Lorazepam Tzf

Leaflet accompanying the packaging: Patient information

Lorazepam TZF, 0.5 mg, tablets

Lorazepam TZF, 1 mg, tablets

Lorazepam TZF, 2.5 mg, tablets

Lorazepam

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lorazepam TZF and what is it used for
• 2. Important information before using Lorazepam TZF
• 3. How to use Lorazepam TZF
• 4. Possible side effects
• 5. How to store Lorazepam TZF
• 6. Contents of the packaging and other information

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

Lorazepam TZF is a sedative and anxiolytic belonging to the group of medicines called benzodiazepines.
Indications for use

• Symptomatic short-term treatment of anxiety states, tension and excitement, and sleep disorders caused by these states.
• Pre-medication before diagnostic procedures and before and after surgical procedures.

Note:
Treatment with Lorazepam TZF is not required in all cases of anxiety, tension, and excitement or sleep disorders. Often these are symptoms of a physical or mental illness that can be treated with other methods or by treating the underlying disease. Anxiety and tension associated with everyday stress usually do not require the use of sedatives. The use of lorazepam as a sleeping pill is justified only when the effect of benzodiazepines is also desirable during the day.

2. Important information before using Lorazepam TZF

When not to use Lorazepam TZF

• if the patient is allergic to lorazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is addicted or has been addicted to drugs, alcohol, or opioid drugs in the past,
• if the patient has muscle weakness, a feeling of easy fatigue (myasthenia),
• if the patient has movement disorders (ataxia of the cerebellum and brainstem),
• in patients with acute poisoning caused by alcohol or drugs that depress the activity of the central nervous system (e.g., sleeping pills or painkillers, drugs used in the treatment of mental disorders, such as neuroleptics, antidepressants, and lithium salts),

Treatment with Lorazepam TZF

• if the patient has periodic, transient respiratory arrest during sleep (sleep apnea syndrome),
• in patients with severe respiratory disorders or chest pain, e.g., chronic obstructive pulmonary disease,
• if the patient has severe liver disease.

The above information also applies to the past.

Children and adolescents

Children and adolescents under the age of 18 should not be treated with Lorazepam TZF, unless it is necessary for sedation before and after surgical procedures or before diagnostic procedures. It is not recommended to use Lorazepam TZF in children under the age of 6. For more information, see section 3.

Warnings and precautions

At the beginning of treatment, the doctor should monitor the patient's response to the medicine to detect potential overdose as soon as possible. This applies especially to children, the elderly, and the frail. These patients may be more sensitive to the effects of Lorazepam TZF and should be monitored more frequently during treatment.
Before starting treatment with Lorazepam TZF, you should discuss it with your doctor or pharmacist.
Treatment with benzodiazepines in patients with depression may exacerbate symptoms of depression and (or) reveal suicidal tendencies. Therefore, Lorazepam TZF should not be used in these patients without appropriate antidepressant treatment.
If the patient has kidney or liver dysfunction, heart failure, and (or) low blood pressure (hypotension), they may be more sensitive to the effects of this medicine. This also applies to elderly patients, who are at increased risk of falls.
When using lorazepam as a sleeping pill, the patient should ensure that they can have uninterrupted sleep for 7-8 hours. If the patient follows this recommendation, they can usually avoid after-effects (e.g., fatigue, impaired reaction).
You should ask your doctor for detailed instructions on daily life, taking into account your specific lifestyle (e.g., profession) during treatment with lorazepam.
During the use of benzodiazepines, paradoxical reactions have been reported (see section 4). Such reactions can be expected especially in children and the elderly. If paradoxical reactions occur, treatment with Lorazepam TZF should be discontinued.
Like all benzodiazepines, lorazepam can exacerbate hepatic encephalopathy (brain disease caused by liver damage). Therefore, caution should be exercised when using Lorazepam TZF in patients with hepatic encephalopathy.

Warnings

The use of benzodiazepines, including lorazepam, can cause respiratory depression, which can lead to death.
The use of lorazepam is associated with a high risk of dependence. There is a risk of developing physical and psychological dependence even after daily use for just a few weeks. This applies not only to abuse of particularly high doses but also to the use of Lorazepam TZF in therapeutic doses. The risk of dependence is higher in patients with a history of alcoholism or prescription drug abuse, as well as in patients with significant personality disorders. Benzodiazepines should always be prescribed for only a short period (e.g., 2 to 4 weeks). Treatment should be continued only in cases of urgent indications and after careful consideration of the therapeutic benefits versus the risk of habituation and dependence. Long-term use of lorazepam is not recommended.
During the use of benzodiazepines, severe allergic reactions have been reported. In patients after taking the first dose or subsequent doses of benzodiazepines, cases of skin and (or) mucous membrane edema (angioedema) involving the tongue, larynx, or vocal cords have been reported. In some patients, other side effects have occurred during the use of benzodiazepines, such as shortness of breath, throat swelling, or nausea and vomiting.
Some patients may require immediate medical attention. Blockage of the airways caused by angioedema involving the tongue, larynx, or vocal cords can be fatal.
Anxiety or insomnia may be symptoms of many other diseases. The doctor should consider that these symptoms may be related to an underlying somatic or mental illness for which there is more specific treatment. Anxiety and tension associated with everyday stress usually do not require the use of Lorazepam TZF.

Lorazepam TZF and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Lorazepam TZF with other medicines that depress the activity of the central nervous system may enhance the sedative effect on the central nervous system, e.g.,

• medicines used in the treatment of mental disorders (psychoactive substances),
• sleeping pills, sedatives, anesthetics,
• medicines that lower blood pressure (beta-blockers),
• certain painkillers used in the treatment of addiction and cough (opioids),
• antihistamines,
• medicines used in the treatment of epilepsy (antiepileptic drugs).

Concomitant use of Lorazepam TZF and opioids (strong painkillers, drugs used in substitution therapy, some cough medicines) increases the risk of somnolence, respiratory depression, coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered if other treatment options are not possible.
If, however, the doctor prescribes Lorazepam TZF concomitantly with opioids, the dose and duration of concomitant treatment should be limited by the doctor.
The patient should inform the doctor about all opioid medicines they are taking and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform friends or relatives so that they are aware of the possibility of these symptoms. In case of such symptoms, you should contact your doctor.
There may be an increase in the effect of muscle relaxants and painkillers.
If lorazepam is used with clozapine, significant sedation, excessive salivation, and movement disorders may occur.
Concomitant administration of Lorazepam TZF and valproic acid may increase the concentration of lorazepam in the blood. If valproic acid is used concomitantly, the dose of Lorazepam TZF should be reduced by about half.
Concomitant administration of Lorazepam TZF and probenecid may accelerate the onset of action or prolong the action of lorazepam. In the case of concomitant use of probenecid, the dose of Lorazepam TZF should be reduced by half.
The use of theophylline or aminophylline may weaken the sedative effect of Lorazepam TZF.

Alcohol and Lorazepam TZF

You should avoid consuming alcoholic beverages at the same time, as alcohol can unpredictably change and enhance the effect of Lorazepam TZF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Lorazepam TZF should not be taken during pregnancy.
If you become pregnant while using Lorazepam TZF, you must immediately inform your doctor so that they can decide whether to discontinue treatment.
Long-term use of Lorazepam TZF by a pregnant woman may cause withdrawal symptoms in the newborn. If you take Lorazepam TZF at the end of pregnancy or during childbirth, the newborn may experience decreased activity, decreased muscle tone, decreased body temperature (hypothermia), and (or) low blood pressure (hypotension), respiratory depression, apnea, and feeding problems (floppy infant syndrome).
Breastfeeding
Lorazepam TZF passes into breast milk, and therefore, it should not be taken during breastfeeding. Taking Lorazepam TZF during breastfeeding may cause significant sedation and feeding problems in the baby. It is recommended to monitor the baby.

Driving and using machines

Lorazepam TZF used as directed may cause slowed reactions, especially in the first few days of treatment. In this case, the patient is not able to react quickly enough to unexpected and sudden events. You should not drive vehicles or operate any hazardous electrical tools or machines. The patient should not work without secure foot support. In particular, remember that alcohol also impairs reaction ability.
The doctor will decide whether the patient can drive vehicles or operate machines, taking into account the individual response to treatment and the dose taken.

Lorazepam TZF contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Lorazepam TZF contains sodium

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

3. How to use Lorazepam TZF

This medicine should always be used exactly as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

Dosage

The dosage and duration of treatment should be adjusted to the individual response of the patient to treatment, the indication for use (i.e., the disease for which the medicine was prescribed), and the severity of the disease. In principle, the smallest effective dose should be used for the shortest possible time.
The following information applies unless the doctor has prescribed a different dosage of Lorazepam TZF.
Treatment of anxiety states, tension, and excitement, and sleep disorders caused by these states
The daily dose in adults is usually 0.5 to 2.5 mg of lorazepam, given in 2 to 3 divided doses or once in the evening, about half an hour before sleep, if the medicine is used mainly for sleep disorders requiring treatment.
The doctor may increase the daily dose to a maximum of 7.5 mg, taking into account all warnings and precautions, especially in hospital settings.
Pre-medication before diagnostic procedures and before and after surgical procedures
In adults, 1 to 2.5 mg of lorazepam in the evening before the procedure and (or) 2 to 4 mg about 1 to 2 hours before the procedure. After the procedure, 1 to 2.5 mg of lorazepam at appropriate intervals.

Use in children and adolescents

The dose should be reduced accordingly. In children, single doses should not exceed 0.5 to 1 mg of lorazepam and 0.05 mg per kilogram of body weight.

Use in the elderly or frail

The initial total daily dose should be reduced by about 50% in elderly or frail patients. These patients, as well as children, should receive the medicine in the smallest effective dose. The doctor will adjust the dose according to the patient's needs and tolerance.

Patients with liver function disorders

In patients with mild or moderate liver function disorders, the doctor will adjust the dose according to the individual response to treatment.
Lorazepam TZF is contraindicated in patients with severe liver function disorders.

Method of administration

The tablet should be swallowed whole, with a liquid (e.g., half to 1 glass of water). The tablets can be taken regardless of meals.
If Lorazepam TZF is used for sleep disorders, the medicine should be taken before sleep. The medicine should not be taken on a full stomach. Taking the medicine on a full stomach may cause delayed action of the medicine and consequently shift its action to the next day.
Lorazepam TZF 1 mg and Lorazepam TZF 2.5 mg tablets can be divided into equal doses.

Duration of treatment

The doctor will decide on the duration of treatment. The use of Lorazepam TZF should be limited to single doses or, in the case of acute illness, used only for a few days.
The duration of treatment in chronic disease depends on the course of the disease. After 2 weeks of daily use of the medicine, the doctor should gradually reduce the dose to determine if the use of Lorazepam TZF is still necessary.
After a longer period of use (more than a week) and sudden discontinuation, a transient recurrence of sleep disorders, anxiety, tension, and inner restlessness may occur. Therefore, treatment should not be discontinued abruptly, but rather by gradually reducing the dose.

Use of a higher than recommended dose of Lorazepam TZF

In case of suspected poisoning after taking a larger amount of the medicine, you should immediately contact a doctor. In case of a phone call, you should carefully follow the instructions received over the phone regarding first aid. You should not induce vomiting unless it has been explicitly recommended.
Symptoms of overdose are: drowsiness, confusion, sleepiness, shallow breathing, coordination disorders, apathy, and in severe cases, loss of consciousness.

Missing a dose of Lorazepam TZF

If you forget to take a tablet, you should take Lorazepam TZF at the usual time the next day. You should not take a double dose to make up for the missed dose.

Discontinuing Lorazepam TZF

You should never discontinue or stop treatment on your own, unless you suspect a serious side effect. In such cases, you should immediately consult your doctor.
In case of sudden discontinuation of treatment after a longer period of use, withdrawal symptoms may occur (see section 4). To avoid the occurrence of such symptoms, treatment should be discontinued by gradually reducing the dose (see section 3).
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should expect the occurrence of side effects, especially at the beginning of treatment, if the dose is too high, and in patient groups mentioned in the "Warnings and precautions" section (see section 2).
If any of the following serious side effects occur, treatment with Lorazepam TZF should be discontinued immediately. You should immediately inform your doctor and (or) seek immediate medical attention.

• paradoxical reactions, such as anxiety, excitement, restlessness, aggressive behavior (hostility, aggression, anger), sleep disorders / insomnia, increased sexual drive, hallucinations,
• suicidal thoughts / attempts,
• hypersensitivity reactions, anaphylactic / anaphylactoid reactions, skin and (or) mucous membrane edema (angioedema),
• jaundice - yellowing of the skin, eyes, nose, mouth, light-colored stools (feces) and dark-colored urine,
• allergic skin reactions - rashes and skin inflammation,
• respiratory depression (dose-dependent), respiratory arrest (apnea), worsening of sleep apnea (transient cessation of breathing during sleep).

Other side effects that may occur during treatment with Lorazepam TZF

Very common: occur more frequently than in 1 in 10 patients

• sedation, fatigue, drowsiness

Common: occur less frequently than in 1 in 10 patients

• ataxia, confusion, depression, unveiling of depression, dizziness
• muscle weakness, fatigue

Uncommon: occur less frequently than in 1 in 100 patients

• changes in libido, impotence, decreased orgasm
• nausea

Frequency not known: frequency cannot be estimated from the available data

• changes in blood morphology (thrombocytopenia, agranulocytosis, pancytopenia)
• prolonged reaction time
• movement disorders (extrapyramidal symptoms)
• tremors
• vision disorders (double vision, blurred vision)
• speech disorders (dysarthria) / unclear speech
• headache
• seizures / convulsions
• amnesia
• disinhibition (psychic), euphoria
• coma
• decreased alertness / concentration, balance disorders
• low blood pressure (hypotension), mild decrease in blood pressure
• worsening of chronic obstructive pulmonary disease (narrowing of the airways)
• constipation
• increased bilirubin levels, increased activity of liver enzymes (transaminases, alkaline phosphatase)
• hair loss
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• low sodium levels (hyponatremia)
• decreased body temperature (hypothermia)

Dependence / abuse

Even after a few days of daily use of lorazepam, after discontinuation of treatment, especially sudden, withdrawal symptoms may occur (e.g., sleep disorders, intense dreams). Anxiety, tension states, as well as excitement and inner restlessness (rebound phenomena) may worsen.
Other symptoms reported after discontinuation of benzodiazepines include headache, depression, confusion, irritability, sweating, dysphoria, dizziness, depersonalization, behavioral disorders, hypersensitivity to sounds, numbness and tingling of limbs, hypersensitivity to light, noise, and physical contact, sensory disturbances, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations / delirium, seizures / convulsions, tremors, muscle cramps, excitement, palpitations, accelerated heart rate, anxiety attacks, vertigo of labyrinthine origin, hyperreflexia, short-term memory loss, and fever. In case of need, you should discuss this with your doctor.
There are reports of the development of tolerance (increased dose due to habituation) with regard to the sedative effect of benzodiazepines.
Lorazepam TZF has the potential for dependence. The group at particular risk includes patients who have abused prescription drugs or alcohol in the past.

Measures in case of side effects

Many of the listed side effects will resolve on their own during continued treatment or after dose reduction. If side effects persist, you should tell your doctor, who will decide whether to discontinue treatment. You should immediately contact your doctor if you experience a skin rash, skin discoloration, or edema of unknown origin.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 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 the medicine.

5. How to store Lorazepam TZF

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use the medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Lorazepam TZF contains:

The active substance of the medicine is lorazepam
Lorazepam TZF, 0.5 mg, tablets
Each tablet contains 0.5 mg of lorazepam.
Other ingredients are: microcrystalline cellulose (type 102), sodium carboxymethylcellulose (type A), magnesium stearate, lactose monohydrate.
Lorazepam TZF, 1 mg, tablets
Each tablet contains 1 mg of lorazepam.
Other ingredients are: microcrystalline cellulose (type 102), sodium carboxymethylcellulose (type A), magnesium stearate, lactose monohydrate.
Lorazepam TZF, 2.5 mg, tablets
Each tablet contains 2.5 mg of lorazepam.
Other ingredients are: microcrystalline cellulose (type 102), sodium carboxymethylcellulose (type A), magnesium stearate, lactose monohydrate.

What Lorazepam TZF looks like and contents of the pack

Lorazepam TZF, 0.5 mg:
White or almost white, round, flat tablet. Diameter is 4.5 mm.
Lorazepam TZF, 1 mg:
White or almost white, round, flat tablet with a dividing line on one side and the number "1" embossed on the other side. Diameter is 6 mm. The tablet can be divided into equal doses.
Lorazepam TZF, 2.5 mg:
White or almost white, round, flat tablet with a dividing line on one side and the number "2.5" embossed on the other side. Diameter is 8 mm. The tablet can be divided into equal doses.
Packaging:14, 20, 28, 30, 50, 60, or 90 tablets. The tablets are packaged in blisters, and then in a carton box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: (22) 811 18 14
To obtain more detailed information about this medicine, you should contact the marketing authorization holder.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Lorazepam TZF
Portugal:
Lorazepam Bluepharma

Date of last revision of the leaflet:

April 2024

Notes for the patient

The medicine contains an active substance belonging to the group of benzodiazepines.
Benzodiazepines are medicines used to treat diseases related to excitement and anxiety, tension, and insomnia. In addition, benzodiazepines are used to treat epilepsy and certain muscle tension states.
Not all anxiety or sleep disorders require pharmacological treatment. Some symptoms may be related to an underlying somatic or mental illness for which there is more specific treatment.
Benzodiazepines do not act on the cause. They reduce the symptoms and can also be a great help, for example, in facilitating access to ongoing treatment and the appropriate solution to the problem.
During the use of benzodiazepines, physical and psychological dependence may develop. To minimize the risk as much as possible, you should pay particular attention to the following instructions:

• 1. Benzodiazepines are intended only for the treatment of the disease and should be used only as directed by the doctor.
• 2. You should not take benzodiazepines if you are addicted or have been addicted to drugs, alcohol, or narcotics in the past, unless in rare situations where the doctor decides that they are necessary.
• 3. You should avoid uncontrolled, long-term use, as it may lead to dependence on prescription drugs. At the beginning of treatment, you should schedule a follow-up appointment with your doctor to decide whether to continue treatment. If you take this medicine without a doctor's recommendation, it reduces the possibility of helping you by prescribing these medicines on a prescription.
• 4. You should never increase the dose prescribed by the doctor or shorten the intervals between taking the medicine, even if the effect of the medicine is no longer so strong. This may be the first sign of dependence. Changing the dose prescribed by the doctor on your own makes it difficult to treat the patient.
• 5. You should never suddenly stop taking benzodiazepines, but rather gradually reduce the dose. After discontinuation of treatment after a longer period of use, excitement, anxiety, insomnia, seizures, and hallucinations may occur - often with a delay of several days. These withdrawal symptoms will resolve after a few days or weeks. If necessary, you should discuss this with your doctor.
• 6. You should never take benzodiazepines from other people and not use them because "they helped others". You should also never give this medicine to other people.