Lorazepam Hualan: detailed information

Package leaflet: Information for the patient

Lorazepam Hualan 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets, 2.5 mg tablets

lorazepam
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Lorazepam Hualan is and what it is used for
What you need to know before taking Lorazepam Hualan
How to take Lorazepam Hualan
Possible side effects
How to store Lorazepam Hualan
Contents of the pack and other information

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

Lorazepam Hualan is a sedative and anxiolytic (tranquilizer) medicine belonging to the group of active substances known as benzodiazepines.
Lorazepam Hualan is used in adults for the short-term treatment of anxiety or sleep disorders caused by anxiety.
It may also be used as a sedative before diagnostic procedures and surgical interventions in adults, adolescents, and children from the age of 6 years.
Lorazepam Hualan must not be used for the treatment of mild or moderate anxiety in adults or for anxiety and sleep disorders in children.

2. What you need to know before taking Lorazepam Hualan

Do not take Lorazepam Hualan
─ if you are allergic to lorazepam, to other benzodiazepines, or to any of the other ingredients of
this medicine (listed in section 6).
─ if you have severe liver problems (severe hepatic insufficiency)
─ if you are pregnant (see section "Pregnancy and breastfeeding")
─ if you have, or have previously had, drug, alcohol, or drug addiction
─ if you suffer from abnormal muscle weakness (myasthenia gravis)
─ if you have motor coordination disorders (spinal and cerebellar ataxias)
─ in case of acute intoxication with alcohol or central nervous system depressant drugs (e.g.
sleeping pills or painkillers, drugs for the treatment of mental disorders such as neuroleptics,
antidepressants and lithium)
─ if you suffer from breathing problems during sleep (sleep apnea syndrome)
─ if you suffer from severe respiratory problems (chronic obstructive pulmonary disease)
Lorazepam Hualan must not be used in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam Hualan if:
─ you suffer from depression, as Lorazepam Hualan may increase suicidal thoughts or impulses
you may have
─ you are elderly, as you may be more likely to fall
─ you have liver problems
─ you abuse or have previously abused medicines or alcohol
─ you have chronic breathing difficulties
─ you have been diagnosed with angioedema (sudden swelling of the skin, mucous membranes, or
internal organs) associated with benzodiazepine treatment

In patients with depression, symptoms of depression associated with the disease may appear or worsen. In these patients, treatment with benzodiazepines may increase the risk of suicide; lorazepam should not be administered without adequate antidepressant therapy. If you are depressed, have irrational fears and obsessions, or have started thinking about suicide or self-harm, inform your doctor immediately.

At the beginning of treatment, your doctor will monitor your individual response to this medicine to detect any overdosing as early as possible. If you are a child, an elderly or debilitated patient, you may show increased sensitivity to the effects of Lorazepam Hualan. Therefore, your treatment should be monitored more frequently.

If you suffer from renal or hepatic dysfunction, pre-existing heart failure and/or low blood pressure (hypotension), you may be more sensitive to the effects of this medicine; the same applies if you are elderly. You may be at higher risk of falls, especially when getting up during the night.

The use of lorazepam may cause hepatic encephalopathy (a brain disorder caused by liver damage). Therefore, lorazepam must not be used in patients with severe liver problems and/or hepatic encephalopathy.

When used to promote sleep, ensure you get sufficient sleep (approximately 7–8 hours). Following this recommendation may help avoid possible side effects (e.g., fatigue, reduced reaction times) the following morning. For detailed instructions on managing your daily life, considering your specific situation (e.g., work activities), consult your doctor.

Following the use of benzodiazepines, paradoxical reactions have occasionally been reported (see section 4). Such reactions are particularly expected in children and the elderly. If paradoxical reactions occur, treatment with lorazepam must be discontinued.

Elderly patients
In elderly patients, lorazepam must be used with caution due to the risks of sedation and/or muscle weakness, which may increase the risk of falls, with serious consequences for patients in this group. In elderly patients, the dose must be reduced.

The use of benzodiazepines, including lorazepam, may cause breathing difficulties (respiratory depression), which may be fatal.

Dependence
Lorazepam may lead to dependence (primary dependence potential). Even if Lorazepam Hualan is taken daily for several weeks, it may lead to the development of physical and psychological dependence. This risk does not only concern the abusive use of particularly high doses, but also occurs within the therapeutic dosage range. The risk increases with the duration of treatment and dosage, and is higher in patients with a history of alcohol or drug abuse or with marked personality disorders.

In general, benzodiazepines should only be prescribed for short periods (2–4 weeks). Continuous use is only possible if strictly necessary, after careful evaluation of the benefit of treatment versus the risk of dependence. Long-term use of Lorazepam Hualan is not recommended. Therefore, you should take Lorazepam Hualan for the shortest possible time (see section 4).

Treatment with Lorazepam Hualan must be gradually discontinued to avoid withdrawal symptoms. See section 3 "If you stop taking Lorazepam Hualan".

Serious allergic reactions have been reported with the use of benzodiazepines. Cases of angioedema (swelling of the skin and/or mucous membranes) involving the tongue, larynx, or the laryngeal area responsible for voice production (glottis) have been reported after ingestion of the first dose or subsequent doses of benzodiazepines. Some patients undergoing treatment with benzodiazepines have experienced other symptoms such as shortness of breath (dyspnea), throat swelling, or nausea and vomiting. Some patients required emergency treatment. If angioedema involving the tongue, larynx, or glottis occurs, the airways may become obstructed, with potentially fatal consequences.

Children and adolescents
Children and adolescents under 18 years of age must not be treated with Lorazepam Hualan, except in urgent cases for sedation prior to diagnostic or surgical procedures.
Lorazepam Hualan must not be used in children under 6 years of age.

Other medicines and Lorazepam Hualan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

The simultaneous use of Lorazepam Hualan with other medicines that depress the central nervous system may result in mutual potentiation of central nervous system depressant effects, for example:

medicines for the treatment of mental disorders (psychotropic drugs)
sleeping pills, sedatives, anesthetics
medicines for the treatment of high blood pressure (beta-blockers)
some painkillers, drugs for substitution therapy, and cough sedatives (opioids)
medicines for allergies (antihistamines)
medicines used for the treatment of seizure disorders (antiepileptics)

The simultaneous use of Lorazepam Hualan and opioids (strong painkillers, drugs for substitution therapy, and some cough sedatives) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered if no other therapeutic options are available.
However, if Lorazepam Hualan is prescribed together with opioids, your doctor should limit the dose and duration of concomitant treatment.
Inform your doctor about all opioid-containing medicines you are taking and strictly follow their recommendations regarding dosage. It may be helpful to ask friends or family members to watch for the signs and symptoms listed above that you may experience. Inform your doctor if such symptoms occur.

The effect of medicines that reduce muscle tension (muscle relaxants) and analgesics may be enhanced.

The concomitant use of lorazepam and clozapine may cause severe drowsiness, excessive salivation, and motor coordination problems.

The concomitant administration of Lorazepam Hualan and valproic acid may increase lorazepam blood concentrations. If valproic acid is used together with Lorazepam Hualan, the dose of the latter should be reduced by approximately half.

The concomitant administration of Lorazepam Hualan and probenecid may accelerate the onset or prolong the effect of lorazepam. The dosage of Lorazepam Hualan must be halved when used together with probenecid.

The use of theophylline or aminophylline may reduce the sedative effects of Lorazepam Hualan.

Lorazepam Hualan and alcohol
Avoid consuming alcoholic beverages simultaneously, as alcohol may alter and unpredictably enhance the effects of Lorazepam Hualan.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Lorazepam Hualan must not be taken during pregnancy.
If pregnancy occurs during treatment with Lorazepam Hualan, inform your doctor immediately so they can decide whether to discontinue treatment. Prolonged use of Lorazepam Hualan by a pregnant woman may cause withdrawal symptoms in the newborn.
If Lorazepam Hualan is administered towards the end of pregnancy or during childbirth, the newborn may show reduced activity, decreased muscle tone, lowered body temperature (hypothermia) and/or blood pressure (hypotension), respiratory depression, apnea, and weak sucking (so-called "floppy infant syndrome").

Breastfeeding
Since the active ingredient of Lorazepam Hualan passes into breast milk, it must not be taken during breastfeeding unless the expected benefit to the mother outweighs the potential risk to the infant. When Lorazepam Hualan is taken during breastfeeding, the infant may show sedation and weak sucking. Close clinical monitoring of the infant is recommended.

Driving and using machines
Even if you take Lorazepam Hualan as directed, you should expect limitations in your reaction ability, especially during the first days of treatment. You may therefore not be able to react quickly enough to unexpected and sudden events. Do not drive a car or other vehicles! Do not use dangerous machinery or electrical tools! Do not work without a secure support point! Pay particular attention to the fact that alcohol further impairs reaction ability.
Your doctor will assess whether and to what extent it is safe for you to drive or perform other risky activities, taking into account your individual reaction ability and dosage.

Lorazepam Hualan contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Lorazepam Hualan tablets

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage
The dose and duration of treatment must be adjusted according to the individual response to therapy, the indication, and the severity of the illness. The guiding principle is to keep the dose as low as possible and the duration of treatment as short as possible.

Treatment of anxiety and associated sleep disturbances
The usual daily dose for adults ranges from 0.5 to 2.5 mg of lorazepam, divided into 2 or 3 single doses or taken as a single evening dose. In individual cases, particularly in hospital settings, the doctor may increase the daily dose up to a maximum of 7.5 mg of lorazepam, taking all necessary precautions into account. For lower or higher dosage requirements, formulations with lower or higher single doses are available.

If sleep disturbances are the main concern, the daily dose (0.5 to 2.5 mg of lorazepam) may be taken as a single dose approximately half an hour before bedtime. For this purpose, formulations with lower or higher single doses are also available.

Sedation before diagnostic and surgical procedures
In adults, 1 to 2.5 mg of lorazepam the evening before and/or 2 to 4 mg of lorazepam approximately 1–2 hours before the surgical procedure. Formulations with lower or higher single doses are also available, suitable for lower or higher dosages.

Use in children and adolescents
Children from six years of age and adolescents
In children, the dose should be appropriately reduced; single doses should not exceed 0.5–1 mg of lorazepam or 0.05 mg per kg of body weight. Formulations with lower single doses are available, suitable for lower dosage requirements.

Use in elderly or debilitated patients
In elderly or debilitated patients and in patients with organic brain disorders, the total initial daily dose should be reduced by approximately 50%. The dose should be adjusted by the doctor according to the required effect and individual tolerability.

Use in patients with impaired liver function
Do not take Lorazepam Hualan if you have severe liver problems (severe hepatic insufficiency). Like all medicines that depress the central nervous system, benzodiazepines may cause encephalopathy (brain disease due to liver damage) in patients with severe hepatic insufficiency.

Method of administration
Take the tablets without chewing, with some liquid (e.g., half to one glass of water). The score line is not intended for breaking the tablet. The tablets may be taken regardless of meals.

If used as a sleeping aid, the tablets should be taken approximately half an hour before bedtime and not on a full stomach; otherwise, onset of effect may be delayed and, depending on sleep duration, more pronounced residual effects may occur the following morning.

Duration of use
The duration of treatment will be determined by your doctor. In acute conditions, the use of Lorazepam Hualan should be limited to single doses or a few days. For chronic conditions, the duration of treatment depends on the course of the illness. After two weeks of daily use, your doctor should evaluate whether continued treatment with Lorazepam Hualan is still indicated, by gradually reducing the dose.

It should be noted that after prolonged use (more than 1 week) and abrupt discontinuation of the medicine, sleep disturbances, anxiety and tension, inner restlessness, and agitation may temporarily reappear, but with greater intensity. Therefore, treatment should not be stopped abruptly, but the dose should be gradually reduced.

If you take more Lorazepam Hualan than you should
If overdose is suspected, contact a doctor immediately. Follow the first aid instructions provided by telephone. Do not induce vomiting unless explicitly instructed to do so.

Signs of overdose include: drowsiness, confusion, reduced breathing, movement problems (impaired coordination), apathy, and, in severe cases, loss of consciousness.

If you forget to take Lorazepam Hualan
If you miss a dose once, take Lorazepam Hualan as usual at the next scheduled time. Do not take a double dose to make up for the missed dose.

If you stop taking Lorazepam Hualan
You should never stop or discontinue treatment on your own initiative, unless you suspect a serious side effect. In this case, contact your doctor immediately.

If you abruptly stop treatment after long-term use, withdrawal symptoms described in section 4 may occur. To avoid these effects, discontinue treatment by gradually reducing the dose (see section 3).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Side effects are particularly expected at the beginning of treatment, at very high doses, and in the patient groups indicated under "Warnings and precautions" (see section 2).

Very common: may affect more than 1 in 10 people treated

Sedation, fatigue, drowsiness

Common: may affect up to 1 in 10 people treated

Unsteady movements and gait (ataxia)
Confusion
Depression, onset of depression
Dizziness
Muscle weakness, fainting

Uncommon: may affect up to 1 in 100 people treated

Changes in libido, impotence, less intense orgasm
Feeling unwell (nausea)

Not known: frequency cannot be estimated from the available data

Changes in blood cell counts (thrombocytopenia, agranulocytosis, pancytopenia)
Prolonged reaction times
Difficulty in coordinating movements (extrapyramidal symptoms)
Tremor
Vision disturbances (double vision, blurred vision)
Difficulty articulating words / confused speech
Headache
Seizures / epileptic fits
Memory gaps (amnesia)
Disinhibition, euphoria
Coma
Suicidal thoughts/attempts
Problems with attention/concentration
Balance disorders
Dizziness
Paradoxical reactions such as anxiety, agitation, delirium, excitability, aggressive behaviour (hostility, aggression, rage), sleep disturbances/insomnia, sexual excitement, fixations. If such reactions occur, treatment with Lorazepam Hualan must be discontinued.
Low blood pressure (hypotension), mild drop in blood pressure
Respiratory depression (severity varying according to dose), shortness of breath (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep)
Worsening of obstructive bronchopulmonary disease (airway constriction)
Constipation
Increased bilirubin
Jaundice, increased liver enzymes (transaminases, alkaline phosphatase)
Allergic skin reactions
Hair loss
Hypersensitivity reactions, anaphylactic/anaphylactoid reactions, swelling of the skin and/or mucous membranes (angioedema)
Inappropriate secretion of antidiuretic hormone (SIADH)
Low sodium levels in the blood (hyponatremia)
Decrease in body temperature (hypothermia)

Benzodiazepines cause dose-dependent central nervous system depression.

Dependence/Abuse
After even a few days of daily treatment with Lorazepam Hualan, withdrawal symptoms (e.g., sleep disturbances, increased dreaming) may occur upon discontinuation of therapy, particularly if stopped abruptly. Anxiety, tension, agitation, and inner restlessness may reappear with greater intensity. Other symptoms reported following benzodiazepine withdrawal include: headache, depression, confusion, irritability, sweating, dysphoria, dizziness, depersonalization, behavioural disturbances, hyperacusis, numbness and tingling of limbs, hypersensitivity to light, noise and touch, altered perception, involuntary movements, nausea, vomiting, diarrhoea, loss of appetite, hallucinations/delirium, epileptic seizures/convulsions, tremors, abdominal cramps, muscle pain, restlessness, palpitations, increased heart rate, panic attacks, dizziness, exaggerated reflexes, short-term memory loss, and fever. In cases of chronic use of Lorazepam Hualan in epileptic patients, or when taking other medicines that may lower the seizure threshold (e.g., antidepressants), abrupt discontinuation may trigger further seizures. The risk of withdrawal symptoms increases with the duration of treatment and the previously taken dose. These phenomena can generally be avoided by gradually reducing the dose.

Tolerance (increased dose due to habituation) to the sedative effect of benzodiazepines has been demonstrated.

Lorazepam has potential for abuse. Patients with a history of drug and/or alcohol abuse are particularly at risk.

What measures should be taken if side effects occur?
Many of the side effects listed above may disappear spontaneously during continued treatment or by reducing the dose. If side effects persist, inform your doctor, who will decide whether treatment should be discontinued. Immediately inform your doctor if you develop unexplained skin rashes, skin discoloration, or swelling.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lorazepam Hualan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blisters after
"EXP". The expiry date refers to the last day of that month.
Store the medicine below 25 °C.
Keep the medicine in the original blister to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lorazepam Hualan contains

The active substance is lorazepam. Each tablet contains 0.25 mg, 0.5 mg, 1 mg or 2.5 mg of lorazepam.
The other ingredients are monohydrate lactose (see section 2 “Lorazepam Hualan contains lactose”), microcrystalline cellulose (E460), polacrylic acid potassium salt and magnesium stearate (E470b).

Description of the appearance of Lorazepam Hualan and package contents

The 0.25 mg Lorazepam Hualan tablets are white, round, flat, with bevelled edges, a score line on one side and smooth on the other. The score line is not intended for dividing the tablet. The tablet size is 5.00 mm x 1.85 mm.
The 0.5 mg Lorazepam Hualan tablets are white, round, flat, with bevelled edges, marked with the letter “L” on one side and smooth on the other. The tablet size is 6.00 mm x 2.60 mm.
The 1 mg Lorazepam Hualan tablets are white, round, flat, with bevelled edges, marked with the letter “M” on one side and smooth on the other. The tablet size is 6.00 mm x 2.60 mm.
The 2.5 mg Lorazepam Hualan tablets are white, round, flat, with bevelled edges, a score line on one side and smooth on the other. The score line is not intended for dividing the tablet. The tablet size is 8.50 mm x 3.60 mm.

Lorazepam Hualan is available in OPA/Alu/PVC-Alu blisters containing 28 tablets.
Marketing Authorisation Holder
Hualan Pharmaceuticals Limited
16/17 College Green, Dublin 2,
Dublin,
D02 V078
Ireland
Manufacturer
Elara Pharmaservices Europe Limited
Regus Block 1, Blanchardstown Corporate Park
Ballycoolin Road,
Dublin 15, D15 AKK1
Ireland
This medicinal product is authorised in the European Economic Area countries under the
following names:
Lithuania: Lorazepam Hualan 0.25 mg tabletės, Lorazepam Hualan 0.5 mg tabletės, Lorazepam Hualan 1 mg tabletės and Lorazepam Hualan 2.5 mg tabletės
Malta: Lorazepam Hualan 0.25 mg Tablets, Lorazepam Hualan 0.5 mg Tablets, Lorazepam Hualan 1 mg Tablets and Lorazepam Hualan 2.5 mg Tablets

For the patient's attention!
This medicine contains an active substance belonging to the group of benzodiazepines.
Benzodiazepines are medicines used to treat conditions associated with restlessness, anxiety, inner tension or insomnia. Benzodiazepines are also used in the treatment of epilepsy and certain muscle spasms.
Not all anxiety or sleep disorders require pharmacological treatment. Often, they are manifestations of a physical or mental illness or other conflicts and may be influenced by other measures or by treating the underlying condition.
Benzodiazepines do not eliminate the cause of the disorder. They reduce the burden of suffering and may provide important support, for example, by facilitating access to further treatments and resolution of the problem.
The use of benzodiazepines may lead to the development of physical and psychological dependence.
To minimize this risk, it is important to strictly follow the instructions below:

Benzodiazepines are suitable only for the treatment of pathological conditions and may be taken only as directed by a physician.
If you currently or in the past have suffered from alcohol, drug or substance dependence, you should not take benzodiazepines, except in rare cases which can only be assessed by your doctor. Inform your doctor about this condition.
Prolonged and uncontrolled use should be avoided, as it may lead to dependence. At the beginning of treatment, schedule a follow-up visit with your doctor so that they can decide on further management. Taking these medicines without medical instructions reduces the possibility of receiving proper medical supervision.
Never increase the dose prescribed by your doctor or shorten the intervals between doses, even if the effect seems to diminish. This could be the first sign of emerging dependence. Unauthorized changes to the prescribed dosage make treatment more difficult.
Treatment with benzodiazepines must never be stopped abruptly, but only gradually tapered off. If treatment is discontinued after prolonged use, symptoms such as restlessness, anxiety, insomnia, seizures and hallucinations may occur, often with a delay of several days. These withdrawal symptoms usually disappear after a few days or weeks. Consult your doctor if necessary.
Never accept benzodiazepines from other people and do not take them just because "they helped others so well". Never give these medicines to others.