Lormetazepam Tecnigen 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lormetazepam Tecnigen 2 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lormetazepam Tecnigen is and what it is used for

2. What you need to know before taking Lormetazepam Tecnigen

3. How to take Lormetazepam Tecnigen

4. Possible adverse effects

5. How to store Lormetazepam Tecnigen

6. Contents of the pack and other information

1. What Lormetazepam Tecnigen is and what it is used for

Lormetazepam Tecnigen 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 severe disorders that significantly impair the patient's daily activities or cause considerable distress.

2. What you need to know before taking Lormetazepam Tecnigen

Do not take Lormetazepam Tecnigen

• 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 fatigued muscles).

• If you have severe respiratory insufficiency.

• If you suffer from sleep apnoea syndrome.

• If you have a history of alcohol or drug dependence.

In cases of acute intoxication with alcohol, sleeping pills, painkillers, or psychotropic medicines (neuroleptics, antidepressants, lithium salts).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lormetazepam:

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

• If you suffer from 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 a long-term treatment, periodic blood tests and liver function tests are advisable.
• If you become pregnant during treatment, you must inform your doctor.
• Its use is not recommended in children or adolescents.
• If you are being treated with opioids, as this may cause difficulty breathing, sedation, coma, and even death.

Please note that you may experience the following reactions:

Tolerance

After continuous use for several weeks, a certain degree of reduced effectiveness regarding hypnotic effects may be observed.

Amnesia

Benzodiazepines, including lormetazepam, may induce amnesia (memory impairment). This is more frequent several hours after administration of the medicine; therefore, to reduce the associated risk, patients should ensure they can sleep uninterrupted for 7–8 hours after taking the tablet.

Dependence and abuse

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

To minimize this risk, the following precautions should be observed:

• Benzodiazepines should only be taken on medical prescription (never because they worked for someone else), and you should never recommend them to others.
• Do not increase the dose prescribed by your doctor, or extend the treatment beyond the recommended duration.
• In patients with a history of drug or alcohol abuse, there may be potential for misuse of the medicine.
• Consult your doctor regularly so they can decide whether treatment should continue.

Rebound insomnia and anxiety

When stopping treatment, the symptoms that led to taking the medicine may reappear, along with mood changes, anxiety, insomnia, restlessness, and others. Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

Abrupt discontinuation of lormetazepam should be avoided, and a gradual dose reduction process should be followed.

Psychiatric and paradoxical reactions

During treatment with benzodiazepines, including lormetazepam, pre-existing depression may reappear or worsen. In addition, suicidal tendencies in depressed patients may be unmasked, which should be closely monitored in such patients.

The medicine should be discontinued if these reactions occur.

Taking Lormetazepam Tecnigen with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

The simultaneous use of lormetazepam with opioids (analgesics, substitution therapy medicines, and some antitussives) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, combined administration should only be considered when no other alternative treatments are possible.

However, if your doctor prescribes lormetazepam together with opioids, the dosage and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all opioids you are taking, and carefully follow the dosage recommendations provided 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; therefore, alcohol consumption should be avoided.

Certain medicines may interact with lormetazepam and cause increased drowsiness. These are medicines known as central nervous system depressants, including those used to treat mental illnesses such as antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants; those used to relieve severe pain (narcotic analgesics); those used to treat seizures/epileptic attacks (antiepileptics); anaesthetics; barbiturates; and medicines used to treat allergies (sedating antihistamines).

Concomitant administration of lormetazepam with other medicines such as theophylline or aminophylline, beta-blockers, cardiac glycosides, oral contraceptives, and some antibiotics may alter the effect of lormetazepam, prolonging or reducing its activity. The effect of muscle relaxants may be enhanced.

Taking Lormetazepam Tecnigen with food, drink, and alcohol

Avoid alcohol consumption during treatment with lormetazepam, 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 lormetazepam, appears to be associated with a possible increased risk of congenital malformations during the first trimester of pregnancy. Passage of benzodiazepines and their metabolites across the placenta has been demonstrated.

If, due to strict medical necessity, the product is administered during late pregnancy or at high doses during labour, effects on the neonate such as hypoactivity, hypothermia, hypotonia (low muscle tone), apnoea (breathing difficulty), moderate respiratory depression, feeding difficulties, and impaired metabolic response to cold stress may be expected.

Infants born to mothers who have chronically taken benzodiazepines for several weeks during pregnancy or during the final stages of pregnancy may develop physical dependence and experience withdrawal syndrome in the postnatal period.

Breastfeeding

Lormetazepam should not be used during breastfeeding, as benzodiazepines, including lormetazepam, are excreted in breast milk. Cases of sedation and inability to suckle have been reported in neonates whose mothers were receiving benzodiazepine treatment. These newborns should be monitored for any of the pharmacological effects mentioned (including sedation and irritability).

Use in children and adolescents:

Benzodiazepines are not indicated in children or adolescents, except for premedication prior to diagnostic or surgical procedures (anaesthesiology, intensive care). In such 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 those who get up during the night.

Use in patients with respiratory insufficiency

Lormetazepam is contraindicated in patients with severe respiratory insufficiency.

Use in patients with hepatic insufficiency

Lormetazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy.

Grief or bereavement

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

Driving and using machines

Lormetazepam is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or if your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

Lormetazepam Tecnigen contains lactose

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

Lormetazepam Tecnigen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Lormetazepam Tecnigen

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with lormetazepam. Treatment duration should be as short as possible.

Treatment should be initiated at the lowest dose and the maximum dose must not be exceeded.

Adults:

The recommended dose is 1 mg of lormetazepam daily, taken 15 to 30 minutes before bedtime, administered orally.

The usual dose may be increased at the physician's discretion in cases of severe or persistent insomnia unresponsive to standard treatment, up to a maximum of 2 mg of lormetazepam.

Use in children and adolescents

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

Elderly patients, debilitated patients, or those with cerebrovascular disorders (e.g., arteriosclerosis), mild to moderate respiratory insufficiency, and/or renal and/or hepatic impairment:

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

For severe respiratory insufficiency, see section 2.

Do not stop treatment abruptly. Your doctor will advise you on the appropriate way to gradually reduce the dose, as symptoms that led to initiating the treatment may reappear upon discontinuation.

The tablet may be divided into equal doses.

If you take more Lormetazepam Tecnigen than you should

Symptoms of overdose with benzodiazepines are generally manifested by varying degrees of central nervous system depression, ranging from drowsiness to coma.

In moderate cases, symptoms include drowsiness, confusion, lethargy, and dysarthria (speech disorders). In more severe cases, ataxia (lack of coordination of voluntary muscle movements), paradoxical reactions, central nervous system depression, hypotonia, hypotension, respiratory depression (breathing difficulties), cardiac depression, coma, and death may occur.

Treatment of overdose: The clinical management of overdose with any drug should always consider the possibility that the patient may have ingested multiple substances.

Following a benzodiazepine overdose, vomiting should be induced (within one hour) if the patient is conscious. Inducing vomiting is not recommended if there is a risk of aspiration. If the patient is unconscious, gastric lavage should be performed with airway protection. If gastric emptying provides no benefit, activated charcoal should be administered to reduce absorption.

Particular attention should be paid to respiratory and cardiovascular functions. Hospital admission to an intensive care unit may be required for monitoring.

Use of antidote in overdose: In hospitalized patients, flumazenil (a benzodiazepine antagonist) may be used as an adjunctive treatment for overdose, but never as a substitute for the previously described measures. Special caution is required when administering flumazenil to patients on chronic benzodiazepine therapy or in cases of overdose involving cyclic antidepressants, as this combination may increase the risk of seizures.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Lormetazepam Tecnigen

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

If you stop taking Lormetazepam Tecnigen

Do not discontinue treatment with lormetazepam unless instructed by your doctor.

If you stop taking lormetazepam, especially abruptly, you may experience mood changes, anxiety, insomnia, restlessness, and other symptoms.

Your doctor will explain how to gradually reduce the dose until treatment is completed.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

According to frequency, they are defined as follows:

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

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

Anxiety, libido disorders, and bradifrenia. Dizziness, sedation, somnolence, attention disturbance, dysarthria (slurred speech), dysgeusia. Tachycardia. Vomiting, nausea, upper abdominal pain, constipation, dry mouth. Pruritus. Urinary disorders. Asthenia, hyperhidrosis, malaise.

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

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

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lormetazepam Tecnigen

Keep this medicine out of sight and reach of children.

Store below 30°C. Keep in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Lormetazepam Tecnigen 2 mg tablets

• The active substance is lormetazepam. Each tablet contains 2 mg of lormetazepam.

• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the container

Lormetazepam Tecnigen 2 mg is presented in boxes containing 20 tablets. The tablets are white, round, bevelled, engraved with a "2" on one side and scored on the other. The tablets may be divided into equal doses.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid) – Spain

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 – Alcorcón (Madrid)

Spain

Date of the most recent review of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.