Lorabex

Package leaflet: Information for the patient

Lorabex, 4 mg/ml, solution for injection
Lorazepamum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• 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 identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

This medicine contains lorazepam, which belongs to a group of medicines called benzodiazepines. The medicine helps relieve anxiety and muscle tension.
Lorabex is usually indicated for premedication before surgery or before invasive or prolonged diagnostic procedures. It may also be used to alleviate acute anxiety states, acute agitation, or acute mania, as well as for controlling seizures.
If there is no improvement or if the patient feels worse after receiving Lorabex, inform the doctor.
Lorabex must not be used in children under 12 years of age, except in status epilepticus, 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

You should tell your doctor or pharmacist if the patient has received Lorabex before
using any other medicine, if the patient becomes pregnant, or if the patient is admitted
to hospital for treatment.
When not to use Lorabex

• if the patient has significant breathing difficulties or experiences chest pain
• if in the past a doctor prescribed benzodiazepines and they proved inappropriate
• if the patient is allergic to benzodiazepines, including lorazepam, or any of the other ingredients of this medicine (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 apnoea syndrome (breathing problems during sleep)
• if the child is under 12 years of age, except for controlling status epilepticus. Lorabex must not be used in neonates for status epilepticus.

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

• if the patient is pregnant, planning to become pregnant, or breastfeeding
• if the patient abuses drugs or alcohol
• if the patient has kidney or liver problems
• if the patient is elderly or frail
• if the patient has or has had depression
• if the patient has a personality disorder
• if the patient has had psychotic disorders in the past
• if the patient has had seizures/epileptic fits in the past
• if the patient has breathing difficulties
• if the patient has eye problems – glaucoma
• if the patient is taking any other medicines, as they may affect the way Lorabex works.

If the patient is being treated as an outpatient, Lorabex should not be administered unless accompanied by a caregiver who will escort the patient home.
Tolerance and dependence
Tolerance to benzodiazepines may occur, so after several weeks of using Lorabex, the effect may become less noticeable.
Lorazepam may cause dependence, particularly in patients who have previously abused
drugs, narcotics, and (or) alcohol.
Dependence is unlikely, but the risk increases with higher doses and long-term use, and is further increased in patients with a history of alcohol, drug, or narcotic dependence, or in patients with marked personality disorders. Therefore, lorazepam should be avoided in individuals dependent on alcohol, drugs, or narcotics.
Dependence may lead to withdrawal symptoms, especially after abrupt discontinuation of treatment. Therefore, the medicine should always be discontinued gradually – if necessary, using lorazepam in oral form.
Some patients may feel drowsy after taking Lorabex. It may be advisable to remain in hospital for at least 8 hours or overnight after receiving the injection. If the patient leaves hospital soon after receiving Lorabex, they should be under the supervision of a caregiver.
Dizziness may occur in some elderly patients after taking Lorabex, and these patients have an increased risk of falls.
Transient memory loss has been reported after administration of benzodiazepines.
Children
Lorabex must not be used in children under 12 years of age, except for controlling status
epilepticus. In the case of status epilepticus, Lorabex must not be used in neonates.
Lorabex and other medicines
You should tell your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any other sedatives, anxiolytics, antidepressants, strong painkillers (e.g. opioids, methadone – doses should be reduced and duration of use minimized as advised by the doctor), antiepileptics, antihistamines, or psychotropic medicines for mood or psychiatric disorders (e.g. haloperidol or chlorpromazine). Taking Lorabex with painkillers increases the risk of drowsiness; in rare cases, breathing difficulties may occur, which could lead to death.
Barbiturates (sedative medicines) and anaesthetics (medicines causing anaesthesia – reversible loss of sensation), clozapine (a medicine for mood or psychiatric disorders), sodium valproate (used in the treatment of epilepsy and bipolar affective disorder), probenecid (a medicine used in gout), theophylline, aminophylline (medicines used in respiratory diseases), disulfiram (a medicine supporting alcoholism treatment), and metronidazole (an antibiotic): doses of these medicines may need to be reduced before administering Lorabex. You should also inform the doctor if the patient is taking a medicine called scopolamine, which may be used for bowel problems or before surgery.
You should tell your doctor or pharmacist if the patient has received Lorabex before
using any other medicine, if the patient becomes pregnant, or if the patient is admitted
to hospital for treatment.
Lorabex with food, drink, and alcohol
Alcohol should be avoided for 24 to 48 hours before administration of Lorabex. See section 3.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Benzodiazepines, including Lorabex, may harm the unborn baby if taken during early pregnancy. Therefore, if the patient is pregnant or may become pregnant, she should not take this medicine without consulting a doctor. If the patient takes this medicine during late pregnancy or during labour, the newborn baby may be less active than usual and may experience symptoms such as: low body temperature, reduced muscle tone, breathing problems, or difficulty feeding. The baby may also have a temporary impaired response to cold. Withdrawal symptoms may occur in the newborn baby if the mother has regularly taken lorazepam for a prolonged period during late pregnancy.
Breastfeeding
Lorabex should not be given to breastfeeding mothers unless, in the doctor’s opinion, the expected benefit to the mother outweighs the potential risk to the infant, because the medicine may pass into breast milk.
Driving and using machines
Some patients may experience drowsiness or dizziness on the day of receiving Lorabex.
Do not drive or operate machinery within 24 to 48 hours after receiving Lorabex.
Lorabex contains benzyl alcohol, propylene glycol (E1520), and macrogol 400
This medicine 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 a doctor or pharmacist before use, as the excipients may cause adverse effects. The doctor may adjust the dose if the patient or child is taking other medicines containing benzyl alcohol, propylene glycol, or alcohol.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children carries a risk of severe adverse effects, including breathing disorders (so-called “gasping syndrome”), although Lorabex is not used in infants under 1 month of age.
Do not administer to young children (under 3 years of age) for longer than one week without a doctor’s or pharmacist’s advice.
3. How to take Lorabex
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
The doctor will administer Lorabex as an injection into a vein or into a muscle.
Recommended dose:
For premedication, the usual recommended dose is 0.05 mg per kilogram of body weight (e.g. if the patient weighs 70 kg, they will likely receive 3.5 mg of lorazepam).
Lorabex must not be used for premedication in children under 12 years of age.
For acute anxiety, the usual recommended dose is 0.025 to 0.03 mg per kilogram of body weight (e.g. if the patient weighs 70 kg, they will likely receive 1.75 to 2.1 mg of lorazepam). Lorabex must not be used for treating acute anxiety in children under 12 years of age.
The doctor may prescribe a different dose or recommend a different treatment duration, especially in elderly or frail patients.
Patients with impaired kidney or liver function: lower doses may be sufficient in these patients. Use in patients with severe liver impairment is contraindicated.
For controlling epileptic status in adults, lorazepam is usually administered intravenously at a dose of 4 mg. Children receive a lower intravenous dose of 0.1 mg per kilogram of body weight. The dose should not exceed 4 mg. 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 related to 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 must not be used in children under 12 years of age, except for controlling status
epilepticus (see also section 2). In the case of status epilepticus, the medicine must not be used in neonates (see also section 2).
Long-term use may lead to dependence on benzodiazepines. For this reason,
Lorabex is usually prescribed in one or two doses or for a short treatment period.
This reduces the risk of dependence on Lorabex or the occurrence of withdrawal symptoms after stopping treatment (see “Discontinuing Lorabex” below).
The doctor will prescribe the lowest effective dose for the shortest possible duration.
If Lorabex is administered at doses significantly higher than those stated above, the risk of adverse effects, such as those listed in section 4 “Possible side effects”, increases. Inform the doctor if any of these symptoms or other adverse effects occur.
Discontinuing Lorabex
After completing treatment with Lorabex, the doctor will decide whether further treatment is needed.
After treatment ends, the dose of Lorabex should be gradually reduced. This allows the body to adapt to the absence of Lorabex and reduces the risk of adverse effects.
Withdrawal symptoms
After stopping Lorabex, withdrawal symptoms may occur, such as: headache, muscle pain, anxiety, tension, depression, restlessness, dizziness, nausea, diarrhoea, loss of appetite, insomnia, confusion, irritability, agitation, tremor, abdominal pain, changes in heart rate, short-term memory loss, dysphoria (feeling of sadness (low mood), anxiety, irritability, or restlessness), high body temperature, and sweating. If these symptoms occur, they usually do not last long. If the patient experiences any of these symptoms, contact the doctor.
If the patient experiences any of the following withdrawal symptoms: loss of sense of reality, feeling of unreality or detachment from life and inability to feel emotions, tinnitus (ringing in the ears), numbness or tingling in hands or feet, vomiting, tremor, hallucinations, seizures, or effects on vision, hearing, or touch, contact the doctor immediately.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Severe allergic reactions have been reported during the use of benzodiazepines, even after the first dose.
Cases of skin swelling and (or) mucous membranes affecting the tongue, larynx, or vocal cords (angioedema) have been reported in patients after administration of the first or subsequent doses of benzodiazepines. In some patients, other adverse reactions during benzodiazepine use have included shortness of breath, throat swelling, or nausea and vomiting.
Benzodiazepines, including lorazepam, may cause potentially fatal breathing problems.
During treatment with Lorabex, adverse reactions may occur sporadically. Usually, they are not severe and do not last long. However, you should inform your doctor if any of the following adverse reactions are severe or troublesome.
Other possible adverse reactions include:
Very common: affects more than 1 in 10 patients

• sedation
• fatigue
• drowsiness

Common: affects less than 1 in 10 patients

• muscle weakness
• asthenia (weakness)
• ataxia (lack of voluntary coordination of muscle movements)
• confusion
• depression
• emergence of depression (unmasking of depressive symptoms previously hidden)
• dizziness

Uncommon: affects less than 1 in 100 patients

• nausea
• decreased libido
• impotence
• reduced intensity of orgasm

Frequency not known: frequency cannot be estimated from available data

• increased sensitivity to light, sound, and touch
• seizures and (or) convulsions
• constipation, jaundice (yellowing of the skin and eyes)
• tremor
• visual disturbances (double vision, blurred vision)
• difficulty speaking and (or) slurred speech
• headache
• memory loss
• heightened emotions
• coma
• suicidal thoughts and (or) suicide attempts
• attention and (or) concentration disturbances
• disinhibition (loss of psychological inhibitions)
• increased liver enzyme activity (bilirubin, aminotransferases, alkaline phosphatase)
• anxiety, agitation, hostility, aggression, sexual arousal
• balance disorders
• breathing difficulties
• breathing problems during sleep
• worsening of lung disease
• allergic skin reactions (e.g., rash, swelling)
• alopecia (hair loss from head or body)
• hypersensitivity reactions
• angioedema (facial, hand, and foot swelling)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body releases too much antidiuretic hormone (ADH). Increased ADH may lead to excessive water retention in the body.
• hyponatremia (low sodium levels in the blood, which may cause fatigue, confusion, muscle twitching, seizures, and coma)
• hypothermia (lowered body temperature)
• low blood pressure
• thrombocytopenia (unexplained bruising, nosebleeds, and/or gum bleeding), agranulocytosis (severe infection), pancytopenia (bleeding, easy bruising, fatigue, shortness of breath, and weakness)
• vertigo of labyrinthine origin
• sleep problems

The following adverse reactions may be more likely in children and elderly patients:

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

In rare cases, patients may experience pain, skin inflammation, or a rash at the injection site. If this occurs, the doctor should be informed immediately.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lorabex

Keep this medicine out of sight and reach of children.
Store and transport in a refrigerated condition (2°C–8°C). Store in the original packaging to protect from light.
Chemical and physical stability of the diluted product has been demonstrated for one hour at 2°C–8°C.
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbiological contamination, the medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration of use.
Do not use this medicine after the expiry date stated on the label and carton 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 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Lorabex contains

• The active substance is lorazepam. Each 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
A clear, colourless or almost colourless solution, free from visible particles.
Lorabex is supplied in 2 ml ampoules made of colourless type I glass. Each ampoule contains 1 ml of solution.
The ampoules are arranged on PVC trays sealed with a transparent PE foil and packed into a cardboard box with a leaflet.
Lorabex is available in packs containing either 5 or 10 ampoules of 1 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne 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

Information intended exclusively for healthcare professionals:

Dosage and administration
Dosage:
Dosage and duration of treatment should be individually determined for each patient.
The lowest effective dose for the shortest possible time should be used. The risk of withdrawal syndrome and rebound phenomena is higher after abrupt discontinuation of the drug; therefore, the drug should be withdrawn gradually in all patients.
Premedication:
Adults: 0.05 mg/kg body weight (3.5 mg at an average body weight of 70 kg). The drug should be administered intravenously 30–45 minutes before surgery; sedative effects occur after 5–10 minutes, and loss of consciousness occurs within a maximum of 30–45 minutes.
Alternatively, the drug may be administered intramuscularly 1–1.5 hours before surgery; sedative effects occur after 30–45 minutes, and loss of consciousness occurs within a maximum of 60–90 minutes.
Children and adolescents: Lorabex must not be used in children under 12 years of age.
Acute anxiety state:
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 must not be used in children under 12 years of age.
Status epilepticus:
Adults: 4 mg administered intravenously.
Children and adolescents (from 1 month of age and older): 0.1 mg/kg body weight administered intravenously. Maximum dose per administration: 4 mg.
Due to the potential risk of toxicity related to accumulation of excipients, the maximum dose of Lorabex medicinal product should not be repeated within 24 hours in children under 5 years of age.
In status epilepticus, Lorabex medicinal product must not be used in neonates.
If seizures persist within the next 10–15 minutes, the dose may be repeated, but no more than 2 doses should be administered. Do not exceed 4 mg per dose.
Elderly and debilitated patients: Elderly and debilitated patients may respond to lower doses, and half the recommended adult dose may be sufficient.
Patients with renal or hepatic impairment
Lower doses may be sufficient in patients with renal impairment or mild to moderate hepatic impairment. Administration in patients with severe hepatic impairment is contraindicated.
Elderly and debilitated patients
In elderly and debilitated patients, the initial dose should be reduced by approximately 50%, and the dose should be adjusted according to the patient's needs and tolerance.
Administration method
Lorabex may be administered intravenously or intramuscularly; however, intravenous administration is preferred.
Care should be taken during administration to avoid intra-arterial injection or injection into small veins.
Absorption from the injection site is significantly slower after intramuscular administration, and a similar onset of action can be achieved with oral administration of lorazepam tablets.
Lorabex should not be used long-term.
Preparation of 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 injections.
Intravenous administration:
In case of intravenous administration, Lorabex must always be diluted with 0.9% sodium chloride solution, 5% glucose solution, or water for injections in a 1:1 ratio.
Lorabex is available as 1 mL solution in a 2 mL ampoule to facilitate dilution.
Lorabex must not be mixed with other drugs in the same syringe.
Pharmaceutical incompatibilities
Due to lack of compatibility data, this medicinal product must not be mixed with other drugs, except those mentioned in the section "Dosage and administration".
Shelf life
Before opening: 18 months.
After opening: Use immediately after opening.
Special precautions during storage
Store and transport under refrigerated conditions (2°C–8°C).
Store in the original packaging to protect from light.
Special precautions regarding disposal and preparation for use
Lorabex must not be mixed with other drugs in the same syringe. Do not use if the solution changes color or if a precipitate appears (see "Dosage and administration").
No special requirements for disposal.
Any unused portions or waste material should be disposed of in accordance with local regulations.