LUZUL 1 мг Таблетка

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1. Luzul 2,5 mg/mL oral drops, solution
   1. What is Luzul and what is it 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

Luzul 2,5 mg/mL oral drops, solution

Lormetazepam

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Luzul and what is it used for

Luzul belongs to the pharmaceutical category of benzodiazepines, sedative-hypnotic drugs.

Therapeutic indications
This medicine is used for the short-term treatment of insomnia.
Benzodiazepines are indicated only when insomnia is severe, disabling and subjects the
patient to severe discomfort.

2. What you need to know before taking Luzul

Do not take Luzul
If you are:

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

If you suffer from:

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

If you have:

• sleep apnea syndrome (cessation of breathing);
• narrow-angle glaucoma (rapid increase in pressure inside the eye);
• acute intoxication (excessive use) from alcohol, hypnotics (sleeping pills), analgesics (pain relievers) or psychotropic drugs (drugs that act 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 (severe disturbance of movement coordination) (see “Do not take Luzul”);
• you suffer from chronic respiratory failure (the inability of the lungs to absorb oxygen and eliminate carbon dioxide effectively). In this case, the 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, the doctor will assess whether to prescribe a lower dose (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 heart failure (weak heart) and low blood pressure, as in this case you will need to undergo regular checks during treatment with this medicine;
• you are an elderly person. In this case, the doctor will prescribe a reduced dose, as some adverse reactions, such as lack of coordination of movements, may occur. Benzodiazepines, like this medicine, and benzodiazepine-like agents are indicated only when the disorder is severe, disabling or subjects the patient to severe discomfort. Benzodiazepines are not recommended for the primary treatment of psychotic illnesses 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: maximum four weeks, including a period of gradual withdrawal at the end.

Tolerance
After repeated use for a few weeks, a certain loss of effectiveness of the hypnotic effects of the
medicine (“tolerance”) may develop.

Dependence and abuse
The use of this medicine and other benzodiazepines can lead to the development of physical and
psychological dependence on these medicines. The risk in this regard increases with the dose and with the
duration of treatment, and is greater in patients who abuse drugs or alcohol. Therefore, if you have a
history of alcohol or drug abuse, use this medicine with extreme caution (see “Warnings and
precautions”).
The possibility of dependence is reduced when this medicine is used at the appropriate dose
with short-term treatment.
Benzodiazepine abuse 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
consist of:

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

In severe cases, the following symptoms may occur:

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

Other symptoms are:

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

At the interruption of the treatment may also occur:

• rebound insomnia, a transient syndrome in which the symptoms that led to treatment with benzodiazepines recur in an aggravated form. This may be accompanied by other reactions including: mood changes, anxiety, restlessness or sleep disturbances. If benzodiazepines are administered for a short duration, withdrawal symptoms may appear within the dosing interval, particularly for high doses. However, when switching to treatment with Luzul after using benzodiazepines with a significantly longer duration of action for a prolonged period of time and/or at high doses, withdrawal symptoms may occur. Withdrawal symptoms, especially the most severe, are more common in patients who have taken excessive doses for a long time; however, they can also occur after discontinuation of benzodiazepines taken continuously at therapeutic doses, especially if the discontinuation is abrupt. Because the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, treatment should be discontinued with a gradual reduction of the dosage.

Amnesia
Luzul can induce anterograde amnesia (difficulty memorizing new information). This happens
more often in the first few hours after ingestion of the medicine and therefore, to reduce the risk, before
taking Luzul make sure you can sleep for 7-8 hours without interruption (see “Possible side
effects”).

Psychiatric and paradoxical reactions
The use of benzodiazepines, such as this medicine, can lead to reactions such as restlessness,
agitation, irritability, aggression, delirium, delusions, anger, rage, 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
should happen, stop using the medicine. These reactions are more likely to occur
in children and the elderly 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 those who play sports
This medicine contains ethanol (ethyl alcohol). The use of medicines containing ethyl alcohol may
result in a positive doping test in relation to the alcohol concentration limits indicated
by some sports federations.

Children and adolescents
Luzul should not be administered to patients under the age of 18. If
it is necessary to administer the medicine to children, 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 of movements), muscle weakness, dizziness, drowsiness, fatigue and exhaustion. In this
case, the doctor will prescribe a reduced dose (see “Use in the elderly”).

Patients with psychosis (mental illness):
Luzul should not be used alone to treat insomnia associated with depression.
Benzodiazepines are not recommended for the primary treatment of psychotic illnesses and should 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, even those available without a prescription.
The concomitant use of Luzul and opioids (strong painkillers, medicines for substitution therapy
and some medicines for cough) increases the risk of drowsiness, difficulty breathing
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be considered only when other
treatment options are not possible.
However, if your doctor prescribes Luzul together with opioids, the dose and duration of concomitant treatment
should be limited by the doctor himself.
Tell your doctor all the opioid medicines you are taking and strictly follow
the doctor's recommendations on dosage. It may be helpful to inform friends and relatives so
they are aware of the signs and symptoms reported above. Contact your doctor if you experience these
symptoms.

Interactions with other medicines:

• Other psychotropic drugs (medicines that act on the central nervous system); the association of these medicines with Luzul requires particular attention and vigilance on the part of the doctor to avoid unexpected adverse interaction effects.
• Medicines that depress respiratory function, such as opioids (analgesics [pain relievers], antitussives [cough medicines], substitution treatments), especially in elderly patients; the association with these medicines requires particular attention.

Medicines that depress the Central Nervous System (CNS):

• Neuroleptic antipsychotics (medicines for the treatment of mental illnesses), hypnotics (medicines that facilitate sleep), anxiolytics/tranquilizers/sedatives, some antidepressants, narcotic analgesics (pain relievers) and opioid anesthetics, especially if you are an elderly patient, antiepileptics (medicines for the treatment of epilepsy), anticonvulsants (medicines against convulsions) and sedative antihistamines (some medicines for the treatment of allergies that induce sedation). The concomitant use of these medicines with Luzul may increase the effect of the latter and narcotic analgesics may cause an increase in euphoria leading to increased psychological dependence.
• Cardiac glycosides (medicines for heart failure);
• Beta-blockers (medicines for the treatment of arrhythmias and heart failure);
• Methylxanthines, theophylline or aminophylline (asthmatics), may reduce the effect of Luzul;
• Oral contraceptives (hormone-containing medicines);
• Some antibiotics;
• Clozapine (medicine for the treatment of mental illnesses); concomitant use with Luzul may produce marked sedation, excessive salivation, ataxia (loss of coordination of movements).

Luzul with alcohol
Do not drink alcohol during treatment with Luzul. Benzodiazepines cause an additive effect
when taken with alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy and 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
stopping treatment if you intend to become pregnant or suspect you are pregnant.
Pregnancy
If, for serious medical reasons, Luzul is administered during the last period of pregnancy, or
during labour and delivery, effects on the newborn such as hypothermia (decrease in
body temperature compared to the normal value), hypotonia (loss of muscle tone),
hypotension (low blood pressure), difficulty sucking (“infant hypotonia”) and
moderate respiratory depression (increased level of carbon dioxide in the blood) may occur due to
the pharmacological action of the medicine.
In addition, newborns born to mothers who have taken Luzul or other benzodiazepines for a long time
during the advanced stages of pregnancy may develop physical dependence and may
present a certain risk of developing withdrawal symptoms in the period after delivery.
Breastfeeding
Since small amounts of the medicine may pass into breast milk, do not take Luzul
during the breastfeeding period (see “Do not take Luzul”).

Driving and using machines
Luzul significantly affects the ability to drive vehicles or use machines in
as it causes sedation, amnesia (memory loss), altered concentration and
impairment of muscle function. If the duration of sleep has been insufficient, there may be
a greater likelihood that your state of alertness is altered.
Reactions may be altered in relation to the time of ingestion, your individual sensitivity
and the dose taken. This occurs with a high dose in association 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 dose of 20 drops.
Luzul contains 561 mg of propylene glycol per dose of 20 drops.
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 following exactly the instructions of 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 is equivalent to
10 drops), i.e. 10 – 20 drops.
The availability of oral drops facilitates the administration of the correct dose.
Dilute the drops in a little liquid, half an hour before bedtime.
The maximum dose must not be exceeded.

Use in children and adolescents
The doctor will prescribe Luzul to patients under 18 years of age only in case 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 established 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 failure or impaired liver and/or kidney function
In patients with mild to moderate breathing difficulties or patients with hepatic
and/or renal impairment, a dose reduction should be considered.

Duration of treatment
Your doctor will explain that the treatment is of limited duration and that the dose can be gradually reduced
before the end of the treatment.
Treatment with Luzul should be as short as possible. Your doctor will regularly re-evaluate your
condition and the need for continued treatment with this medicine, particularly 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 period of gradual discontinuation.
In certain cases, an extension beyond the maximum treatment period may be necessary,
but this will only occur after re-evaluation of your condition by your doctor.
Treatment should be started with the lowest recommended dose and should be increased
taking care not to exceed the maximum dose, and should be as short as possible.
If treatment lasts longer than two weeks, the administration of Luzul should not be
stopped abruptly, as sleep disturbances could temporarily recur
with increased intensity. For this reason, it is recommended to end the treatment by gradually reducing
the doses taken.

If you take more Luzul than you should
In case of accidental ingestion/intake of an excessive dose of Luzul, immediately
inform your doctor or go to the nearest hospital.
As with other benzodiazepines, an overdose of Luzul should not pose a risk
to life, unless there is concomitant intake of other medicines that depress the
central nervous system (including alcohol). Benzodiazepine overdose usually manifests
with varying degrees of central nervous system depression ranging
from obtundation (temporary clouding of the senses or reason) to coma.
Symptoms of mild intoxication are drowsiness, fatigue, ataxia (loss of
coordination of movements), visual disturbances, obtundation (temporary clouding
of the senses or reason), mental confusion and lethargy (predisposition to continuous sleep and
lack of response to normal stimuli).
Oral administration of higher doses can 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.
Overdose treatment
In the treatment of overdose, the possibility of concomitant intake of other substances should be considered
and that respiratory depression (increased level of carbon dioxide in the blood), rarely coma and, very rarely, death may occur.
Patients with milder 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 with protection of the airways should be performed, if
the patient is unconscious.
If no improvement is observed with gastric emptying, activated charcoal should be administered to reduce absorption.
Special attention should be paid to respiratory and cardiovascular functions in emergency therapy.
In case of hypotension (low blood pressure), peripheral circulation medicines such as noradrenergic and volemic should be used. Assisted ventilation is required in case of
respiratory impairment, which may also be caused by peripheral muscle relaxation.
In the presence of mixed intoxication, hemodialysis and peritoneal dialysis (blood dialysis) may be useful.
However, they are not effective in case of mono-intoxication with Luzul.
Flumazenil may be useful as an antidote (to reverse the harmful effects of the medicine).
Morphine antagonists are contraindicated.

If you stop taking Luzul
Discontinuation of treatment with this medicine should be carried out by gradually reducing
the dosage. Discontinuation, especially if abrupt, may be accompanied by
withdrawal symptoms (see “Withdrawal symptoms”).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
At the beginning of treatment, drowsiness during the day, emotional disturbances,
depressed state of consciousness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (loss of coordination of movements) or diplopia (double vision) may occur. These
reactions generally disappear with the continuation of treatment.
The adverse reactions that are most frequently observed in patients receiving Luzul are
headache, sedation and anxiety.
The more 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 the
unmasking of a 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 (decreased sexual desire),
• dizziness§,
• sedation,
• drowsiness§,
• attention disorder,
• amnesia (memory disorder)§,
• impaired vision,
• speech disorder,
• dysgeusia (altered taste),
• psychomotor slowing,
• diplopia (double vision),
• tachycardia (accelerated heartbeat),
• vomiting,
• nausea,
• pain in the upper abdomen,
• constipation,
• dry mouth,
• pruritus (itching),
• urinary disturbance (difficulty urinating),
• asthenia (muscle weakness),
• 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 hepatic transaminases (liver enzymes),
• increased alkaline phosphatase (an enzyme),
• thrombocytopenia (deficiency of platelets in the blood),
• agranulocytosis (lack of white blood cells called granulocytes),
• pancytopenia (deficiency of all types of blood cells),
• syndrome of inappropriate secretion of antidiuretic hormone (hormonal disorder).

Side effects with unknown frequency(frequency cannot be estimated on the basis of 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§,
• rage§,
• nightmare§,
• abnormal behavior§,
• emotional disturbance,
• confusional state,
• decreased alertness,
• ataxia (loss of coordination of movements)§,
• muscle weakness§,
• drowsiness during the day,
• blunting (numbness) of emotions,
• confusion,
• vertigo,
• urticaria (hives),
• skin rash,
• fatigue,
• fall.

* cases that are life-threatening or fatal have been reported
§ see “Warnings and precautions”

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at the address: 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 that is reported on the pack after “Expiry”.
The expiry date refers to the last day of that month. The expiry date refers to the
product in intact 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Luzul contains

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

Description of the appearance of Luzuland contents of the pack
Oral drops, solution. Clear, colourless solution. 1 bottle of 20 mL.

Marketing authorisation holder and manufacturer
LABORATORI BALDACCI S.p.A. - Via San Michele degli Scalzi,73 - 56124 Pisa

Manufacturer
ABC Farmaceutici S.p.A Via Cantone Moretti, 29 –Località San Bernardo- 10090 Ivrea (TO).