Estazolam tzf

Package leaflet: Information for the user

Estazolam TZF, 2 mg, tablets
Estazolamum
Read the entire leaflet carefully before taking this medicine.

• Keep this leaflet, as you may need to read it again.
• Consult 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. This medicine may harm someone else, even if their symptoms are the same.
• If any of the side effects worsen or if any side effects occur that are not listed in this leaflet, inform your doctor.

Leaflet contents:

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

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

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

2. Important information before taking Estazolam TZF

When not to use Estazolam TZF
Do not use Estazolam TZF if the patient has:

• hypersensitivity (allergy) to estazolam or to any other benzodiazepine or to any of the excipients listed in section 6;
• severe respiratory insufficiency;
• sleep apnoea syndrome (frequent, brief interruptions in breathing during sleep);
• dizziness, balance disorders;
• disturbances of consciousness;
• myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
• acute porphyria (a rare metabolic disorder related to blood);
• alcohol intoxication or intoxication with medicines acting on the central nervous system.

Warnings and precautions
General information regarding effects observed during treatment with benzodiazepines and other medicines with benzodiazepine-like action, which should be considered when using Estazolam TZF.

➢ Tolerance
After several weeks of treatment with Estazolam TZF, its effectiveness may decrease.

➢ Dependence
Prolonged use of estazolam may lead to psychological and physical dependence. The risk of dependence increases with higher doses and longer duration of treatment, and is greater in patients with drug or alcohol dependence or personality disorders.

➢ Withdrawal symptoms
If the medicine is stopped abruptly, withdrawal symptoms may occur, such as: headache, muscle pain, increased anxiety, tension, agitation, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of reality perception, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling and numbness in the limbs, hallucinations and delusions, epileptic seizures.

➢ Rebound phenomenon and anxiety
During discontinuation of Estazolam TZF, a temporary recurrence of intensified symptoms that were the reason for treatment may occur (so-called "rebound" phenomenon). These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these effects, gradual dose reduction is recommended.

➢ Anterograde amnesia (inability to remember events after taking the medicine)
Estazolam may cause anterograde amnesia (difficulty in learning and remembering new information – new data are not permanently stored). This usually occurs within a few hours after taking the medicine, especially at higher doses. If the doctor has prescribed Estazolam TZF once daily, to reduce the risk of anterograde amnesia, it is recommended to take the medicine half an hour before going to bed and to ensure appropriate conditions for uninterrupted sleep lasting 7–8 hours.

➢ Psychiatric and paradoxical reactions
In children and elderly patients, the risk of psychiatric and paradoxical (opposite to expected) reactions is increased, such as: anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioural disturbances.
If such symptoms occur, inform your doctor immediately.

Specific patient groups

➢ Elderly patients should receive lower doses of Estazolam TZF (see section 3), due to the increased risk of adverse effects, particularly disturbances in orientation and motor coordination (falls, injuries).

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

➢ Use in depression
Before using Estazolam TZF, inform the doctor about any psychiatric disorders. Patients with symptoms of depression or anxiety associated with depression should be treated with multiple medicines. Administering only Estazolam TZF to patients with depression may worsen depressive symptoms, including suicidal thoughts.

➢ During treatment with benzodiazepines, a masked depression may become apparent.

➢ Patients with alcohol, drug, or medicine dependence should inform their doctor about such habits before taking Estazolam TZF. These patients have a high risk of developing psychological and physical dependence. Therefore, this patient group should use Estazolam TZF only under strict medical supervision.

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

➢ During prolonged treatment with estazolam, the doctor will usually recommend periodic blood tests (complete blood count with smear) and urine analysis.

Other medicines and Estazolam TZF
Inform your doctor about all medicines currently taken, recently taken, or planned for use.
This is particularly important if the patient is taking any of the following medicines:

• fluvoxamine, fluoxetine, and other medicines used to treat psychiatric disorders;
• medicines used for insomnia;
• antiallergic medicines that may cause drowsiness;
• antiepileptic medicines (e.g. carbamazepine, phenytoin, hydantoin);
• medicines used for peptic ulcer disease (e.g. cimetidine, omeprazole, cisapride);
• rifampicin (a medicine used to treat tuberculosis);
• ketoconazole (an antifungal medicine);
• general anaesthetics;
• strong analgesics (e.g. morphine, codeine);
• skeletal muscle relaxants (e.g. Baclofen);
• medicines used in Parkinson's disease (e.g. levodopa);
• opioids

Concomitant use of Estazolam TZF and opioids (strong analgesics, medicines used in substitution therapy [treatment of addiction], some cough medicines) increases the risk of excessive drowsiness, breathing difficulties (respiratory depression), coma, and may even be life-threatening. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available. If your doctor prescribes Estazolam TZF together with opioids, the dose and duration of combined treatment should be minimized. The patient must inform the doctor about all opioid medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform family members or friends so they are aware of the possible occurrence of these symptoms. If such symptoms occur, contact your doctor immediately.

Alcohol: Drinking alcohol while taking Estazolam TZF may enhance its effects and lead to paradoxical reactions such as psychomotor excitation and aggressive behaviour (see section 2; Warnings and precautions).

Pregnancy and breastfeeding
Before taking any medicine, consult your doctor or pharmacist.

If the patient is pregnant or suspects she may be pregnant
If the patient suspects she is pregnant or plans to become pregnant, she should inform her doctor.
Estazolam TZF should not be taken during pregnancy.

If the patient is breastfeeding
Estazolam TZF passes into human milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery
During treatment with Estazolam TZF, patients should not drive or operate machinery.
The ability to drive and operate machinery may be impaired due to possible side effects such as drowsiness, concentration disturbances, or other adverse effects that reduce concentration (see section 4. Possible side effects).

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

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

3. How to use Estazolam TZF

Estazolam TZF should always be taken as directed by the physician.
In case of doubts, contact your doctor.
Adults
The usual dose is 1 mg to 2 mg (½ to 1 tablet) taken 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 physician.
Method of administration
Estazolam TZF tablets should be taken orally, with a small amount of water, 30 minutes before bedtime.
The physician will start treatment with the lowest effective dose and, if necessary, gradually increase it.
Use of a higher than recommended dose of Estazolam TZF
Symptoms of overdose include disturbances in consciousness, drowsiness, slurred speech. In severe cases of poisoning, the following may occur: motor incoordination, hypotension, muscle weakness, respiratory depression, coma.
In the event of taking a higher than recommended dose of Estazolam TZF, contact a doctor immediately or go to the nearest hospital emergency department. The medicine should be taken along in the original packaging so that medical staff can clearly identify which drug was taken.
Missed dose of Estazolam TZF
If a patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the next dose taken as prescribed. If a patient misses two or more doses, they should contact their doctor.
Do not take a double dose to make up for a missed dose.
Discontinuation of Estazolam TZF
Do not stop taking the medicine unless advised by the physician. Symptoms of the illness may recur. If the physician decides to discontinue treatment, the dose should be gradually reduced over several days.
In case of any doubts regarding the use of the medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, Estazolam TZF may cause adverse reactions, although not everyone experiences them.

Serious adverse reactions
If any of the following adverse symptoms occur, you should immediately contact your doctor or go to the emergency department of the nearest hospital:

• Severe allergic reaction presenting as itching, swelling of the lips or tongue, or wheezing, shortness of breath. These symptoms have been reported very rarely (may occur in up to 1 in 10,000 people);
• Disorientation, states of excitement and agitation, depression with suicidal tendencies, anxiety, irritability, hallucinations, nightmares, illusions (seeing or hearing things that do not exist), psychoses (loss of contact with reality), unusual behaviours. These disorders most commonly occur after alcohol consumption and in elderly patients or those with psychiatric disorders. The frequency is unknown (cannot be estimated based on available data).

Other adverse reactions that may occur during treatment with Estazolam TZF
Adverse reactions occurring rarely (occur in fewer than 1 in 1,000 people):

• Gastrointestinal discomfort, dry mouth

Adverse reactions with unknown frequency (frequency cannot be estimated based on available data):

• Changes in the number of certain blood cells
• Skin rashes, itching, urticaria
• Loss of appetite
• Paradoxical reactions – psychomotor agitation, insomnia, increased excitability and aggressiveness, muscle tremor, seizures. Paradoxical reactions most commonly occur after alcohol consumption, in elderly patients, and in patients with psychiatric disorders.
• Psychological and physical dependence may develop during treatment with estazolam at therapeutic doses. Abrupt discontinuation of treatment may lead to withdrawal syndrome. Patients who abuse alcohol or drugs are more susceptible to developing dependence. Previously existing, undiagnosed depression may become apparent during treatment with estazolam.
• Drowsiness, dizziness, slowed reactions may occur during the first few days of treatment.
• Drowsiness, memory disturbances, impaired motor coordination, speech disturbances, changes in libido
• Visual disturbances (blurred or double vision)
• Slowed heart rate, chest pain
• Slight decrease in blood pressure
• Slight increase in liver enzyme activity, liver function disturbances with jaundice (yellowing of the skin, whites of the eyes)
• Muscle tremor, muscle weakness
• Urinary retention, urinary incontinence
• Menstrual disorders
• General weakness, fainting

If any adverse symptoms occur, including any possible adverse symptoms not listed in this leaflet, consult a doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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 TZF

Keep out of the sight and reach of children.
Store below 25 °C. Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must 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 package and other information

What Estazolam TZF contains
The active substance 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, monohydrate lactose.

What Estazolam TZF looks like and contents of the pack
Yellow, round, biconvex tablets.
Pack size: 20 or 28 tablets.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint-Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: 22 811-18-14

For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative.