Estazolam Espefa

Leaflet attached to the packaging: patient information

Estazolam Espefa, 2 mg, tablets

Estazolam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Estazolam Espefa and what is it used for
• 2. Important information before taking Estazolam Espefa
• 3. How to take Estazolam Espefa
• 4. Possible side effects
• 5. How to store Estazolam Espefa
• 6. Contents of the packaging and other information

1. What is Estazolam Espefa and what is it used for

Estazolam Espefa belongs to the group of benzodiazepines. The medicine has a sedative effect, making it easier to fall asleep.
In a small degree, it reduces skeletal muscle tension and has a weak anticonvulsant effect.

Indications for use:

Short-term treatment of sleep disorders such as: difficulty falling asleep, frequent nighttime awakenings,
early morning awakenings.

2. Important information before taking Estazolam Espefa

When not to take Estazolam Espefa:

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of the medicine (listed in section 6);
• if the patient has myasthenia gravis (a disease characterized by excessive muscle weakness);
• if the patient has severe respiratory failure;
• if the patient has severe liver failure;
• if the patient has sleep apnea syndrome (a disease characterized by pauses in breathing during sleep, so-called apnea, lasting longer than 10 seconds);
• if the patient has glaucoma with closed-angle filtration;
• in women during pregnancy and breastfeeding.

Warnings and precautions

Before starting treatment with Estazolam Espefa, the patient should inform their doctor:

• if they have a history of mental illness;
• if they have been treated for addiction, e.g. to drugs or alcohol;
• if they have liver failure;
• if they have kidney failure;
• if they have respiratory failure (characterized by: shortness of breath, blue discoloration of the skin, wheezing);
• if they are elderly (over 65 years old), as there is a greater risk of increased side effects (see section 4: Possible side effects).

If insomnia persists or worsens after 7-10 days of treatment, the patient should inform their doctor.
If paradoxical reactions occur, i.e. anxiety, agitation, irritability, aggressive behavior,
delusions, nightmares, hallucinations, and other changes in behavior, the medicine should be discontinued immediately.
If treatment is long-term, the doctor will prescribe regular blood and urine tests.
If the medicine has been used for a long time, i.e. longer than 4 weeks, it should be discontinued under medical supervision (see section: Discontinuation of Estazolam Espefa).
Long-term use of Estazolam Espefa may cause physical and psychological dependence.

Estazolam Espefa and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Estazolam Espefa enhances the effect of the following medicines and should not be taken at the same time:

• medicines used for general anesthesia;
• psychotropic medicines (used to treat, among others, schizophrenia);
• antihistamine medicines (used to treat allergies);
• other sedatives;
• medicines used to treat depression and anxiety;
• medicines used to treat epilepsy;
• opioid analgesics (e.g. codeine, morphine), as there is a risk of psychological dependence.

Medicines that may enhance the effect of Estazolam Espefa:

• cimetidine - a medicine used to treat stomach and duodenal ulcers;
• erythromycin - an antibiotic.

Medicines that may weaken the effect of Estazolam Espefa:

• oral contraceptives.

Smoking weakens the effect of Estazolam Espefa.

Using Estazolam Espefa with food, drinks, and alcohol

During treatment with Estazolam Espefa and up to 3 days after its completion, the patient should not consume
any alcoholic beverages.
Alcohol enhances the sedative effect of the medicine and increases the risk of paradoxical reactions
(see section 4: Possible side effects).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Estazolam Espefa should not be used during pregnancy. The medicine passes through the placenta and may be
harmful to the unborn child.
Taking the medicine in the last three months of pregnancy and during childbirth may cause the child to experience
hypothermia (excessive lowering of body temperature below 36°C), decreased blood pressure, and respiratory disorders.
Estazolam Espefa passes into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

During treatment with Estazolam Espefa and up to 3 days after its completion, the patient should not drive
vehicles or operate machinery.

Estazolam Espefa contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Estazolam Espefa

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
The medicine should be taken orally.
The dose and duration of treatment are determined by the doctor.
The dose size depends on the patient's age and their reaction to the medicine.
Do not exceed the recommended dose of the medicine.

Usual dose of the medicine:

For the treatment of sleep disorders:
half a tablet or 1 tablet (1 mg to 2 mg) 30 minutes before bedtime.

Use in children and adolescents

Estazolam Espefa should not be used in children and adolescents under the age of 18.

Use in elderly patients (over 65 years old)

The use of this medicine will be decided by the doctor.

Use in patients with liver and/or kidney failure

The use of this medicine will be decided by the doctor.

Taking a higher dose of Estazolam Espefa than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately inform their doctor or pharmacist.
The following symptoms of overdose may occur:

• drowsiness;
• disorientation;
• unsteady gait, difficulty maintaining balance;
• significant decrease in blood pressure;
• respiratory disorders (shallow irregular breathing, decreased breathing frequency);
• rarely, coma.

Overdose of Estazolam Espefa and alcohol or Estazolam Espefa and other central nervous system depressants can be life-threatening.
In case of overdose, the patient should be taken to the hospital immediately.

Missing a dose of Estazolam Espefa

The patient should not take a double dose to make up for a missed dose.

Discontinuation of Estazolam Espefa

The patient should not stop taking the medicine on their own. The doctor will decide on a gradual reduction in dose.
Sudden discontinuation of the medicine may cause withdrawal symptoms:

• insomnia;
• headaches;
• muscle pain;
• increased anxiety, restlessness;
• increased restlessness;
• disorientation and irritability.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Estazolam Espefa can cause side effects, although not everybody gets them.
The frequency of side effects increases when the recommended doses are exceeded.
The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• unknown: (frequency cannot be estimated from the available data).

Common side effects:

• drowsiness during the day, drowsiness;
• headaches, dizziness;
• nervousness;
• thinking disorders;
• disorientation;
• prolonged reaction time;
• nausea, constipation;
• anxiety;
• dry mouth;
• malaise, fatigue, general weakness.

Rare side effects:

• inability to learn and remember new information (anterograde amnesia);
• loss of interests, apathy;
• sleep disorders (difficulty falling asleep, frequent awakenings);
• unsteady gait, difficulty maintaining balance;
• decreased libido;
• vomiting, bloating;
• sudden mood changes (sudden outbursts of anger, crying, joy);
• paradoxical reactions (aggressive behavior, insomnia, irritability, delusions - false beliefs, nightmares, changes in behavior);
• hallucinations (perception of non-existent objects or people);
• rash (itchy, red bumps on the skin);
• urticaria (light red itchy blisters on the skin);
• feeling of rapid or slow heartbeat;
• fainting;
• increased thirst;
• changes in appetite, changes in taste;
• decreased or increased body weight;
• muscle cramps, joint and muscle pain;
• cough, difficulty breathing;
• vision disorders;
• menstrual disorders;
• decreased white blood cell count (leukopenia and agranulocytosis).

In elderly patients (over 65 years old), side effects may be more severe.

Particularly dangerous may be: difficulty maintaining balance, muscle weakness, and a feeling of general weakness.
These can cause falls and dangerous bone fractures in these individuals.

Long-term use of the medicine may cause physical and psychological dependence.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products,
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Estazolam Espefa

The medicine should be stored in a place that is out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Estazolam Espefa contains:

• The active substance of the medicine is estazolam. One tablet contains 2 mg of estazolam.
• The other ingredients (excipients) are: cornstarch, microcrystalline cellulose, lactose monohydrate, potato starch, magnesium stearate, talc.

What Estazolam Espefa looks like and what the packaging contains

The packaging contains 20 or 28 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA,
J. Lea 208, 30-133 Kraków
Phone: 12 639 27 27

Information for the blind and visually impaired: 800-007-777

Date of last update of the leaflet:

• 19.04.2023