LORAZEPAM 1 mg Coated Tablet

Зміст інструкції

1. Lorazepam Aurobindo 1 mg tablets, 2.5 mg tablets
   1. What is Lorazepam Aurobindo and what is it used for
   2. What you need to know before taking Lorazepam Aurobindo
   3. How to take Lorazepam Aurobindo
   4. Possible side effects
   5. How to store Lorazepam Aurobindo
   6. Contents of the pack and other information

Lorazepam Aurobindo 1 mg tablets, 2.5 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Lorazepam Aurobindo tablets contain the active ingredient lorazepam, a sedative and
anxiolytic (tranquilizer) medicine. It belongs to the group of active substances called benzodiazepines.

What is it used for

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

2. What you need to know before taking Lorazepam Aurobindo

Do not take Lorazepam Aurobindo:

• 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, or have ever had, a dependence on drugs, alcohol or narcotics;
• if you have severe breathing problems, e.g. chronic obstructive bronchopneumonia;
• if you have abnormal muscle weakness (myasthenia gravis);
• if you have severe liver problems;
• if you suffer from breathing problems during sleep (sleep apnea syndrome);
• in case of acute poisoning with alcohol or depressants that affect the Central Nervous System (CNS) (e.g. sleeping pills or painkillers, medicines 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 Aurobindo if:

• you have problems controlling your movements (spinal or cerebellar ataxia);
• you suffer from breathing problems, e.g. chronic obstructive pulmonary disease;
• you have problems with your kidneys or liver;
• you suffer from an eye problem called glaucoma, e.g. high pressure inside the eye;
• you abuse or have abused drugs or alcohol in the past;
• you have a personality disorder; this may mean that you have a greater chance of becoming dependent on lorazepam;
• you have suffered from depression previously, because it may recur during treatment with lorazepam;
• you suffer from depression, as lorazepam may increase any feelings or suicidal ideas you may have;
• you are elderly, you may be more prone to falling;
• you have low blood pressure.

Children and adolescents
Lorazepam Aurobindo is not recommended for use in children and adolescents under the age of 18 years of
age, because there is no data on safety and efficacy in this population.

Other medicines and Lorazepam Aurobindo
Tell 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:

• remedies for cough or cold containing dextromethorphan, ephedrine or pseudoephedrine;
• medicines called selective serotonin reuptake inhibitors (SSRIs) usually used in the treatment of anxiety disorders and some personality disorders (e.g. fluoxetine or fluvoxamine);
• medicines called serotonin and 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;
• antibiotic of the fluoroquinolone category such as ciprofloxacin;
• medicines that act on the immune system such as methotrexate;
• medicines for the treatment of metastatic carcinoma such as topotecan;
• medicines for the treatment of pain and inflammatory states such as diclofenac;
• medicines for the treatment of type 2 diabetes such as gliburide, metformin;
• medicines for the treatment of viral infections such as acyclovir, ganciclovir.

Some patients have experienced suicidal thoughtswhile taking medicines containing
lorazepam, especially if they were already depressed. If you are depressed, have irrational fears and obsessions, have
started to develop thoughts of suicide or harm to yourself, tell your doctor immediately.
At the beginning of therapy, your doctor will monitor your individual response to this medicine, so
that a potential overdose can be detected as quickly as possible. If you are a child and
an elderly or debilitated patient, you may show a more sensitive response to the effect of Lorazepam
Aurobindo. Therapy should therefore be monitored more frequently.
If you suffer from kidney or liver dysfunction, with the presence of 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
elderly. You may be at greater risk of falls, especially when getting up at night.
Hepatic encephalopathy (brain disease due to liver damage) may occur with the use of lorazepam. Lorazepam therefore should not be used in patients with severely
impaired liver function and/or hepatic encephalopathy.
You may experience memory loss during treatment with lorazepam.
When used as a sleeping aid, you should make sure you have enough sleep time (about 7-8
hours). If you follow this recommendation, you can usually avoid side effects the next morning (e.g.
fatigue, impaired reaction ability).
Ask your doctor for more detailed instructions on how to proceed in everyday life, taking into
account your particular lifestyle (e.g. occupation).
There have been reports of unusual paradoxical reactions occurring with the use of benzodiazepines
such as anxiety, states of agitation, delusion, excitability, aggressive behaviour, sleep disturbances,
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.
Respiratory depression, potentially
fatal, can occur with the use of benzodiazepines, including lorazepam.
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 Aurobindo for the shortest possible time (see section 4).
If after a few weeks you notice that the medicine is not working as when you started treatment,
you should see your doctor.
Treatment with Lorazepam Aurobindo must be discontinued gradually to avoid withdrawal symptoms. See section 3 “If you stop taking Lorazepam Aurobindo”.
Severe allergic reactions have been reported with the use of benzodiazepines. Cases of
swelling of the skin and/or mucous membranes involving the tongue, larynx or vocal cord region
(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 (dyspnea), swelling of the throat or a feeling of unwellness.
Some patients have been treated in an emergency medical setting. If these symptoms occur, tell
your doctor immediately or go to hospital immediately. The airways may become blocked,
which may be life-threatening.

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 before
diagnostic procedures. For children under 6 years of age, Lorazepam Aurobindo is contraindicated. Further
information is available in section 3.

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

• Medicines for narcolepsy with cataplexy (e.g. sodium oxybate).
• Medicines for the treatment of HIV (e.g. zidovudine).
• Medicines for the treatment of delusions or hallucinations (e.g. chlorpromazine, loxapine or clozapine).
• Medicines useful for indigestion (e.g. antacids, cisapride or omeprazole).
• A medicine to treat nausea and vomiting induced by a chemotherapeutic agent called nabilone.
• Medicines for the treatment of 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 the treatment of 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 valproic acid/valproate).
• A medicine for gout called probenecid.
• Contraceptives containing estrogens.
• Medicines that affect liver enzymes (e.g. cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If Lorazepam Aurobindo is used at the same time as other medicines that depress the
central nervous system (e.g. psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers,
opioid painkillers, sedative antihistamines, antiepileptics), there may be some interactions,
causing additive depressive effects on the central nervous system.
The concomitant use of Lorazepam Aurobindo and opioids (e.g. strong painkillers, some medicines for
cough and drugs for substitution therapy) increases the risk of drowsiness, respiratory depression
(respiratory depression), coma and may be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not possible.
However, if your doctor prescribes Lorazepam Aurobindo together with opioids, the dose and duration
of concomitant therapy must be limited by the doctor. Tell your doctor about all opioid medicines you are taking and carefully follow the dosage recommended by your doctor. It may
be helpful to inform friends or relatives that you are aware of the signs and symptoms above. Contact
your doctor when these symptoms occur.
The effect of drugs to reduce muscle tension (muscle relaxants) and painkillers may be
increased.
If lorazepam is used at the same time as clozapine, marked sedation, excessive salivation and impaired coordination of movement may occur.
The administration of Lorazepam Aurobindo simultaneously with valproic acid/sodium valproate
may increase the levels of lorazepam in the blood. If valproic acid/sodium valproate is used at the same time, the dose of Lorazepam Aurobindo should be reduced by about half.
The administration of Lorazepam Aurobindo simultaneously with probenecid may accelerate the onset
of action or prolong the effect of lorazepam. If used simultaneously 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 increases the effects of Lorazepam Aurobindo
in an unpredictable way.
Grapefruit juice and beverages containing caffeine should be avoided as they may
affect the functioning of lorazepam.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, 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 period 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, apnea and
difficulty drinking (“floppy baby syndrome”). If you take Lorazepam Aurobindo for a prolonged
period in the late stages of pregnancy, the baby may also develop withdrawal symptoms after
birth.

Breastfeeding
Because lorazepam passes into breast milk and may cause sedation and inability to suck in the
baby, you should not take Lorazepam Aurobindo while breastfeeding.

Driving and using machines
Even when Lorazepam Aurobindo is used as directed, you should expect your reaction abilities to be impaired, especially during the first few days of treatment. In
this case, you will no longer be able to react quickly enough to unexpected and 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 foothold. In particular, remember that alcohol further impairs your ability to react.
The treating doctor will decide to what extent you will be able to drive or perform other dangerous activities, taking into
account the individual response and dosage.

Lorazepam Aurobindo contains lactose monohydrate
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Lorazepam Aurobindo

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.
The dose and duration of treatment must be adjusted to the individual response to therapy,
to the therapeutic indication (i.e. the condition for which this medicine has been prescribed) and to 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
Always follow the instructions for use, as Lorazepam Aurobindo may otherwise
not work correctly.
The following information applies unless Lorazepam Aurobindo has been prescribed
differently by your doctor:

Treatment of anxiety and sleep disorders caused by anxiety:
The daily dose for adults is generally from 0.5 to 2.5 mg of lorazepam, divided into 2 or 3 single doses
or in a single evening 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 consideration.
If the main purpose is to treat sleep disorders that require treatment, the daily dose (from
0.5 to 2.5 mg of lorazepam) can be taken as a single dose about half an hour before going to
sleep.
If used as a sleeping aid, you should 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 -
will likely cause more serious side effects the next morning.
If you take the entire dose in the evening, it should not be taken on 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 about 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 changes, the total initial 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, based on the desired effect and tolerability in each individual case.

Use in patients with impaired renal function
Patients with kidney problems may take lower doses. The initial dose is usually half
the normal recommended dose for adults. Your doctor will assess the reaction to the medicine and
adjust the dose if necessary.

Use in patients with impaired hepatic function
Patients with moderate to mild liver problems may take lower doses. The initial dose is
usually half the normal recommended dose for adults.
Lorazepam is contraindicated in patients with severe hepatic failure (see section 4.3).

Use in children and adolescents
Lorazepam Aurobindo should not be used for the treatment of anxiety or insomnia in children and
adolescents under 18 years of age.

Under 6 years of age:
Children under six years of age should not be treated with lorazepam.

Age between 6 and 12 years:
Before diagnostic procedures or before surgical interventions: the recommended dose is between 0.5
mg and 1 mg, depending on the child's weight (do not exceed 0.05 mg/kg of body weight), to be
taken at least one or two hours before the operation.

Age between 13 and 18 years:
Before diagnostic procedures or before surgical interventions: the recommended dose is between 1
mg and 4 mg, to be taken one or two hours before the operation.

Method of administration
Lorazepam Aurobindo is for oral use.
Swallow the tablets whole with some liquid (e.g. with half a glass or a glass of water).
The break 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 established by your doctor.
For acute illnesses, the use of Lorazepam Aurobindo should be limited to single doses or a few
days. For chronic illnesses, the duration of use will depend on the progression of the illness. After 2
weeks of daily intake, the doctor must establish with a gradual reduction of the dose whether the
treatment with Lorazepam Aurobindo is still indicated.

If you take more Lorazepam Aurobindo than you should
Immediately inform your doctor if you suspect that an intoxication has occurred after taking large quantities of this medicine. You must contact a doctor for first aid instructions,
which he must then apply. Do not induce vomiting unless expressly requested.
The signs of an overdose are: drowsiness, confusion, sleepiness, shallow breathing,
impaired coordination of movement, apathy and, in severe cases, loss of consciousness.

If you forget to take Lorazepam Aurobindo
If you forget to take a tablet, take it normally next time. Do not take a double
dose to make up for the missed dose.

If you stop taking Lorazepam Aurobindo
If you suddenly stop treatment after prolonged use, withdrawal symptoms mentioned in section 4 may occur.
To avoid these symptoms, treatment will be discontinued with a gradual reduction of the dose.
It should be emphasized that, after prolonged periods of use (more than 1 week) and in case of abrupt discontinuation of this drug, sleep disorders, states of anxiety and tension, inner restlessness and agitation may temporarily return in an exaggerated form. Therefore, treatment should not be
stopped abruptly, but rather discontinued with a gradual reduction of the dose.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Normally side effects are observed especially at the beginning of treatment, if the dose is too
high and in patient groups mentioned in “Warnings and precautions” (see paragraph 2).

Very common: may affect more than 1 in 10 people

• sedation, fatigue, drowsiness.

Common: may affect up to 1 in 10 patients treated

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

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

• leukopenia.

Not known: frequency cannot be estimated based on available data

• changes in blood count (thrombocytopenia, agranulocytosis, pancytopenia)
• prolonged reaction times
• altered movement coordination (extrapyramidal symptoms)
• tremor
• visual disturbances (double vision, blurred vision)
• difficulty in articulation/slurred speech
• headache
• convulsions/seizures
• memory lapses (amnesia)
• disinhibition, euphoria
• coma
• thoughts/suicidal attempts
• attenuated attention/concentration
• balance disorders
• vertigo
• paradoxical reactions such as anxiety, states of agitation, delirium, excitability, aggressive behavior (hostility, aggression, outbursts of anger), sleep disturbances/insomnia, sexual excitement, hallucinations, psychosis. If such reactions occur, treatment with Lorazepam Aurobindo must be stopped
• low blood pressure (hypotension), slight decrease in blood pressure
• respiratory depression (dose-dependent in severity), shortness of breath (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep)
• worsening of obstructive pulmonary disease (constriction of the airways)
• constipation
• elevated 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 blood sodium levels (hyponatremia)
• decreased body temperature (hypothermia).

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

Dependence/abuse
Even after a period of treatment of a few days with daily intake of Lorazepam
Aurobindo, withdrawal phenomena (e.g. sleep disturbances, increased dreams) may occur in
following discontinuation of therapy, especially in case of abrupt discontinuation. Anxiety, states of
tension, as well as agitation and inner restlessness can reappear in an exaggerated form. Other
symptoms reported after discontinuation of benzodiazepines include headache, depression,
confusion, irritability, sweating, depressed mood (dysphoria), loss of reality, behavioral
disorders, numbness and tingling in the limbs, hypersensitivity to light, noises and touch,
altered perception, involuntary movements, nausea, vomiting, diarrhea, loss of appetite,
hallucinations/delirium, convulsions/seizures, tremor, abdominal spasms, muscle pain, states of
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 those taking other medicines that lower the seizure threshold (e.g.
antidepressants), abrupt discontinuation can trigger more frequent seizures. The risk of withdrawal
phenomena increases with the duration of previous treatment and the dose. Usually these phenomena
can be avoided with a gradual reduction of the dose.
There is evidence of the development of tolerance (increased dose due to habituation) for
the sedative effect of benzodiazepines.
Lorazepam has an abuse potential. Patients with a history of drug and/or alcohol abuse are
particularly at risk.

What measures should be taken in case of side effects?
Many of the side effects mentioned subside during further treatment or when the dose
is reduced. If side effects persist, inform your doctor, who must decide whether to
interrupt the treatment. Immediately inform your doctor if you experience unexplained rash,
discoloration or swelling of the skin.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature below 30°C.
Keep the blisters in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Return any unused medicines to the
pharmacist. This will help protect the environment.

6. Contents of the pack and other information

What Lorazepam Aurobindo contains

• The active ingredient is lorazepam. Each tablet contains 1 mg of lorazepam. Each tablet contains 2.5 mg of lorazepam.
• The other ingredients are: Microcrystalline cellulose (Microcel 101 & 102), lactose monohydrate, potassium polyacrilin, magnesium stearate.

Description of the appearance of Lorazepam Aurobindo and contents of the pack
Tablet.

Lorazepam Aurobindo 1 mg tablets
Uncoated tablets, circular, approximately 6.5 mm, with a flat surface, bevelled edges, white-whitish in colour, imprinted with ‘L’ and ‘1’ separated by a fracture line on one side and smooth on the other side.
The tablets can be divided into equal doses.

Lorazepam Aurobindo 2.5 mg tablets
Uncoated tablets, circular, approximately 9 mm, with a flat surface, bevelled edges, white-
whitish in colour, imprinted with ‘L’ and ‘2.5’ separated by a fracture line on one side and smooth on the other side. The
tablets can be divided into equal doses.
Lorazepam Aurobindo tablets is available in packs of 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Lorazepam Aurobindo
Portugal: Lorazepam Ritisca