Package Insert: Information for the User

Lormetazepam Tecnigen 2 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. Possible Adverse Effects
2. Storage of Lormetazepam Tecnigen
3. Contents of the Package and Additional Information

LormetazepamTecnigencontains 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.

Do not take Lormetazepam Tecnigen

• If you are allergic to the active ingredient, to benzodiazepines, or to any of the other components of this medication (listed in section 6).

• If you have myasthenia gravis (very weak or tired muscles).
• If you have severe respiratory insufficiency.
• If you have sleep apnea syndrome.
• If you have a history of alcohol or drug dependence.

In case of acute intoxication with alcohol, sleeping medications, 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 angle-closure glaucoma.
• If your doctor has prescribed long-term treatment, it is advisable to have blood tests performed periodically and liver function tests.
• If you become pregnant during treatment, inform your doctor.
• Do not recommend its use in children or adolescents.
• If you are being treated with opioids, it may cause difficulty breathing, sedation, coma, and even death.

Be aware that you may experience the following reactions:

Tolerance

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

Amnesia

Benzodiazepines, including lormetazepam, may induce amnesia (memory alteration). This occurs more frequently after several hours of administration of the medication, so patients should ensure that they sleep uninterrupted for 7-8 hours after taking the tablet.

Dependence and abuse

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

To prevent this risk to the maximum, follow these precautions:

• Take benzodiazepines only under medical prescription (never because they have worked in other patients) and never advise others.
• Do not increase, at all, the prescribed doses, or prolong the treatment 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 to decide if treatment should continue.

Rebound insomnia and anxiety

After stopping administration, the symptoms that led to taking the medication may reappear, as well as mood changes, anxiety, insomnia, restlessness, and others. Your doctor will inform you precisely how togradually reduce the dose.

Avoid abrupt discontinuation of lormetazepam and follow a gradual reduction of the dose.

Psychiatric and paradoxical reactions

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

The medication should be discontinued if these reactions appear.

Use of Lormetazepam Tecnigen with other medications

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

The simultaneous use of lormetazepam with opioids (analgesics, medication for substitution therapy, and some antitussives) increases the risk of somnolence, respiratory depression, coma, and may put your life in danger. Therefore, concomitant administration should only be considered when other alternative treatments are not possible.

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

Please inform your doctor about all the opioids you are taking, and follow carefully the dosage recommendations given 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 medication, so it is recommended to avoid alcohol consumption.

Certain medications may interact with lormetazepam and make you feel more drowsy than usual. These are the 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, barbiturates, 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, prolonging or reducing its activity. The effect of muscle relaxants may be potentiated.

Taking Lormetazepam Tecnigen with food, drink, and alcohol

Avoid consuming alcohol during treatment with lormetazepamas it increases the sedative effect of this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of benzodiazepines, including lormetazepam, appears to be related to a possible increase in the 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 reasons, the product is administered during a late stage of pregnancy, or at high doses during delivery, it is predictable that they may appear effects on the newborn such as hyporeactivity, hypothermia, hypotonia (low muscle tone), apnea (respiratory difficulty), moderate respiratory depression, feeding problems, and metabolic imbalance in response to cold stress.

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

Lactation

Lormetazepam should not be used during lactation, as benzodiazepines, including lormetazepam, are excreted in breast milk. Cases of sedation and inability to breastfeed have been detected in neonates 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 patients and debilitated patients should receive a lower dose, as they are more susceptible to the effects of the medication. Follow your doctor's instructions carefully.

Due to the muscle relaxation effect, there is a risk of falls and subsequent fractures in elderly patients, especially in patients who get up at night.

Use in patients with respiratory insufficiency

Lormetazepam is contraindicated in patients with severe respiratory insufficiency.

Use in patients with liver insufficiency

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

Loss or bereavement

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

Driving and operating machinery

Lormetazepam is a medication that causes sleepiness. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Lormetazepam Tecnigen contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Lormetazepam Tecnigen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

Your doctor will inform you of the duration of your treatment with lormetazepam. The treatment duration should be as short as possible.

The treatment should start with the lowest doses and should not exceed the maximum dose.

Adults:

The recommended dose is 1 mg of lormetazepam per day, 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.

Use in children and adolescentss

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

Older adults, debilitated patients or with cerebral vascular alterations (arteriosclerosis), mild or moderate respiratory insufficiency and/or renal and/or hepatic insufficiency.

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 inform you of the precise way to gradually reduce 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

Symptoms of overdosewith benzodiazepines generally manifest by different degrees of central nervous system depression, ranging from drowsiness to coma.

In moderate cases, symptoms include drowsiness, confusion, lethargy, and dysarthria (language disorders). In more serious cases, ataxia (involuntary movement coordination disorders), 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 any medication overdose should always take into account the possibility that the patient has ingested multiple products.

After a benzodiazepine overdose, inducing vomiting (before one hour) is recommended if the patient remains conscious. Vomiting should not be induced if there is a risk of aspiration. If the patient is unconscious, gastric lavage with airway conservation should be performed. If gastric lavage does not provide any benefit, 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 (benzodiazepine antagonist) may be used as an adjunctive treatment for overdose, but never as a substitute for the method described above. In patients taking benzodiazepines chronically or in cases of overdose with cyclic antidepressants, special care should be taken when administering flumazenil, as this combination of medications may increase the risk of seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 compensate for the missed doses.

If you stop treatment with Lormetazepam Tecnigen

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

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

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

According to frequencies, they are defined as:

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

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

Anxiety, libido alterations, and bradypsychia. Dizziness, sedation, somnolence, attention alteration, amnesia, dysarthria (slurred speech), dysgeusia. Tachycardia. Vomiting, nausea, upper abdominal pain, constipation, dry mouth. Pruritus. Urination alterations. Asthenia, hyperhidrosis, discomfort.

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 insufficiency, apnea, worsening of sleep apnea, worsening of chronic obstructive pulmonary disease (COPD). Elevated liver transaminases and elevated alkaline phosphatase in blood. Allergic dermatitis.

Unknown Frequency (cannot be estimated from 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, withdrawal/rebound insomnia syndrome, agitation, aggression, irritability, restlessness, anger, nightmares, confusion state, delirium, abnormal behavior, emotional disorder, psychomotor delay. Low level of consciousness, ataxia, convulsion, tremor, extrapyramidal alterations. 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 subsequent fractures in elderly people.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

any unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lormetazepam Tecnigen 2 mg tablets

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

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

Appearance of the product and contents of the packaging

Lormetazepam Tecnigen 2 mg is presented in boxes containing 20 tablets. The tablets are white, round, bisected, engraved with a “2” on one face and scored on the other. The tablets can be divided into equal doses.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid) – Spain

Responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 – Alcorcón (Madrid)

Spain

Last review date of this leaflet: May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.