Leaflet: information for the user

Lormetazepam Alter 2 mg tablets EFG

Read this 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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

It is indicated for:

• Treatment of short-term insomnia.
• Induction of sleep in pre and postoperative periods.

Lormetazepam Alter belongs to a group of hypnotic medications called benzodiazepines. Benzodiazepines are only indicated for the treatment of an intense disorder, which limits the patient's activity or subjects them to an important stress situation.

Do not take Lormetazepam Alter:

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

Warnings and precautions:

• If you have chronic respiratory insufficiency, as you should receive a lower dose than usual.
• If you have liver insufficiency.
• If you have severe renal insufficiency.
• Lormetazepam Alter should not be used as a first-line treatment for psychiatric disease or as a single 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 medication.

Tolerance

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

Dependence

• Lormetazepam Alter may induce the appearance of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also higher in patients with a history of substance abuse or alcohol consumption. Abrupt termination of treatment may be accompanied by withdrawal symptoms, such as severe anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In more severe cases, derealization, depersonalization, hallucinations, paresthesia in the extremities, intolerance to light, sound, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for Lormetazepam Alter indicated by your doctor to avoid these symptoms as much as possible.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of symptoms that led to the initiation of treatment). The probability of appearance of a withdrawal/rebound phenomenon is higher after abrupt termination of treatment, so it is recommended to gradually reduce the dose until its definitive suppression.

Follow exactly the recommendations for use and administration instructions for Lormetazepam Alter indicated by your doctor to avoid these symptoms as much as possible.

Amnesia

• Lormetazepam Alter may induce anterograde amnesia, that is, difficulty remembering recent events; this occurs more frequently in the first hours after taking the medication, so to reduce this risk, you should ensure that you can sleep without interruption for 7-8 hours (see section 4).

Psychiatric and paradoxical reactions

• Lormetazepam Alter may produce restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, abnormal and inappropriate 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 suspend your treatment with Lormetazepam Alter if these reactions appear.
• Inform your doctor if you have depression. Lormetazepam Alter should not be used as a single treatment for sleep disorders associated with depression.
• Lormetazepam Alter should not be used as a first-line treatment for psychiatric disease (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 it by your doctor. In addition, the duration of treatment should be the minimum possible (see section 3).

Use in elderly people

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

Use of Lormetazepam Alter with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those acquired without a prescription.

A potentiation of the effect of Lormetazepam Alter may occur when administered concomitantly with the following medications:

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

Interactions have also been reported with some medications used to treat hypertension (beta-blockers) and with central nervous system stimulants (methylxanthines).

The concomitant use of lormetazepam and opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may 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 should limit the dose and duration of concomitant treatment.

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

Consult your doctor if you are taking other medications.

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 substance abuse or alcohol consumption. The sedative effect may be potentiated when this medication is administered in combination with alcohol, so it is recommended to avoid the consumption of alcoholic beverages. This should be taken into account especially since it affects the ability to drive or operate machinery (see section “Driving and operating machinery”).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

If, by strict medical necessity, the medication is administered during the third trimester of pregnancy or during delivery, it is predictable that there may be effects on the newborn 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, which may trigger a withdrawal syndrome in the postnatal period.

Lactation

Due to the fact that benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Driving and operating machinery

Lormetazepam Alter is a medication that induces sleep, so it significantly affects the ability to drive or operate machinery. 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 Altercontains lactose and sodium.

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

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

Follow exactly the administration instructions for Lormetazepam Alter indicated by your doctor. Consult your doctor or pharmacist if you have doubts. Remember to take your medication.

Short-term treatment of insomnia

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

The tablets should be taken with a little liquid a short time before going to bed.

Adults

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

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

Older adults

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

In older adults, 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 estimate that 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

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

Children

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

Older adults and patients at risk

Generally, a dose of 1 mg of lormetazepam per day is recommended. An hour before surgery, half of these doses are recommended.

A dose reduction should be considered in patients with mild or moderate respiratory difficulties or in patients with liver insufficiency.

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.

If you take more Lormetazepam Alter than you should

Overdose does not represent a vital threat unless its administration is combined with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient has ingested multiple products.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, ataxia (coordination disorder), visual disturbances, hypotonia (muscle tone decrease), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death may appear.

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 Alter

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lormetazepam Alter

Your doctor will indicate the duration of treatment with Lormetazepam Alter. Do not suspend treatment prematurely, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 beginning of treatment, daytime drowsiness, emotional alteration, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (alteration of movement coordination) or double vision may appear. All these side effects predominantly appear 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 or attempted suicide, usually associated with the masking of 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)

Common side effects

(may affect up to 1 in 10 patients)

Side effects of unknown frequency

(cannot be estimated from available data)

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

Dependence:

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

Mental disorders:

Insomnia rebound may appear when the medication is withdrawn (see "Warnings and precautions" section).

• Psychiatric and paradoxical reactions: When using Lormetazepam Alter, reactions such as restlessness, agitation, irritability, aggression, delirium (false ideas that are believed to be true and cannot be proven), anger attacks, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), abnormal and inappropriate behavior, and other conduct alterations may appear.

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

Nervous system disorders

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the reach and sight of children.

Lormetazepam Alter does not require special conditions for conservation.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Lormetazepam Alter Composition

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

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

Product appearance and packaging contents

Lormetazepam Alter 2 mg tablets: round, white, scored on both sides, approximately 7 mm in diameter. The tablet can be divided into equal doses. It is presented in a PVC/PVDC – aluminum blister, in packs of 20 tablets.

Other presentations:

Lormetazepam Alter 1 mg tablets EFG, 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 leaflet was approved in October 2024

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