Lorabex

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms appear identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Lorabex is and what it is 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 Lorabex is and what it is used for

Lorabex contains lorazepam as the active substance. Lorazepam is an anxiolytic and sedative medicine 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 results in extreme distress for the patient;
• for premedication prior to diagnostic or 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 serious breathing problems or chest pain, e.g. chronic obstructive pulmonary disease;
• if the patient has excessive muscle weakness ( myasthenia gravis );
• if the patient has serious liver problems;
• if the patient has sleep apnoea syndrome (breathing problems during sleep).

Warnings and precautions
Before starting to take Lorabex, discuss this with your doctor or pharmacist:

• if the patient abuses or has previously abused drugs, illegal substances, or alcohol. 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 likelihood of becoming dependent 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 previously had depression, depression may recur during treatment with lorazepam;
• if the patient has depression, lorazepam may increase the occurrence of suicidal thoughts;
• if the patient has motor coordination problems (spinal or cerebellar ataxia);
• if the patient has breathing difficulties;
• if the patient has eye problems – glaucoma (high pressure in the eye);
• if the patient has low blood pressure.

In some patients, particularly those with depression, suicidal thoughts have occurred during treatment with medicines containing lorazepam. If the patient has depression, irrational fears and obsessions, or experiences suicidal or self-harming thoughts, contact a doctor immediately.
At the beginning of treatment, the doctor will monitor the patient's response to this medicine to detect any potential overdose as quickly as possible. Increased sensitivity to the effects of lorazepam may occur in children, elderly or weakened individuals. For this reason, treatment with lorazepam in these groups should be under frequent medical supervision.
If the patient has impaired kidney or liver function, heart failure and/or low blood pressure (hypotension), increased sensitivity to the effects of this medicine may occur; the same applies to elderly patients. In such patients, there is an increased risk of falls, especially when getting up at night.
Hepatic encephalopathy (brain disorder caused by liver damage) may occur during treatment with lorazepam. Lorazepam must 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 aid, the patient should ensure they can have an uninterrupted 7-8 hour sleep. If the patient follows this recommendation, they can usually avoid after-effects upon waking (e.g. fatigue, impaired reactions).
Ask your doctor for detailed advice regarding daily activities, taking into account your specific lifestyle (e.g. occupation) during lorazepam treatment.
Paradoxical reactions have been reported infrequently during benzodiazepine use, such as anxiety, agitation, hallucinations, irritability, aggressive behaviour, sleep disturbances, sexual excitement, illusions, and psychosis (see section 4). The occurrence of these adverse 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, may lead to life-threatening respiratory depression.
The risk of dependence increases with higher doses and longer duration of treatment, and is greater in patients dependent on alcohol or drugs. Lorabex should be used for the shortest possible time (see section 4).
If after several weeks of treatment the patient notices that the medicine is no longer as effective as it was initially, contact the doctor.
Lorazepam should be discontinued gradually to avoid withdrawal symptoms (see section 3).
Severe allergic reactions have been reported during benzodiazepine use. Cases of skin and/or mucous membrane swelling involving the tongue, larynx or vocal cords (angioedema) have been reported in patients after taking the first or subsequent doses of benzodiazepines. Other adverse effects have also been reported in some patients taking benzodiazepines, such as shortness of breath, throat swelling, nausea and vomiting.
Some patients may require hospitalization. If any of the above symptoms occur, contact the treating doctor immediately or go to the nearest emergency department. Airway obstruction may be fatal.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, unless necessary to calm them before surgical or diagnostic procedures. Lorazepam is contraindicated in children under 6 years of age. For further information, see section 3.

Lorabex with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This especially includes:

• medicines used for narcolepsy (sudden sleep) with cataplexy (sudden loss of muscle strength and tone) (e.g. sodium oxybate);
• medicines used in HIV treatment (e.g. zidovudine);
• medicines used to treat delusions or hallucinations (e.g. chlorpromazine, loxapine or clozapine);
• medicines used for indigestion (e.g. antacids, cisapride or omeprazole);
• a medicine used for nausea and vomiting caused by chemotherapy (nabilone);
• medicines used in addiction treatment (e.g. lofexidine and disulfiram);
• strong painkillers (e.g. methadone, tramadol, codeine, morphine);
• medicines used in tuberculosis, such as isoniazid;
• antibiotics, such as erythromycin;
• medicines used for high blood pressure (e.g. ACE inhibitors, alpha-blockers, angiotensin II receptor antagonists, calcium channel blockers, adrenergic neuron blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside and diuretics);
• medicines used for asthma (e.g. theophylline);
• muscle relaxants (e.g. baclofen and tizanidine);
• other sedative medicines (e.g. barbiturates or antihistamines);
• other medicines used for anxiety;
• medicines used for depression;
• antihistamine medicines for allergies;
• medicines used for Parkinson's disease (e.g. levodopa);
• medicines used for epilepsy (e.g. phenobarbital or valproate / valproic acid);
• medicines used for gout (e.g. probenecid);
• hormonal contraceptives containing oestrogen;
• medicines affecting liver enzymes (e.g. cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If lorazepam is used at the same time as other central nervous system depressants (e.g. psychotropic drugs, hypnotics, sedatives, anaesthetics, beta-blockers, opioid-type painkillers, sedative antihistamines, anticonvulsants), interactions may occur, leading to additive depressant effects on the central nervous system.
Concurrent use of lorazepam and opioids (e.g. strong painkillers, some antitussives, and medicines used in replacement therapy) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may result in death. Concurrent use should only be considered when other treatment options are not possible.
If a doctor prescribes lorazepam together with opioids, the lorazepam dose and duration of treatment should be limited. Inform the doctor about all opioid medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform family members or friends about the above symptoms.
Inform the doctor if any of the above symptoms occur.
The effects of muscle relaxants and painkillers may be enhanced.
If lorazepam is used simultaneously with clozapine, marked sedation, excessive salivation and impaired motor coordination may occur.
Concurrent administration of lorazepam with valproic acid / sodium valproate may increase lorazepam blood levels. If valproic acid / sodium valproate is used concurrently, the lorazepam dose should be reduced by about half.
Concurrent administration of lorazepam with probenecid may accelerate the onset or prolong the effect of lorazepam. If probenecid is used concurrently, the lorazepam dose should be reduced by half.
Theophylline or aminophylline may reduce the sedative effect of lorazepam.

Lorabex with food, drink and alcohol
Avoid drinking alcohol, as alcohol may unpredictably alter and enhance the effects of lorazepam.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Lorazepam should not be taken during pregnancy. The doctor will decide whether treatment should be discontinued.
If the patient takes lorazepam in late pregnancy or during delivery, the baby may be less active than other babies, may have reduced muscle tone, low body temperature (hypothermia) and/or low blood pressure (hypotension), respiratory depression, apnoea, and feeding difficulties ("floppy infant syndrome"). The newborn may experience withdrawal symptoms if the mother has taken lorazepam for a prolonged period in late pregnancy.

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

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

Driving and operating machinery
Lorazepam, when used as directed, may impair reaction abilities, especially 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. Do not drive vehicles. Do not operate any dangerous electrical tools or machinery. The patient should not work without secure foot support. It is particularly important to remember that alcohol further impairs reaction ability.
The treating doctor will decide whether the patient can drive or operate machinery, taking into account the individual response to treatment and the dose taken.

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

3. How to take Lorabex

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The dosage and duration of treatment should be adjusted according to the individual patient's response to treatment, the therapeutic indication (i.e. the condition for which this medicine has been prescribed), and the severity of the disease.
In general, the lowest effective dose should be used for the shortest possible time.

Adults
Follow your doctor's instructions carefully, otherwise lorazepam may not work properly.
Lorazepam should be taken according to the dosing regimen below, unless your doctor advises otherwise:

Anxiety and sleep disturbances due to anxiety:
The usual daily dose for adults is 0.5 mg – 2.5 mg of lorazepam, divided into 2 – 3 doses or taken as a single dose before bedtime.

Sedation before diagnostic or surgical procedures:
For adults: 1 mg – 2.5 mg of lorazepam the evening before the procedure and (or) 2 mg – 4 mg of lorazepam approximately 1 – 2 hours before the procedure.

Use in elderly or debilitated patients
In elderly or debilitated patients, as well as in patients with organic brain damage, the initial total daily dose should be reduced by half. Patients should be given the lowest effective dose. Your doctor will decide on the best treatment regimen tailored to the individual needs of the patient.

Use in patients with renal impairment
Patients with impaired kidney function may require lower doses. The initial dose is usually half the recommended adult dose. Your doctor will monitor the patient's response to the medicine and adjust the dose if necessary.

Use in patients with hepatic impairment
Patients with mild to moderate liver impairment may require lower doses. The initial dose is usually half the recommended adult dose.
Lorazepam is contraindicated in patients with severe liver failure.

Use in children and adolescents
Lorazepam should not be used in the treatment of anxiety or insomnia in children and adolescents under 18 years of age.

• Children under 6 years of age: Lorazepam is not intended for use in children under 6 years of age.
• Children aged 6–12 years: Before diagnostic or surgical procedures: the recommended dose is 0.5 mg – 1 mg, depending on the child's body weight (dose should not exceed 0.05 mg/kg body weight), taken at least 1–2 hours before surgery.
• Adolescents aged 13–18 years: Before diagnostic or surgical procedures: the recommended dose is 1 mg – 4 mg, taken 1–2 hours before surgery.

Method of administration
Lorazepam is intended for oral administration.
Tablets should be swallowed whole with an adequate amount of liquid (e.g. ½ to 1 glass of water).
The score line on the tablet facilitates breaking the tablet for easier swallowing if the patient has difficulty swallowing the tablet whole.
Lorabex 1 mg and Lorabex 2.5 mg: tablets may be divided into equal doses.

Duration of treatment
The duration of treatment is determined by the doctor.
In acute medical conditions, lorazepam should be used only for single doses or for a few days.
In chronic conditions, the duration of treatment depends on the stage of the disease. After 2 weeks of daily use, the doctor should gradually reduce the dose and decide whether continued treatment with lorazepam is still necessary.

Taking more than the recommended dose of Lorabex
If a patient takes more than the recommended dose, possibly causing poisoning, contact a doctor immediately. Call your doctor for advice on first aid and follow the instructions given. Do not induce vomiting unless otherwise advised by a doctor. Symptoms of overdose include drowsiness, confusion, lethargy, shallow breathing, impaired motor coordination, apathy, and in severe cases, loss of consciousness.

Missed dose of Lorabex
If a dose is missed, take the next tablet at the usual time the following day. Do not take a double dose to make up for a missed dose.

Stopping treatment with Lorabex
Suddenly stopping treatment with Lorabex after prolonged use may lead to withdrawal symptoms (see section 4). To avoid this, the dose should be gradually reduced.
After prolonged use (more than one week) and sudden discontinuation, sleep disturbances, anxiety and tension, inner restlessness, and agitation may temporarily return in an intensified form. Do not stop treatment abruptly, but gradually reduce the dose.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects should be expected, particularly at the beginning of treatment, if the dose is too high, and in the patient groups mentioned in "Warnings and precautions" (see section 2).

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

• Sedation, fatigue, drowsiness

Common: may occur in less than 1 in 10 patients

• Motor incoordination (ataxia)
• Confusion, depression, onset of depression
• Dizziness
• Muscle weakness, feeling of weakness (fatigue)

Uncommon: may occur in less than 1 in 100 patients

• Decreased libido, impotence, reduced intensity of orgasm
• Malaise

Rare: may occur in less than 1 in 1,000 patients

• Rash
• Attention disturbances
• Changes in saliva secretion

Very rare: may occur in less than 1 in 10,000 patients

• Leukopenia

Unknown frequency (cannot be estimated from available data):

• Blood count abnormalities (thrombocytopenia, agranulocytosis, pancytopenia)
• Prolonged reaction time
• Impaired motor coordination (extrapyramidal symptoms)
• Tremor
• Visual disturbances (double vision, blurred vision)
• Speech difficulties / slurred speech
• Headache
• Seizures / epileptic fits
• Memory loss (amnesia)
• Disinhibition (psychological), euphoria
• Coma
• Suicidal thoughts / suicide attempts
• Attention / concentration disturbances
• Balance disorders
• Dizziness
• Paradoxical reactions such as anxiety, agitation, restlessness, aggressive behaviour (hostility, aggression, rage), sleep disturbances / insomnia, increased sexual drive, hallucinations, psychoses. If such adverse reactions occur, treatment with lorazepam should be discontinued.
• Low blood pressure (hypotension), slight decrease in blood pressure
• Respiratory depression (dose-dependent severity), shortness of breath (dyspnoea), worsening of sleep apnoea (transient interruption of breathing during sleep)
• Worsening of obstructive lung disease (airway narrowing)
• Constipation
• Increased bilirubin levels
• Jaundice, increased liver enzyme activity (aminotransferases, alkaline phosphatase)
• Allergic skin reactions
• Hair loss
• Hypersensitivity reactions and anaphylactic / pseudoanaphylactic reactions, skin and (or) mucous membrane swelling (angioedema)
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• Low blood sodium levels (hyponatremia)
• Decrease in body temperature (hypothermia)

Benzodiazepines cause dose-dependent depression of the central nervous system.

Dependence / abuse
Even after a few days of daily lorazepam use, withdrawal symptoms (e.g. sleep disturbances, vivid dreams) may occur upon discontinuation of treatment, especially if stopped abruptly. Anxiety, tension, as well as agitation and inner restlessness (rebound phenomena) may worsen. Other symptoms reported after discontinuation of benzodiazepines include: headache, depression, confusion, irritability, sweating, mood disturbances, loss of sense of reality, behavioural disturbances, numbness and tingling of limbs, sensitivity to light, sound and touch, difficulty concentrating, involuntary movements, nausea, vomiting, diarrhoea, loss of appetite, hallucinations / delirium, seizures / epileptic fits, tremor, intestinal cramps, muscle pain, states of agitation, palpitations, tachycardia, panic attacks, dizziness, hyperreflexia, short-term memory loss, and increased body temperature. In patients with epilepsy receiving long-term lorazepam treatment or those taking other medicines that lower the seizure threshold (e.g. antidepressants), abrupt discontinuation of lorazepam may lead to more frequent epileptic seizures. The risk of withdrawal symptoms increases with duration of treatment and dose. This can usually be avoided by gradually reducing the dose.

Tolerance to the sedative effect of benzodiazepines has also been observed (increasing dose due to the body adapting).

Lorazepam has abuse potential. Patients with a history of drug or alcohol abuse are at particular risk.

What to do if adverse effects occur
Many of the adverse effects listed above resolve during continued treatment or after dose reduction. If adverse effects persist, inform your doctor, who will decide whether treatment should be discontinued. Inform your doctor if you develop a skin rash of unknown origin, skin discolouration, or swelling.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorisation holder.
Reporting adverse effects helps provide 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.
Keep the medicine out of 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 stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Lorabex contains

• The active substance is lorazepam; each tablet contains 0.5 mg, 1 mg, or 2.5 mg of lorazepam respectively.
• The other ingredients are: lactose monohydrate, povidone (K 30), crospovidone (type A), maize starch, microcrystalline cellulose (E 460), sodium carboxymethyl starch (type A), potassium polacrylin, 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 bevelled edges, embossed with the mark "1.0" on one side.
Lorabex 2.5 mg are white, round, flat tablets with bevelled edges.
Lorabex 1 mg and 2.5 mg tablets can be divided into equal doses.
The pack contains 25 tablets.

Marketing Authorisation 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
The Netherlands

Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański