Lormetazepam Alter 1 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lormetazepam Alter 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Package leaflet:

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

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

Lormetazepam Alter is a hypnotic medicine that promotes sleep: it normalizes the time required to fall asleep and the total duration of sleep, while reducing the number of sleep interruptions.

It is indicated for:

• Short-term treatment of insomnia.
• Sleep induction in pre- and postoperative periods.

Lormetazepam Alter belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's functioning or cause considerable stress.

2. What you need to know before starting Lormetazepam Alter

Do not take Lormetazepam Alter:

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

Warnings and precautions:

• If you have chronic respiratory insufficiency, as you should receive a lower than usual dose.
• If you have hepatic insufficiency.
• If you have severe renal insufficiency.
• Lormetazepam Alter must not be used as first-line treatment for psychotic illness, nor as sole treatment for anxiety or sleep disorders associated with depression.
• Lormetazepam Alter should be administered with caution in patients with medullary or cerebellar ataxia.

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

Tolerance

• After continuous use for several weeks, a certain degree of reduced efficacy regarding hypnotic effects may be observed.

Dependence

• Lormetazepam Alter may lead to the development of physical and psychological dependence. The risk of dependence increases with dose and duration of treatment, and is also higher in patients with a history of drug or alcohol abuse. Abrupt discontinuation of treatment may be accompanied by withdrawal symptoms such as marked anxiety, tension, restlessness, confusion, irritability, headache, and muscle pain. In more severe cases, derealization, depersonalization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for Lormetazepam Alter provided by your doctor in order to minimize the possible occurrence of these symptoms.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient recurrence of symptoms that led to initiating treatment). The likelihood of withdrawal/rebound phenomena is higher following abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until treatment is definitively stopped.

Follow exactly the usage recommendations and administration instructions for Lormetazepam Alter provided by your doctor in order to minimize the possible occurrence of these symptoms.

Amnesia

• Lormetazepam Alter may cause anterograde amnesia, that is, difficulty in remembering recent events; this occurs most frequently within the first few hours after taking the medicine. 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 cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, abnormal and inappropriate behavior, and other adverse behavioral effects. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders causing a decline in mental functions). Your doctor will discontinue your treatment with Lormetazepam Alter if such reactions occur.
• Inform your doctor if you suffer from depression. Lormetazepam Alter must not be used as the sole treatment for sleep disturbances associated with depression.
• Lormetazepam Alter must not be used as first-line treatment for psychotic illness (see section 4).

Children and adolescents

Lormetazepam Alter must not be administered to patients under 18 years of age for the treatment of insomnia without careful physician assessment of the necessity for treatment. In addition, treatment duration should be as short as possible (see section 3).

Use in elderly patients

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

Use of Lormetazepam Alter with other medicines

Inform your doctor or pharmacist if you are using or have recently used any 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 increased feeling of euphoria may also occur, which could increase the risk of psychological dependence.
• Medicines used in the treatment of epilepsy (antiepileptics).
• Anaesthetics.
• Medicines used to treat allergic symptoms (sedating antihistamines).
• Medicines used to treat cardiovascular diseases (calcium antagonists, cardiac glycosides).
• Medicines used to treat hypertension (beta-blockers).
• Oral contraceptives.
• Certain antibiotics (such as rifampicin).

Interactions have also been reported with some medicines used to treat high blood pressure (beta-blockers) and with central nervous system stimulants (methylxanthines).

Concomitant use of lormetazepam and opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are available.

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

Inform your doctor about all opioid medicines you are taking and strictly follow your doctor's advice regarding dosage. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience any of 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 must 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 taken together with alcohol; therefore, consumption of alcoholic drinks is not recommended. This is particularly important as it affects the ability to drive or operate machinery (see section “Driving and use of 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 are planning 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 delivery, effects on the newborn such as hypothermia, hypotonia, moderate respiratory depression, and difficulties at the time of breastfeeding may be expected.

Infants born to mothers who have chronically taken benzodiazepines during the last trimester of pregnancy may develop physical dependence, which could lead to a postnatal withdrawal syndrome.

Breastfeeding

Because benzodiazepines pass into breast milk, their use is contraindicated in nursing mothers.

Driving and use of machines

Lormetazepam Alter is a medicine that causes drowsiness and therefore significantly impairs the ability to drive or operate machinery. Do not drive or operate machinery if you feel sleepy or if your attention and reaction capacity are reduced. Pay particular attention at the beginning of treatment or when the dose is increased.

Lormetazepam Alter contains lactose and sodium.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Lormetazepam Alter

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

Short-term treatment of insomnia

The duration of treatment should be as short as possible. Generally, it ranges from a few days to two weeks, with a maximum period— including gradual dose reduction—of four weeks.

The tablets should be taken with some liquid shortly before going to bed.

Adults

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

In cases of severe or persistent insomnia, and always according to strict medical judgment, 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

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

In elderly individuals, benzodiazepines may be associated with an increased risk of falls due to possible muscle weakness, dizziness, somnolence, and fatigue. Therefore, your doctor will determine the dose best suited to your condition.

If you feel that the effect of Lormetazepam Alter is too strong or too weak, consult your doctor or pharmacist.

Induction of sleep in pre- and postoperative periods

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

Adults

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

Children

A daily dose of 0.5 mg to 1 mg of lormetazepam is recommended.

Elderly patients and patients at risk

A daily dose of 1 mg of lormetazepam is generally recommended. One hour before surgery, half of this dose is recommended.

Dose reduction should be considered in patients with mild to moderate breathing difficulties or in those with hepatic insufficiency.

Children and adolescents

Lormetazepam Alter must not be used in children and adolescents under 18 years of age without a careful assessment of the necessity of treatment.

If you take more lormetazepam Alter than you should

Overdose is not usually life-threatening unless the drug is taken together with other central nervous system depressants (including alcohol). In cases of overdose, consider the possibility that the patient may have ingested multiple substances.

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, ataxia (impaired coordination of movement), visual disturbances, hypotonia (reduced muscle tone), hypotension (low blood pressure), 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 at telephone number: 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 make up for missed doses.

If treatment with lormetazepam Alter is interrupted

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

If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If the dosage is not adjusted to the individual condition of each patient, adverse effects due to excessive sedation and muscle relaxation may occur.

At the beginning of treatment, daytime drowsiness, emotional disturbance, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movements), or double vision may occur. All these effects occur 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 suicide attempt, 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 adverse effects

(may affect more than 1 in 10 patients)

• Headache

Frequent adverse effects

(may affect up to 1 in 10 people)

• Angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing).
• Anxiety, decreased libido (sexual desire).
• Dizziness, sedation, somnolence (drowsiness), attention disturbance, amnesia, visual disturbance, speech disorder, dysgeusia, mental slowing.
• Tachycardia (increased heart rate).
• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
• Pruritus (itching).
• Urinary disorder.
• Asthenia (lack of energy), excessive sweating.

Adverse reactions of unknown frequency

(Cannot be estimated from the available data)

• Suicide attempt or completed suicide (unmasking of pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, depression (unmasking of pre-existing depression), delirium (false beliefs considered as true and impossible to disprove), withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage attacks, nightmares, inappropriate behavior, emotional disturbances.
• Confusion, decreased level of consciousness, ataxia (impaired coordination of movements), muscle weakness.
• Urticaria, exanthema (rash).
• Fatigue.
• Falls.

For further information on the following points, see section “Warnings and precautions”.

Dependence:

Administration of Lormetazepam Alter and other benzodiazepines may lead to the development of physical and psychological dependence (see section “Warnings and precautions”).

Psychiatric disorders:

Rebound insomnia may occur upon discontinuation of the medication (see section “Warnings and precautions”).

• Psychiatric and paradoxical reactions: When using Lormetazepam Alter, reactions such as restlessness, agitation, irritability, aggressiveness, delirium (false beliefs considered as true and impossible to disprove), rage attacks, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate abnormal behavior, and other behavioral disturbances may occur.

• 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 cause anterograde amnesia (difficulty in 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 a reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse reactions, you can help provide 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 any special storage conditions.

Do not use Lormetazepam Alter after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lormetazepam Alter

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

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

Appearance of the product and contents of the pack

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 – aluminium blisters, in packs 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 patient information leaflet has been 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