Package leaflet: Information for the patient

ESILGAN 1 mg tablets, 2 mg tablets

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

Contents of this leaflet:

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

1. What ESILGAN is and what it is used for

ESILGAN contains estazolam, an active substance belonging to a class of medicines called
"benzodiazepines".
ESILGAN is indicated in adults for the short-term treatment of insomnia (when you are unable to
sleep), in cases where this disorder is severe and causes significant distress in normal daily life.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ESILGAN

Do not take ESILGAN

If you are allergic to estazolam or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from a severe disease affecting the muscles and characterized by weakness and fatigue (severe myasthenia gravis).
If you suffer from severe reduction in respiratory system activity (severe respiratory insufficiency).
If you suffer from temporary cessation of breathing during sleep (sleep apnea syndrome).
If you suffer from a severe liver disease (severe hepatic insufficiency).
If you are in the first 3 months of pregnancy (see section 2. Pregnancy and breastfeeding).

ESILGAN is also contraindicated in pediatric age.
Warnings and precautions
Talk to your doctor or pharmacist before taking ESILGAN.
In particular, inform your doctor if:

you are debilitated;
you are elderly;
you suffer from a liver or kidney disease;
you suffer from reduced respiratory system activity (respiratory insufficiency);
you suffer from depression or anxiety associated with depression, because ESILGAN may worsen your condition and increase suicidal tendencies (attempts to kill oneself);
you have previously had problems with drug or alcohol abuse;
you suffer from a mental disorder causing altered perception of reality, thought disturbances, mental confusion (psychosis).

Tolerance development
After repeated use of ESILGAN for several weeks, a decrease in its effectiveness (tolerance) may occur.
Dependence development
The use of high doses and/or prolonged treatment with ESILGAN may lead to physical and psychological dependence, as occurs with other similar medicines. The risk increases with dose and duration of treatment and is greater if you have previously abused drugs or alcohol, as you are more prone to developing habituation and dependence. Pay special attention if dependence develops. In this case, do not stop treatment abruptly, as withdrawal symptoms may occur (see section 3 “If you stop taking ESILGAN”);
Anterograde amnesia
You may experience memory gaps (anterograde amnesia) even several hours after taking the medicine (see section 4 “Possible side effects”). To reduce this risk, ensure you have 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, delirium, anger, suicidal tendencies, sleep disturbances, as well as psychological reactions: nightmares, hallucinations, psychosis, and other behavioral disorders. If you experience these disturbances, consult your doctor, as treatment interruption may be necessary (see section 4 “Possible side effects”). These reactions are more frequent in children and the elderly.
After stopping treatment, "rebound insomnia" may occur, meaning you may experience more intensely the symptoms that led you to take this medicine (see section “If you stop taking ESILGAN”).
The duration of treatment should be as short as possible and must 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 doses and if your dose is high.
Children and adolescents
ESILGAN is contraindicated in pediatric age.
Other medicines and ESILGAN
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines together with ESILGAN, as caution is required when combining ESILGAN with medicines that reduce or block the activity of the central nervous system:

medicines used for certain mental illnesses (antipsychotics/neuroleptics)
calming and sleep-inducing medicines (hypnotics)
medicines causing physical and mental drowsiness (anxiolytics/sedatives)
medicines used to treat depression (antidepressants)
medicines used to treat severe acute or chronic pain (narcotic analgesics). Narcotic analgesics may increase euphoria, leading to increased psychological dependence
medicines used to treat epilepsy (antiepileptics)
medicines used to counteract allergic reactions (sedating antihistamines)
anesthetics
medicines inducing 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 muscle relaxation, which may lead to falls—often with serious consequences in the elderly—respiratory difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Esilgan together with opioids, the dose and duration of concomitant therapy must be limited by the doctor. Inform your doctor about all opioid-containing medicines you are taking and carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if these symptoms occur.
ESILGAN with alcohol
Do not consume alcohol during treatment with ESILGAN.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ESILGAN during the first 3 months of pregnancy.
After the first 3 months of pregnancy, ESILGAN will be prescribed only if absolutely necessary and under direct medical supervision. If, for serious health reasons, your doctor decides to prescribe this medicine during the last stage of pregnancy or during labor at high doses, the newborn may experience serious adverse effects, including low body temperature (hypothermia), muscle weakness (hypotonia), and breathing difficulties (“Floppy Infant Syndrome” or infantile hypotonia).
Moreover, if ESILGAN has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence or withdrawal symptoms.
Breastfeeding
Since ESILGAN passes into breast milk, do not take it during breastfeeding.
Driving and use of machines
ESILGAN impairs the ability to drive vehicles and operate machinery.
Do not drive or operate machinery if, during treatment with ESILGAN, you experience side effects such as sedation (physical and mental relaxation with dizziness), amnesia (memory disturbances), impaired concentration, or altered muscle function, which may be induced by taking ESILGAN. Your alertness may be impaired, especially if you have not slept long enough (7–8 hours) after taking ESILGAN.
ESILGAN contains lactose
ESILGAN contains lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take ESILGAN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose and frequency for you, depending on your age, symptoms, and general health condition.
The recommended dose is generally:
◼ for mild insomnia and in elderly patients: 0.5–2 mg (corresponding to a quarter of a 2 mg tablet, or 1 tablet of 1 mg or 1 tablet of 2 mg) in the evening before bedtime;
◼ for persistent insomnia or insomnia related to nervous or somatic diseases: 2–4 mg (corresponding to 1–2 tablets of 2 mg) in 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, ensure that you have an uninterrupted sleep of 7–8 hours.
Your doctor may reduce your dose if:

you are debilitated;
you are elderly;
you have a mental, mood, or behavioural disorder caused by disease (organic brain changes);
you have liver or kidney disease;
your heart is unable to supply adequate blood flow to meet the body's needs (cardiorespiratory failure);
you have reduced respiratory activity (chronic respiratory insufficiency).

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

If you take more ESILGAN than you should
In case of accidental ingestion/overdose of ESILGAN, contact your doctor immediately or go to the nearest hospital.
Symptoms
There is no life-threatening risk if you accidentally take a higher dose of ESILGAN, unless you also consume alcohol or other medicines at the same time.
In mild cases, symptoms of accidental overdose may include:

blurred senses (obnubilation);
mental confusion;
prolonged drowsiness and reduced response to normal stimuli (lethargy).
In more severe cases, symptoms may include:
reduced motor coordination and gait (ataxia);
decreased muscle tone (hypotonia);
low blood pressure (hypotension);
reduced breathing (respiratory depression);
coma;
death.

Treatment
Your doctor, after evaluating your symptoms, will provide appropriate supportive therapy (e.g. inducing vomiting, activated charcoal, and/or gastric lavage).
Flumazenil may also be administered as an antidote.

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

If you stop taking ESILGAN
Do not stop treatment with ESILGAN without first consulting your doctor.

Your doctor will gradually reduce your dose during the discontinuation phase.
Abruptly stopping this medicine may cause:
- withdrawal symptoms, such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, you may experience feeling detached from reality (derealization), feeling detached from your body (depersonalization), increased sensitivity to sounds (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical touch, hallucinations, or uncontrolled body movements accompanied by loss of consciousness (epileptic seizures). You may experience these symptoms even between doses, especially if the dosage is high.
- rebound symptoms (when the symptoms that led to treatment with ESILGAN return in a more severe form after stopping treatment), such as mood changes, anxiety, restlessness, or sleep disturbances.
These symptoms are especially likely if you have developed physical dependence on this medicine (see section “Warnings and precautions”).

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 everybody gets them.
Immediately contact your doctor, who will stop treatment immediately, if you experience any of the following side effects while using
ESILGAN:

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

These reactions are so-called "paradoxical" reactions and are more frequent in elderly patients and children.
Additionally, 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 estimated from the available data):

daytime drowsiness
reduced alertness
headache
dizziness
reduced motor coordination and impaired gait (ataxia)
muscle weakness
double vision
fatigue
lack of emotional sensitivity (emotional blunting)
confusion

Further side effects of unknown frequency may include:

stomach and intestinal disorders
changes in sexual desire (changes in libido)
skin reactions
skin rashes
itching
nausea
dry mouth
constipation
reduced breathing (respiratory depression)
memory disturbances (anterograde amnesia). This side effect may also occur at the recommended therapeutic doses; the risk increases with higher doses. This effect may be associated with behavioural disturbances. This effect often occurs several hours after taking the medicine; therefore, to reduce the risk, before taking this medicine you must ensure you have an uninterrupted sleep period of 7–8 hours (see section 3. “How to take ESILGAN”).
dependence:
- physical dependence. If you have developed physical dependence on this medicine, the risk increases that you will experience withdrawal symptoms and/or rebound symptoms when stopping treatment (see section “If you stop treatment with ESILGAN”);
- psychological dependence. The risk of developing dependence increases with higher doses and longer duration of treatment, and if you have previously abused drugs or alcohol (see section “Warnings and precautions”).

If you suffer from depression, ESILGAN may worsen your condition and increase suicidal tendencies (attempting to kill yourself).
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 the following website: 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 special storage conditions.
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 Exp.
The expiry date refers to the last day of that month.
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 ESILGAN contains
ESILGAN 1 mg tablets

The active substance 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 substance 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 package contents
ESILGAN 1 mg is presented as white, round tablets with flat surfaces, marked with "1" on one side.
ESILGAN 2 mg is presented as white, round tablets with flat surfaces, marked with "2" on one side and a cross-score on the other side.
Available pack sizes:
1 mg 30 tablets
2 mg 30 divisible tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 24 - 17489 Greifswald, Germany
Manufacturer
Delpharm Novara S.r.l. - Via Crosa 86 - Cerano (NO)