Lorazepam Aurovitas 1 mg tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lorazepam Aurovitas 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Lorazepam Aurovitas tablets contain the active substance lorazepam, a sedative and anxiolytic (tranquilizer) 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 causes unacceptable distress to the individual.
Premedication sedation prior to diagnostic procedures, as well as before surgical interventions.

2. What you need to know before taking Lorazepam Aurovitas

Do not take Lorazepam Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before taking lorazepam if:

you have problems controlling your movements (spinal or cerebellar ataxia).
you suffer from breathing problems, for example, chronic obstructive pulmonary disease (COPD).
you have kidney or liver problems.
you have a condition affecting the eyes called glaucoma, e.g., high pressure inside the eye.
you abuse or have previously abused drugs or alcohol.
you have a personality disorder; this may mean you are more likely to become dependent on lorazepam.
you have previously suffered from depression, as it could reappear during treatment with lorazepam.
you suffer from depression, as lorazepam may increase suicidal thoughts or feelings you may have.
you are an elderly patient, as you are more likely to fall.
you have low blood pressure.

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

At the beginning of treatment, your doctor will monitor your individual response to this medicine so that any possible overdose can be detected as early as possible. If you are a child, elderly, or debilitated patient, you may show increased sensitivity to the effects 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 be more sensitive to the effects of this medicine; the same applies if you are elderly. You may be at increased risk of falls, especially when getting up at night.

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

You may experience memory loss during treatment with lorazepam.

When taking the tablet before bedtime, you should ensure that you will be able to sleep uninterrupted (approximately 7–8 hours). Following this recommendation usually helps avoid next-day side effects (e.g., fatigue, reduced reaction capacity).

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

Rare cases of paradoxical reactions have been reported with the use of benzodiazepines, such as anxiety, agitation, delirium, excitability, aggressive behavior, sleep disturbances, increased sexual arousal, hallucinations, and 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.

The use of benzodiazepines, including lorazepam, may cause potentially life-threatening respiratory depression.

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

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

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

Serious allergic reactions have been reported with the use of benzodiazepines. Cases of swelling of the skin and/or mucous membranes 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 experienced other symptoms while taking benzodiazepines, such as difficulty breathing (dyspnea), throat swelling, or nausea and vomiting.

Some patients required urgent treatment. If you experience these symptoms, inform your doctor immediately or go to the hospital without delay. Airway obstruction may occur, which can be fatal.

Children and adolescents

Lorazepam should not be administered to children and adolescents under 18 years of age, unless urgently needed for sedation before surgery or diagnostic procedures. Lorazepam is contraindicated in children under 6 years of age. More information can be found in section 3.

Other medicines and Lorazepam Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, particularly:

Medicines for narcolepsy (excessive daytime sleepiness and sleep attacks) with cataplexy (e.g., sodium oxybate).
Medicines for treating HIV (e.g., zidovudine).
Medicines for treating delusions or hallucinations (e.g., chlorpromazine, loxapine, or clozapine).
Medicines to aid digestion (e.g., antacids, cisapride, or omeprazole).
A medicine used to control chemotherapy-induced nausea and vomiting called nabilone.
Medicines for treating addiction (e.g., lofexidine and disulfiram).
Strong analgesics (e.g., methadone, tramadol, codeine, morphine).
Medicines used to treat tuberculosis, such as isoniazid.
Antibiotics, such as erythromycin.
Medicines for treating high blood pressure (e.g., ACE inhibitors, alpha-blockers, angiotensin II receptor antagonists, calcium channel blockers, adrenergic neuron blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside, and diuretics).
Medicines used to treat asthma (e.g., theophylline).
Muscle relaxants (e.g., baclofen and tizanidine).
Other sedatives (e.g., barbiturates or antihistamines).
Other medicines used to treat anxiety.
Medicines used to treat depression.
Antihistamines for allergies.
Medicines for Parkinson’s disease, e.g., levodopa.
Medicines for epilepsy (e.g., phenobarbital or valproate/valproic acid).
A medicine for gout called probenecid.
Contraceptives containing estrogens.
Medicines affecting liver enzymes (e.g., cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If lorazepam is used simultaneously with other central nervous system (CNS) depressants (e.g., psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers, opioid-type analgesics, sedating antihistamines, antiepileptics), an interaction may occur, resulting in additive CNS depressant effects.

Concomitant use of lorazepam and opioids (e.g., strong analgesics, some cough medicines, and medications for substitution therapy) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, simultaneous use should only be considered when no other treatment options are possible.

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

The effects of muscle relaxants and analgesics may be enhanced.

If lorazepam is used together with clozapine, intense sedation, excessive salivation, and impaired motor coordination may occur.

Concomitant administration of lorazepam with valproic acid/sodium valproate may increase lorazepam blood levels. If valproic acid/sodium valproate is used at the same time, the lorazepam dose should be reduced by approximately half.

Concomitant administration of lorazepam with probenecid may accelerate the onset or prolong the effect of lorazepam. If used together with probenecid, the lorazepam dose should be reduced by half.

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

Taking Lorazepam Aurovitas with food, drinks, and alcohol

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

Grapefruit juice and beverages containing caffeine should also be avoided, as they may affect how lorazepam works.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you take lorazepam during the first trimester of pregnancy: numerous data have not demonstrated an increased risk of malformations with benzodiazepines. However, some studies have reported a potentially higher risk of cleft lip or cleft palate in newborns compared to the general population risk. Cleft lip or cleft palate is a congenital malformation caused by incomplete fusion of the upper lip and palate. According to these data, the incidence of cleft lip or cleft 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 during the second and/or third trimester of pregnancy, reduced fetal movement and variability in fetal heart rate may occur.

If you take lorazepam late in pregnancy, inform the medical team, and the newborn may be monitored: symptoms such as muscle weakness (axial hypotonia), feeding difficulties (sucking disorders leading to poor weight gain), hyperexcitability, restlessness, or tremor may appear in the newborn. These disorders are reversible. At high doses, respiratory insufficiency or apnea, and decreased body temperature (hypothermia) may also occur in newborns.

Breastfeeding

Since lorazepam passes into breast milk and may cause sedation and feeding difficulties 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 impaired, especially during the first days of treatment. In this case, you may not react quickly enough to unexpected or sudden events. Do not drive a car or any other vehicle. Do not operate dangerous tools or machinery. Do not work without secure support. In particular, remember that alcohol will further impair your reaction capacity.

The decision on whether you can drive or perform other potentially dangerous activities will be made by your doctor, based on your individual response and dosage.

Lorazepam Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Lorazepam Aurovitas

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Dosage

Always follow the instructions for use, as otherwise lorazepam may not work properly.

Unless your doctor has prescribed lorazepam differently, the following information applies:

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 as a single nightly 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 all precautions into account.

If the main problem involves sleep disorders requiring treatment, the daily dose (0.5 to 2.5 mg of lorazepam) may be taken as a single dose approximately half an hour before bedtime.

When used to aid sleep, it should be taken approximately half an hour before bedtime; otherwise, it will likely take longer to take effect and, depending on the duration of sleep, may cause more severe side effects the following morning.

If the full dose is taken at night, it should not be taken 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 formulations with a lower active substance content. The dose must be adjusted by the doctor depending on the required effect and individual tolerability.

Use in patients with renal impairment

Patients with kidney problems may require lower doses. The initial dose is usually half the normal recommended adult dose. Your doctor will monitor your response to the medicine and adjust the dose if necessary.

Use in patients with hepatic impairment

Patients with mild to moderate liver problems may require lower doses. The initial dose is usually half the normal recommended adult dose.

Lorazepam is contraindicated in patients with severe hepatic impairment.

Use in children and adolescents

Lorazepam should not be used for the treatment of 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.

Ages 6 to 12 years:

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

Ages 13 to 18 years:

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

Method of administration

Oral use.

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

The tablet may be divided into equal doses.

Duration of use

The duration of treatment will be determined by your doctor.

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

For chronic conditions, the duration of use will depend on the progression of your illness. After two weeks of daily intake, your doctor should assess, by gradually reducing the dose, whether continued treatment with lorazepam is still indicated.

If you take more Lorazepam Aurovitas than you should

If you suspect poisoning due to ingestion of large quantities of this medicine, consult a doctor immediately. You must call a doctor immediately for first aid instructions, which you should then follow. Do not induce vomiting unless specifically instructed to do so.

Signs of overdose include: drowsiness, confusion, somnolence, shallow breathing, impaired motor coordination, apathy, and, in severe cases, loss of consciousness.

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

If you forget to take Lorazepam Aurovitas

If you forget to take a tablet, take it at the next scheduled time as usual. Do not take a double dose to make up for missed doses.

If you stop taking Lorazepam Aurovitas

If you stop treatment suddenly after prolonged use, withdrawal symptoms mentioned in section 4 may occur. To avoid these symptoms, treatment should be discontinued by gradually reducing the dose.

It should be noted that, after prolonged use (more than 1 week) and abrupt withdrawal of this medicine, sleep disturbances, anxiety and tension, inner restlessness, and agitation may temporarily appear in an exaggerated form. Therefore, treatment should not be stopped abruptly, but rather by gradual dose reduction.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are expected especially at the beginning 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 treated patients

Sedation, tiredness, drowsiness.

Common: may affect up to 1 in 10 treated patients

Unsteady movements and gait (ataxia).
Confusion.
Depression, onset of depression.
Feeling dizzy.
Muscle weakness, feeling of tiredness (lassitude).

Uncommon: may affect up to 1 in 100 treated patients

Changes in sexual desire, impotence, less intense orgasms.
Feeling unwell.

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

Rash.
Reduced level of alertness.
Changes in salivation.

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

Leukopenia.

Frequency not known: cannot be estimated from available data

Changes in blood counts (thrombocytopenia, agranulocytosis, pancytopenia).
Prolonged reaction times.
Impaired movement coordination (extrapyramidal symptoms).
Tremor, dizziness.
Visual disturbances (double vision and blurred vision).
Difficulty articulating words/speech difficulty.
Headache.
Seizures/convulsions.
Memory lapses (amnesia).
Disinhibition, euphoria.
Coma.
Suicidal thoughts/attempts.
Impaired attention/concentration.
Balance disorders.
Vertigo.
Paradoxical reactions such as anxiety, agitation, delirium, excitability, aggressive behavior (hostility, aggression, rage), sleep disorders/insomnia, increased sexual arousal, hallucinations, psychosis. If these reactions occur, treatment with lorazepam should be discontinued.
Low blood pressure (hypotension), mild drop in blood pressure.
Respiratory failure (severity depends on dose), difficulty breathing (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep).
Worsening of chronic obstructive pulmonary disease (airway constriction).
Constipation.
Increased bilirubin.
Jaundice, increased liver enzymes (transaminases, alkaline phosphatase).
Skin allergic reactions.
Hair loss.
Hypersensitivity reactions, anaphylactic/anaphylactoid reactions, swelling of the skin and/or mucous membranes (angioedema).
Inappropriate antidiuretic hormone secretion (SIADH).
Low sodium levels in the blood (hyponatremia).
Decreased body temperature (hypothermia).

Benzodiazepines produce a dose-dependent central nervous system depression.

Dependence/abuse

Even after a few days of daily lorazepam treatment, withdrawal symptoms (e.g., sleep disturbances, increased dreaming) may occur upon discontinuation, especially if stopped abruptly. Anxiety, tension, as well as agitation and inner restlessness may reappear in an exaggerated form. Other symptoms reported after discontinuation of benzodiazepines include headache, depression, confusion, irritability, sweating, low mood (dysphoria), loss of reality, behavioral disturbances, numbness and tingling in the extremities, hypersensitivity to light, noise, and touch, perceptual disturbances, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, seizures/convulsions, tremor, abdominal cramps, muscle pain, agitation, palpitations, rapid pulse, panic attacks, dizziness, hyperreflexia, short-term memory loss, and hyperthermia. With chronic use of lorazepam in patients with epilepsy or in those taking other medications that lower the seizure threshold (e.g., antidepressants), abrupt discontinuation may trigger more frequent seizures. The risk of withdrawal symptoms increases with duration of use and dose. These symptoms can generally be avoided by gradually reducing the dose.

There is evidence of tolerance development (increasing dose due to habituation) 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 higher risk.

What to do if adverse effects occur

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lorazepam Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30 °C.

For blister packs: Keep 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. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Lorazepam Aurovitas

The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
The other components (excipients) are: microcrystalline cellulose (grades 101 and 102), lactose monohydrate, polacriline potassium, and magnesium stearate.

Appearance of the product and contents of the pack

Uncoated tablets, white or almost white, round, approximately 6.5 mm in diameter, with flat faces and bevelled edges, marked with "L" and "1" separated by a score line on one side and smooth on the other. The tablets can be divided into equal doses.

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

Pack sizes:

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

HDPE bottles: 500 and 1,000 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Belgium: Lorazepam AB 1 mg tabletten/comprimés/Tabletten
Spain: Lorazepam Aurovitas 1 mg comprimidos EFG
France: LORAZEPAM ARROW 1 mg, comprimé sécable
Netherlands: Lorazepam Auro 1 mg, tabletten
Portugal: Lorazepam Generis Phar

Date of the most recent review of this leaflet: December 2024

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