Patient Information Leaflet

ESTAZOLAM POLFARMEX, 2 mg, tablets
Estazolamum
Please read all of this leaflet carefully before taking this medicine, as it contains important information
for you.

Keep this leaflet, as you may need to read it again.
Ask your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm someone else, even if their symptoms are the same.
If any of the side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents:

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

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

Estazolam belongs to the group of benzodiazepines; it has a hypnotic effect, facilitates sleep onset, mildly reduces skeletal muscle tension, and has weak anticonvulsant activity.
Estazolam primarily shortens the time to fall asleep, with a weaker effect on prolonging total sleep duration.
After oral administration, it is rapidly absorbed from the gastrointestinal tract. Estazolam is metabolized in the liver and excreted in the urine.
Estazolam Polfarmex is indicated for:

Short-term and immediate treatment of sleep disorders (difficulty falling asleep, frequent nocturnal awakenings, early morning awakenings).

2. Important information before using Estazolam Polfarmex

When not to use Estazolam Polfarmex:

if the patient is allergic to the active substance, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
if the patient has myasthenia gravis;
if the patient has severe respiratory insufficiency;
if the patient has severe liver insufficiency;
if the patient has sleep apnoea syndrome;
if the patient has closed-angle glaucoma;
during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Estazolam Polfarmex, consult a doctor or pharmacist.
States of tension and anxiety related to everyday problems are not an indication for the use of estazolam.
Patients who are using the medicine long-term or using high doses should remain under continuous medical supervision. Long-term use of the medicine leads to a gradual weakening of its effect due to the development of tolerance.
Persistence or worsening of insomnia after 7–10 days of treatment may indicate an underlying condition and should prompt a reassessment of the diagnosis.
Long-term use of estazolam may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer duration of treatment, as well as in patients who abuse alcohol or drugs. Sudden discontinuation of the medicine after prolonged use of high doses may cause withdrawal syndrome, with symptoms such as insomnia, headache, muscle pain, increased anxiety and tension, psychomotor agitation, confusion, and irritability. In severe cases, the following may occur: depersonalization (feeling of altered personality); derealization (altered perception of reality); auditory hypersensitivity; numbness and tingling of limbs; hypersensitivity to light, noise, and touch; hallucinations or epileptic seizures. The severity of withdrawal symptoms depends on the duration of treatment and the dose used. In patients who have used high doses or have used the medicine for longer than 4 weeks, the medicine should be discontinued gradually under medical supervision by tapering the dose.
Estazolam should be used with particular caution in patients with psychiatric disorders following detoxification therapy after overdose, e.g. of drugs. Particular caution is advised in patients with liver insufficiency, renal insufficiency, and in patients over 65 years of age. In these patients, a reduced initial dose is recommended, with individual dose adjustment according to the patient's condition. In elderly patients, the risk of adverse effects increases, particularly disturbances in orientation and motor coordination.
Estazolam may worsen respiratory insufficiency; caution is advised in patients with respiratory disorders, and the lowest recommended doses should be used.
The medicine should be discontinued if paradoxical reactions occur (psychomotor agitation, insomnia, irritability, delusions, nightmares, hallucinations, psychoses, changes in behavior). The medicine may cause anterograde amnesia, especially if less than 7–8 hours of sleep are achieved after taking the medicine.
There are no data on the safety and efficacy of the medicine in children and adolescents under 18 years of age.
During long-term treatment with estazolam, periodic blood tests (complete blood count with smear) and urine analysis are recommended.
During treatment with estazolam and for 3 days after its discontinuation, alcoholic beverages should not be consumed.
Consult a doctor, even if the above warnings refer to conditions that occurred in the past.

Other medicines and Estazolam Polfarmex
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Alcohol enhances the hypnotic effect of estazolam and increases the risk of paradoxical reactions (psychomotor agitation, aggression, irritability).
Estazolam enhances the effect of agents that depress the central nervous system (general anesthetics, neuroleptics, antihistamines with sedative properties, as well as hypnotics, anxiolytics, antidepressants, anticonvulsants), and increases the euphoric effect of opioid analgesics, thereby increasing the risk of psychological dependence.
Drugs that inhibit the cytochrome P450 system (e.g. cimetidine, erythromycin) may enhance the effects of benzodiazepine derivatives. Oral contraceptives accelerate the metabolism of estazolam; simultaneously, their use may reduce the effectiveness of estazolam. Tobacco smoking reduces the effect of the medicine.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Estazolam Polfarmex is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
Patients should not drive or operate machinery during treatment with this medicine.

Estazolam Polfarmex contains excipients – lactose monohydrate and sodium
This medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is considered "sodium-free".

3. How to use Estazolam Polfarmex

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The dosage should be individually adjusted according to age and the patient's response to the medicine.
In the treatment of sleep disorders: the recommended initial dose is 1 to 2 mg (half – 1 tablet) 30 minutes before bedtime.
Elderly patients (over 65 years of age): the dose should be reduced by half.
Patients with hepatic and/or renal impairment: dose reduction is recommended.
Treatment should be initiated with the lowest recommended dose. The recommended dose must not be exceeded.
Use of a higher than recommended dose of Estazolam Polfarmex
Any overdose requires medical intervention.
Symptoms of estazolam overdose: drowsiness; confusion (disorientation); coordination disturbances (ataxia); hypotension; respiratory dysfunction; rarely coma.
Life-threatening poisoning may occur with combined intoxication involving estazolam and alcohol or estazolam and other central nervous system depressants. In case of estazolam poisoning, vomiting should be induced (provided consciousness is preserved) and activated charcoal administered.
Immediate contact with a physician is required.
Missed dose of Estazolam Polfarmex
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Drowsiness during the day; headache; somnolence; dizziness; asthenia (reduced functional capacity of the body); constipation; dryness of the oral mucosa; anxiety; coordination disorders; nausea; fatigue; malaise; general weakness; nervousness; thinking disorders; disorientation; prolonged reaction time.
Other adverse reactions, observed rarely (in 1 to 10 people per 10,000) during treatment with the medicine: palpitations; change in appetite; vomiting; flatulence; increased thirst; muscle cramps; joint and muscle pain; anterograde amnesia; apathy; emotional lability; sleep disturbances; cough; asthma; rash; urticaria; visual disturbances; taste disturbances; menstrual disorders; sporadic cardiac arrhythmia; fainting; blood picture changes (leukopenia, agranulocytosis); body weight changes; ataxia; decreased libido (reduced sexual drive); paradoxical reactions.
Prolonged use of the medicine may lead to physical or psychological dependence. Abrupt discontinuation of the medicine after prolonged use may cause withdrawal syndrome symptoms.
In elderly patients, neurological symptoms (feeling of fatigue, movement coordination disorders, skeletal muscle tone disturbances) may occur. These symptoms may lead to patient falls and dangerous bone fractures.

Reporting adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of using the medicine can be collected.

5. How to store Estazolam Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Estazolam Polfarmex contains

The active substance is estazolam. One tablet contains 2 mg of estazolam.
The other ingredients are: maize starch, lactose monohydrate, povidone, sodium carboxymethyl starch (type A), magnesium stearate.

What Estazolam Polfarmex looks like and contents of the pack
The pack contains 20 or 28 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]