LORMETAZEPAM ALTER 2 mg TABLETS

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 post-operative 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 taking 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 the 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 marked anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In severe cases, even depersonalization, derealization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic seizures. Follow your doctor's instructions for administration of Lormetazepam Alter exactly 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 start 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 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 can sleep uninterrupted for 7-8 hours (see section 4).

Psychiatric and Paradoxical Reactions

• Lormetazepam Alter may produce restlessness, agitation, irritability, aggression, delirium, rage, 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 discontinue your treatment with Lormetazepam Alter if these reactions appear.
• Inform 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 since 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

Inform 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.

Inform 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 can 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 necessity, the medicine is administered during the third trimester of pregnancy or during childbirth, it is foreseeable that effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression and difficulties during breastfeeding may appear.

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 produces sleep, 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 (1 mmol) 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 can 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 post-operative periods

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

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

It is generally recommended to administer a dose of 1 mg of lormetazepam per day. One hour before the operation, it is recommended to administer half of these doses.

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.

If You Take More Lormetazepam Alter Than You Should

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.

If You Forget to Take Lormetazepam Alter

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

If You Stop Taking Lormetazepam Alter

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 due to excessive sedation and muscle relaxation may appear.

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, 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.
• Dizziness, sedation, drowsiness, attention disorder, amnesia, visual disturbance, speech disorder, dysgeusia, mental slowing.
• Tachycardia.
• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
• Pruritus.
• Urination disorder.
• Asthenia, 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, hallucinations, dependence, depression (masking a pre-existing depression), delirium, withdrawal syndrome, agitation, aggression, irritability, restlessness, rage, nightmares, abnormal and inadequate behavior, emotional changes.
• Confusion, decreased level of consciousness, ataxia, muscle weakness.
• Urticaria, exanthema.
• 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 withdrawing the medicine (see section "Warnings and Precautions").

• Psychiatric and paradoxical reactions: When using Lormetazepam Alter, reactions such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, abnormal and inadequate behavior, and other changes in behavior 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 produce anterograde amnesia (difficulty remembering recent events). (See section "Warnings and Precautions").

Reporting of Adverse Reactions

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 leaflet. 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 medicine.

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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lormetazepam Alter

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

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

Appearance of the Product and Package 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 PVC/PVDC-aluminum blisters, in packages 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

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