Estazolam Tzf

Package Leaflet: Information for the Patient

Estazolam TZF, 2 mg, Tablets

Estazolam

Read the Leaflet Carefully Before Taking the Medication.

• Keep this leaflet, you may need to read it again.
• In case of any further questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Table of Contents of the Leaflet:

• 1. What is Estazolam TZF and What is it Used For
• 2. Important Information Before Taking Estazolam TZF
• 3. How to Take Estazolam TZF
• 4. Possible Side Effects
• 5. How to Store Estazolam TZF
• 6. Contents of the Pack and Other Information

1. What is Estazolam TZF and What is it Used For

Estazolam TZF contains the active substance estazolam, which belongs to a group of medicines called benzodiazepines. Estazolam has a sedative effect and a weaker anticonvulsant and muscle relaxant effect. Estazolam TZF is used for the short-term treatment of sleep disorders:

• difficulty falling asleep;
• frequent nocturnal awakenings;
• early morning awakenings.

2. Important Information Before Taking Estazolam TZF

When Not to Take Estazolam TZF

If the patient has:

• hypersensitivity (allergy) to estazolam or other benzodiazepines or any of the excipients of the medication (listed in section 6);
• severe respiratory failure;
• sleep apnea syndrome (frequent, short pauses in breathing during sleep);
• dizziness, balance disorders;
• consciousness disorders;
• myasthenia (a disease that causes muscle weakness and excessive fatigue);
• acute porphyria (a rare metabolic disorder related to blood);
• alcohol or drug intoxication.

Warnings and Precautions

General information about the effects observed after treatment with benzodiazepines and other medicines with similar effects to benzodiazepines, which should be taken into account when taking Estazolam TZF.

➢ Tolerance: After taking Estazolam TZF for several weeks, its effectiveness may decrease.

➢ Dependence: Long-term use of estazolam can lead to psychological and physical dependence. The risk of developing dependence increases with the dose and duration of treatment and is higher in patients addicted to drugs, alcohol, or patients with personality disorders.

➢ Withdrawal symptoms: In case of sudden withdrawal of the medication, the patient may experience withdrawal symptoms, such as headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, irritability. In severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations, and delusions, epileptic seizures.

➢ Rebound phenomenon and anxiety: When discontinuing Estazolam TZF, a transient recurrence of intensified symptoms that were the reason for taking the medication (so-called rebound phenomenon) may occur. These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these symptoms, it is recommended to gradually reduce the dose of the medication.

➢ Anterograde amnesia (inability to remember events after taking the medication): Estazolam may cause anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored). This condition usually occurs within a few hours of taking the medication, especially in high doses. If the doctor has prescribed Estazolam TZF to be taken once a day, to reduce the risk of anterograde amnesia, it is recommended to take the medication half an hour before going to bed and ensure adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

➢ Psychiatric and paradoxical reactions: In children and the elderly, the risk of abnormal psychiatric and paradoxical reactions (opposite to expected) increases, such as anxiety, excitement, irritability, aggression, anger, fury, delusions, nightmares, hallucinations, psychoses, behavioral disorders. If such symptoms occur, the doctor should be informed immediately.

Specific patient groups

➢ Elderly patients should receive lower doses of Estazolam TZF (see section 3), due to the possibility of increased side effects, mainly orientation and motor coordination disorders (falls, injuries).

➢ Patients with liver or kidney failure or chronic respiratory failure should inform their doctor about these conditions before taking Estazolam TZF.

➢ Use in depression: Before taking Estazolam TZF, the doctor should be informed about any mental illnesses. Patients with symptoms of depression or anxiety related to depression should take several medications at the same time. Administering Estazolam TZF to patients with depression may exacerbate symptoms of depression, including suicidal thoughts.

➢ During the use of benzodiazepines, masked depression may be revealed.

➢ Patients with alcohol, drug, or medication addiction should inform their doctor about these addictions before taking Estazolam TZF. These patients are at high risk of developing psychological and physical dependence. Therefore, this group of patients should take Estazolam TZF only under strict medical supervision.

➢ Estazolam TZF in patients with porphyria may exacerbate symptoms of the disease. Patients with porphyria should inform their doctor about this disease before starting treatment with Estazolam TZF.

➢ During prolonged treatment with estazolam, the doctor usually orders periodic blood tests (morphology with smear) and urine analysis.

Other Medications and Estazolam TZF

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take. This is especially important if you are taking any of the following medications:

• fluvoxamine, fluoxetine, and other medications used to treat mental illnesses;
• medications used to treat insomnia;
• medications used to treat allergic diseases that may cause drowsiness;
• medications used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin);
• medications used to treat stomach and duodenal ulcers (e.g., cimetidine, omeprazole, cisapride);
• rifampicin (a medication used to treat tuberculosis);
• ketoconazole (an antifungal medication);
• medications used for general anesthesia;
• strong painkillers (e.g., morphine, codeine);
• muscle relaxants (e.g., baclofen);
• medications used to treat Parkinson's disease (e.g., levodopa);
• opioids: Concomitant use of Estazolam TZF and opioids (strong painkillers, medications used for substitution therapy, some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medications can only be considered when other treatment options are not possible. If the doctor prescribes Estazolam TZF concomitantly with opioids, the dose and duration of concomitant treatment should be limited. The patient should inform the doctor about all opioid medications being taken and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform friends or relatives to be aware of the possibility of these symptoms. In case of such symptoms, contact a doctor.

Alcohol: Drinking alcohol while taking Estazolam TZF may enhance its effect and lead to paradoxical reactions, such as psychomotor excitement, aggressive behavior (see section 2; Warnings and Precautions).

Pregnancy and Breastfeeding

Before taking any medication, consult your doctor or pharmacist.

If you are pregnant or think you may be pregnant

If you suspect you are pregnant or plan to become pregnant, inform your doctor. Estazolam TZF should not be taken during pregnancy.

If you are breastfeeding

Estazolam TZF passes into breast milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and Operating Machines

Do not drive or operate machines while being treated with Estazolam TZF. The ability to drive or operate machines may be impaired due to the possibility of drowsiness, concentration disorders, or other side effects that reduce concentration (see section 4. Possible Side Effects).

Estazolam TZF Contains Lactose Monohydrate

The medication contains lactose monohydrate. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medication.

Estazolam TZF Contains Sodium

Estazolam TZF contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

3. How to Take Estazolam TZF

Estazolam TZF should always be taken as directed by your doctor. In case of doubts, consult your doctor.

Adults

Usually, 1 mg to 2 mg (1/2 to 1 tablet) is administered half an hour before bedtime.

Children

The safety and efficacy of estazolam in children under 18 years of age have not been established.

Duration of Treatment

The duration of treatment is determined by the doctor.

Method of Administration

Estazolam TZF tablets should be taken orally, with a small amount of water, 30 minutes before bedtime. The doctor will start treatment with the lowest effective dose and, if necessary, will gradually increase it.

Taking a Higher Dose of Estazolam TZF Than Recommended

Symptoms of overdose are disorders of consciousness, drowsiness, slurred speech. In severe cases of poisoning, the following may occur: motor incoordination, hypotension, muscle weakness, respiratory disorders, coma. In case of taking a higher dose of Estazolam TZF than recommended, contact a doctor or go to the emergency department of the nearest hospital immediately. Take the medication in its original packaging so that the medical staff can check exactly which medication was taken.

Missing a Dose of Estazolam TZF

If you forget to take a dose, take the next dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose as directed. If you forget to take two or more doses, consult your doctor.

Do not take a double dose to make up for a missed dose.

Stopping Treatment with Estazolam TZF

Do not stop treatment unless it is in accordance with your doctor's recommendation. It is possible that the symptoms of the disease will recur. If the doctor decides to discontinue treatment, the dose of the medication should be gradually reduced over several days.

In case of doubts related to the use of the medication, consult your doctor.

4. Possible Side Effects

Like all medications, Estazolam TZF can cause side effects, although not everybody gets them.

Severe Side Effects

If you experience any of the following side effects, tell your doctor immediately:

• severe allergic reaction, such as itching, swelling of the lips or tongue, or wheezing, shortness of breath. These symptoms are very rare (may occur in up to 1 in 10,000 people);
• disorientation, excitement, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses, abnormal behavior. These disorders usually occur after consuming alcohol and in elderly patients or patients with mental illnesses. They occur with an unknown frequency (frequency cannot be determined based on available data).

Other Side Effects That May Occur After Treatment with Estazolam TZF

Rare side effects (occurring in less than 1 in 1,000 people):

• gastrointestinal disorders, dry mouth

Side effects with unknown frequency (frequency cannot be determined based on available data):

• changes in the number of some blood cells
• rash, itching, urticaria
• loss of appetite
• paradoxical reactions - psychomotor anxiety, insomnia, increased excitability and aggression, muscle tremors, seizures. Paradoxical reactions usually occur after consuming alcohol, in elderly patients, and in patients with mental illnesses.
• psychological and physical dependence may develop during treatment with estazolam at therapeutic doses. Sudden discontinuation of treatment may cause withdrawal syndrome. Patients who abuse alcohol or medications are more prone to developing dependence. During treatment with estazolam, previously undiagnosed depression may be revealed.
• drowsiness, dizziness, slowed reactions may occur during the first few days of treatment.
• drowsiness, memory disorders, coordination disorders, speech disorders, changes in libido
• visual disturbances (blurred, double vision)
• slow heart rate, chest pain
• mild decrease in blood pressure
• mild increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin, whites of the eyes)
• muscle tremors, muscle weakness
• urinary retention, incontinence
• menstrual disorders
• general weakness, fainting

If You Experience Any Side Effects, Including Any Possible Side Effects Not Listed in This Leaflet, Consult Your Doctor.

Reporting Side Effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Estazolam TZF

Keep out of the sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture. Do not use the medication after the expiration date (EXP) stated on the packaging. The expiration date refers to the last day of the given month. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Estazolam TZF Contains

The active substance of the medication is estazolam. One tablet contains 2 mg of estazolam. The other ingredients are potato starch, sodium carboxymethyl starch (type A), gelatin, quinoline yellow (E 104), talc, magnesium stearate, lactose monohydrate.

What Estazolam TZF Looks Like and Contents of the Pack

Yellow, round, flat tablets on both sides.

Packaging:20 or 28 tablets.

Marketing Authorization Holder and Manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, phone: 22 811-18-14. For more detailed information about this medication, contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet: