Lorabex

Package Leaflet: Information for the Patient

Lorabex, 4 mg/ml, Solution for Injection

Lorazepam

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Lorabex and what is it used for
• 2. Important information before using Lorabex
• 3. How to use 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

This medication contains lorazepam, which belongs to a group of medicines called benzodiazepines. The medication helps to relieve anxiety and muscle tension. Lorabex is usually indicated for premedication before surgery or before invasive or prolonged diagnostic examinations. It may also be used to relieve acute anxiety states, acute excitement, or acute mania, and to control seizures. If there is no improvement or if the patient feels worse after taking Lorabex, they should tell their doctor. Lorabex should not be used in children under 12 years of age, except for the control of seizures, in which case Lorabex may be used in adults, children, and infants from 1 month of age and older.

2. Important information before using Lorabex

Tell your doctor or pharmacist if you have taken Lorabex before taking any other medication, if you are pregnant, or if you are admitted to the hospital for treatment.

When not to use Lorabex

• if the patient has significant breathing difficulties or chest pain
• if the doctor has previously prescribed benzodiazepines and they were not suitable
• if the patient is allergic to benzodiazepines, including lorazepam or any of the other ingredients of this medication (listed in section 6)
• if the patient has myasthenia gravis (excessive muscle weakness or fatigue)
• if the patient has significant liver problems
• if the patient has sleep apnea syndrome (breathing problems during sleep)
• if the child is under 12 years of age, except for the control of seizures. In the case of seizures, Lorabex should not be used in newborns.

Warnings and precautions

Before starting treatment with Lorabex, discuss with your doctor, pharmacist, or nurse:

• if you are pregnant, planning to have a baby, or breastfeeding
• if you abuse drugs or alcohol
• if you have kidney or liver problems
• if you are elderly or weakened
• if you have had depression in the past
• if you have a personality disorder
• if you have had psychotic disorders in the past
• if you have had seizures/epileptic fits in the past
• if you have breathing difficulties
• if you have eye problems - glaucoma
• if you are taking any other medications, as they may affect the action of Lorabex.

If the patient is being treated on an outpatient basis, Lorabex should not be administered unless the patient is accompanied by an escort who can take them home.

Tolerance and dependence

Tolerance to benzodiazepines may occur, so after several weeks of using Lorabex, the effect may be less noticeable. Lorazepam may cause dependence, especially in patients who have previously abused drugs, narcotics, and/or alcohol. It is unlikely that dependence will occur, but the risk increases with higher doses and longer use, and is further increased in patients who have been dependent on alcohol, drugs, or narcotics in the past, or in patients with marked personality disorders. Therefore, lorazepam should be avoided in individuals dependent on alcohol, drugs, or narcotics. Dependence can lead to withdrawal symptoms, especially when treatment is stopped abruptly. Therefore, the medication should always be discontinued gradually - if necessary, using oral lorazepam. Some patients may feel drowsy after taking Lorabex. It is recommended to stay in the hospital for at least 8 hours or overnight after receiving the injection. If the patient is to leave the hospital soon after receiving Lorabex, they should be under the care of an escort. In some elderly patients, dizziness may occur after taking Lorabex, and these patients are at increased risk of falls. Transient memory loss has been reported after taking benzodiazepines.

Children

Lorabex should not be used in children under 12 years of age, except for the control of seizures. In the case of seizures, Lorabex should not be used in newborns.

Lorabex and other medications

Tell your doctor or pharmacist about all medications you are currently taking, or have recently taken, and about any medications you plan to take. In particular, inform your doctor about taking any other sedative, anxiolytic, antidepressant, strong pain-relieving (e.g., opioids, methadone - the dose and duration of use of both medications should be minimized in accordance with the doctor's recommendations), antiepileptic, antihistamine, or psychotropic medications for mood or mental disorders (e.g., haloperidol or chlorpromazine). Taking Lorabex with pain-relieving medications increases the risk of drowsiness, and in rare cases, breathing difficulties, and may result in death. Barbiturates (sedatives) and anesthetics (medications that cause reversible loss of sensation), clozapine (a medication for mood or mental disorders), sodium valproate (used to treat epilepsy and bipolar disorder), probenecid (a medication used to treat gout), theophylline, aminophylline (medications used to treat respiratory diseases), disulfiram (a medication used to support the treatment of alcoholism), and metronidazole (an antibiotic): it may be necessary to reduce the doses of these medications before administering Lorabex. You should also inform your doctor about taking a medication called scopolamine, which may be used for intestinal problems or before surgery. Tell your doctor or pharmacist if you have taken Lorabex before taking any other medication, if you are pregnant, or if you are admitted to the hospital for treatment.

Lorabex with food, drink, and alcohol

Avoid drinking alcohol for 24 to 48 hours before taking Lorabex. See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication. Pregnancy Benzodiazepines, including Lorabex, may cause harm to the fetus if taken early in pregnancy. Therefore, if you are pregnant or may become pregnant, do not take this medication without consulting your doctor. If you take this medication during late pregnancy or during childbirth, the baby may be less active than other babies after birth, and may experience symptoms such as: low body temperature, low muscle tone, breathing difficulties, or feeding problems. The baby may also experience transient disturbances in temperature regulation. After birth, the baby may experience withdrawal symptoms if the mother takes lorazepam regularly for a long time during late pregnancy. Breastfeeding Lorabex should not be given to breastfeeding mothers, unless the doctor considers that the expected benefits to the mother outweigh the potential risk to the baby, as the medication may pass into breast milk.

Driving and using machines

On the day of taking Lorabex, some patients may experience drowsiness or dizziness. Do not drive or operate machinery for 24 to 48 hours after taking Lorabex.

Lorabex contains benzyl alcohol, propylene glycol (E1520), and macrogol 400

This medication contains 21 mg of benzyl alcohol, 840 mg of propylene glycol, and 189 mg of macrogol 400 in each 1 ml. In children under 5 years of age, patients with liver or kidney disease, or pregnant or breastfeeding women, consult your doctor or pharmacist before using the medication, as the excipients may cause side effects. The doctor may adjust the dose if the patient or child is taking other medications containing benzyl alcohol, propylene glycol, or alcohol. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to small children is associated with a risk of serious side effects, including breathing difficulties (so-called "gasping syndrome"), but Lorabex is not used in infants under 1 month of age. Do not give to small children (under 3 years of age) for more than a week without consulting a doctor or pharmacist.

3. How to use Lorabex

Always use this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The doctor will administer Lorabex by injection into a vein or into a muscle. The recommended dose is: In premedication, the usual recommended dose is 0.05 mg per kilogram of body weight (e.g., if the patient weighs 70 kilograms, they will probably receive 3.5 mg of lorazepam). Lorabex should not be used in premedication in children under 12 years of age. In acute anxiety, the usual recommended dose is from 0.025 to 0.03 mg per kilogram of body weight (e.g., if the patient weighs 70 kilograms, they will probably receive from 1.75 to 2.1 mg of lorazepam). Lorabex should not be used to treat acute anxiety in children under 12 years of age. The doctor may prescribe a different dose or recommend a different treatment duration, especially for elderly or weakened patients. Patients with kidney or liver function disorders: smaller doses may be sufficient for these patients. Use in patients with severe liver failure is contraindicated. In controlling seizures in adults, lorazepam is usually administered intravenously in a dose of 4 mg. Children receive a lower dose of 0.1 mg per kilogram of body weight intravenously. Do not exceed 4 mg per dose. If seizures persist within 10-15 minutes after administration, the doctor may decide to administer a second dose. Due to the potential risk of toxicity associated with the accumulation of excipients, the maximum dose of Lorabex should not be repeated within 24 hours in children under 5 years of age.

Use in children

Lorabex should not be used in children under 12 years of age, except for the control of seizures (see also section 2). In the case of seizures, Lorabex should not be used in newborns (see also section 2).

During long-term treatment, dependence on benzodiazepines may occur. For this reason

Lorabex is usually prescribed for a single dose or for a short period of treatment. This reduces the risk of dependence on Lorabex or the occurrence of withdrawal symptoms after stopping its use (see "Stopping Lorabex" below). The doctor will prescribe the smallest effective dose for the shortest possible time. If Lorabex is administered in doses significantly higher than those listed above, the risk of side effects increases, such as those listed in section 4 "Possible side effects". You should inform your doctor if you experience any of these symptoms or other side effects.

Stopping Lorabex

After completing treatment with Lorabex, the doctor will decide whether further treatment is necessary. After completing treatment, the dose of Lorabex should be gradually reduced. This will allow the body to get used to the absence of Lorabex and reduce the risk of side effects.

Withdrawal symptoms

After stopping Lorabex, withdrawal symptoms may occur, such as: headache, muscle pain, anxiety, tension, depression, restlessness, dizziness, nausea, diarrhea, loss of appetite, insomnia, confusion, irritability, agitation, tremors, abdominal pain, changes in heart rate, short-term memory loss, dysphoria (feeling of sadness, anxiety, irritability, or restlessness), high fever, and sweating. If these symptoms occur, they usually do not last long. If you experience any of these symptoms, you should contact your doctor. If you experience any of the following withdrawal symptoms: loss of reality, feeling of unreality or detachment from life, and inability to feel emotions, ringing in the ears, numbness or tingling of hands or feet, vomiting, tremors, hallucinations, seizures, or effects on vision, hearing, or touch, you should contact your doctor immediately. If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Lorabex can cause side effects, although not everybody gets them. Severe allergic reactions have been reported during the use of benzodiazepines, even after the first dose. In patients after taking the first dose or subsequent doses of benzodiazepines, cases of skin and/or mucous membrane swelling, including the tongue, throat, or vocal cords (angioedema), have been reported. In some patients taking benzodiazepines, other side effects have occurred, such as shortness of breath, throat swelling, or nausea and vomiting. Benzodiazepines, including lorazepam, may cause potentially life-threatening breathing problems. During the use of Lorabex, side effects may occur occasionally. They are usually not serious and do not last long. However, you should inform your doctor if any of the following side effects are severe or troublesome.

Other side effects that may occur include:

Very common: occur in more than 1 in 10 patients

• sedation
• fatigue
• drowsiness

Common: occur in less than 1 in 10 patients

• muscle weakness
• asthenia (weakness)
• ataxia (lack of coordination)
• confusion
• depression
• uncovering of depression (uncovering of previously hidden depressive symptoms)
• dizziness

Uncommon: occur in less than 1 in 100 patients

• nausea
• disturbed sexual desire
• impotence
• less intense orgasm

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

• increased sensitivity to light, sound, and touch
• seizures and/or epileptic fits
• constipation, jaundice
• tremors
• vision disturbances (double vision, blurred vision)
• speech difficulties and/or slurred speech
• headache
• amnesia
• increased emotions
• coma
• suicidal thoughts and/or suicide attempts
• attention and/or concentration disorders
• lack of restraint (psychological)
• increased liver enzyme levels (bilirubin, aminotransferases, alkaline phosphatase)
• anxiety, agitation, hostility, aggression, increased sexual desire
• balance disorders
• breathing difficulties
• sleep apnea
• worsening of lung disease
• allergic skin reactions (e.g., rash, swelling)
• hair loss (hair loss from the head or body)
• hypersensitivity reactions
• angioedema (swelling of the face, hands, and feet)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body produces too much antidiuretic hormone (ADH). Excessive ADH can cause excessive water retention in the body.
• hyponatremia (low sodium levels in the blood, which can cause fatigue and confusion, muscle tremors, seizures, and coma)
• hypothermia (low body temperature)
• low blood pressure
• thrombocytopenia (unexplained bruising, nosebleeds, and/or bleeding gums), agranulocytosis (severe infection), pancytopenia (bleeding, easy bruising, fatigue, shortness of breath, and weakness)
• vertigo of labyrinthine origin
• sleep disorders

The following side effects may be more likely in children and elderly patients:

• restlessness
• excitement
• irritability
• aggression
• sudden anger
• nightmares
• hallucinations
• personality disorders
• behavioral disorders
• delusions

In rare cases, patients may experience pain, inflammation, or rash at the injection site. In such cases, the doctor should be informed immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Lorabex

Keep this medication out of the sight and reach of children. Store and transport in a cool place (2°C-8°C). Store in the original packaging to protect from light. The chemical and physical stability of the medication has been demonstrated after dilution for 1 hour at 2°C-8°C. From a microbiological point of view, unless the method of opening/dilution excludes the risk of microbial contamination, the medication should be used immediately. If not used immediately, the user is responsible for the storage conditions during use. Do not use this medication after the expiry date stated on the label and carton after: EXP. The expiry date stated on the packaging refers to the last day of the stated month. The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lorabex contains

• The active substance of Lorabex is lorazepam. Each 1 ml of solution contains 4 mg of lorazepam.
• The other ingredients are: propylene glycol (E1520), macrogol 400, benzyl alcohol.

What Lorabex looks like and contents of the pack

Clear, colorless or almost colorless solution, without visible particles. Lorabex is packaged in 2 ml colorless glass type I ampoules, containing 1 ml of solution. The ampoules are placed on PVC trays, sealed with transparent PE foil, in a cardboard box with a leaflet. Lorabex is packaged in 5 or 10 ampoules of 1 ml solution each. Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Medochemie Ltd 48 Iapetou Street, Agios Athanassios Industrial Area 4101 Agios Athanassios, Limassol Cyprus Date of last revision of the leaflet:March 2025 --------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Dosage and administration

Dosage:

Dosage and duration of treatment should be determined for each patient individually. The smallest effective dose should be used for the shortest possible time. The risk of withdrawal syndrome and rebound phenomenon is greater after abrupt discontinuation of the medication; therefore, in all patients, the medication should be discontinued gradually. Elderly and weakened patients may react to smaller doses, and half of the recommended dose for adults may be sufficient.

Premedication:

Adults: 0.05 mg/kg body weight (3.5 mg at an average body weight of 70 kg). The medication should be administered intravenously 30-45 minutes before surgery, sedative effects occur within 5-10 minutes, and loss of consciousness occurs within 30-45 minutes. The medication should be administered intramuscularly 1-1.5 hours before surgery, sedative effects occur within 30-45 minutes, and loss of consciousness occurs within 60-90 minutes. Children and adolescents: Lorabex should not be used in children under 12 years of age.

Acute anxiety:

Adults: 0.025-0.03 mg/kg body weight (1.75-2.1 mg at an average body weight of 70 kg). Repeat every 6 hours. Children and adolescents: Lorabex should not be used in children under 12 years of age.

Seizures:

Adults: 4 mg intravenously. Children and adolescents(from 1 month of age and older): 0.1 mg/kg body weight intravenously. Maximum 4 mg per dose. Due to the potential risk of toxicity associated with the accumulation of excipients, the maximum dose of Lorabex should not be repeated within 24 hours in children under 5 years of age. In the case of seizures, Lorabex should not be used in newborns. If seizures persist within the next 10-15 minutes, the dose can be repeated, but do not exceed 4 mg per dose. Elderly and weakened patients: Elderly and weakened patients may react to smaller doses, and half of the recommended dose for adults may be sufficient.

Patients with kidney or liver function disorders

Smaller doses may be sufficient for patients with kidney or liver function disorders. Administration in patients with severe liver failure is contraindicated.

Elderly and weakened patients

The initial dose should be reduced by about 50% and the dose adjusted according to the patient's needs and tolerance.

Administration

Lorabex can be administered intravenously or intramuscularly, but the intravenous route is preferred. Caution should be exercised when administering the medication to avoid intra-arterial or intravenous injection into small veins. Absorption from the injection site is significantly slower in the case of intramuscular administration, and a similar rate of action can be achieved with oral lorazepam tablets. Lorabex should not be used for prolonged periods.

Preparation of the injection

Intramuscular administration: To facilitate intramuscular administration, it is recommended to dilute Lorabex in a 1:1 ratio with 0.9% sodium chloride solution, 5% glucose solution, or water for injection. Intravenous administration: In the case of intravenous administration, Lorabex should always be diluted with 0.9% sodium chloride solution, 5% glucose solution, or water for injection in a 1:1 ratio. Lorabex is available as a 1 ml solution in a 2 ml ampoule to facilitate dilution. Lorabex should not be mixed with other medications in the same syringe.

Incompatibilities

Due to the lack of data on compatibility, this medication should not be mixed with other medications, except for those listed in the "Dosage and administration" section.

Shelf life

Before opening: 18 months. After opening: use immediately after opening.

Special precautions for storage

Store and transport in a cool place (2°C-8°C). Store in the original packaging to protect from light.

Special precautions for disposal and preparation of the medication for administration

Lorabex should not be mixed with other medications in the same syringe. Do not use if the solution has discolored or a precipitate has formed (see "Dosage and administration"). No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.