Minias: detailed information

Package leaflet: Information for the patient

Minias 1 mg film-coated tablets, 2 mg film-coated 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Minias is and what it is used for

Minias belongs to the pharmaceutical category 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 should know before taking Minias

Do not take Minias
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:

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 (nocturnal breathing pauses);
narrow-angle glaucoma (a rapid increase in pressure within 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 Minias.
Speak to your doctor especially if:

you have a history of drug or alcohol abuse;
you suffer from spinocerebellar 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 Minias" and "Do not take Minias");
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 Minias"), as in patients with severe hepatic insufficiency and/or hepatic 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 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 Minias, 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 in this regard 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 likelihood 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, unreal, or unfamiliar way), 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, tinnitus (ringing in the ears) persisting, involuntary movements, vomiting, paresthesia (altered sensation), perceptual disturbances, abdominal and muscular 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 appear between doses, particularly at high dosages. However, when switching to treatment with Minias after prolonged use and/or high-dose treatment with 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 gradually by tapering the dose.
Amnesia
Minias 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 after taking Minias (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 (mental disorder characterized by detachment from reality), inappropriate behaviour, and other behavioural 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 MINIAS, a pre-existing depressive state may be unmasked. If you suffer from depression, you should use MINIAS with caution.
Children and adolescents
Minias must not be administered to patients under 18 years of age. If administration to children is necessary, the doctor will first evaluate 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)
Minias 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 Minias
Inform 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 Minias requires particular 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), especially in elderly patients; combining with these medicines requires particular 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 used to treat severe mental illnesses), hypnotics (medicines that facilitate sleep), anxiolytics/tranquilizers/sedatives (medicines that help reduce anxiety or induce calmness), antidepressants (medicines used for depression), antiepileptics (medicines to prevent epileptic seizures), anticonvulsants (medicines against convulsions), anaesthetics, and sedating antihistamines (some medicines for allergies that cause sedation), as their effects may be enhanced. Concomitant use of Minias and these medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Minias 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 with Minias may enhance the effect of both, 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 cardiac glycoside levels in the blood.
Beta-blockers (medicines for treating arrhythmias and heart failure); may increase the clinical effects of Minias.
Methylxanthines, theophyllines or aminophyllines (anti-asthmatics), rifampicin (antibiotic); may reduce the effect of Minias.
Medicines containing oestrogens (hormones); concomitant use may reduce benzodiazepine levels in the blood. Clozapine (a medicine for treating mental illnesses); concomitant use with Minias may cause marked sedation, excessive salivation, and ataxia (loss of coordination of movements).

Minias and alcohol
Do not consume alcohol during treatment with Minias. Benzodiazepines cause an additive effect when taken with alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy or breastfeeding (see "Do not take Minias").
If you have been prescribed Minias 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, Minias 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.
Moreover, newborns born to mothers who have taken Minias 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 postnatal period.
Since small amounts of the medicine may pass into breast milk, do not take Minias during breastfeeding (see "Do not take Minias").
Driving and using machines
Minias significantly impairs the ability to drive or operate machinery due to sedation, amnesia (memory loss), impaired concentration, and compromised 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 ingestion, individual sensitivity, and dose taken. This is particularly evident with high doses in combination with alcohol (see "Minias and alcohol").
Minias contains:

Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., essentially "sodium-free".

3. How to take Minias

1 mg tablets: 1–2 tablets
2 mg tablets: ½ (half) – 1 tablet

The availability of divisible tablets facilitates the 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 Minias 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 your doctor.

Use in the elderly
In elderly patients, the single dose is 0.5–1 mg, i.e.:

1 mg tablets: ½ (half) – 1 tablet
2 mg tablets: ¼ (one quarter) – ½ (half) tablet

Use in patients with chronic respiratory insufficiency or impaired hepatic and/or renal function
In patients with impaired renal function, your doctor will carefully determine the appropriate dosage for your condition and may consider reducing the doses indicated above.
In patients with mild to moderate respiratory difficulties or with impaired liver 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 Minias 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 period of gradual withdrawal.
In certain cases, extension beyond the maximum treatment period may be necessary; however, this will only occur after your condition has been re-evaluated by your doctor.
Treatment should be initiated at the lowest recommended dose and increased cautiously, taking care not to exceed the maximum dose, and should be kept as brief as possible.
If treatment exceeds two weeks, Minias should not be stopped abruptly, as sleep disturbances may temporarily recur with increased intensity. Therefore, it is recommended to complete treatment by gradually reducing the dose.

If you take more Minias than you should
In case of accidental ingestion/overdose of Minias, contact your doctor immediately or go to the nearest hospital.
As with other benzodiazepines, an overdose of Minias is not usually life-threatening unless taken concomitantly with other medicines that depress the central nervous system (including alcohol). Overdose of benzodiazepines typically 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), 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 level of carbon dioxide in the blood), rarely coma, and very rarely death.

Treatment of overdose
In managing overdose, consider the possibility of concomitant intake of other substances, which may result in 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), vasoactive drugs such as noradrenergic agents 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, these methods are not efficient in cases of isolated intoxication with Minias.
Flumazenil may be useful as an antidote (to reverse the harmful effects of the medicine).
Morphine antagonists are contraindicated.

If you stop taking Minias
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 everybody gets them.
At the beginning of treatment, daytime sleepiness, 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 Minias are headache, sedation, and anxiety.
The most serious adverse reactions in patients receiving Minias 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,
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 (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 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 (absence 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 estimated 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 actually present),
dependence,
depression (unmasking of pre-existing depression),
delirium,
withdrawal syndrome (rebound insomnia),
agitation,
aggression,
irritability,
restlessness,
anger,
nightmare,
abnormal behaviour,
emotional disturbance,
confusional state,
reduced vigilance,
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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 Minias

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 unopened packaging, stored correctly.
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 Minias contains

The active substance is lormetazepam. 1 mg film-coated tablets: each film-coated tablet contains 1 mg of lormetazepam. 2 mg film-coated tablets: each film-coated tablet contains 2 mg of lormetazepam.
The other components are: lactose, maize starch, povidone 25,000, magnesium stearate, quinoline yellow SS-E 104 (only in 2 mg tablets), Eudragit E 30 D, talc, titanium dioxide, macrogol 5/6000, polysorbate 80, sodium carmellose, silicone oil.

Description of the appearance of Minias and contents of the pack
Carton containing 30 film-coated tablets.
Marketing Authorization Holder and Manufacturer
NEOPHARMED GENTILI S.p.A. Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturer
Vamfarma S.r.l.
Via Kennedy, 5
26833 - Comazzo (LO)

Package leaflet: Information for the patient

Minias 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Minias is and what it is used for
What you need to know before taking Minias
How to take Minias
Possible side effects
How to store Minias
Package contents and other information

1. What Minias is and what it is used for

Minias 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 marked distress to the patient.

2. What you should know before taking Minias

Do not take Minias
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:

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 (nocturnal breathing pauses);
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 Minias.
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 Minias" and "Do not take Minias");
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 Minias"), as in patients with severe hepatic insufficiency and/or hepatic encephalopathy, the use of benzodiazepines may worsen hepatic encephalopathy (altered consciousness level 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 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 Minias, 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 efficacy 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 in this regard 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 possibility 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, 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 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 Minias after prolonged use and/or high doses of benzodiazepines with significantly longer duration of action, withdrawal symptoms may also occur.
Withdrawal symptoms, especially the more severe ones, are more common in patients who have taken excessive doses for a long period of time; however, they may also occur after abrupt discontinuation of benzodiazepines taken continuously at therapeutic doses, especially if the discontinuation is sudden.
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
Minias 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 Minias (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, rage, anger, nightmares, hallucinations (seeing or
hearing things that are not present in reality), psychosis (mental disorder characterized by detachment from reality), inappropriate behaviour, and other behavioural changes. If this occurs, stop taking 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 MINIAS, a pre-existing depressive state may be unmasked. If you suffer from depression, you should use MINIAS with caution.
For athletes
This medicine contains ethanol (ethyl alcohol). The use of medicines containing ethyl alcohol may result in positive anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
Minias 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)
Minias 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 Minias
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Interactions with other medicines:

Other psychotropic medicines (medicines acting on the central nervous system); combining these medicines with Minias 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), especially in elderly patients; combining with these medicines requires particular caution.

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 used for severe mental illnesses), hypnotics (medicines that promote sleep), anxiolytics/tranquilizers/sedatives (medicines that help reduce anxiety or induce calmness), antidepressants (medicines used for depression), antiepileptics (medicines to prevent epileptic seizures), anticonvulsants (medicines against convulsions), anaesthetics, and sedative antihistamines (some medicines for allergies that cause sedation), as their effects may be enhanced. Concomitant use of Minias 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 available. However, if your doctor prescribes Minias 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 with Minias may enhance the effect of both and narcotic analgesics may increase euphoria, thereby increasing the risk of psychological dependence.
Cytochrome P450 inhibitors (medicines that slow 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 cardiac glycoside levels in the blood.
Beta-blockers (medicines for arrhythmias and heart failure); may enhance the clinical effects of Minias.
Methylxanthines, theophyllines or aminophyllines (anti-asthmatics), rifampicin (antibiotic); may reduce the effect of Minias.
Medicines containing oestrogens (hormones); concomitant use may reduce benzodiazepine blood levels.
Clozapine (a medicine for mental illnesses); concomitant use with Minias may cause marked sedation, excessive salivation, and ataxia (loss of coordination of movements).

Minias and alcohol
Do not consume alcohol during treatment with Minias. Benzodiazepines cause an additive effect when taken with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning 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 Minias").
If you have been prescribed Minias 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, Minias 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), hypotonia (loss of muscle tone), hypotension (low blood pressure), difficulty in sucking ("infant hypotonia"), and moderate respiratory depression (increased carbon dioxide levels in the blood) due to the pharmacological action of the medicine.
Moreover, newborns born to mothers who have taken Minias 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 postnatal period.
Since small amounts of the medicine may pass into breast milk, do not take Minias during breastfeeding (see "Do not take Minias").
Driving and using machines
Minias significantly impairs the ability to drive 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 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 "Minias and alcohol").
MINIAS oral drops contain:

small amounts of ethanol (alcohol) less than 100 mg per mL (1 mL corresponds to 25 drops). This may be harmful to alcoholics. This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy;
712 mg of propylene glycol per mL;
less than 1 mmol (23 mg) of sodium per mL (1 mL corresponds to 25 drops), i.e., essentially "sodium-free".

3. How to take Minias

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, taken half an hour before going to bed.
The maximum dose must not be exceeded.

Use in children and adolescents
Your doctor will prescribe Minias 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.
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 liver and/or kidney function
In patients with impaired renal function, your doctor will carefully determine the appropriate dosage for your case and may consider reducing the doses indicated above.
In patients with mild to moderate respiratory difficulties or with hepatic impairment, a dose reduction should be considered.

Duration of treatment
Your doctor will explain that treatment should be limited in duration and that the dose may be gradually reduced before stopping treatment.
Treatment with Minias should be as short as possible. Your doctor will regularly reassess your condition and the need for continued treatment, 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 period of gradual withdrawal.
In certain cases, extension beyond the maximum treatment period may be necessary; however, this will only occur after your doctor has re-evaluated your condition.
Treatment should be initiated with the lowest recommended dose and increased cautiously, taking care not to exceed the maximum dose, and should be kept as brief as possible.
If treatment exceeds two weeks, administration of Minias should not be stopped abruptly, as sleep disturbances may temporarily recur with increased intensity. Therefore, it is recommended to conclude treatment by gradually reducing the dose.

If you take more Minias than you should
In case of accidental ingestion/overdose of Minias, contact your doctor immediately or go to the nearest hospital.
As with other benzodiazepines, an overdose of Minias alone is unlikely to be life-threatening, unless other centrally acting nervous system depressants (including alcohol) are taken concomitantly. Benzodiazepine overdose typically 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 voluntary muscle movements), visual disturbances, mental confusion, lethargy (tendency to prolonged drowsiness and unresponsiveness to normal stimuli), and mental clouding (transient confusion or disorientation).
Oral administration of higher doses may lead to symptoms ranging from deep sleep to unconsciousness, ataxia (loss of coordination), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression (increased carbon dioxide levels in the blood), rarely coma, and very rarely death.

Management of overdose
In managing overdose, consider the possibility of concomitant ingestion of other substances, which may lead to 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 airway 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 cases of hypotension (low blood pressure), peripheral-acting circulatory medications such as noradrenergic agents and volume expanders should be used. Assisted ventilation is required in case of respiratory impairment, which may also result from peripheral muscle relaxation.
In cases of mixed intoxication, hemodialysis or peritoneal dialysis (blood dialysis) may be beneficial. However, these methods are not effective in cases of isolated Minias intoxication.
Flumazenil may be useful as an antidote (to reverse the harmful effects of the medicine).
Opioid antagonists are contraindicated.

If you stop treatment with Minias
Discontinuation of treatment with this medicine should be done by gradually reducing the dose. Abrupt interruption, especially, may be accompanied by withdrawal symptoms (see "Withdrawal symptoms").
If you have any questions 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 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 Minias are headache, sedation, and anxiety.
The most serious adverse reactions in patients receiving Minias 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 disorder),
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 (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 (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 behaviour,
emotional disturbance,
confusion,
reduced alertness,
ataxia (loss of coordination of movements),
muscle weakness,
vertigo,
urticaria,
skin rash,
fatigue,
falls.

* Life-threatening or fatal cases have been reported
§ see "Warnings and precautions"
Following the instructions contained in this leaflet helps reduce the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://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 Minias

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, unopened packaging stored correctly.
The shelf life after first opening the bottle is 80 days.
Store below 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 Minias contains

The active substance is lormetazepam. 100 mL of solution contain 250 mg of lormetazepam.
The other components are: sodium saccharin, orange flavour, lemon essence, caramel flavour, glycerol, ethyl alcohol 95%, propylene glycol.

Description of the appearance of Minias and pack contents
Oral drops, solution. 1 bottle of 20 mL.
Marketing Authorization Holder and Manufacturer
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturers
Doppel Farmaceutici S.r.l., Cortemaggiore (Piacenza)
Vamfarma S.r.l., Via Kennedy 5 – 26833 Comazzo (Lodi)