Estazolam espefa

Patient Information Leaflet

Estazolam Espefa, 2 mg, tablets
Estazolamum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Estazolam Espefa is and what it is 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 pack and other information

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

Estazolam Espefa belongs to the group of medicines called benzodiazepines. It has a hypnotic effect, facilitating sleep onset.
It also mildly reduces skeletal muscle tension and has a weak anticonvulsant action.
Indications:
Short-term and transient treatment of sleep disorders such as: difficulty falling asleep, frequent nocturnal awakenings, early morning awakenings.

2. Important information before using Estazolam Espefa

When not to use Estazolam Espefa:

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

Warnings and precautions
Before starting treatment with Estazolam Espefa, the patient should inform the doctor:

• if they have diagnosed mental disorders;
• if they have previously been treated for addiction, e.g. to drugs or alcohol;
• if they have hepatic insufficiency;
• if they have renal insufficiency;
• if they have respiratory insufficiency (manifested, among others, by shortness of breath, bluish skin discoloration, wheezing);
• if they are elderly (over 65 years of age), as there is an increased risk of intensified adverse effects (see section 4: Possible side effects).

If insomnia persists or worsens after 7–10 days of treatment, the patient should inform the doctor.
If paradoxical reactions occur, such as anxiety, excitement, irritability, aggressive behaviour, delusions, nightmares, hallucinations, psychosis, or other behavioural changes, the medicine should be discontinued immediately.
If treatment is prolonged, the doctor will order regular blood and urine tests.
If the medicine has been used long-term, i.e. longer than 4 weeks, it should be discontinued under medical supervision (see section: Discontinuation of treatment with Estazolam Espefa).
Long-term use of Estazolam Espefa may lead to physical and psychological dependence.

Estazolam Espefa and other medicines
The patient should inform the doctor about all medicines currently used or recently taken, as well as any medicines planned for future use.
Estazolam Espefa enhances the effects of the following medicines and should not be taken simultaneously with them:

• medicines used for general anaesthesia;
• psychotropic medicines (used in the treatment of, among others, schizophrenia);
• antihistamines (used in the treatment of allergies);
• other hypnotic medicines;
• medicines used in the treatment of depression and anxiety;
• medicines used in the treatment of epilepsy;
• opioid analgesics (e.g. codeine, morphine), due to the risk of psychological dependence.

Medicines that may enhance the effect of Estazolam Espefa:

• cimetidine – a medicine used in the treatment of peptic ulcer disease of the stomach and duodenum;
• erythromycin – an antibiotic.

Medicines that may reduce the effect of Estazolam Espefa:

• oral contraceptives.

Smoking reduces the effect of Estazolam Espefa.

Taking Estazolam Espefa with food, drink, and alcohol
During treatment with Estazolam Espefa and for 3 days after discontinuation, alcoholic beverages should not be consumed.
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 she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Estazolam Espefa should not be used during pregnancy. The medicine crosses the placenta and may be harmful to the unborn child.
Taking the medicine during the last three months of pregnancy and during delivery may cause hypothermia (excessive lowering of body temperature below 36°C), low blood pressure, and breathing difficulties in the newborn.
Estazolam Espefa passes into breast milk; therefore, it should not be used during breastfeeding.

Driving and operating machinery
During treatment with Estazolam Espefa and for 3 days after discontinuation, the patient should not drive or operate machinery.

Estazolam Espefa contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

3. How to use Estazolam Espefa

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor or pharmacist.
The medicine should be taken orally.
The dosage and duration of treatment are determined by the doctor.
The dose depends on the patient's age and individual response to the medicine.
Do not exceed the recommended dose.
The usual dose is:
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 18 years of age.
Use in elderly patients (over 65 years of age)
The decision on using this medicine will be made by the doctor.
Use in patients with liver and/or kidney impairment
The decision on using this medicine will be made by the doctor.
Taking a higher than recommended dose of Estazolam Espefa
If a higher than recommended dose has been taken, inform your doctor or pharmacist immediately.
Symptoms of overdose may include:

• drowsiness;
• disorientation;
• unsteady gait, difficulty maintaining balance;
• significant drop in blood pressure;
• breathing difficulties (shallow, irregular breathing, reduced respiratory rate);
• rarely, coma.

Life-threatening poisoning may occur when Estazolam Espefa is combined with alcohol or with other medicines acting on the central nervous system.
In case of poisoning with Estazolam Espefa, the patient should be taken to hospital immediately.
Missed dose of Estazolam Espefa
Do not take a double dose to make up for a missed dose.
Stopping treatment with Estazolam Espefa
Do not stop taking this medicine on your own. Your doctor will decide on gradually reducing the dose.
Suddenly stopping the medicine may lead to withdrawal symptoms:

• insomnia;
• headache;
• muscle pain;
• increased anxiety, restlessness;
• excessive activity;
• disorientation and irritability.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions increases when recommended doses are exceeded.
The frequency of the possible adverse reactions listed below is defined as follows:

• very common: (occurs in more than 1 in 10 people);
• common: (occurs in 1 to 10 people in 100);
• uncommon: (occurs in 1 to 10 people in 1,000);
• rare: (occurs in 1 to 10 people in 10,000);
• very rare: (occurs in less than 1 person in 10,000);
• not known: (frequency cannot be determined from available data).

Common adverse reactions:

• daytime drowsiness, somnolence;
• headache, dizziness;
• nervousness;
• disturbances in thinking;
• disorientation;
• prolonged reaction time;
• nausea, constipation;
• anxiety;
• dry mouth;
• malaise, fatigue, general weakness.

Rare adverse reactions:

• inability to learn and remember new information (anterograde amnesia);
• loss of interest, passivity (apathy);
• sleep disturbances (difficulty falling asleep, frequent awakening);
• unsteady gait, difficulty maintaining balance;
• decreased libido;
• vomiting, bloating;
• sudden mood changes (sudden outbursts of anger, crying, joy);
• paradoxical reactions (aggressive behaviour, insomnia, irritability, delusions – false beliefs, nightmares, behavioural changes);
• hallucinations (perception of non-existent objects or people);
• rash (itchy, red skin bumps);
• urticaria (bright pink, itchy wheals on the skin);
• sensation of fast or slow heartbeat;
• fainting;
• increased thirst;
• change in appetite, altered taste;
• decrease or increase in body weight;
• muscle cramps, joint and muscle pain;
• cough, breathing difficulties;
• visual disturbances;
• menstrual disorders;
• decreased white blood cell count (leukopenia and agranulocytosis).

In elderly patients (over 65 years of age), adverse effects may be more pronounced.
Particularly dangerous may be: difficulty maintaining balance, decreased muscle tone,
and general weakness. These may lead to falls and dangerous bone fractures in such
individuals.
Long-term use of the medicine may lead to physical and psychological dependence.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Estazolam Espefa

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Estazolam Espefa contains:

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

What Estazolam Espefa looks like and contents of the pack
The pack contains 20 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA,
J. Lea 208 Street, 30-133 Kraków
Tel.: 12 639 27 27
Information for the blind and visually impaired: 800-007-777
19.04.2023