ESILGAN 1 mg Tablet

Зміст інструкції

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

ESILGAN 1 mg tablets, 2 mg tablets

Estazolam

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

1. What is ESILGAN and what is it used for

ESILGAN contains estazolam, an active ingredient belonging to the class of medicines called
“benzodiazepines”.
ESILGAN is indicated in adultsfor the short-term treatment of insomnia (when you are unable to
fall asleep), in cases where this disorder is severe and causes significant distress in normal daily life.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take ESILGAN

Do not take ESILGAN

• If you are allergic to estazolam or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a severe illness that affects the muscles and manifests with weakness and fatigue (myasthenia gravis).
• If you suffer from severe impairment of respiratory function (severe respiratory failure).
• If you suffer from temporary cessation of breathing during sleep (sleep apnea syndrome).
• If you suffer from severe liver disease (severe hepatic failure).
• If you are in the first 3 months of pregnancy (see section 2. Pregnancy and breastfeeding).

ESILGAN is also contraindicated in children.

Warnings and precautions
Talk to your doctor or pharmacist before taking ESILGAN.
In particular, tell your doctor if:

• you are debilitated;
• you are elderly;
• you suffer from a liver or kidney disease;
• you suffer from impaired respiratory function (respiratory failure);
• you suffer from depression or anxiety associated with depression, because ESILGAN may worsen your condition and the tendency to suicide (attempting to kill yourself);
• you have had problems with drug or alcohol abuse in the past;
• you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis).

Development of tolerance
Following repeated use of ESILGAN for several weeks, a decrease
in its effectiveness (tolerance) may occur.

Development of dependence
The use of high doses and/or for prolonged periods of ESILGAN can cause physical and psychological dependence,
as can happen with other similar medicines. The risk increases based on the dose and duration of
treatment and is greater if you have previously abused drugs or alcohol, as you are more likely to
develop habit and dependence. Pay particular attention if you experience dependence. In this
case, you should not abruptly stop treatment with this medicine, as withdrawal symptoms may occur (see section 3 “If you stop taking
ESILGAN ”);

Anterograde amnesia
You may experience memory lapses (anterograde amnesia) even several hours after taking
the medicine (see section 4 “Possible side effects”). To reduce this risk, make sure
you get an uninterrupted sleep of 7-8 hours after taking ESILGAN.

Psychiatric and paradoxical reactions
You may experience behavioral disturbances (psychiatric and paradoxical reactions) such as restlessness,
agitation, irritability, aggression, anxiety, delusion, anger, suicidal tendencies, sleep disturbances, as well as psychological reactions: nightmares, hallucinations, psychosis and other behavioral disturbances. If you experience these disturbances, consult your doctor as treatment needs to be stopped (see section 4 “Possible side effects”). These reactions are more common
in children and the elderly.
After stopping treatment, “rebound insomnia” may occur, i.e. you may experience, in
a more intense way, the symptoms that led you to take this medicine (see the section
“If you stop taking ESILGAN”).
The duration of treatment should be as short as possible and should not exceed 4 weeks. Treatment with this medicine will be discontinued by gradually reducing the dose to
minimize the occurrence of withdrawal symptoms (see section 3 “If you stop taking
ESILGAN”). However, you may still experience these symptoms, especially between taking
one dose and the next, and if the dose you are taking is high.

Children and adolescents
ESILGAN is contraindicated in children.

Other medicines and ESILGAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking any of the following medicines together with ESILGAN because
caution is required when combining ESILGAN with medicines that reduce and block the activity of the
central nervous system:

• medicines used for some mental illnesses (antipsychotics/neuroleptics)
• medicines that calm and induce sleep (hypnotics)
• medicines that cause physical and mental torpor (anxiolytics/sedatives)
• medicines used to treat depression (antidepressants)
• medicines for the treatment of acute or chronic severe pain (narcotic analgesics). Narcotic analgesics can cause an increase in euphoria leading to an increase in psychological dependence
• medicines used to treat epilepsy (antiepileptics)
• medicines used to counteract allergic reactions (sedative antihistamines)
• anesthetics
• medicines that induce muscle relaxation (muscle relaxants)
• medicines containing ritonavir.

The concomitant use of Esilgan and opioids (strong painkillers, medicines for substitution therapy and some
cough medicines) increases the risk of drowsiness and/or a relaxing effect on muscle tone
that can lead to falls often with serious consequences in the elderly, respiratory distress
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not possible.
However, if the doctor prescribes Esilgan together with opioids, the dose and duration of concomitant therapy must be limited by the doctor. Tell your doctor about all opioid-based medicines
you are taking and carefully follow your doctor's recommendations on dosage. It may be
helpful to inform friends or relatives to pay attention to the signs and symptoms described above. Contact your
doctor when these symptoms occur.

ESILGAN with alcohol
Do not drink alcohol during treatment with ESILGAN.

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

Do not take ESILGAN in the first 3 months of pregnancy.
After the first 3 months of pregnancy, ESILGAN will only be prescribed to you if absolutely necessary and
under the direct supervision of your doctor. If, for serious health reasons, your doctor decides to prescribe
this medicine during the last period of pregnancy or during labor at high doses, the
newborn may experience adverse effects, even serious ones, a low body temperature
(hypothermia), muscle weakness (hypotonia) and difficulty breathing (“Floppy Infant
Syndrome” or infant hypotonia).
In addition, if ESILGAN has been taken regularly during the last stages of pregnancy, your
baby may experience physical dependence or withdrawal symptoms.
Breastfeeding
Because ESILGAN passes into breast milk, do not take it during breastfeeding.

Driving and using machines
ESILGAN impairs the ability to drive vehicles and operate machinery.
Do not drive or operate machinery if you experience side effects during treatment with ESILGAN
such as sedation (physical and mental relaxation with dizziness), amnesia (memory disorders),
impaired concentration and muscle function, which may be induced
by taking ESILGAN. Your vigilance may be altered especially if you have not slept for
enough time (7-8 hours) after taking ESILGAN.

ESILGAN contains lactose
ESILGAN contains lactose (milk sugar).
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take ESILGAN

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have doubts, consult your doctor or pharmacist.
The doctor will establish the dose and frequency of administration most suitable for you, depending on your age, your
symptoms and your general state of health.
The recommended dose is generally:
◼ mild insomnia and in elderly patients: 0.5-2 mg (corresponding to a quarter of a 2 mg tablet, or 1 1 mg tablet or 1 2 mg tablet) the evening before bedtime;
◼ persistent insomnia or related to nervous or somatic diseases: 2-4 mg (corresponding to 1-2
2 mg tablets) the evening before bedtime.
The 2 mg tablet can be divided into equal parts.
In general, start treatment with the lowest recommended dose and do not exceed the maximum recommended dose.
After taking this medicine, make sure you have 7-8 hours of uninterrupted sleep.
The doctor may reduce your dose if:

• you are debilitated;
• you are elderly;
• you suffer from an alteration of mental state, mood or behavior caused by an illness (cerebral organic changes);
• you suffer from a liver or kidney disease;
• your heart fails to provide blood in an adequate quantity compared to the actual request of the body (cardiorespiratory insufficiency);
• you suffer from a reduction in respiratory activity (chronic respiratory insufficiency).

Duration of treatment
The doctor will prescribe you the shortest possible duration of treatment.
Generally the duration of treatment varies from a few days to 2 weeks, up to a maximum of 4
weeks, including a period of gradual withdrawal.
At the beginning of treatment with ESILGAN, the doctor will explain how to gradually reduce the dose
of this medicine in order to reduce the risk of developing withdrawal and rebound symptoms
(see paragraphs “If you stop taking ESILGAN” and “Possible side effects”).
In certain cases the doctor, after re-evaluating your health status, may decide to extend
the duration of treatment as indicated above.

If you take more ESILGAN than you should
In case of accidental ingestion/administration of an excessive dose of ESILGAN, immediately warn
your doctor or go to the nearest hospital.

Symptoms
There are no life-threatening risks if you accidentally take a dose of medicine higher than
that prescribed, unless you also take alcohol or other medicines at the same time.
In mild cases, the symptoms in case of accidental ingestion/administration of an excessive dose of
ESILGAN may be:

• confusion;
• mental confusion;
• continuous sleep and reduced response to normal stimuli (lethargy). In more severe cases, the symptoms may be:
• reduced motor and gait coordination (ataxia);
• reduced muscle tone (hypotonia);
• low blood pressure (hypotension);
• reduced breathing (respiratory depression);
• coma;
• death.

Treatment
The doctor, after evaluating the symptoms, will carry out the appropriate supportive therapy (for example with
inducing vomiting, activated charcoal and/or gastric lavage).
He/she may also administer flumazenil as an antidote.

If you forget to take ESILGAN
Do not take a double dose to make up for a missed dose.

If you stop taking ESILGAN
Donot stop treatment with ESILGAN without first consulting your doctor.

• The doctor will gradually reduce your dose during the phase of suspension of therapy.
• Abrupt interruption of this medicine can cause:
• withdrawal symptomssuch as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, feelings of unreality (derealization), feeling detached from one's body (depersonalization), increased sensitivity to sounds (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or uncontrolled body movements accompanied by loss of consciousness (seizures) may occur. You may experience these symptoms also in the interval between 2 doses, especially if the dosage is high.
• rebound symptoms(when the symptoms that led to treatment with ESILGAN reappear in a more severe form after stopping treatment) such as mood changes, anxiety, restlessness or sleep disturbances.
• These symptoms occur especially if you have developed physical dependence on this medicine (see paragraph “Warnings and precautions”).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately, who will immediately stop the treatment, if you experience any of the following side effects during the use of
ESILGAN:

• restlessness
• agitation
• irritability
• aggression
• delusion
• rage
• nightmares
• perception of things that do not exist in reality (hallucinations)
• mental disorder that causes an altered perception of reality, thought disorders, confusion (psychosis)
• behavioural changes
• suicidal tendencies
• sleep disturbances
• muscle cramps

These reactions are so-called “paradoxical” and are more frequent in the elderly and in children.
In addition, you may experience the following side effects for which the frequency is unknown.
These side effects occur mainly at the beginning of therapy and usually
disappear with subsequent administrations:

Frequency not known(the frequency cannot be defined based on available data):

• drowsiness during the day
• reduced alertness
• headache
• dizziness
• reduced motor and gait coordination (ataxia)
• muscle weakness
• double vision
• fatigue
• lack of emotional sensitivity (blunting of emotions)
• confusion Further side effects with unknown frequency may be:
• stomach and intestinal disorders
• altered sexual desire (changes in libido)
• skin reactions
• skin rashes
• itching
• nausea
• dry mouth
• constipation
• reduced breathing (respiratory depression)
• memory problems (anterograde amnesia). This side effect can also occur at the recommended therapeutic doses, the risk increases with higher doses. This effect may be associated with behavioural disorders. This effect occurs more often several hours after taking the medicine and therefore, to reduce the risk, before taking this medicine you must ensure you have a sufficient uninterrupted period of sleep of 7-8 hours (see section 3. “How to take ESILGAN”).
• dependence:
• physical dependence. If you have developed physical dependence on this medicine, you increase the risk of experiencing withdrawal symptoms and/or rebound symptoms during the discontinuation phase of treatment (see the section “If you stop taking ESILGAN”);
• psychological dependence. The risk of developing dependence increases with increasing dose and duration of treatment, and if you have previously abused drugs or alcohol (see the section “Warnings and precautions”).

If you suffer from depression, ESILGAN may worsen your condition and suicidal tendencies (attempting
to kill yourself).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 ESILGAN

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
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 ESILGAN contains

ESILGAN 1 mg tablets

• The active ingredient is estazolam. Each tablet contains 1 mg of estazolam.
• The other ingredients are lactose(see section 2 ESILGAN contains lactose), corn starch, hydroxypropylcellulose, magnesium stearate

ESILGAN 2 mg tablets

• The active ingredient is estazolam. Each tablet contains 2 mg of estazolam.
• The other ingredients are lactose(see section 2 ESILGAN contains lactose), corn starch, hydroxypropylcellulose, magnesium stearate

Description of the appearance of ESILGAN and contents of the pack
ESILGAN 1 mg presents as round, white tablets with flat surfaces and with
“1” inscribed on one side.
ESILGAN 2 mg presents as round, white tablets with flat surfaces, with
“2” inscribed on one side and with a cross-shaped score line on the other side.
It is available in the following packs:
1 mg 30 tablets
2 mg 30 divisible tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 24 - 17489 Greifswald, Germany

Manufacturer
Delpharm Novara S.r.l. - V. Crosa 86 - Cerano (NO)