LORAZEPAM AUROVITAS 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lorazepam Aurovitas 0.5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the pack

1. What is Lorazepam Aurovitas and what is it used for
2. What you need to know before you take Lorazepam Aurovitas
3. How to take Lorazepam Aurovitas
4. Possible side effects
5. Storing Lorazepam Aurovitas
6. Contents of the pack and other information

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

Lorazepam Aurovitas tablets contain the active substance lorazepam, a sedative and anxiolytic (tranquilizing) medicine. It belongs to a group of medicines called benzodiazepines.

What it is used for

• Short-term symptomatic treatment of anxiety and sleep disorders caused by anxiety, when anxiety is severe, disabling, or subjects the individual to unacceptable distress.
• Sedation before diagnostic procedures, as well as before surgical interventions.

2. What you need to know before you take Lorazepam Aurovitas

Do not takeLorazepamAurovitas

• if you are allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• if you have severe respiratory problems, for example, chronic obstructive pulmonary disease.
• if you have abnormal muscle weakness (myasthenia gravis).
• if you have severe liver problems.
• if you have sleep apnea syndrome (breathing problems when sleeping).
• in case of acute intoxication with alcohol or central nervous system depressants (for example, sleeping pills or analgesics, medicines for the treatment of mental disorders, such as antipsychotics, antidepressants, and lithium).
• if you are under 6 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking lorazepam if:

• you have problems controlling your movements (spinal or cerebellar ataxia).
• you have respiratory problems, for example, chronic obstructive pulmonary disease.
• you have kidney or liver problems.
• you have a eye problem called glaucoma, for example, high pressure inside the eye.
• you have abused or have a history of abusing drugs or alcohol.
• you have a personality disorder; it may mean you have a higher chance of becoming dependent on lorazepam.
• you have had depression before, as it could come back during treatment with lorazepam.
• you are depressed, as lorazepam may increase suicidal thoughts or feelings you may have.
• you are an elderly patient, as you are more likely to suffer from falls.
• you have low blood pressure.

Some patients have experienced suicidal thoughtswhile taking medicines containing lorazepam, especially if they are already depressed. If you are depressed, have fears or irrational obsessions, have started to experience suicidal thoughts or self-harm, inform your doctor immediately.

At the start of treatment, your doctor will monitor your individual response to this medicine, so that a possible overdose can be detected as soon as possible. If you are a child, or an elderly or frail patient, you may show a more sensitive response to the effect of lorazepam. Therefore, therapy should be monitored more frequently.

If you have kidney or liver dysfunction, heart failure, and/or low blood pressure (hypotension), you may have a greater sensitivity to the effect of this medicine; the same applies if you are an elderly person. You may be at a higher risk of suffering from falls, especially when getting up at night.

You may suffer from hepatic encephalopathy (brain disease due to liver damage) with the use of lorazepam. Therefore, lorazepam should not be used in patients with severe liver failure and/or hepatic encephalopathy.

You may experience memory loss during treatment with lorazepam.

When taking the tablet before sleeping, you should ensure that you will be able to sleep uninterrupted (around 7-8 hours). If you follow this recommendation, you will normally avoid side effects the next morning (for example, fatigue, decreased reaction ability).

Ask your doctor to give you more detailed instructions on how to manage your daily life, taking into account your particular lifestyle (for example, your profession).

There have been reports of rare cases of paradoxical reactions with the use of benzodiazepines, such as anxiety, agitation, delirium, excitability, aggressive behavior, sleep disorders, sexual excitement, hallucinations, psychosis (see section 4). These reactions are more likely if you are a child or an elderly patient. Treatment with lorazepam should be discontinued if paradoxical reactions occur.

With the use of benzodiazepines, including lorazepam, potentially life-threatening respiratory depression may occur.

When taking this medicine, there is a risk of dependence, which increases with the dose and duration of treatment and also in patients with a history of alcoholism and drug abuse. Therefore, you should take lorazepam for as short a time as possible (see section 4).

If after a few weeks you notice that the medicine is not working as well as at the start of treatment, you should consult your doctor.

Treatment with lorazepam should be gradually discontinued to avoid withdrawal symptoms. See section 3 "If you stop taking Lorazepam Aurovitas".

There have been reports of serious allergic reactions with the use of benzodiazepines. Cases of skin and/or mucous membrane swelling affecting the tongue, larynx, or vocal cord area (angioedema) have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients have experienced other symptoms while taking benzodiazepines, such as difficulty breathing (dyspnea), throat swelling, or feeling nauseous and vomiting.

Some patients had to be treated urgently. If you experience these symptoms, inform your doctor immediately or go to the hospital immediately. Your airways may become blocked, which can be fatal.

Children and adolescents

Lorazepam should not be given to children and adolescents under 18 years old, unless it is urgently needed as sedation before surgery or before diagnostic procedures. Lorazepam is contraindicated in children under 6 years old. You can find more information in section 3.

Other medicines andLorazepamAurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular:

• Medicines for narcolepsy (excessive daytime sleepiness and sleep attacks) with cataplexy (for example, sodium oxybate).
• Medicines for the treatment of HIV (for example, zidovudine).
• Medicines for the treatment of delusions or hallucinations (for example, chlorpromazine, loxapine, or clozapine).
• Medicines to aid digestion (for example, antacids, cisapride, or omeprazole).
• A medicine to control nausea and vomiting induced by chemotherapy called nabilone.
• Medicines for the treatment of addiction (for example, lofexidine and disulfiram).
• Strong painkillers (for example, methadone, tramadol, codeine, morphine).
• Medicines used to treat tuberculosis, such as isoniazid.
• Antibiotics, such as erythromycin.
• Medicines used to treat high blood pressure (for example, 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 to treat asthma (for example, theophylline).
• Muscle relaxants (for example, baclofen and tizanidine).
• Other sedatives (for example, barbiturates or antihistamines).
• Other medicines used to treat anxiety.
• Medicines used to treat depression.
• Antihistamines for allergies.
• Medicines for Parkinson's disease, for example, levodopa.
• Medicines for epilepsy (for example, phenobarbital or valproate/sodium valproate).
• A medicine for gout called probenecid.
• Contraceptives containing estrogens.
• Medicines that affect liver enzymes (for example, cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If lorazepam is used at the same time as other central nervous system depressant medicines (for example, psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers, opioid analgesics, sedating antihistamines, antiepileptics), an interaction may occur, producing additive central nervous system depressant effects.

The concomitant use of lorazepam and opioids (for example, strong painkillers, some cough medicines, and substitution therapy medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes lorazepam with opioids, they should limit the dose and duration of concomitant treatment. Inform your doctor about all opioid medicines you are taking and follow the recommended dose carefully. It may be useful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience these symptoms.

The effect of muscle relaxants and painkillers may increase.

If lorazepam is used at the same time as clozapine, intense sedation, excessive salivation, and altered movement coordination may occur.

Administration of lorazepam at the same time as valproic acid/sodium valproate may increase lorazepam levels in the blood. If valproic acid/sodium valproate is used at the same time, the dose of lorazepam should be reduced to approximately half.

Administration of lorazepam at the same time as probenecid may accelerate the onset of action or prolong the effect of lorazepam. If probenecid is used at the same time, the dose of lorazepam should be reduced to half.

The use of theophylline or aminophylline may reduce the sedative effect of lorazepam.

TakingLorazepamAurovitas with food, drinks, and alcohol

You should avoid drinking alcohol, as alcohol may unpredictably alter and increase the effects of lorazepam.

You should avoid grapefruit juice and drinks containing caffeine, as they may affect the way lorazepam works.

Pregnancy and breastfeeding

Pregnancy

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 medicine.

The use of lorazepam is not recommended during pregnancy. Your doctor will decide whether you should stop treatment.

If you take lorazepam during the first trimester of pregnancy: numerous data have not shown the occurrence of malformations with benzodiazepines. However, some studies have described a potentially higher risk of developing cleft lip or palate in newborns, compared to the risk in the general population. Cleft lip or palate is a congenital malformation caused by the incomplete fusion of the palate and upper lip. According to these data, the incidence of cleft lip or palate in newborns is less than 2/1,000 after exposure to benzodiazepines during pregnancy, while the expected rate in the general population is 1/1,000.

If you take lorazepam in the second and/or third trimester of pregnancy, it may cause a decrease in fetal movement and variability in fetal heart rate.

If you take lorazepam at the end of pregnancy, inform the medical team, and it is possible that the newborn will be monitored: axial hypotonia (weakness), feeding difficulties (suction disorders causing low weight gain), hyperexcitability, restlessness, or tremors in the newborn may occur. These disorders are reversible. At high doses, respiratory failure or apnea, and a decrease in body temperature (hypothermia) may also occur in newborns.

Breastfeeding

Because lorazepam passes into breast milk and may cause sedation and inability to feed in your baby, you should not take this medicine during breastfeeding.

Driving and using machines

Even if you take lorazepam as directed, you should expect your reaction abilities to be affected, especially during the first few days of treatment. In this case, you will not be able to react quickly enough to unexpected and sudden events. Do not drive a car or any other vehicle. Do not use hazardous electrical tools or machines. Do not work without a secure support. In particular, remember that alcohol will further impair your reaction ability.

The decision on how far it is possible to drive or engage in other hazardous activities will be made by your doctor, taking into account your individual response and dose.

LorazepamAurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Lorazepam Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose and duration of treatment should be adjusted to your individual response to therapy, the therapeutic indication (i.e., the disease for which this medication has been prescribed) and the severity of your disease. As a basic rule, the dose should be kept as low as possible and the duration of treatment as short as possible.

Dose

Follow the instructions for use at all times, as otherwise, lorazepam may not work correctly.

Unless your doctor has prescribed lorazepam otherwise, the following information will apply:

Treatment of anxiety and sleep disorders caused by anxiety:

The usual daily dose for adults is 0.5 to 2.5 mg of lorazepam, divided into 2 to 3 doses per day or in a single nighttime dose. In individual cases, especially in a hospital setting, the doctor may increase the daily dose up to a maximum of 7.5 mg of lorazepam, taking into account all precautions.

If the primary approach involves sleep disorders that require treatment, the daily dose (0.5 to 2.5 mg of lorazepam) can be taken as a single dose approximately 30 minutes before bedtime.

When used for sleep, it should be taken approximately 30 minutes before bedtime; otherwise, it will likely take longer to take effect and, depending on the duration of sleep, will likely cause more severe side effects the next morning.

If you take the full dose at night, do not take it with a full stomach.

Sedation prior to diagnostic procedures, as well as before surgical interventions:

For adults, 1 to 2.5 mg of lorazepam the night before and/or 2 to 4 mg of lorazepam approximately 1 to 2 hours before the procedure.

The tablets can be taken with or without food.

Use in elderly or debilitated patients

In elderly or debilitated patients, as well as in patients with organic brain changes, the initial total daily dose should be reduced by approximately 50%. These patients should preferably use preparations with a lower active substance content. The dose should be adjusted by the doctor, depending on the required effect and tolerability in each individual case.

Use in patients with renal insufficiency

Patients with kidney problems may receive lower doses. The initial dose is usually half of the normal recommended dose for adults. Your doctor will see how you respond to the medication and adjust the dose if necessary.

Use in patients with hepatic insufficiency

Patients with moderate to mild liver problems may receive lower doses. The initial dose is usually half of the normal recommended dose for adults.

Lorazepam is contraindicated in patients with severe hepatic insufficiency.

Use in children and adolescents

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

Under 6 years:

Children under six years of age should not be treated with lorazepam.

From 6 to 12 years of age:

Prior to diagnostic procedures or prior to surgical interventions: the recommended dose is between 0.5 and 1 mg, depending on the child's weight (the dose should not exceed 0.05 mg/kg of body weight), taken at least one or two hours before the operation.

From 13 to 18 years of age:

Prior to diagnostic procedures or prior to surgical interventions: the recommended dose is 1 mg to 4 mg, taken one or two hours before the operation.

Method of administration

Oral.

Swallow the tablets whole with a little liquid (e.g., with half a glass or a glass of water). The score line allows you to break the tablet if you have difficulty swallowing it whole.

The tablet can be divided into equal doses.

Duration of use

The duration of treatment will be determined by your doctor.

For acute diseases, the use of lorazepam should be limited to single doses or for a few days.

For chronic diseases, the duration of use will depend on the progression of your disease. After 2 weeks of daily intake, the doctor should clarify, through a gradual reduction of the dose, whether treatment with lorazepam is still indicated.

If you take more Lorazepam Aurovitas than you should

If you suspect that an overdose has occurred after ingesting large amounts of this medication, consult a doctor immediately. You should call a doctor immediately to receive first-aid instructions, which you should then apply. Do not induce vomiting unless you are explicitly instructed to do so.

The signs of overdose are: drowsiness, confusion, somnolence, shallow breathing, alteration of movement coordination, apathy, and, in severe cases, loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lorazepam Aurovitas

If you forget to take a tablet, take it in the usual way the next time. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Lorazepam Aurovitas

If you suddenly stop treatment after prolonged use, you may experience the withdrawal symptoms mentioned in section 4. To avoid these symptoms, treatment will be discontinued with a gradual reduction of the dose.

It should be noted that after prolonged periods of use (more than 1 week) and after abrupt withdrawal of this medication, sleep disorders, anxiety states, and tension, internal restlessness and agitation may temporarily appear in an exaggerated form. Therefore, treatment should not be stopped abruptly, but with a gradual reduction of the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Side effects are expected to appear especially at the start of treatment, if the dose is too high, and in patients mentioned in "Warnings and precautions" (see section 2).

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

• sedation, fatigue, somnolence.

Common:may affect up to 1 in 10 patients treated

• unstable movements and gait (ataxia).
• confusion.
• depression, onset of depression.
• feeling dizzy.
• muscle weakness, feeling of fatigue (lassitude).

Uncommon:may affect up to 1 in 100 patients treated

• altered sexual desire, impotence, less intense orgasms.
• feeling sick.

Rare:may affect up to 1 in 1,000 patients treated

• rash.
• reduced alertness.
• changes in salivation.

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

• leukopenia.

Frequency not known:cannot be estimated from available data

• changes in blood counts (thrombocytopenia, agranulocytosis, pancytopenia).
• prolonged reaction times.
• alteration of movement coordination (extrapyramidal symptoms).
• tremors, dizziness.
• visual problems (double vision and blurred vision).
• difficulty articulating words/difficulty speaking.
• headache.
• seizures/convulsions.
• memory lapses (amnesia).
• disinhibition, euphoria.
• coma.
• suicidal thoughts/attempts.
• decreased attention/concentration.
• balance disorders.
• vertigo.
• paradoxical reactions such as anxiety, agitation states, delirium, excitability, aggressive behavior (hostility, aggressiveness, anger), sleep disorders/insomnia, sexual excitement, hallucinations, psychosis. If these reactions occur, treatment with lorazepam should be discontinued.
• low blood pressure (hypotension), mild drop in blood pressure.
• respiratory failure (the severity depends on the dose), difficulty breathing (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep).
• worsening of chronic obstructive pulmonary disease (constriction of the airway).
• 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).
• inadequate secretion of antidiuretic hormone (SIADH).
• low sodium levels in the blood (hyponatremia).
• decreased body temperature (hypothermia).

Benzodiazepines produce a dose-dependent depression of the central nervous system.

Dependence/abuse

Even after a treatment period of a few days with daily intake of lorazepam, withdrawal symptoms (e.g., sleep disorders, increased sleep) may occur when treatment is discontinued, especially when done abruptly. Anxiety, tension states, as well as agitation and internal restlessness may reappear in an exaggerated form. Other symptoms reported after discontinuation of benzodiazepine treatment include headache, depression, confusion, irritability, sweating, low mood (dysphoria), loss of reality, behavioral disorders, numbness and tingling in the limbs, hypersensitivity to light, noise, and touch, altered perception, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, seizures/convulsions, tremors, abdominal spasms, muscle pain, agitation states, palpitations, rapid pulse, panic attacks, dizziness, hyperreflexia, short-term memory loss, and hyperthermia. With chronic use of lorazepam in patients with epilepsy or those taking other medications that reduce the seizure threshold (e.g., antidepressants), abrupt discontinuation may trigger more frequent seizures. The risk of withdrawal symptoms increases with the duration of use and dose. These symptoms can usually be avoided with a gradual reduction of the dose.

There are indications of tolerance development (dose increase due to habituation) with regard to the sedative effect of benzodiazepines.

There is a risk of abuse with lorazepam. Patients with a history of drug and/or alcohol abuse are at greater risk.

What measures should be taken in case of side effects?

Many of the side effects mentioned above will disappear during treatment or when the dose is reduced. If side effects persist, inform your doctor, who will decide whether to discontinue treatment. Inform your doctor immediately if you have an unexplained skin rash, discoloration, or swelling of the skin.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lorazepam Aurovitas

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

Store below 30 °C.

For blister pack:Store the blisters in the outer packaging to protect them from light.

For HDPE bottle:Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lorazepam Aurovitas

• The active ingredient is lorazepam. Each tablet contains 0.5 mg of lorazepam.
• The other ingredients (excipients) are: microcrystalline cellulose (grades 101 and 102), lactose monohydrate, potassium polacrylate, and magnesium stearate.

Appearance of the product and package contents

Uncoated white or almost white tablets, round, approximately 5 mm, with flat faces and beveled edges, with the mark "0.5" on one face and "L" on the other.

Lorazepam Aurovitas tablets are available in blister packs and HDPE bottles.

Package sizes:

Blister pack:20, 25, 30, 40, 50, and 60 tablets.

HDPE bottle:500 and 1,000 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medication is authorized in the member states of the European Economic Area under the following names:

Spain: Lorazepam Aurovitas 0.5 mg tablets EFG

France: LORAZEPAM ARROW 0.5 mg, tablet

Netherlands: Lorazepam Auro 0.5 mg, tablets

Portugal: Lorazepam Generis Phar

Date of the last revision of this leaflet: December 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).