LORABEX 1 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Lorabex, 0.5 mg, tablets
3. Lorabex, 1 mg, tablets
4. Lorabex, 2.5 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Lorabex and what is it used for
6. Important information before taking Lorabex
   1. When not to take Lorabex:
   2. Warnings and precautions
   3. Children and adolescents
   4. Lorabex and other medicines
   5. Lorabex with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnancy
   8. Breastfeeding
   9. Fertility
   10. Driving and using machines
   11. Lorabex contains lactose monohydrate
7. How to take Lorabex
   1. Adults
   2. Use in elderly or frail patients
   3. Use in patients with renal impairment
   4. Use in patients with hepatic impairment
   5. Use in children and adolescents
   6. Method of administration
   7. Duration of treatment
   8. Taking a higher dose of Lorabex than recommended
   9. Missing a dose of Lorabex
   10. Stopping treatment with Lorabex
8. Possible side effects
   1. Reporting side effects
9. How to store Lorabex
10. Contents of the pack and other information
    1. What Lorabex contains
    2. What Lorabex looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet

Leaflet accompanying the packaging: patient information

Lorabex, 0.5 mg, tablets

Lorabex, 1 mg, tablets

Lorabex, 2.5 mg, tablets

Lorazepam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lorabex and what is it used for
• 2. Important information before taking Lorabex
• 3. How to take Lorabex
• 4. Possible side effects
• 5. How to store Lorabex
• 6. Contents of the pack and other information

1. What is Lorabex and what is it used for

Lorabex contains the active substance lorazepam. Lorazepam is a sedative and anxiolytic, belonging to the benzodiazepine group.
Lorabex is indicated:

• for the short-term symptomatic treatment of anxiety disorders and insomnia caused by anxiety, when anxiety is severe, disabling, or causes the patient extreme suffering.
• for sedation before diagnostic procedures or before surgical procedures.

2. Important information before taking Lorabex

When not to take Lorabex:

• 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 severe breathing problems or chest pain, e.g., chronic obstructive pulmonary disease;
• if the patient has excessive muscle weakness (myasthenia gravis);
• if the patient has severe liver problems;
• if the patient has sleep apnea syndrome (breathing problems during sleep).

Warnings and precautions

Before starting treatment with Lorabex, the patient should discuss it with their doctor or pharmacist:

• if the patient has a history of drug, alcohol, or substance abuse. Lorabex should not be used in such cases, as the risk of dependence on lorazepam is increased;
• if the patient has personality disorders, as there is a higher risk of dependence on lorazepam;
• if the patient has kidney or liver problems;
• if the patient is elderly, as there is an increased risk of falls;
• if the patient has a history of depression, as lorazepam may cause a relapse of depression;
• if the patient has depression, lorazepam may increase the risk of suicidal thoughts;
• if the patient has coordination problems (ataxia);
• if the patient has breathing problems;
• if the patient has eye problems - glaucoma (high pressure in the eye);
• if the patient has low blood pressure.

In some patients, especially those with depression, suicidal thoughts have occurred while taking lorazepam.
If the patient has depression, irrational fears, and obsessions, or has suicidal thoughts or thoughts of self-harm, they should contact their doctor immediately.
At the beginning of treatment, the doctor will monitor the patient's response to the medicine to detect potential overdose as soon as possible.
A greater sensitivity to the effects of lorazepam may occur in children, the elderly, or the frail. Therefore, in these groups, treatment with lorazepam should be carried out under closer medical supervision.
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; the same applies to the elderly. In these patients, there is an increased risk of falls, especially when getting up at night.
During treatment with lorazepam, hepatic encephalopathy (brain disease caused by liver damage) may occur. Lorazepam should not be used in patients with severe liver dysfunction and/or hepatic encephalopathy.
Memory loss may occur during treatment with lorazepam.
When using lorazepam as a sleeping pill, the patient should ensure they can have 7-8 hours of uninterrupted sleep. If the patient follows this recommendation, they can usually avoid post-awakening effects (e.g., fatigue, reaction disorders).
The patient should ask their doctor for detailed instructions on daily life, taking into account their specific lifestyle (e.g., profession) during treatment with lorazepam.
Paradoxical reactions have been reported in patients taking benzodiazepines, such as anxiety, excitement, delusions, agitation, aggressive behavior, sleep disturbances, sexual stimulation, hallucinations, and psychoses (see section 4). The occurrence of these side effects is more likely in children or elderly patients. Treatment with lorazepam should be discontinued if paradoxical reactions occur.
The use of benzodiazepines, including lorazepam, can lead to life-threatening respiratory depression.
The risk of dependence increases with the dose and duration of treatment and is higher in patients who are dependent on alcohol and drugs. Lorabex should be used for as short a time as possible (see section 4).
If, after a few weeks of treatment, the patient finds that the medicine is not working as well as it did at the beginning of treatment, they should contact their doctor.
Lorazepam should be withdrawn gradually to avoid withdrawal symptoms (see section 3).
Severe allergic reactions have been reported in patients taking benzodiazepines. In patients who have taken the first dose or subsequent doses of benzodiazepines, cases of skin and/or mucous membrane edema (angioedema) have been reported, including the tongue, throat, or vocal cords. In some patients, other side effects have occurred, such as shortness of breath, throat swelling, or nausea and vomiting.
Some patients may require hospitalization. If any of the above symptoms occur, the patient should immediately inform their doctor or go to the nearest hospital emergency department. Airway obstruction can be fatal.

Children and adolescents

Lorabex should not be used in children and adolescents under 18 years of age, unless it is necessary for sedation before surgical or diagnostic procedures. For children under 6 years of age, lorazepam is contraindicated. See section 3 for more information.

Lorabex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important for medicines such as:

• medicines used to treat narcolepsy (excessive daytime sleepiness) with cataplexy (sudden loss of muscle tone and strength)
• medicines used to treat HIV (e.g., zidovudine)
• medicines used to treat delusions or hallucinations (e.g., chlorpromazine, loxapine, or clozapine)
• medicines used to treat indigestion (e.g., antacids, cisapride, or omeprazole)
• medicines used to treat nausea and vomiting caused by chemotherapy (nabilone)
• medicines used to treat addictions (e.g., lofexidine and disulfiram)
• strong painkillers (e.g., methadone, tramadol, codeine, morphine)
• medicines used to treat tuberculosis, such as isoniazid
• antibiotics, such as erythromycin
• medicines used to treat high blood pressure (e.g., ACE inhibitors, alpha-blockers, angiotensin II receptor antagonists, calcium channel blockers, adrenergic neuron blockers, beta-adrenergic blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside, and diuretics)
• medicines used to treat asthma (e.g., theophylline)
• muscle relaxants (e.g., baclofen and tizanidine)
• other sedatives (e.g., barbiturates or antihistamines)
• other anxiolytic medicines
• antidepressant medicines
• antihistamines for allergies
• medicines used to treat Parkinson's disease (e.g., levodopa)
• medicines used to treat epilepsy (e.g., phenobarbital or valproate/sodium valproate)
• medicines used to treat gout (e.g., probenecid)
• estrogen-containing contraceptives
• medicines that affect liver enzymes (e.g., cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If lorazepam is used at the same time as other medicines that depress the central nervous system (e.g., psychotropic medicines, sleeping pills, sedatives, anesthetics, beta-adrenergic blockers, painkillers of the opioid type, sedative antihistamines, antiepileptics), interactions may occur, resulting in the summation of their depressant effects on the central nervous system.
The concomitant use of lorazepam and opioids (e.g., strong painkillers, some antitussive medicines, and substitution therapy medicines) increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and may be fatal. Concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes lorazepam with opioids, they should limit the dose of lorazepam and the duration of treatment. The patient should inform their doctor about all opioid medicines they are taking and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform relatives or friends about the above symptoms.
The patient should inform their doctor if any of the above symptoms occur.
The effect of muscle relaxants and painkillers may be enhanced.
If lorazepam is used concomitantly with clozapine, significant sedation, excessive salivation, and coordination disorders may occur.
Concomitant administration of lorazepam with valproic acid/sodium valproate may increase the lorazepam concentration in the blood. If valproic acid/sodium valproate is used concomitantly, the dose of lorazepam should be reduced by about half.
Concomitant administration of lorazepam with 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 should be reduced by half.
Theophylline or aminophylline may weaken the sedative effect of lorazepam.

Lorabex with food, drink, and alcohol

The patient should avoid drinking alcohol, as it may change and enhance the effect of lorazepam in an unpredictable way.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Lorazepam should not be taken during pregnancy. The doctor will decide whether to discontinue treatment.
If the patient takes lorazepam during advanced pregnancy or during childbirth, the baby may be less active than other babies, may have low muscle tone, low body temperature (hypothermia), and/or low blood pressure (hypotension), respiratory depression, apnea, and feeding difficulties ("floppy infant syndrome"). In the baby, after birth, withdrawal symptoms may occur if the mother takes lorazepam for a longer period during advanced pregnancy.

Breastfeeding

Lorazepam passes into breast milk and may cause sedation and feeding problems in the baby. Lorazepam should not be taken during breastfeeding.

Fertility

There is no data on the effect of the medicine on fertility in women. In men, benzodiazepines may cause ejaculation disorders and delayed orgasm.

Driving and using machines

Lorazepam used as directed may cause reaction disorders, especially in the first few days of treatment. In such cases, the patient is not able to react quickly enough to unexpected and sudden events. The patient should not drive vehicles. The patient should not operate any hazardous electrical equipment or machines. The patient should not work without secure foot support. In particular, remember that alcohol also disrupts reaction ability.
The attending physician will decide whether the patient can drive or operate machines, taking into account the individual response to treatment and the dose taken.

Lorabex contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Lorabex

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dosage and duration of treatment should be adjusted to the individual response of the patient to treatment, the therapeutic indication (i.e., the disease for which the medicine is prescribed), and the severity of the disease.
As a rule, the smallest effective dose should be used for as short a time as possible.

Adults

The patient should follow the doctor's instructions, otherwise, lorazepam may not work properly.
Lorazepam is taken according to the following dosage schedule, unless the doctor recommends otherwise:
Treatment of anxiety and insomnia caused by anxiety:
The daily dose for adults is usually 0.5 mg - 2.5 mg of lorazepam, in 2 - 3 divided doses or once before bedtime.
Sedation before diagnostic procedures or before surgical procedures:
For adults, 1 mg - 2.5 mg of lorazepam in the evening before the procedure and/or 2 mg - 4 mg of lorazepam about 1 - 2 hours before the procedure.

Use in elderly or frail patients

In elderly or frail patients, as well as in patients with organic brain damage, the initial total daily dose should be reduced by half. Patients should take the medicine in the smallest effective dose. The doctor will decide on the best treatment schedule, tailored to the individual needs of the patient.

Use in patients with renal impairment

Patients with renal impairment may take lower doses. The initial dose is usually half the recommended dose for adults. The doctor will monitor the patient's response to the medicine and adjust the dose if necessary.

Use in patients with hepatic impairment

Patients with moderate to mild hepatic impairment may receive lower doses. The initial dose is usually half the recommended dose for adults.
Lorazepam is contraindicated in patients with severe hepatic impairment.

Use in children and adolescents

Lorazepam should not be used to treat anxiety or insomnia in children and adolescents under 18 years of age.

• Children under 6 years of age Children under 6 years of age should not be treated with lorazepam.
• Children aged 6-12 years Before diagnostic procedures or before surgical procedures: the recommended dose is 0.5 mg - 1 mg, depending on the child's body weight (do not exceed 0.05 mg/kg body weight), taken at least 1 - 2 hours before the operation.
• Adolescents aged 13-18 years Before diagnostic procedures or before surgical procedures: the recommended dose is 1 mg - 4 mg, taken 1 - 2 hours before the operation.

Method of administration

Lorazepam is intended for oral administration.
Tablets should be swallowed whole, with a sufficient amount of liquid (e.g., ½ to 1 glass of water).
The dividing line on the tablet makes it easier to break it into smaller pieces for easier swallowing, if the patient has difficulty swallowing the tablet whole.
Lorabex 1 mg and Lorabex 2.5 mg: tablets can be divided into equal doses.

Duration of treatment

The duration of treatment is determined by the doctor.
In acute conditions, the use of lorazepam should be limited to single doses or administration for a few days.
In the case of chronic diseases, the duration of treatment depends on the severity of the disease. After 2 weeks of daily administration, the doctor should gradually reduce the dose and decide whether treatment with lorazepam is still necessary.

Taking a higher dose of Lorabex than recommended

In case of overdose, the patient should immediately inform their doctor. The patient should call their doctor for instructions on first aid and then follow them. The patient should not induce vomiting unless the doctor recommends it. Symptoms of overdose are: drowsiness, confusion, lethargy, shallow breathing, coordination disorders, apathy, and in severe cases, loss of consciousness.

Missing a dose of Lorabex

If the patient misses a dose, they should take the next tablet at the usual time the next day. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Lorabex

Sudden discontinuation of Lorabex after prolonged use may lead to withdrawal symptoms (see section 4). To avoid this, the dose should be gradually reduced.
After a longer period of treatment (more than a week) and sudden discontinuation, sleep disorders, anxiety, and tension may temporarily return in an intensified form. The patient should not suddenly stop treatment but gradually reduce the dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lorabex can cause side effects, although not everybody gets them.
The patient should expect side effects, especially at the beginning of treatment, if the dose is too high, and in the patient groups mentioned in "Warnings and precautions" (see section 2).

• 2.

Very common: may affect more than 1 in 10 people

• sedation, fatigue, drowsiness.

Common: may affect up to 1 in 10 people

• ataxia (lack of coordination).
• confusion, depression, onset of depression.
• dizziness.
• muscle weakness, feeling of weakness (fatigue).

Uncommon: may affect up to 1 in 100 people

• disturbed sexual desire, impotence, less intense orgasm.
• malaise.

Rare: may affect up to 1 in 1,000 people

• rash.
• concentration disorders.
• changes in salivation.

Very rare: may affect up to 1 in 10,000 people

• leukopenia.

Unknown(frequency cannot be estimated from the available data):

• changes in blood morphology (thrombocytopenia, agranulocytosis, pancytopenia)
• prolonged reaction time
• impaired coordination (extrapyramidal symptoms)
• tremor
• vision disorders (double vision, blurred vision)
• speech disorders (dysarthria)
• headache
• seizures/epileptic fits
• amnesia (memory loss)
• disinhibition (psychic), euphoria
• coma
• suicidal thoughts/attempts
• attention/concentration disorders
• balance disorders
• dizziness
• paradoxical reactions, such as anxiety, excitement, agitation, aggressive behavior (hostility, aggression, anger), sleep disorders/insomnia, sexual stimulation, hallucinations, psychoses. If such side effects occur, treatment with lorazepam should be discontinued.
• low blood pressure (hypotension), slight decrease in blood pressure
• respiratory depression (dose-dependent), shortness of breath (apnea), worsening of sleep apnea (transient cessation of breathing during sleep)
• worsening of chronic obstructive pulmonary disease (narrowing of the airways)
• constipation
• increased bilirubin levels
• jaundice, increased liver enzyme activity (transaminases, alkaline phosphatase)
• allergic skin reactions
• hair loss
• hypersensitivity reactions and anaphylactic/pseudoanaphylactic reactions, skin and/or mucous membrane edema (angioedema)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• low sodium levels in the blood (hyponatremia)
• decreased body temperature (hypothermia).

Benzodiazepines cause dose-dependent depression of the central nervous system.
Dependence/addiction
Even after a few days of daily administration of lorazepam, and after discontinuation of treatment, especially sudden, withdrawal symptoms may occur (e.g., sleep disorders, intense dreams). Anxiety, tension, and restlessness may worsen (rebound phenomena). Other symptoms reported after discontinuation of benzodiazepines include: headache, depression, confusion, irritability, sweating, mood disorders, loss of sense of reality, behavioral disorders, numbness and tingling of limbs, hypersensitivity to light, sound, and touch, concentration disorders, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, seizures/epileptic fits, tremor, muscle cramps, mood swings, tachycardia, panic attacks, dizziness, hyperreflexia, loss of short-term memory, and increased body temperature. In the case of chronic use of lorazepam in patients with epilepsy or those taking other medicines that lower the seizure threshold (e.g., antidepressants), sudden discontinuation of lorazepam may cause more frequent seizures. The risk of withdrawal symptoms increases with the duration of treatment and dose. This can usually be avoided by gradual dose reduction.
Tolerance to the sedative effect of benzodiazepines may also develop (increased dose due to habituation).
Lorazepam has the potential for dependence. Patients who have abused drugs or alcohol in the past are at particular risk.
Procedure in case of side effects
Many of the above side effects will resolve during treatment or after dose reduction. If side effects persist, the patient should tell their doctor, who will decide whether to discontinue treatment. The patient should tell their doctor if they experience a skin rash of unknown origin, discoloration, or skin swelling.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lorabex

Do not store above 25°C. Store in the original packaging to protect from light.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lorabex contains

• The active substance of the medicine is lorazepam; each tablet contains 0.5 mg, 1 mg, or 2.5 mg of lorazepam.
• The other ingredients are: lactose monohydrate, povidone (K 30), crospovidone (type A), corn starch, microcrystalline cellulose (E 460), sodium carboxymethyl cellulose (type A), potassium polacrilin, magnesium stearate (E 572).

What Lorabex looks like and contents of the pack

Lorabex 0.5 mg are white, round tablets with rounded edges.
Lorabex 1 mg are white, round, flat tablets with beveled edges, with the inscription "1.0" on one side.
Lorabex 2.5 mg are white, round, flat tablets with beveled edges.
The Lorabex 1 mg and 2.5 mg tablets can be divided into equal doses.
The pack contains 25 tablets.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA SA, ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Farmaceutisch Analytisch Laboratorium Duiven B.V., Dijkgraaf 30, 6921 RL Duiven, Netherlands
Zakłady Farmaceutyczne POLPHARMA SA, ul. Pelplińska 19, 83-200 Starogard Gdański

Date of last revision of the leaflet