Lorazepam Tzf

Leaflet attached to the packaging: patient information

Lorazepam TZF, 2 mg/mL, solution for injection

Lorazepam TZF, 4 mg/mL, solution for injection

Lorazepam

You should carefully read the contents of this 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.
• If you have any doubts, you should consult a doctor or nurse.
• 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 any not listed in this leaflet, you should tell your doctor or nurse. 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 active substances called benzodiazepines.
Indications for use

• Pre-medication - as a sedative (basic sedation) before surgical and diagnostic procedures and chemotherapy or during them, in order to reduce anxiety, tension and memory of the event.
• Initial treatment of symptoms of severe neurotic anxiety and exacerbated phobias (best administered intravenously).
• Short-term, supportive treatment of severe anxiety disorders and agitation in psychoses and depression, when basic treatment with neuroleptics and/or antidepressants does not provide or has not yet provided sufficient control over such symptoms.
• Treatment of a seizure state in adults, adolescents, children, and infants from 1 month of age due to various types of focal or generalized seizures. Lorazepam TZF is effective in treating generalized seizures (tonic-clonic, "grand mal" type), generalized absence seizures ("petit mal" type), or loss of consciousness in the form of spike-wave stupor, focal motor or psychomotor seizures, as well as combinations of these, such as generalized seizures with a focal onset. Initial treatment with Lorazepam TZF results in prolonged cessation of seizure activity.
• Lorazepam is not intended for long-term treatment of epilepsy. After the cessation of seizure activity, other medications that prevent the occurrence of seizures should be used, as decided by the doctor. In the treatment of seizure states caused by acute, reversible metabolic disorders (e.g., hypoglycemia, hypocalcemia, hyponatremia, etc.), it is particularly important to immediately attempt to eliminate the underlying disease.

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 has sleep apnea syndrome (transient cessation of breathing during sleep);
• if the patient has significant breathing problems;
• if the patient has muscle weakness and easy fatigue (myasthenia);
• if the patient has severe liver failure (significant liver dysfunction);
• when used concurrently with scopolamine, as this combination leads to increased sedation, hallucinations, and irrational behavior.

Lorazepam TZF must not be administered intrarterially. This may lead to arterial spasms, resulting in interruption of blood flow, which may lead to gangrene and necessitate amputation.

Children and adolescents

Lorazepam TZF in the form of a solution for injection is contraindicated in children under 12 years of age, except for the control of seizure states and only in rare, special cases, based on the decision of a specialist (child neurologist, psychiatrist) and under their supervision. In the case of a seizure state, Lorazepam TZF should not be used in newborns.
Children may be particularly sensitive to one or more of the other ingredients of Lorazepam TZF (see "Lorazepam TZF contains propylene glycol and macrogol 400").

Warnings and precautions

Before starting treatment with Lorazepam TZF, you should discuss it with your doctor or pharmacist.
Particular caution should be exercised in patients with pathological muscle weakness (myasthenia), coordination disorders (ataxia of the spinal cord and cerebellum), acute alcohol or drug poisoning, or central nervous system depressants (e.g., sleeping pills or painkillers, neuroleptics, antidepressants).
This medicine should be used with particular caution in elderly patients and seriously ill patients, as well as in patients with low respiratory reserve or central respiratory disorders, due to the risk of respiratory arrest or respiratory failure.
Caution should be exercised in patients with a tendency to alcohol, drugs, or other medications, or in individuals who are addicted. Long-term use of benzodiazepines can lead to dependence.
It is not recommended to use Lorazepam TZF in patients with renal or significant liver dysfunction. In patients with significant liver dysfunction, medications like Lorazepam TZF may cause degenerative brain disease (encephalopathy) (see "When not to use Lorazepam TZF").
If the patient has a certain type of glaucoma, i.e., an eye disease with increased intraocular pressure, they should inform their doctor.
Lorazepam TZF is not indicated as the main therapy for psychotic or depressive states and should not be used as the only medication for depression. If basic treatment with antidepressants or neuroleptics does not eliminate co-existing anxiety or insomnia, sedatives like Lorazepam TZF can be used temporarily. In patients with depression, benzodiazepines may reduce inhibitions and induce suicidal tendencies; they should not be used without adequate antidepressant therapy. Anxiety may be a symptom of various other conditions. It is often a manifestation of a physical or mental illness and can be treated with other specific treatments.
If the patient has Lennox-Gastaut syndrome (a type of epilepsy), caution should be exercised, as benzodiazepines may induce seizures in them.
Using Lorazepam TZF in patients with severe sedation, especially during anesthesia, in patients with obstructive pulmonary diseases, in elderly patients, and in debilitated patients, may lead to respiratory disorders. Therefore, it is necessary to have the necessary equipment available to ensure airway patency and support breathing/ventilation.
Particular caution should be exercised when administering lorazepam to a patient in a seizure state, especially if the patient has received other central nervous system depressants or is seriously ill. Breathing problems, partial or complete cessation of breathing, may occur. It is necessary to have appropriate ventilation and resuscitation equipment available.
After receiving an injection, patients should go home with a companion. They should remain under observation for 24 hours after the injection. For 24 to 48 hours after the injection, they should not engage in any activities that require special attention.
There have been reports of changes in blood morphology or increased liver enzyme activity in serum during the use of benzodiazepines. Therefore, in the case of repeated use, it is recommended to monitor blood morphology and assess liver function at certain time intervals.
During the use of benzodiazepines, paradoxical reactions (see section 4) have been reported. Such reactions can be expected, especially in children and the elderly. If paradoxical reactions occur, treatment with lorazepam should be discontinued.
The use of benzodiazepines, including Lorazepam TZF, can lead to respiratory depression, potentially leading to death.
During the use of benzodiazepines, severe allergic reactions have been reported. Cases of angioedema (swelling of the skin and/or mucous membranes) involving the tongue, throat, or glottis, after the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have experienced additional symptoms, such as shortness of breath, throat swelling, or nausea and vomiting. Some patients required emergency treatment. If angioedema involves the tongue, throat, or glottis, it can lead to airway obstruction, which can be life-threatening. If a patient experiences angioedema, the medicine should not be used again.
In the case of longer use, it is recommended to monitor kidney function.
Lorazepam TZF has addictive properties. There is a risk of developing psychological and physical dependence, even after daily use of Lorazepam TZF for just a few weeks.
This applies not only to abuse of particularly high doses but also to the range of therapeutic doses. The risk of dependence is further increased 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 only for a short period (e.g., 2 to 4 weeks). Treatment should only be continued if there are compelling reasons and after careful consideration of the therapeutic benefits versus the risk of habituation and dependence. Long-term use of Lorazepam TZF is not recommended.

Lorazepam TZF and other medicines

You should tell your doctor or nurse about all the medicines you are currently taking, or have recently taken, and about the medicines you plan to take.
Concurrent use of Lorazepam TZF with other medicines that have a depressant effect on the central nervous system and alcohol may cause mutual enhancement of the depressant effect on the central nervous system, e.g.,

• medicines used to treat mental illnesses (neuroleptics, antidepressants)
• sleeping pills, sedatives, anesthetics
• medicines that lower blood pressure (beta-blockers)
• certain painkillers used in substitution therapy and anti-cough medications (opioids)
• sedative anti-allergic medications (antihistamines)
• medicines used to treat epilepsy (antiepileptic drugs).

Concurrent use of Lorazepam TZF and opioids (strong painkillers, medications used in substitution therapy, and some anti-cough medications) increases the risk of drowsiness, breathing disorders (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use of these medications should only be considered if other treatment methods are not possible.
If the doctor prescribes Lorazepam TZF concurrently with opioids, they should limit the dose and duration of concurrent treatment.
You should tell your doctor about all opioid-containing medications you are taking and strictly follow the dosage recommended by your doctor. It may be helpful to inform friends or relatives to observe the patient for the above objective and subjective symptoms. If such symptoms occur, you should contact your doctor.
There may be an enhancement of the effect of muscle relaxants and painkillers.
Concurrent use of scopolamine with Lorazepam TZF enhances sedative, hallucinogenic, and inappropriate behavior effects. The concurrent use of these medications is contraindicated.
During concurrent use of Lorazepam TZF and clozapine, severe sedation, excessive salivation, and movement disorders may occur.
During concurrent use of Lorazepam TZF and haloperidol, severe side effects (respiratory arrest, slow heart rate, cardiac arrest, coma, and even death) have been reported.
Concurrent use of Lorazepam TZF and valproic acid may cause an increase in lorazepam levels in the blood. In the case of concurrent use of valproic acid, the dose of Lorazepam TZF should be reduced by about half.
Concurrent administration of Lorazepam TZF and probenecid may cause a faster onset of action or prolonged action of lorazepam. In the case of concurrent 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.
It may be necessary to increase the dose of Lorazepam TZF in female patients taking oral contraceptives due to the accelerated elimination of Lorazepam TZF.
You should tell your doctor if you are taking disulfiram (a medication used to treat chronic alcoholism) or metronidazole (an antibiotic). Patients taking these medications have impaired dehydrogenase and aldehyde dehydrogenase enzyme systems and are predisposed to the accumulation of propylene glycol and potential side effects associated with it.

Lorazepam TZF and alcohol

You should avoid consuming alcoholic beverages at the same time, as alcohol may change and enhance the effect of Lorazepam TZF in an unpredictable way.
You should avoid consuming alcoholic beverages for at least 24 to 48 hours after administration of Lorazepam TZF, due to the additive effect on central nervous system depression.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Lorazepam TZF should only be used in exceptional cases with significant indications, as the therapeutic experience with lorazepam during this period is insufficient.
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 Lorazepam TZF is administered at the end of pregnancy or during delivery, the newborn may experience decreased activity, decreased muscle tone, decreased body temperature (hypothermia), and/or decreased blood pressure (hypotension), respiratory depression, apnea, and feeding problems (floppy infant syndrome).
Breastfeeding
The medicine passes into breast milk in small amounts. Lorazepam TZF should not be used during breastfeeding. If you are breastfeeding, you should contact your doctor, who will decide whether to discontinue breastfeeding or discontinue the use of Lorazepam TZF.

Driving and operating machinery

If you are using Lorazepam TZF, you should not operate hazardous machinery, drive vehicles, or perform work that requires high concentration, until you are sure that you do not feel drowsy or dizzy due to the use of Lorazepam TZF.
Patients who have received Lorazepam TZF should not drive motor vehicles, operate hazardous machinery, or engage in activities that require maximum concentration for 24 to 48 hours. Impaired performance may persist for a longer period in very elderly or very young patients, or due to concurrent use of other medications or the patient's general condition.

Lorazepam TZF contains propylene glycol and macrogol 400.

Lorazepam TZF 2 mg/mL contains 845 mg of propylene glycol and 203 mg of macrogol 400 in each mL.
Lorazepam TZF 4 mg/mL contains 843 mg of propylene glycol and 203 mg of macrogol 400 in each mL.
In the case of children under 5 years of age, patients with liver or kidney disease, or pregnant or breastfeeding women, you should consult a doctor or pharmacist before using the medicine, as the excipients may cause side effects. The doctor may adjust the dose if the patient or child is taking other medications containing propylene glycol or alcohol.
This medicine should only be used if prescribed by a doctor. The doctor may order additional tests during the use of this medicine.
There have been reports of toxicity associated with macrogol 400 (e.g., acute renal tubular necrosis) during the use of Lorazepam TZF, even when the doses were higher than recommended.

3. How to use Lorazepam TZF

This medicine will be administered to you by medical personnel in the form of an intramuscular or intravenous injection, or, if necessary, into an infusion tube.
Information on dosing and administration is presented in the section "Information intended only for healthcare professionals".
This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
When determining the dose and duration of treatment, your doctor will take into account your condition and needs.

Using a higher dose of Lorazepam TZF than recommended

If you have used too much of the medicine, you should immediately contact your doctor, hospital, or poison control center.
Symptoms:Overdose of benzodiazepines is usually characterized by depression of the central nervous system, ranging from drowsiness to coma. Symptoms of mild overdose may include drowsiness, confusion, and lethargy. In severe cases, symptoms such as ataxia (unsteady gait), hypotonia (muscle weakness), decreased blood pressure, breathing problems, sometimes coma, and even death may occur. In the case of using Lorazepam TZF with other central nervous system depressants, the risk of poisoning with multiple medications increases, and the risk of death should be considered.
Treatment:In the case of overdose, general supportive treatment should be used first. Vital functions will be closely monitored, and if necessary, assisted ventilation will be used. Hypotension can be treated with fluid replacement or norepinephrine. In the case of severe poisoning with coma or respiratory depression, the use of flumazenil, a benzodiazepine antidote, may be helpful. The value of hemodialysis in Lorazepam TZF poisoning is low, but it may be useful in mixed poisonings.

Missing a dose of Lorazepam TZF

You should not take a double dose to make up for a missed dose.

Stopping the use of Lorazepam TZF

You should never stop treatment abruptly. In the case of sudden discontinuation of treatment in high doses or after a longer period of use, withdrawal symptoms may occur, which are listed in section 4. To avoid such symptoms, the dose should be gradually reduced.
If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually occur at the beginning of treatment. They are usually mild or moderate and often disappear or decrease during continued treatment or after dose reduction.
If you experience any of the following serious side effects, you should stop using Lorazepam TZF and immediately consult your doctor and/or seek immediate medical attention.

• paradoxical reactions, such as anxiety, agitation, restlessness, aggressive behavior

(hostility, aggression, anger), sleep disturbances/insomnia, increased sexual desire, hallucinations.

• suicidal thoughts/attempts.
• hypersensitivity reactions, anaphylactic reactions/pseudo-anaphylactic reactions, angioedema (swelling of the skin and/or mucous membranes).
• allergic skin reactions.
• respiratory depression (dose-dependent), respiratory arrest, worsening of sleep apnea (transient cessation of breathing during sleep).

Side effects that may occur when using Lorazepam TZF, along with their frequency categories
Very common: may occur in more than 1 in 10 treated patients

• sedation, feeling of fatigue, lethargy

Common: may occur in up to 1 in 10 treated patients

• unsteady movements and gait (ataxia), dizziness, confusion, depression, revelation of depression
• muscle weakness

Uncommon: may occur in up to 1 in 100 treated patients

• changes in libido, impotence, decreased orgasm
• nausea, vomiting, changes in appetite

Rare: may occur in up to 1 in 1,000 treated patients

• decreased blood pressure (hypotension)

Unknown: frequency cannot be estimated from available data

• changes in blood morphology (thrombocytopenia, agranulocytosis, pancytopenia)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• decreased sodium levels (hyponatremia)
• disinhibition, euphoria
• coordination disorders (extrapyramidal symptoms)
• tremors
• vertigo of labyrinthine origin
• visual disturbances (double vision, blurred vision)
• dyarthria/slurred speech
• headache
• seizures
• amnesia
• coma
• hypertensive and hypotensive circulatory reactions
• respiratory depression (dose-dependent)
• worsening of obstructive pulmonary disease (narrowing of airways)
• constipation
• increased bilirubin levels, increased liver enzyme activity (aminotransferases, alkaline phosphatase)
• hair loss (alopecia)
• decreased body temperature (hypothermia)

In addition, after intramuscular injection, the following symptoms may occur: pain, burning sensation, and redness.
After intravenous administration, local phlebitis, pain, and redness may occur.

Dependence / abuse

After stopping treatment, especially sudden cessation, withdrawal symptoms may occur (e.g., sleep disturbances).
Withdrawal symptoms may have varying severity - from mild dysphoria (state of anxiety) and sleep disturbances to severe clinical symptoms, including generalized seizures, tremors, abdominal cramps, and muscle cramps, vomiting, and sweating. The risk of withdrawal symptoms increases with the duration of treatment. These phenomena can usually be avoided by gradually reducing the dose.
There have been reports of tolerance development (increased dose due to habituation) regarding the sedative effect of benzodiazepines.
Lorazepam TZF may cause abuse. Patients who have abused prescription drugs or alcohol in the past are particularly at risk.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 medicine.

5. How to store Lorazepam TZF

The medicine should be stored out of sight and reach of children.
Store in a refrigerator (2°C-8°C). Store in the original packaging to protect from light. The chemical and physical stability of the product has been demonstrated after opening for at least 24 hours at 2-8°C and 25°C. From a microbiological point of view, the product should be used immediately. If the solution is not used immediately, the responsibility for the storage conditions and time after opening lies with the user.
Do not use the medicine after the expiry date stated on the carton and ampoule after "EXP". The expiry date refers to the last day of the month stated.
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, 2 mg/mL, solution for injection
Each mL contains 2 mg of lorazepam.
Lorazepam TZF, 4 mg/mL, solution for injection
Each mL contains 4 mg of lorazepam.
The other ingredients are macrogol 400 and propylene glycol.

What Lorazepam TZF looks like and what the packaging contains

Colorless solution. The pH of the solution is 3.5 ÷ 7.5.

Packaging

10 ampoules in a cardboard box

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: (22) 811 18 14

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

Poland:
Lorazepam TZF
Portugal:
Lithuania
Lorazepam TZF
Lorazepam Polfa Tarchomin 2 mg/mL injection solution
Lorazepam Polfa Tarchomin 4 mg/mL injection solution
Lorafen 2 mg/mL solution for injection
Lorafen 4 mg/mL solution for injection
Date of last revision of the leaflet:February 2025
Latvia:

Information intended only for healthcare professionals

Dosage and administration
Dosage
Pre-medication
To achieve the best effects of pre-medication, the dose should be adjusted according to the patient's body weight.
The usual dose administered intravenously is 0.044 mg/kg body weight. The medicine is administered 15 to 20 minutes before the procedure. This intravenous dose will be sufficient for most adults and should not be exceeded in patients over 50 years of age. In these patients, the usual initial dose is 2 mg. In some cases, a higher dose of up to 0.05 mg/kg body weight, up to a maximum of 4 mg, can be administered.
In the case of intramuscular injection, the usual dose is 0.05 mg/kg body weight, up to a maximum of 4 mg, at least 2 hours before the planned procedure.
In elderly patients, debilitated patients, and patients with severe respiratory or cardiovascular disorders, a lower dose should be chosen. In elderly and debilitated patients, the initial dose should be reduced by about 50% and adjusted according to needs and tolerance (see "Warnings and precautions").
Psychiatry
In the case of an acute anxiety attack, the recommended initial dose is 0.05 mg/kg body weight, if administered intravenously or intramuscularly. Intravenous administration is preferred. If necessary, the dose can be repeated after 2 hours. After the acute symptoms have subsided, tablets can be used instead of injections.
Seizure state
The usual initial dose in patients over 18 years of age is 4 mg of Lorazepam TZF in slow intravenous injection (2 mg/min). If seizures persist or recur within the next 10 to 15 minutes, the same dose can be injected again. If such re-injection does not bring improvement within the next 10 to 15 minutes, other measures should be taken.
Elderly patients may respond to smaller doses, and a sufficient dose may be half of the dose used in adults.
Infants from 1 month of age, children, and adolescents should receive an initial dose of 0.1 mg/kg body weight. The maximum dose is 4 mg/dose. If seizures persist or recur within the next 10 to 15 minutes, the same dose can be injected again, but no more than 2 doses should be administered.
Due to the potential risk of toxicity associated with the accumulation of excipients, the maximum dose of Lorazepam TZF should not be repeated within 24 hours in children under 5 years of age (see "Lorazepam TZF contains propylene glycol and macrogol 400").

Use in children and adolescents

Lorazepam is not recommended for use in children under 12 years of age, except for the treatment of seizure states, in rare, special cases, based on the decision of a specialist (child neurologist, psychiatrist) and under their supervision. In the case of a seizure state, Lorazepam TZF should not be used in newborns (see also section 2).

Patients with renal or hepatic impairment

In patients with mild or moderate liver or kidney dysfunction, the smallest effective dose should be used, as prolonged action can be expected in such cases.

Duration of treatment

The duration of treatment should be as short as possible. Long-term use of Lorazepam TZF can lead to the development of physical and psychological dependence.
Treatment should not be discontinued abruptly, but the dose should be gradually reduced.

Method of administration

Lorazepam TZF can be used undiluted for intramuscular administration. The medicine should be administered deep into the muscle. Since the injection solution is slightly viscous, injection can be facilitated by diluting the contents of the ampoule with an equal volume of a compatible solution (see below).
For intravenous injection, Lorazepam TZF should be diluted before use in a ratio of 1:1 with a saline solution, water for injection, or glucose solution. Compatible solutions are water for injection, 0.9% sodium chloride solution, 5% glucose solution, and 10% glucose solution. After dilution, a slow intravenous injection or, if necessary, injection into an infusion tube should be performed. Accidental intra-arterial injection should be strictly avoided (see "Warnings and precautions"). The injection rate should not exceed 2 mg of lorazepam per minute.
The solution should not be used if it contains solid particles or has changed color.

Instructions for opening the ampoule

The ampoules are equipped with a one-point cut (OPC) system and should only be opened according to the following instructions:

• Hold the lower part of the ampoule with one hand, so that the colored dot is facing the person opening it.
• With the other hand, grasp the upper part of the ampoule, place your thumb over the colored dot, and press.

Instructions for preparing the dilution

Draw the required amount of the injection solution from the ampoule into a syringe, and then the appropriate volume of the diluent. Then, pull back the syringe plunger and gently rotate its contents back and forth until the solution is evenly mixed. Do not shake vigorously, as this will cause air bubbles to form in the injection solution.

Incompatibilities

Not applicable.
This medicinal product must not be mixed with other medicinal products except for those mentioned in the "Method of administration" section.
It is recommended to administer each additional medicinal product in a separate syringe.