Package leaflet: Information for the patient

Lormetazepam ABC 2.5 mg/ml oral drops, solution

Lormetazepam
Equivalent medicine
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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lormetazepam ABC is and what it is used for
What you need to know before taking Lormetazepam ABC
How to take Lormetazepam ABC
Possible side effects
How to store Lormetazepam ABC
Contents of the pack and other information

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

Lormetazepam ABC belongs to the pharmaceutical category of benzodiazepines, which are sedative-hypnotic drugs.
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 need to know before taking Lormetazepam ABC

Do not take Lormetazepam ABC
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 gravis (a serious disorder of muscle function);
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 (breathing interruptions during sleep);
narrow-angle glaucoma (a rapid increase in pressure inside the eye);
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 Lormetazepam ABC.
Speak to your doctor especially if:

you have a history of drug or alcohol abuse;
you suffer from spinal or cerebellar ataxia (a serious disorder of movement coordination);
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 Lormetazepam ABC” and “Do not take Lormetazepam ABC”);
you suffer from hepatic insufficiency (reduced liver function). In this case, your doctor will evaluate whether a lower dose should be prescribed (see “How to take Lormetazepam ABC”), 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 elderly. 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 precipitated in such patients) (see “Patients with psychosis”).
Treatment with Lormetazepam ABC, 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 effectiveness of the hypnotic effects of the medicine (“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 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 for a 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 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, unreal, or unfamiliar way), depersonalization (loss of sense of personal identity), hyperacusis (difficulty tolerating certain sounds), numbness and tingling of the extremities, paresthesia of the limbs (altered limb sensation), 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, tinnitus (ringing in the ears) persisting, involuntary movements, vomiting, paresthesia (altered sensation), perceptual disturbances, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations, tachycardia (increased 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 appear between doses, particularly at high doses. However, when switching to treatment with Lormetazepam ABC after prolonged and/or high-dose use 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.
Because the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, treatment should be stopped gradually by tapering the dose.
Amnesia
Lormetazepam ABC may cause anterograde amnesia (difficulty in memorizing new information). 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 Lormetazepam ABC (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, delusion, delirium, 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 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 Lormetazepam ABC, a pre-existing depressive state may be unmasked.
If you suffer from depression, you should use Lormetazepam ABC with caution.
Children and adolescents
Lormetazepam ABC 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)
Lormetazepam ABC 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 Lormetazepam ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Interactions with other medicines:

other psychotropic medicines (medicines acting on the central nervous system); combining these medicines with Lormetazepam ABC requires special attention and monitoring by your 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 attention.

Medicines that depress the Central Nervous System (CNS)

medicines that depress the CNS such as narcotic analgesics, anaesthetics, opioids (medicines for pain such as morphine and codeine and some cough medicines), antipsychotics/neuroleptics (medicines for severe mental illnesses), hypnotics (medicines that help sleep), anxiolytics/tranquillisers/sedatives (medicines that help reduce anxiety or promote calmness), antidepressants (medicines used for depression), antiepileptics (medicines to prevent epileptic seizures), anticonvulsants (medicines against seizures), anaesthetics, and sedative antihistamines (some medicines for allergies that cause sedation), as their effects may be enhanced. Concomitant use of Lormetazepam ABC and these 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 Lormetazepam ABC together with opioids, the dose and duration of concomitant treatment must 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.
opioids/narcotic analgesics (e.g. pain medicines such as morphine and codeine and some cough medicines): concomitant use of these medicines and Lormetazepam ABC may enhance the effect of the latter, and narcotic analgesics may increase euphoria, thereby increasing the risk of psychological dependence;
cytochrome P450 inhibitors (medicines that slow down the activity of certain enzymes involved in drug metabolism); may increase the activity of benzodiazepines;
cardiac glycosides (medicines for heart failure); concomitant use may increase blood levels of cardiac glycosides;
beta-blockers (medicines for treating arrhythmias and heart failure) may enhance the clinical effects of Lormetazepam ABC;
methylxanthines, theophylline or aminophylline (anti-asthmatics), rifampicin (antibiotic); may reduce the effect of Lormetazepam ABC;
medicines containing oestrogens (hormones); concomitant use may reduce blood levels of benzodiazepines;
clozapine (a medicine for treating mental illnesses); concomitant use with Lormetazepam ABC may cause marked sedation, excessive salivation, and ataxia (loss of coordination of movements).

Lormetazepam ABC and alcohol
Do not consume alcohol during treatment with Lormetazepam ABC. Benzodiazepines cause an additive effect when taken with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy and breastfeeding (see “Do not take Lormetazepam ABC”).
If you have been prescribed Lormetazepam ABC 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.
If, for serious medical reasons, Lormetazepam ABC is administered during the last stage of pregnancy, or during labour and delivery, effects on the newborn may occur 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.
In addition, newborns born to mothers who have taken Lormetazepam ABC or other benzodiazepines long-term during the later stages of pregnancy may develop physical dependence and may be at risk of developing withdrawal symptoms in the period after birth.
Since small amounts of the medicine may pass into breast milk, do not take Lormetazepam ABC during breastfeeding (see “Do not take Lormetazepam ABC”).
Driving and using machines
Lormetazepam ABC 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 state of alertness is altered. Reactions may vary depending on the time of intake, your individual sensitivity, and the dose taken. This is particularly evident with high doses combined with alcohol (see “Lormetazepam ABC and alcohol”).
Lormetazepam ABC contains ethanol (ethyl alcohol)
Lormetazepam ABC contains 33 mg of alcohol (ethanol) per 10-drop dose, equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
Lormetazepam ABC contains sodium
Lormetazepam ABC contains less than 1 mmol (23 mg) of sodium per 10-drop dose, i.e., essentially “sodium-free”.
Lormetazepam ABC contains propylene glycol
Lormetazepam ABC contains 283 mg of propylene glycol per 10-drop dose. If the child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
Lormetazepam ABC contains benzyl alcohol
Lormetazepam ABC contains 0.084 mg of benzyl alcohol per 10-drop dose. Benzyl alcohol (contained in the orange flavour) may cause allergic reactions.
Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems (gasping syndrome), in young children. Do not administer to neonates up to 4 weeks of age unless otherwise recommended by a doctor. Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.

3. How to take Lormetazepam ABC

Take this medicine exactly as directed 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 going to bed.
Do not exceed the maximum dose.

Use in children and adolescents
Your doctor will prescribe Lormetazepam ABC 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 elderly patients
For elderly patients, the single dose is 0.5–1 mg, i.e. 5–10 drops.

Use in patients with chronic respiratory insufficiency or impaired liver and/or kidney function
In patients with impaired renal function, your doctor will carefully determine the appropriate dosage and may
consider reducing the doses indicated above.
In patients with mild to moderate respiratory difficulties or with impaired liver function, a reduced dose 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 Lormetazepam ABC should be as brief as possible. Your doctor will regularly reassess your
condition and the need for continued treatment with this medicine, especially if you are symptom-free.
Treatment duration 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, extension beyond the maximum treatment period may be necessary, but only after your doctor has reassessed your condition.
Treatment should begin with the lowest recommended dose and increased cautiously, without exceeding the maximum dose, and should be as short as possible. If treatment lasts longer than two weeks, Lormetazepam ABC should not be stopped abruptly, as sleep disturbances may temporarily return with increased intensity. For this reason, it is recommended to conclude treatment by gradually reducing the dose.

If you take more Lormetazepam ABC than you should
In case of accidental ingestion/overdose of Lormetazepam ABC, contact your doctor immediately or go to the nearest hospital.
As with other benzodiazepines, an overdose of Lormetazepam ABC is not usually life-threatening unless other medicines that depress the central nervous system (including alcohol) are taken concomitantly. Overdose of benzodiazepines typically results in varying degrees of central nervous system depression, ranging from drowsiness (temporary clouding of the senses or consciousness) to coma.
Symptoms of mild intoxication include drowsiness, fatigue, ataxia (loss of coordination of movements), visual disturbances, mental confusion, and lethargy (tendency to prolonged sleep and unresponsiveness to normal stimuli).
Oral intake 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 carbon dioxide levels in the blood), rarely coma, and very rarely death.

Treatment of overdose
In managing overdose, it should be considered that other substances may have been taken simultaneously, potentially causing respiratory depression (increased carbon dioxide levels 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 gastric emptying, activated charcoal should be administered to reduce absorption.
Special attention must be paid to respiratory and cardiovascular functions during emergency treatment.
In case of hypotension (low blood pressure), peripheral-acting vasopressors such as noradrenaline 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 or peritoneal dialysis (blood dialysis) may be beneficial. However, these methods are not efficient in cases of isolated intoxication with Lormetazepam ABC.
Flumazenil may be useful as an antidote (to counteract the harmful effects of the medicine). Morphine antagonists are contraindicated.

If you stop taking Lormetazepam ABC
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 how to use 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 Lormetazepam ABC are headache, sedation, and anxiety.
The most serious adverse reactions in patients receiving Lormetazepam ABC are angioedema (swelling of the skin of the face, lips, and tongue), suicide or attempted suicide associated with the 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;
speech disorder;
dysgeusia (altered taste);
psychomotor slowing;
diplopia (double vision);
tachycardia (increased heart rate);
vomiting;
nausea;
upper abdominal pain;
constipation;
dry mouth;
micturition disorder (urination difficulty);
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 present 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 in the blood);
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 the 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;
aggressiveness;
irritability;
restlessness;
anger;
nightmares;
abnormal behaviour;
emotional disturbance;
confusion;
reduced alertness;
ataxia (loss of coordination of movements);
muscle weakness;
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 reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lormetazepam ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after
expiry.
The expiry date refers to the last day of that month. The expiry date applies to the product in
its original packaging, correctly stored.
The shelf life after first opening of the bottle is 12 months.
Store at a temperature not exceeding 25 °C.
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 Lormetazepam ABC contains
The active substance is lormetazepam. 1 ml of solution contains 2.5 mg of lormetazepam.
The other components are: sodium saccharin, glycerol 85%, ethyl alcohol 96%, orange flavour, lemon flavour, caramel flavour, propylene glycol.
Description of the appearance of Lormetazepam ABC and the contents of the pack
Pack containing one 20 ml bottle with dropper.
The bottle has a child-resistant closure to protect against tampering by children.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10212 Turin
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO)

Lorazepam ABC