Luzul

Package leaflet: Information for the patient

Luzul 1 mg tablets, 2 mg tablets

Lormetazepam
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Luzul is and what it is used for

Luzul belongs to the pharmaceutical category of benzodiazepines, sedative-hypnotic medicines.
Therapeutic indications
This medicinal product is used for the short-term treatment of insomnia.
Benzodiazepines are indicated only when insomnia is severe, disabling, and causes the patient severe distress.

2. What you should know before taking Luzul

Do not take Luzul
If you are:

• allergic to lormetazepam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
• pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you suffer from:

• severe myasthenia (a serious disorder of muscle function);
• spinal and cerebellar ataxia (a severe disorder of movement coordination);
• severe respiratory insufficiency (the inability of the lungs to effectively absorb oxygen and eliminate carbon dioxide—for example, severe chronic obstructive pulmonary disease);
• severe hepatic insufficiency (reduced liver function).

If you have:

• sleep apnoea syndrome (episodes of breathing cessation during sleep);
• narrow-angle glaucoma (a rapid increase in pressure inside the eye);
• acute intoxication (excessive use) with alcohol, hypnotics (sleeping pills), analgesics (painkillers), or psychotropic medicines (medicines acting on mental functions such as neuroleptics, antidepressants, lithium).

Warnings and precautions
Talk to your doctor or pharmacist before taking Luzul.
Speak with your doctor especially if:

• you have a history of drug or alcohol abuse;
• you suffer from spinal and cerebellar ataxia (severe disorder of movement coordination) (see "Do not take Luzul");
• you suffer from chronic respiratory insufficiency (the inability of the lungs to effectively absorb oxygen and eliminate carbon dioxide). In this case, your doctor may prescribe a lower dose due to the risk of respiratory depression (increased level of carbon dioxide in the blood) (see "How to take Luzul" and "Do not take Luzul");
• you suffer from hepatic insufficiency (reduced liver function). In this case, your doctor will assess whether a lower dose should be prescribed (see "How to take Luzul"), as in patients with severe hepatic insufficiency and/or encephalopathy, the use of benzodiazepines may worsen hepatic encephalopathy (altered level of consciousness and coma due to liver failure);
• you suffer from severe renal insufficiency (reduced kidney function);
• you suffer from cardiac insufficiency (weak heart) and low blood pressure, as you will need regular monitoring during treatment with this medicine;
• you are an elderly person. In this case, your doctor will prescribe a reduced dose, as adverse reactions such as lack of coordination in movements may occur. Benzodiazepines, such as this medicine, and benzodiazepine-like agents are indicated only when the condition is severe, disabling, or causes severe distress. Benzodiazepines are not recommended for the primary treatment of psychotic disorders and must not be used alone to treat depression or anxiety associated with depression (suicide may be triggered in such patients) (see "Patients with psychosis"). Treatment with Luzul, as with all benzodiazepines, should be as short as possible: a maximum of four weeks, including a gradual withdrawal period at the end.

Tolerance
After repeated use for several weeks, a certain loss of hypnotic effect of the medicine may develop ("tolerance").
Dependence and abuse
The use of this medicine and other benzodiazepines may lead to the development of physical and psychological dependence on these medicines. The risk increases with dose and duration of treatment, and is higher in patients with a history of drug or alcohol abuse. Therefore, if you have a history of alcohol or drug abuse, use this medicine with extreme caution (see "Warnings and precautions").
The risk of dependence is reduced when this medicine is used at the appropriate dose and for short-term treatment.
Abuse of benzodiazepines has been reported.
Withdrawal symptoms
Once physical dependence has developed, abrupt discontinuation of treatment may be accompanied by withdrawal symptoms (see section "Undesirable effects"). These may include:

• extreme anxiety, tension, restlessness, confusion, irritability, headache, muscle pain.

In severe cases, the following symptoms may occur:

• derealization (a feeling of perceiving reality in a distorted way, as unreal or unfamiliar), depersonalization (loss of sense of personal identity), hyperacusis (difficulty tolerating certain sounds), numbness and tingling of the extremities, paresthesia of the limbs (altered sensation in the limbs), hypersensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not present in reality), and epileptic seizures.

Other symptoms include:

• depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (altered sensation), perceptual disturbances, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (accelerated heart rate), panic attacks, dizziness, hyperreflexia (exaggerated reflexes), short-term memory loss, hyperthermia (increased body temperature).

Upon discontinuation of treatment, the following may also occur:

• rebound insomnia, a transient syndrome in which the symptoms that led to benzodiazepine treatment recur in a worsened form. This may be accompanied by other reactions including: mood changes, anxiety, restlessness, or sleep disturbances.

When short-acting benzodiazepines are administered, withdrawal symptoms may occur between doses, particularly at high dosages. However, when switching to treatment with Luzul after prolonged use and/or high dosages of benzodiazepines with significantly longer duration of action, withdrawal symptoms may occur. Withdrawal symptoms, especially the more severe ones, are more common in patients who have taken excessive doses over a long period; however, they may also occur after discontinuation of benzodiazepines taken continuously at therapeutic doses, especially if stopped abruptly. Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, treatment should be discontinued gradually by tapering the dose.
Amnesia
Luzul may cause anterograde amnesia (difficulty in memorizing new information). This most commonly occurs within the first few hours after taking the medicine; therefore, to reduce the risk, ensure you can sleep uninterrupted for 7–8 hours after taking Luzul (see "Possible side effects").
Psychiatric and paradoxical reactions
The use of benzodiazepines, such as this medicine, may lead to reactions such as restlessness, agitation, irritability, aggression, delirium, delusion, anger, rage, nightmares, hallucinations (seeing or hearing things that are not present in reality), psychosis (a mental disorder characterized by detachment from reality), inappropriate behavior, and other behavioral changes. If this occurs, stop taking the medicine.
These reactions are more likely to occur in children and elderly patients, as well as in patients with organic brain syndrome (reduced mental function). During the use of benzodiazepines, including Luzul, a pre-existing depressive state may become unmasked. If you suffer from depression, you should use Luzul with caution.
Children and adolescents
Luzul must not be administered to patients under 18 years of age. If administration to children is necessary, the doctor will first assess the actual need for treatment. The duration of treatment should be as short as possible (see "Use in children and adolescents").
Elderly:
The use of benzodiazepines, including this medicine, may be associated with an increased risk of falls due to side effects such as ataxia (lack of coordination in movements), muscle weakness, dizziness, drowsiness, fatigue, and tiredness. In this case, your doctor will prescribe a reduced dose (see "Use in the elderly").
Patients with psychosis (mental illnesses):
Luzul must not be used alone to treat insomnia associated with depression.
Benzodiazepines are not recommended for the primary treatment of psychotic disorders and must not be used alone to treat depression or anxiety associated with depression (the risk of suicide may be increased in these patients).
Other medicines and Luzul
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Concomitant use of Luzul and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Luzul together with opioids, the dose and duration of concomitant treatment should be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow the doctor’s dosage recommendations. It may be helpful to inform friends and family so they are aware of the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Interactions with other medicines:

• Other psychotropic medicines (medicines acting on the central nervous system); combining these medicines with Luzul requires special attention and monitoring by the doctor to avoid unexpected adverse interactions.
• Medicines that depress respiratory function, such as opioids (analgesics [painkillers], antitussives [cough suppressants], substitution treatments), particularly in elderly patients; combining with these medicines requires special caution.

Medicines that depress the Central Nervous System (CNS):

• Antipsychotic neuroleptics (medicines for mental illnesses), hypnotics (medicines that promote sleep), anxiolytics/tranquilizers/sedatives, certain antidepressants, narcotic analgesics and opioid anesthetics (pain medicines), especially if you are an elderly patient, antiepileptics (medicines for epilepsy), anticonvulsants (medicines for seizures), and sedating antihistamines (some medicines for allergies that cause drowsiness). Concomitant use of these medicines with Luzul may enhance its effects, and narcotic analgesics may increase euphoria, leading to increased psychological dependence.
• Cardiac glycosides (medicines for heart failure);
• Beta-blockers (medicines for arrhythmias and heart failure);
• Methylxanthines, theophyllines, or aminophyllines (anti-asthma medicines), which may reduce the effect of Luzul;
• Oral contraceptives (hormone-containing medicines);
• Some antibiotics;
• Clozapine (a medicine for mental illnesses); concomitant use with Luzul may cause marked sedation, excessive salivation, and ataxia (loss of movement coordination).

Luzul and alcohol
Do not consume alcohol during treatment with Luzul. Benzodiazepines produce an additive effect when taken with alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy or breastfeeding (see "Do not take Luzul").
Women of childbearing potential
If you have been prescribed Luzul and are a woman of childbearing age, contact your doctor regarding discontinuation of treatment if you plan to become pregnant or suspect you are pregnant.
Pregnancy
If, for serious medical reasons, Luzul is administered during the late stages of pregnancy, or during labor and delivery, effects on the newborn such as hypothermia (decreased body temperature below normal), hypotonia (loss of muscle tone), hypotension (low blood pressure), difficulty in sucking ("floppy infant syndrome"), and moderate respiratory depression (increased carbon dioxide levels in the blood) due to the pharmacological action of the medicine may occur.
Additionally, newborns born to mothers who have taken Luzul or other benzodiazepines long-term during advanced pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period.
Breastfeeding
Since small amounts of the medicine may pass into breast milk, do not take Luzul during breastfeeding (see "Do not take Luzul").
Driving and use of machines
Luzul significantly impairs the ability to drive vehicles or operate machinery, as it causes sedation, amnesia (memory loss), concentration disturbances, and impaired muscle function. If sleep duration has been insufficient, there may be a higher likelihood of altered alertness.
Reactions may vary depending on the time of intake, individual sensitivity, and dose taken. This is particularly evident with high doses in combination with alcohol (see "Luzul and alcohol").
Luzul contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Luzul

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose for adults is 1–2 mg, i.e.:
1 mg tablets: 1–2 tablets
2 mg tablets: ½ (half) – 1 tablet.
The availability of divisible tablets facilitates administration of the correct dose.
Take the tablets with a little liquid, without chewing, half an hour before going to bed. The maximum dose must not be exceeded.

Use in children and adolescents
Your doctor will prescribe Luzul to patients under 18 years of age only if absolutely necessary and only after careful evaluation (see section 2, “Warnings and precautions”). The duration of treatment should be as short as possible.
The dosage will be determined solely by the doctor.

Use in elderly patients
In elderly patients, the single dose is 0.5–1 mg, i.e.:
1 mg tablets: ½ (half) – 1 tablet.

Use in patients with chronic respiratory insufficiency or impaired liver and/or kidney function
In patients with mild to moderate respiratory difficulties or impaired liver and/or kidney function, a dose reduction should be considered.

Duration of treatment
Your doctor will explain that treatment should be short-term and that the dose may be gradually reduced before stopping treatment.
Treatment with Luzul should be as short as possible. Your doctor will regularly reassess your condition and the need for continued treatment, especially if you are symptom-free.
The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary, but only after your doctor has reassessed your condition.
Treatment should start with the lowest recommended dose and be increased carefully without exceeding the maximum dose, and should be as brief as possible.
If treatment lasts longer than two weeks, Luzul should not be stopped abruptly, as sleep disturbances may temporarily reappear with increased intensity.
Therefore, it is recommended to complete treatment by gradually reducing the dose.

If you take more Luzul than you should
In case of accidental ingestion or overdose of Luzul, contact your doctor immediately or go to the nearest hospital.
As with other benzodiazepines, an overdose of Luzul is unlikely to be life-threatening unless other medications that depress the central nervous system (including alcohol) have been taken concomitantly. Overdose of benzodiazepines usually results in varying degrees of central nervous system depression, ranging from drowsiness (transient clouding of the senses or consciousness) to coma.
Symptoms of mild intoxication include drowsiness, fatigue, ataxia (loss of coordination of movements), blurred vision, drowsiness (transient clouding of the senses or consciousness), confusion, and lethargy (tendency to prolonged sleep and unresponsiveness to normal stimuli).
Oral administration of higher doses may lead to symptoms ranging from deep sleep to unconsciousness, ataxia (loss of coordination of movements), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression (increased level of carbon dioxide in the blood), rarely coma, and very rarely death.

Treatment of overdose
In managing overdose, it must be considered that other substances may have been taken simultaneously, potentially causing respiratory depression (increased level of carbon dioxide in the blood), rarely coma, and very rarely death.
Patients with mild symptoms of intoxication should sleep under observation. Following an oral overdose of benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious, or gastric lavage should be performed with protection of the airways if the patient is unconscious.
If no improvement is observed after emptying the stomach, activated charcoal should be administered to reduce absorption.
Special attention must be paid to respiratory and cardiovascular functions in emergency treatment. In case of hypotension (low blood pressure), medications affecting peripheral circulation such as noradrenergic and volume-expanding agents should be used. Assisted ventilation is required in case of respiratory impairment, which may also be caused by peripheral muscle relaxation.
In cases of mixed intoxication, hemodialysis and peritoneal dialysis (blood dialysis) may be useful. However, these methods are not efficient in cases of isolated intoxication with Luzul.
As an antidote (to counteract the harmful effects of the medicine), Flumazenil may be helpful. Morphine antagonists are contraindicated.

If you stop treatment with Luzul
Discontinuation of treatment with this medicine should be done by gradually reducing the dose. Stopping treatment, especially abruptly, may be accompanied by withdrawal symptoms (see “Withdrawal symptoms”).
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
At the beginning of treatment, daytime drowsiness, emotional disturbances, depressed level of consciousness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (loss of coordination of movements), or diplopia (double vision) may occur. These reactions usually disappear with continued treatment.
The most frequently observed adverse reactions in patients receiving Luzul are headache, sedation, and anxiety.
The most serious adverse reactions in patients receiving Luzul are angioedema (swelling of the skin of the face, lips, and tongue), suicide or attempted suicide associated with unmasking of pre-existing depression.

Very common side effects (may affect more than 1 in 10 people)

• headache.

Common side effects (may affect up to 1 in 10 people)

• angioedema* (swelling of the skin of the face, lips, and tongue),
• anxiety,
• decreased libido (reduced sexual desire),
• dizziness§,
• sedation,
• somnolence§,
• attention disturbance,
• amnesia (memory impairment)§,
• visual impairment,
• language disorder,
• dysgeusia (altered taste),
• psychomotor slowing,
• diplopia (double vision),
• tachycardia (increased heart rate),
• vomiting,
• nausea,
• upper abdominal pain,
• constipation,
• dry mouth,
• pruritus,
• urinary disorder (difficulty urinating),
• asthenia (reduced muscle strength),
• hyperhidrosis (excessive sweating).

Rare side effects (may affect up to 1 in 1,000 people)

• anaphylactic/anaphylactoid reactions (severe allergic or allergy-like reactions),
• increased bilirubin (a pigment contained in bile),
• jaundice (yellowish discoloration of the skin, mucous membranes, and whites of the eyes),
• increased liver transaminases (liver enzymes),
• increased alkaline phosphatase (an enzyme),
• thrombocytopenia (low platelet count),
• agranulocytosis (lack of blood cells called granulocytes),
• pancytopenia (deficiency of all types of blood cells),
• syndrome of inappropriate antidiuretic hormone secretion (a hormonal disorder).

Side effects with unknown frequency (frequency cannot be determined from available data)

• suicide (unmasking of pre-existing depression)*,
• attempted suicide (unmasking of pre-existing depression)§;
• acute psychosis (mental disorder)§,
• hallucination (seeing or hearing things that are not present in reality)§,
• dependence§,
• depression (unmasking of pre-existing depression)§,
• delirium§,
• withdrawal syndrome (rebound insomnia)§,
• agitation§,
• aggression§,
• irritability§,
• restlessness§,
• anger§,
• nightmares§,
• abnormal behavior§,
• emotional disturbance,
• confusion,
• reduced alertness,
• ataxia (loss of coordination of movements)§,
• muscle weakness§,
• daytime drowsiness,
• emotional blunting (numbness),
• confusion,
• vertigo,
• urticaria,
• skin rash,
• fatigue,
• fall.

* Life-threatening or fatal cases have been reported
§ See “Warnings and precautions”

Following the instructions contained in this leaflet can reduce the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luzul

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month. The expiry date applies to the product in its original packaging, stored correctly.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Luzul contains

• The active substance is lormetazepam.
  1 mg tablets: each tablet contains 1 mg of lormetazepam.
  2 mg tablets: each tablet contains 2 mg of lormetazepam.

• The other components are: lactose monohydrate, maize starch, povidone K 30, magnesium stearate, hypromellose.

Description of the appearance of Luzul and pack sizes
White, round tablets with a score line; each tablet can be divided into two equal halves.
Carton pack containing 30 tablets.

Marketing Authorization Holder
LABORATORI BALDACCI S.p.A.
Via San Michele degli Scalzi, 73
56124 Pisa (PI)
Italy

Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO)
Italy

January 2026

Package leaflet: information for the patient

Luzul 2.5 mg/mL oral drops, solution

Lormetazepam
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Luzul is and what it is used for

Luzul belongs to the pharmaceutical class of benzodiazepines, which are sedative-hypnotic medicines.
Therapeutic indications
This medicine is used for the short-term treatment of insomnia.
Benzodiazepines are indicated only when insomnia is severe, disabling, and causes significant distress to the individual.

2. What you need to know before taking Luzul Do not take Luzul if you:

• are allergic to lormetazepam, to benzodiazepines, or to any of the other components of this medicine (listed in section 6);
• are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Do not take Luzul if you suffer from:

• severe myasthenia gravis (a serious disorder of muscle function);
• spinal and cerebellar ataxia (a severe disorder of movement coordination);
• severe respiratory insufficiency (the inability of the lungs to effectively absorb oxygen and eliminate carbon dioxide – for example, severe chronic obstructive pulmonary disease);
• severe hepatic insufficiency (reduced liver function).

Do not take Luzul if you have:

• sleep apnea syndrome (breathing interruptions during sleep);
• narrow-angle glaucoma (a rapid increase in intraocular pressure);
• acute intoxication (excessive use) of alcohol, hypnotics (sleeping pills), analgesics (painkillers), or psychotropic medicines (medicines acting on mental functions such as neuroleptics, antidepressants, lithium).

Warnings and precautions
Talk to your doctor or pharmacist before taking Luzul.
Talk to your doctor especially if:

• you have a history of drug or alcohol abuse;
• you suffer from spinal and cerebellar ataxia (a severe disorder of movement coordination) (see "Do not take Luzul");
• you suffer from chronic respiratory insufficiency (the inability of the lungs to effectively absorb oxygen and eliminate carbon dioxide). In this case, your doctor will prescribe a lower dose due to the risk of respiratory depression (increased level of carbon dioxide in the blood) (see "How to take Luzul" and "Do not take Luzul");
• you suffer from hepatic insufficiency (reduced liver function). In this case, your doctor will assess whether a lower dose should be prescribed (see "How to take Luzul"), as in patients with severe hepatic insufficiency and/or encephalopathy, the use of benzodiazepines may worsen hepatic encephalopathy (altered level of consciousness and coma due to liver failure);
• you suffer from severe renal insufficiency (reduced kidney function);
• you suffer from cardiac insufficiency (weak heart) and low blood pressure, as regular monitoring will be required during treatment with this medicine;
• you are an elderly person. In this case, your doctor will prescribe a reduced dose, as adverse reactions such as lack of coordination in movements may occur. Benzodiazepines, such as this medicine, and benzodiazepine-like agents are indicated only when the condition is severe, disabling, or causes significant distress. Benzodiazepines are not recommended for the primary treatment of psychotic disorders and should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients) (see "Patients with psychosis"). Treatment with Luzul, as with all benzodiazepines, should be as short as possible: up to four weeks, including a gradual discontinuation period at the end.

Tolerance
After repeated use for several weeks, a certain loss of hypnotic effect ("tolerance") may develop.
Dependence and abuse
The use of this medicine and other benzodiazepines may lead to the development of physical and psychological dependence on these medicines. The risk increases with dose and duration of treatment and is greater in patients with a history of drug or alcohol abuse. Therefore, if you have a history of alcohol or drug abuse, use this medicine with extreme caution (see "Warnings and precautions").
The risk of dependence is reduced when this medicine is used at the appropriate dose for a short-term treatment. Abuse of benzodiazepines has been reported.
Withdrawal symptoms
Once physical dependence has developed, abrupt discontinuation of treatment may be accompanied by withdrawal symptoms (see section "Undesirable effects"). These may include:

• extreme anxiety, tension, restlessness, confusion, irritability, headache, muscle pain.

In severe cases, the following symptoms may occur:

• derealization (the feeling of perceiving reality in a distorted way, as unreal or unfamiliar), depersonalization (loss of sense of personal identity), hyperacusis (difficulty tolerating certain sounds), numbness and tingling in the extremities, paresthesia of the limbs (altered sensation in the limbs), hypersensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not present in reality), and epileptic seizures.

Other symptoms include:

• depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (altered sensation), perceptual disturbances, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (accelerated heart rate), panic attacks, dizziness, hyper-reflexia (exaggerated reflexes), short-term memory loss, hyperthermia (increased body temperature).

Upon discontinuation of treatment, the following may also occur:

• rebound insomnia, a transient syndrome in which the symptoms that led to benzodiazepine treatment recur in an aggravated form. This may be accompanied by other reactions including: mood changes, anxiety, restlessness, or sleep disturbances. When short-acting benzodiazepines are administered, withdrawal symptoms may occur between doses, particularly at high dosages. However, when switching to treatment with Luzul after prolonged use and/or high doses of benzodiazepines with significantly longer duration of action, withdrawal symptoms may occur. Withdrawal symptoms, especially the more severe ones, are more common in patients who have taken excessive doses for a long time; however, they may also occur after abrupt discontinuation of benzodiazepines taken continuously at therapeutic doses. Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, treatment should be discontinued by gradually reducing the dose.

Amnesia
Luzul may cause anterograde amnesia (difficulty in forming new memories). This occurs most often in the first few hours after taking the medicine; therefore, to reduce the risk, ensure you can sleep uninterrupted for 7–8 hours before taking Luzul (see "Possible undesirable effects").
Psychiatric and paradoxical reactions
The use of benzodiazepines, such as this medicine, may lead to reactions such as restlessness, agitation, irritability, aggression, delirium, delusion, rage, anger, nightmares, hallucinations (seeing or hearing things that are not present in reality), psychosis (mental disorder characterized by detachment from reality), inappropriate behavior, and other behavioral changes. If this occurs, stop using the medicine.
These reactions are more likely to occur in children and elderly patients, as well as in patients with organic brain syndrome (reduced mental function). During the use of benzodiazepines, including Luzul, a pre-existing depressive state may be unmasked. If you suffer from depression, use Luzul with caution.
For athletes
This medicine contains ethanol (ethyl alcohol). The use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
Luzul must not be administered to patients under 18 years of age. If administration to children is necessary, the doctor will first assess the actual need for treatment. The duration of treatment should be as short as possible (see "Use in children and adolescents").
Elderly:
The use of benzodiazepines, including this medicine, may be associated with an increased risk of falls due to adverse effects such as ataxia (lack of coordination in movements), muscle weakness, dizziness, drowsiness, fatigue, and exhaustion. In this case, your doctor will prescribe a reduced dose (see "Use in the elderly").
Patients with psychosis (mental illnesses):
Luzul must not be used alone to treat insomnia associated with depression. Benzodiazepines are not recommended for the primary treatment of psychotic disorders and must not be used alone to treat depression or anxiety associated with depression (the risk of suicide may be increased in these patients).
Other medicines and Luzul
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
The concomitant use of Luzul and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Luzul together with opioids, the dose and duration of concomitant treatment should be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends and family so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.
Interactions with other medicines:

• Other psychotropic medicines (medicines acting on the central nervous system); the combination of these medicines with Luzul requires special attention and monitoring by the doctor to avoid unexpected adverse interactions.
• Medicines that depress respiratory function, such as opioids (analgesics [painkillers], antitussives [cough suppressants], substitution therapies), especially in elderly patients; combination with these medicines requires special attention.

Central Nervous System (CNS) depressants:

• Neuroleptic antipsychotics (medicines for mental illnesses), hypnotics (medicines that promote sleep), anxiolytics/tranquilizers/sedatives, certain antidepressants, narcotic analgesics and opioid anesthetics (pain medicines), especially if you are an elderly patient, antiepileptics (medicines for epilepsy), anticonvulsants (medicines for seizures), and sedative antihistamines (some medicines for allergies that cause sedation). Concomitant use of these medicines with Luzul may enhance its effect, and narcotic analgesics may increase euphoria, leading to increased psychological dependence.

• Cardiac glycosides (medicines for heart failure);

• Beta-blockers (medicines for arrhythmias and heart failure);

• Methylxanthines, theophyllines, or aminophyllines (anti-asthma medicines), which may reduce the effect of Luzul;

• Oral contraceptives (hormone-containing medicines);

• Some antibiotics;

• Clozapine (a medicine for mental illnesses); concomitant use with Luzul may cause marked sedation, excessive salivation, ataxia (loss of coordination of movements).

Luzul with alcohol
Do not consume alcohol during treatment with Luzul. Benzodiazepines cause an additive effect when taken with alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take this medicine during pregnancy or breastfeeding (see "Do not take Luzul").
Women of childbearing potential
If you have been prescribed Luzul and are a woman of childbearing age, contact your doctor regarding discontinuation of treatment if you plan to become pregnant or suspect you are pregnant.
Pregnancy
If, for serious medical reasons, Luzul is administered during the late stages of pregnancy, or during labor and delivery, effects on the newborn such as hypothermia (decreased body temperature below normal), hypotonia (loss of muscle tone), hypotension (low blood pressure), difficulty in sucking ("infant hypotonia"), and moderate respiratory depression (increased level of carbon dioxide in the blood) due to the pharmacological action of the medicine may occur.
Moreover, newborns born to mothers who have taken Luzul or other benzodiazepines long-term during advanced stages of pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period.
Breastfeeding
Since small amounts of the medicine may pass into breast milk, do not take Luzul during breastfeeding (see "Do not take Luzul").
Driving and operating machinery
Luzul significantly affects the ability to drive vehicles or operate machinery as it causes sedation, amnesia (memory loss), concentration disturbances, and impaired muscle function. If sleep duration has been insufficient, there may be a higher likelihood that your level of alertness is impaired.
Reactions may vary depending on the time of ingestion, individual sensitivity, and dose taken. This is particularly evident with high doses combined with alcohol (see "Luzul with alcohol").
Luzul contains ethanol (ethyl alcohol) and propylene glycol
Luzul contains small amounts of ethanol (alcohol), less than 100 mg per 20-drop dose. Luzul contains 561 mg of propylene glycol per 20-drop dose.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially sodium-free.

3. How to take Luzul Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Unless otherwise prescribed by your doctor, the recommended dose for adults is 1–2 mg (1 mg equals 10 drops), i.e., 10–20 drops.

The availability of oral drops facilitates accurate dosing.
Dilute the drops in a small amount of liquid, half an hour before bedtime. Do not exceed the maximum dose.
Use in children and adolescents
Your doctor will prescribe Luzul to patients under 18 years of age only in cases of absolute necessity and only after careful evaluation (see section 2 "Warnings and precautions"). The duration of treatment should be as short as possible. The dosage will be determined solely by the doctor.
Use in the elderly
In elderly patients, the single dose is 0.5–1 mg, i.e., 5–10 drops.
Use in patients with chronic respiratory insufficiency or impaired hepatic and/or renal function
In patients with mild to moderate respiratory difficulty or those with impaired hepatic and/or renal function, a dose reduction should be considered.
Duration of treatment
Your doctor will explain that treatment is of limited duration and that the dose may be gradually reduced before the end of treatment.
Treatment with Luzul should be as short as possible. Your doctor will regularly reassess your condition and the need for continued treatment with this medicine, especially if you are asymptomatic.
The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual discontinuation period.
In certain cases, extension beyond the maximum treatment period may be necessary, but only after reassessment of your condition by the doctor.
Treatment should start with the lowest recommended dose and be increased carefully without exceeding the maximum dose, and should be as short as possible.
If treatment exceeds two weeks, Luzul should not be discontinued abruptly, as sleep disturbances may temporarily reappear with greater intensity. Therefore, it is recommended to conclude treatment by gradually reducing the doses.
If you take more Luzul than you should
In case of accidental ingestion/overdose of Luzul, contact your doctor immediately or go to the nearest hospital.
As with other benzodiazepines, an overdose of Luzul should not pose a life-threatening risk unless taken concomitantly with other medicines that depress the central nervous system (including alcohol). Overdose of benzodiazepines typically manifests as varying degrees of central nervous system depression, ranging from drowsiness (clouding of the senses or reason) to coma.
Symptoms of mild intoxication include drowsiness, fatigue, ataxia (loss of coordination of movements), visual disturbances, mental confusion, and lethargy (tendency to continuous sleep and unresponsiveness to normal stimuli).
Oral administration of higher doses may lead to symptoms ranging from deep sleep to unconsciousness, ataxia (loss of coordination of movements), hypotonia (loss of muscle tone), hypotension (low blood pressure), respiratory depression (increased level of carbon dioxide in the blood), rarely coma, and very rarely death.
Treatment of overdose
In treating overdose, consider the possibility of concomitant intake of other substances, which may cause respiratory depression (increased level of carbon dioxide in the blood), rarely coma, and very rarely death.
Patients with mild intoxication symptoms should sleep under observation. Following an oral overdose of benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious, or gastric lavage with airway protection should be performed if the patient is unconscious.
If no improvement is observed after stomach emptying, activated charcoal should be administered to reduce absorption.
Special attention must be paid to respiratory and cardiovascular functions in emergency treatment.
In case of hypotension (low blood pressure), peripheral circulation medicines such as noradrenergic and volume expanders should be used. Assisted ventilation is required in case of respiratory impairment, which may also be caused by peripheral muscle relaxation. In cases of mixed intoxication, hemodialysis and peritoneal dialysis (blood dialysis) may be helpful. However, they are not efficient in cases of mono-intoxication with Luzul.
Flumazenil may be useful as an antidote (to counteract the harmful effects of the medicine). Morphine antagonists are contraindicated.
If you stop treatment with Luzul
Discontinuation of treatment with this medicine should be done by gradually reducing the dose. Stopping treatment, especially abruptly, may be accompanied by withdrawal symptoms (see "Withdrawal symptoms").
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone experiences them. At the beginning of treatment, drowsiness during the day, emotional disturbances, depressed consciousness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (loss of coordination of movements), or diplopia (double vision) may occur. These reactions usually disappear with continued treatment. The most frequently observed adverse reactions in patients receiving Luzul are headache, sedation, and anxiety.

The most serious adverse reactions in patients receiving Luzul are angioedema (swelling of the skin of the face, lips, and tongue), suicide, or attempted suicide in association with unmasking of pre-existing depression.
Very common side effects (may affect more than 1 in 10 people)

• headache.

Common side effects (may affect up to 1 in 10 people)

• angioedema* (swelling of the skin of the face, lips, and tongue),
• anxiety,
• decreased libido (reduced sexual desire),
• dizziness§,
• sedation,
• drowsiness§,
• attention disturbance,
• amnesia (memory disturbance)§,
• visual impairment,
• speech disorder,
• dysgeusia (altered taste),
• psychomotor slowing,
• diplopia (double vision),
• tachycardia (accelerated heart rate),
• vomiting,
• nausea,
• upper abdominal pain,
• constipation,
• dry mouth,
• pruritus,
• urinary disturbance (difficulty urinating),
• asthenia (reduced muscle strength),
• hyperhidrosis (excessive sweating).

Rare side effects (may affect up to 1 in 1,000 people)

• anaphylactic/anaphylactoid reactions (severe allergic or allergy-like reactions),
• increased bilirubin (a pigment contained in bile),
• jaundice (yellowing of the skin, mucous membranes, and whites of the eyes),
• increased liver transaminases (liver enzymes),
• increased alkaline phosphatase (an enzyme),
• thrombocytopenia (low platelet count),
• agranulocytosis (lack of blood cells called granulocytes),
• pancytopenia (deficiency of all types of blood cells),
• syndrome of inappropriate antidiuretic hormone secretion (hormonal disorder).

Side effects with unknown frequency (frequency cannot be determined from available data)

• suicide (unmasking of pre-existing depression) *,
• attempted suicide (unmasking of pre-existing depression) §
• acute psychosis (mental disorder)§,
• hallucination (seeing or hearing things that are not present in reality)§,
• dependence§,
• depression (unmasking of pre-existing depression)§,
• delirium§,
• withdrawal syndrome (rebound insomnia)§,
• agitation§,
• aggression§,
• irritability§,
• restlessness§,
• anger§,
• nightmare§,
• abnormal behavior§,
• emotional disturbance,
• confusion,
• reduced alertness,
• ataxia (loss of coordination of movements)§,
• muscle weakness§,
• daytime drowsiness,
• emotional blunting,
• confusion,
• dizziness,
• urticaria,
• skin rash,
• fatigue,
• fall. * life-threatening or fatal cases have been reported § see "Warnings and precautions" Following the instructions in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luzul Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month. The expiry date refers to the product in its original unopened packaging, correctly stored.
Store the medicine at a temperature not exceeding 25°C.
The shelf life after first opening of the bottle is 20 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Luzul contains

• The active substance is lormetazepam. 1 mL of solution contains 2.5 mg of lormetazepam.
• The other components are: sodium saccharin, orange flavour, lemon flavour, caramel cream flavour, ethanol 96 percent, glycerol, propylene glycol.

Description of the appearance of Luzul and contents of the pack
Oral drops, solution. Clear, colourless solution. 1 bottle of 20 mL.
Marketing Authorisation Holder
LABORATORI BALDACCI S.p.A.
Via San Michele degli Scalzi, 73
56124 Pisa (PI)
Italy
Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10090 Ivrea (TO)
Italy
January 2026