Lorazepam tzf: detailed information

Package leaflet: Information for the patient

Lorazepam TZF, 0.5 mg, tablets
Lorazepam TZF, 1 mg, tablets
Lorazepam TZF, 2.5 mg, tablets
Lorazepamum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Lorazepam TZF is and what it is used for
Important information before taking Lorazepam TZF
How to take Lorazepam TZF
Possible side effects
How to store Lorazepam TZF
Contents of the pack and other information

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

Lorazepam TZF is a tranquilizer and anxiolytic medicine belonging to a group of medicines called benzodiazepines.
Indications for use:

Short-term symptomatic treatment of anxiety states, tension and agitation, and sleep disturbances caused by these conditions.
Premedication prior to diagnostic procedures and surgical procedures.

Note:
Treatment with Lorazepam TZF is not required in all cases of anxiety, tension, agitation or sleep disturbances. Often these are symptoms of a physical or mental disorder that can be treated by other methods or by treating the underlying condition. Anxiety and tension associated with everyday stress usually do not require the use of tranquilizers. The use of lorazepam as a sleeping aid appears justified only when the daytime effect of benzodiazepines is simultaneously desirable.

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 currently dependent on, or has previously been dependent on, drugs, alcohol, or opioid medications,
if the patient suffers from muscle weakness and easy fatigability (myasthenia),
if the patient has movement disorders (spinal and cerebellar ataxia),
in patients with acute intoxication due to alcohol or medications that depress central nervous system function (e.g. sleeping pills or painkillers, medications used in the treatment of mental disorders such as neuroleptics, antidepressants, and lithium salts),
if the patient suffers from periodic, transient breathing cessation during sleep (sleep apnoea 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 past medical history.

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

Warnings and precautions
At the beginning of treatment, the treating physician should monitor the patient's response to the medicine in order to detect potential overdose as quickly as possible. This particularly applies to children, elderly, and debilitated patients. These patients may be more sensitive to the effects of Lorazepam TZF and therefore should be monitored more frequently during treatment.
Before starting treatment with Lorazepam TZF, consult your doctor or pharmacist.
Treating patients with depression using benzodiazepines may worsen depressive symptoms and/or reveal suicidal tendencies. Therefore, Lorazepam TZF should not be used in such patients without appropriate antidepressant therapy.
If the patient has impaired kidney or liver function, heart failure, and/or low blood pressure (arterial hypotension), increased sensitivity to the effects of this medicine may occur. This also applies to elderly patients, in whom the risk of falls is increased.
When using lorazepam as a sleeping aid, the patient should ensure that they can have an uninterrupted 7–8 hour sleep. Following this recommendation usually helps avoid after-effects upon waking (e.g. drowsiness, impaired reaction).
Ask your doctor for detailed advice regarding daily activities, taking into account your specific lifestyle (e.g. occupation) during treatment with lorazepam.
Paradoxical reactions have been reported rarely during benzodiazepine use (see section 4). Such reactions are particularly expected in children and elderly patients. If paradoxical reactions occur, treatment with Lorazepam TZF should be discontinued.
Like all benzodiazepines, lorazepam may 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, may 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 psychological and physical dependence even after daily use for only a few weeks. This applies not only to the misuse of particularly high doses but also to the use of Lorazepam TZF at 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 only for a short period (e.g. 2 to 4 weeks). Treatment should only continue in cases of acute necessity and after careful consideration of the therapeutic benefits versus the risks of habituation and dependence. Long-term use of lorazepam is not recommended.
Severe allergic reactions have been reported during benzodiazepine use. After taking the first or subsequent doses of benzodiazepines, cases of skin and/or mucosal swelling involving the tongue, larynx, or vocal cords (angioedema) have been reported. In some patients, other adverse effects such as shortness of breath, throat swelling, or nausea and vomiting have occurred during benzodiazepine use.
Some patients may require immediate medical intervention. Airway obstruction due to angioedema affecting the tongue, larynx, or vocal cords may 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 psychiatric condition for which more specific treatment exists. Anxiety and tension related to everyday stress usually do not require treatment with Lorazepam TZF.

Lorazepam TZF and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Concomitant use of Lorazepam TZF with other medicines that depress central nervous system function may mutually enhance their CNS-depressant effects, for example:

medicines used in the treatment of mental disorders (psychotropic drugs),
sleeping pills, sedatives, anaesthetics,
blood pressure-lowering medicines (beta-blockers),
certain painkillers, medications used in addiction treatment and cough suppressants (opioids),
antiallergic medicines (antihistamines),
medicines used in the treatment of epilepsy (antiepileptic drugs).

Concomitant use of Lorazepam TZF and opioids (strong painkillers, medications used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may even be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not feasible.
If, however, your doctor prescribes Lorazepam TZF together with opioids, the dose and duration of concomitant treatment should be limited by the doctor.
The patient should inform the doctor about all opioid medications being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or relatives so they are aware of the possibility of these symptoms occurring. If such symptoms occur, contact your doctor immediately.
The effects of muscle relaxants and painkillers may be enhanced.
If lorazepam is used together with clozapine, marked sedation, excessive salivation, and movement disorders may occur.
Concomitant administration of Lorazepam TZF and valproic acid may increase blood concentrations of lorazepam. If valproic acid is used concomitantly, the dose of Lorazepam TZF should be reduced by approximately half.
Concomitant use of Lorazepam TZF and probenecid may accelerate the onset or prolong the effect of lorazepam. If probenecid is used concomitantly, the dose of Lorazepam TZF should be reduced by half.
The use of theophylline or aminophylline may reduce the sedative effect of Lorazepam TZF.

Alcohol and Lorazepam TZF
Avoid consuming alcoholic beverages simultaneously, as alcohol may unpredictably alter and intensify the effects of Lorazepam TZF.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Lorazepam TZF should not be taken during pregnancy.
If a patient becomes pregnant while taking Lorazepam TZF, she must immediately inform her doctor so that a decision can be made about discontinuing treatment.
Long-term use of Lorazepam TZF by a pregnant woman may cause withdrawal symptoms in the newborn. If a patient takes Lorazepam TZF towards the end of pregnancy or during delivery, the infant may experience reduced activity, decreased muscle tone, lowered body temperature (hypothermia), and/or low blood pressure (arterial hypotension), respiratory depression, apnoea, and feeding difficulties (floppy infant syndrome).

Breastfeeding
Lorazepam TZF passes into human milk and therefore should not be taken during breastfeeding. Taking Lorazepam TZF during breastfeeding may cause marked sedation and sucking difficulties in the infant. Monitoring of the infant is recommended.

Driving and operating machinery
Lorazepam TZF, when used as directed, may slow reaction times, particularly during the first few days of treatment. In such cases, the patient may not be able to react quickly enough to unexpected or sudden events. The patient should not drive vehicles or operate any dangerous electrical tools or machinery. The patient should not work without secure foot support. It is especially important to remember that alcohol additionally impairs reaction ability.
The treating physician will decide whether the patient may drive or operate machinery, taking into account the individual patient's response to treatment and the dose being taken.

Lorazepam TZF contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

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

3. How to use Lorazepam TZF

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
The dosage and duration of treatment should be adjusted according to the individual patient's response to therapy, the indication (i.e. the condition for which the medicine was prescribed), and the severity of the condition. In general, the lowest effective dose should be used for the shortest possible time.
The following information applies unless your doctor has instructed you otherwise regarding the dosage of Lorazepam TZF.
Treatment of anxiety, tension, agitation, and sleep disturbances caused by these conditions
The usual daily dose in adults is 0.5 to 2.5 mg of lorazepam, given in 2 to 3 divided doses or as a single evening dose approximately half an hour before bedtime, if the medicine is used mainly for sleep disorders requiring treatment.
Your doctor may increase the daily dose up to a maximum of 7.5 mg, taking into account all warnings and precautions, especially in hospital settings.
Premedication before diagnostic or surgical procedures
In adults: 1 to 2.5 mg of lorazepam the evening before the procedure and (or) 2 to 4 mg approximately 1 to 2 hours before the procedure.
Use in children and adolescents
The dose should be appropriately reduced. In children, single doses should not exceed 0.5 to 1 mg of lorazepam or 0.05 mg per kg of body weight.
Use in elderly or debilitated patients
The initial total daily dose should be reduced by approximately 50% in elderly or debilitated patients. These patients, as well as children, should receive the lowest effective dose. Your doctor will adjust the dose according to the patient's needs and tolerance.
Patients with impaired liver function
In patients with mild to moderate liver impairment, your doctor will adjust the dose according to individual response to treatment.
Lorazepam TZF is contraindicated in patients with severe liver impairment.
Patients with impaired kidney function
In patients with mild to severe kidney impairment, your doctor will cautiously reduce the dose depending on the individual response to treatment. The usual starting dose is generally half the recommended adult dose. Your doctor will assess the patient's response to the medicine and adjust the dose if necessary.
Method of administration
The tablet should be swallowed whole with liquid (e.g. half to one glass of water). Lorazepam TZF tablets may be taken independently of meals.
If Lorazepam TZF is used to treat sleep disorders, the medicine should be taken before bedtime. The medicine should not be taken on a full stomach. Taking the medicine on a full stomach may delay its effect and consequently shift its action into the next day.
Lorazepam TZF 1 mg and Lorazepam TZF 2.5 mg tablets may be divided into equal doses.
Duration of treatment
Your 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 conditions, only for a few days. In chronic conditions, the duration of treatment depends on the course of the disease. After two weeks of daily treatment, your doctor should gradually reduce the dose to determine whether continued use of Lorazepam TZF is still necessary.
After prolonged use (more than one week), abrupt discontinuation of the medicine may lead to a transient recurrence of sleep disturbances, anxiety, tension, inner restlessness, and agitation. Therefore, treatment should not be stopped suddenly, but rather by gradually reducing the dose.
Use of a higher than recommended dose of Lorazepam TZF
If overdose is suspected, contact your doctor immediately. In case of a telephone consultation, strictly follow the instructions received over the phone regarding first aid measures. Do not induce vomiting unless explicitly advised to do so.
Symptoms of overdose include: drowsiness, confusion, somnolence, shallow breathing, impaired motor coordination, apathy, and in severe cases, loss of consciousness.
Missed dose of Lorazepam TZF
If a patient forgets to take a tablet, the medicine should be taken at the usual time the next day. Do not take a double dose to make up for the missed dose.
Stopping treatment with Lorazepam TZF
Never discontinue or stop treatment on your own, unless you suspect a serious adverse reaction. In such cases, contact your doctor immediately.
Abrupt discontinuation after prolonged use may result in withdrawal symptoms described in section 4. To avoid such symptoms, treatment should be discontinued by gradually reducing the dose (see section 3).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects may be expected, particularly at the beginning of treatment, if the dose is too high, and in patient groups mentioned in section "Warnings and precautions" (see section 2).
If any of the following serious adverse effects occur, treatment with Lorazepam TZF should be stopped immediately. You should immediately inform your doctor and (or) seek immediate medical help.

paradoxical reactions such as anxiety, excitation, psychomotor agitation, aggressive behaviour (hostility, aggression, anger), sleep disturbances / insomnia, sexual stimulation, hallucinations,
suicidal thoughts/attempts,
hypersensitivity reactions, anaphylactic/anaphylactoid reactions, skin and (or) mucous membrane swelling (angioedema),
jaundice - yellowing of the skin, eyes, nose, lips, pale stool and dark urine,
allergic skin reactions - rashes and skin inflammation,
respiratory depression (dose-dependent severity), breathing pauses (apnoea), worsening of sleep apnoea (temporary cessation of breathing during sleep).

Other adverse effects that may occur during treatment with Lorazepam TZF
Very common: occurs in more than 1 in 10 patients

sedation, fatigue, drowsiness

Common: occurs in less than 1 in 10 patients

motor incoordination (ataxia), confusion, depression, uncovering of depression, dizziness
muscle weakness, tiredness

Uncommon: occurs in less than 1 in 100 patients

changes in libido, impotence, reduced orgasm
nausea

Frequency unknown: frequency cannot be determined from available data

blood morphology changes (thrombocytopenia, agranulocytosis, pancytopenia)
prolonged reaction time
motor coordination disorders (extrapyramidal symptoms)
tremors
visual disturbances (double vision, blurred vision)
speech difficulties (dysarthria) / slurred speech
headache
seizures / convulsions
memory loss
disinhibition (mental), euphoria
coma
reduced alertness / concentration, balance disorders
low blood pressure (hypotension), mild drop in blood pressure
worsening of obstructive lung disease (airway narrowing)
constipation
increased bilirubin levels, increased liver enzyme activity (aminotransferases, alkaline phosphatase)
hair loss
syndrome of inappropriate antidiuretic hormone secretion (SIADH)
decreased sodium levels (hyponatremia)
decreased body temperature (hypothermia)

Dependence / abuse
Even after a few days of daily lorazepam use, withdrawal symptoms (e.g. sleep disturbances, vivid dreams) may occur after stopping treatment, especially if stopped abruptly. Anxiety, tension, excitation and inner restlessness may worsen (rebound phenomena).
Other symptoms reported after discontinuation of benzodiazepines include: headache, depression, confusion, irritability, sweating, restlessness (dysphoria), dizziness, derealization, behavioural disturbances, hypersensitivity to sound, numbness and tingling of limbs, hypersensitivity to light, noise and physical contact, sensory disturbances, involuntary movements, nausea, vomiting, diarrhoea, loss of appetite, hallucinations / delirium, seizures / epileptic fits, tremor, intestinal cramps, muscle pain, excitation, palpitations, tachycardia, panic attacks, labyrinthine dizziness, hyperreflexia, short-term memory loss and fever. In patients with epilepsy or those taking other drugs that lower the seizure threshold (e.g. antidepressants), abrupt discontinuation of Lorazepam TZF after long-term use may trigger more frequent epileptic seizures. The risk of withdrawal symptoms increases with duration of treatment and dose. These phenomena can usually be avoided by gradually reducing the dose.
There have been reports of tolerance development (increased dose due to the body adapting) to the sedative effect of benzodiazepines.
Lorazepam TZF has abuse potential. Patients with a history of substance or alcohol abuse are at particular risk.
Management in case of adverse effects
Many of the listed adverse effects resolve spontaneously during continued treatment or after dose reduction. If adverse effects persist, you should inform your doctor, who will decide whether treatment should be discontinued. You should contact your doctor immediately if the patient develops a skin rash, skin discoloration or swelling of unknown origin.
Reporting of adverse effects
If any adverse symptoms occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects 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 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Lorazepam TZF
Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use the medicine after the expiry date stated on the carton and container after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lorazepam TZF contains:
The active substance is lorazepam.
Lorazepam TZF, 0.5 mg, tablets
Each tablet contains 0.5 mg of lorazepam.
Other ingredients: microcrystalline cellulose (type 102), sodium carboxymethyl starch (type A),
magnesium stearate, lactose monohydrate.
Lorazepam TZF, 1 mg, tablets
Each tablet contains 1 mg of lorazepam.
Other ingredients: microcrystalline cellulose (type 102), sodium carboxymethyl starch (type A),
magnesium stearate, lactose monohydrate.
Lorazepam TZF, 2.5 mg, tablets
Each tablet contains 2.5 mg of lorazepam.
Other ingredients: microcrystalline cellulose (type 102), sodium carboxymethyl starch (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 score line on one side and the engraved number "1" 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 score line on one side and the engraved number "2.5" on the other side. Diameter is 8 mm. The tablet can be divided into equal doses.
Pack sizes: 14, 20, 28, 30, 50, 60 or 90 tablets. Tablets are packed in blisters and then placed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: (22) 811 18 14
For further information about this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Lorazepam TZF 0.5 mg, 1 mg, 2.5 mg tablets
Portugal: Lorazepam Bluepharma 0.5 mg, 1 mg, 2.5 mg tablets
Bulgaria: Лоразепам TZF 0.5 mg, 1 mg, 2.5 mg таблетки
Hungary: Lorazepam TZF 0.5 mg, 1 mg, 2.5 mg tabletta
Latvia: Lorazepam TZF 0.5 mg, 1 mg, 2.5 mg tabletes
Lithuania: Dalixen 0.5 mg, 1 mg, 2.5 mg tabletės
Netherlands: Lorazepam TZF 0.5 mg, 1 mg, 2.5 mg tabletten

Patient information
The medicine contains an active substance belonging to the group of benzodiazepines.
Benzodiazepines are medicines used in the treatment of conditions related to anxiety, inner tension or insomnia. Additionally, benzodiazepines are used in the treatment of epilepsy and certain states of muscle tension.
Not all anxiety states or sleep disorders require pharmacological treatment. Some symptoms may be related to an underlying somatic or psychiatric condition for which more specific treatment exists.
Benzodiazepines do not act on the cause. They reduce symptoms and may also provide significant support, for example by facilitating access to ongoing treatment and appropriate problem resolution.
Physical and psychological dependence may develop during benzodiazepine use. To ensure the lowest possible risk, please pay special attention to the following instructions:

Benzodiazepines are intended solely for medical treatment and must be used only as prescribed by a doctor.
Benzodiazepines should not be taken if the patient is dependent on, or has previously been dependent on, alcohol, medicines or drugs, except in rare cases where the doctor decides their use is necessary.
Uncontrolled, long-term use should be avoided, as it may lead to dependence on prescription medicines. At the beginning of treatment, a follow-up appointment with the treating physician should be scheduled to assess whether continued treatment is necessary. If the patient takes this medicine without a doctor's prescription, it reduces the possibility of receiving appropriate medical help through a prescription.
Never increase the dose prescribed by the doctor or shorten the intervals between doses, even if the medicine's effect seems weaker. This may be the first sign of dependence. Self-adjusting the prescribed dose complicates patient-focused treatment.
Benzodiazepines should never be stopped abruptly, but the dose should be gradually reduced. After discontinuation following prolonged use, symptoms such as restlessness, anxiety, insomnia, seizures and hallucinations may occur—often with a delay of several days. These withdrawal symptoms usually resolve within a few days or weeks. If necessary, discuss this with your doctor.
Never take benzodiazepines prescribed for another person, even if they "helped someone else." Never give this medicine to another person.