LORMETAZEPAM ALTER 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lormetazepam Alter 1 mg tablets EFG

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

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

Contents of the Package Leaflet

1. What is Lormetazepam Alter and what is it used for
2. What you need to know before you take Lormetazepam Alter
3. How to take Lormetazepam Alter
4. Possible side effects
5. Storing Lormetazepam Alter
6. Contents of the pack and other information

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

Lormetazepam Alter is a medicine from the group of hypnotics that promotes sleep: it normalizes the time needed to fall asleep and its total duration, while reducing the number of interruptions.

It is indicated for:

• Short-term treatment of insomnia.
• Induction of sleep in pre and postoperative periods.

Lormetazepam Alter belongs to a group of hypnotic medicines called benzodiazepines. 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 you take Lormetazepam Alter

Do not take Lormetazepam Alter:

• If you are allergic (hypersensitive) to lormetazepam, benzodiazepines, or any of the other components of this medicine (listed in section 6).
• If you have myasthenia gravis (a disease characterized by an abnormal degree of muscle weakness).
• If you have severe respiratory failure.
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• In case of acute intoxication with alcohol, hypnotics, analgesics, or medicines that act on the central nervous system (neuroleptics, antidepressants, lithium).

Warnings and Precautions:

• If you have chronic respiratory failure, you should receive a lower dose than usual.
• If you have liver failure.
• If you have severe kidney failure.
• Lormetazepam Alter should not be used as a first-line treatment for psychotic illness or as sole treatment for anxiety or sleep disorders associated with depression.
• Lormetazepam Alter should be administered with caution to patients with medullary or cerebellar ataxia.

Consult your doctor or pharmacist before starting to take this medicine.

Tolerance

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

Dependence

• Lormetazepam Alter may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also greater in patients with a history of drug or alcohol abuse. Abrupt termination of treatment may be accompanied by withdrawal symptoms, such as pronounced anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In the most severe cases, even derealization, depersonalization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic convulsions. Follow your doctor's instructions for administration of Lormetazepam Alter exactly, in order to avoid these symptoms as much as possible.

Rebound Insomnia and Anxiety

• You may experience a rebound episode (transient reappearance of symptoms that determined the initiation of treatment). The likelihood of a withdrawal/rebound phenomenon is greater after abruptly stopping treatment, so it is recommended to gradually decrease the dose until its definitive suppression.

Follow your doctor's recommendations for use and administration instructions of Lormetazepam Alter exactly, in order to avoid these symptoms as much as possible.

Amnesia

• Lormetazepam Alter may induce anterograde amnesia, i.e., difficulty remembering recent events; this occurs more frequently in the first hours after taking the medicine, so to reduce this risk, you should ensure that you will be able to sleep uninterrupted for 7-8 hours (see section 4).

Psychiatric and Paradoxical Reactions

• Lormetazepam Alter may produce restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, abnormal and inadequate behavior, and other adverse effects on behavior. These reactions occur more frequently in children, the elderly, and patients with organic brain syndrome (physical disorders that produce a decrease in mental functions). Your doctor will discontinue your treatment with Lormetazepam Alter if these reactions appear.
• Tell your doctor if you have depression. Lormetazepam Alter should not be used as the sole treatment for sleep disorders associated with depression.
• Lormetazepam Alter should not be used as a first-line treatment for psychotic illness (see section 4).

Children and Adolescents

Lormetazepam Alter should not be administered to patients under 18 years of age for the treatment of insomnia without a careful evaluation of the need for treatment by the doctor. Additionally, the duration of treatment should be as short as possible (see section 3).

Use in Elderly Patients

Elderly patients should receive a lower dose than usual, as they are more susceptible to the effects of the medicine. Your doctor will recommend the most suitable dosage (see section 3).

Use of Lormetazepam Alter with Other Medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

The effect of Lormetazepam Alter may be enhanced when administered concomitantly with the following medicines:

• Medicines used in the treatment of psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medicines used to relieve severe pain (narcotic analgesics). With these medicines, an increase in the sensation of euphoria may also occur, which can increase psychological dependence.
• Medicines used in the treatment of epilepsy (antiepileptics).
• Anesthetics.
• Medicines used in the treatment of allergic symptoms (sedating antihistamines).
• Medicines used in the treatment of cardiovascular diseases (calcium antagonists, cardiac glycosides).
• Medicines used in the treatment of hypertension (beta-blockers).
• Oral contraceptives.
• Certain antibiotics (such as rifampicin).

Interactions have also been reported with some medicines used in the treatment of arterial hypertension (beta-blockers) and with central nervous system stimulants (methylxanthines).

The concomitant use of lormetazepam and opioids (potent analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes lormetazepam along with opioids, your doctor must limit the dose and duration of concomitant treatment.

Tell your doctor about all opioid medicines you are taking and follow your doctor's recommendation regarding the dose strictly. It may be useful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

If you are taking other medicines, consult your doctor.

Taking Lormetazepam Alter with Food, Drinks, and Alcohol

During treatment with Lormetazepam Alter, avoid alcoholic beverages.

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be enhanced when this medicine is administered in combination with alcohol, so it is recommended to avoid consuming alcoholic beverages. This should be taken into account especially since it affects the ability to drive or operate machinery (see section "Driving and Using Machines").

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

If, for strict medical reasons, the medicine is administered during the third trimester of pregnancy or during childbirth, it is foreseeable that effects on the newborn may appear, such as hypothermia, hypotonia, and moderate respiratory depression, and difficulties during breastfeeding.

Children born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence, and a withdrawal syndrome may be triggered in the postnatal period.

Breastfeeding

Since benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Driving and Using Machines

Lormetazepam Alter is a medicine that causes drowsiness, so it significantly affects the ability to drive or operate machinery. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction are reduced. Pay special attention at the start of treatment or if the dose is increased.

Lormetazepam Altercontains lactose and sodium.

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

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

3. How to Take Lormetazepam Alter

Follow your doctor's instructions for administration of Lormetazepam Alter exactly. Consult your doctor or pharmacist if you have doubts. Remember to take your medicine.

Short-term treatment of insomnia

The duration of treatment should be as short as possible. In general, it varies between a few days and two weeks, with a maximum period, including the gradual reduction of the dose, of four weeks.

The tablets should be taken with a little liquid shortly before bedtime.

Adults

It is recommended to administer 1 mg of lormetazepam (one tablet of Lormetazepam Alter 1 mg or ½ tablet of the alternative presentation Lormetazepam Alter 2 mg) in a single dose.

In cases of severe or persistent insomnia and always according to strict medical criteria, the dose may be increased to 2 mg of lormetazepam (two tablets of Lormetazepam Alter 1 mg or one tablet of Lormetazepam Alter 2 mg).

Elderly Patients

It is recommended to administer ½ tablet of Lormetazepam Alter 1 mg per day (0.5 mg of lormetazepam) as a single dose.

In elderly patients, benzodiazepines may be associated with a higher risk of falls due to muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will indicate the dose that best suits your condition.

If you think the action of Lormetazepam Alter is too strong or too weak, consult your doctor or pharmacist.

Induction of sleep in pre and postoperative periods

The doses will depend on the patient's age, weight, and general condition.

Adults

It is recommended to administer a medium dose of 2 mg of lormetazepam per day. The dose range is 0.5 to 3 mg of lormetazepam per day.

Children

A dose of 0.5 mg to 1 mg of lormetazepam per day is recommended.

Elderly Patients and Patients at Risk

A dose of 1 mg of lormetazepam per day is generally recommended. One hour before the operation, half of these doses is recommended.

A reduction in dose should be considered in patients with mild or moderate breathing difficulties or in patients with liver failure.

Children and Adolescents

Lormetazepam Alter should not be used in children and adolescents under 18 years of age without a careful evaluation of the need for treatment.

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Overdose is not life-threatening unless it is combined with other central nervous system depressants (including alcohol). In case of overdose, it should be taken into account that the patient may have ingested multiple products.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, which can range from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, ataxia, vision disorders, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death.

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 medicine and the amount ingested.

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

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Your doctor will indicate the duration of treatment with Lormetazepam Alter. Do not stop treatment before, as the desired effect may not be achieved.

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

4. Possible Side Effects

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

If the dosage is not adapted to the individual conditions of each patient, side effects may appear due to excessive sedation and muscle relaxation.

At the start of treatment, drowsiness, emotional changes, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision may appear. All these effects appear predominantly at the beginning of treatment and usually disappear with repeated administration.

The most serious adverse reactions observed in patients treated with Lormetazepam Alter are angioedema (swelling), completed suicide or attempted suicide, usually associated with masking a pre-existing depression.

The most frequently observed adverse reactions in patients treated with Lormetazepam Alter are headache, sedation, and anxiety.

Very Common Side Effects

(may affect more than 1 in 10 patients)

• Headache

Common Side Effects

(may affect up to 1 in 10 patients)

• Angioedema (swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing).
• Anxiety, decreased libido (sexual desire).
• Dizziness, sedation, drowsiness (lethargy), attention disorder, amnesia, visual disorder, speech disorder, dysgeusia, mental slowing.
• Tachycardia (accelerated heart rate).
• Vomiting, nausea, pain in the upper abdomen, constipation, dry mouth.
• Pruritus (itching).
• Urination disorder.
• Asthenia (lack of strength), excessive sweating.

Side Effects of Unknown Frequency

(cannot be estimated from the available data)

• Suicide attempt or completed suicide (masking a pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false perceptions of the senses), dependence, depression (masking a pre-existing depression), delirium (false ideas that are believed to be true and cannot be proven), withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, fits of rage, nightmares, abnormal and inadequate behavior, and other effects on behavior.
• Confusion, decreased level of consciousness, ataxia (coordination disorder), muscle weakness.
• Urticaria, exanthema (rash).
• Fatigue.
• Falls.

For more information on the following points, see section "Warnings and Precautions".

Dependence:

The administration of Lormetazepam Alter and other benzodiazepines may induce the development of physical and psychological dependence (see section "Warnings and Precautions").

Psychiatric Disorders:

Rebound insomnia may appear when the medicine is withdrawn (see section "Warnings and Precautions").

• Psychiatric and paradoxical reactions: When using Lormetazepam Alter, reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, abnormal and inadequate behavior, and other effects on behavior may appear.

• Depression: The use of benzodiazepines may mask a pre-existing depression. In these patients, suicide may be triggered. Lormetazepam Alter should be used with caution in patients with depression.

Nervous System Disorders

• Amnesia: Lormetazepam Alter may produce anterograde amnesia (difficulty remembering recent events). (See section "Warnings and Precautions").

Adverse Reaction Reporting

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

5. Storage of Lormetazepam Alter

Keep out of the reach and sight of children.

Lormetazepam Alter does not require special storage conditions.

Do not use Lormetazepam Alter after the expiration date shown on the packaging after CAD. The expiration date is the last day of the indicated month.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lormetazepam Alter

The active ingredient is lormetazepam. Each tablet contains 1 mg of lormetazepam.

The other components are lactose monohydrate, sodium croscarmellose, magnesium stearate, cornstarch, and povidone.

Appearance of the Product and Package Contents

Lormetazepam Alter 1 mg tablets: round, white, scored on one side, approximately 7 mm in diameter. The tablet can be divided into equal doses. It is presented in PVC/PVDC-aluminum blisters, in packages of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

KERN PHARMA, S.L.

Venus 72

Polígono Ind. Colón II

08228 Terrassa - (Barcelona).

Spain

This prospectus was approved in October 2024

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