LORMETAZEPAM CINFA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lormetazepam Cinfa 1 mg Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lormetazepam Cinfa and what is it used for
2. What you need to know before taking Lormetazepam Cinfa
3. How to take Lormetazepam Cinfa
4. Possible side effects
5. Storage of Lormetazepam Cinfa

Contents of the pack and additional information

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

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

Benzodiazepines are only indicated for the treatment of intense disorders that limit the patient's activity or subject them to significant stress.

2. What you need to know before taking Lormetazepam Cinfa

Do not take Lormetazepam Cinfa

• If you are allergic to lormetazepam, benzodiazepines, or any of the other components of this medication (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 Cinfa.

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 should inform your doctor.
• It is not recommended for use in children or adolescents.

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 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 medication, 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 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 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 administration is stopped, the symptoms that led to taking the medication may reappear, as well as mood changes, anxiety, insomnia, and 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 lormetazepam, pre-existing depressions may reappear or worsen. Additionally, they may unmask suicidal tendencies in depressive patients, which should be monitored in these patients.

The medication should be discontinued if these reactions appear.

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, as they are more susceptible to the effects of the medication. Carefully follow your doctor's instructions.

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 Hepatic Failure

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

Grief or Loss

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

Taking Lormetazepam Cinfa with Other Medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

The simultaneous use of lormetazepam with opioids (analgesics, substitution therapy medications, and some cough medicines) increases the risk of drowsiness, respiratory difficulty (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 about 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 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, making you feel more drowsy than necessary. These include central nervous system depressants, such as antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants; pain relievers (narcotic analgesics); medications for the treatment of convulsions/epileptic seizures (antiepileptics); anesthetic medications; barbituric medications; and medications used for the treatment of 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 enhanced.

Taking Lormetazepam Cinfa with Food, Drinks, and Alcohol

Avoid alcohol consumption during treatment with lormetazepam, as it increases the sedative effect of this medication.

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 medication.

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 crossing the placenta.

If, due to strict medical necessity, the medication is administered during late pregnancy or at high doses during labor, it is predictable that effects on the newborn, such as hypoactivity, hypothermia, hypotonia (low muscle tone), apnea (respiratory difficulty), 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).

Driving and Using Machines

Lormetazepam is a medication 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 Cinfa contains Lactose

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

Lormetazepam Cinfa contains Sodium

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

3. How to Take Lormetazepam Cinfa

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

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

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

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 Adolescents

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

Elderly, Debilitated Patients, or those with Cerebrovascular Disorders (Arteriosclerosis), Mild or Moderate Respiratory Failure, and/or Renal and/or Hepatic Insufficiency

The dose should be reduced to 0.5 mg of lormetazepam per day. The tablet can be divided into equal doses.

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 stopping administration may cause the symptoms that led to taking the medication to reappear.

If you take more Lormetazepam Cinfa 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 dysarthria (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. Inducing 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 take benzodiazepines chronically 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 Lormetazepam Cinfa

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

If you interrupt treatment with Lormetazepam Cinfa

Do not interrupt 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 may appear, among others.

Your doctor will explain how to gradually reduce the dose until the end of your treatment.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

According to frequency, they are defined as:

Very Common(may affect more than 1 in 10 patients):

Headache.

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

Anxiety, changes in libido, and bradypnea. Dizziness, sedation, drowsiness, attention disorders, amnesia, dysarthria (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 1,000 patients):

No data available.

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

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 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, 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lormetazepam Cinfa

Keep this medication out of sight and reach of children.

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

Do not store above 30°C.

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

6. Packaging Content and Additional Information

Composition of Lormetazepam Cinfa

• The active ingredient is lormetazepam. Each tablet contains 1 mg of lormetazepam.
• The other components are: microcrystalline cellulose (E-460), lactose monohydrate, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate, magnesium carbonate (E-504), and pregelatinized corn starch.

Product Appearance and Packaging Content

Lormetazepam Cinfa 1 mg is presented in the form of white, cylindrical, biconvex tablets, scored on one side and marked with the code "Z1" on the other side.

It is presented in PVC-PVDC/Aluminum blisters. Each package contains 30 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:July 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68371/P_68371.html

QR code at: https://cima.aemps.es/cima/dochtml/p/68371/P_68371.html