. It is indicated for the short-term treatment of insomnia.

Benzodiazepines are only indicated for the treatment of a severe disorder, which limits the patient's activity or subjects them to a situation of significant stress.

2. What you need to know before you take Loramet

Do not take Loramet

• If you are allergic to the active substance, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from myasthenia gravis (very weak or tired muscles).
• If you have severe respiratory failure.
• If you suffer from sleep apnea syndrome.
• If you have a history of alcohol or drug dependence.
• In case of acute intoxication with alcohol, sleeping pills, pain relievers, or psychotropic medications (neuroleptics, antidepressants, lithium salts).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Loramet.

If any of the following cases apply to you, inform your doctor. Your doctor will take this into account during treatment with Loramet.

• If you have spinal or cerebellar ataxia (lack of coordination of movements).

If you have any liver or kidney disorder.

• If you have closed-angle glaucoma.
• If your doctor has prescribed you prolonged treatment, it is advisable to have periodic blood tests and liver function tests.
• If you become pregnant during treatment, you must inform your doctor.
• The use of Loramet is not recommended in children and adolescents.
• If you are being treated with opioids, as it may cause breathing difficulties, sedation, coma, and even death.

Keep in mind that you may experience the following reactions:

Tolerance

After continuous use for several weeks, a certain degree of loss of efficacy with respect to the hypnotic effects may be detected.

Amnesia

Benzodiazepines, including Loramet, may induce amnesia (memory alteration). This fact occurs more frequently after several hours of administering the medicine, so to reduce the associated risk, patients should ensure they sleep uninterrupted for 7-8 hours after taking the tablet.

Dependence and abuse

Treatment with benzodiazepines may lead to the development of physical and psychological dependence. This risk increases with the dose and duration, but dependence can also occur during short-term treatment with the therapeutic dose range.

To prevent this risk as much as possible, the following precautions should be taken:

? The intake of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and never advise other people to take them.

? Do not increase the prescribed doses by your doctor, nor prolong the treatment for longer than recommended.

• In patients with a history of drug and/or alcohol abuse, potential abuse of the medication may occur.

? Consult your doctor regularly so that they can decide if treatment should continue.

Rebound insomnia and anxiety

When administration is stopped, the symptoms that led to taking the medicine may reappear, as well as mood changes, anxiety, insomnia, restlessness, among others, so your doctor will indicate precisely how to gradually reduce the dose.

It is essential to avoid sudden suspension of lormetazepam and follow a gradual dose reduction process.

Psychiatric and paradoxical reactions

In treatment with benzodiazepines, including Loramet, pre-existing depressions may reappear or worsen. Additionally, they may unmask the suicidal tendencies of depressive patients, which should be monitored in these patients.

The medication should be discontinued if these reactions appear.

Using Loramet with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

The simultaneous use of Loramet with opioids (pain relievers, substitution therapy medications, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this, combined administration should only be considered when no alternative treatments are possible.

However, if your doctor prescribes Loramet along with opioids, the dosage and duration of concurrent treatment should be limited by your doctor.

Please inform your doctor of all opioids you are taking and follow carefully the dosage recommendations indicated by your doctor. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Alcohol increases the sedative effect of this medicine, so it is recommended to avoid alcohol consumption.

Certain medications may interact with Loramet and make you feel more drowsy than expected. These are medications called central nervous system depressants, including those used to treat mental illnesses such as antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants; those used to relieve strong pain (narcotic analgesics); those used to treat convulsions/epileptic seizures (antiepileptics); anesthetic medications; barbituric medications; and medications used to treat allergies (sedating antihistamines).

The combined administration of Loramet with other medications such as theophylline or aminophylline, beta-blockers, cardiac glycosides, oral contraceptives, and some antibiotics may alter the effect of Loramet by prolonging or reducing its activity.

The effect of muscle relaxants may be enhanced.

Taking Loramet with food and drinks

Avoid consuming alcohol during treatment with Loramet, as it increases the sedative effect of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of benzodiazepines, including Loramet, appears to be related to a possible increased risk of congenital malformations in the first trimester of pregnancy. Benzodiazepines and their metabolites have been detected passing through the placenta.

If, for strict medical necessity, the product is administered during late pregnancy or at high doses during delivery, it is foreseeable that effects on the newborn such as hypoactivity, hypothermia, hypotonia (low muscle tone), apnea (breathing difficulties), moderate respiratory depression, feeding problems, and metabolic response imbalance to cold stress may appear.

Children born to mothers who take benzodiazepines chronically during several weeks of pregnancy or during the last period of pregnancy may develop physical dependence and trigger withdrawal syndrome in the postnatal period.

Breastfeeding

Loramet should not be used during breastfeeding, as benzodiazepines, including Loramet, are excreted in breast milk. Cases of sedation and inability to breastfeed have been detected in newborns whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect any of the mentioned pharmacological effects (including sedation and irritability).

Use in children and adolescents:

Benzodiazepines are not indicated in children and adolescents, except for premedication for diagnostic or surgical procedures (anesthesiology, intensive care). In these cases, a single dose of 1 mg is recommended.

Use in elderly and debilitated patients

Elderly and debilitated patients should receive a lower dose, as they are more susceptible to the effects of the medicine. Follow your doctor's instructions carefully.

Due to the muscle relaxant effect, there is a risk of falls and consequently fractures in elderly patients, especially in patients who get up during the night.

Use in patients with respiratory failure

Lormetazepam is contraindicated in patients with severe respiratory failure.

Use in patients with liver failure

Lormetazepam should be used with caution in patients with severe liver failure and/or encephalopathy.

Grief or loss

In cases of grief or loss, psychological adjustment may be inhibited by benzodiazepines.

Driving and using machines

Loramet is a medicine that causes drowsiness. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if the dose is increased.

Loramet contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Loramet

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Loramet. The duration of treatment should be as short as possible.

Treatment should be started with the lowest doses and the maximum dose should not be exceeded.

Adults:

The recommended dose is 1 mg of lormetazepam per day (1 tablet of Loramet 1 mg), 15 to 30 minutes before bedtime, administered orally.

The usual dose may be increased at the doctor's discretion in case of severe or persistent insomnia that does not respond to the usual regimen, up to a maximum of 2 mg of Lormetazepam (1 tablet of Loramet 2 mg).

Use in children and adolescentsLormetazepam is not indicated for the treatment of insomnia in children and adolescents.

Elderly patients, debilitated patients, or patients with cerebrovascular disorders (arteriosclerosis), mild or moderate respiratory failure, and/or renal and/or hepatic impairment.

The dose should be reduced to 0.5 mg of lormetazepam per day. To achieve this dose, other presentations of lormetazepam are available.

For severe respiratory failure, see section 2.

Do not interrupt treatment abruptly. Your doctor will indicate the precise way to gradually reduce the dose, as when administration is stopped, the symptoms that led to taking the medicine may reappear.

If you take more Loramet than you should

The symptoms of benzodiazepine overdose are generally manifested by different degrees of central nervous system depression, ranging from drowsiness to coma.

In moderate cases, symptoms include drowsiness, confusion, lethargy, and disarthria (speech disorders). In more severe cases, ataxia (incoordination of voluntary movement), paradoxical reactions, central nervous system depression, hypotonia, hypotension, respiratory depression (breathing difficulties), cardiac depression, coma, and death may appear.

Treatment of overdose: the clinical management of overdose of any medication should always consider the possibility that the patient has ingested multiple products.

After a benzodiazepine overdose, vomiting should be induced (within an hour) if the patient is conscious. Vomiting is not recommended if there is a risk of aspiration. If the patient is unconscious, gastric lavage should be performed while maintaining the airway. If gastric emptying does not provide any advantage, activated charcoal should be administered to reduce absorption.

Special attention should be paid to respiratory and cardiovascular functions if the patient requires admission to an intensive care unit for monitoring.

Use of an antidote in case of overdose: in hospitalized patients, flumazenil (a benzodiazepine antagonist) can be used as an adjunctive method in the treatment of overdose, but never as a substitute for the method described above. In patients who chronically take benzodiazepines or in cases of overdose with tricyclic antidepressants, special care should be taken when administering flumazenil, as this combination of medications can increase the risk of seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Loramet

Do not take a double dose to make up for forgotten doses.

If you stop taking Loramet

Do not stop taking Loramet until your doctor tells you to.

If you stop taking Loramet, especially if it is sudden, mood changes, anxiety, insomnia, restlessness, lack of concentration, headache, and sweating, among others, may appear.

Your doctor will explain how to gradually reduce the dose until you finish your treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

According to frequency, they are defined as:

Very common(may affect more than 1 in 10 people): Headache.

Common(may affect up to 1 in 10 people):

Anxiety, changes in libido, and bradypnea. Dizziness, sedation, drowsiness, attention disorders, amnesia, disarthria (slurred speech), dysgeusia. Tachycardia. Vomiting, nausea, upper abdominal pain, constipation, dry mouth. Pruritus. Urination disorders. Asthenia, hyperhidrosis, malaise.

Rare(may affect up to 1 in 10,000 people):

Hypersensitivity. Syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatremia. Visual problems (including double vision and blurred vision). Hypotension (low blood pressure). Respiratory failure, apnea, worsening of sleep apnea, worsening of chronic obstructive pulmonary disease (COPD). Increased liver transaminases and alkaline phosphatase in blood. Allergic dermatitis.

Frequency not known (cannot be estimated from the available data):

Angioedema, completed suicide, attempted suicide (due to unmasking of pre-existing depression), acute psychosis, hallucination, dependence, drug abuse, depression (unmasking of pre-existing depression), deception, rebound insomnia syndrome, agitation, aggression, irritability, restlessness, anger, nightmares, confusion, delirium, abnormal behavior, emotional disorder, psychomotor retardation. Low level of consciousness, ataxia, convulsion, tremor, extrapyramidal disorders. Nystagmus (involuntary eye movement). Urticaria, rash. Muscle weakness, muscle cramps. Fatigue, hypothermia, paradoxical reactions.

Due to the muscle relaxant effect, there is a risk of falls and consequently fractures in elderly patients.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Loramet

Keep this medicine out of the sight and reach of children. Loramet does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Loramet 2 mg tablets

• The active ingredient is lormetazepam. Each tablet contains 2 mg of lormetazepam
• The other components are lactose monohydrate, cornstarch, povidone, and magnesium stearate.

Product Appearance and Packaging Content

Loramet 2 mg is presented in packs containing 20 tablets. The tablets are round and white in color, scored on one side and marked with L2 on the other side. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:December 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/