LORMETAZEPAM TECNIGEN 1 mg TABLETS

2. What you need to know before you take 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 tired muscles).
• If you have severe respiratory failure
• If you suffer from sleep apnea syndrome.
• If you have a history of dependence on alcohol or drugs

In case of acute intoxication with alcohol, sleeping pills, pain relievers, or psychotropic medications (neuroleptics, antidepressants, lithium salts).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lormetazepam:

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

• 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 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.
• It is not recommended for use in children or 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 continued use for several weeks, a certain degree of loss of efficacy with respect to the hypnotic effects may be detected.

Amnesia

Benzodiazepines, including lormetazepam, may induce amnesia (memory alteration). This fact occurs more frequently after several hours of administering the medicine, so to minimize 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 into account:

• The intake of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and never advise other people.
• Do not increase the prescribed doses by the 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.
• Regularly consult your doctor to decide if treatment should continue.

Rebound insomnia and anxiety

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

Lormetazepam should not be stopped abruptly and a gradual dose reduction process should be followed.

Psychiatric and paradoxical reactions

In treatment with benzodiazepines, including lormetazepam, 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 Lormetazepam Tecnigen 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 lormetazepam with opioids (analgesics, 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, concomitant administration should only be considered when no alternative treatments are possible.

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

Please inform your doctor of all opioids you are taking and carefully follow 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 indicated 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 lormetazepam 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 seizures/epileptic attacks (antiepileptics); anesthetic medications; barbituric medications; and medications used to treat allergies (sedating antihistamines).

The concomitant administration of lormetazepam with other medications such as theophylline or aminophylline, beta-blockers, cardiac glycosides, oral contraceptives, and some antibiotics may alter the effect of lormetazepam by prolonging or decreasing 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 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, due to strict medical necessity, the product is administered during a late stage of pregnancy or at high doses during labor, 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

Lormetazepam should not be used during breastfeeding, as benzodiazepines, including lormetazepam, 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 or 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 since 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.

Loss or grief

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

Driving and using machines

Lormetazepam is a medicine that causes sleepiness. 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.

Lormetazepam Tecnigen contains lactose

If your doctor has told 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; this is essentially "sodium-free".

3. How to take Lormetazepam Tecnigen

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

Your doctor will indicate the duration of your treatment with lormetazepam. 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 tablet (1 mg of lormetazepam) daily, 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 2 tablets daily, which means a maximum of 2 mg of lormetazepam.

Use in children and adolescentss

Lormetazepam 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 decrease the dose, as stopping administration may cause the symptoms that led to taking the medication to reappear.

The tablet can be divided into equal doses.

If you take more Lormetazepam Tecnigen than you should

The symptoms of overdose with benzodiazepines are generally manifested by different degrees of central nervous system depression, which can range from drowsiness to coma.

In moderate cases, symptoms include drowsiness, confusion, lethargy, and disarthria (speech disorders). In more serious 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 with preservation of 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 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, caution should be exercised 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 Lormetazepam Tecnigen

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

If you stop taking Lormetazepam Tecnigen

Do not stop treatment with lormetazepam until your doctor tells you to.

If you stop taking lormetazepam, especially if it is sudden, mood changes, anxiety, insomnia, and restlessness, among others, may appear.

Your doctor will explain how to gradually decrease the dose until the end of 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.

Very 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 (decreased 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 the available data):

Angioedema. Completed suicide, attempted suicide (due to the 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, even if it is possible side effects not listed in this leaflet. You can also report them 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. Storage of Lormetazepam Tecnigen

Keep this medicine out of the sight and reach of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Lormetazepam Tecnigen 1 mg tablets

• The active ingredient is lormetazepam. Each tablet contains 1 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 packaging content

Lormetazepam Tecnigen 1 mg is presented in boxes containing 30 tablets. The tablets are white, round, beveled, engraved with a "1" on one of their faces and scored on the other. The tablets can 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 last revision of this leaflet: May 2023

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/.