PASADEN 0.5 MG Coated tablet

Зміст інструкції

1. Pasaden 0.5 mg/ml oral drops, solution
   1. What is Pasaden and what is it used for
   2. What you need to know before taking Pasaden
   3. How to take Pasaden
   4. Possible side effects
   5. How to store Pasaden
   6. Contents of the pack and other information
2. Pasaden 0.5 mg coated tablets, 1 mg coated tablets
   1. What is Pasaden and what is it for
   2. What you need to know before taking Pasaden
   3. How to take Pasaden
   4. Possible side effects
   5. How to store Pasaden
   6. Contents of the pack and other information

Pasaden 0.5 mg/ml oral drops, solution

etizolam

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

1. What is Pasaden and what is it used for

The active ingredient of Pasaden is etizolam, the first representative of the chemical class of
"thienotriazolodiazepines" (it is a benzodiazepine-like substance), and as such it belongs to the category of
sedative-hypnotic drugs. Etizolam is rapidly eliminated from the body: the risk of accumulation
is thus significantly reduced, even in prolonged treatments.
This medicine is used in cases of anxiety, tension and other somatic or psychiatric manifestations
associated with anxiety syndrome. Insomnia.
Pasaden is indicated only when the disorder is severe, disabling and subjects the individual to severe distress.

2. What you need to know before taking Pasaden

Do not take Pasaden

• if you are allergic to etizolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);

If you suffer from:

• myasthenia gravis (a severe disorder of muscle function);
• severe respiratory insufficiency (severe breathing problems);
• severe hepatic insufficiency (severe liver problems);
• nighttime sleep apnea syndrome (cessation of breathing);
• an eye disease called acute closed-angle glaucoma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pasaden.

Talk to your doctor especially if:

• you are an elderly person. In this case, the doctor will prescribe a reduced dose because certain adverse reactions may occur, such as lack of coordination of movements;
• you suffer from respiratory problems (chronic respiratory insufficiency). The doctor will prescribe a lower dose due to the risk of respiratory depression (reduced breathing due to alteration of the activity of the respiratory centers), with consequent worsening of your condition;
• you suffer from depression or anxiety or anxiety associated with depression because Pasaden may increase the risk of suicidal thoughts. In this case, the doctor will prescribe other medicines in addition.
• you have a history of drug or alcohol abuse;
• you suffer from organic brain disorders (caused by damage to brain tissue). In this case, the effect of the medicine may be potentiated;
• you suffer from kidney or liver disorders. In this case, the effect of the medicine may be potentiated; you suffer from hypotonia (reduced muscle tone). In this case, the effect of the medicine may be potentiated;
• you suffer from heart disorders, as the medicine can lead to a lowering of blood pressure.

Benzodiazepines are not indicated in patients with severe hepatic insufficiency as they can cause
encephalopathy (brain disease).
Furthermore, benzodiazepines are not recommended for the primary treatment of psychotic illnesses.
Treatment with Pasaden, as with similar medicines, should be as short as possible in
relation to the therapeutic indication: maximum four weeks for sleep disorders and eight to twelve
weeks for anxiety, including a period of gradual discontinuation at the end.

Tolerance
After repeated use for several weeks of benzodiazepines and related substances, a certain
loss of efficacy ("tolerance") may develop.

Dependence
Prolonged use can also lead to the development of physical and psychological dependence; the risk in this regard
increases with the dose and duration of treatment and is greater in patients who abuse drugs or
alcohol.
In patients with physical dependence on benzodiazepines, abrupt discontinuation of treatment will produce
so-called "withdrawal" symptoms: in most cases headache, muscle pain, severe anxiety,
tension, restlessness, confusion and irritability. In more 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 sounds),
numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact,
hallucinations (seeing or hearing things that are not present in reality) or seizures.
Withdrawal symptoms and rebound phenomena may also occur upon discontinuation of treatment;
this is why the doctor will gradually reduce the dosage of Pasaden.
In certain cases, treatment may need to be prolonged beyond the maximum recommended period; in
these cases, the doctor will decide after a careful reassessment of the patient's condition.

Children and adolescents
Pasaden should only be used in adult patients. If it is necessary to administer the medicine
to children, the doctor will first assess the actual need for treatment and adopt the same precautions.

Other medicines and Pasaden
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Pasaden at the same time as:

• all medicines that act in a depressant manner on the Central Nervous System (e.g. other anxiolytics and/or hypnotics, antidepressants, analgesics, antiepileptics, phenothiazine derivatives (other antipsychotics (neuroleptics), and barbiturate derivatives);
• anaesthetics and sedative antihistamines.

Taking these medicines in combination with Pasaden increases the sedative effect of Pasaden and drowsiness, hypotension, ataxia (lack of coordination of movements) and altered
state of consciousness may occur.
The concomitant use of Pasaden 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 only be considered when other treatment options are not possible.
However, if your doctor prescribes Pasaden together with opioids, the dose and duration of concomitant treatment
must be limited by the doctor himself.
Tell your doctor 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 reported above. Contact your doctor if you experience these symptoms.

Tell your doctor if you are taking:

• narcotic analgesics. If you take this type of medicine in combination with Pasaden, an increase in the euphoric effect of the narcotic may occur.
• medicines that inhibit certain liver enzymes (such as cytochrome P450) or monoamine oxidase inhibitors (medicines used to treat depression), as they may increase the activity of benzodiazepines.
• medicines capable of inhibiting the cytochrome isoenzymes CYP2C9 and CYP3A4, such as fluvoxamine maleate (medicine used for the treatment of obsessive-compulsive disorder, major depressive disorder and anxiety disorder), as it may potentiate the effects of Pasaden. In this case, the doctor will reduce the dose of Pasaden.

Warnings for athletes
If you are a professional athlete, the use of medicines containing ethyl alcohol may result in positive
doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Pasaden with alcohol
The consumption of alcoholic beverages during treatment with Pasaden should be avoided as it increases
the sedative effect of the medicine and drowsiness, hypotension, ataxia (lack of
coordination of movements) and altered state of consciousness may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, your doctor will prescribe this medicine only if absolutely necessary, for short periods
of time and under direct medical supervision. Administration in the last period of pregnancy and during
labor can produce effects on the newborn: reduced activity, feeding disorders, lethargy
(predisposition to continuous sleep, reduced psychic reactions and lack of response to normal stimuli),
tachycardia (accelerated heartbeat), vomiting, increased serum CK (an enzyme that indicates liver function), decreased temperature and reduced muscle tone, difficulty breathing.
Furthermore, newborns born to mothers who have chronically taken benzodiazepines during the advanced stages of
pregnancy may develop physical dependence and present a certain risk of developing withdrawal symptoms in the postnatal period and present symptoms such as apnea (cessation of breathing), cyanosis
(bluish discoloration of the skin and mucous membranes due to inadequate oxygenation of
blood), decreased sucking, decreased muscle tone, reduced activity and withdrawal syndrome.

Breastfeeding
This medicine passes into breast milk, therefore you should not take Pasaden if you are breastfeeding. In
case the doctor considers administration of Pasaden necessary, you must stop
breastfeeding, as the medicine can block weight gain in the newborn and cause worsening
of jaundice (yellowing of the skin and whites of the eyes).

Driving and using machines
Pasaden can reduce the ability to react, concentration, muscle function. Therefore you
should consider this aspect if you think of engaging in activities that require promptness and precision, as
required, in particular, in driving vehicles or using potentially dangerous machinery.
This medicine contains less than 1 mmol (23 mg) of sodiumper dose, i.e. essentially “sodium-free”;
This medicine contains up to 306 mg of pure alcohol (ethanol) per maximum daily dose (4 ml),
which is equivalent to 8.1 ml of beer or 3.4 ml of wine. The amount of alcohol in this medicine does not seem
to have an effect on adults and adolescents and its effects in children are not evident. Some effects may occur
in young children, for example feeling sleepy. The alcohol in this medicine may alter
the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If
you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If
you have an alcohol dependence, talk to your doctor before taking this medicine.
This medicine contains 715 mg of propylene glycolper mL;

3. How to take Pasaden

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Anxiety, tension and other somatic or psychiatric manifestations associated with anxious syndrome:
0.25-0.50 mg two or three times a day or 1 mg, in cases of greater intensity.

Insomnia: 1-2 mg before bedtime, according to individual needs, as prescribed by your doctor.
10 drops are equivalent to 0.25 mg.

Use in the elderly and in patients with impaired liver and/or kidney function
The doctor will carefully determine the appropriate dosage for your case and assess a possible reduction of the doses
above.
If you are an elderly person, the daily dose should not exceed 1.5 mg.
The use of the product is intended for adult patients.
The doctor will prescribe the minimum recommended dose. This dose will be gradually increased, taking
care not to exceed the maximum daily dose, for the shortest possible period.
If you suffer from anxiety, your doctor will regularly re-evaluate your condition to consider the need to
continue treatment, especially if you do not have symptoms.

Duration of treatment
The overall duration of treatment should generally not exceed 8-12 weeks, including a
period of gradual discontinuation.
In the case of sleep disorders, the duration of treatment generally ranges from a few days to two weeks,
including a period of gradual discontinuation.
In certain cases, the doctor may decide to extend beyond the maximum treatment period, after a
careful re-evaluation of your condition.

If you take more Pasaden than you should
Taking excessive doses of Pasaden, as with similar medicines, should not pose a risk to
life, unless other medicines that depress the Central Nervous System, including alcohol, have been taken simultaneously.
Overdosage manifests with a range of symptoms affecting the Central Nervous System, ranging
from drowsiness and mental confusion in less severe cases to coma, rarely, and death, very
rarely. In addition, cases of lack of coordination of movements, hypotension (low
blood pressure), respiratory failure have been reported.
If you have accidentally taken an excessive dose of Pasaden, immediately notify your doctor or
go to the nearest hospital.
Treatment of overdose consists of immediate induction of vomiting if the patient is conscious and gastric lavage with protection of the airways and possible administration of activated charcoal, to
reduce absorption, if the patient is unconscious.
Flumazenil can be used as an antidote (to cancel out the harmful effects of the medicine).

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Pasaden is generally well tolerated. If the dose is not adjusted to individual needs, the following side effects may
however occur:

• drowsiness (during the day if the product is used for sleep disorders);
• emotional blunting (progressive reduction of intellectual and sensory liveliness);
• reduced alertness;
• confusion;
• speech disorders;
• fatigue;
• headache;
• dizziness;
• muscle weakness;
• lack of coordination of movements;
• double vision;
• thirst;
• nausea;
• skin rash (eruptions on the skin).

These phenomena usually occur at the beginning of therapy and usually disappear with
subsequent administrations.
Occasionally, other reactions have been reported, including:

• gastrointestinal disorders;
• changes in sexual desire;
• erythema (redness) and skin reactions;
• feeling of difficulty breathing;
• palpitations (rapid and irregular heartbeat);
• gynecomastia (development of breasts in men);
• hyperprolactinemia (increased levels of a hormone called prolactin in the blood);
• blepharospasms (involuntary contractions of the eyelid muscle). If you experience eye symptoms, such as excessive blinking, photophobia (sensitivity to light) and dry eyes, your doctor will intervene with appropriate therapy;
• sweating;
• edema (swelling caused by excessive fluid accumulation in the tissues);
• urinary disorders;
• nasal obstruction;
• anterograde amnesia (difficulty memorizing new information), more likely with the use of higher doses.

Depression
In patients with pre-existing depressive state, and in any case more frequently in children and the
elderly, the use of benzodiazepines can cause psychiatric and "paradoxical" reactions
(contrary to those expected) such as:

• restlessness;
• agitation;
• irritability;
• aggression;
• delirium;
• anger;
• nightmares;
• hallucinations (seeing or hearing things that are not present in reality);
• psychosis (a mental disorder characterized by detachment from reality);
• behavioral changes.

These reactions can be quite serious. They are more likely in children and the elderly.

Dependence
Physical dependence can develop; in this case, abrupt discontinuation of therapy can cause
rebound or withdrawal phenomena.
Psychological dependence can occur. Abuse of benzodiazepines has been reported.

Seek immediate medical attentionif you experience the following side effects (their frequency cannot
be established from the available data):

• respiratory depression, CO narcosis: in patients with severely impaired respiratory function, respiratory depression (reduced breathing due to alteration of the activity of the respiratory centers) and CO narcosis (state of stupor and unconsciousness caused by increased carbon dioxide levels in the blood) may occur. If you experience any of these symptoms, seek immediate medical attention and he will intervene with appropriate measures, such as airway control and ventilation.
• malignant syndrome: this syndrome, in addition to the administration of this medicine, can be caused by the concomitant use of antipsychotics and other medicines, by the abrupt reduction of the dosage and by the interruption of the administration. If fever, muscle rigidity, dysphagia (difficulty swallowing), tachycardia (rapid heartbeat), changes in blood pressure, sweating, increased white blood cells, increased creatine phosphokinase in the blood occur,

inform your doctor who will intervene with total body measures, such as cooling the body and
hydration. In addition, if this syndrome occurs, renal dysfunction (poor
kidney function) with myoglobinuria (reddish coloration of the urine caused by the presence
of myoglobin) may occur.

• rhabdomyolysis(an acute, potentially fatal disease that destroys skeletal muscle and damages the kidneys). This condition is characterized by myalgia (muscle pain), asthenia (lack of strength and energy), increased levels of myoglobin in the blood and the presence of myoglobin in the urine (causing the reddish coloration of the urine). If rhabdomyolysis occurs, discontinue the medicine and seek immediate medical attention, who will adopt appropriate therapeutic measures.
• interstitial pneumonia. Discontinue the medicine and have a chest X-ray if you experience fever, cough, dyspnea (difficulty breathing), crepitations and abnormal breathing sounds. In these cases, your doctor may administer you adrenocortical hormones.
• alteration of liver function, jaundice. Disorders of liver function may occur, indicated by the results of the following blood tests: increased levels of aspartate aminotransferase (AST(GOT), alanine aminotransferase (ALT(GPT), gamma glutamyl transferase (γ-GT), lactic dehydrogenase (LDH), alkaline phosphatase (ALP) and bilirubin, etc. and jaundice (yellowish coloration of the skin and whites of the eyes). If the results of the blood tests are abnormal, your doctor will carefully monitor your condition and, if necessary, will advise you to discontinue treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system, at the address 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 Pasaden

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after expiry. The expiry date refers to the last day of that month. The expiry date refers to the product that is intact and
correctly stored .
Do not store above 25°C.
Do not dispose of any medicine in waste water 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 Pasaden contains

• The active ingredient is: etizolam. 100 ml of solution contain etizolam 0.05 g.
• The other ingredients are: sodium saccharin, ethanol, glycerol, orange flavour, caramel flavour, lemon flavour, propylene glycol.

Description of the appearance of Pasaden and contents of the pack
Oral drops, solution: bottle of 30 ml.

Marketing Authorisation Holder
Farmaka srl – Via Villapizzone, 26 – 20156 Milan, Italy

Manufacturer
ITC Farma srl – Via Pontina, km 29 – 00071 Pomezia (RM), Italy

Pasaden 0.5 mg coated tablets, 1 mg coated tablets

etizolam

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 pass it on to others, even if they have the same symptoms as you, as it may 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 Pasaden is and what it is used for
• 2. What you need to know before you take Pasaden
• 3. How to take Pasaden
• 4. Possible side effects
• 5. How to store Pasaden
• 6. Contents of the pack and other information

1. What is Pasaden and what is it for

The active ingredient of Pasaden is etizolam, the first representative of the chemical class of
"thienotriazolodiazepines" (a benzodiazepine-like substance), and as such it belongs to the category of
sedative-hypnotic drugs. Etizolam is rapidly eliminated from the body: the risk of accumulation
is thus significantly reduced, even with prolonged treatments.
Pasaden is used in cases of anxiety, tension and other somatic or psychiatric manifestations associated with
anxiety syndrome. Insomnia.
Pasaden is indicated only when the disorder is severe, disabling and subjects the individual to severe distress.

2. What you need to know before taking Pasaden

Do not take Pasaden

• if you are allergic to etizolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);

If you suffer from:

• myasthenia gravis (a severe disorder of muscle function);
• severe respiratory failure (serious breathing problems);
• severe hepatic failure (serious liver problems);
• nighttime sleep apnea syndrome (cessation of breathing);
• an eye disease called acute closed-angle glaucoma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pasaden.

Talk to your doctor especially if:
you are an elderly person. In this case, your doctor will prescribe a reduced dose because some
adverse reactions may occur, such as lack of coordination of movements;

• you suffer from respiratory problems (chronic respiratory failure). Your doctor will prescribe a lower dose due to the risk of respiratory depression (reduced breathing due to alteration of the activity of the respiratory centers), resulting in a worsening of your condition; you suffer from depression or anxiety or anxiety associated with depression because Pasaden may increase the risk of suicidal thoughts. In this case, your doctor will prescribe other medicines in addition; you have a history of drug or alcohol abuse; you suffer from organic brain disorders (caused by damage to brain tissue). In this case, the effect of the medicine may be potentiated; you suffer from kidney or liver disorders. In this case, the effect of the medicine may be potentiated; you suffer from hypotonia (reduced muscle tone). In this case, the effect of the medicine may be potentiated;
• you suffer from heart disorders, as the medicine may lead to a lowering of blood pressure.

Benzodiazepines are not indicated in patients with severe hepatic failure as they can cause
encephalopathy (a brain disease).
Furthermore, benzodiazepines are not recommended for the primary treatment of psychotic illnesses.
Treatment with Pasaden, as with similar medicines, should be as short as possible in
relation to the therapeutic indication: maximum four weeks for sleep disorders and eight to twelve
weeks for anxiety, including a period of gradual withdrawal at the end.

Tolerance
After repeated use for several weeks of benzodiazepines and related substances, a certain
loss of efficacy ("tolerance") may develop.

Dependence
Prolonged use can also lead to the development of physical and psychological dependence; the risk in this regard
increases with the dose and duration of treatment, and is greater in patients with a history of abuse of
drugs or alcohol.
In patients with physical dependence on benzodiazepines, abrupt discontinuation of treatment will produce
so-called "withdrawal" symptoms: in most cases headache, muscle pain, severe anxiety,
tension, restlessness, confusion and irritability. In more 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 sounds),
numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact,
hallucinations (seeing or hearing things that are not present in reality) or seizures.
Withdrawal symptoms and rebound phenomena may also occur when treatment is discontinued;
this is why the doctor will gradually reduce the dosage of Pasaden.
In certain cases, it may be necessary to prolong treatment beyond the maximum recommended period; in
these cases, the doctor will decide after a careful reassessment of the patient's conditions.

Children and adolescents
Pasaden should only be used in adult patients. If it is necessary to administer the medicine
to children, the doctor will first assess the actual need for treatment and take the same precautions.

Other medicines and Pasaden
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Pasaden at the same time as:

• all medicines that have a depressing effect on the Central Nervous System (e.g. other anxiolytics and/or hypnotics, antidepressants, analgesics, antiepileptics, phenothiazine derivatives, other antipsychotics (neuroleptics), and barbituric acid derivatives);
• anaesthetics and sedative antihistamines.

Taking these medicines at the same time as Pasaden increases the sedative effect of Pasaden and
drowsiness, hypotension, ataxia (lack of coordination of movements) and altered
consciousness may occur.
The concomitant use of Pasaden 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 only be considered when other treatment options are not possible.
However, if your doctor prescribes Pasaden together with opioids, the dose and duration of concomitant treatment
must be limited by the doctor himself.
Tell your doctor all the opioid medicines you are taking and strictly follow
your doctor's dosage recommendations. It may be helpful to inform friends and family so that they are
aware of the signs and symptoms reported above. Contact your doctor if you experience these symptoms.

Tell your doctor if you are taking:

• narcotic analgesics. If you take this type of medicine at the same time as Pasaden, an increase in the euphoric effect of the narcotic may occur.
• medicines that inhibit certain liver enzymes (such as cytochrome P450), or monoamine oxidase inhibitors (medicines used to treat depression), as they may increase the activity of benzodiazepines.
• medicines capable of inhibiting the cytochrome isoenzymes CYP2C9 and CYP3A4, such as fluvoxamine maleate (medicine used for the treatment of obsessive-compulsive disorder, major depressive disorder and anxiety disorder), as it may potentiate the effects of Pasaden. In this case, the doctor will reduce the dose of Pasaden.

Pasaden with alcohol
Drinking alcoholic beverages during treatment with Pasaden should be avoided as it increases
the sedative effect of the medicine and drowsiness, hypotension, ataxia (lack of
coordination of movements) and altered consciousness may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, your doctor will prescribe this medicine only if it is absolutely necessary, for short periods
of time and under direct medical supervision. Administration in the last period of pregnancy and
during labour may produce the following effects on the newborn: reduced activity, feeding disorder,
lethargy (predisposition to continuous sleep, reduced psychic reactions and lack of response to normal
stimuli), tachycardia (accelerated heartbeat), vomiting, increased serum CK (an enzyme indicating
liver function), decreased temperature and reduced muscle tone, breathing difficulties.
Furthermore, newborns born to mothers who have taken benzodiazepines chronically during the advanced stages
of pregnancy may develop physical dependence and present a certain risk of developing withdrawal symptoms in the postnatal period and present symptoms such as apnea (cessation of breathing), cyanosis
(bluish discoloration of the skin and mucous membranes due to inadequate oxygenation of
blood), decreased sucking, decreased muscle tone, reduced activity and withdrawal syndrome.

Breastfeeding
This medicine passes into breast milk, therefore you should not take Pasaden if you are breastfeeding. In
the event that the doctor considers administration of Pasaden necessary, you must stop
breastfeeding, as the medicine may block weight gain in the newborn and cause a worsening
of jaundice (yellowing of the skin and whites of the eyes).

Driving and using machines
Pasaden may reduce your ability to react, concentration, and muscle function. Therefore, you should
consider this aspect if you think of engaging in activities that require promptness and precision, as
required, in particular, when driving vehicles or using potentially dangerous machinery.
This medicine contains lactose. Patients with rare hereditary disorders of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, should not
take this medicine;
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which is
essentially “sodium-free”.

3. How to take Pasaden

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Anxiety, tension and other somatic or psychiatric manifestations associated with anxious syndrome:
0.25-0.50 mg two or three times a day or 1 mg, two tablets a day (one in the morning and one in the
evening) in cases of greater intensity.

Insomnia: 1-2 mg before bedtime, depending on individual needs, as prescribed by your doctor.

Use in the elderly and in patients with impaired liver and/or kidney function
The doctor will carefully determine the dosage appropriate for your case and evaluate a possible reduction of the
above doses.
If you are an elderly person, the daily dose should not exceed 1.5 mg.
The use of the product is intended for adult patients.
The doctor will prescribe the minimum recommended dose. This dose will be gradually increased, taking
care not to exceed the maximum daily dose, for the shortest possible period.
If you suffer from anxiety, your doctor will regularly reassess your condition to consider the need to
continue treatment, especially if you do not have symptoms.

Duration of treatment
The overall duration of treatment should generally not exceed 8-12 weeks, including a
period of gradual discontinuation.
In the case of sleep disorders, the duration of treatment generally varies from a few days to two weeks,
including a period of gradual discontinuation.
In certain cases, the doctor may decide to extend beyond the maximum treatment period, after a
careful reassessment of your condition.

If you take more Pasaden than you should
Taking excessive doses of Pasaden, as with similar medicines, should not pose a risk to
life, unless other medicines that depress the Central Nervous System, including alcohol, have been taken simultaneously.
Overdosage manifests with a range of symptoms affecting the Central Nervous System, varying
from drowsiness and mental confusion in less severe cases to coma, rarely, and death, very
rarely. Furthermore, cases of lack of coordination of movements, hypotension (low
blood pressure), respiratory failure have been reported.
If you have accidentally taken an excessive dose of Pasaden, immediately inform your doctor or
go to the nearest hospital.
Treatment of overdose consists of immediate induction of vomiting if the patient is conscious and gastric
lavage with protection of the airways and possible administration of activated charcoal, to
reduce absorption, if the patient is unconscious.
Flumazenil can be used as an antidote (to cancel out the harmful effects of the medicine).

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pasaden is generally well tolerated. If the dose is not adjusted to individual needs, the following side effects may
occur:

• drowsiness (during the day if the product is used for sleep disorders);
• blunting of emotions (progressive reduction of intellectual and sensory liveliness);
• reduced alertness;
• confusion;
• speech disorders;
• fatigue;
• headache;
• dizziness;
• muscle weakness;
• lack of coordination of movements;
• double vision;
• thirst;
• nausea;
• skin rash (eruptions on the skin).

These phenomena usually occur at the beginning of therapy and usually disappear with
subsequent administrations.
Occasionally, other reactions have been reported, including:

• gastrointestinal disorders;
• changes in sexual desire;
• erythema (redness) and skin reactions;
• feeling of difficulty breathing;
• palpitations (rapid and irregular heartbeat);
• gynecomastia (development of breasts in men);
• hyperprolactinemia (increased levels of a hormone called prolactin in the blood);
• blepharospasms (involuntary contractions of the eyelid muscle). If you experience eye symptoms, such as excessive blinking, photophobia (sensitivity to light) and dry eyes, your doctor will intervene with appropriate therapy;
• sweating;
• edema (swelling caused by excessive fluid accumulation in the tissues);
• urinary disorders;
• nasal obstruction;
• anterograde amnesia (difficulty remembering new information), more likely with the use of higher doses.

Depression
In patients with pre-existing depressive state and in any case more frequently in children and the
elderly, the use of benzodiazepines can cause psychiatric and "paradoxical" (contrary to those expected) reactions
such as:

• restlessness;
• agitation;
• irritability;
• aggression;
• delirium;
• anger;
• nightmares;
• hallucinations (seeing or hearing things that are not present in reality);
• psychosis (a mental disorder characterized by detachment from reality);
• behavioral changes.

These reactions can be quite serious. They are more likely in children and the elderly.

Dependence
Physical dependence can develop; in this case, abrupt discontinuation of therapy can cause
rebound or withdrawal phenomena.
Psychological dependence can occur. Benzodiazepine abuse has been reported.

Contact your doctor immediatelyif you experience the following side effects (their frequency cannot
be established from the available data).

• respiratory depression, CO narcosis: in patients with severely impaired respiratory function, respiratory depression (reduced breathing due to alteration of the activity of the respiratory centers) and CO narcosis (a state of stupor and unconsciousness caused by increased levels of carbon dioxide in the blood) may occur. If you experience any of these symptoms, contact your doctor immediately and he will intervene with appropriate measures, such as airway control and ventilation.
• malignant syndrome: this syndrome, in addition to the administration of this medicine, can be caused by the concomitant use of antipsychotics and other medicines, by a sudden reduction in dosage and by discontinuation of administration. If fever, muscle rigidity, dysphagia (difficulty swallowing), tachycardia (fast heartbeat), changes in blood pressure, sweating, increased white blood cells or creatine phosphokinase in the blood occur, inform your doctor who will intervene with total body measures, such as cooling the body and hydration. In addition, if this syndrome occurs, renal dysfunction (poor kidney function) with myoglobinuria (reddish discoloration of urine due to the presence of myoglobin) may occur.
• rhabdomyolysis(an acute, potentially fatal disease that destroys skeletal muscle and damages the kidneys). This condition is characterized by myalgia (muscle pain), asthenia (lack of strength and energy), increased levels of myoglobin in the blood and the presence of myoglobin in the urine (causing the reddish discoloration of urine). If rhabdomyolysis occurs, discontinue the medicine and contact your doctor immediately, who will adopt appropriate therapeutic measures.
• interstitial pneumonia. Discontinue the medicine and have a chest X-ray if you experience fever, cough, dyspnea (difficulty breathing), crepitus and abnormal breath sounds. In these cases, your doctor may administer you adrenocortical hormones.
• impaired liver function, jaundice. Disorders of liver function indicated by the results of the following blood tests may occur: increased levels of aspartate aminotransferase (AST(GOT), alanine aminotransferase (ALT(GPT), gamma-glutamyl transferase (γ-GT), lactic dehydrogenase (LDH), alkaline phosphatase (ALP) and bilirubin, etc. and jaundice (yellowing of the skin and whites of the eyes). If the blood test results are abnormal, your doctor will carefully monitor your condition and, if necessary, advise you to discontinue treatment.

Reporting of side effects
If you get any side effects, see your doctor or pharmacist. You can also report side effects directly through the national
reporting system, at the address 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 Pasaden

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after expiry. The expiry date refers to the last day of that month. The expiry date refers to the product that is intact and
correctly stored .
Do not store above 25°C.
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 Pasaden contains
0.5 mg coated tablets:

• The active ingredient is: etizolam. Each coated tablet contains etizolam 0.5 mg.
• The other ingredients are: lactose, microcrystalline cellulose, corn starch, talc, magnesium stearate, polymethacrylic esters, macrogol 5/6000, polysorbate 80, sodium carboxymethylcellulose, silicone oil, Opadry Blue*. *Components of Opadry Blue: hypromellose, titanium dioxide, macrogol 400, Brilliant Blue FCF (E 133), Carmoisine (E 122).

1 mg coated tablets:

• The active ingredient is: etizolam. Each coated tablet contains etizolam 1 mg.
• The other ingredients are: lactose, microcrystalline cellulose, corn starch, talc, magnesium stearate, polymethacrylic esters, macrogol 5/6000, polysorbate 80, sodium carboxymethylcellulose, silicone oil, titanium dioxide.

Description of the appearance of Pasaden and contents of the pack
0.5 mg etizolam coated tablets: pack with 30 tablets.
1 mg etizolam coated tablets: pack with 20 tablets.

Marketing Authorisation Holder
Farmaka srl – Via Villapizzone, 26 – 20156 Milano, Italy

Manufacturer
Bayer Healthcare Manufacturing Srl - via delle Groane 126, Garbagnate Milanese (MI)