Package leaflet: Information for the user

Lorazepam Aurobindo 1 mg tablets, 2.5 mg tablets

Equivalent medicine
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 could be dangerous.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Lorazepam Aurobindo tablets contain the active substance lorazepam, a sedative and
anxiolytic (tranquilliser) medicine. It belongs to the group of active substances known as benzodiazepines.
What it is used for

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

2. What you need to know before taking Lorazepam Aurobindo

Do not take Lorazepam Aurobindo:

if you are allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
if you have, or have ever had, drug, alcohol, or drug addiction;
if you have severe respiratory problems, e.g. chronic obstructive pulmonary disease (COPD);
if you have abnormally weak muscles (myasthenia gravis);
if you have serious liver problems;
if you suffer from breathing difficulties during sleep (sleep apnoea syndrome);
in case of acute poisoning with alcohol or central nervous system (CNS) depressants (e.g. sleeping pills or painkillers, medicines for treating 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 Aurobindo if:

you have problems controlling your movements (spinal or cerebellar ataxia);
you suffer from breathing problems, e.g. chronic obstructive lung disease;
you have kidney or liver problems;
you have a condition of the eye 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 have a higher risk of becoming dependent on lorazepam;
you have previously suffered from depression, as it may recur during treatment with lorazepam;
you suffer from depression, because lorazepam may increase any suicidal thoughts or feelings you may have;
you are elderly, you may be more prone to falls;
you have low blood pressure.

Children and adolescents
Lorazepam Aurobindo is not recommended for use in children and adolescents under 18 years of age, because there is no data on safety and efficacy in this population.
Other medicines and Lorazepam Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Ask your doctor for advice before taking any of the following medicines together with Lorazepam Aurobindo:

cough or cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine;
medicines called selective serotonin reuptake inhibitors (SSRIs) usually used in the treatment of anxiety disorders and certain personality disorders (e.g. fluoxetine or fluvoxamine);
medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine;
medicines for high cholesterol such as rosuvastatin, pitavastatin, pravastatin;
an antibiotic from the fluoroquinolone class such as ciprofloxacin;
medicines that act on the immune system such as methotrexate;
medicines for metastatic cancer such as topotecan;
medicines for pain and inflammatory conditions such as diclofenac;
medicines for type 2 diabetes such as glibenclamide, metformin;
medicines for viral infections such as aciclovir, ganciclovir.

Some patients have experienced suicidal thoughts while taking medicines containing lorazepam, particularly if they were already depressed. If you are depressed, have irrational fears and obsessions, or have started to develop suicidal or self-harming thoughts, inform your doctor immediately.
At the beginning of treatment, your doctor will monitor your individual response to this medicine so that any potential overdose can be detected as quickly as possible. If you are a child, elderly, or debilitated patient, you may show a more sensitive response to the effect of Lorazepam Aurobindo. Therefore, treatment should be monitored more frequently.
If you suffer from renal or hepatic dysfunction, with heart failure and/or low blood pressure (hypotension), you may have increased sensitivity to the effects of this medicine; the same applies if you are elderly. You may be at higher risk of falls, especially when waking up at night.
Encephalopathy (brain disease due to liver damage) may occur during treatment with lorazepam. Therefore, lorazepam must not be used in patients with severely impaired liver function and/or hepatic encephalopathy.
During treatment with lorazepam, you may experience memory loss.
When used as a sleeping aid, ensure you have sufficient time for sleep (approximately 7–8 hours). Following this recommendation usually helps avoid next-day side effects (e.g. drowsiness, impaired reaction ability).
Ask your doctor for more detailed advice on how to manage daily life, considering your individual lifestyle (e.g. occupation).
Unusual reports of paradoxical reactions have occurred with benzodiazepines, such as anxiety, agitation, dysphoria, excitability, aggressive behaviour, sleep disturbances, sexual excitement, hallucinations, and psychosis (see section 4). Such reactions are more likely if you are a child or elderly patient. Treatment with lorazepam should be discontinued if paradoxical reactions occur.
Respiratory depression, potentially fatal, may occur with the use of benzodiazepines, including lorazepam.
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 Aurobindo for the shortest time possible (see section 4).
If after a few weeks you notice the medicine is no longer working as effectively as when you started treatment, consult your doctor.
Treatment with Lorazepam Aurobindo should be discontinued gradually to avoid withdrawal symptoms. See section 3 “If you stop taking Lorazepam Aurobindo”.
Serious allergic reactions have been reported with the use of benzodiazepines. Cases of skin and/or mucosal swelling involving the tongue, larynx, or vocal cord area (angioedema) have been reported in patients after taking the first dose or subsequent doses of benzodiazepines.
Some patients have reported other symptoms while taking benzodiazepines, such as shortness of breath (dyspnoea), throat swelling, or a feeling of malaise.
Some patients have required emergency medical treatment. If you experience these symptoms, inform your doctor immediately or go to hospital straight away. Airway obstruction may occur, which could be fatal.
Children and adolescents
Children and adolescents under 18 years of age should not be treated with lorazepam unless urgently required for sedation before surgery or diagnostic procedures. Lorazepam Aurobindo is contraindicated in children under 6 years of age. Further information is available in section 3.
Other medicines and Lorazepam Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly:

Medicines for narcolepsy with cataplexy (e.g. sodium oxybate).
Medicines for HIV treatment (e.g. zidovudine).
Medicines for treating delirium or hallucinations (e.g. chlorpromazine, loxapine, or clozapine).
Medicines used for indigestion (e.g. antacids, cisapride, or omeprazole).
A medicine used to treat chemotherapy-induced nausea and vomiting called nabilone.
Medicines for treating addiction (e.g. lofexidine and disulfiram).
Strong painkillers (e.g. methadone, tramadol, codeine, morphine).
Medicines used to treat tuberculosis such as isoniazid.
Antibiotics such as erythromycin.
Medicines for 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 oestrogens.
Medicines that affect liver enzymes (e.g. cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If Lorazepam Aurobindo is used simultaneously with other medicines that depress the central nervous system (e.g. psychotropic agents, sleeping pills, sedatives, anaesthetics, beta-blockers, opioid-type painkillers, sedating antihistamines, antiepileptics), interactions may occur, causing additive depressive effects on the central nervous system.
Concomitant use of Lorazepam Aurobindo and opioids (e.g. strong painkillers, some cough medicines, and drugs for opioid substitution therapy) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Lorazepam Aurobindo together with opioids, the dose and duration of concomitant therapy must be limited by your doctor. Inform your doctor about all opioid medicines you are taking and follow the recommended dosage carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if such symptoms occur.
The effects of muscle relaxants and painkillers may be enhanced.
If lorazepam is used together with clozapine, marked sedation, excessive salivation, and impaired motor coordination may occur.
Concomitant administration of Lorazepam Aurobindo and valproic acid/sodium valproate may increase lorazepam blood levels. If valproic acid/sodium valproate is used concomitantly, the dose of Lorazepam Aurobindo should be reduced by approximately half.
Concomitant administration of Lorazepam Aurobindo and probenecid may accelerate the onset or prolong the effect of lorazepam. If used together with probenecid, the dose of Lorazepam Aurobindo should be halved.
The use of theophylline or aminophylline may reduce the sedative effect of Lorazepam Aurobindo.
Lorazepam Aurobindo with food, drinks, and alcohol
You should avoid drinking alcohol, as alcohol impairs and unpredictably increases the effects of Lorazepam Aurobindo.
Grapefruit juice and caffeine-containing beverages should be avoided, as they may affect how lorazepam works.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Lorazepam should not be taken during pregnancy. Your doctor will decide whether treatment should be discontinued.
If you take Lorazepam Aurobindo during the last stages of pregnancy or during labour, the baby may be less active than other babies, have lower muscle tone, low body temperature (hypothermia) and/or low blood pressure (hypotension), respiratory depression, apnoea, and feeding difficulties (“floppy infant syndrome”). If you take Lorazepam Aurobindo for a prolonged period during late pregnancy, the baby may also develop withdrawal symptoms after birth.
Breastfeeding
Since lorazepam passes into breast milk and may cause sedation and impaired sucking in the infant, you must not take Lorazepam Aurobindo during breastfeeding.
Driving and using machines
Even when used as directed, your reaction ability may be impaired, especially during the first days of treatment. In such cases, you may no longer be able to react quickly enough to unexpected or sudden events.
Do not drive a car or any other vehicle. Do not use dangerous electrical tools or machinery. Do not work without a secure support. In particular, remember that alcohol further impairs your reaction ability.
Your treating doctor will decide to what extent you may drive or perform other hazardous activities, taking into account your individual response and dosage.
Lorazepam Aurobindo contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Lorazepam Aurobindo

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dose and duration of treatment must be adjusted according to the individual response to therapy,
the therapeutic indication (i.e. the condition for which this medicine has been prescribed), and the
severity of the illness. As a general rule, the dose should be kept as low as possible and the duration of treatment as short as possible.
Dose
Please always follow the instructions for use, otherwise Lorazepam Aurobindo may not work properly.
The following information applies unless your doctor has prescribed Lorazepam Aurobindo differently:
Treatment of anxiety and sleep disturbances caused by anxiety:
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, especially in hospital settings, your doctor may
increase the daily dose up to a maximum of 7.5 mg of lorazepam, taking all necessary precautions.
If the main purpose is to treat sleep disturbances requiring therapy, the daily dose (0.5 to 2.5 mg of lorazepam)
can be taken as a single dose approximately half an hour before going to bed.
When used as a sleeping aid, take the tablet about half an hour before going to sleep; otherwise, it will
probably take longer to take effect and—depending on the duration of sleep—may cause more pronounced
side effects the following morning.
If taking the entire dose in the evening, it should not be taken with a full stomach.
Sedation before diagnostic procedures, as well as before surgical interventions:
For adults, 1 to 2.5 mg of lorazepam the evening before and/or 2 to 4 mg of lorazepam approximately 1 or 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 disorders, the total initial 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 according to the desired effect and tolerability in each individual case.
Use in patients with impaired renal function
Patients with kidney problems may need to take lower doses. The initial dose is usually half the normal recommended dose for adults. Your doctor will assess your response to the medicine and adjust the dose if necessary.
Use in patients with impaired hepatic function
Patients with mild to moderate liver problems may need to take lower doses. The initial dose is
usually half the normal recommended dose for adults.
Lorazepam is contraindicated in patients with severe hepatic insufficiency (see section 4.3).
Use in children and adolescents
Lorazepam Aurobindo must not be used for the treatment of anxiety or insomnia in children and adolescents under 18 years of age.
Children under 6 years of age:
Children under six years of age must not be treated with lorazepam.
Children aged 6 to 12 years:
Before diagnostic procedures or surgical interventions: the recommended dose is between 0.5 mg and 1 mg, depending on the child's weight (should not exceed 0.05 mg/kg body weight), to be taken at least one or two hours before the procedure.
Adolescents aged 13 to 18 years:
Before diagnostic procedures or surgical interventions: the recommended dose is between 1 mg and 4 mg, to be taken one or two hours before the procedure.
Method of administration
Lorazepam Aurobindo is for oral use.
Swallow the tablets whole with some liquid (e.g. 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 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 Aurobindo should be limited to single doses or a few days. For chronic conditions, the duration of use will depend on the progression of the disease. After two weeks of daily intake, your doctor must determine whether continued treatment with Lorazepam Aurobindo is still indicated, by gradually reducing the dose.
If you take more Lorazepam Aurobindo than you should
Inform your doctor immediately if you suspect an overdose has occurred after taking large quantities of this medicine. You must contact a doctor 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 more severe cases, loss of consciousness.
If you forget to take Lorazepam Aurobindo
If you forget to take a tablet, take it as usual at the next scheduled time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Lorazepam Aurobindo
If you stop treatment suddenly after prolonged use, withdrawal symptoms described in section 4 may occur. To avoid these symptoms, treatment should be discontinued by gradually reducing the dose.
It should be emphasized that, after prolonged use (more than 1 week) and in case of abrupt discontinuation of this medicine, sleep disturbances, anxiety and tension, inner restlessness, and agitation may temporarily return in an exaggerated form. Therefore, treatment must not be stopped abruptly, but rather discontinued gradually by tapering the dose.
If you have any further 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 everyone experiences them.
Side effects usually occur especially at the beginning of treatment, if the dose is too high, and in the patient groups mentioned in "Warnings and precautions" (see section 2).

Very common: may affect more than 1 in 10 people

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, feeling of fatigue (lassitude).

Uncommon: may affect up to 1 in 100 people

altered sexual drive, impotence, less intense orgasm
feeling unwell.

Rare: may affect up to 1 in 1,000 people

skin rash
reduced alertness
changes in salivation.

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

leucopenia.

Not known: frequency cannot be estimated from the available data

changes in blood cell counts (thrombocytopenia, agranulocytosis, pancytopenia)
prolonged reaction times
impaired motor coordination (extrapyramidal symptoms)
tremor
visual disturbances (double vision, blurred vision)
difficulty in articulation / slurred speech
headache
seizures / epileptic fits
memory lapses (amnesia)
disinhibition, euphoria
coma
suicidal thoughts/attempts
reduced attention/concentration
balance disorders
vertigo
paradoxical reactions such as anxiety, agitation, delirium, irritability, aggressive behaviour (hostility, aggressiveness, rage attacks), sleep disturbances/insomnia, sexual excitement, hallucinations, psychosis. If such reactions occur, treatment with Lorazepam Aurobindo must be discontinued
low blood pressure (hypotension), slight decrease in blood pressure
respiratory depression (severity dose-dependent), shortness of breath (apnea), worsening of nocturnal apnea (temporary cessation of breathing during sleep)
worsening of obstructive lung disease (airway constriction)
constipation
elevated 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 blood sodium levels (hyponatremia)
decrease in body temperature (hypothermia).

Benzodiazepines cause dose-dependent depression of the central nervous system.

Dependence/abuse
Even after a few days of daily treatment with Lorazepam Aurobindo, withdrawal symptoms (e.g. sleep disturbances, increased dreaming) may occur following discontinuation of therapy, especially if stopped abruptly. Anxiety, tension, as well as restlessness and inner agitation may reappear in an exaggerated form. Other symptoms reported after discontinuation of benzodiazepines include headache, depression, confusion, irritability, sweating, depressed mood (dysphoria), loss of reality, behavioural disturbances, numbness and tingling in limbs, hypersensitivity to light, noise and touch, altered perception, involuntary movements, nausea, vomiting, diarrhoea, loss of appetite, hallucinations/delirium, seizures/epileptic fits, tremor, abdominal cramps, muscle pain, agitation, palpitations, rapid pulse, panic attacks, dizziness, hyperactive reflexes, short-term memory loss and elevated body temperature. With chronic use of Lorazepam Aurobindo in patients with epilepsy or in those taking other medicines that lower the seizure threshold (e.g. antidepressants), abrupt discontinuation may trigger more frequent seizures. The risk of withdrawal phenomena increases with the duration of prior treatment and dose. Usually, these phenomena can be avoided by gradually reducing the dose.

There is evidence of tolerance development (increasing dose due to habituation) regarding the sedative effect of benzodiazepines.

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 resolve during continued treatment or when the dose is reduced. If side effects persist, inform your doctor, who will decide whether treatment should be discontinued. Immediately inform your doctor if you develop unexplained skin rash, discoloration or swelling of the skin.

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 Aurobindo

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 packaging after EXP. The
expiry date refers to the last day of that month.
Store below 30°C.
Keep the blisters in the outer packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Return unused medicines
to the pharmacist. This will help protect the environment.

6. Package contents and other information

What Lorazepam Aurobindo contains

The active substance is lorazepam. Each tablet contains 1 mg of lorazepam. Each tablet contains 2.5 mg of lorazepam.
The other components are: microcrystalline cellulose (Microcel 101 & 102), lactose monohydrate, potassium polacrilin, magnesium stearate.

Description of the appearance of Lorazepam Aurobindo and contents of the pack
Tablet.
Lorazepam Aurobindo 1 mg tablets
Uncoated, circular tablets, approximately 6.5 mm in diameter, with a flat surface, bevelled edges, white to off-white in colour, marked with 'L' and '1' separated by a breakline on one side and smooth on the other side.
The tablets can be divided into equal doses.
Lorazepam Aurobindo 2.5 mg tablets
Uncoated, circular tablets, approximately 9 mm in diameter, with a flat surface, bevelled edges, white to off-white in colour, marked with 'L' and '2.5' separated by a breakline on one side and smooth on the other side.
The tablets can be divided into equal doses.
Lorazepam Aurobindo tablets are available in packs of 20 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102 - 21047 Saronno (VA), Italy

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG3000, Malta
Generis Farmacêutica SA
Rua João de Deus, n. 19, Venda Nova, 2700-487 Amadora, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Lorazepam Aurobindo
Portugal: Lorazepam Ritisca